www.uspto.gov
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address; COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`15/986,951
`
`05/23/2018
`
`Hirokazu KIMIYA
`
`ISHII-59229
`
`5760
`
`PEARNE & GORDON LLP
`1801 EAST OTH STREET
`SUITE1200
`
`CLEVELAND, OH 44114-3108
`
`BECKHARDT, LYNDSEY MARIE
`
`1613
`
`01/22/2019
`
`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):
`
`patdocket@ pearne.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Office Action Summary
`
`Application No.
`15/986 ,951
`Examiner
`LYNDSEY M BECKHARDT
`
`Applicant(s)
`KIMIYA, Hirokazu
`Art Unit
`AIA Status
`1613
`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 05/23/2018.
`C) A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2a)(] This action is FINAL. 2b))This action is non-final.
`3)() An election was made bythe applicant in responseto a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
`4) Since this application is in condition for allowance except for formal matters, prosecution as to the meritsis
`closed in accordance with the practice under Exparfe Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`6 7
`
`Disposition of Claims*
`1-10 is/are pending in the application.
`5)
`Claim(s)
`5a) Of the above claim(s)__ is/are withdrawn from consideration.
`C] Claim(s} _is/are allowed.
`Claim(s) 1-10 is/are rejected.
`8) ( Claim(s)__ is/are objected to.
`9)
`(4 Claim(s)
`are subject to 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) The drawing(s) filed on __is/are: a). 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)() Acknowledgmentis made ofa claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`c)1) None of the:
`b)( Some**
`a)Q All
`1.1) 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)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3) (J Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(7) Other:
`
`4)
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20190115
`
`

`

`Application/Control Number: 15/986,951
`Art Unit: 1613
`
`Page 2
`
`DETAILED ACTION
`
`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.
`
`Claims 1-10 are currently pending and under examination.
`
`Election/Restrictions
`
`Applicant’s election without traverse of rayon, collagen peptide, hyaluronic acid
`
`salt and water soluble in the reply filed on 11/14/2018 is acknowledged.
`
`No claims are withdrawn as a result of the species election.
`
`Priority
`
`The instant application claims foreign priority to Japan application JP2017-
`
`117994, filed 06/15/2017.
`
`Information Disclosure Statement
`
`Applicant’s Informational Disclosure Statement, filed on 05/23/2018 has been
`
`considered. Please refer to Applicant's copy of the 1449 submitted herein.
`
`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
`
`correction of the statutory basis for the rejection will not be considered a new ground of
`
`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
`
`obviousnessrejections setforth in this Office action:
`
`

`

`Application/Control Number: 15/986,951
`Art Unit: 1613
`
`Page 3
`
`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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148
`
`USPQ 459 (1966), that are applied 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.
`
`Claims 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over
`
`JP 09-238738 in view of JP 2014-129314 (Applicant provided) and US 4,196,245.
`
`Regarding claims 1 and 7, the limitation of a stacked body comprising a fiber
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`substrate layer that contains first fibers and an assembly that is stacked on the fiber
`
`substrate layer, wherein the assembly includes a water soluble first component as a
`
`main component and a second component that is capable of forming a hydrogel the
`
`‘738 publication teaches a cosmetic sheet used for moisturization of people’s skin
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`[0001]. The moisturization cosmetic sheet supports a moisturizer to a fibrous sheet.
`
`The moisturizer which was chosen from hyaluronic acid, soluble collagen [0005]. The
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`cosmetic sheet is a nonwoven fabric such as a fibrous sheet, wherein the fibers are
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`rayon [0008]. Soluble collagen and hyaluronic acid are widely used moisturizers for
`
`cosmetics [0009].
`
`

`

`Application/Control Number: 15/986,951
`Art Unit: 1613
`
`Page 4
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`Regarding claim 8, the limitation of wherein the first component is any of
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`collagens is met by the ‘738 publication teaching collagen [0009].
`
`The ‘738 publication does not specifically teach a fiber assembly layer, wherein
`
`the fiber assembly includes a second fiber that contains a water soluble first component
`
`as a main component and particulates that contain a second component that is capable
`
`of forming a hydrogel, in a case where the second fiber contain the second component
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`mass proportion of the second component containedin the particulates is greater than a
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`mass proportion of the second component containedin the second fibers (claim 1).
`
`The ‘738 publication does not specifically teach an averagefiber diameter D1 of
`
`the first fibers and an average fiber diameter D2 of the second fiber satisfy the
`
`relationship D1 is greater than D2 (claim 1).
`
`The ‘738 publication does not specifically teach wherein the average fiber
`
`diameter D2 of the second fibers and an average particle size D2 that satisfy the
`
`relationship D2 less than D3 (claim 2), wherein D1 is less than D3 (claim 3).
`
`The ‘738 publication teaches wherein at least a portion of the particulates are
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`supported by the second fibers, wherein the second fibers are 500 nm or less (claims 4-
`
`5).
`
`The ‘738 publication does not specifically teach wherein the average particle size
`
`D3 of the particulates is 0.2 um or more (claim 6).
`
`The ‘314 application teaches a sheetlike material formed from nanofibers and
`
`capsule that include a substance. The nanocapsule is capable of being in the nanofiber
`
`or may exist on the outside (abstract). The ‘314 publication teaches the sheet material
`
`

`

`Application/Control Number: 15/986,951
`Art Unit: 1613
`
`Page 5
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`being formed of collagen and the capsule is formed with hyaluronic acid (claims 5-6).
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`The capsule is taught to be formed byelectro field spinning with the capsule content
`
`polymer in the solution (claim 9, [0011], [0022], [0028]). The ‘314 publication teaches
`
`the elected hyaluronic acid and thus would be capable of forming a hydrogel. The fibers
`
`are taught to consist of the nanofiber which is formed of collagen, and therefore would
`
`be the main component. The ‘314 publication teaching the fiber being several
`
`nanometers and the capsule being 300 to 5,000 nm ([0013], [(0018]). As MPEP 2144.05
`
`recites “where the general conditions of a claim are disclosedin the prior art, it is not
`
`inventive to discover the optimum or workable ranges by routine optimization’ (claims 2,
`
`5 and 6). The ‘314 publication teaching collagen (claim 5). The ‘314 publication teaching
`
`the fiber to be formed of collagen and ceramide (claim 5) and the capsule formed of
`
`hyaluronic acid (claim 6).
`
`The ‘245 patent teaches composite nonwoven fabric used in surgical items,
`
`wherein the fibers have a diameter of up to about 10 microns (abstract). The fibers are
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`taught to be spun bonded material made of most common material such as rayon
`
`(column 5, lines 55-65).
`
`The ‘245 patent teaches the rayon fiber diameter being up to about 10 microns
`
`(abstract, column 5, lines 55-65) and the ‘314 publication teaches the collagen fiber to
`
`be a few nanometers [0013], thus satisfying the relationship of wherein the first fiber
`
`dimeter is greater than the second fiber diameter.
`
`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).
`
`

`

`Application/Control Number: 15/986,951
`Art Unit: 1613
`
`Page 6
`
`It would have been prima facie obvious to one of ordinary skill in the art before
`
`the filing date of the claimed invention to use the collagen particles and hyaluronic acid
`
`capsules taught by the ‘314 publication on the cosmetic sheets taught by the ‘738
`
`publication because the ‘314 publication teaches the nanofiber layer and capsule to
`
`show the beauty effect (abstract) wherein the capsules are sized to permeate human
`
`skin [0019] and the beauty effect by collagen is expected as a cosmetic [0021]. One of
`
`ordinaryskill in the art before the filing date of the claimed invention would have a
`
`reasonable expectation of success as the ‘738 publication teaches a cosmetic sheet
`
`containing collagen and hyaluronic acid as moisturizer components [0009] and the ‘314
`
`publication teaches the use of collagen and hyaluronic acid for a sheet with beauty
`
`effects (abstract) including lotions [0017].
`
`Claims 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over
`
`JP 09-238738 in view of JP 2014-129314 and US 4,196,245 as applied to claims 1-8
`
`above, andfurther in view of US 2002/0197328.
`
`As mentionedin the above 103(a) rejection, all the limitations of claims 1-8 are
`
`taught by the combination of the ‘738 publication, the ‘314 publication and the ‘245
`
`patent.
`
`Regarding claim 10, the limitation of wherein the first component is any of
`
`collagens, at least either of the second fibers and the particulates further contain a third
`
`component other than the first and second componentis met by the ‘314 publication
`
`teaching the composition including collagen and ceramide [0020].
`
`The combination of references does not specifically teach the elected hyaluronic
`
`acid salt (claim 9-10).
`
`

`

`Application/Control Number: 15/986,951
`Art Unit: 1613
`
`Page 7
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`The ‘328 publication teaches a sustained release drug composition including
`
`microparticles of hyaluronic acid (abstract), wherein the microparticles may be formed of
`
`hyaluronic acid or an inorganic salt thereof dissolved in water ([O008], [0011] and
`
`example 3).
`
`It would have been obvious to one of ordinary skill in the art to substitute a first
`
`polymer particle formed of hyaluronic acid as taught by the ‘314 publication with a
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`second polymer particle formed of sodium hyaluronate as taught by the ‘328 publication
`
`(abstract, [0008], [0011] and example 3) with a reasonable expectation of success
`
`because the simple substitution of one known element for another would have yielded
`
`predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P.
`
`§2144.07 states "The selection of a known material based on its suitability for its
`
`intended use supported a prima facie obviousness determination in Sinclair & Carroll
`
`Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting
`
`equivalents knownin the prior art for the same purpose, an express suggestion to
`
`substitute one equivalent component or process for another is not necessary to render
`
`such substitution obvious. /n re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
`
`M.P.E.P. §2144.06.
`
`One of ordinary skill in the art before the effective filing date of the instant
`
`invention would have a reasonable expectation of successin substituting sodium
`
`hyaluronate for hyaluronic acid in forming the particles or capsules taught by the ‘314
`
`publication because the ‘328 publication teaches the interchangeability of hyaluronic
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`acid and sodium hyaluronate in forming particles intended for drug release ([0008],
`
`[0011] and example 3).
`
`

`

`Application/Control Number: 15/986,951
`Art Unit: 1613
`
`Page 8
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`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
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`doctrine groundedin public policy (a policy reflected in the statute) so as to prevent the
`
`unjustified or improper timewise extension of the “right to exclude” granted by a patent
`
`and to prevent possible harassment by multiple assignees. A nonstatutory double
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`patenting rejection is appropriate where the conflicting claims are not identical, but at
`
`least one examined application claim is not patentably distinct from the reference
`
`claim(s) because the examined application claim is either anticipated by, or would have
`
`been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46
`
`USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed.
`
`Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
`
`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timelyfiled terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`
`may be used to overcome an actual or provisional rejection based on nonstatutory
`
`double patenting provided the reference application or patent either is shown to be
`
`commonly owned with the examined application, or claims an invention made as a
`
`result of activities undertaken within the scope of a joint research agreement. See
`
`MPEP § 717.02 for applications subject to examination under the first inventor to file
`
`provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(I)(1) -
`
`706.02(l)(3) for applications not subject to examination under the first inventor to file
`
`provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR
`
`1.321 (b).
`
`

`

`Application/Control Number: 15/986,951
`Art Unit: 1613
`
`Page 9
`
`The USPTOInternet website contains terminal disclaimer forms which may be
`
`used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application
`
`in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26,
`
`PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may
`
`befilled out completely online using web-screens. An eTerminal Disclaimer that meets
`
`all requirements is auto-processed and approved immediately upon submission. For
`
`more information about eTerminal Disclaimers, refer to
`
`www.uspto.gov/patents/process/file/efs/guidance/eT D-info-l.jsp.
`
`Claims 1-10 are provisionally rejected on the ground of nonstatutory double
`
`patenting as being unpatentable over claims 1-13 of copending Application No.
`
`15/986,906in view of JP 09-238738 and US 4,196,245. The instant case and the ‘906
`
`application is directed to a fiber assembly formedofa first collagen component forming
`
`a nanofiber and a second hyaluronic acid salt forming a particulate of greater size than
`
`the nanofiber. The instant application and the ‘906 application differ in that the instant
`
`application requires a fiber substrate wherein the first fiber layers have a diameter
`
`greater than the collagen layer fibers. The ‘738 publication teaches the use of a rayon
`
`backing layer used for cosmetics containing hyaluronic acid and collagen [0009]. The
`
`‘245 patent teaches up to 10 microns of rayon fibers used in fabrics in the surgical
`
`setting (abstract, column 5, lines 50-65).
`
`It would have been prima facie obvious to one
`
`of ordinary skill in the art before the effective filing date of the claimed invention to use a
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`rayon backing sheet of up to 10 micron fiber dimeter on the fiber assembly taught by the
`
`

`

`Application/Control Number: 15/986,951
`Art Unit: 1613
`
`Page 10
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`‘906 application because the ‘738 publication teaches the use of rayon backing layer on
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`cosmetic compositions which comprise hyaluronic acid and collagen.
`
`This is a provisional nonstatutory double patenting rejection.
`
`Conclusion
`
`No claims are allowed.
`
`Examiner Contact Information
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to LYNDSEY MARIE BECKHARDTwhosetelephone
`
`number is (571)270-7676. The examiner can normally be reached on Monday,
`
`Tuesday and Thursday 7:30 to 3pm.
`
`Examiner interviews are available via telephone, in-person, and video
`
`conferencing using a USPTO supplied web-basedcollaboration tool. To schedule an
`
`interview, applicant is encouraged to use the USPTO Automated Interview Request
`
`(AIR) at http:/Avwww.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Brian-Yong Kwon can be reached on 571-272-0581. The fax phone number
`
`for the organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on accessto the Private PAIR system, contact the Electronic
`
`

`

`Application/Control Number: 15/986,951
`Art Unit: 1613
`
`Page 11
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`Business Center (EBC) at 866-217-9197(toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automatedinformation
`
`system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/LMB/
`Examiner, Art Unit 1613
`
`/DENNIS J PARAD/
`Primary Examiner, Art Unit 1612
`
`