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 .
This Office action is responsive to Applicant’s amendment and remarks, filed 31 March 2026, in which claim 1 is amended to change the scope and breadth of the claim.
This application is a domestic application, filed 12 July 2022; and claims benefit as a CON of 17/003377,filed 26 Aug 2020, issued as PAT 11,406,738; which claims benefit as a CON of 16/037402, filed 17 July 2018, issued as PAT 10,786,601; which claims benefit as a CON of 15/895220, filed 13 Feb 2018, issued as PAT 10,322,212; which claims benefit as a CON of 15/705809, filed 15 Sep 2017, issued as PAT 9,925,309; which claims benefit as a CON of 15/044236, filed 16 Feb 2016, issued as PAT 9,789,226; and which claims benefit as a DIV of 13/954360, filed 30 July 2013, issued as PAT 9,421,198.
Claims 1-10 and 12-21 are pending in the current application and are examined on the merits herein.
Rejections Withdrawn
Applicant’s amendment, filed 31 March 2026, has been fully considered and is persuasive with respect to the following rejections:
Claims 1-3 and 5-8 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,789,226.
Claims 1-3 and 5-8 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 9,925,309.
Claims 1-3 and 5-7 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,322,212.
Claims 1, 3, 5, 9, 12, 14, 17, and 21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,786,601.
Claims 1-10 and 12-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,786,601 in view of US’206 (Lebreton, US 2011/0118206, published 19 May 2011, of record), Busillo et al. (Journal of Medical Devices, 2009, 3(4), article 041004, 8 pages, of record), Farley et al. (Regional Anaesthesia, 1994, 19(1), p48-51, provided by Applicant in IDS mailed 12 July 2022), and Liu et al. (US 2013/0123210 A1, published 16 May 2013, filed 1 Jun 2012, of record).
Claims 1-3 and 5-8 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,413,637.
as amended claim 1 further recites the composition comprises from 50% to 99% by weight of hyaluronic acid present in the form of a crosslinked gel, from 1% to 50% by weight of hyaluronic acid present in a non-crosslinked form, and the ratio between crosslinked and non-crosslinked hyaluronic acids being between 1:1 to 1:0.02 by weight, and upon reconsideration the claims of each of the above patents alone do not provide guidance for selecting the composition having the combination of all features as claimed. Regarding the rejection over claims 1-28 of U.S. Patent No. 10,786,601 in view of US’206, Busillo et al., Farley et al., and Liu et al., the combined teachings of the prior art do not provide sufficient guidance to select the combination of crosslinked and non-crosslinked hyaluronic acids as claimed.
The above rejections have been withdrawn.
Applicant’s remarks, filed 31 March 2026, with respect that claims 1-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 9,789,226 in view of US’206 (Lebreton, US 2011/0118206, published 19 May 2011, of record) and Busillo et al. (Journal of Medical Devices, 2009, 3(4), article 041004, 8 pages, of record). (typo for US 9,925,309 has been fully considered and is persuasive, as upon reconsideration the rejection includes a typographical error identifying the incorrect US Patent number.
This rejection has been withdrawn.
The following are modified grounds of rejection necessitated by Applicant’s amendment, filed 31 March 2026, in which claim 1 is amended to change the scope and breadth of the claim.
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.
Amended Claims 1-5, 9-10, 12-14, 16-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US’206 (Lebreton, US 2011/0118206, published 19 May 2011, of record) in view of US’438 (Lebreton, US 2010/0028438, published 04 Feb 2010, of record).
US’206 teaches soft tissue fillers, for example, dermal and subdermal fillers, based on low molecular weight hyaluronic acids and pharmaceutically acceptable salts thereof, and methods of manufacturing same (abstract). The composition generally comprises a crosslinked hyaluronic acid (HA) component and an uncrosslinked hyaluronic acid component (page 2, paragraph 19). Working example 1 describes the formation of a crosslinked HA gel mixture, the addition of lidocaine, and addition of an amount of uncrosslinked HA, packaging the gel in a sterile syringe, and autoclaving for about 1 minute (page 7, paragraphs 91-98). The uncrosslinked HA solution is added to the crosslinked HA component, to produce a dermal filler composition having a final weight percent of between 0.5% and 10% uncrosslinked HA (page 6, paragraph 81-84). In some embodiments of the invention, HA-based compositions are provided which include a therapeutically effective amount of at least one anesthetic agent, for example, but not limited to, lidocaine (page 2, paragraph 17). In embodiments with anesthetics, the concentration of one or more anesthetics is in an amount effective to mitigate pain experienced upon injection of the composition, and the one or more anesthetics can be selected from the group including mepivacaine (paragraph 61 spanning pages 4-5). A composition in accordance with the invention may include a low molecular weight component having a weight average molecular weight of about 500,000 Da, and a high molecular weight component having a weight average molecular weight of about, or at least about, 1.0 MDa (page 4, paragraph 50), addressing limitations of claim 2 and 10. Generally, the concentration of HA in the compositions described herein is preferably at least 10 mg/mL and up to about 40 mg/mL (page 4, paragraph 59), and assuming an aqueous density of approximately 1g/mL, approximately 1 to 4% by weight HA relative to the total weight of the composition, addressing limitations of claim 3 and 12. In the example of the HA component crosslinked with 1,4-butanediol diglycidyl ether (BDDE), said HA component has a degree of crosslinking of less than about 5%, for example, about 2% (page 3, paragraph 30), addressing limitations of claims 4 and 13. The amount of the anesthetic agent is present at a concentration between about 0.1% and about 5.0% by weight of the composition. In still another embodiment, the anesthetic agent is present at a concentration between about 0.2% and about 1.0% by weight of the composition (page 2, paragraph 26), addressing limitations of claim 5 and 14. A method of preparing a HA-based composition containing an effective amount of lidocaine, generally comprises the steps of providing the HA gel, adding to the gel a solution comprising lidocaine, packaging the composition in syringes for dispensing, which are then sterilized by autoclaving. In accordance with the present description, the packaged and sterilized HA/lidocaine gels exhibit enhanced stability relative to HA-based compositions including lidocaine which are made using conventional methods (page 5, paragraph 63), addressing limitations of claim 9, 16-17, and 21. Syringes useful according to the present description include any syringe known in the art capable of delivering viscous dermafiller compositions and include needles having gauges preferably about 25G to about 33G (page 6, paragraph 85-86), addressing structural limitations of claims 18-19.
US’206 does not specifically teach the composition comprises from 50% to 99% by weight of hyaluronic acid present in the form of a crosslinked gel, from 1% to 50% by weight of hyaluronic acid present in a non-crosslinked form, and the ratio between crosslinked and non-crosslinked hyaluronic acids being between 1:1 to 1:0.02 by weight (claim 1).
US’438 teaches cohesive soft tissue fillers, for example, dermal and subdermal fillers, based on hyaluronic acids and pharmaceutically acceptable salts thereof. In one aspect, hyaluronic acid-based compositions described herein include a therapeutically effective amount of at least one anesthetic agent, for example, lidocaine. The present hyaluronic acid based compositions including lidocaine have an enhanced stability and cohesivity, relative to conventional compositions including lidocaine, for example when subjected to sterilization techniques or when stored for long periods of time (abstract). In some embodiments the soft tissue filler composition has a particulate nature in that it comprises particles of crosslinked HA dispersed in a fluid soluble HA medium (page 2, paragraph 27). The method of preparing the soft tissue filler comprises adjusting the pH of the HA solution to be alkaline and crosslinking the alkaline HA composition (page 2, paragraph 29). US’438 teaches the working example 4 including sample 5 in which the composition comprising lidocaine and with pH control shows the relative viscosity/elasticity characteristics comparable to the composition without lidocaine (figure 6; paragraph 35 spanning pages 2-3; example 4 at page 8, paragraph 111 to page 9, paragraph 126).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine US’206 in view of US’438 in order to select the amount of the crosslinked HA component and the uncrosslinked HA component in the composition, and to produce a soft tissue filler based on hyaluronic acids and including a therapeutically effective amount of at least one anesthetic agent and having enhanced stability and cohesivity, relative to conventional compositions including lidocaine, when subjected to sterilization techniques. One of ordinary skill in the art would have been motivated to combine US’206 in view of US’438 with a reasonable expectation of success because both US’206 and US’438 are drawn to soft tissue filler based on hyaluronic acids and including a therapeutically effective amount of at least one anesthetic agent, and both US’206 and US’438 desire to formulate the composition having improved stability when subjected to sterilization techniques. Regarding the amount of the crosslinked HA component and the uncrosslinked HA component in the composition, US’206 teaches the composition formulated to a final weight percent of between 0.5% and 10% uncrosslinked HA, and teaches the working example where the uncrosslinked HA is added to a crosslinked HA component in a gel form containing 0.3% w/w lidocaine, implying the remainder of the composition is the crosslinked HA component in a gel form, suggesting a composition comprising 89.7-99.2% by weight crosslinked HA gel, 0.3% by weight of the anesthetic, and 0.5-10% by weight uncrosslinked HA, and derived weight ratio of the crosslinked HA gel to uncrosslinked HA such as 1:0.11. See MPEP 2144.095 at I. providing “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)” In this case US’206 teaches a composition comprising the same components in amount ranges that overlap with the claimed ranges, to be used for the same purpose as a soft tissue filler, therefore a prima facie case of obviousness exists. Regarding the selection of the anesthetic agent to be mepivacaine, US’206 teaches the at least one anesthetic agent is not limited to the working example of lidocaine and teaches it is selected from the group including mepivacaine, suggesting that it would have been prima facie obvious to select a known material based on its suitability for its intended use. See also MPEP 2144.07.
Response to Applicant’s Remarks:
Applicant’s remarks, filed 31 March 2026, have been fully considered and not found to be persuasive.
Regarding amended claim 1, in the modified grounds of rejection above newly cited teachings of US’206 are relied on to make obvious selection of the amount of the crosslinked HA component and the uncrosslinked HA component in the composition and the derived weight ratio of the crosslinked HA gel to uncrosslinked HA.
Applicant remarks that the combined teachings of US’206 in view of US’438 do not provide any incentive to use mepivacaine over lidocaine. However, as detailed in the rejection above, US’206 teaches the at least one anesthetic agent is not limited to the working example of lidocaine and teaches it is selected from the group including mepivacaine, suggesting that it would have been prima facie obvious to select a known material based on its suitability for its intended use. Further, MPEP 2144.06 provides “An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).” In this case US’206 suggests the listed anesthetic agents are equivalent components in the context of the invention of US’206, and selection of the known material based on its suitability for its intended use would have been obvious even without an express suggestion to substitute one for another.
Applicant notes that the filed application provides evidence of improved or unexpected results regarding the viscosity of the sterilized composition comprising mepivacaine compared to lidocaine. Data in Example 2 is provided for a single formulation comprising using 8 g of HA to make the crosslinked gel and adding a non-crosslinked gel comprising 4g of HA, or a composition that is approximately 66% by weight of the crosslinked gel and 33% by weight of the non-crosslinked HA, and this evidence is not commensurate in scope with the claim. Applicant notes that US’438 in example 4 at page 8, paragraph 111 to page 9, paragraph 126 compares 6 different formulations comprising different components. However, the evidence in US’438 suggests that the different components in different amounts affect the stability of the resulting formulation, supporting a conclusion that the evidence provided is not commensurate in scope with the claim.
Therefore applicant’s remarks and the evidence of record are not persuasive for the full scope of the claimed invention.
Amended Claims 6-7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US’206 (Lebreton, US 2011/0118206, published 19 May 2011, of record) in view of US’438 (Lebreton, US 2010/0028438, published 04 Feb 2010, of record) as applied to claims 1-5, 9-10, 12-14, 16-19, and 21 above, and further in view of Farley et al. (Regional Anaesthesia, 1994, 19(1), p48-51, provided by Applicant in IDS mailed 12 July 2022).
US’206 in view of US’438 teaches as above. US’206 further teaches the gels can be swelled in phosphate buffered saline (page 6, paragraph 75).
US’206 in view of US’438 does not specifically teach the composition further comprises at least a balanced salt solution (claims 6-7 and 15).
Farley et al. teaches the dilution of lidocaine and mepivacaine with balanced salt solution produces a solution that is both painless on injection and of moderate duration (page 48, abstract; page 50, paragraph spanning left and right column). Farley et al. teaches relevant field of art is intradermal injection of local anesthetics for painless transdermal insertion of needles (page 51, Conclusions paragraph spanning left and right column).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to combine US’206 in view of US’438 further in view of Farley et al. to select the physiologically acceptable solution to be a balanced salt solution. One of ordinary skill in the art would have been motivated to combine US’206 in view of US’438 further in view of Farley et al. with a reasonable expectation of success because US’206 teaches the composition swelled with phosphate buffered saline, and Farley et al. teaches dilution of lidocaine or mepivacaine with balanced salt solution provides additional advantages of being painless on injection and of moderate duration in the relevant field of art, suggesting it would have been obvious to combine US’206 in view of US’438 further in view of Farley et al. in order to improve the composition of US’206 in view of US’438 in the same way and in a predictable manner.
Response to Applicant’s Remarks:
Applicant’s remarks, filed 31 March 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks regarding the combined teachings of US’206 in view of US’438 as modified are addressed as above.
Amended Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over US’206 (Lebreton, US 2011/0118206, published 19 May 2011, of record) in view of US’438 (Lebreton, US 2010/0028438, published 04 Feb 2010, of record) as applied to claims 1-5, 9-10, 12-14, 16-19, and 21, and further in view of Liu et al. (US 2013/0123210 A1, published 16 May 2013, filed 1 Jun 2012, of record).
US’206 in view of US’438 teaches as above.
US’206 in view of US’438 does not specifically teach the composition further comprising a compound such as alpha-lipoic acid or reduced glutathione (claim 8).
Liu et al. teaches injectable HA-based hydrogel compositions (abstract), and generally relates to dermal filler compositions, and more specifically relates to injectable dermal filler compositions including antioxidants (page 1, paragraph 0002). Liu et al. teaches the hydrogel compositions may optionally comprise an anesthetic agent (page 7, paragraph 0058) or a combination of anesthetic agents (page 7, paragraph 0059). Liu et al. teaches the aspect in which an injectable dermal filler is provided which comprises a glycosaminoglycan polymer, at least a portion of which is crosslinked, and an antioxidant agent in an amount effective to reduce or prevent degradation of the composition, where the non-limiting examples of antioxidant agents include a lipoic acid or glutathione (page 8, paragraph 0072). Liu et al. teaches an example of an antioxidant lipoic acid in the relevant art is alpha-lipoic acid (page 8, paragraph 0069).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to combine US’206 in view of US’438 further in view of Liu et al. to formulate the composition to further comprise an antioxidant such as alpha-lipoic acid or reduced glutathione. One of ordinary skill in the art would have been motivated to combine US’206 in view of US’438 further in view of Liu et al. with a reasonable expectation of success because all of US’206, US’438, and Liu et al. are drawn to HA-based injectable dermal filler compositions, and Liu et al. teaches the desired advantage of an antioxidant agent in an amount effective to reduce or prevent degradation of the composition. It would have been obvious to one of ordinary skill in the art to select an antioxidant such as alpha-lipoic acid or reduced glutathione because Liu et al. provides guidance for selecting an antioxidant lipoic acid such as alpha-lipoic acid, or selecting an antioxidant glutathione, and one of ordinary skill in the art would have understood that glutathione that functions as an antioxidant must be reduced glutathione.
Response to Applicant’s Remarks:
Applicant’s remarks, filed 31 March 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks regarding the combined teachings of US’206 in view of US’438 as modified are addressed as above.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over US’206 (Lebreton, US 2011/0118206, published 19 May 2011, of record) in view of US’438 (Lebreton, US 2010/0028438, published 04 Feb 2010, of record) as applied to claims 1-5, 9-10, 12-14, 16-19, and 21, and further in view of Busillo et al. (Journal of Medical Devices, 2009, 3(4), article 041004, 8 pages, of record).
US’206 in view of US’438 teaches as above.
US’206 in view of US’438 does not specifically teach the needle or the cannula has a length varying from 4 to 70 mm (claim 20).
Busillo et al. teaches design of plastic hypodermic needles as an alternative to current steel needles (page 1, abstract). The plastic hypodermic needles are compared to commercially available steel hypodermic needles (InviroMedical InviroSNAP Exchangeable Needles, No. 110021, 22 gauge, 38.1 mm length) (page 1, paragraph spanning left and right column). Busillo et al. compares plastic needles of 25.4mm and 38.1mm length to the steel needle of 25.4mm length in the penetration of pig skin as a model of human skin (page 5, left column, and table 8 at bottom of left column). Busillo et al. teaches the length of the needle will affect buckling strength (page 3, paragraph spanning left and right columns).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine US’206 in view of US’438 further in view of Busillo et al. in order to select the size of the needle. One of ordinary skill in the art would have been motivated to combine US’206 in view of US’438 further in view of Busillo et al. with a reasonable expectation of success because US’206 teaches a person of ordinary skill in the art can determine the correct syringe dimensions and needle gauge required and generally include gauges between about 18G and about 40G, preferably about 25G to about 33G, and Busillo et al. teaches commercially available steel hypodermic needles of 22 gauge and 38.1 mm length, provides guidance for needles of 25.4 mm length, and suggests one of ordinary skill in the art would have selected the length of the needle according to predictable properties such as buckling strength.
Response to Applicant’s Remarks:
Applicant’s remarks, filed 31 March 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks regarding the combined teachings of US’206 in view of US’438 as modified are addressed as above.
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.
Amended Claims 1-10 and 12-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,789,226 in view of US’206 (Lebreton, US 2011/0118206, published 19 May 2011, of record).
Reference claims 1-13 of the reference patent are drawn to a sterile, injectable composition for intraepidermal, intradermal, and/or subcutaneous administration to a subject in need thereof comprising: hyaluronic acid or a salt thereof at a concentration ranging from 0.1 to 5 wt % of an overall weight of the sterile, injectable composition; and mepivacaine or a salt thereof as a first anesthetic agent at a concentration ranging from 0.05 to 3 wt % of the overall weight of the sterile, injectable composition, addressing limitations of claims 1, 3, and 5. Reference claim 4 recites the hyaluronic acid or the salt thereof comprises crosslinked and non-crosslinked hyaluronic acids at a ratio ranging from 1:1 to 1:0.02 of crosslinked to non-crosslinked hyaluronic acid in the single, sterile injectable composition. Reference claim 2 corresponds to the limitations of claim 2. Reference claim 3 recites the hyaluronic acid or the salt thereof is selected from the group consisting of crosslinked hyaluronic acids, non-crosslinked hyaluronic acids, and a mixture thereof, where the alternative of the mixture provides guidance to address the limitations of claim 1. Reference claims 10 and 11 correspond to limitations of claims 6 and 7. Reference claims 8 and 13 correspond to limitations of claim 8.
Reference claims 1-13 do not specifically teach the composition comprises from 50% to 99% by weight of hyaluronic acid present in the form of a crosslinked gel, from 1% to 50% by weight of hyaluronic acid present in a non-crosslinked form, and the ratio between crosslinked and non-crosslinked hyaluronic acids being between 1:1 to 1:0.02 by weight (claim 1). Reference claims 1-13 do not specifically teach the hyaluronic acid is crosslinked with a degree of modification ranging from 0.1 to 20% (claims 4 and 13). Reference claims 1-13 do not specifically teach an injection device comprising a composition (claim 9).
US’206 teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-13 in view of US’206 to select the amounts and weight ratio of the HA in the composition, degree of crosslinking modification of the hyaluronic acid, and to formulate the injectable composition in a syringe for injection. One of ordinary skill in the art would have been motivated to combine Reference claims 1-13 in view of US’206 because both teachings are drawn to a sterile, injectable composition for intraepidermal, intradermal, and/or subcutaneous administration comprising hyaluronic acid and mepivacaine, US’206 suggests one of ordinary skill in the art would have been motivated to select the degree of crosslinking modification, and US’206 suggests the artisan would have been motivated to formulate the injectable composition into a syringe for injection. Regarding the amount of the crosslinked and non-crosslinked hyaluronic acids in the composition and the derived weight ratio, Reference claim 4 recites the crosslinked and non-crosslinked hyaluronic acids at a ratio ranging from 1:1 to 1:0.02, and US’206 teaches selecting the amounts of the crosslinked and non-crosslinked hyaluronic acids in the composition, providing guidance for selecting this ratio to be weight ratio of the HA in the composition.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,789,226 in view of US’206 (Lebreton, US 2011/0118206, published 19 May 2011, of record) further in view of Busillo et al. (Journal of Medical Devices, 2009, 3(4), article 041004, 8 pages, of record).
Reference claims 1-13 in view of US’206 teach as above.
Reference claims 1-13 in view of US’206 does not specifically teach the needle or the cannula has a diameter ranging between 18 and 34 G and a length varying from 4 to 70 mm (claim 20).
Busillo et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-13 in view of US’206 further in view of Busillo et al. in order to select the size of the needle. One of ordinary skill in the art would have been motivated to combine Reference claims 1-13 in view of US’206 further in view of Busillo et al. with a reasonable expectation of success because Busillo et al. teaches commercially available steel hypodermic needles of 22 gauge and 38.1 mm length, provides guidance for needles of 25.4 mm length, and suggests one of ordinary skill in the art would have selected the length of the needle according to predictable properties such as buckling strength.
Amended Claims 1-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 9,925,309 in view of US’206 (Lebreton, US 2011/0118206, published 19 May 2011, of record) and Busillo et al. (Journal of Medical Devices, 2009, 3(4), article 041004, 8 pages, of record).
Reference claims 1-33 of the reference patent are drawn to a sterile, injectable composition for intraepidermal, intradermal, and/or subcutaneous administration to a subject in need thereof comprising: hyaluronic acid or a salt thereof at a concentration ranging from 0.1 to 5 wt % of an overall weight of the sterile, injectable composition; and mepivacaine or a salt thereof as a first anesthetic agent at a concentration ranging from 0.05 to 3 wt % of the overall weight of the sterile, injectable composition, addressing limitations of claims 1, 3, and 5. Reference claim 13 recites wherein the hyaluronic acid or the salt thereof comprises crosslinked and non-crosslinked hyaluronic acids at a ratio ranging from 1:1 to 1:0.02 of crosslinked to non-crosslinked hyaluronic acid in the single, sterile injectable composition. Reference claims 5 and 10 recite limitations corresponding to the limitations of claim 2. Reference claims 7 and 12 recite the hyaluronic acid or the salt thereof is selected from the group consisting of crosslinked hyaluronic acids, non-crosslinked hyaluronic acids, and a mixture thereof, addressing limitations of claim 1. Reference claims 11 and 14 correspond to limitations of claims 6 and 7. Reference claim 8 recites the composition comprising an antioxidant such as glutathione, and reference claim 27 recites the composition comprising an amino acid such as arginine, isoleucine, leucine, and glycine, providing guidance for selecting the composition and addressing limitations of claim 8.
Reference claims 1-33 do not specifically teach the composition comprises from 50% to 99% by weight of hyaluronic acid present in the form of a crosslinked gel, from 1% to 50% by weight of hyaluronic acid present in a non-crosslinked form, and the ratio between crosslinked and non-crosslinked hyaluronic acids being between 1:1 to 1:0.02 by weight (claim 1). Reference claims 1-33 do not specifically teach the hyaluronic acid is crosslinked with a degree of modification ranging from 0.1 to 20% (claims 4 and 13). Reference claims 1-33 do not specifically teach an injection device comprising a composition (claim 9). Reference claims 1-33 do not specifically teach the needle or the cannula has a diameter ranging between 18 and 34 G and a length varying from 4 to 70 mm (claim 20).
US’206 teaches as above.
Busillo et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-33 in view of US’206 to select the amounts and weight ratio of the HA in the composition, select the degree of crosslinking modification of the hyaluronic acid and to formulate the injectable composition in a syringe for injection, and in view of Busillo et al. in order to select the size of the needle. One of ordinary skill in the art would have been motivated to combine Reference claims 1-13 in view of US’206 because both teachings are drawn to a sterile, injectable composition for intraepidermal, intradermal, and/or subcutaneous administration comprising hyaluronic acid and mepivacaine, US’206 suggests one of ordinary skill in the art would have been motivated to select the degree of crosslinking modification, and US’206 suggests the artisan would have been motivated to formulate the injectable composition into a syringe for injection. One of ordinary skill in the art would have been motivated to combine Reference claims 1-13 in view of US’206 further in view of Busillo et al. with a reasonable expectation of success because Busillo et al. teaches commercially available steel hypodermic needles of 22 gauge and 38.1 mm length, provides guidance for needles of 25.4 mm length, and suggests one of ordinary skill in the art would have selected the length of the needle according to predictable properties such as buckling strength. Regarding the amount of the crosslinked and non-crosslinked hyaluronic acids in the composition and the derived weight ratio, Reference claim 13 recites the crosslinked and non-crosslinked hyaluronic acids at a ratio ranging from 1:1 to 1:0.02, and US’206 teaches selecting the amounts of the crosslinked and non-crosslinked hyaluronic acids in the composition, providing guidance for selecting this ratio to be weight ratio of the HA in the composition.
Amended Claims 1-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,322,212 in view of US’206 (Lebreton, US 2011/0118206, published 19 May 2011, of record), Busillo et al. (Journal of Medical Devices, 2009, 3(4), article 041004, 8 pages, of record), and Liu et al. (US 2013/0123210 A1, published 16 May 2013, filed 1 Jun 2012, of record).
Reference claims 1-20 of the reference patent are drawn to a sterile, injectable composition for intraepidermal, intradermal, and/or subcutaneous administration to a subject in need thereof comprising: hyaluronic acid or a salt thereof at a concentration ranging from 0.1 to 5 wt % of an overall weight of the sterile, injectable composition; and mepivacaine or a salt thereof as a first anesthetic agent at a concentration ranging from 0.05 to 3 wt % of the overall weight of the sterile, injectable composition, and the hyaluronic acid or salt thereof comprises cross-linked hyaluronic acids or a mixture of cross-linked and non-crosslinked hyaluronic acids, where the alternative of the mixture addresses limitations of claims 1, 3, and 5. Reference claim 3 recites the hyaluronic acid or the salt thereof comprises crosslinked and non-crosslinked hyaluronic acids at a ratio ranging from 1:1 to 1:0.02 of crosslinked to non-crosslinked hyaluronic acid in the stable, sterile injectable composition. Reference claim 2 recites limitations corresponding to the limitations of claim 2. Reference claims 4 and 5 correspond to limitations of claims 6 and 7. Reference claim 14 recites the composition further comprising at least one antioxidant.
Reference claims 1-20 do not specifically teach the composition comprises from 50% to 99% by weight of hyaluronic acid present in the form of a crosslinked gel, from 1% to 50% by weight of hyaluronic acid present in a non-crosslinked form, and the ratio between crosslinked and non-crosslinked hyaluronic acids being between 1:1 to 1:0.02 by weight (claim 1). Reference claims 1-20 do not specifically teach the hyaluronic acid is crosslinked with a degree of modification ranging from 0.1 to 20% (claims 4 and 13). Reference claims 1-20 do not specifically teach an injection device comprising a composition (claim 9). Reference claims 1-20 do not specifically teach the needle or the cannula has a diameter ranging between 18 and 34 G and a length varying from 4 to 70 mm (claim 20).
US’206 teaches as above.
Busillo et al. teaches as above.
Liu et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-20 in view of US’206 to select the amounts and weight ratio of the HA in the composition, to select the degree of crosslinking modification of the hyaluronic acid and to formulate the injectable composition in a syringe for injection, Busillo et al. in order to select the size of the needle, and Liu et al. to select the antioxidant in the composition. One of ordinary skill in the art would have been motivated to combine Reference claims 1-20 in view of US’206 because both teachings are drawn to a sterile, injectable composition for intraepidermal, intradermal, and/or subcutaneous administration comprising hyaluronic acid and mepivacaine, US’206 suggests one of ordinary skill in the art would have been motivated to select the degree of crosslinking modification, and US’206 suggests the artisan would have been motivated to formulate the injectable composition into a syringe for injection. One of ordinary skill in the art would have been motivated to combine Reference claims 1-20 in view of US’206 further in view of Busillo et al. with a reasonable expectation of success because Busillo et al. teaches commercially available steel hypodermic needles of 22 gauge and 38.1 mm length, provides guidance for needles of 25.4 mm length, and suggests one of ordinary skill in the art would have selected the length of the needle according to predictable properties such as buckling strength. One of ordinary skill in the art would have been motivated to combine Reference claims 1-20 in view of US’206, Busillo et al., and Liu et al. with a reasonable expectation of success because Liu et al. teaches the desired advantage of an antioxidant agent in an amount effective to reduce or prevent degradation of the composition, suggesting it would have been obvious to improve similar compositions in the same way with predictable results. Regarding the amount of the crosslinked and non-crosslinked hyaluronic acids in the composition and the derived weight ratio, Reference claim 3 recites the crosslinked and non-crosslinked hyaluronic acids at a ratio ranging from 1:1 to 1:0.02, and US’206 teaches selecting the amounts of the crosslinked and non-crosslinked hyaluronic acids in the composition, providing guidance for selecting this ratio to be weight ratio of the HA in the composition.
Amended Claims 1-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,413,637 in view of US’206 (Lebreton, US 2011/0118206, published 19 May 2011, of record), Busillo et al. (Journal of Medical Devices, 2009, 3(4), article 041004, 8 pages, of record), Farley et al. (Regional Anaesthesia, 1994, 19(1), p48-51, provided by Applicant in IDS mailed 12 July 2022), and Liu et al. (US 2013/0123210 A1, published 16 May 2013, filed 1 Jun 2012, of record).
Reference claims 1-19 of the reference patent are drawn to a sterile, injectable composition for intraepidermal, intradermal, and/or subcutaneous administration to a subject in need thereof comprising: hyaluronic acid or a salt thereof at a concentration ranging from 0.1 to 5 wt % of an overall weight of the sterile, injectable composition; and mepivacaine or a salt thereof as a first anesthetic agent at a concentration ranging from 0.05 to 3 wt % of the overall weight of the sterile, injectable composition, and a balanced salt solution, addressing limitations of claims 1, 3, and 5-6. Reference claim 7 recites the hyaluronic acid comprises crosslinked and non-crosslinked hyaluronic acid at a ratio of 1:1 to 1:0.02 of crosslinked to non-crosslinked hyaluronic acid in the single, sterile injectable composition. Reference claim 2 recites the hyaluronic acid comprises crosslinked hyaluronic acids, non-crosslinked hyaluronic acids, or a mixture thereof, where the alternative of the mixture addresses limitations of claim 1. Reference claim 6 recites limitations corresponding to the limitations of claim 2. Reference claim 5 recites the balanced salt solution is a phosphate saline buffer corresponding to limitations of claim 7. Reference claim 11 recites the composition comprising an antioxidant such as glutathione, and reference claim 13 recites the composition comprising an amino acid such as arginine, isoleucine, leucine, and glycine, providing guidance for selecting the composition and addressing limitations of claim 8.
Reference claims 1-19 do not specifically teach the composition comprises from 50% to 99% by weight of hyaluronic acid present in the form of a crosslinked gel, from 1% to 50% by weight of hyaluronic acid present in a non-crosslinked form, and the ratio between crosslinked and non-crosslinked hyaluronic acids being between 1:1 to 1:0.02 by weight (claim 1). Reference claims 1-19 do not specifically teach the hyaluronic acid is crosslinked with a degree of modification ranging from 0.1 to 20% (claims 4 and 13). Reference claims 1-19 do not specifically teach the physiologically acceptable solution is a balanced salt solution (instant claim 6-7 and 15). Reference claims 1-19 do not specifically teach the composition further comprising a compound such as alpha-lipoic acid or reduced glutathione (claim 8). Reference claims 1-19 do not specifically teach an injection device comprising a composition (claim 9). Reference claims 1-19 do not specifically teach the needle or the cannula has a diameter ranging between 18 and 34 G and a length varying from 4 to 70 mm (claim 20).
US’206 teaches as above.
Busillo et al. teaches as above.
Farley et al. teaches as above.
Liu et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-19 in view of US’206 in order to select the amounts and weight ratio of the HA in the composition, select the degree of crosslinking modification of the hyaluronic acid and to formulate the injectable composition in a type of syringe for injection, in view of Busillo et al. in order to select the size of the needle, in view of Farley et al. in order to formulate the composition with a balanced salt solution, and Liu et al. to select the antioxidant in the composition. One of ordinary skill in the art would have been motivated to combine Reference claims 1-19 in view of US’206 because both teachings are drawn to a sterile, injectable composition for intraepidermal, intradermal, and/or subcutaneous administration comprising hyaluronic acid and mepivacaine, US’206 suggests one of ordinary skill in the art would have been motivated to select the degree of crosslinking modification, and US’206 suggests the artisan would have been motivated to formulate the injectable composition into a syringe for injection. One of ordinary skill in the art would have been motivated to combine Reference claims 1-19 in view of US’206 further in view of Busillo et al. with a reasonable expectation of success because Busillo et al. teaches commercially available steel hypodermic needles of 22 gauge and 38.1 mm length, provides guidance for needles of 25.4 mm length, and suggests one of ordinary skill in the art would have selected the length of the needle according to predictable properties such as buckling strength. One of ordinary skill in the art would have been motivated to combine Reference claims 1-19 in view of US’206, Busillo et al., and Farley et al. with a reasonable expectation of success because Farley et al. teaches dilution of lidocaine or mepivacaine with balanced salt solution provides additional advantages of being painless on injection and of moderate duration in the relevant field of art,, suggesting it would have been obvious to improve similar compositions in the same way with predictable results. One of ordinary skill in the art would have been motivated to combine Reference claims 1-19 in view of US’206, Busillo et al., and Liu et al. with a reasonable expectation of success because Liu et al. teaches the desired advantage of an antioxidant agent in an amount effective to reduce or prevent degradation of the composition, suggesting it would have been obvious to improve similar compositions in the same way with predictable results. Regarding the amount of the crosslinked and non-crosslinked hyaluronic acids in the composition and the derived weight ratio, Reference claim 7 recites the crosslinked and non-crosslinked hyaluronic acids at a ratio ranging from 1:1 to 1:0.02, and US’206 teaches selecting the amounts of the crosslinked and non-crosslinked hyaluronic acids in the composition, providing guidance for selecting this ratio to be weight ratio of the HA in the composition.
Amended Claims 1-7, 9-10, and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,406,738 in view of US’206 (Lebreton, US 2011/0118206, published 19 May 2011, of record).
Reference claims 1-13 of the reference patent are drawn to an injection device comprising a composition which is sterilized and injectable, the composition comprising hyaluronic acid or a salt thereof at a concentration ranging from 0.1 to 5 wt % of an overall weight of the sterile, injectable composition; and mepivacaine or a salt thereof as a first anesthetic agent at a concentration ranging from 0.05 to 3 wt % of the overall weight of the sterile, injectable composition, addressing limitations of claims 1, 3, 5, 9, 12 and 14. Reference claim 3 recites the hyaluronic acid comprises crosslinked hyaluronic acids, non-crosslinked hyaluronic acids, or a mixture thereof, where the alternative of the mixture thereof addresses limitations of claim 1. Reference claim 2 recites limitations corresponding to the limitations of claim 2 and 10. Reference claim 4 recites limitations corresponding to the limitations of claim 4 and 13. Reference claim 5 recites a balanced salt solution corresponding to limitations of claims 6 and 15. Reference claim 11 recites the balanced salt solution corresponding to limitations of claim 7. Reference claims 6-10 recite the structure of the injection device corresponding to claims 16-20.
Reference claims 1-19 do not specifically teach the composition comprises from 50% to 99% by weight of hyaluronic acid present in the form of a crosslinked gel, from 1% to 50% by weight of hyaluronic acid present in a non-crosslinked form, and the ratio between crosslinked and non-crosslinked hyaluronic acids being between 1:1 to 1:0.02 by weight (claim 1).
US’206 teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-19 in view of US’206 in order to select the amounts and weight ratio of the HA in the composition. One of ordinary skill in the art would have been motivated to combine Reference claims 1-19 in view of US’206 because both teachings are drawn to a sterile, injectable composition comprising hyaluronic acid and mepivacaine, Reference claim 3 recites the alternative of a mixture of crosslinked hyaluronic acids and non-crosslinked hyaluronic acids, and US’206 teaches the composition formulated to a final weight percent of between 0.5% and 10% uncrosslinked HA, and teaches the working example where the uncrosslinked HA is added to a crosslinked HA component in a gel form containing 0.3% w/w lidocaine, implying the remainder of the composition is the crosslinked HA component in a gel form, suggesting a composition comprising 89.7-99.2% by weight crosslinked HA gel, 0.3% by weight of the anesthetic, and 0.5-10% by weight uncrosslinked HA, and derived weight ratio of the crosslinked HA gel to uncrosslinked HA such as 1:0.11.
Amended Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,406,738 in view of US’206 (Lebreton, US 2011/0118206, published 19 May 2011, of record), further in view of Liu et al. (US 2013/0123210 A1, published 16 May 2013, filed 1 Jun 2012, of record).
Reference claims 1-13 of the reference patent in view of US’206 teaches as above.
Reference claims 1-13 of the reference patent in view of US’206 do not specifically recite the composition further comprising a compound such as alpha-lipoic acid or reduced glutathione (claim 8).
Liu et al. teaches as above.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to combine Reference claims 1-13 of the reference patent in view of US’206 further in view of Liu et al. to formulate the composition to further comprise an antioxidant such as alpha-lipoic acid or reduced glutathione. One of ordinary skill in the art would have been motivated to combine Reference claims 1-13 in view of Liu et al. with a reasonable expectation of success because all of Reference claims 1-13, US’206, and Liu et al. are drawn to HA-based injectable compositions, and Liu et al. teaches the desired advantage of an antioxidant agent in an amount effective to reduce or prevent degradation of the composition. It would have been obvious to one of ordinary skill in the art to select an antioxidant such as alpha-lipoic acid or reduced glutathione because Liu et al. provides guidance for selecting an antioxidant lipoic acid such as alpha-lipoic acid, or selecting an antioxidant glutathione, and one of ordinary skill in the art would have understood that glutathione that functions as an antioxidant must be reduced glutathione.
Response to Applicant’s Remarks:
Applicant’s remarks, filed 31 March 2026, have been fully considered and not found to be fully persuasive.
New grounds of rejection are detailed above, necessitated by Applicant’s amendment, filed 31 March 2026, in which claim 1 is amended to change the scope and breadth of the claim.
Conclusion
No claim is found to be allowable.
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.
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/JONATHAN S LAU/Primary Examiner, Art Unit 1693
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