DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 May 2026 has been entered.
Claims 52-57, 61, and 64-73 were pending the previous office action of 18 December 2025. In the amendment of 18 May 2026, claims 74 and 75 were added. Claims 52-57, 61, and 64-75 are pending and are examined on the merits herein.
Priority
The application claims priority to provision application 63/025,078, filed on 14 May 2020, and is a 371 of PCT/IB2021/054177, filed on 14 May 2021. The effective filing date is 04 May 2020.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 20 April 2023, 25 March 2025, 18 May 2026 have been considered by the examiner.
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.
Claims 52-57, 61, 64-75 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0235547 (herein Mithieux) and Wise SG, et al. (2014) Tropoelastin: a versatile, bioactive assembly module. Acta Biomater. 2014 Apr;10(4):1532-41 (herein Wise) with Nakab L, et al. (2020) Improvements in Skin Quality Biological Markers in Skin Explants Using Hyaluronic Acid Filler VYC-12L. Plast Reconstr Surg Glob Open. 2020 Mar 27;8(3):e2723 (herein Nakab) providing additional evidentiary value.
In regard to claims 52, 72, and 73, Mithieux teaches methods for restoring tissue elasticity comprising the administration of compositions containing tropoelastin (Abstract). It is taught that the administered tropoelastin may be recombinant in nature, and that, in order to be effective, the recombinantly produced tropoelastin should be of a form found in human physiology (Relevant to instant claims 55-57) ([0079]). An embodiment of this method is taught, which comprises tropoelastin cross-linked to derivatized hyaluronic acid (HA) (Relevant to instant claims 53 and 61) ([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 (Relevant to instant claim 54) ([0120] in publication US 20230255875). Mithieux teaches that suitable formulations may include 10-30 mg/ml tropoelastin cross-linked to 0.25% to 1% HA cross-linker ([0130]).
Despite teaching compositions, comprising overlapping components concentration ranges, Mithieux does not explicitly teach a formulation of tropoelastin cross-linked to hyaluronic acid, comprising about 30 mg/mL tropoelastin and about 0.5% HA. Wise partially teaches these deficiencies.
Wise et al provides a review of past biological and mechanical characterizations of mature elastin (Abstract). It is taught that tropoelastin molecules rapidly self-associated, following secretion from cells (Section 1.3). The authors teaches that self-assembling tropoelastin monomers form nanospheres, following initiation of coacervation, with the diameter of the nanosphere being concentration dependent. It is also taught that these nanospheres further assemble into larger interconnected sphere structures, with the degree of order also being concentration dependent. The authors note that tropoelastin concentrations between 30-40 mg/mL produce fibers with diameters similar to in vivo elastic fibers and adding the additional feature of nascent pores.
It would have been obvious to combine the composition taught by Mithieux with the teachings of Wise (tropoelastin concentration between 30-40 mg/mL). Wise’s teaching regarding the properties of elastin fibers, formed following coacervation of tropoelastin monomers at 30-40 mg/mL, makes the selection of a tropoelastin concentration of about 30 mg/mL obvious, due to the more native-like properties of the resulting fibers (i.e. diameter and nascent pore formation). These teachings, when combined, 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, 72, and 73.
Therefore, Mithieux and Wise teach 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 (Relevant to instant claims 64, 66, and 67) ([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 (Relevant to instant claims 68-72, 74, and 75), see MPEP 2112. Despite Mithieux being silent in regard to the effect of the disclosed composition, on moisture content, the prior art, as evidenced by Nakab et al (which teaches that HA either crosslinked or noncrosslinked provides a moisturizing effect), makes it clear that injections of HA were known to have an effect on skin hydration levels (Relevant to instant claim 65) (Background, Results, and Results-Hydration and Hydration Markers). Thus, despite Mithieux’s silence, in regard to moisture content, it was well-known in the art that HA has a moisturizing effect, and as such using a composition comprising tropoelastin crosslinked with hyaluronic acid for the treatment of dry skin would have been obvious to one skilled in the art.
Response to Arguments
Applicant's arguments filed on 18 May 2026 have been fully considered but they are not persuasive. One of the applicant’s arguments is that there is no motivation to use the claimed composition to increase the moisture content of skin, because skin moisturization is not associated with skin elasticity, and as such the use of Mithieux in prior art rejections is not valid (Argument #3 Pages 8 and 9 of the Applicant Arguments/Remarks). This argument was found to be uncompelling, based on the teachings of Nakab et al, which establishes that HA was known in the art to influence skin moisture content (Background, Results, and Results-Hydration and Hydration Markers). Thus, whether or not Mithieux disclosed that the taught composition could be used to increase the moisture content of skin is irrelevant, as it was well-known in the art that HA has an inherent moisturizing capability, and as such the use of composition, comprising HA, for the treatment of dry skin would have been obvious to one skilled in the art. This also relates to the applicant’s argument that Mithieux fails to teach each and every element of the claimed invention, in which the applicant argues that the Office has failed to establish inherency of the moisturizing properties of the composition taught by Mithieux (Argument #1 Pages 6-7 of the Applicant Arguments/Remarks). Within this section of the applicant’s response, it is also argued that Mithieux fails to teach, either expressly or inherently, a composition comprising about 30 mg/mL tropoelastin and about 0.5 % HA. As discussed in the 35 U.S.C. 103 rejections of claims 52-57, 61, 64-75, the teachings of Wise et al provide rationale for selecting of a composition of comprising 30 mg/mL of tropoelastin, that being a more native-like diameter of the resulting fibers (Section 1.3). Thus, in the context of the current rejections, this argument is found to be uncompelling. Furthermore, as discussed later, in response to Argument #4, the applicant has failed to demonstrate any criticality in regard to % HA, within the composition.
The applicant also argues that there was no motivation to select the specific combination of TE and HA, and that claimed composition possessed unpredictable and surprising results, in regard to increased moisture content (Argument #2 Pages 7-8 and Argument #4 pages 10-11 of the Applicant Arguments/Remarks). These arguments are also uncompelling. As discussed above, Mithieux teaches a composition comprising TE (10-30 mg/mL) cross-linked with HA (0.25 – 1.0 %), which as discussed previously, encompasses composition, claimed in the current application. When combined with the teaching of Wise, the narrowing of this range, in regard to tropoelastin, becomes obvious, due to the more native-like features of fibers formed using the higher concentration. Thus, the use of the claimed tropoelastin concentration, 30 mg/mL, would have been obvious, regardless of its effect on moisture content. Furthermore, the applicant has failed to establish any criticality in regard to HA concentration. As established in Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992), the burden is on the applicant to establish that the results are unexpected and significant, which has not been achieved, regarding HA concentration (see MPEP 716.02(d)).
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.
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) and Wise SG, et al. (2014) Tropoelastin: a versatile, bioactive assembly module. Acta Biomater. 2014 Apr;10(4):1532-41 (herein Wise) with Nakab L, et al. (2020) Improvements in Skin Quality Biological Markers in Skin Explants Using Hyaluronic Acid Filler VYC-12L. Plast Reconstr Surg Glob Open. 2020 Mar 27;8(3):e2723 (herein Nakab) providing additional evidentiary value.
Patented claims 1, 6, 13, and 18 are drawn to 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.
‘803 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). When combining these teachings with those of Wise et al (tropoelasin concentration being ≥ 30 mg/mL), as discussed in the 35 U.S.C. 103 rejections of claims 52-57, 61, 64-75, the patented claims recite administration of the same composition as in all pending claims. Additionally, the teachings of Nakab establish the inherent moisturizing properties of compositions comprising HA and make obvious their use in influencing skin moisture content.
Response to Arguments
Applicant's arguments filed on 18 May 2026 have been fully considered but they are not persuasive. The applicant argues that neither ‘814 nor ‘803 teach a composition comprising about 30 mg/mL TE crosslinked to about 0.5% HA for increasing moisture content in a soft tissue. As discussed for the current 35 U.S.C. 103 rejections of claims 52-57, 61, 64-75, Wise teaches that tropoelastin concentrations between 30-40 mg/mL produce fibers with diameters similar to in vivo elastic fibers and adding the additional feature of nascent pores (Section 1.3). This provides rationale for narrowing the tropoelastin concentration range of the crosslinked composition.
Additionally, it is argued that neither ‘814 nor ‘803 teach or suggest using the claimed composition to increase moisture content of a soft tissue. As discussed for the current 35 U.S.C. 103 rejections of claims 52-57, 61, 64-75, Nakab establishes that HA, either alone or crosslinked, is known, in the art, to possess moisturizing properties, which render obvious the use of composition, comprising crosslinked HA, for increasing moisture content (Background, Results, and Results-Hydration and Hydration Markers).
It is also argued that the claimed composition exhibits unexpected results. As previously stated, the use of the claimed tropoelastin concentration, 30 mg/mL, would have been obvious, regardless of its effect on moisture content. Furthermore, the applicant has failed to establish any criticality in regard to HA concentration. As established in Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992), the burden is on the applicant to establish that the results are unexpected and significant, which has not been achieved, regarding HA concentration (see MPEP 716.02(d)).
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW CURRAN METCALF whose telephone number is (571)272-5520. The examiner can normally be reached 7:30AM-5:00PM.
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/MATTHEW CURRAN METCALF/ Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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