DETAILED ACTION
Claims 1-7 and 9 are currently pending. Claims 1-7 are currently under examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/27/2026 has been entered.
Examiner’s Note
Applicant's amendments and arguments filed 04/27/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed 04/27/2026, it is noted that claim 1 has been amended and no new matter or claims have been added.
New Objection:
Claim Objections
The reply filed on 04/27/2026 is not fully responsive to the prior Office Action because of the following omission(s) or matter(s):
The amendments to the claims do not comply with the Revised Amendment Practice of 37 CFR 1.121 (See OG Notice 23 September 2003). Specifically, a list of all claims should be submitted, the text of withdrawn claims must be included in the listing of the claims, the text of canceled claims must be omitted and the text of any added subject matter must be shown by underlinking the added text. Further the claims must have the proper identifiers in parenthetical expression.
Claim 1 is objected as not underlining the claim amendment. Claim 1 is identified as amended however no limitations are underlined. The limitation of “and wherein the anti-adhesion polymer composition is injectable” is newly added and not underlined.
It is noted that 37 CFR 1.121 also states a claim which is previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments.
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.
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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0010490 (previously applied) in view of US 2011/0274726 (previously applied), CN 102198087 (previously applied) and US 6,323,189 (previously applied).
Regarding claims 1-4, the limitation of an anti-adhesion polymer composition comprising: 24-50 wt% of a polyethylene glycol-polypropylene glycol-polyethylene glycol (PEG-PPG-PEG) block copolymer represented by the following chemical formula 1: 0.03-5wt% of gelatin, 0.03 to 5 wt% of chitosan; wherein x and z are 75-110, y is 20-70 and the PEG-PPG-PEG block copolymer has a molecular weight of 6,000 to 20,000 Da and wherein the anti-adhesion polymer compristion is injectable is met by the ‘490 publication teaching anti-adhesion polymer composition capable of supporting growth factor. The anti-adhesion polymer composition capable of supporting growth factor comprises 24-50wt% of polyethylene glycol-polypropylene glycol-polyethylene glycol (PEG-PPG-PEG) block copolymer having a PEG content of 65-85 wt% and molecular weight of 6,000-20,000 Da; 0.03-5 wt% gelatin, 0.03-5wt% of chitosan and distilled water (abstract). The formulation is taught to be injectable [0012]. Anti-adhesion polymer composition that comprises a biopolymer such as chitosan or gelatin and thus effectively exhibits anti-adhesion function and the same time has an excellent adhesive property so can be easily and continuously adhered to a wound site [0021]. Exemplified compositions are taught to include 3 wt% chitosan, 15 wt% of poloxamer 188 (PEG-PPG-PEG block copolymer) and 16 wt% poloxamer 407 (PEG-PPG-PEG block copolymer) were dissolved by stirring, the resulting mixture was combined with gelatin and glycerol [0042]. The instant specification discloses poloxamer 188 and poloxamer 407 fall within Formula I (page 9, lines 1-10, page 12, lines 10-15, Example 1).
Regarding clam 6, the limitation of further comprising a growth factor wherein the group factor is selected from a group including epidermal growth factors is met by the ‘490 publication teaching epidermal growth factor [0040].
Regarding claim 7, the limitation of further comprising a stabilizer wherein the stabilizer comprises one or more selected from the group consisting of glycerol, glycerides and glycols is met by the ‘490 publication teaching the inclusion of glycerol [0042].
The ‘490 publication does not specifically teach 0.01 to 1 wt% of an acid solution, wherein the antiadhesion polymer composition as a pH of 3.5 or more (claim 1) wherein the acid solution is selected from a group which includes acetic acid (claim 5).
The ‘087 publication teaches in situ gelling agent for ophthalmic solutions containing chitosan, stabilizer, acetic acid, pH regulator and water. Chitosan is taught as an in-situ gelling agent increases the solubility and has biological adhesive action (abstract). In situ gelling agents for eyes is taught to include 3-60 wt% chitosan, 2.1-7.35 acetic acid (page 2). Dissolving chitosan with deionized water and acetic acid to obtain a chitosan solution (page 2).
The ‘726 publication teaches a solid foam wound dressing (abstract). A protic acid is used in the aqueous solution may be a proton donor acid that facilitates dissolving chitosan and stabilizes foam formed during the process. The acid can include acetic acid and be present from 0.01 to 10 wt%, preferably 0.1 to 5 % by weight depending on the stability of the foam during the process, and the softness, flexibility and adhesiveness of the final product desirable for medical treatment [0037]. The composition may additionally include pluronics [0038].
The ‘189 patent teaches chitosan containing liquid compositions and method of their preparation (title). Chitosan is taught as dissolved in weak acids such as acetic acid (column 3, lines 10-20). Compositions are taught to include chitosan, acetic acid, water (Example 3). The pH is taught to be between 2 and 4, typically about 3.9 (column 23, lines 55-65, column 24, lines 1-8). The composition is taught be used for wound applications (column 19-20, line 5).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use acetic acid in the composition taught by the ‘490 publication because the ‘490 publication teaches anti-adhesion polymer composition to be used in a wound site wherein the composition is injected and gels in the body and the ‘087 publication teaches in situ gelling solutions containing chitosan and acetic acid. Thus the ‘087 publication teaches that it is known to use acetic acid and chitosan on in situ gelling solutions applied to the body. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to include acetic acid in the composition aught by the ‘490 publication because the ‘726 publication teaches the use of acetic acid to dissolve chitosan and stabilize foam in a wound dressing composition as the ‘490 publication teaches an aqueous solution used for wound treatment containing chitosan. Thus one of ordinary skill in the art before the filing date of the claimed invention would be motivated to include acetic acid in the compositions of the 490 publication to solubilize chitosan. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known pH for wound containing composition as taught by the ‘189 patent, wherein the wound containing composition containing acetic acid and chitosan as taught by the combination of the ‘490 publication and the ‘087 publication.
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.
Claims 1-2 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9,327,049 in view of US 20110274726 and US 6,323,189. The instant claims and the ‘049 patent are directed to anti-adhesion polymer comprising overlapping amounts of PEG-PPG-PEG polymer having an overlapping molecular weight, gelatin, chitosan, water and glycerol in overlapping amounts with a growth factor, wherein the copolymer may be two different block copolymers, wherein the amount of PEG and PPG in the copolymer is taught as optimizable by the ranges in the ‘049 patent and x,y and z values in the instant claims. The instant claims differ from those of the ‘049 patent in that the instant claims requires an acid solution from 0.01 to 1 wt% and a pH of 3.5 or more, wherein the composition is injectable.
The ‘726 publication teaches a solid foam wound dressing (abstract). A protic acid is used in the aqueous solution may be a proton donor acid that facilitates dissolving chitosan and stabilizes foam formed during the process. The acid can include acetic acid and be present from 0.01 to 10 wt%, preferably 0.1 to 5 % by weight depending on the stability of the foam during the process, and the softness, flexibility and adhesiveness of the final product desirable for medical treatment [0037]. The composition may additionally include pluronics [0038].
The ‘189 patent teaches chitosan containing liquid compositions and method of their preparation (title). Chitosan is taught as dissolved in weak acids such as acetic acid (column 3, lines 10-20). Compositions are taught to include chitosan, acetic acid, water (Example 3). The pH is taught to be between 2 and 4, typically about 3.9 (column 23, lines 55-65, column 24, lines 1-8). The composition is taught be used for wound applications (column 19-20, line 5).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to include acetic acid in overlapping amounts as in the composition of the ‘049 patent as the ‘726 publication teaches the use of acetic acid to solubilize and stabilize chitosan containing compositions and the ‘049 patent teaches a composition including chitosan. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use a known pH to dissolve chitosan as taught by the ‘189 patent as the ‘049 patent teaches a composition including chitosan in a composition which may be injectable and the ‘189 patent teaches known pH to dissolve chitosan.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: The ‘490 publication (Kim) in view of the ‘726 publication (Guo), the ‘087 publication (Wei) and the ‘189 patent (Hardinge-Lyme)
Applicant argues the combination of references fail to suggest an anti-adhesion polymer composition which is injectable.
In response, the ‘490 publication teaches the formulation is taught to be injectable [0012].
Applicant argues they discovered that chitosan precipitation does not occur when about 0.01 to 1 wt% of acid solution is included in an anti-adhesion composition.
In response, the ‘087 publication teaches in situ gelling agents for eyes is taught to include 3-60 wt% chitosan, 2.1-7.35 acetic acid (page 2). Dissolving chitosan with deionized water and acetic acid to obtain a chitosan solution (page 2). The ‘726 publication teaches a protic acid is used in the aqueous solution may be a proton donor acid that facilitates dissolving chitosan and stabilizes foam formed during the process. The acid can include acetic acid and be present from 0.01 to 10 wt%, preferably 0.1 to 5 % by weight depending on the stability of the foam during the process, and the softness, flexibility and adhesiveness of the final product desirable for medical treatment [0037]. Thus, it was known in the art to include acid in solutions containing chitosan to dissolve and stabilize the solutions.
Applicant argues the ‘490 publication makes repeated comments warning against the inclusions of acid additives in an anti-adhesion composition. The ‘490 publication states that acids material such as PLA may cause inflammation and may be harmful in the human body, thus teaches away from the addition of acids to an anti-adhesive composition.
In response, the ‘490 publication states the PLA as a polymer has a disadvantage in that it can cause inflammation [0007] wherein PGA is taught away from because of the acidic degradation product and acidic irritates the surrounding tissue [0015]. It additionally teaches acidity influences physical properties of gelatin and the polymer [0008]. Thus the ‘490 publication teaches away from the use of acidic polymers which comprise acidic degradation products. The use of acidic polymer and acids are different structurally, thus teaching away form one of those doesn’t necessarily extend to adding an acid. Additionally, the amounts of polymer and those taught acid. The ‘490 publication teaches 24-50wt% PEG-PPG-PEG polymeric material, wherein the ‘726 publication teaches acid present from 0.1 to 10 wt% [0038]. Additionally, the ‘189 patent teaches the addition of chitosan containing material dissolved in weak acid to wounds (title, Example 3, column 19-20, line 5) thus teaches it is known to apply chitosan and acetic acid containing material to the skin.
Applicant argues neither the ‘726 publication, the ‘087 publication and the ‘189 patent disclose an injectable anti-adhesion polymer composition and are rather non-analogues art. Applicant argues the ‘726 publication is directed to a solid implant and thus not injectable. Applicant argues the ‘087 publication is directed to artificial teaches.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The ‘490 publication teaches an injectable compositions as discussed above. In response, the ‘490 publication teaches the chitosan, poloxamer were added to water and completely dissolved [0042] thus teaching the desire for chitosan to be dissolved and the ‘726 publication teaches a protic acid being used to dissolve chitosan (abstract, [0037]). Thus, it would be obvious to add acetic acid to dissolve the chitosan as is desired by the ‘490 publication. The ‘490 publication and the ’189 patent are both directed to composition which comprise chitosan and may be applied to wounds (‘490 publication: abstract, ‘189 patent column 19-20, line 5). Thus, the cited are directed to chitosan containing compositions used in the medical field on the body.
Applicant argues the ‘726 publication chitosan is the main component of the solid wound dressing however nothing suggests the addition of an acid solution to an anti-adhesion polymer composition comprising PEG-PPG-PEG, gelatin and chitosan. In response, the ‘490 publication teaches PEG-PPG-PEG block copolymer, gelatin, chitosan and distilled water [0020]. The ‘087 publication teaches solutions containing chitosan, stabilizer, acetic acid and water, wherein the chitosan is taught as in situ gelling agent increased the solubility and has biological adhesion action (abstract) wherein acetic acid is known to dissolve chitosan (page 2). The ‘726 publication teaches a solid foam wound dressing (abstract) in a composition comprising chitosan and acetic acid [0037]. It was well known to use acetic acid in combination with chitosan containing compositions to solubilize the chitosan, wherein the acid is known to be used in wound dressing composition and the ‘490 publication is directed to a chitosan containing composition to be used at a wound site. Applicant has presented no evidence the acetic acid could not be used in combination with the PEG-PPG-PEG block copolymer or gelatin.
Applicant argues the ‘189 patent teaches acetic acid being used to dissolve chitosan during initial preparation however does not suggest the addition to prevent precipitation of chitosan form and anti-adhesion polymer composition of long-term storage stability.
In response, the ‘189 patent teaches chitosan containing liquid compositions and method of their preparation (title). Chitosan is taught as dissolved in weak acids such as acetic acid (column 3, lines 10-20). Compositions are taught to include chitosan, acetic acid, water (Example 3). The pH is taught to be between 2 and 4, typically about 3.9 (column 23, lines 55-65, column 24, lines 1-8). The composition is taught be used for wound applications (column 19-20, line 5). Thus the ‘189 patent teaches application to the body (wounds).
Double Patenting:
Applicant argues the ‘049 patent is equivalent to the ‘490 publication discussed above. The ‘490 publication teaches away from the addition of acids to an anti-adhesive composition.
In response, Applicant’s arguing regarding the ‘490 publication are addressed above as first presented. Additionally the double patenting rejection is based on the claims of the ‘049 patent, wherein the claims do not contain a teaching away for the use of an acid.
Applicant argues the ‘726 publication and the ‘189 patent are non-analogues prior art references and neither suggest the inclusion of 0.01 to 1 wt% of an acid solution in an injectable anti-adhesive composition.
In response, the ‘049 patent teaches an injectable composition as discussed above. A chitosan, poloxamer were added to water to form a solution (claim 2) thus teaching the desire for chitosan to be dissolved and the ‘726 publication teaches a protic acid being used to dissolve chitosan (abstract, [0037]), wherein the amount of acid is taught [0037]. Thus, it would be obvious to add acetic acid to dissolve the chitosan as is desired by the ‘049 patent. The ‘049 patent and the ’189 patent are both directed to composition which comprise chitosan and may be applied to wounds (‘049 patent claim 2, ‘189 patent column 19-20, line 5). Thus, the cited are directed to chitosan containing compositions used in the medical field on the body. Thus the ‘049 patent, the ‘726 publication and the ‘189 patent are all directed to chitosan containing compositions for use with wounds.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
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