DETAILED ACTION
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 .
Formal Matters
Receipt of Applicant’s response, dated 11/10/2025, is acknowledged.
Claims 1-10, 17, and 20-29 are pending.
Claims 11-16 and 18-19 are canceled.
Claims 1-7, 9, and 20 are amended.
Claims 28-29 are new.
Claims 10, 17, and 24-27 remain withdrawn from consideration as being drawn to a nonelected invention.
Claim 23 remains withdrawn from consideration as being drawn to a nonelected species.
Claims 1-9, 20-22, and 28-29 are under consideration in the instant Office action to the extent of the elected species, i.e., the nanofiber structure further comprises cells.
Information Disclosure Statement
The information disclosure statements (IDS) filed 11/10/2025 and 12/01/2025 have been considered by the Examiner. A signed copy of each IDS is included with the present Office Action.
OBJECTIONS/REJECTIONS WITHDRAWN
Specification
The objection to the abstract set forth in the Office action dated 07/08/2025 is hereby withdrawn in light of Applicant’s amendments to the abstract.
Claim Objections
The objections to claims 1, 5, and 9 set forth in the Office action dated 07/08/2025 are hereby withdrawn in light of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112(b)
The indefiniteness rejections of claims 2-7, 9, and 20 set forth in the Office action dated 07/08/2025 are hereby withdrawn in light of Applicant’s amendments to the claims.
MAINTAINED/NEW GROUNDS OF REJECTIONS
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The rejection of claims 1-9 and 20-22 and newly applied to added claims 28-29 under 35 U.S.C. 102(a)(1) as being anticipated by Xie (WO 2019/060393 A1, published 03/28/2019, cited in IDS dated 09/08/2023) as evidenced by the specification is maintained.
Xie teaches a method of synthesizing 3D electrospun nanofiber scaffolds (also referred to as nanofiber structures, See Page 7 Lines 8-10) comprising electrospinning polycaprolactone (abbreviated as PCL, See Page 8 Line 15) and Pluronic F-127 to form 2D electrospun nanofiber mats (also referred to as nanofiber membranes or layers), cutting the 2D electrospun nanofiber mats into a desired shape, and then expanding the nanofiber mats until a desired thickness is reached (i.e., each of the nanofiber mats are expanded to the same thickness), forming 3D electrospun nanofiber structures (e.g., Page 18 Line 32-Page 19 Line 24). The electrospinning step involves a solution comprising PCL being pumped into a core solution comprising Pluronic F-127 (the relative amount of Pluronic F-127 to PCL in the electrospinning step changes over the time of nanofiber mat collection as more PCL is added, i.e., the ratio of Pluronic F-127:PCL decreases from the production of the first to the second to the third nanofiber mats etc.) (e.g., Page 19 Lines 2-6). The expanding step involves contacting (e.g., submerging or immersing) the nanofiber mat or structure with subcritical CO2 (e.g., in a sealed container) and then depressurizing (e.g., Page 13 Line 31-Page 14 Line 1). The thickness of the 3D electrospun nanofiber structures can be tailored by the number of CO2 fluid processing times (e.g., Page 23 Lines 5-6). As the number of CO2 fluid processing times is increased, the porosity and the thickness of the nanofiber structures increase (e.g., Page 23 Lines 9-11). Images of the 3D electrospun nanofiber structures show layered structures with preserved nanotopographic cues rendered by aligned nanofibers which is critical for regeneration of tendon, muscle, and nerve tissues (e.g., Page 23 Lines 19-22, Figure 1).
The method may comprise coating the nanofiber structures with a material that enhances the nanofiber structure's ability to absorb fluids, particularly aqueous solutions, wherein said materials include gelatin and hydrogels (e.g., Page 9 Line 29-Page 10 Line 15). The method may comprise crosslinking the nanofiber structure or mat (e.g., before or after expansion) (e.g., Page 14 Lines 4-5, Page 10 Lines 16-24). The method may further comprise seeding cells and/or tissue into inserted holes of the expanded nanofiber structure (e.g., Page 14 Lines 7-8 and 10-11).
The method of synthesizing 3D electrospun nanofiber structures of Xie reads on the method of instant claims 1-9 and 20-22.
Regarding instant claims 3-5, Pluronic F-127 is an amphiphilic block copolymer (i.e., a copolymer of polypropylene oxide and polyethylene oxide) synonymous with Poloxamer 407, as evidenced by Page 10 Lines 27-28 of the instant specification. It is noted that, therefore, Pluronic F-127 also meets the limitation of the surfactant of instant claim 1.
Regarding instant claims 6-7, polycaprolactone is a hydrophobic polymer (See Page 8 Lines 12 and 15 of Xie). It is noted that, therefore, polycaprolactone also meets the limitation of the polymer of instant claim 1.
The electrospinning step in the method of Xie comprising pumping a solution comprising polycaprolactone into a core solution comprising Pluronic F-127 forming a plurality of 2D electrospun nanofiber mats reads on ‘electrospinning a first nanofiber region with a polymer and…a surfactant and a second nanofiber region with a polymer and…a surfactant’ required by instant claim 1 and ‘electrospinning further nanofiber regions with a polymer and a surfactant’ required by instant claim 2.
Regarding the method of synthesizing a nanofiber structure ‘comprising regions with different pore sizes’ required by instant claim 1, because the method of Xie of synthesizing a 3D electrospun nanofiber scaffold is the same as the method of instant claim 1 (i.e., comprises electrospinning a first nanofiber region with polycaprolactone and Pluronic F-127 and a second nanofiber region with polycaprolactone and Pluronic F-127, wherein the relative amounts of polycaprolactone and Pluronic F-127 are different in the first nanofiber region and the second nanofiber region, the method of Xie necessarily produces a nanofiber structure comprising regions with different pore sizes as evidenced by the specification (See Page 8).
The 2D electrospun nanofiber mats in the method of Xie being cut to a desired shape (i.e., a defined length of each nanofiber mat) and expanded to a desired thickness (i.e., a defined width of each nanofiber mat) forming layered structures read on instant claim 8 requiring the first nanofiber region and the second nanofiber region being layers having the same length and width.
The 3D electrospun nanofiber structures in the method of Xie being fabricated from 2D electrospun nanofiber mats comprising polycaprolactone and Pluronic F-127 read on instant claims 9, 28, and 29 requiring the polymer and surfactant be the same in all of the regions of the nanofiber structure.
The method of Xie involving the nanofiber structures being coated with a material that include hydrogels and gelatin reads on instant claim 20 requiring the nanofiber structure being coated with a hydrogen or gelatin.
The method of Xie involving crosslinking the nanofiber structure reads on instant claim 21 requiring crosslinking or thermally treating the nanofiber structure.
The method of Xie involving seeding cells into the nanofiber structure reads on instant claim 22 requiring adding cells (i.e., the elected species of what is further added to the nanofiber structure) to the nanofiber structure.
Thus, the teaching of Xie anticipates instant claims 1-9, 20-22, and 28-29.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in 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 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 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 be filled 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/apply/applying-online/eterminal-disclaimer.
The provisional rejection of claims 1-9 and 20-22 and newly applied to added claims 28-29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8, 10-13, 18-19, 21-22, and 24 of copending Application No. 17/413,147 (hereafter ‘147) in view of Xie (WO 2019/060393 A1, published 03/28/2019, cited in IDS dated 09/08/2023) is maintained.
This is a provisional nonstatutory double patenting rejection.
Claim 1 of ‘147 recites a method for producing a nanofiber or microfiber structure, said method comprising: a) fixing at least one point of a nanofiber or microfiber mat, and b) expanding the nanofiber or microfiber mat after step a) by exposing the nanofiber or microfiber mat to gas bubbles, thereby producing said nanofiber or microfiber structure. Claims 2-5 of ‘147 recite step b) comprising immersing the nanofiber or microfiber mat in a subcritical fluid followed by depressurizing, wherein the subcritical fluid comprises CO2, N2, N2O, hydrocarbons, or fluorocarbons. Claims 6 and 8 of ‘147 recite synthesizing the nanofiber or microfiber mat by electrospinning prior to step a) and that the nanofiber or microfiber mat comprises electrospun fibers. Claims 10-12 of ‘147 recite the nanofiber or microfiber mat comprises polycaprolactone, a poloxamer, and poloxamer 407, respectively. Claims 13 and 21 of ‘147 recite thermally fixing and crosslinking, respectively, the nanofiber or microfiber structure. Claims 18-19 of ‘147 recite the nanofiber or microfiber structure comprising an active agent selected from the group consisting of a therapeutic agent, a growth factor, a signaling molecule, a cytokine, a hemostatic agent, an antimicrobial, and an antibiotic. Claim 22 of ‘147 recites the nanofiber or microfiber structure further comprising a material selected from the group consisting of gelatin, chitosan, starch, pectin, cellulose, methylcellulose, sodium polyacrylate, and starch-acrylonitrile co-polymers. Claim 24 of ‘147 recites a method for producing a nanofiber or microfiber structure, said method comprising: a) thermally fixing at least one point of a nanofiber or microfiber mat, wherein said nanofiber or microfiber mat comprises polycaprolactone (PCL) and a poloxamer, wherein said nanofiber or microfiber mat comprises electrospun fibers, and b) expanding the nanofiber or microfiber mat after step a) by exposing the nanofiber or microfiber mat to subcritical fluid CO2 and depressurizing, thereby producing said nanofiber or microfiber structure.
The claims of ‘147 do not recite a) electrospinning a first nanofiber region with a polymer and a first amount of a surfactant and a second nanofiber region with a polymer and a second amount of a surfactant, wherein the first amount of a surfactant is different than the second amount of a surfactant, thereby synthesizing said nanofiber structure comprising regions with different pore sizes, b) electrospinning further nanofiber regions with a polymer and a surfactant, c) the first nanofiber region and the second nanofiber region are layers having the same length and width, or d) the polymer and the surfactant being the same in all of the regions of the nanofiber structure.
These deficiencies are made up for in the teaching of Xie, which has been discussed supra.
It would have been prima facie obvious to one of ordinary skill in the art to use the fabrication protocol of the 2D electrospun nanofiber mats of Xie comprising pumping a solution comprising polycaprolactone into a core solution comprising Pluronic F-127 forming a plurality of 2D electrospun nanofiber mats and use the fabrication protocol of the 3D electrospun nanofiber structures of Xie comprising cutting the 2D electrospun nanofiber mats into a desired shape and then expanding the nanofiber mats until a desired thickness is reached in order to modify the method for producing the nanofiber or microfiber structure of the claims of ‘147 in order to produce a nanofiber or microfiber structure having 3D layers.
Thus, instant claims 1-9, 20-22, and 28-29 are rendered obvious by the claims of ‘147 in view of Xie.
NEW GROUNDS OF OBJECTION
Claim Objections
Claims 3 and 5-7 are objected to because of the following:
In each of claims 3 and 5, the recitation of “said surfactant of the first nanofiber region and the surfactant of the second nanofiber region” should be amended to “said surfactant of the first nanofiber region and said surfactant of the second nanofiber region” in order to improve claim consistency and readability; and
In each of claims 6 and 7, the recitation of “said polymer of the first nanofiber region and the polymer of the second nanofiber region” should be amended to “said polymer of the first nanofiber region and said polymer of the second nanofiber region” in order to improve claim consistency and readability.
Appropriate correction is required.
Response to Applicant’s Arguments
Applicant’s arguments filed on 11/10/2025 have been considered.
On Page 7 of Applicant’s remarks, which the Examiner believes is a typographical error, Applicant states that “The Examiner has also rejected claims 1-30 for allegedly failing to satisfy the written description requirement of 35 U.S.C. §112(a)”, however no rejections under 35 USC 112(a) were set forth in the Office action dated 07/08/2025.
Regarding the anticipation rejection of claims 1-9, 20-22 and 28-29 by Xie, Applicant argues that the electrospinning step of Xie does not involve pumping a solution comprising PCL into a core solution comprising Pluronic F-127, and rather, it is quite clear that a core-sheath nanofiber was generated from two separate compositions wherein the LL37 and pluronic F127 formed the core of the nanofiber while the PCL formed the sheath which encapsulated the core of the nanofiber and Applicant points to the teaching of Xie at Page 24 that “LL37 and pluronic F127 (a surfactant) were encapsulated in the core of LL37/pluronic F127-PCL core-sheath fibers using co-axial electrospinning (Xie, et al. (2012) Acta Biomater., 8:811-819)”. Applicant argues that Xie never teaches nor suggests changing the ratio of Pluronic F-127 and fails to teach or suggest that the modulation of the amount of the surfactant would affect pore size of an expanded nanofiber structure.
The above arguments have been fully considered by the Examiner but are not found persuasive because, firstly, it is not clear that the teaching of Xie on Page 24 that Applicant pointed to as evidence that “the electrospinning step of Xie does not involve pumping a solution comprising PCL into a core solution comprising Pluronic F-127” applies to the teaching of Xie on Page 19, i.e., the teaching on Page 24 regards “The effect of subcritical CO2 processing on the encapsulated molecules”. The Examiner disagrees that “the electrospinning step of Xie does not involve pumping a solution comprising PCL into a core solution comprising Pluronic F-127” and points to the same teaching contained in the above maintained grounds of rejection under 35 USC 102 that in the discussion of the “Examples: Materials and Methods” the method of fabricating 2D nanofiber membranes involves a step of pumping a solution comprising PCL into a core solution comprising Pluronic F-127 (See “Fabrication of 2D nanofiber membranes” spanning Pages 18-19, specifically Page 19 Lines 2-6). As can be seen in the above maintained grounds of rejection under 35 USC 102, the relative amount of Pluronic F-127 to PCL in the electrospinning step in the method of Xie changes over the time of nanofiber mat collection as more PCL is added, i.e., the ratio of Pluronic F-127:PCL decreases from the production of the first to the second to the third nanofiber mats etc. and therefore the argument that Xie fails to teach or suggest changing the ratio of Pluronic F-127 is not found persuasive. Regarding the argument that Xie fails to teach or suggest that the modulation of the amount of the surfactant would affect pore size of an expanded nanofiber structure, as can be seen in the above maintained grounds of rejection under 35 USC 102, because the method of Xie of synthesizing a 3D electrospun nanofiber scaffold is the same as the method of instant claim 1 (see above rejection for more details), the method of Xie necessarily produces a nanofiber structure comprising regions with different pore sizes and it is not a requirement for Xie to state a feature that is necessarily present. For at least these reasons, the anticipation rejection of claims 1-9 and 20-22 by Xie is hereby maintained. The Examiner suggests that Applicant amend the claims, particularly base claim 1, to include details of the method of the instant invention that distinguish the instant method from the method taught by Xie.
Regarding the provisional nonstatutory double patenting rejection of claims 1-9, 20-22 and 28-29 over copending Application No. 17/413,147 in view of Xie, Applicant argues that Xie fails to teach or suggest using different amounts of a surfactant in different regions of a nanofiber structure which fails to make up for the deficiencies of the claims of copending Application No. 17/413,147.
The above argument has been fully considered by the Examiner but is not found persuasive because, as can be seen in the above maintained grounds of rejection under 35 USC 102, the relative amount of Pluronic F-127 to PCL in the electrospinning step in the method of Xie changes over the time of nanofiber mat collection as more PCL is added, and therefore, the ratio of Pluronic F-127:PCL decreases from the production of the first to the second to the third nanofiber mats etc. For at least this reason, the provisional nonstatutory double patenting rejection of claims 1-9, 20-22 and 28-29 over copending Application No. 17/413,147 in view of Xie is hereby maintained.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in 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 CFR 1.136(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 shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619