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 .
Withdrawn Rejections
The prior rejection of claims 3-4 and 6 under 112(b) is withdrawn in light of Applicant amended instant claim 3 to clarify and remove beta urogastrone a mixture of two PEG-PPG-PEG block copolymers, which the Examiner finds persuasive.
Examiner’s Note
Applicant's amendments and arguments filed 11/04/2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 11/04/2025, it is noted that claims 1, 3-4 and 6 have been amended and no new matter or claims have been added.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments and to correct typographical errors.
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 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). 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 form 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 form 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.
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 full considered and are not deemed to be persuasive.
103: the ‘490 publication (Kim), the ‘726 publication (Guo), the ‘087 publication (Wei) and the ‘189 patent (Hardinge-Lyme)
Applicant argues the ‘490 publication fails to disclose 0.01 to 1wt% of an acid solution, wherein the anti-adhesion polymer composition has a pH of 3.5 or more.
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 ‘087 publication teaches chitosan in situ gelling comprising acetic acid, wherein the acetic acid is used to dissolve chitosan (page 2). The ‘726 publication teaches acetic acid used in 0.01 to 10 wt% [0037]. The ‘189 patent teaches a chitosan and acetic acid containing solution wherein the pH is 2 to 4 (example 3, column 23, lines 55-65, column 24, lines 1-8).
Applicant argues they have found that chitosan precipitates with the passage of storage time and thus lacks long term stability. In order to address this problem Applicant discovered that chitosan precipitation does not occur when about 0.1 to 1 wt% of an acid solution is included in an anti-adhesion polymer composition.
In response, Applicant is arguing unexpected results however has not presented factual evidence. Attorney’s arguments may not take the place of factual evidence wherein factual evidence is required. Additionally, as taught by the ‘087 publication and the ‘726 publication teaches the use of an acid to dissolve chitosan is known in the art.
Applicant argues the composition of claim 1 does not solely contain chitosan. In order to add one component (an acid), the person of skill must consider its interaction with each of the other components such as reactivity between PEG-PPG-PEG block copolymer and acid solutions, the reactivity between gelatin and acid solutions.
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 ‘726 publication (Guo) is not directed to anti-adhesion composition but instead discloses a solid foam wound dressing. The ‘726 publication is directed to non-analogous art, and the person of ordinary skill would not look to the ‘726 publication for guidance.
In response, the ‘726 publication is directed to wound dressing comprising chitosan, wherein the ‘726 publication is directed to compositions which may be applied to the wound and comprise chitosan (abstract), thus the compositions contain overlapping ingredients such as chitosan and are taught to be applied wounds.
Applicant argues the ‘726 publication is a solid foam wound dressing that uses chitosan as its main component and must be supersaturated during initial preparation. Nothing in the ‘726 publication suggests addition of an acid solution to an anti-adhesion polymer composition comprising PEG-PPG-PEG block copolymer, gelatin and chitosan let alone in order to improve long term storage stability of chitosan.
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. Applicant has presented no data regarding the storage stability of the composition; thus, Applicant is arguing limitations not present in the claim or unexpected result supported by factual evidence.
Applicant argues the ‘087 publication is not directed to anti-adhesion composition and is non-analogues art. The ‘087 publication fails to teach or suggest the addition of an acid solution to prevent precipitation of chitosan form an anti-adhesion polymer composition thus improving long term stability.
In response, the instant claims do not contain limitations directed to the storage stability, long term stability or the composition not containing precipitates, thus Applicant is arguing limitations not present in the instant claims.
Applicant argues the ‘189 patent fails to teach or suggest an anti-adhesion polymer comprising a PEG-PPG-PEG block copolymer, gelatin, chitosan and 0.01 to 1 wt% of acetic acid solution, wherein the anti-adhesion polymer composition has a pH of 3.5 pr more. The ‘189 patent is directed to chitosan suspension which may be ingested and be use as a general detergent or cleaning composition.
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]) and the ‘189 patent teaches chitosan to be dissolved in weak acids such as acetic acid at a pH between 2 and 4 (column 3, line 10-20, column 23, lines 55-65, column 24, lines 1-8). Thus, it would be obvious to add acetic acid to dissolve the chitosan as is desired by the ‘490 publication. Applicant has presented no data regarding the storage stability of the composition; thus, Applicant is arguing limitations not present in the claim or unexpected result supported by factual evidence.
Applicant argues the ‘189 patent is directed to non-analogous art.
In response 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).
Double Patenting:
Applicant argues instant claim 1 is not amended to specify the amount of acid and pH of the composition.
In response, Applicant is referred to the modified rejection above wherein the ‘189 patent teaches the pH of a chitosan containing composition.
Conclusion
No claims are 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.
Examiner Contact Information
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613