DETAILED ACTION
Claims 1-2, 4-7, 9, 11, 15-26 are currently pending. Claims 7, 9, 11, 15-19, 21-26 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 .
Election/Restrictions
Applicant’s election of Group II in the reply filed on 06/25/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-2, 4-6 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/25/2025.
Applicant’s election of VS-6062/PF-562271 in the reply filed on 06/25/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
No claims are withdrawn as a result of the species election.
Terminal Disclaimer
The terminal disclaimer filed on 11/07/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 12,178,940 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Rejections
The prior rejection of claims 7, 9, 11 and 14-17 under 112(a) written description is withdrawn in light of Applicant amending instant claim 7 to be directed to specifically named FAK inhibitors.
The prior rejection of claims 7,9, 11 and 14-17 under 112(b) is withdrawn as Applicant has specified the meaning of “disposing the composition” and amended claim 7 from dispensing to releasing which examiner find persuasive.
Examiner’s Note
Applicant's amendments and arguments filed 11/06/2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 11/06/2025, it is noted that claim 7 has been amended and claims 22-26 are newly presented. No new matter or claims have been added.
Maintained Rejections:
The following rejections are maintained.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 9 is directed to the compristion comprising the FAK inhibitor is administered locally. Instant claim 7, from which claim 9 depends, is directed to the FAK inhibitor being administered in proximity to the wounded tissue, and thus is already directed to local administration. Therefor claim 9 does not further limit. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
New Rejections:
The following rejections are newly applied.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19 and 21-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 is directed to wherein the effective amount of the focal adhesion kinase inhibitor is from 30 to 100 micrograms/g tissue by weight. It is unclear if the g tissue by weight is in regards to the damaged tissue that requires healing or if is regarding the tissue of the large mammal as a whole.
Claim 21 contains the limitation “wherein the composition is adapted to reduce fibroblast proliferation in tissue of large mammals and promote tissue regeneration…”. Instant claim 21 contains unclear metes and bounds as it is not clear if the fibroblast proliferation in the tissue of large mammals and promote tissue regeneration is a property of the composition or if there is an additional component or step (adapted to) which is required.
Claim 22 contains the limitation of “three or more of the following genes in the large mammal:…” wherein no conjunction is used in the gene list, thus leading the unclear metes and bounds in the instant claim.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments and newly added claims.
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) 7, 9, 11, 15-18 and 21-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma (Applicant provided) in view of US 2017/0157296 (previously applied).
Regarding claims 7, 9 and 16, the limitation of a method of promoting tissue healing while reducing fibrosis in a large mammal, comprising disposing a composition comprising an effective amount of a focal adhesion kinase inhibitor disposed in pores of a pullan-collagen hydrogel scaffold in proximity to a tissue wherein the tissue comprises a wound, releasing the Fak inhibitor from the compristion into the proximity of the wounded tissue and reducing a level of foal adhesion kinase for a selected period of time, thereby reducing fibrosis while inducing regenerative cell populations to promote skin regeneration and healing the wounded tissue is met by Ma teaching FAK inhibitor can be attenuate scar development. The use of Pullulan collagen-based hydrogel to delivery FAKI to excisional and burn wounds in mice. Drug-laden hydrogel was developed for rapid and sustained release of FAKI for treatment of burn wounds and excisional wounds. FAKI via pullulan collagen hydrogel accelerated wound healing and reduced collagen disposition and activation of scar-forming myofibroblasts in both wound healing models (abstract). FAKI is taught to be incorporated into the porous hydrogel, which enabled slow and sustained release of the FAKI to the wound environment over a few days (page 2453, first column, first paragraph). Reduced inflammation and fibrosis in an incision HTS model using FAK knockout mice is taught (page 2452, second column, second paragraph, page 2456, second column, last paragraph). Thus Ma teaches that the active step of disposing the claimed composition and releasing the FAKI and thus would necessarily result in reducing fibrosis while inducing regenerative cell population to promote skin regeneration and healing the wounded tissue. The limitation of wherein the FAK inhibitor is the elected VS-6062 is met by Ma teaching VS-6062. Ma teaches the wound is taught to use silicone rings to prevent wound contracture (primary means of rodent wound healing) but to allow the wound to closely re-epithelization (similar to human wounds (page 2458, second column, last paragraph, page 2452, second column, last paragraph, page 2453, second column, second paragraph). Thus Ma teaches the desire to treat humans and mimicking human wound healing.
Regarding claim 11, the limitation of wherein the pullan collagen hydrogel is a thin film is met by Ma teaching hydrogel films were 2 mm thick (page 2457, second column, second paragraph). 2mm meets the definition of thin film, absent a definition of thin, as thin is a relative term.
Regarding claim 15, the limitation of wherein the wound is a burn is met by Ma teaching the treated tissue is a burn (abstract).
Regarding claims 17-18, the limitation of wherein the selected period of time for treatment with the composition comprising the FAK inhibitor is from about 7 days to about 100 days is met by Ma teaching administration for 17 days (Figure 3, page 2453) wherein the dressing is replaced every day 2-3 days and then every other day thereafter (page 2459, first column, second paragraph).
Regarding claims 21-26, claims 21-26 are directed to FAK inhibit modulations mechanical signaling and promotes tissue regeneration, induces reduction of transcription or translation of three or more genes, induces regenerative cell population, induces a disruption in mechanotransduction in the large mammal and induces increased MMP1 and MMP3 expression in the large mammal. Ma teaches that the active step of disposing the claimed composition and releasing the FAKI and thus would necessarily result in functions of the FAK inhibitor, as claimed.
Ma does not specifically teach a large mammal having an adult weight of greater than about 7 kilograms (claim 7).
The ‘296 publication teaches compositions for enhanced healing of wounds, e.g. cutaneous wounds by application of a scaffold comprising a hydrogel film (abstract). The hydrogel is taught to be pullulan and collagen ([0011]-[0012]). The composition is taught to include porous wound dressings and the like used to treat dermal tissues including burn wounds [0075]. Treatment is taught to be applied to wound of a subject wherein the subject includes mice, pigs, rate and primates including humans [0081].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to apply the composition of Ma to human as the ‘296 publication teaches mammals to be treated include mice and humans. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as Ma and the ‘296 publication are both directed to composition including pullulan-collagen scaffolds used to treat burns, thus it would be obvious to use the compositions of Ma to treat the patient population disclosed by the ‘296 publication and Ma teaches the desire to treat humans an mimics human wound healing.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma and US 2017/0157296 as applied to claims 7, 9, 11, 15-18 and 21-26 above, and further in view of US 2005/0009831.
As mentioned in the above 103 rejection, all of the limitations of claims 7, 9, 11, 15-18 and 21-26 are taught by the combination of Ma and the ‘296 publication.
The combination of references does not specifically teach wherein the effective amount of the focal adhesion kinase inhibitor is from 30 to 100 micrograms/g tissue by weight (claim 19).
The’ 831 publication teaches compounds for use for preventing or treating diseases that may be modulated by inhibitors such as kinase proteins (abstract). Kinase proteins belong to the group including FAK and treating or preventing diseases modulated by the inhibition of such kinase proteins is taught ([0003], [0026]). The dose employed will be determined by physical and depends on the desired therapeutic effect, the route of administration and the duration of treatment. Adult doses are generally from 0.001 to about 50 mg/kg body weight per day ([0703]-[0704]), leading to 0.001-50 ug/g.
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 known dosing ranges of FAK inhibitor compounds for the hydrogels taught by Ma as the ‘831 publication kinase inhibitors taught to be used in dosage range, wherein the range is taught to be an optimizable parameter. One of ordinary skill in the art before the filing date of the claimed invention would have a motivation to use known concentrations of kinase inhibiting compounds to be used and optimize as the ‘831 publication teaches known amounts of kinase initiators and teaches that the dosage amount is determined by a physician.
That being said and in lieu of objective evidence of unexpected results, the dosage can be viewed as a variable which achieves the recognized result of successfully treating a specific patient. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of dosage nonobvious.
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.
Claim 7, 9, 11, 15-16 and 21-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-20 of copending Application No. 18/288,652 (reference application) in view of Ma. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the ‘940 patent are directed to placing a composition so FAK inhibitor and pullulan-collagen porous scaffold at a wound site to release the FAK inhibitor locally, wherein the wound site is a burn and the FAK inhibitor is controlled release, thus teaching the same active steps of the same composition, thus would necessarily result in functions of the FAK inhibitor, as claimed thus anticipating the instant claims.
The ‘652 publication does specifically teak FAK inhibitor selected form the group which includes VS-6062.
Ma teaching FAK inhibitor can be attenuate scar development. The use of Pullulan collagen-based hydrogel to delivery FAKI to excisional and burn wounds in mice. Drug-laden hydrogel was developed for rapid and sustained release of FAKI for treatment of burn wounds and excisional wounds. FAKI via pullulan collagen hydrogel accelerated wound healing and reduced collagen disposition and activation of scar-forming myofibroblasts in both wound healing models (abstract). FAKI is taught to be incorporated into the porous hydrogel, which enabled slow and sustained release of the FAKI to the wound environment over a few days (page 2453, first column, first paragraph). Reduced inflammation and fibrosis in an incision HTS model using FAK knockout mice is taught (page 2452, second column, second paragraph, page 2456, second column, last paragraph). Ma teaches VS-6062 (page 2455, first column, first paragraph).
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 known FAK inhibitors to treat wounds as taught by Ma for the wound treating compositions as taught by the ’652 publication as MA teaches specific FAK inhibitors known to treat wounds.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103:
Applicant argues Ma does not disclose the use of FAK inhibitor releasing hydrogel scaffolds in mammals having body weight greater than 7kg. The ‘296 publication (Walmsley) there is no indication or suggestion that the composition include focal adhesion kinase. Ma and the ‘296 publication use different active agents and neither provides any scientific use of its agent in a large mammal.
In response, Ma teaches FAKI therapy via pullan-collagen hydrogel was shown it be effective in reducing scar formation while promoting healing of excisional and burn wounds in mouse models. Results of this study enable the translation of FAKI scar reduction therapy in highly translational preclinical large animal model and potential human clinical trials (page 2457, second column, first paragraph). The wound is taught to use silicone rings to prevent wound contracture (primary means of rodent wound healing) but to allow the wound to closely re-epithelization (similar to human wounds (page 2458, second column, last paragraph, page 2452, second column, last paragraph, page 2453, second column, second paragraph). Thus Ma teaches the desire to treat humans and mimicking human wound healing. The ‘296 publication teaches compositions for enhanced healing of wounds, e.g. cutaneous wounds by application of a scaffold comprising a hydrogel film (abstract). The hydrogel is taught to be pullulan and collagen ([0011]-[0012]). The composition is taught to include porous wound dressings and the like used to treat dermal tissues including burn wounds [0075]. Treatment is taught to be applied to wound of a subject wherein the subject includes mice, pigs, rate and primates including humans [0081]. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to apply the composition of Ma to human as the ‘296 publication teaches mammals to be treated include mice and humans. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as Ma and the ‘296 publication are both directed to compristion including pullulan-collagen scaffolds used to treat burns, thus it would be obvious to use the compositions of Ma to treat the patient population disclosed by the ‘296 publication.
Applicant argues neither Ma or the ‘296 publication teach or suggest that a FAK inhibitor would or could have the claimed effect on inducing regenerative cell population to promote skin regeneration in large mammals.
In response, Ma teaches that the active step of disposing the claimed composition and releasing the FAKI and thus would necessarily result in reducing fibrosis while inducing regenerative cell population to promote skin regeneration and healing the wounded tissue.
Applicant argues it is well established that there is a very low success rate in mouse models predicting effects in human trials and even lower in the field of inflammation. Applicant points to Exhibit A, Exhibit B. Neither Ma nor the ‘296 publication proves any evidence that anything other than a mouse model was used or the results would be transferable to large mammals. It was known by at least 2004 that there is currently no model of wound healing in rodents that closely parallel human wound healing. The functional mental difference has significantly limited the translation relevance of fibrosis studies performed in rodent models. The way to disrupt the functional relationship between mass and force that can erase the volition tradeoff between organism complexity and ergative capability manifested at the gene and healing cascade pathway. Mice are not extrapolatable to large mammals. Therefore it would not be appropriate based on the cited art to extrapolate the mechanism underlying portion of tissue healing and fibrosis modulation in healing tissue based in large mammals as there would be no reasonable expectation of success.
In response, Ma teaches FAKI therapy via pullan-collagen hydrogel was shown it be effective in reducing scar formation while promoting healing of excisional and burn wounds in mouse models. Results of this study enable the translation of FAKI scar reduction therapy in highly translational preclinical large animal model and potential human clinical trials (page 2457, second column, first paragraph). The wound is taught to use silicone rings to prevent wound contracture (primary means of rodent wound healing) but to allow the wound to closely re-epithelization (similar to human wounds (page 2458, second column, last paragraph, page 2452, second column, last paragraph, page 2453, second column, second paragraph). Thus Ma teaches the desire to treat humans and mimicking human wound healing. The ‘296 publication teaches compositions for enhanced healing of wounds, e.g. cutaneous wounds by application of a scaffold comprising a hydrogel film (abstract). The hydrogel is taught to be pullulan and collagen ([0011]-[0012]). The composition is taught to include porous wound dressings and the like used to treat dermal tissues including burn wounds [0075]. Treatment is taught to be applied to wound of a subject wherein the subject includes mice, pigs, rate and primates including humans [0081]. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to apply the composition of Ma to human as the ‘296 publication teaches mammals to be treated include mice and humans. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as Ma and the ‘296 publication are both directed to compristion including pullulan-collagen scaffolds used to treat burns, thus it would be obvious to use the compositions of Ma to treat the patient population disclosed by the ‘296 publication.
Double Patenting:
Applicant requests the double patenting rejection be held in abeyance until allowable subject matter is identified.
In response, Applicant has presented no substantive arguments and thus the double patenting rejection is maintained for reasons of record.
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