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
`
`07/23/2019
`
`1801 EAST 9TH STREET
`SUITE 1200
`
`CLEVELAND, OH 44114-3108
`
`BECKHARDT, LYNDSEY MARIE
`
`1613
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`07/23/2019
`
`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):
`
`patdoeket@pearne.eom
`
`PTOL-90A (Rev. 04/07)
`
`

`

`0,7709 A0170” Summary
`
`Application No.
`15/986,906
`Examiner
`LYN DSEY M BECKHARDT
`
`Applicant(s)
`KIMIYA et al.
`Art Unit
`1613
`
`AIA (FITF) 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 04/22/2019.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2a). This action is FINAL.
`
`2b) C] 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)
`
`1—19 is/are pending in the application.
`
`5a) Of the above claim(s) fl is/are withdrawn from consideration.
`
`E] Claim(s)
`
`is/are allowed.
`
`Claim(s) 1—7 and 14—19 is/are rejected.
`
`C] Claim(s) _
`
`is/are objected to.
`
`) ) ) )
`
`6 7
`
`8
`
`
`
`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 05/08/2019 is/are: a). accepted or b)C] 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)I:] All
`
`b)|:] Some**
`
`c)C] None of the:
`
`1.|:] Certified copies of the priority documents have been received.
`
`21:] Certified copies of the priority documents have been received in Application No.
`
`3D 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 20190709
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 2
`
`DETAILED ACTION
`
`Claims 1-19 are currently pending. Claims 1-7 and 14-19 are currently under
`
`examination.
`
`Notice of Pre-AIA 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.
`
`Information Disclosure Statement
`
`Applicant’s Informational Disclosure Statement, filed on 02/01/2019, 02/22/2019
`
`and 03/28/2019 has been considered. Please refer to Applicant's copy of the 1449
`
`submitted herein.
`
`Terminal Disclaimer
`
`The terminal disclaimer filed on 04/22/2019 disclaiming the terminal portion of
`
`any patent granted on this application which would extend beyond the expiration date of
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`15/986,951 has been reviewed and is accepted. The terminal disclaimer has been
`
`recorded.
`
`Examiner’s Note
`
`Unless otherwise indicated, previous objection/rejections that have been
`
`rendered moot in view of the amendment will not be reiterated. The arguments in the
`
`04/22/2019 response will be addressed to the extent they apply to current rejection(s).
`
`New Reiections:
`
`The following rejections are newly applied based on Applicant’s claim
`
`amendments and newly added claims.
`
`Claim Rejections - 35 USC § 1 12 — New Matter
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 3
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
`
`(a) IN GENERAL—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 which it
`is most nearly connected, to make and use the same, and shall set forth the best mode
`contemplated by the inventor orjoint inventor of carrying out the invention.
`
`The following is a quotation of the first paragraph of pre-AIA 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 which it 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 16-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA),
`
`first paragraph, as failing to comply with the written description requirement. The
`
`claim(s) contains subject matter which was not described in the specification in such a
`
`way as to reasonably convey to one skilled in the relevant art that the inventor or a joint
`
`inventor, or for pre-AIA the inventor(s), at the time the application was filed, had
`
`possession of the claimed invention.
`
`Claim 16 contains the newly added limitation ‘wherein the fibers and the
`
`particulates each contain a different mass proportion of the first and second
`
`components than a mass proportion of the first and second components contain in the
`
`raw material liquid’. Applicant points to support for the newly added claim in paragraphs
`
`[0012] and [0043]. The instant specification provides support for the raw material liquid
`
`containing the water soluble first component and the second component for forming the
`
`hydrogel, and wherein the fibers contains the first and second component, with the first
`
`component being higher, and wherein the particles contain the first and second
`
`component, wherein the second component is at a greater mass proportion. This
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`

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`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 4
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`however does not provide support for the mass proportion of the first and second
`
`component in the fibers and particles being different than that in the raw material.
`
`Alternatively, if Applicant believes that support for claim 16, drawn to ‘wherein the
`
`fibers and the particulates each contain a different mass proportion of the first and
`
`second components than a mass proportion of the first and second components contain
`
`in the raw material liquid’, is present and clearly envisaged in the instant application or
`
`earlier filed priority documents, applicant must, in responding to this Office Action, point
`
`out with particularity, where such support may be found.
`
`Applicant does not indicate where these limitations are supported by the original
`
`specification, or how, as is Applicant's burden. See MPEP §714.02, last sentence of the
`
`third paragraph from the end and MPEP §2163.06 (I) last sentence.
`
`Claim Rejections - 35 USC § 1 12
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION—The specification shall conclude with one or more claims particularly
`pointing out and distinctly claiming the subject matter which the inventor or a joint inventor
`regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`Claim 16-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA),
`
`second paragraph, as being indefinite for failing to particularly point out and distinctly
`
`claim the subject matter which the inventor or a joint inventor, or for pre-AlA the
`
`applicant regards as the invention.
`
`Claim 16 is directed to wherein the fibers and particulates each contain a
`
`different mass proportion of the first and second component than a mass proportion of
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 5
`
`the first and second components contained in the raw material.
`
`It is unclear if this is
`
`referring to the combination of fiber and particulates having a different mass proportion
`
`than the raw material, or if the raw material has a different proportion than the fiber and
`
`the raw material has a different proportion then the particles. For examination purposes
`
`this limitation will be deemed to be met if the concentration in the fiber is a distinct ratio
`
`from the raw material and the ratio in the particle is distinct ration from the raw material.
`
`Claims 17-19 do not clarify claim 16.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all
`
`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.
`
`4. Considering objective evidence present in the application indicating
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`obviousness or nonobviousness.
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 6
`
`Claims 1-3, 5-7 and 14-19 is/are rejected under 35 U.S.C. 103 as being
`
`unpatentable over JP 2014/129314 (previously applied) in view of Fisher
`
`(previously applied), Zhou (previously applied) and US 2009/0289387.
`
`Regarding claim 1, the limitation of a method for manufacturing a fiber assembly,
`
`the method comprising a preparation step of a raw material a liquid that contains a
`
`second component that is capable of forming a hydrogel and an electrospinning
`
`method, the fibers containing the first component as a main component and the
`
`particles being supported by a plurality of fibers and containing the second component,
`
`wherein the fibers contain the second component the ‘314 publication teaching a sheet
`
`like material formed from nanofibers and a capsule that includes 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 being formed of collagen 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
`
`capsule being 300 to 5,000 nm ([0013], [0018]). As MPEP 2144.05 recites “where the
`
`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”.
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 7
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`Regarding claim 3, the limitation of wherein the fibers have an average fiber
`
`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
`
`collagens, the second component is hyaluronic acid and the raw material liquid further
`
`contains a third component other than the first and second component is met by the
`
`‘314 publication teaching the fiber to be formed of collagen and ceramide (claim 5) and
`
`the capsule formed of hyaluronic acid (claim 6).
`
`Regarding claim 15, the limitation of wherein an average fiber diameter D1 of the
`
`fibers and an average particle size D2 of the particulate satisfied the relationship: D1 <
`
`D2 x 1/20 is met by the ‘314 publication teaching the fiber being several nanometers
`
`and the capsule being 300 to 5,000 nm ([0013], [0018]). 1/20th of the particle diameter
`
`leads to 15 nm (300/15) which is still larger than the few nanometer fiber size taught.
`
`As MPEP 2144.05 recites “where the 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 16, the limitation of a method for manufacturing a fiber
`
`assembly, the method comprising: preparation step of preparing a raw material liquid
`
`that contains a second component that is capable of forming a hydrogel; and an
`
`electrospinning step that forms particulates that are supported by a plurality of fibers
`
`and contain the second component from the raw material liquid by an electrospinning
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 8
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`method is met by the ‘314 publication teaching a sheet like material formed from
`
`nanofibers and a capsule that includes 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 being formed of collagen 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 17, the limitation of wherein the fibers contain a larger mass
`
`proportion of the first component and wherein the particulates contain a larger mass
`
`portion of the second component is met by the ‘314 publication teaching the sheet
`
`material being formed of collagen and the capsule is formed with hyaluronic acid (claims
`
`5-6). The fibers are taught to consist of the nanofiber which is formed of collagen, and
`
`therefore would be the main component.
`
`The ‘314 publication does not specifically teach a raw material liquid that
`
`contains a water-soluble first component, a second component that is capable of
`
`forming a hydrogel and water (claim 1).
`
`The ‘314 publication does not specifically teach wherein the fibers contain the
`
`second component, a mass proportion of the second component contained in the
`
`particulates is greater than a mass proportion of the second component contained in the
`
`fibers (claim 1 and 18) wherein the particulates contain the first component and the
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 9
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`mass proportion of the first component contained in the particulates is less than a mass
`
`proportion of the first component contained in the fibers (claim 14 and 19).
`
`The ‘314 publication does not specifically teach the preparation containing water
`
`(claim 1).
`
`The ‘314 publication does not specifically teach wherein the third component is a
`
`pH adjusting agent (claim 7).
`
`The ’314 publication does not specifically teach wherein the fibers and the
`
`particulates teach contain a different mass proportion of the first and second
`
`components than the mass proportion of the first and second components contained in
`
`the raw material liquid (claim 16).
`
`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
`
`as added to NaOH at least 12 hours before electrospinning to allow proper dissolution
`
`(page 33, third paragraph), thus teaching a pH adjusting agent being present (claim 7).
`
`Zhou teaches greener synthesis of electrospun collagen fibers (title).
`
`Electrospinning collagen uses cytotoxic organic solvents, however an effective greener
`
`method for preparation includes the use of phosphate buffered saline/ethanol solution
`
`(abstract). The buffered solution includes distilled water (page 2, third paragraph).
`
`The ’387 publication teaches two types of solutions are provided for an
`
`electrospinning process is performed to form a composite material. Each type of
`
`

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`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 10
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`material forming the composite material is selected from the group including a fiber,
`
`particle and combination of fiber and particle (abstract). The particles are taught to be
`
`larger than the fiber formed (Figure 1c). Simultaneously preparing micro/nano fibers for
`
`multiple materials by the improved electrospinning technique and control the dimension
`
`of the prepared fibers so as to mimic natural extracellular matrix. Polymer micro/nano-
`
`fibers and particles can be simultaneously prepared [0011]. The electrospinning
`
`technique to quickly massively produce and blend micro and nanopolymeric
`
`fibers/particles/combinations of fibers and particles and therefore has an economic
`
`advantage [0012]. At least two types of solutions are provided where at least one of the
`
`solution forms the scaffold and at least one is pore forming, the solutions are filled into
`
`different needs to blend in the injection device [0013]. The fiber is taught to be 10 to
`
`2,000 nm and the particles is taught to be 1,000 nm to 200,000 nm [0026]. The type of
`
`each material component included in the composite material is related to the
`
`concentration of the corresponding solution, higher concentration is closer to a fiber.
`
`The lower content is closer to a particle. The electric field intensity additionally forms
`
`the fiber or particle via voltage difference [0031]. The solutions are taught as electrically
`
`conductive blending injection device [0035] formed to a collection plate ([0037], [0041]).
`
`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 form the nano fiber and capsule
`
`taught by the ‘314 publication via the joint electrospraying taught by the ‘387 publication
`
`as the ‘387 publication teaches economic gains in being able to quickly massively
`
`product a blend of polymer fibers and particle combinations [0012]. One of ordinary skill
`
`in the art before the effective filing date of the claimed invention was made would have
`
`

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`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 11
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`a reasonable expectation of success as the ‘314 publication teaches the formation of
`
`nanofiber by electro field spinning wherein the fibers may be collagen and the capsule
`
`may be hyaluronic acid, the ‘387 publication teaches the formation of both particle and
`
`fiber through an electrospinning process and Fischer teaches the electrospinning of
`
`both collagen and hyaluronic acid is known, thus it was known to use electrospinning
`
`with the ingredients and known to use electrospinning as a process of forming fibers
`
`and particles, rending it obvious to one of ordinary skill in the art to use the
`
`electrospinning to form the collagen fibers and hyaluronic acid particles/capsules.
`
`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
`
`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).
`
`It would have been prima facie obvious to one of ordinary skill before the filing
`
`date of the claimed invention to use NaOH in the electrospinning solution as Fischer
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`

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`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 12
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`teaches that it is known to NaOH at least 12 hours before electrospinning to allow for
`
`proper dissolution.
`
`The ‘387 publication teaches the solutions for the fibers and particles being
`
`emitted from the needles simultaneously and blending before forming on the collecting
`
`device (Claim 1 and 9), thus allowing for mixing of the fiber and particle forming
`
`components and providing a mechanism for materials being present in both the fiber
`
`and particle, however being present mainly as the fiber or particle, as the ‘387
`
`publication teaches the materials for the fiber and particles and additionally teaches the
`
`use of solution concentration and voltage playing a roll in fiber or particle formation
`
`(claims 14-15). The solution concentrations upon mixing and forming the particle or
`
`fiber would lead a distinct ration between the solution containing both fiber and particle
`
`polymer and that in the fiber formed mainly of the fiber polymer and particle formed
`
`manly of the particle polymer.
`
`Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP
`
`2014/129314 (previously applied), Fisher (previously applied), Zhou (previously
`
`applied) and US 2009/0289387as 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.
`
`The combination of references does not specifically teach the elected hyaluronic
`
`acid salt (claim 4).
`
`

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`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 13
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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 ([0008], [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
`
`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. lnz‘erchemical Corp, 325 US. 327, 65 USPQ 297 (1945).” When substituting
`
`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],
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`[0011] and example 3).
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Response to Arguments:
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`Page 14
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`Applicant’s arguments have been fully considered and are not deemed to be
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`persuasive.
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`Applicant argues the combination of references do not teach or suggest providing
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`a raw material liquid having a first component, a second component and water and
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`forming fibers and particulates therefrom, wherein the first and second components are
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`in both the fibers and particulates. Rather the ‘314 publication discloses nano capsules
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`are preformed and are mixed into polymer solution prior to electric field spinning. The
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`‘314 publication makes no mention of including either HA or collagen in fibers, rather
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`collagen is to be delivered as the cosmetic with the HA and to form the fiber of the
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`cosmetic delivery.
`
`In response, Applicant is referred to the newly applied rejection above wherein
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`the fibers and particulates are taught to be formed simultaneously through
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`electrospinning as taught by the ‘387 publication. The ‘314 publication teaches the
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`desire for use of collagen for its beautifying effects and Fischer teaches electrospinning
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`of collagen for form fibers.
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`Applicant argues Fisher teaches forming a mesh and has no particulates. Fisher
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`makes not mention of forming particulates or of the forming particulates having a
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`second component of different mass proportions.
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`In response, Applicant is referred to the newly applied rejection above wherein
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`the ‘387 publication teaches the formation of fiber and particles at the same wherein the
`
`solutions are mixed during the electrospinning process before collection.
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 15
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`Applicant argues Hussain makes no mention of forming particulates and fibers
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`having a second component in different mass preparations.
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`In response, the Hussain reference is removed from the current rejection.
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`Applicant argues Zhou makes no mention of forming particulates of forming
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`fibers having a second component having a different mass proportion thereof. One
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`having ordinary skill in the art would not have turned to any of these references for
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`modification of another since none make of the difficulties.
`
`In response, Applicant is referred to the newly applied rejection above wherein
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`the ‘387 publication teaches the formation of fiber and particles at the same wherein the
`
`solutions are mixed during the electrospinning process before collection.
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`The double patenting rejection is withdrawn in light of Applicant filing a terminal
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`disclaimer.
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`No claims are allowed.
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`Conclusion
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`Applicant's amendment necessitated the new ground(s) of rejection presented in
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`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
`
`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
`
`CFR1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHS from the mailing date of this action.
`
`In the event a first reply is filed within
`
`TWO MONTHS of the mailing date of this final action and the advisory action is not
`
`mailed until after the end of the THREE-MONTH shortened statutory period, then the
`
`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 16
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action.
`
`In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the date of this final action.
`
`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.
`
`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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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`

`

`Application/Control Number: 15/986,906
`Art Unit: 1613
`
`Page 17
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`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571 -272-1 000.
`
`/LYNDSEY M BECKHARDT/
`
`Examiner, Art Unit 1613
`
`/DENNIS J PARAD/
`
`Primary Examiner, Art Unit 1612
`
`