www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address; COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`16/402,253
`
`05/03/2019
`
`Chia-Li Wei
`
`3236-EV-US
`
`6040
`
`HannahM.Tien mayenl
`
`Hannah M. Tien
`2F., No.26, Sec. 3, Heping E. Rd., Da"an Dist.
`Taipei City, 106
`
`PAPCIAK, SHARON M
`
`
`
`1651
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`05/11/2021
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`htien9777 @ yahoo.com
`patent0 1092015 @ gmail.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Application No.
`Applicant(s)
`16/402,253
`Wei etal.
`
`Office Action Summary Art Unit|AIA (FITF) StatusExaminer
`SHARON M PAPCIAK
`1651
`Yes
`
`
`
`-- The MAILING DATEofthis communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133}.
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`
`
`1) Responsive to communication(s) filed on 05 February 2021.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`2a)¥) This action is FINAL.
`2b) (J This action is non-final.
`3)02 An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4\0) Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`10-15 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) ___ is/are withdrawn from consideration.
`C] Claim(s)__ is/are allowed.
`Claim(s) 10-15 is/are rejected.
`(1 Claim(s)__is/are objectedto.
`C} Claim(s)
`are subjectto restriction and/or election requirement
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) ) ) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)0) The drawing(s) filedon__ is/are: a)(J accepted or b)() objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)1) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)Z None ofthe:
`b)() Some**
`a)C All
`1.2 Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No.
`3.1.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) ([] Notice of References Cited (PTO-892)
`
`2) (J Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3) (J Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`4)
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20210426
`
`

`

`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 2
`
`Notice of Pre-AlA or AIA Status
`
`The present application, filed on or after March 16, 2013, is being examined
`
`under the first inventor to file provisions of the AIA.
`
`DETAILED ACTION
`
`Action Is Final, Necessitated by Amendment
`
`Applicants’ response to the Non-Final Office Action mailed 07 October 2020, has
`
`been entered and the Remarkstherein, filed 05 February 2021, are fully considered
`
`here.
`
`This action is a Final Office Action, based on new grounds under 35 U.S.C. §103
`
`over Entani et al., Huynh et al., and Devi et al., necessitated by Applicants’ anendment
`
`received 05 February 2021, specifically, canceled claims 1-9 and new claims 13-15.
`
`See MPEP 706.07(a). Applicant is reminded of the extension of time policy as set forth
`
`in 37 CFR 1.136(a).
`
`It is noted that Applicant filed a Response to Election/Restriction document (Doc
`
`Code: ELC) on 05 February 2021. However, the Office did not mail a Requirement for
`
`Election/Restriction Office Action to Applicant. Therefore, the documenttypeis
`
`assumedto be incorrect, especially in view of the fact that the content of said document
`
`is not related to an Election/Restriction.
`
`Status of Claims
`
`Claims 10-15 are pending.
`
`Claims 10-15 are rejected.
`
`

`

`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 3
`
`Claim Rejections - 35 U.S.C. § 112
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
`
`INGENERAL.—The specification shall contain a written description of the invention, and of
`(a)
`the manner and process of making and using it,
`in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with whichit is most nearly connected,
`to make and use the same, and shall set forth the best mode contemplated by the inventor or
`joint inventor of carrying out the invention.
`
`The following is a quotation of the first paragraph of pre-AlA 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the manner
`and process of making and using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with whichit is most nearly
`connected, to make and use the same, and shall set forth the best mode contemplated
`by the inventor of carrying out his invention.
`
`Claims 10-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA),
`
`first paragraph, as failing to comply with the enablement requirement. The claims
`
`contain subject matter which was not describedin the specification in such a way asto
`
`enable one skilled in the art to which it pertains, or with whichit is most nearly
`
`connected, to make and/or use the invention.
`
`The invention employs the specific strain of Lactobacillus acetotolerans LES. It is
`
`not clearif the written description is sufficiently repeatable to avoid the need for a
`
`deposit. Further it is unclearif the starting materials were readily available to the public
`
`at the time of invention.
`
`It appears that a deposit was made in this application as filed, as noted on pp. 9
`
`thru 10, para. [0018] of the clean copy specification filed 18 February 2020. However,it
`
`does not appearthat the deposit meetsall of the criteria set forth in 37 CFR 1.801-
`
`

`

`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 4
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`1.809. Applicant or applicant's representative may provide assurance of compliance
`
`with the requirements of 35 U.S.C § 112(a) or 35 U.S.C. §112 (pre-AlA), first paragraph,
`
`in the following manner.
`
`SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
`
`A declaration by applicant, assignee, or applicant's agent identifying a deposit of
`
`biological material and averring the following may be sufficient to overcome an objection
`
`and rejection based ona lackof availability of biological material.
`
`1. Identifies declarant.
`
`2. States that a deposit of the material has been madein a depository
`
`affording permanenceof the deposit and ready accessibility thereto by the
`
`public if a patent is granted. The depository is to be identified by name and
`
`address.
`
`3. States that the deposited material has been accorded a specific (recited)
`
`accession number.
`
`4. States thatall restriction on the availability to the public of the material
`
`so deposited will be irrevocably removed upon the granting of a patent.
`
`5. States that the material has been deposited under conditions that access
`
`to the material will be available during the pendencyof the patent
`
`application to one determined by the Commissionerto be entitled thereto
`
`under 37 CFR 1.14 and 35 U.S.C § 122.
`
`

`

`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 5
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`6. States that the deposited material will be maintained with all the care
`
`necessary to keep it viable and uncontaminated for a period of at least five years
`
`after the most recent request for the furnishing of a sample of the deposited
`
`microorganism, and in any case, for a period of at least thirty (80) years after the
`
`date of deposit for the enforceable life of the patent, whichever period is longer.
`
`7. That he/she declares further that all statements made therein of his/her own
`
`knowledge are true and that all statements made on information and belief are
`
`believed to be true, and further that these statements were made with knowledge
`
`that willful false statements and the like so made are punishable byfine or
`
`imprisonment, or both, under section 1001 of Title 18 of the United States Code
`
`and that such willful false statements may jeopardize the validity of the instant
`
`patent application or any patent issuing thereon.
`
`Alternatively, it may be averred that deposited material has been accepted for
`
`deposit under the Budapest Treaty on the International Recognition of the Deposit of
`
`Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and
`
`that all restrictions on the availability to the public of the material so deposited will be
`
`irrevocably removed upon the granting of a patent.
`
`It is noted that both Budapest Treaty and non-Budapest Treaty deposits must
`
`provide assurances that:
`
`(1) Access to deposited material will be available, during pendency of a patent
`
`application making referencetoit, to anyone determined by the Director to be entitled to
`
`

`

`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 6
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`access under 37 CFR 1.14 and 35 U.S.C. 122 (see In re Lundak, 227 USPQ 90, 94-95
`
`(Fed. Cir. 1985)(citing 35 U.S.C. 114)); and
`
`(2) Subject to paragraph (b) of 37 CFR 1.808, all restrictions imposed by the
`
`depositor on the availability to the public of the deposited material will be irrevocably
`
`removed upon the granting of the patent.
`
`Additionally, the deposit must be referred to in the bodyof the specification and
`
`be identified by deposit (accession) number, date of deposit, name and addressof the
`
`depository and the complete taxonomic description.
`
`It is noted that Applicants have filed an amendmentto the specification on 05
`
`February 2021 in which para. [0086] now recites the deposit (accession) number, date
`
`of deposit, name and address of the depository and the complete taxonomic
`
`description, and that the deposit has been made under the Budapest Treaty. However,
`
`although Applicant states in their Remarksfiled 05 February 2021 (pg. 7) that “The
`
`deposit was made for a term ofat least thirty (80) years and at least five (5) years after
`
`the most recent request for the furnishing of a sample of the deposit was received by
`
`the depository’, this statement does not contain the necessary language, as stipulated
`
`above, with regard to the deposit’s relationship to a pending or awarded patent.
`
`Therefore, Applicant has failed to comply with the directive for a Biological
`
`Deposit, as stipulated in the bold numbered entries above.
`
`Claim Rejections - 35 USC § 101
`
`The rejection of Claims 1-12 under 35 U.S.C. §101 because the claimed
`
`

`

`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 7
`
`invention is directed to non-statutory subject matter, because the claims do notrecite
`
`something significantly different from a judicial exception nor provide additional
`
`elements that integrate the judicial exception into a practical application, in the Non-
`
`Final Office Action mailed 07 October 2020, is withdrawnin view of Applicant’s
`
`amendment and argument filed 05 February 2021.
`
`Applicant canceled claims 1-9 and, as a result, the examined claims are 10-15,
`
`which describe a food composition, which, in turn, comprises the acid-resistant lactic
`
`acid bacterial strain of Lactobacillus acetotolerans LE36 and an acidic fermentation
`
`juice. Applicant remarks that the food composition shows markedly different
`
`characteristics/functions from naturally occurring products (Remarks, pg. 4). Applicant
`
`remarks that the viable number of L. acetotolerans LE36 bacteria were maintained
`
`and/or increased in two types of fermentation juice having a pH value of 3 to 4 overa 14
`
`day period. In contrast, the viable number of reference strain (La) L. acetotolerans
`
`bacteria (to which LE36 was compared) decreased over time under identical culturing
`
`conditions, such that a decreased number or no viable bacteria were recovered after 14
`
`days in either of the two fermentation juice types (Remarks, pg. 5 and Fig. 3B).
`
`Therefore, claimed strain L. acetotolerans LE36 showssignificantly different
`
`characteristics from the standard L. acetotolerans referencestrain, its naturally
`
`occurring counterpart (i.e., Step 2B: YES).
`
`Claim Rejections - 35 USC § 103
`
`In the event the determination of the status of the application as subject to AIA 35
`
`U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103)is incorrect, any
`
`

`

`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 8
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`correction of the statutory basis for the rejection will not be considered a new ground of
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`rejection if the prior art relied upon, and the rationale supporting the rejection, would be
`
`the same under either status.
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all
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`obviousnessrejections setforth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that the
`
`claimed invention is not identically disclosed as set forth in section 102, if the
`
`differences between the claimed invention and the prior art are such that the claimed
`
`invention as a whole would have been obvious before the effective filing date of the
`
`claimed invention to a person having ordinary skill in the art to which the claimed
`
`invention pertains. Patentability shall not be negated by the manner in which the
`
`invention was made.
`
`The factual inquiries for establishing a background for determining obviousness
`
`under 35 U.S.C. 103 are summarized asfollows:
`
`1. Determining the scope and contents of the prior art.
`
`2. Ascertaining the differences between the prior art and the claims at issue.
`
`3. Resolving the level of ordinary skill in the pertinent art.
`
`4. Considering objective evidence presentin the application indicating
`
`obviousness or nonobviousness.
`
`This application currently names joint inventors. In considering patentability of the
`
`claims the examiner presumes that the subject matter of the various claims was
`
`commonly ownedasof the effective filing date of the claimed invention(s) absent any
`
`

`

`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 9
`
`evidenceto the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to
`
`point out the inventor and effective filing dates of each claim that was not commonly
`
`ownedas ofthe effectivefiling date of the later invention in order for the examiner to
`
`consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2)
`
`prior art against the later invention.
`
`Claims 10 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable
`
`over Entani et a/ (Entani, E. et al. 1986. Lactobacillus acetotolerans, a New
`
`Species Fermented from Vinegar Broth. International Journal of Systematic
`
`Bacteriology. 36(4): 544-549), Huynh et a/ (Huynh, V. T. et a/. 2014. Improved
`
`release and metabolism of flavonoids by steered fermentation processes: a
`
`review. Int J Mol Sci. 15: 19369-19388.), and Devi et a/ (Devi, S. M. et a/. 2018. In
`
`vitro anti-inflammatory activity among probiotic Lactobacillus species isolated
`
`from fermented foods. Journal of Functional Foods. 47: 19-27.).
`
`Regarding claim 10, Entani et a/ teaches fermented rice vinegar comprising
`
`Lactobacillus acetotolerans as the source of the bacteria. One of skill in the art would
`
`understand that fermented rice broth vinegar, also referred to as acetic acid, is acidic.
`
`Additionally, one of skill in the art would recognize that rice vinegar is a food
`
`composition.
`
`Entani et a/ teaches the isolation of Lactobacillus acetotolerans bacteria from
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`fermented rice vinegar broth (abstract; page 544, col. 1, section: “Materials and
`
`Methods: Bacterial strains”). Entani et a/ teaches that the Lactobacillus acetotolerans
`
`

`

`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 10
`
`isolated are Gram positive, can grow at a pH range of 3.3-6.6, and are resistant to
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`acetic acid concentrations of 4 to 5% and 9 to 11% at a pH of 3 and 5, respectively
`
`(page 547, col. 2, section: “Description of Lactobacillus acetotolerans sp. nov.”). The
`
`Lactobacillus acetotolerans of Entani et a/ also has the ability to produce acid from D-
`
`fructose, D-glucose, D-mannose, trehalose, esculin, and salicin (page 548, 1°full
`
`paragraph).
`
`Regarding claim 13, which recites the property of the claimed Lactobacillus
`
`having an acid resistance ranging from pH 3 to pH 4,
`
`the Lactobacillus acetotolerans
`
`bacteria taught by Entani et a/ are resistant to acetic acid between a pH of 3 to 5.
`
`Additionally, the Lactobacillus acetotolerans bacteria taught by Entani et a/ grow at a pH
`
`between 3.3 and 6.6. In the case where the claimed ranges "overlap or lie inside ranges
`
`disclosed by the prior art" a prima facie case of obviousnessexists. In re Wertheim, 541
`
`F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d
`
`1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-
`
`66 (Fed. Cir. 1997) See MPEP 2144.05.
`
`The Lactobacillus acetotolerans bacteria taught by Entani et a/ are similar to the
`
`instantly claimed Lactobacillus acetotolerans strain LES6 in claim 10.
`
`Whatdifferentiates the teachings of Entani et a/ from the instantly claimed
`
`Lactobacillus acetotolerans and composition comprising said bacteria is the strain and
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`accession number; Entani et a/ does not teach Lactobacillus acetotolerans strain LE36
`
`deposited under DSMZ Accession No. DSM 33168.
`
`

`

`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 11
`
`The USPTOis not equipped to perform experiments to ascertain whether
`
`applicants’ strain differs from the strains of Entani et a/. Both bacteria were isolated from
`
`fermented liquid, albeit the claimed strain was obtained from fermented vegetable and
`
`fruit broth in contrast to Entani et as strains being isolated from fermented rice vinegar.
`
`Additionally, the claimed strain has shared properties with the Lactobacillus
`
`acetotolerans of the prior art. Shared properties include a positive Gram-stain, acid
`
`resistance at a pH range of 3-5, and the ability to metabolize D-fructose, D-glucose, D-
`
`mannose, and trehalose. Because of the shared properties and having the same
`
`species classification, the prior art strains demonstrate a reasonable probability that the
`
`bacteria taught by Entani et a/ may be identical to the strain being claimed. Hence, the
`
`burden of establishing novelty by objective evidenceis shifted to applicants. It should be
`
`noted that merely because a characteristic of a knownstrain is not disclosed ina
`
`reference does not make the knownstrains patentable. The knownstrains possess
`
`inherent characteristics which might not be displayed in the tests used the prior art.
`
`However, the disclosed strains may be the same strain being claimed. Clear evidence
`
`that the strains of the cited prior art do not possessa critical characteristic that is
`
`possessedbythe claimed strain, would advance prosecution.
`
`Furthermore, given the shared characteristics between the Lactobacillus
`
`acetotolerans strain of the prior art and the instantly claimed strain, one of skill in the art
`
`would have been apprised a reasonable level of success in obtaining the features of the
`
`instantly claimed composition by using the strain taught by Entani et al. From the
`
`teachings of the reference, it is apparent that one of ordinary skill in the art would have
`
`had a reasonable expectation of successin producing the claimed invention. Therefore,
`
`

`

`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 12
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`the invention as a whole was prima facie obvious to one of ordinary skill in the before
`
`the effective filing date of the claimed invention, as evidenced bythe references,
`
`especially in the absence of evidence to the contrary.
`
`Entani et a/ does not teachthe ability of L. acetotoleransto facilitate flavonoid
`
`production, as recited in claim 14, and have anti-inflammatory functions, as recited in
`
`claim 15. It is noted that these would be considered a property of the claimed
`
`Lactobacillus.
`
`\t would be obvious that the claimed Lactobacillus would have these
`
`properties due to the teachings of Huynh and Devi.
`
`Huynh et a/ teaches that phenolic compounds(e.g. flavonoids) are secondary
`
`metabolites producedin plants (page 19370, paragraph 1). Huynh ef a/ further teaches
`
`the use of bacterial fermentation processes to enhance the release of bound phenolic
`
`compounds from cell walls (page 19370, paragraph 3). Food-derived lactic acid bacteria
`
`have been evaluated for their potential to help release flavonoids from plant sources
`
`(page 19373, paragraph 2). Huynh et a/teaches the effect of various Lactobacilli in
`
`aiding the release of phenolic compounds including flavonoids from plants including
`
`beans, grains, and apples (page 19372, Table 1; page 19373, paragraph 2).
`
`Though claim 14 recites a property of L. acetotolerans having a function of aiding
`
`in flavonoid production, Huynh et a/ teaches that this is a common property of lactic acid
`
`bacteria, particularly Lactobacilli. Huynh et a/ specifically provides examples of
`
`Lactobacilli that have been demonstrated to aid in the release of flavonoids from plants,
`
`namely vegetables, fruits, and grains. Because the teachings of Huynh et a/
`
`demonstrates that aiding in flavonoid production is a feature of many Lactobacill, it
`
`

`

`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 13
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`would be obvious for the claimed L. acetotolerans to exhibit the same properties given
`
`that it is a lactic acid bacteria belonging to the Lactobacillus genus.
`
`The teachings of Huynh et a/ addresses the property of flavonoid production, as
`
`recited in claim 14.
`
`Devi et al teaches that probiotic bacteria have the ability to treat inflammatory
`
`diseases via their modulation of the immune response (abstract). In particular, various
`
`Lactobacillus bacteria isolated from fermented foods weretested for their anti-
`
`inflammatory properties (page 20, col. 1, section: “2. Materials & Methods- 2.1 Bacterial
`
`isolates and culture conditions”) and demonstrated the ability to downregulate pro-
`
`inflammatory cytokines and upregulate anti-inflammatory cytokines (abstract). Devi et al
`
`concludedthat probiotic Lactobacillus from vegetable sources have potent anti-
`
`inflammatory activities (page 26, col. 1, section: “Conclusion”, lines 1-2).
`
`Though claim 15 recites a property of L. acetotolerans having a function of anti-
`
`inflammatory properties, Devi et a/ teaches that this is also a common property of lactic
`
`acid bacteria, particularly Lactobacilli. Devi et al teaches that probiotic Lactobacilli
`
`isolated from fermented food sources have anti-inflammatory properties. Devi ef a/
`
`further emphasizes that, in particular, Lactobacillus bacteria originating from fermented
`
`vegetable sources have potent anti-inflammatory functions. Given that the claimed L.
`
`acetotolerans bacteria is a lactic acid Lactobacilli isolated from a fermented vegetable
`
`juice, it would be obvious for one of skill in the art to expect the claimed strain to
`
`perform the same functions as other Lactobacilli isolated from fermented vegetables
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`that have been identified to have anti-inflammatory properties, as taught by Devi et al.
`
`

`

`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 14
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`The teachings of Devi et a/ addresses the property of anti-inflammatory function,
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`as recited in claim 15.
`
`Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Entani
`
`et al, Huynh et al, and Devi et a/ as applied to claims 10 and 13-15 above, and
`
`further in view of Swain et a/ (Swain, M. R. et al. 2014. Fermented Fruits and
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`Vegetables of Asia: A Potential Source of Probiotics. Biotechnology Research
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`International.)
`
`The teachings of Entani et a/, Huynh eft a/, and Devi et a/ are discussed above.
`
`Entani et a/, Huynh et a/, and Devi et a/ does not teach a Lactobacillus
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`acetotolerans strain LE36 composition comprising fermented fruit and vegetable juices.
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`Swain et al teaches that fermented fruit and vegetable products have a long
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`history in human nutrition and can be used as a potential source of probiotics due to the
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`number of lactic acid bacteria that they harbor (abstract). The consumption of fermented
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`fruits and vegetables helps to enhance humannutrition in several ways such as the
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`attainment of balanced nutrition, providing vitamins, minerals, and carbohydrates, and
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`preventing several diseases such as diarrhea and cirrhosis ofliver due to probiotic
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`properties (page 6, col. 1, paragraph 2). Swain ef a/ further teaches that the acidic
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`nature of fruits and vegetables provides a conducible medium for fermentation by lactic
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`acid bacteria, like Lactobacilli (page 2, col. 1, paragraph 1).
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`The teachings of Swain et a/ correspond to the instantly claimed fermentedfruit
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`and vegetable juice recited in claim 11.
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`

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`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 15
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`It would have been obvious to one of skill in the art to combine the teachings of
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`Entani et a/ and Swain et a/ to provide a fermented vegetable and juice composition
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`comprising Lactobacillus acetotolerans. Entani et al teaches that Lactobacillus
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`acetotoleransis a lactic acid bacteria that grows under acidic conditions. Swain et a/
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`teaches that fermented fruit and vegetable products are knownto harbor lactic acid
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`bacteria and additionally teaches that the acidic nature of fruits and vegetables provides
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`a conducive medium for lactic acid bacteria to conduct fermentation. One of skill in the
`
`art would have been motivated to provide Lactobacillus acetotolerans in a fermented
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`fruit and vegetable juice composition given thatit is a hospitable environment for lactic
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`acid bacteria like Lactobacilli. Additionally, one of skill in the art would have been further
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`motivated to do so given the identified health benefits of fermented vegetable and fruit
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`juices for providing nutrients and preventing diseases, as also taught by Swain efal.
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`Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Entani
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`et al, Huynh et al, and Devi et a/ as applied to claims 10 and 13-15 above, and
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`further in view of Chen et a/ (Chen, C. L. et a/. 2014. Anti-Inflammatory Effects of
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`81 Chinese Herb Extracts and Their Correlation with the Characteristics of
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`Traditional Chinese Medicine. Evidence-Based Complementary andAlternative
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`Medicine.).
`
`The teachings of Entani et a/, Huynh ef a/, and Devi et a/ are discussed above.
`
`Entani et a/, Huynh ef a/, and Devi et a/ do not teach a Lactobacillus
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`acetotolerans strain LE36 composition comprising Chinese herbal medicine or an
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`extract thereof.
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`

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`Application/Control Number: 16/402,253
`Art Unit: 1651
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`Page 16
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`Chen et a/ teaches that extracts from numerous traditional Chinese herbs
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`inhibited nitrogen oxide production; the inhibition of nitrogen oxide is sought after for
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`anti-inflammatory effects (abstract). Chinese herbs are the rich sourcesfor anti-
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`inflammatory agents and efforts have been made to identify effective components in
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`these herbs (page 6, col. 1, section: “Discussion”, paragraph 2). Chen ef a/ analyzed the
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`correlation between the herbs’ anti-inflammatory activities and their Traditional Chinese
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`Medicine characteristics to determine that those herbs with the most pungentflavor
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`have the mostpotent anti-inflammatory effects (abstract; page 7, col. 1, paragraph 2).
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`It would have been obvious to one ofskill in the art to use the teachings of Chen
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`et alto include Chinese herbal extracts in the modified composition of Entani et a/ and
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`Devi et al. Devi et al teaches that lactic acid bacteria, particularly Lactobacillus from
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`fermented products, have potent anti-inflammatory activities and can be usedto treat
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`inflammatory diseases. Entani et a/ teaches the isolation of L. acetotolerans from
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`fermented rice vinegar. It would be obvious to one ofskill in the art to also include
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`Chinese herbal extracts for their demonstrated anti-inflammatory properties. One of skill
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`in the art would be motivated to do so in order to produce a composition that has potent
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`anti-inflammatory activities by combining to components knownfor their anti-
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`inflammatory abilities (i.e. L. acetotolerans and Chinese herbal medicine extracts).
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`Responseto Arguments
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`Applicant’s arguments, pp. 7-10, filed 05 February 2021, with respect to the 35
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`U.S.C. §112(a) rejection, and the prior art references cited in the 35 U.S.C. §103
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`rejections, have been fully considered, but they are not persuasive.
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`

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`Application/Control Number: 16/402,253
`Art Unit: 1651
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`Page 17
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`Applicant remarks (pp. 6-10), with regard to the 112(a) rejection, that Applicant
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`hereby amends paragraph [0086] to include the date of the deposit, a description of the
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`deposited microorganism, and the name and address of the depository. The deposit
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`was made for a term of at least thirty (80) years and at least five (5) years after the most
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`recent requestfor the furnishing of a sample of the deposit was received by the
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`depository. Thus, the requirements of 37 CFR 1.806 and 1.809 (d) and (e) have been
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`satisfied.
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`However, in response to Applicant, first of all, Applicant argues against a 35 USC
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`§112(b) rejection instead of a 35 USC §112(a) rejection, although it is clear that
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`Applicant is responding to the 35 USC §112(a) rejection. However, the 112(a)
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`enablement rejection is maintained (see 112(a) rejection above).
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`Applicant remarks (pp. 7-9), with regard to the 103 rejections, that Entani et al
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`teaches the isolation of Lactobacillus acetotolerans bacteria from fermented rice vinegar
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`broth, which are Gram positive, can grow at a pH range of 3.3-6.6, and are resistant to
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`acetic acid concentrations of 4 to 5% and 9 to 11 % ata pH of 3 and 5, respectively.
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`The Lactobacillus acetotolerans bacteria isolated from fermented rice vinegar broth are
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`Lactobacillus acetotolerans sp. nov., NBI 3014 (=JCM 3825) disclosed by Entani etal,
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`whichis identical to L. acetotolerans BCRC 17709T disclosed by the present invention
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`(See paragraph [0085]-[0089] of the Specification as originally filed). According to the
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`information at the BCRC website, BCRC 17709! bacteria is originated from Entani, i.e.,
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`NBI 3014 disclosed by Entani et al. Based on the "RESULTS"section of Entani et al
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`(page 545, right column, lines 5-7), the Office finds that the Lactobacillus acetotolerans
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`

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`Application/Control Number: 16/402,253
`Art Unit: 1651
`
`Page 18
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`bacteria isolated from rice vinegar broth can grow from pH 3.3 to 6.6.
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`Applicant respectfully disagrees and submits that under the "MATERIALS AND
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`METHODS"section of Entani et al, almost all experiments were conducted at pH 5.0 or
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`5.5. Further, according to Table 1, NBI 3014 were able to grow at pH 3.3 and the
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`tolerance of acetic acid was 10% at pH 5.0 and 4% at pH 3.5. Unlike Entani etal,
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`quantitative experiments were conducted by the present invention, which showedthat
`
`the claimed LES6 bacteria are markedly different from the NBI 3014 disclosed in Enta