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 .
Applicants' arguments, filed July 9, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Rejections - 35 USC § 112 – Indefiniteness (New Rejection)
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 1-6 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.
Claim 1 recites “any one of a first synthesis process”. It is not clear if the “any one of” means a first synthesis process or “any one” chosen from the first and second process. It is suggested Applicant amend the claims to recite “is prepared by a first synthesis process or a second synthesis process.
Claim Rejections - 35 USC § 103 – Obviousness (New Rejection)
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Shu et al. (CN 103083282) in view of Thompson et al. (Nanomaterials (2021) and Liu et al. (CN 103494877).
Shu et al. disclose a patch for wound healing. The purpose of the patch is to reduce the appearance of scars (paragraph 0012). The composition comprises 0.4 to 3% carbomer (instant claim 1), 0.1 to 1% polyvinyl alcohol (thickener), 4 to 8.5% polyacrylic acid resin (thickener), 0.1 to 2% sodium carboxymethyl cellulose (instant claim 2, thickener), 0.01 to 0.5% kollidon (polyvinyl pyrrolidone, thickener), 20 ~ 30% humectant, 0.05 to 1% bacteriostat (plant extract), 50 to 70% deionized water, pH regulator proper quantities and 1 to 20% the medicine (Abstract). The medicine may be aloe (plant extract, aloe extract of instant claim 4). The pH regulator may be NaOH (instant claim 6). The humectant may be glycerol (instant claim 3).
Shu et al. differ from the instant claims insofar as they do not disclose hyperbranched polylysine grafted compound.
Thompson et al. disclose highly branched polymer based on polyaminoacids for biomedical application. The polyaminoacids include polylysine. Lysine is an one of the 20 essential amino acids (Abstract). The highly branched polymer may be used to deliver drugs. The drugs are covalently bonded to the hyperbranched polymers (section 3). Since poly(amino acid)s are built from natural amino acids, the same building blocks proteins are made of, they are biocompatible, biodegradable and their degradation products are metabolizable (Abstract).
Liu discloses a skin wound repairing medicine composition comprising asiaticoside. Asiaticoside can promote ectoderm tissue cell regeneration, repair, gel and membrane glycoprotein interaction to form a physically entangled, forming stronger mucus gel net structure, the mucosal system keeps long adhesion time that absorbs wound bacteria, virus or other pathogen.
It would have been obvious for one of ordinary skill in the art prior to filing the instant application to have made a hyperbranched polylysine (H-PLL) complexed to asiaticoside (AS) and used it with the wound dressing Shu et al. motivated by the desire to produce a wound dressing that can promote ectoderm tissue cell regeneration and repair. Binding the asiaticoside with a hyperbranched polylysine would provide a delivery system that is biocompatible and capable of breaking down into metabolites.
In regards to the amounts, the claims do not recite a total parts. The total amount of possible parts ranges from about 154 to about 239 parts. The components comprise 0.4 to 3% carbomer (instant claim 1), 0.1 to 1% polyvinyl alcohol (thickener), 4 to 8.5% polyacrylic acid resin (thickener), 0.1 to 2% sodium carboxymethyl cellulose (instant claim 2, thickener), 0.01 to 0.5% kollidon (polyvinyl pyrrolidone, thickener), 20 ~ 30% humectant, 0.05 to 1% bacteriostat (plant extract), 50 to 70% deionized water, pH regulator proper quantities and 1 to 20% the medicine. However, it does appear that the amounts in parts overlap that of the percentages disclosed by Shu et al. It is well-settled, however, that even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05. Accordingly, since an overlap plainly exists here, it would have been obvious to have selected values within the overlap, consistent with the reasoning. It would have been in the relative skill of one of ordinary skill in the art to have adjusted each amount based on the teaching of Shu et al. to arrive at amount for the desired therapeutic effect.
In regards to the pH, the claims recite 6.8-7.2 whereas Shu et al. disclose a pH range of 6.5 to 8.0. However, it does appear that the amounts in parts overlap that of the percentages disclosed by Shu et al. It is well-settled, however, that even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05. Accordingly, since an overlap plainly exists here, it would have been obvious to have selected values within the overlap, consistent with the reasoning.
In regards to the transitional language “consists”, the claim recites alkali pH adjusting agents. Aluminum salts may be used to buffer pH.
In regards to the cross linker (the aluminum salts) and EDTA (a linker regulator), it would have been obvious to omit a component of a reference where the function attributed to such is not desired or required. See MPEP 214404, II.A. Therefore, it would have been obvious to have removed a crosslinker and a linker regulator if the properties of these two components were not desired.
In regards to the process of making the hyperbranched polylysine, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." Therefore the combination of references meet the limitation of a hyperbranched polylysine anti-scar grafted compound, absent of evidence to the contrary. See MPEP 2113, I.
Obvious-Type Double Patenting (Maintained Rejection)
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.
Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/757,627 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as they both recite a wound dressing comprising a hyperbranched polylysine. The instant claims differ from the copending claims insofar as the instant claims recited more components in the dressing and do not recite a method for making the dressing. The copending claims are genus claims and use the transitional language comprising and therefore do not exclude the components of the instant claims. It would have been obvious to have made the composition of the instant claims with the method of the copending claims because the method makes a wound dressing with hyperbranched lysine. Therefore the instant claims are obvious over the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
The Examiner submits that the copending claims recite a hyperbranched polylysine. This would include different types of polylysine, including grafted polylysine. Therefore, the rejection is maintained.
Conclusion
Claims 1-6 are rejected.
No claims allowed.
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 LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
