DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Amendments to the Claims and Arguments/Remarks filed 05 January 2026, in response to the Office Correspondence dated 30 October 2025, are acknowledged.
The listing of the claims filed 05 January 2026, have been examined. Claims 1, 2, 7-10, 15-17, 21-23 are pending. Claims 1, 9, 17, 21, and 22 are amended and are supported by the originally-filed disclosure. Claims 3-6, 11-14, and 18-20 are canceled and new claim 23 has been added.
Information Disclosure Statement
The Information Disclosure Statement (IDS), filed 02 March 2026, is acknowledged and has been considered.
Response to Amendment
A thorough examination has been made of the applicant’s response filed 05 January 2026. The applicant has amended claims 21 and 22 to remove the previously recited transitional phrases and to introduce additional structural limitations relating to plasticizers (claim 21), and equilibrium swelling properties (claim 22). These amendments correct the prior defects to the claims and accordingly, the prior rejection under 35 U.S.C. §112(d) is withdrawn.
While the amendments to claims 21 and 22 have overcome the prior rejection under 35 U.S.C. § 112(d), the arguments presented regarding patentability over the prior art have been fully considered but are not persuasive. The amendments do not place the claims in condition for allowance because the cited prior art continues to teach or render obvious the claimed subject matter. Where appropriate, the rejections are maintained and further clarified.
In addition, new grounds of rejection are made with respect to newly amended claims and newly added claim 23. Furthermore, the newly presented claims introduce new issues that are objected to as presented below.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 30 October 2025, since the art which was previously cited continues to read on the amended/newly cited limitations.
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, 2, 7, 21 and 22 are rejected under 35 U.S.C. § 103 as being unpatentable over Krausz and Friedman (Krausz A and Friedman AJ. Nitric oxide as a surgical adjuvant. Future Sci OA, 1(1):FSO56; publication date 01 August 2015; hereinafter referred to as “Krausz”) in view of Malone-Povilny et al. (Malone-Povolny MJ et al., Nitric Oxide Therapy for Diabetic Wound Healing. Adv Healthc Mater. 2019 Jun;8(12):e1801210; e-publication date: 15 January 2019; hereinafter referred to as “Malone-Povilny”) and Weller and Finnen (Weller R, Finnen MJ. The effects of topical treatment with acidified nitrite on wound healing in normal and diabetic mice. Nitric Oxide., 15(4):395-9; publication date Dec 2006; hereinafter referred to as “Weller”).
Krausz discloses the use of nitric oxide donors as surgical adjuvants to accelerate post-surgical revascularization and wound repair (Abstract; pages 7-8, Nitric oxide & vascular surgery). Krausz identifies nitric oxide donors including S-nitrosothiols and diazeniumdiolates as suitable agents (page 7, right column ¶2). Surgical site “not comprising cancerous tissue” is a field-of-use limitation without structural or functional distinction, in which Krausz’s examples (e.g., arterial graft and incision repair) are non-cancerous surgical sites.
Malone-Povolny discloses nitric oxide donor formulations prepared as lyophilized or dry powders, including GSNO and NONOate-modified diethylenetriamine, which are reconstituted or applied directly to wounds (page 17, ¶1 and page 19, ¶1, respectivey). The reference teaches that powdered formulations improve NO donor stability and handling, particularly for surgical or diabetic wound use (id., p. 18–19).
Weller further discloses acidified nitrite salts as nitric oxide donors that accelerate wound closure in diabetic and normal mice (page 1, Abstract).
In summary, Krausz teaches NO donor therapy at non-cancerous surgical site, Malone-Povolny teaches dry powder form and the specific GSNO species, Weller teaches nitrite salts as NO donors. Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine these teachings and use the nitric oxide donor system of Krausz (promoting post-surgical vascular repair) in the dry-powder delivery format of Malone-Povolny to improve shelf stability and surgical handling and employ nitrite salts as NO precursors as shown in Weller. No critical or unexpected result is identified in the specification distinguishing the claimed dry powder nitrite formulations from the cited prior art. One would be motivated to do so improve surgical handling and stability. The combination represents predictable use of known agents and formulations for the same intended purpose of promoting wound and vessel healing. Under KSR Int’l Co. v. Teleflex, 550 U.S. 398 (2007), it would have been obvious to one skilled in the art to substitute or combine these known elements to yield the claimed invention.
As discussed previously, instant claims 21 and 22 do not further limit claim, reciting “consists essentially of” and “consists of” limitations but introduce no new functional restrictions. Thus, these claims are obvious for the same reasons as claim 1 and are also rejected.
Claims 1 and 8 are rejected under 35 U.S.C. § 103 as being unpatentable over Krausz and Friedman (Krausz A and Friedman AJ. Nitric oxide as a surgical adjuvant. Future Sci OA, 1(1):FSO56; publication date 01 August 2015; hereinafter referred to as “Krausz”) in view of Malone-Povilny et al. (Malone-Povolny MJ et al., Nitric Oxide Therapy for Diabetic Wound Healing. Adv Healthc Mater. 2019 Jun;8(12):e1801210; e-publication date: 15 January 2019; hereinafter referred to as “Malone-Povilny”) and Weller and Finnen (Weller R, Finnen MJ. The effects of topical treatment with acidified nitrite on wound healing in normal and diabetic mice. Nitric Oxide., 15(4):395-9; publication date Dec 2006; hereinafter referred to as “Weller”) and Wong et al. (Wong JB, et al. 2nd. A Novel, Easy-to-Use Staple Line Reinforcement for Surgical Staplers. Med Devices (Auckl), 13:23-29; publication date 29 Jan 2020; hereinafter referred to as “Wong”).
Krausz, Malone-Povolny and Weller teach the limitations of instant claim 1 (as described above), from which instant claim 8 depends, however does not teach specific limitations of instant claim 8.
Wong discloses staple line reinforcement materials and methods for reducing post-surgical leakage and bleeding following tissue resection (Abstract; page 1, Background).
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date applying the NOD therapy of Krausz for revascularization using the powdered form taught by Malone-Povolny and the nitrate salt taught by Weller, to combine these therapies with a staple line reinforcement as disclosed by Wong to improve healing integrity. This combination is a predictable use of known surgical adjuncts for their established effects in post-operative repair (MPEP §2143, KSR). No new structural or mechanistic synergy is shown. Claim 8 is therefore obvious over Krausz, Malone-Povolny and Weller in view of Wong.
Claims 9, 10, and 15 and 16 are rejected under 35 U.S.C. § 103 as being unpatentable over Krausz and Friedman (Krausz A and Friedman AJ. Nitric oxide as a surgical adjuvant. Future Sci OA, 1(1):FSO56; publication date 01 August 2015; hereinafter referred to as “Krausz”) in view of Weller and Finnen (Weller R, Finnen MJ. The effects of topical treatment with acidified nitrite on wound healing in normal and diabetic mice. Nitric Oxide., 15(4):395-9; publication date Dec 2006; hereinafter referred to as “Weller”), Chiang et al. (Chiang et al., Local administration of nitric oxide donor significantly impacts microvascular thrombosis. Laryngoscope 113(3):406-9; publication date: March 2003; hereinafter referred to as “Chiang”), and as evidence by Xie et al. (Xie et al., Risk factors and clinical impact of seroma formation following laparoscopic inguinal hernia repair: a retrospective study. BMC Surg., 24(1):274; publication date 01 Oct 2024; hereinafter referred to as Xie).
Krausz discloses the use of nitric oxide donors as surgical adjuvants to accelerate post-surgical revascularization and wound repair (Abstract; pages 7-8, Nitric oxide & vascular surgery). Krausz identifies nitric oxide donors including S-nitrosothiols and diazeniumdiolates as suitable agents (page 7, right column ¶2). Surgical site “not comprising cancerous tissue” is a field-of-use limitation without structural or functional distinction, in which Krausz’s examples (e.g., arterial graft and incision repair) are non-cancerous surgical sites.
Krausz further discloses “The antimicrobial properties of NO have been harnessed to prevent postoperative infection by coating external fixation pins with diazeniumdiolate NO donor-functionalized xerogels. This reduced the incidence of infection in the treatment arm as compared with controls, and the surrounding surgical wounds showed qualitatively decreased erythema and edema.” (page 9).
Xie identifies that seroma formation results from lymphatic leakage and poor vascular perfusion, wherein edema can contribute to the accumulation of serous fluid resulting in seroma formation at the surgical site and recommends interventions that enhance vascular repair to reduce seroma (page 1, Abstract).
A reduction in post-surgical seroma formation is anticipated because it constitutes merely a newly discovered result of a known method or treatment regimen of administering NODs to wound or surgical treatment sites to patients likely to develop seroma, otherwise taught in the prior art, directed for the same use, in the treatment of surgical sites and the promotion of accelerated wound healing processes/reduction of impediments delaying wound healing. Thus, the method is directed for the same use and consists of the same known treatment regimen for the same medical indication as described in the prior art. In re May, 574 F.3d 1082 (CCPA 1978) and Bristol-Myers Squibb Co., 246 F.3d at 1377 establish that such inherent claim limitations do not impart patentability to the claims.
Chiang teaches applying 100 micromol/L spermine NONOate nitric oxide donor solution (liquid) to microvascular surgical site of a femoral artery graft surgery (page 1, Abstract Methods). Arterial inversion graft anastomotic patency rates significantly improved with liquid administration at the surgical site (page 1, Abstract Results), indicating local administration of nitric oxide donors improved vascular repair, reduces microvascular thrombosis and improves microcirculatory flow (page 1, Abstract). Formation of seromas arising from fluid accumulation is known to be associated with poor vascular repair.
Weller further discloses acidified nitrite salts as nitric oxide donors that accelerate wound closure in diabetic and normal mice (page 1, Abstract).
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine these teachings and use the nitric oxide donor system of Krausz to promote post-surgical vascular repair and expected seroma formation in the liquid delivery format of Chiang to achieve localized delivery, ease of application, and uniform distribution at the surgical site ,and employ nitrite salts as NO precursors as shown in Weller as a known alternative. The reduction of seroma would have been a predictable result of reduced inflammation and exudate, consistent with known properties of nitric oxide donors, supported by the teachings of Krausz, as evidence by Xie, and improved vascular repair indicated by Chiang (see MPEP § 2141). The specific known NOD species of the instant claims are disclosed in Chiang and Krausz. No critical or unexpected result is identified in the specification distinguishing the claimed liquid nitrite formulations from the cited prior art. The field-of-use limitation (non-cancerous site) not patentably distinguishing and is taught by Krausz as previously mentioned. The combination represents predictable use of known agents and formulations for the same intended purpose of promoting wound and vessel healing, expected to result in a reduced incidence of seroma formation at the surgical site. The prior art of record teaches or renders obvious each limitation of the claimed invention. No evidence of unexpected results, criticality, or structural difference has been provided that would overcome the prima facie case of obviousness. Under KSR Int’l Co. v. Teleflex, 550 U.S. 398 (2007), it would have been obvious to one skilled in the art to substitute or combine these known elements to yield the claimed invention with a reasonable expectation of success in making the change.
Claims 9 and 16 are rejected under 35 U.S.C. § 103 as being unpatentable over Krausz and Friedman (Krausz A and Friedman AJ. Nitric oxide as a surgical adjuvant. Future Sci OA, 1(1):FSO56; publication date 01 August 2015; hereinafter referred to as “Krausz”) in view of Weller and Finnen (Weller R, Finnen MJ. The effects of topical treatment with acidified nitrite on wound healing in normal and diabetic mice. Nitric Oxide., 15(4):395-9; publication date Dec 2006; hereinafter referred to as “Weller”), Chiang et al. (Chiang et al., Local administration of nitric oxide donor significantly impacts microvascular thrombosis. Laryngoscope 113(3):406-9; publication date: March 2003; hereinafter referred to as “Chiang”), and as evidence by Xie et al. (Xie et al., Risk factors and clinical impact of seroma formation following laparoscopic inguinal hernia repair: a retrospective study. BMC Surg., 24(1):274; publication date 01 Oct 2024; hereinafter referred to as Xie), and in further view of Wong et al. (Wong JB, et al. 2nd. A Novel, Easy-to-Use Staple Line Reinforcement for Surgical Staplers. Med Devices (Auckl), 13:23-29; publication date 29 Jan 2020; hereinafter referred to as “Wong”).
Krausz, Weller, Chiang and Xie teach the limitations of instant claim 9 (as described above), from which instant claim 16 depends, however does not teach specific limitation of staple line reinforcement of instant claim 16.
Wong discloses staple line reinforcement materials and methods for reducing post-surgical leakage and bleeding following tissue resection (Abstract; page 1, Background).
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date applying the NOD therapy of Krausz and the nitrate salt taught by Weller for use in seroma treatment as a liquid as indicated by teachings of Chiang and Xie, to combine these therapies with a staple line reinforcement (standard adjunct) as disclosed by Wong to reduce the incidence of seroma formation following surgeries employing staples. The reduction of seroma would have been a predictable result of reduced inflammation and exudate, consistent with known properties of nitric oxide donors, supported by the teachings of Krausz, as evidence by Xie, and improved vascular repair indicated by Chiang (see MPEP § 2141). This combination is a use of known surgical adjuncts in an established surgical closure method for predictable effects in post-operative repair (MPEP §2143, KSR). No new structural or mechanistic synergy is shown. Claim 16 is therefore obvious over Krausz, Weller, Chiang and Xie in view of Wong. Under KSR Int’l Co. v. Teleflex, 550 U.S. 398 (2007), it would have been obvious to one skilled in the art to substitute or combine these known elements to yield the claimed invention with a reasonable expectation of success in making the change.
Claim 17 is rejected under 35 U.S.C. § 103 as being unpatentable over Li et al. (Li Y, Lee PI. Controlled nitric oxide delivery platform based on S-nitrosothiol conjugated interpolymer complexes for diabetic wound healing. Mol Pharm.;7(1):254-66; publication date: 1 February 2010; hereinafter referred to as “Li”), in view of Krausz and Friedman (Krausz A and Friedman AJ. Nitric oxide as a surgical adjuvant. Future Sci OA, 1(1):FSO56; publication date 01 August 2015; hereinafter referred to as “Krausz”).
Li teaches a surgical kit comprising nitric oxide donor and wound dressing to be used during or after surgery comprising the application of the nitric oxide donor (NOD), S-nitrosoglutathione (GSNO) encapsulated in a PVMMA/PVP to surgically created full thickness excisional wounds as a dry lyophilized powder, followed by the application sterile saline, transparent Tagederm dressing and edge sealing with benzoin (page 6, left column, paragraph 2). Li’s GSNO compositions are designed to be applied to diabetic wounds or surgical sites, and the materials are provided as components used together for wound management, meeting the broadest reasonable interpretation of a “kit”.
Li further discloses the benefits of the delivery of nitric oxide [such as by GSNO] to the wound healing process including angiogenesis (page 2, right column, paragraph 1), wherein the topical administration of GSNO in the diabetic rat model resulted in controlled release of nitric oxide and effectively accelerated wound closure (page 13, left column, paragraph 1).
Krausz teaches the use of NONOates in the study of NO for wound healing (page 2, last paragraph), specifically mentioning DETA-NONOates [diethylenetriamine NONOate, NOC-18] (page 3, right column, paragraph 2). He further teaches the incorporation of NO-donating drugs, particularly diazeniumdiolates [NONOates including NOC-18] and S-nitrosothiols [which includes S-nitrosoglutathione, GSNO] into hydrogels and polymers as a means of generating NO locally for extended periods of time (page 6, right column, paragraph 2).
Therefore, Li teaches each element of instant claim 17. The disclosure by Li of a polymer-encapsulated GSNO system used with wound dressings reasonably falls within the scope of the term “kit” under the broadest reasonable interpretation and thus, instant claim 17 is anticipated. No structural or compositional difference has been shown that would distinguish the claimed kit from Li’s disclosure. Accordingly, instant claim 17 is anticipated by Li.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to substitute the NO-donating GSNO in the invention of Li with a different NO-donating drug such as NONOates, including NOC-18, known to be used for the same purpose, as described by Krausz to the invention of Li with a reasonable expectation of success since they both function to serve the same purpose of donating NO. One would be motivated to make the change to substitute GSNO for NOC-18 to achieve a faster, more immediate release of nitric oxide. The choice would be a matter of desired release kinetics.
New Objections and Rejections
The following new objections and rejections are made from the previous Office Correspondence dated 30 October 2025, as the Applicant's amendment necessitated the new grounds of objection and rejection presented below based on the amended/newly cited limitations.
Claim Objections
Claims 1, 9, and 17 are objected to because of the following informalities:
Claims 1, 9, and 17 are objected to because of a typographical error. The claims recite the term "polysaccharaides." This appears to be a misspelling of "polysaccharides." While this may be considered a minor typographical error, the correct spelling is required for clarity and proper searching. The applicant is required to correct this typographical error in all instances where it appears (claims 1, 9, and 17) (see 37 C.F.R. § 1.52).
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-AlA) 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 and 23 are rejected under 35 U.S.C. § 103 as being unpatentable over Krausz and Friedman (Krausz A and Friedman AJ. Nitric oxide as a surgical adjuvant. Future Sci OA, 1(1):FSO56; publication date 01 August 2015; hereinafter referred to as “Krausz”) in view of Malone-Povilny et al. (Malone-Povolny MJ et al., Nitric Oxide Therapy for Diabetic Wound Healing. Adv Healthc Mater. 2019 Jun;8(12):e1801210; e-publication date: 15 January 2019; hereinafter referred to as “Malone-Povilny”) and Weller and Finnen (Weller R, Finnen MJ. The effects of topical treatment with acidified nitrite on wound healing in normal and diabetic mice. Nitric Oxide., 15(4):395-9; publication date Dec 2006; hereinafter referred to as “Weller”) and Wong et al. (Wong JB, et al. 2nd. A Novel, Easy-to-Use Staple Line Reinforcement for Surgical Staplers. Med Devices (Auckl), 13:23-29; publication date 29 Jan 2020; hereinafter referred to as “Wong”).
Krausz, Malone-Povolny and Weller teach the limitations of instant claim 1, as described above, from which instant claim 23 depends. New claim 23 recites administering the nitric oxide donor in conjunction with a surgical sealant.
As described above, Krausz teaches nitric oxide donors applied to surgical wounds to improve healing, Malone-Povolny teaches polymer delivery systems and wound dressings for NO donors and Wong teaches surgical sealants and reinforcement materials used during surgery to improve tissue closure.
Surgical sealants are standard adjuncts used in conjunction with other materials to prevent leakage and support and reinforce wound closures. Using a known surgical sealant alongside the NOD-hydrogel of Krausz is a simple combination of two known surgical tools to achieve their predictable, respective functions.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add the missing surgical sealant limitation. A person of ordinary skill in the art would have been motivated to apply nitric oxide donor therapy together with surgical sealants because both are used to enhance wound healing and tissue repair at surgical sites. Combining known wound-healing adjuncts represents a predictable use of known techniques to improve surgical outcomes (see MPEP §2143). Therefore, claim 23 is obvious.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 05 January, have been fully considered.
The applicant argues that Krausz, Malone-Povolny, and Weller fail to disclose NOD administration via cross-linked hydrogels comprising the specific polymers recited in the claims. This argument is not persuasive.
Krausz explicitly teaches incorporating NO-donating drugs into hydrogels and polymers for localized, sustained NO release at surgical sites (Krausz, page 6, right column, ¶2). The reference broadly describes polymeric delivery systems, including hydrogel matrices, for surgical wound healing (pages 6-7). Thus, Krausz establishes the general principle of NOD delivery from polymeric matrices.
The claimed polymers fall into two well-established categories of biomedical hydrogel materials: (1) natural extracellular matrix polymers (collagen, gelatin, fibrin, fibronectin, elastin, keratin, laminin) and (2) synthetic/polysaccharide hydrogel polymers (alginate, chitosan, polyacrylates, polyacrylamides, polycaprolactone, polyoxyethylene). These are conventional, off-the-shelf materials routinely used in drug delivery hydrogels and wound dressings.
A person of ordinary skill would understand that selecting a specific biocompatible, cross-linkable polymer for a hydrogel is a matter of routine optimization. Krausz provides the core teaching of an NOD-loaded hydrogel- selecting from among known polymer candidates to tailor mechanical properties, swelling, biodegradability, or release kinetics does not confer patentability (see In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012), wherein optimization of a variable within a known range is obvious). Malone-Povolny confirms this by explicitly teaching that polymer composition is routinely modified to control NO release kinetics and wound compatibility (pages 10-14).
Substituting one known hydrogel polymer for another performing the same function is ordinarily obvious (see In re Mouttet, 686 F.3d 1322 (Fed. Cir. 2012) and In re Kerkhoven, 626 F.2d 846 (CCPA 1980)). Because the claimed polymers perform the same function (hydrogel drug delivery matrix) as polymers disclosed in the prior art, substitution would have been predictable and routine.
The applicant's emphasis on "cross-linked" hydrogels does not distinguish the claims. Hydrogel matrices inherently require cross-linking to maintain structural integrity and swelling behavior, a fundamental characteristic understood by persons of ordinary skill. The hydrogel systems described in Krausz and Malone-Povolny necessarily involve cross-linked polymer networks. Where a claim recites a property inherently present in the prior art structure, the limitation does not confer patentability (see In re Best, 562 F.2d 1252 (CCPA 1977)).
Under KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007), multiple motivations support the combination: (1) improved localized delivery (Krausz teaches NOD therapy requires controlled local delivery; hydrogels provide sustained release and wound retention); (2) optimization of release kinetics (Malone-Povolny teaches polymer composition controls NO release rates); and (3) established use of hydrogels in surgical wound treatment. Combining NODs with hydrogel delivery matrices represents a predictable integration of known wound-healing technologies with a reasonable expectation of success (see In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009)).
Claim 21 merely adds known plasticizers (polyethylene glycol, sorbitol, glycerol), standard hydrogel additives for modifying mechanical flexibility. Claim 22 recites an equilibrium swell range of 500%-1100%, typical for cross-linked hydrogels and adjustable through routine experimentation by varying cross-linking degree. Both represent routine formulation optimization (see MPEP §2144.05).
The applicant's arguments regarding hydrogel polymers fail for the same reasons. Chiang teaches local NOD delivery at surgical sites to improve microvascular function. Xie establishes the connection between poor vascular repair and seroma formation. Xie is cited as evidence of the mechanism, not for NODs or hydrogels. A person of skill, aware of Krausz (NODs enhance revascularization) and Chiang (local NODs improve vascular repair), would have a clear motivation to apply the NOD-hydrogel to reduce seroma as a predictable consequence of improved vascularization (see In re May, 574 F.2d 1082 (CCPA 1978), wherein newly discovered results of known treatments do not impart patentability).
Regarding the staple line reinforcement (claims 8, 16) and surgical sealants (claim 23), Wong teaches that staple line reinforcement improves post-surgical healing. Combining NO-mediated healing therapies with standard surgical reinforcement techniques is an obvious aggregation of known adjuncts for improving post-operative outcomes. Claim 23 is obvious for the same reasons, using a surgical sealant alongside an NOD-hydrogel is a routine combination.
Regarding the kit claim (claim 17), Li explicitly teaches a "surgical kit" comprising a nitric oxide donor (GSNO) encapsulated in an interpolymer complex (PVMMA/PVP) applied as a dry lyophilized powder to surgically created wounds, along with dressing and other materials (Li, page 6, left column, ¶2). PVMMA and PVP are functional equivalents of the polyacrylates, polymethacrylates, and polyacrylamides recited in the claim, synthetic polymers capable of forming hydrogel matrices upon hydration. Li's wound treatment components satisfy the broadest reasonable interpretation of a "kit." The applicant's amendment removing GSNO and adding other NODs strengthens the obviousness rejection. Krausz teaches that other NODs (e.g., NONOates) are suitable for polymer incorporation. Substituting one known NOD for another to achieve predictable results (e.g., altered release kinetics) is obvious (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)).
The claimed polymer selection represents routine optimization of known hydrogel carriers for NOD delivery. The prior art teaches each element and provides motivation to combine them with a reasonable expectation of success. The applicant has provided no evidence of unexpected results or criticality. The claims remain unpatentable under 35 U.S.C. § 103.
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 (87 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.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615