www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 2231371450
`
`15/986,906
`
`05/23/2018
`
`Hirokazu KIMIYA
`
`ISHII-59228
`
`1556
`
`759°
`52°“
`PEARNE & GORDON LLP
`
`01/22/2019
`
`1801 EAST 9TH STREET
`SUITE 1200
`
`CLEVELAND, OH 44114-3108
`
`BECKHARDT, LYNDSEY MARIE
`
`1613
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`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
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`following e—mail address(es):
`
`patdoeket@pearne.eom
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Off/09 A0170” Summary
`
`Application No.
`15/986,906
`Examiner
`LYN DSEY M BECKHARDT
`
`Applicant(s)
`KIMIYA et al.
`Art Unit
`1613
`
`AIA Status
`Yes
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1. 136(a). In no event, however, may a reply be timely filed after SIX (6) MONTHS from the mailing
`date of this communication.
`|f NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from 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, even if 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.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a)D This action is FINAL.
`
`2b)
`
`This action is non-final.
`
`3)[:] An election was made by the applicant in response to 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 merits is
`closed in accordance with the practice under Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)
`Claim(s)
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`1—13 is/are pending in the application.
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`5a) Of the above claim(s) fl is/are withdrawn from consideration.
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`E] Claim(s)
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`is/are allowed.
`
`Claim(s) fl is/are rejected.
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`E] Claim(s) _ is/are objected to.
`
`) ) ) )
`
`6 7
`
`8
`
`
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`are subject to restriction and/or election requirement
`[:1 Claim(s)
`9
`* If any claims have been determined allowable, you may be eligible 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.'sp or send an inquiry to PPeredback@uspto.gov.
`
`Application Papers
`10):] The specification is objected to by the Examiner.
`
`11):] The drawing(s) filed on
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`is/are: a)C] accepted or b)E] 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)C] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)C] All
`
`b)C] Some”
`
`c)C] None of the:
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`1C] Certified copies of the priority documents have been received.
`
`2C] Certified copies of the priority documents have been received in Application No.
`
`3.[:] Copies of the certified copies of the priority documents have been received in 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) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20190107
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 2
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`DETAILED ACTION
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`Notice of Pre-AIA or AIA Status
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`The present application, filed on or after March 16, 2013, is being examined
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`under the first inventor to file provisions of the AIA.
`
`Claims 1-13 are currently pending. Claims 1-7 are currently under examination.
`
`Election/Restrictions
`
`Applicant’s election without traverse of Group | in the reply filed on 11/14/2018 is
`
`acknowledged.
`
`Claims 8-13 are withdrawn from further consideration pursuant to 37 CFR
`
`1.142(b) as being drawn to a nonelected invention, there being no allowable generic or
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`linking claim. Election was made without traverse in the reply filed on 11/14/2018.
`
`Applicant’s election without traverse of collagen peptide, hyaluronic acid salt and
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`water soluble component in the reply filed on 11/14/2018 is acknowledged.
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`No claims are withdrawn as a result of the species election.
`
`The instant case claims priority to Japan Application JP2017-117993, filed
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`Priority
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`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 Objections
`
`Claim 1
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`is objected to because of the following informalities:
`
`Instant claim 1
`
`states ‘an electrospinning step of forming fibers’ ..... ‘by an electrospinning method’. The
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`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 3
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`use of ‘an electrospinning method’ at both the beginning and end of the claimed step
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`appears to be redundant. Appropriate correction is required.
`
`Claim Rejections - 35 USC § 103
`
`In the event the determination of the status of the application as subject to AIA 35
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`U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any
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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
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`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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`obviousness rejections set forth 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 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 as follows:
`
`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.
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`4. Considering objective evidence present in the application indicating
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`obviousness or nonobviousness.
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`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 4
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`Claims 1-3 and 5-7 is/are rejected under 35 U.S.C. 103 as being
`
`unpatentable over JP 2014/129314 (Applicant provided) in view of Fisher, Husain
`
`and Zhou.
`
`Regarding claim 1, the limitation of a method for manufacturing a fiber assembly
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`comprising a preparation step of preparing a raw material liquid that contains a water-
`
`soluble first component, a second component that is capable of forming a hydrogel, an
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`electrospinning step of forming fibers that contain the first component as a main
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`component and particulates that are supposed by a plurality of the fibers and contain
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`the second component from the raw material liquid by an electrospinning method,
`
`wherein in a case where the fibers contain the second component, a mass proportion of
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`the second component contained in the particulates is greater than a mass portion of
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`the second component contained in the fibers is met by the ‘314 publication teaching a
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`sheet like material formed from nanofibers and a capsule that includes a substance.
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`The nanocapsule is capable of being in the nanofiber or may exist on the outside
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`(abstract). The ‘314 publication teaches the sheet material being formed of collagen
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`and the capsule is formed with hyaluronic acid (claims 5-6). The capsule is taught to be
`
`formed by electro 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.
`
`Regarding claim 2, the limitation of wherein an average fiber diameter D1 of the
`
`fibers and an average particle size D2 of the particulate satisfy the relationship: D1 <D2
`
`is met by the ‘314 publication teaching the fiber being several nanometers and the
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 5
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`capsule being 300 to 5,000 nm ([0013], [0018]). As MPEP 2144.05 recites “where the
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`general conditions of a claim are disclosed in the prior art, it is not inventive to discover
`
`the optimum or workable ranges by routine optimization”.
`
`Regarding claim 3, the limitation of wherein the fibers have an average fiber
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`diameter D1 of 600 nm or less is met by the ‘314 publication teaching the fiber diameter
`
`may be a few nanometers [0013].
`
`Regarding claim 5, the limitation of wherein the first component is any of
`
`collagens is met by the ‘314 publication teaching collagen (claim 5).
`
`Regarding claim 6, the limitation of wherein the first component is any of
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`collagens, the second component is hyaluronic acid and the raw material liquid further
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`contains a third component other than the first and second component is met by the
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`‘314 publication teaching the fiber to be formed of collagen and ceramide (claim 5) and
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`the capsule formed of hyaluronic acid (claim 6).
`
`The ‘314 publication does not specifically teach the preparation containing water
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`(claim 1).
`
`Fischer teaches electrospinning collagen and hyaluronic acid nanofiber meshes
`
`(title). The electrospinning is taught to include collagen and hyaluronic acid, which is
`
`interesting due to their roles in the extracellular matrix of humans and their ability to
`
`stimulate bone forming cells. The materials are processed into nanofiber scaffolds
`
`using technique called electrospinning (page viii, first paragraph). Collagen was taught
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`as added to NaOH at least 12 hours before electrospinning to allow proper dissolution
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`(page 33, third paragraph), thus teaching a pH adjusting agent being present (claim 7).
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 6
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`Husain teaches electrospraying for particle generation and electrospinning for
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`fiber production. Producing particle/fibers of the desired size or morphology depends
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`on two factors, properties of the polymer solution used and processing conditions
`
`including flow rate and applied voltage and distance. The particle fiber transition was
`
`analyzed by changing the polymer concentration (abstract).
`
`Zhou teaches greener synthesis of electrospun collagen fibers (title).
`
`Electrospinning collagen uses cytotoxic organic solvents, however an effective greener
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`method for preparation includes the use of phosphate buffered saline/ethanol solution
`
`(abstract). The buffered solution includes distilled water (page 2, third paragraph).
`
`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 water for the electrospinning
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`solvent for the fibers taught by the ‘314 publication because the ‘314 publication
`
`teaches electrospinning fibers using collagen (claim 5 and 9) and Zhou teaches the use
`
`of water in the electrospinning of collagen fibers (abstract, page 2, third paragraph).
`
`One of ordinary skill in the art before the effective filing date of the claimed invention
`
`would have motivation to use water as the solvent as Zhou teaches the use of water
`
`being a greener solution to electrospinning of collagen fibers (abstract). One of ordinary
`
`skill in the art before the effective filing date of the claimed invention would have a
`
`reasonable expectation of success as Zhou teaches success electrospinning of
`
`collagen fibers using PBS buffer solution which includes water (abstract, page 2, third
`
`paragraph).
`
`One of ordinary skill in the art before the effective filing date of the claimed
`
`invention would have a reasonable expectation of success in obtaining particulates
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 7
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`supported by fibers wherein the particle size is greater than the fiber diameter as the
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`‘314 publication teaches a range of collage fiber diameter and hyaluronic acid capsule
`
`size ([0036]—[0038]) thus teaching an optimizable parameter wherein the particle size is
`
`greater than the fiber dimeter. Additionally Husain teaches the concentration of polymer
`
`in the electrospinning solution effects the formation of particles or fibers (abstract), thus
`
`making it obvious to obtain particles and fibers from an electrospinning solution based
`
`on polymer concentration, wherein Fisher teaches electrospinning solutions of collagen,
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`a pH modifier (NaOH) and hyaluronic acid was known in the art before the effective
`
`filing date of the claimed invention.
`
`Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP
`
`2014/129314 (Applicant provided) in view of Fisher, Husain and Zhou as applied
`
`to claims 1-3 and 5-7 above, and further in view of US 2002/0197328.
`
`As mentioned in the above 103(a) rejection, all the limitations of claims 1-3 and
`
`5-7 are taught by the combination of the ‘314 publication, Fisher, Husain and Zhou.
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`The combination of references does not specifically teach the elected hyaluronic
`
`acid salt (claim 4).
`
`The ‘328 publication teaches a sustained release drug composition including
`
`microparticles of hyaluronic acid (abstract), wherein the microparticles may be formed of
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`hyaluronic acid or an inorganic salt thereof dissolved in water ([0008], [0011] and
`
`example 3).
`
`It would have been obvious to one of ordinary skill in the art to substitute a first
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`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
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 8
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`(abstract, [0008], [0011] and example 3) with a reasonable expectation of success
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`because the simple substitution of one known element for another would have yielded
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`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. lnterchemical Corp, 325 US. 327, 65 USPQ 297 (1945).” When substituting
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`equivalents known in 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. In re Fouf, 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 success in 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).
`
`Double Parenting
`
`The nonstatutory double patenting rejection is based on a judicially created
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`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
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`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
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`least one examined application claim is not patentably distinct from the reference
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`

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`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 9
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`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 timely filed 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(l)(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).
`
`The USPTO Internet 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/AlA/25, or PTO/AlA/26) should be used. A web-based eTerminal Disclaimer may
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`be filled out completely online using web-screens. An eTerminal Disclaimer that meets
`
`all requirements is auto-processed and approved immediately upon submission. For
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 10
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`more information about eTerminal Disclaimers, refer to
`
`www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
`
`Claims 1-7 are provisionally rejected on the ground of nonstatutory double
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`patenting as being unpatentable over claims 1-10 of copending Application No.
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`15/986,951 in view of JP 2014-129314. The instant case and the ‘951 application is
`
`directed to a fiber assembly formed of a 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 ‘951 application differ in that the instant
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`application requires the formation through electrospinning. The ‘314 publication teaches
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`the formation of nanofibers containing hyaluronic acid capsules through the use of
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`electrospinning (claims 1-10).
`
`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 known
`
`techniques such as electrospinning to form the nanofibers taught by the ‘951 application
`
`as the ‘951 application and the ‘314 publication are both directed to collagen fibers.
`
`This is a provisional nonstatutory double patenting rejection.
`
`No claims are allowed.
`
`Conclusion
`
`Examiner Contact Information
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone
`
`number is (571 )270-7676. The examiner can normally be reached on Monday,
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`Tuesday and Thursday 7:30 to 3pm.
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 11
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`Examiner interviews are available via telephone, in-person, and video
`
`conferencing using a USPTO supplied web-based collaboration tool. To schedule an
`
`interview, applicant is encouraged to use the USPTO Automated Interview Request
`
`(AIR) at http://www.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
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`
`/LMB/
`
`Examiner, Art Unit 1613
`
`/DENNIS J PARAD/
`
`Primary Examiner, Art Unit 1612
`
`