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 .
Response to Amendment
The Amendment filed 07/08/2026 has been entered. Applicant’s amendments are in response to in the Non-Final Office Action mailed 03/09/2026. Applicant’s claims have been amended in the following manner: independent claim 1 narrows the nanofibrous material thickness to 50-150 micrometers (which is obtained from claim 19), and claim 29 narrows the thickness to 75-125 micrometers. The resulting amendment that narrows the thickness, prompts a new ground of rejection, through the incorporation of the previously-used reference Washington (i.e., in the current rejection, Washington is specifically used to teach thickness of polymeric drug-delivery devices that are able to wrap nerves for the purpose of local drug delivery, which is sufficiently analogous and/or reasonably pertinent to the subject matter of the instant Application).
The following objections/rejections are withdrawn: objection to the Drawings (the substitute drawings filed 07/08/2026 appear sufficiently legible), 112b rejection (based on Applicant amendments).
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Claims 13, 17-19, and 21-23 are withdrawn from consideration as directed to non-elected inventions.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.
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.
Claim 7 is 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 7 (now required, by cancellation of the alternate thickness limitation, that had been rejected in the previous Office Action) only recites “the nanofibrous material has a stiffness when in contact with the damaged or injured nerve, that is similar to or less than the stiffness of the nerve.” When Applicant recites that the stiffness is similar to or less than, “similar to” is also considered a relative term, which may additionally include consideration of "greater than values.”. Thus, claim 7 has a whole does not precisely define the metes and bounds of the invention, with regard to the intended functional limitation of stiffness. The Examiner will address the attempted intention of the functional stiffness limitation in the 103 below.
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 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Calza (WO2019239436A1), as evidenced by Puhl (Nucl Recept Signal, 2015), in further view of Washington (US 20180369160A1; cited on the IDS filed 07/15/2022).
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 50-150 micrometers (i.e. microns, um, etc.).
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.
Also note that claim 7 being “the nanofibrous material has a stiffness when in contact with the damaged or injured nerve, that is similar to or less than the stiffness of the nerve” is an intended use (that does not provided weight in a composition claim) that is coupled with a vague functional limitation (see 112b rejection above). So, the Art will be applied bearing these considerations.
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, 4-6, 8, 10-12, and 26-28: 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 claim 1) (pg 8, lines 1-14). With regard to the numerical range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”).
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.
Regarding claim 7: Regarding intended use, only structural elements of a composition claim are considered with regard to patentability. Furthermore, Calza teaches nanofibrous material (pg 22, (iii)) made of PLGA and PCL (Calza – claim 8), including local delivery to the spinal cord (in which the spinal cord is a bundle of nerves) (abstract). Thus, the functional limitation of “the nanofibrous material has a stiffness when in contact with the damaged or injured nerve, that is similar to or less than the stiffness of the nerve” would be expected, because Calza uses the same ingredients in the same or similar dimensions as the instant Application, in providing devices and/or structures of similar expected properties. The instant physical and chemical parameters (i.e., computed or measured) of the compounds are inherent to the instant ingredients. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Thus, the compositions of the instant invention would be expected to have property values that are indicated by the instant claims.
In summary, Calza teaches the instant composition of the claim set as obvious, because Calza teaches the elements of the instant claim scope, and the rationale for incorporating such elements in order to provide a drug-delivery device for local ibuprofen treatment of nerve fibers.
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 26-28 above, and in further view of Su (US20140336278A1), Zhao (Colloids and Surfaces B: Biointerfaces, 2014), and Washington (US 20180369160A1; cited on the IDS filed 07/15/2022).
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), or the amended, narrowed thickness range of 75-125 micron (instant claim 29).
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).
Washington teaches a wrap device that is useful local delivery of active agents [0069] for nerve regeneration [0004]. Washington teaches (without limitation) that the device is a sheet, wrap, ribbon, tube, or another form configured for therapeutic use, that is further any dimension, but particularly having a thickness ranging from about 1 μm to about 4 mm [0057]. With regard to the numerical range, note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)).
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).
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 use a sheet thickness of from about 1 μm to about 4 mm for a drug device capable of wrapping a nerve, as taught by Washington, because Washington teaches drug device wraps with a sheet thickness of from about 1 μm to about 4 mm as suitable for in vivo drug delivery for nerve treatment (abstract, [0057]), and whereby Calza only briefly discusses the production of sheets that are 150-170 micron thick (pg 8, lines 1-14).
Response to Arguments
Applicants arguments, see pg 7-12, filed 07/08/2026, with respect to the 103 rejection of claims 1, 4-12, and 26-29 under rejection have been fully considered and are persuasive. Therefore, the 103 rejection has been withdrawn. However, upon further consideration and in view of applicant’s amendments to the claims, new grounds of rejection are made by 112(b) rejection and 103 rejection (incorporating Washington to address the new narrowed thickness limitation of claim 29).
On page 7-8, Applicant addresses the application status and amendments related to the drawings and previous 112b rejection, which are found acceptable.
On page 8, Applicant argues that Calza does not teach a nanofibrous material with a thickness between 50-150 micrometers. Note, that Calza teaches thickness of 150-170 um (reads on instant claim 1) (pg 8, lines 1-14), which overlaps the range of instant claim 1. With regard to the numerical range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”).
On page 8, Applicant argues that Calza does not teach a material to be wrapped around a peripheral nerve. Note that this is an intended use, and as such, it does not provide patentable weight in a composition claim (as discussed above). 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, the patentability of a composition claim is based on the structure of the composition, and not its intended use.
Furthermore, an obviousness rejection relies on the combined Prior Art, including Washington who teaches drug-device materials that are wrappable around a nerve, and therefore this specific configuration would be obvious (i.e., Calza teaches local ibuprofen therapeutic action on nerve fibers, so a PHOSITA would find it obvious to create a wrappable drug-device of a certain thickness to wrap around nerve fibers in general for the purpose of local and beneficial drug delivery).
On page 8, Applicant argues that Calza is non-analogous art because Calza is directed to spinal cord injuries. Calza is reasonably analogous to the instant Application because of the reasonably pertinent test: As for the "reasonably pertinent" test, the examiner should consider the problem faced by the inventor, as reflected - either explicitly or implicitly - in the specification. In order for a reference to be "reasonably pertinent" to the problem, it must "logically [] have commended itself to an inventor's attention in considering his problem." In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1379-80 (Fed. Cir. 2007) (quoting In re Clay, 966 F.2d 656,658, 23 USPQ2d 1058, 1061 (Fed. Cir. 1992)). See also In re Klein, 647 F.3d 1343, 1348, 98 USPQ2d 1991, 1993 (Fed. Cir. 2011). Furthermore, a PHOSITA would consider Calza from the same field of endeavor as treatment and healing of nerve tissue. Applicant is reminded that the scope of analogous art is to be considered broadly. Wyers v. Master Lock Co., No. 2009-1412, 2010 WL 2901839 (Fed. Cir. July 22, 2010). Art is analogous if it is (1) from the same field of endeavor, regardless of the problem addressed, or (2) reasonably pertinent to the particular problem with which the inventor is involved. In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992). An inventor is not expected to have been aware of all prior art outside of the field of endeavor. Airbus, 41 F.3d at 1380-82. A reference outside of the field of endeavor is reasonably pertinent if a person of ordinary skill would have consulted it and applied its teachings when faced with the problem that the inventor was trying to solve. Airbus, 41 F.3d at 1380-82. In this case, the spinal cord consists of a bundle of nerve fibers, and Calza’s composition is intended for treatment of these nerve fibers with NSAID drug devices. In comparison, the instant Application is directed toward treatment of nerve fibers with NSAID drug devices.
Further note, that NSAID drug devices are suitable for treatment in a wide variety of medical configurations, and it is well-known in the Art that local ibuprofen release beneficially treats nerves of both the peripheral and central nervous system (e.g., Hurtado (US20130110138A1) teaches conduit/wraps (figure 1E, 14A-14H, [0076, 0086]) that treat peripheral nerve or spinal cord injury (abstract) via local delivery of ibuprofen [0103]; Elfar (US20160038419A1) teaches film wraps [0049] containing ibuprofen [0060] for local delivery and treatment of peripheral nerve injury (abstract)).
On page 8-9, Applicant argues that there is “no indication” that Calza’s scaffold are able to be wrapped around the peripheral nerve. First it is the combined Art that is relevant in an obviousness rejection: All elements of each prior art reference need not read on the claimed invention, rather, the proper test for obviousness is what the combined teachings would have suggested to a person of ordinary skill in the art. In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). In this case, Calza’s compositions are demonstrated as flexible, and furthermore, Washington demonstrates nanofibrous materials (i.e., incorporating polymers of the instant Application) that are able to be wrapped around peripheral nerves to enable local drug delivery. Thus, the combination of the obviousness analysis is enabled by the Prior Art.
Furthermore, with regard to reasonable expectation of success: “Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness).” Furthermore, Applicant has not provided evidence that Calza’s materials, that are adapted with modification from Washington are not able to wrap nerves of the peripheral system.
In further argument, Applicant discusses the different structures of the peripheral nerve and spinal cord (i.e., arguments pertaining to “intended use” and/or “analogous art”, which have been addressed above). The Examiner returns to the expected properties argument of the 103 above, and further points to Washington who demonstrates nanofibrous materials (i.e., incorporating polymers of the instant Application) that are able to be wrapped around peripheral nerves to enable local drug delivery.
On page 9-10, Applicant discusses the amended claim scope of claim 1 to have a thickness of 50-150 micrometers. Note, that Calza teaches thickness of 150-170 um (reads on instant claims 1) (pg 8, lines 1-14). With regard to the numerical range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”).
Applicant’s argument that the 150 micron is an “empirical” teaching and is not a teaching of the device thickness is a semantic-based argument that is not persuasive. Calza teaches verbatim: “All scaffolds were produced by electrospinning the polymeric solution for a period of 2 h, to gain samples with thickness in the range 150-170 um” (pg 8, lines 1-14), and thus a thickness of 150-170 um is an obvious thickness for Calza’s compositions that are described as drug-loaded/implantable scaffolds (pg 8, lines 1-14; Calza – claim 16) (and reads on the instant range of 50-150 micrometers, because the thickness ranges overlap).
Furthermore, Washington is reintroduced (prompted by amendment) to provide teachings of thickness of nerve wrappable drug-devices in general: “Washington teaches (without limitation) that the device is a sheet, wrap, ribbon, tube, or another form configured for therapeutic use, that is further any dimension, but particularly having a thickness ranging from about 1 μm to about 4 mm [0057]. With regard to the numerical range, note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)).” Therefore, the concept of a drug-device that is able to wrap a nerve to locally deliver ibuprofen of the instant dimensions of the instant invention is enabled and obvious from the Prior Art.
Furthermore, just because Calza is silent on a general discussion of scaffold thickness is not an exclusion of all thickness teachings for Calza’s compositions. The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. "The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness." In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983). It can be inferred from examples and figures, that Calza’s compositions are of some thickness (e.g., Calza teaches 150-170 um on pg 8, lines 1-14), and the absence of a restricted thickness limitation in the broader claim scope merely implies a non-limiting thickness.
On page 10-11, Applicant goes into detail about the spinal cord again discussing a particular mechanism, that is different from the mechanism of peripheral nerve treatment (i.e., again “intended use” and/or “analogous art” arguments). This has been addressed above, with regard to the analogous of Calza to the instant Application, and furthermore, the contributions of Washington. Furthermore, Hurtado and Elfar teach local ibuprofen administration has a beneficial effect toward the treatment of peripheral and central nerve fibers, when ibuprofen is locally delivered to the nerve fiber.
On page 11, Applicant argues that the remaining references do not remedy the alleged deficiencies of Calza. The remaining references are used in the 103 rejection above to address various minor limitations of the instant claim set. Furthermore, it is noted that Washington is introduced by prompt of amendment (that narrows the thickness of the sheet), as analogous art, and addresses the new thickness range of instant claim 29, as shown in the 103 rejection above.
On page 11-12, Applicant concludes. However, the claims stand rejected on the new grounds of rejection, as the arguments are not persuasive.
Correspondence
Applicant's amendment necessitated the new ground 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 extension fee 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 date of this final action.
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/R.P./Examiner, Art Unit 1614 7/27/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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