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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/04/2026 has been entered.
Response to Amendment
The Amendment filed 02/04/2026 has been entered. Applicant’s amendments are in response to in the Final Office Action mailed 09/04/2025. Applicant’s claims have been amended in the following manner: independent claim 1 has been modified by inclusion of a biodegradable and thickness limitation from claims 3 (now-cancelled) and 7 of the previous claim set, respectively. Notably, the Affidavit filed has been recognized. Furthermore, new claim 29 has been entered to draw a new ground of rejection.
Note that both previous 103 rejections have been withdrawn based on the persuasiveness of Applicant’s argument. However, a new 103 rejection is applied (based on a reference found in a search), providing a different ground of rejection compared to the previous round of prosecution. The following objections/rejections are withdrawn (see ‘response to arguments’ below for explanation): the 103 rejection (based on Riggin) and the 103 rejection (based on Washington).
The Examiner further acknowledges the following:
Claims 1, 4-13, 17-19, 21-23, and 26-29 are pending.
Claims 13, 17-19, and 21-23 are withdrawn from consideration as directed to non-elected inventions.
Claims 1, 4-12, and 26-29 are presented for examination and rejected as set forth below.
Drawings
The drawings are objected to because Figures 2(c-d), 3(e), 5(d-e), 6(a-d), 8(c-d), 10 (c-f), 13 (a-f), 14 (a-d), and 15 (a-f) are objected for poor resolution of text in the Figures. Compare these figures to figures with high resolution text such as Figure 25.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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-AIA ), 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.
Claims 1, 4-12 and 26-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 7, and 29 recite the term “about” to describe numerical values, which is indefinite because it is an imprecise definition of a value (and is not further defined by the Specification). The Examiner suggests “about” should be removed and considers the claim values as if the term “about” was not present. See MPEP 2173.05(b)(i).
Claims that depend from claim 1 are also rejected.
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 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 obviousness or nonobviousness.
Claims 1, 4-8, 10-12, and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Calza (WO2019239436A1), as evidenced by Puhl (Nucl Recept Signal, 2015).
Applicant’s claims are directed to a nanofibrous material “comprising” a drug, wherein the drug is an NSAID or PPAR, the nanofibrous material is biodegradable and has a thickness of 10-1000 micrometers.
The “treatment of peripheral nerve injury is by delivering the drug locally to a damage or injured nerve” is an intended use, where the only limitation is where the drug must be able to release from the nanofibrous material. Similarly, “wrapping around a peripheral nerve” of claim 1 requires some flexibility of the material and “sustained-release” of claim 12 requires a composition with long-lasting drug release. Particularly, a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Thus, whether a device is applied to a peripheral nerve, a CNS nerve, a tendon, etc., as long as the device meetings the fundamental structural limitations of the instant claim set (i.e., flexibility, drug sustained release, etc.), the device would read on the instant claims.
Calza teaches electrospun fibers for a local release of an anti-inflammatory and a promyelinating agent (Calza – claim 1) over a defined time-window (pg 1, description). Note that both the disclosed electrospun fibers and hydrogels are discussed as delivery platforms (pg 2).
Regarding claims 1, 4-8, 10-12, and 26-29: Calza teaches electrospun fibers (reads on claims 1, 5, and 8) for a local release of an anti-inflammatory (e.g., the NSAID ibuprofen in Calza - claim 5) and a promyelinating agent over a defined time-window (reads on claim 12) (pg 1, description), where the final composition appears flexible (i.e., wraps around a cylindrical form in Figure 1, as a depiction of the manufacturing process (pg 8, lines 1-14), and is made of the same material with the same thickness as the instant application, providing a similar expectation of physical properties), appearing to have a form similar to a sheet/membrane/bandage/wrap/patch (reads on claim 6) (Figure 1). The scaffolds are implanted “upon the spinal cord, bent over it, and then fixed with bioglue” (pg 14, lines 18-25), which describes the implantation of a flexible sheet, as depicted in Figure 1. Calza teaches PLGA 50:50 (reads on instant claim 4 and 26), PLGA 75:25, and a thickness of 150-170 um (reads on instant claims 1, 7, and 29) (pg 8, lines 1-14). Ibuprofen is an NSAID and/or PPAR agonist (as limited by instant claims 1, 10-11, and 27-28), as evidenced by Puhl (abstract).
However, also note that Calza evaluates scaffolds conjugated with ibuprofen (only) (abbv. = ibsc), as an embodiment (pg 12). On pg 23-24, “the TNFα mRNA level decreased in a highest extent (64%) for the scaffold conjugated with ibuprofen (ibsc) compared to sc LPS (p=0,0006) and it was comparable to the control with ibuprofen added as a solution (SC+IBU, p=0.0011, FIG. 6 B). This effect indicates that 3 days of ibsc incubation in the cell culture medium can provide an amount of ibuprofen (around 32 μg), which is effective to significantly inhibit the inflammatory action” and “D2 down-regulation of 83% for ibT3sc compared to the 73% for T3sc and 50% for ibsc suggests on synergistic anti-inflammatory effect when both molecules are present (FIG. 6 C).” Thus, the ibsc (i.e., ibuprofen-only) embodiment provides an effect similar to the ibuprofen + T3 (promyelinating agent) effect. An obvious composition suggested as inferior does not afford patentability: In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” Thus, the ibsc (where no promyelinating agent is present) represents an inferior embodiment in the disclosure of Calza, which is therefore obvious.
Thus, Calza teaches the instant composition of the claim set as obvious.
Claims 1, 4-12 and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Calza (WO2019239436A1), as evidenced by Puhl (Nucl Recept Signal, 2015), as applied to claims 1, 4-8, 10-12, and 26-29 above, and in further view of Su (US20140336278A1) and Zhao (Colloids and Surfaces B: Biointerfaces, 2014).
As discussed above, Calza teaches PLGA electrospun fibers for a local release of an anti-inflammatory over a defined time-window (pg 1, description). However, Calza does not teach a drug complexed with a nanoparticle or microparticle (instant claim 9).
Su teaches controlled release drug delivery implants (abstract), that incorporate ibuprofen [0047] and PLGA (Su – claim 2), where drugs are often complexed [0004] in order to improve delivery, as far as release properties and drug stabilization [0004-0008]. Drug particles are found as nanospheres or microspheres [0034].
Zhao teaches compatibility of mesoporous silica nanoparticles for the tunable release of complexed ibuprofen (“complex IB-MSNs”) in a hydrogel environment based on chitosan (abstract).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Calza to replace ibuprofen of the device with ibuprofen complexed nanoparticles, as taught by Su and Zhao, to locally deliver ibuprofen to a spinal cord injury, because Su teaches ibuprofen nanoparticles suitable for use in PLGA based implants (similar form to Calza’s disclosure) to improve drug bioavailability, and Zhao teaches the compatibility of ibuprofen complexes with polymers such as chitosan hydrogels, that would improve efficacy of Calza’s disclosure for treating spinal cord injury (pg 1).
Response to Arguments
Applicants arguments, see pg 6-14, filed 02/04/2026, including the Affidavit filed, with respect to both 103 rejections of claims 1, 4-12 and 26-29 under rejection have been fully considered and are persuasive. Therefore, both 103 rejections have been withdrawn.
However, upon further consideration and in view of applicant’s amendments to the claims, a new ground of rejection is made in view of over Calza (WO2019239436A1), as evidenced by Puhl (Nucl Recept Signal, 2015), and in further view of Su (US20140336278A1) and Zhao (Colloids and Surfaces B: Biointerfaces, 2014). Note the additional 112b rejection and drawing objections (previously overlooked in the 1st round).
Note that the Examiner recognizes all arguments of Applicant, and because both 103 rejections are withdrawn, the arguments are now moot. In the interest of simplicity, instead of responding to each argument, an understanding of the rationale to withdraw the rejections will be provided below:
The 103 rejections are withdrawn based on: (1) the unexpected and advantageous instant results in comparison to Riggin, as a demonstration of non-obviousness, and (2) the non-obviousness of instant claim 1, based on the teachings of Washington, Salmoria, and/or Pires. The instant claims are directed toward a drug-loaded wrap device (as commonly referred to in the Art) (i.e., this implied by the limitation “wherein the nanofibrous material is able to be wrapped around a peripheral nerve” and in the Specification on pg 3, lines 9-13, described in the form of a sheet, membrane, bandage or wrap), wherein the material has a thickness between 10 and 1000 micrometers (as confirmed in the Specification on pg 4, lines 11-15).
Note that the instant Application is related to treatment of nerves in the peripheral nervous system (PNS) (i.e., differentiated from the intended use for the central nervous system (CNS) or healing of tendons; however, note that ‘intend use’ is not a determination for patentability of a composition) and for wrap devices (differentiated from nerve conduits; explained further below, as applied to Art) (instant claim 1).
Riggin (Annals of Biomedical Engineering, 2017) teaches an electrospun PLGA nanofiber scaffold comprising ibuprofen for pain relief and tissue repair (title). Ibuprofen is an NSAID and/or PPAR agonist (abstract), as evidenced by Puhl (Nucl Recept Signal, 2015). Although the combined Prior Art based on Riggin still teaches the obviousness of the invention (i.e., it would be obvious to make a more flexible version of this nanofiber scaffold of Riggin, regardless of intended use), in view of unexpected results, Riggin does not demonstrate the instant results, as expected results. Applicant’s demonstration of treatment by wrapping CNS nerves (see Figure 8a, 10a, 16 of the Drawings) is a substantially different compared to Riggin, who demonstrates disc-like implant scaffolds (pg 2353, figure 3), for tendon healing (abstract), where the scaffolds of Riggin do not appear wrappable, and thus, would not be suitable for nerve treatment, as demonstrated by the outcome of the instant Specification/Drawings.
Thus, the instant results (as demonstrated by the Drawings filed 07/15/2022) would be considered unexpected compared to Riggin’s disclosure. Although evidence of unexpected results must compare the claimed invention with the closest prior art, applicant is not required to compare the claimed invention with subject matter that does not exist in the prior art. In re Geiger, 815 F.2d 686, 689, 2 USPQ2d 1276, 1279 (Fed. Cir. 1987) (Newman, J., concurring) (Evidence rebutted prima facie case by comparing claimed invention with the most relevant prior art. Note that the majority held the Office failed to establish a prima facie case of obviousness.); In re Chapman, 357 F.2d 418, 148 USPQ 711 (CCPA 1966) (Requiring applicant to compare claimed invention with polymer suggested by the combination of references relied upon in the rejection of the claimed invention under 35 U.S.C. 103 "would be requiring comparison of the results of the invention with the results of the invention." 357 F.2d at 422, 148 USPQ at 714.). Therefore, the modification to introduce flexibility to Riggin’s disclosure does not come into play when comparing unexpected results, and there is no objective evidence to suggest flexibility of Riggin’s device as suitable for nerve wrapping.
Washington (US 20180369160A1; cited on the IDS filed 07/15/2022) teaches a wrap device that is useful local delivery of tacrolimus (abstract) or other active agents [0069] for nerve regeneration [0004]. Per Applicant’s arguments, the Examiner has revisited the meaning of the “other active agents” as discussed by Washington [0069]. What becomes apparent is that the “active agents” of Washington are implicitly limited to traditionally immune suppressing agents. For example, Trevillian (Australian Prescriber, 2006) names traditional immunosuppressants such as prednisone, cyclosporin, sirolimus, everolimus, methotrexate, and mycophenolate (Table 1), which are the same “suitable active agents” found in Washington [0069]. Thus, Washington appears to imply that “other” active agents are immunosuppressive [0069]. The instant ingredients of Ibuprofen, PPAR agonists, nor NSAIDs are not found in a term search of the Trevillian disclosure, as being related to traditional immunosuppressants. By contrast, Huemer (Mediators of Inflammation, 2015) teaches ibuprofen has having potential immunosuppressive effects (title, pg 1); however, Huemer still differentiates ibuprofen from “classical immunosuppressive drugs” (pg 1, ‘introduction’), and thus, a PHOSITA would not recognize the instant Ibuprofen, PPAR agonists, or NSAIDs, as a reasonably suggested active agent or category of active agent, intended for suggestion as an “other” active agent by Washington in [0069].
To summarize, the 103 rejection based on Riggin is withdrawn due to unexpected results, demonstrating nonobviousness. The 103 rejection based on Washington is withdrawn due to Washington not reasonably suggesting the instant active ingredient (i.e., NSAID, PPAR agonist, ibuprofen, etc.).
Furthermore, the Examiner notes Applicant’s advantageous claim of sustained release, in contrast to burst release, in the Specification (pg 26, lines 7-11 and pg 25, lines 35-36). Finally, the Examiner notes Figure 11 referenced on pg 8 (see also Figure 8-10), where after crush injury, the ibuprofen PLGA nanofibers outperformed the control injury group (where the controls consist of the polymeric nanofibers without the drug loaded “materials and methods” on pg 16-17).
Further discussion of the other disclosures from the previous Office Action, is warranted:
Pires (J Tissue Eng Regen Med, 2016) teaches ibuprofen in electrospun fibers for a nerve conduit for nerve regeneration in the central nervous system (CNS) (abstract). The issue with Pires is that Pires is directed to nerve conduit devices. Upon initial glance, conduits and wraps appear only to be different in terms of a closed or open tube-like structure, as shown by Cirillo (EFDTs for Biomaterials and Medical Devices, 2018) (pg 332, figure 16.1, reproduced below), but otherwise made of similar materials for similar purposes such as local drug delivery to nerves.
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However, it has not gone unnoticed that disclosures in this general field for nerve treatment tend to focus on either a wrap or a conduit, individually. Furthermore, the wrap and conduit devices are applied differently and thus, they are implied to have different structural requirements (i.e., conduits are sutured to stumps where flexibility may not be as critical; whereas wrap devices NeuraWrap and NeuroMend are wrapped around the nerve) (pg 333, paragraph 2). Thus, the instant invention is non-obvious based on Pires, because there is no reasonable way based on the Art to modify from the teaching of poly(trimethylene carbonate-co-ϵ-caprolactone) [P(TMC-CL)]-based nerve conduits to the flexible wraps intended for the instant invention.
Salmoria (Procedia 2016) focuses on extrusion-based polycaprolactone/ibuprofen tubes for peripheral nerve regeneration (PNS) with a nerve conduit device (abstract). Although Salmoria incorporates ibuprofen for peripheral never regeneration, Salmoria is ruled out for not teaching or suggesting nanofibrous material (where extrusion-based materials are solid (mainly non-fiber based) structures as shown in Figure 2 (pg 195), and likely has different properties compared to fiber-based materials). As also discussed for Pires, Salmoria is directed to nerve conduits (pg 193, ‘introduction’), which are considered substantially different from nerve wraps.
Thus, the scope of the claims are supported by the results provided in the Specification that demonstrate the instant invention, such that ibuprofen is demonstrated to treat nerves of the peripheral nervous system within a wrappable device based on a biodegradable polymer, where ibuprofen is known as an NSAID (also, sulindac sulfide demonstrated in figure 13) and/or PPAR agonist (thus, the extension of the ibuprofen into the broader categories of active agents such as NSAIDs and/or PPAR agonists in instant claim 1 is logical). Furthermore, 2% ibuprofen loadings in the Specification (pg 23 lines 4-9) reasonably extrapolates to a general amount teaching of ibuprofen.
However, note the new 103 rejection applied based on the Art above, where it should be kept in mind that patentability of a composition does not depend on limitations of intended use.
Response to Amendment
The affidavit under 37 CFR 1.132 filed 02/04/2026 is considered an addressed with the summary in the ‘response to arguments’ above.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 2/23/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614