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 03/10/2026 is acknowledged.
Claims 1 and 3-28 are pending.
Claims 19-28 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/27/2024.
Claims 1 and 3-18 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 Rejections not reiterated herein have been withdrawn.
Withdrawn
The rejection of claims 1, 3, 5-7, 9-10, and 13-18 under 35 U.S.C. 103 as being unpatentable over Bulman, US 20190184060 A1 in view of Badylak, WO 2019246444 A1, Kim, Biomaterials, 178, 2018, and Liang, US 20190269611 has been withdrawn because of Applicant’s amendment. The combined teachings of Bulman, Badylak, Kim, and Liang do not expressly teach wherein the particles of the pre-gel mixture have an average maximum dimension of at most 500 microns.
Applicant has argued Elisseeff does not consider the use of ECM-NPs in a pre-gel mixture that is applied to a surface of the target tissue, where the pre-gel mixture then forms a hydrogel film having a modulus as claimed.
This argument is found persuasive. Elisseeff teaches ECM-NPs which may be topically applied, but Elisseeff is silent to spraying the particles in combination with a gel promoter solution comprising a buffer as claimed. The claimed particle size refers to the pre-gel mixture rather than the ECM particles themselves. In light of these distinctions, the skilled artisan would have had little motivation to apply Elisseeff’s particle size teachings to methods suggested by the combined teachings of Bulman, Badylak, Kim, and Liang with a reasonable expectation of successfully facilitating tissue repair and reduction of scar tissue.
The rejection of claim(s) 2 and 4 under 35 U.S.C. 103 as being unpatentable over Bulman, US 20190184060 A1 in view of Badylak, WO 2019246444 A1, Kim, Biomaterials, 178, 2018, and Liang, US 20190269611 as applied to claims 1, 3, 5-7, 9-10, and 13-18 above, and further in view of Elisseeff, WO 2017024193 A has been withdrawn because of Applicant’s amendment and for the reasons set forth above.
The rejection of claim(s) 1, 8, 11, and 12 under 35 U.S.C. 103 as being unpatentable over Bulman, US 20190184060 A1 in view of Badylak, WO 2019246444 A1, Kim, Biomaterials, 178, 2018, and Liang, US 20190269611 as applied to claims 1, 3, 5-7, 9-10, and 13-18 above, and further in view of Badylak, US 20150010510 (Badylak, ’510) has been withdrawn because of Applicant’s amendment and for the reasons set forth above.
Regarding the double patenting rejection:
Applicant has argued Bulman does not disclose the claims, e.g., Bulman fails to disclose or suggest wherein the particles of the pre-gel mixture have an average maximum dimension of at most 500 µm.
This argument is unpersuasive because Bulman was not cited for teaching wherein the particles of the pre-gel mixture have an average maximum dimension of at most 500 µm. Reference claim 1 teaches wherein the particles of the pre-gel mixture have an average maximum dimension of at most 500 µm.
Bulman teaches practicing a similar method for reducing scarring, wherein the composition is applied to the target tissue site during a surgery for the same purpose, i.e., applied to the incision or excision site prior to closure of the surgical site (Bulman, e.g., 0103). Thus, from Bulman, the skilled artisan understood that methods of reducing scarring may be practiced by applying the composition to the target tissue during surgery as claimed. Bulman provides a teaching which would have prompted the skilled artisan to practice the method of the reference patent claims prior to closure of the surgical site which is during the surgery as presently claimed. The skilled artisan would have had a reasonable expectation of success because Bulman suggests this is an obvious variant of repairing tissue, e.g., remodeling scar tissue, after surgery.
Rejections Addressing Applicant’s Amendment
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.
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 4 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 4 includes the limitation or particles having an average maximum dimension of less than about 500 µm. However, claim 1 requires wherein the particles of the pre-gel mixture have an average maximum dimension of at most 500 µm. To the extent that about 500 µm encompasses particle sizes greater than 500 µm, claim 4 does not include all of the limitations of claim 1 from which it depends. To the extent that about 500 µm includes all particles having an average maximum dimension of 500 µm, claim 4 does not further limit the subject matter of claim 1 from which it depends.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) 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 and 3-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11925731 in view of Bulman, US 20190184060 A1 and Kim, Biomaterials, 178, 2018.
The claims of the reference patent are directed to a method for reducing postsurgical scarring at a target tissue, comprising:
(a) forming particles of a pre-gel mixture, the pre-gel mixture comprising an extracellular matrix (ECM) digest and a buffer solution, wherein the ECM digest comprises a collagen to carbohydrate ratio of at least about 70:1, wherein the buffer solution promotes a phase change of the pre-gel mixture to a hydro gel, wherein the particles of the pre-gel mixture have an average maximum dimension of at most 500 μm;
(b) applying the particles of the pre-gel mixture to the target tissue at a shear rate of at least 1 s−1; and
(c) promoting the formation of the hydrogel by 1) increasing a temperature of the pre-gel mixture by presenting the pre-gel mixture to the target tissue at a temperature that is lower than a temperature of the target tissue, 2) increasing a temperature of the pre-gel mixture by heating the pre-gel mixture, 3) exposing the pre-gel mixture to a light source; 4) interacting a chemical with the pre-gel mixture; 5) interacting an enzyme with the pre-gel mixture; or 6) a combination thereof, and
(d) forming a hydrogel film over the target tissue, wherein the hydrogel film is at least 10 μm thick, and comprises a storage modulus of at least 1,000 Pa when measured by parallel plate rheometry after gelation occurs isothermally at 37° C. at constant shear strain of 1% and a frequency of 1.6 Hz,
wherein the pre-gel mixture is applied onto the target tissue after completion of a surgical procedure,
wherein the forming of the hydrogel reduces the formation of adhesions on an adjacent tissue (Claim 1).
The claims of the reference application are more detailed than the presently claimed method however, all of the steps required by the presently claimed invention are present in the method claimed by the reference application. Further, each of the ranges, e.g., storage modulus, applied shear rate are within the presently claimed ranges.
The presently claimed invention recites applying particles during a surgery while the claims of the reference application teach applying the particles of the pre-gel mixture after completion of a surgery.
However, Bulman teaches practicing a similar method for reducing scarring, wherein the composition is applied to the target tissue site during a surgery for the same purpose, i.e., applied to the incision or excision site prior to closure of the surgical site (Bulman, e.g., 0103).
It would have been obvious before the effective filing date of the presently claimed invention to modify the method claimed by the reference patent by applying the particles of the pre-gel composition to the target tissue site during surgery as suggested by Bulman with a reasonable expectation of success. Bulman provides a teaching which would have prompted the skilled artisan to practice the method of the reference patent claims prior to closure of the surgical site which is during the surgery as presently claimed. The skilled artisan would have had a reasonable expectation of success because Bulman suggests this is an obvious variant of repairing tissue, e.g., remodeling scar tissue, after surgery.
The reference claims and Bulman do not expressly teach the pre gel mixture gels between about 1 and 120 seconds after being disposed on the target tissue.
However, based on the tehaicngs of Kim enumerated above, it is evident that the gelation time of the pre-gel ECM mixture after application to the target tissue site was a known result effective parameter the skilled artisan would have minimized to improve target tissue adhesion, target tissue site retention and firmness, and coating homogeneity on target tissue.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
The prior art time frame of immediately or less than 50 seconds is within the claimed range of from 1 to 120 seconds as recited in claim 1. The prior art time frame or immediately or less than 50 seconds for complete gelation is within or overlapping with the range recited in claim 10.
It would have been obvious before the effective filing date of the presently claimed invention to practice a method suggested by the reference claims and Bulman so that the pre-gel composition completely gels within 50 seconds as taught by Kim with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of known techniques to improve similar methods of treating tissue by spraying gelling ECM compositions in the same way. The skilled artisan would have been motivated to minimize complete gelling time, e.g., within 50 seconds, to improve target tissue adhesion, target tissue site retention and firmness, and coating homogeneity on target tissue in the same way reported by Kim with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success because Kim teaches this technique for improving treatment of tissue by spraying gelling ECM compositions and because Bulman suggests the method may be practiced by forming an adhesive gel upon or shortly following contact with the body at the site of administration or application.
The claimed particle sizes are found in claim 2 of the reference patent.
The hydrogel thickness is found in claim 5 of the reference patent.
Additional limitations of the present dependent claims are found in the dependent claims of the reference patent.
Accordingly, the subject matter of claims 1 and 3-18 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