DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Status of the Claims
The response and amendment filed 12/19/2025 is acknowledged.
Claims 7-11 and 21 are pending.
Applicant’s election without traverse of Group II, claims 7-11 and 18-21 in the reply filed on 07/22/2025 is acknowledged.
Claims 7-11 and 21 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 62670578, 16409495 and 17183083, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim 7 includes the limitations: anionic hydrogel for wound healing comprising: poly(oligoethylene glycol monoacrylate), acrylic, a neutral species and a wild- type fibroblast growth factor 1 (wtFGF1).
The prior filed applications do not appear to support a claim containing the combination of limitations. Although the prior filed applications provide support for a hydrogel containing oligoethylene glycol monoacrylate, and acrylic acid, the prior filed applications appear to be silent to the genus “neutral species”.
Applicable to claims 10, 11, 20, and 21: the prior filed applications do not appear to support a claim including the limitation of “gelatin”.
Applicable to claims 9 and 19: the prior filed applications do not appear to support NIPAM 125
Claims 8 and 18 are supported by the prior filed applications 16409495 and 17183083 because the prior filed applications because the prior filed applications clearly disclose PAA-co-POEGA-co-PNIPAM.
Application Nos. 62670578 does not appear to support PNIPAM copolymers with PAA and POEGA.
Claims 8 and 18 have an effective filing date of 05/10/2019
Claims 9-11, and 19-21 have an effective filing date of 04/10/2023.
Withdrawn
The duplicate claim warning has been withdrawn because of Applicant’s amendment.
The objection to claim 20 has been withdrawn because of Applicant’s amendment.
Rejections of canceled claims 18-20 have been withdrawn.
Response to Arguments
Applicant’s arguments filed 12/19/2025 have been fully considered but they are not persuasive.
Applicants disagree that Kreig et al. is the same as the claimed invention. Applicant argues Krieg describes a synthesis of linear polymers. Applicant argues the resulting gel is not covalently bonded as the resulting gel of the claimed inventions. Applicant argues in contrast, the claimed inventions are created by a synthesis that produces a 3D polymer network through the use of cross-linkers. Applicant argues the resulting 3D network gels of claims 8 and 9 further distinguish over the prior art by claiming a N-isopropylacrylamide (NIPAAm) component which is heat sensitive. Applicant argues NIPAM allows for the controlled delivery of proteins by heating. Applicant argues this is different from the existing patent of PEG-PAA polymers which rely only on passive control.
These arguments are unpersuasive.
It is acknowledged that Kreig does not expressly teach the polymer is a hydrogel and the polymer further comprises a crosslinker. However, Kreig does teach the polymer as a water-soluble polymer. Roos teaches the technique of modifying water soluble polymers with a crosslinker to form a hydrogel. Roos teaches hydrogels comprising N,N’-methylene-bis-acrylamide crosslinker. See Roos, c17:43-55. Roos teaches the concentration of 0.3 to 4 mole percent, wherein the amount of crosslinker is a parameter the skilled artisan would modify to optimize mechanical strength of the gel, swelling degree, and intensity of phase transition trigger (Roos, e.g., c17:43-55). Since Krieg teaches the water-soluble polymer polyacrylate-co-oligoethylene glycol useful in drug delivery the skilled artisan would have been motivated to use the techniques known from Roos to improve the drug delivery capability of Krieg’s polymer in a hydrogel. The skilled artisan would have been motivated to modify the water-soluble polymer of Krieg using techniques known from Roos to achieve the drug delivery objective suggested by Krieg.
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 of this title, 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.
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 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Krieg, Polymer Chemistry, 1, 2010 (cited on Applicant’s IDS dated 04/10/2023) in view of Roos, US 5840338 (cited on Applicant’s IDS dated 04/10/2023) and Hanna, US 20160256604.
Anionic hydrogel based on poly(acrylic acid)-co-poly(oligoethylene glycol monoacrylate) (PAA-co-POEGA) is interpreted to mean a hydrogel comprising poly(acrylic acid)-co-poly(oligoethylene glycol monoacrylate) (PAA-co-POEGA).
Krieg teaches water soluble polymers based on acrylic acid and oligoethylene glycol acrylate (Krieg, e.g., pg. 1671, c2:¶ 2-3, random copolymer and block copolymer). These appear to be the same polymers upon which the presently claimed hydrogel is based.
Krieg teaches the polymers having utility in drug-delivery systems (Krieg, e.g., pg. 1669, c1:¶ 1).
Krieg teaches the polymers capable of absorbing moisture and have the property of water uptake (Krieg, e.g., abstract).
Krieg suggests the water soluble polymers may be crosslinked and in the form of a gel (Krieg, e.g., pg. 1670, c1:¶ 2, Water uptake properties of polymers…).
Krieg does not expressly teach the water-soluble copolymer (PAA-co-POEGA) as a swollen hydrogel.
Krieg does not expressly teach the combination of (PAA-co-POEGA-co-NIPAM).
Krieg does not expressly teach FGF1.
However, the combined teachings of Roos and Hanna cure these defects.
Roos teaches hydrogels comprising water soluble polymers (Roos, e.g., c4:25-34), useful for drug delivery (Roos, e.g., c4:35-43).
Roos teaches hydrogels comprising FGF.
Roos teaches hydrogels in the form of disks (Roos, e.g. example 4 and c49:6-34).
Roos teaches injectable hydrogels (Roos, e.g., c34:1-21).
Roos teaches hydrogels for protein delivery (Roos, e.g., c3:9-30).
Roos teaches hydrogels comprising N,N’-methylene-bis-acrylamide crosslinker. See Roos, c17:43-55. Roos teaches the concentration of 0.3 to 4 mole percent, wherein the amount of crosslinker is a parameter the skilled artisan would modify to optimize mechanical strength of the gel, swelling degree, and intensity of phase transition trigger (Roos, e.g., c17:43-55).
Roos teaches the hydrogel in combination with a phosphate buffer (Roos, e.g., c27:5-38).
Hanna teaches FGF1 was known and used for healing in wound dressings (Hanna, e.g., 0259).
It would have been obvious to one of ordinary skill in the art, before the filing date of the presently claimed invention, to use a water-soluble polymer such as polyacrylate-co-oligoethylene glycol as known from Krieg in a hydrogel for drug delivery as understood from Roos with a reasonable expectation of success. Since Krieg teaches the water-soluble polymer polyacrylate-co-oligoethylene glycol useful in drug delivery the skilled artisan would have been motivated to use the techniques known from Roos to improve the drug delivery capability of Krieg’s polymer in a hydrogel. The skilled artisan would have been motivated to modify the water-soluble polymer of Krieg using techniques known from Roos to achieve the drug delivery objective suggested by Krieg. The skilled artisan would have had a reasonable expectation of success because Roos suggests hydrogels may be formed from similar polymers, e.g., acrylate polymers, for drug release in a stimulus responsive manner. The skilled artisan would have further been motivated to incorporate a fibroblast growth factor known ad used for healing in wound dressings such as FGF1 based on the teachings of Hanna with a reasonable expectation of success. Since Roos teaches the dressings may further comprise fibroblast growth factors, the skilled artisan would have had a reasonable expectation of successfully incorporating the known FGF1 fibroblast growth factor for improved healing.
Applicable to “neutral species” and claim 8: Roos teaches the hydrogel including PNIPAM (Roos, e.g., c15:25-47) for temperature responsiveness (Roos, e.g., c45:34-44).
Accordingly, the subject matter of instant claims 7 and 8 would have been obvious before the filing date of the presently claimed invention absent evidence to the contrary.
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Chen, US 20190343959.
Chen teaches an anionic hydrogel comprising PAA-co-POEGA-co-NIPAM (Chen, e.g., 0071-0077 and table 3). The anionic hydrogel enables electrostatic interactions with proteins for sustained release when used as a wound dressing (Chen, e.g., 0021 and 0051). Hydrogels further comprise wtFGF1 (Chen, e.g., 0014 and 0065-0068).
Chen does not expressly teach the hydrogel monomer ratios of claims 9 and 19.
However, the ratio of monomers was a result effective parameter the skilled artisan would have optimized for desired electrostatic interaction effect (Chen, e.g., 0051), drug release (Chen, e.g., Table 1, 0053 and 0076). Since Chen provides the general ratios effective PAA-co-POEGA-co-NIPAM (Chen, e.g., Table 3), the skilled artisan would have had a starting point from which to optimize the ratios including gelatin with a reasonable expectation of success. There does not appear to be any evidence of criticality associated with the specific ratios claimed.
It would have been obvious before the effective filing date of the presently claimed invention to optimize the monomer ratio in hydrogels comprising PAA-co-POEGA-co-NIPAM and wtFGF1 known from Chen with a reasonable expectation of success. The skilled artisan would have been motivated to optimize the ratio of AA and NIPAM to achieve desired electrostatic interaction effect and drug release when used as wound dressings. The skilled artisan would have had a reasonable expectation of success since Chen sets forth a number of PAA-co-POEGA-co-NIPAM hydrogels as a starting point from which to optimize. There does not appear to be any evidence of criticality associated with the specific ratios claimed.
Accordingly, the subject matter of claims 7 and 9 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 7, 10-11, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Chen, US 20190343959 (cited on Applicant’s IDS dated 04/10/2023) in view of Sojomihardjo, US 6565842.
Chen teaches an anionic hydrogel comprising PAA-co-POEGA (Chen, e.g., Abstract). The anionic hydrogel enables electrostatic interactions with proteins for sustained release when used as a wound dressing (Chen, e.g., 0021 and 0051). Hydrogels further comprise wtFGF1 (Chen, e.g., 0014 and 0065-0068).
Chen does not expressly teach the hydrogel further comprising gelatin.
Sojomihardjo teaches hydrogels comprising acrylic acid polymerized with gelatin (Sojomihardjo, e.g., c15:27-49 and c9:3-35) useful as a wound dressing (Sojomihardjo, e.g., c4:15-40). Gelatin supports cell adhesion and enhances cell growth (Sojomihardjo, e.g., c13:35-65).
It would have been obvious before the effective filing date of the presently claimed invention to modify hydrogels comprising PAA-co-POEGA and wtFGF1 known from Chen by incorporating gelatin as suggested by Sojomihardjo with a reasonable expectation of success. The skilled artisan would have been motivated to improve Chen’s hydrogels with gelatin using techniques known from Sojomihardjo for improved cell adhesion and cell growth when used as wound dressings. The skilled artisan would have had a reasonable expectation of success since both documents teach hydrogels for use as wound dressings.
Applicable to claims 11 and 21: The combined teachings of Chen and Sjomihario do not expressly teach the claimed ratios. However, the ratio of monomers was a result effective parameter the skilled artisan would have optimized for desired electrostatic interaction effect (Chen, e.g., 0051), drug release (Chen, e.g., Table 1, 0053) and optimal cell growth enhancement effect (Sojomihardjo, e.g., c13:35-65). Since Chen provides the general ratios effective for PAA-co-POEGA hydrogels (Chen, e.g., Table 1), the skilled artisan would have had a starting point from which to optimize the ratios including gelatin with a reasonable expectation of success. There does not appear to be any evidence of criticality associated with the specific ratios claimed.
Accordingly, the subject matter of claims 7, 10-11, and 21 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615