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 .
DETAILED ACTION
Applicant’s arguments, filed 10/10/2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
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 or joint 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 1-8 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites “nano- and/or microfibers.” The term “nano- and/or microfibers” is not a term of art and there is no definition or representative number of examples in the application that describe this term in such a way to show that applicant had possession of the invention at the time of filing. While a nanofiber is understood as a fiber of nanomater size, and a microfiber is understood as a fiber of micrometer size, the term “nano- and/or microfibers” is not an art-recognized term, is not described in the application, and therefore fails to meet the written description requirement.
Applicant’s arguments have been fully considered but are not found persuasive. Applicant’s arguments that the term as amended is described is unpersuasive because while a nanofiber is understood as a fiber of nanomater size, and a microfiber is understood as a fiber of micrometer size, the term “nano- and/or microfibers” is not an art-recognized term, is not described in the application, and therefore fails to meet the written description requirement.
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 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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. The recitation in “a method of producing ”poly(n-butyl cyanoacrylate) based nano/microfibers” is unclear because “nano- and/or microfibers” is not a term of art and is nonsensical. “Nano” is an adjective that qualifies if something is nano-size. “Microfibers” is a noun and refers to microfibers. It does make sense to have the recitation of an adjective “nano” (an adjective) and/or microfibers (a noun). Further, it is unclear what the genus of a poly(alkyl cyanoacrylate) based nano/microfiber encompasses, that is, in what way the “nano- and/or microfibers” are based on poly(n-butyl cyanoacrylate), for example, if the claim requires the use of poly(n-butyl cyanoacrylate) or if it is open to anything that may be based on the compound, such as compounds that have similar chemical behavior or derivative compounds that are based on poly(n-butyl cyacnoacrylate).
Applicant’s arguments have been fully considered but are not found persuasive. Applicant’s arguments that the term as amended is now clear. This is not found persuasive because “nano- and/or microfibers” is not a term of art and is nonsensical. “Nano” is an adjective that qualifies if something is nano-size. “Microfibers” is a noun and refers to microfibers. It does make sense to have the recitation of an adjective “nano” (an adjective) and/or microfibers (a noun). Further, it is unclear what the genus of a poly(alkyl cyanoacrylate) based nano/microfiber encompasses, that is, in what way the “nano- and/or microfibers” are based on poly(n-butyl cyanoacrylate), for the reasons given above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over WO2013009010 (hereafter WO’010; IDS 6/11/2021; Translation in record and will be reference hereafter). WO’010 teaches a method of producing poly(alkyl cyanoacrylate) based nano/microfibers (abstract; page 1, first paragraph to page 2 eighth full paragraph), the method comprising (a) providing poly(octyl cyanoacrylate) (n-octyl-2-cyanoacrylate) homopolymer obtained by anionic polymerization of octyl cyanoacrylate (title; page 1, fifth and seventh paragraph) ), (b) dissolving the poly(octyl cyanoacrylate) of step (a) in a solvent (page 2, first and second full paragraph); (c ) electrospinning the solution obtained in step (b) to obtain poly(octyl cyanoacrylate)-based nano/microfibers on a collector (page 2, sixth full paragraph; page 4, fourth paragraph; last page, last paragraph)); and (d) removing the poly(octyl cyanoacrylate) based nano/microfibers from the collector (page 3, third full paragraph), the obtained nano/microfibers are used for wound dressings, as well as nanofiber mesh for adhering to the wound. Polyethylene oxide (poly(ethylene glycol) (a non-PACA polymer) is added to the solution prior to electospinning (last page, second to last paragraph). Regarding claim 8, the phrase “are not comprised by a support” is non-sensical. For the purpose of comparing claim 8 to the prior art, it is deemed that the nano/microfibers obtained in step (d) are not comprised by a support.
WO’010 fails to teach the present ratio of 1.4 to 1.7.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to optimize the method to improve the wound healing/dressing ability of the nano/microfiber, and would find the ratio of 1.4 to 1.7 through routine experimentation with the motivation of improving the product for wound healing/dressing. It would have been further obvious to optimize the ratio of the weight average molecular weight to the number average molecular weight for the improvement of wound healing/dressing ability, and the artisan would find the presently claimed range through routine experimentation. “‘[W]here 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 experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” MPEP § 2144.05, II.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that it would have been non-obvious to find the present range, the examiner’s response is it would have been obvious to one of ordinary skill in the art at the time the invention was filed to optimize the method to improve the wound healing/dressing ability of the nano/microfiber, and would find the ratio of 1.4 to 1.7 through routine experimentation with the motivation of improving the product for wound healing/dressing. It would have been further obvious to optimize the ratio of the weight average molecular weight to the number average molecular weight for the improvement of wound healing/dressing ability, and the artisan would find the presently claimed range through routine experimentation. Regarding applicant’s arguments that in Table 1 of the application hat “it is evidence from the experimental data of the present application that a polyhdispersity index in the claimed range of 1.4 to 1.7 provides for PBCA-based nano- and/or microfibers having advantageous physical and mechanical properties, while at the same time maintaining processability, applicant points to Table 1 on Page 47 for support, but there is no showing in Table 1 of testing of PBCA-based nano- and/or microfibers both inside and outside of the range of 1.4 to 1.7 to show that he range is critical to the results, and further has not shown that the results, which are limited to the particular examples, would necessarily extend over the scope of the invention which is directed to a method of producing poly (n-butyl cyanoacrylate) based nano- and/or microfibers.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
December 9, 2025