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 .
The amendments of 10/31/2025 have been entered in full. Claims 52-57, 61, and 64-73 are pending.
All prior objection/rejections not specifically maintained in this Office action are hereby withdrawn in view of Applicants’ amendment and/or arguments filed 10/31/2025.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 52-57, 61, 64, 66, 72, and 73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 7, 9-14, and 18-24 of U.S. Patent No. US 10653814 (the ‘814 patent), in view of US 8974803 (the ‘803 patent).
Patented claims 1, 6, 13, and 18 are drawn to a methods comprising administering tropoelastin crosslinked to hyaluronic acid. US 10653814 is the same disclosure as US 9611312 which, in turn, is cited as teaching the method of preparing the tropoelastin cross-linked to hyaluronic acid in the instant disclosure ([0120] in publication US 20230255875). Therefore, composition in the patented claims is inherently the same as that of the instant claims with respect to cross-linkage. Patented claims 7, 9, 14, 19, 21-24 encompass administration of the composition to soft tissue and, in particular, skin. Therefore, the patented and pending claims generally encompass administration of the same composition to the same subjects. The patented claims do not recite that the tropoelastin is present in an amount of about 30 mg/mL, and wherein the tropoelastin is crosslinked with about 0.5% hyaluronic acid, as in pending independent claims 52 and 72.
The ‘803 patent teaches and claims a composition comprising a tropoelastin concentration of from 5 mg/mL to 30 mg/mL and hyaluronic acid in an amount from 0.5% to 2.0% w/v (see claims 1, 8, and 9. The composition of pending claims 52 and 72 is included within the broadly defined composition of the ‘803 patent, which in turn is an example of a composition recited for administration in the claims of US 10653814. Like US 10653814, the ‘803 patent further teaches that the composition is useful for treating skin (col. 12, lines 1-31). Therefore, the pending claims are drawn to an obvious embodiment of the generic method of US 10653814 in view of US 8974803.
Claim Rejections - 35 USC § 102 and § 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 52-57, 61, and 64-73 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 20140235547 (Mithieux).
Mithieux teaches methods comprising administration of tropoelastin and hyaluronic acid [0129]. In certain embodiments, the tropoelastin in the composition may be cross linked to derivatized hyaluronic acid (HA) [0130]. Mithieux cites PCT/AU2011/001503 for teaching the method of preparing tropoelastin cross-linked with derivatized hyaluronic acid for use in a clinical study [0216]. PCT/AU2011/001503 is the same disclosure as US 9611312 which, in turn, is cited as teaching the method of preparing the tropoelastin cross-linked to hyaluronic acid in the instant disclosure ([0120] in publication US 20230255875). Mithieux teaches that a suitable formulations may include from 10 to 30 mg/ml tropoelastin cross-linked to from 0.25% to 1% HA cross-linker. This teaching anticipates, or in the alternative renders obvious, the formulation of tropoelastin in an amount of about 30 mg/mL, and wherein the tropoelastin is crosslinked with about 0.5% hyaluronic acid, as recited in pending independent claims 52 and 72.
Therefore, Mithieux teaches administration of the same composition as in all pending claims. Mithieux teaches administration of the composition into the dermis of skin [0142] wherein the typical subject treatment area is characterized by photo-aging, loosened skin, relaxed subcutaneous tissue, loss of density of the extracellular matrix, wrinkling and stretch marks [0150]. Mithieux teaches expected outcomes of improving physical appearance of skin [0110] and providing elasticity [0144], which overlap with outcomes recited in the instant claims. Additional recited outcomes are inherent to the method wherein the same composition is administered to the same subjects.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL C GAMETT, Ph.D., whose telephone number is (571)272-1853. The examiner can normally be reached on M-W. Please note the examiner’s part-time schedule. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached on 5712722911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL C GAMETT/Primary Examiner
Art Unit 1647