DETAILED ACTION
This Office Action is in response to Applicant’s Amendment and Remarks filed on 09 February 2026 in which claims 1-8, 12, 15 and 16 were amended to change the scope and breadth of the claims, and claim 20 was newly added.
Claims 1-20 are pending in the current application and are examined on the merits herein.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Withdrawn Objection and Rejections
Applicant’s amendment, filed 09 February 2026, with respect to the objection of the claims for being misnumbered, has been fully considered and is persuasive because the claims have been renumbered. The objection is hereby withdrawn.
Applicant’s amendment, filed 09 February 2026, with respect to the rejection of claims 1-19 under 35 U.S.C. § 112(b), second paragraph, for indefiniteness, has been fully considered and is persuasive. Claims which recited “at least about” have been amended to say “at least”. The recitation “being added to the crosslinked gel” has been deleted. The antecedent issue in claim 19 has been corrected by renumbering the claims.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). Also, see MPEP 706.02 (section VI).
The disclosures of the prior-filed CIP application(s), 12/393,768 and 12/393,884, fail to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application.
Specifically, these applications fail to provide support for “the uncrosslinked HA gel being added to the crosslinked gel in an amount of between about 0.5% and about 5.0% w/w”; or “wherein the weight average molecular weight of the second, high molecular weight HA material is at least twice that of the first, low molecular weight HA material” – both of which are recited in independent claim 1. Therefore, the effective filing date of US Application No. 12/970,707, filed 16 December 2010 is seen to be the effective filing date of the claimed invention, claims 1-20 .
If applicant disagrees, applicant should present a detailed analysis as to why the claimed subject matter has clear support in the earlier priority applications. Applicant is reminded that such priority for the instant limitations requires written description and enablement under 35 U.S.C. § 112, first paragraph.
In clarifying the priority date of the instant claims, applicant should note or address whether the art rejections are prior to the priority date of the instant claims and whether said art occurred more than one year prior to said priority date. Applicant will note that the art rejections are under both 35 U.S.C. § 102(a) and 102(b) because the priority date of the instant claims is in question.
Response to Arguments
Applicant's arguments filed 09 February 2026 have been fully considered but they are not persuasive.
Applicant contends the present application claims the benefit of priority to US Provisional Application Nos. 61/085,956, filed 04 August 2008 (hereinafter the ‘956 application); 61/087,934, filed 11 August 2008 (hereinafter the ‘934 application); and 61/096,278, filed 11 September 2008 (hereinafter the ‘278 application).
The disclosures of the ‘956 application, ‘934 application and ‘278 application have been reviewed. However, there does not appear to be support for “the uncrosslinked HA gel being added to the crosslinked gel in an amount of between about 0.5% and about 5.0% w/w”; or “wherein the weight average molecular weight of the second, high molecular weight HA material is at least twice that of the first, low molecular weight HA material” – both of which are recited in independent claim 1.
The effective filing date of US Application No. 12/970,707, filed 16 December 2010 is seen to be the effective filing date of the claimed invention, claims 1-20 .
Modified Rejections
The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on 09 February 2026, where the limitations in pending claims 1-8, 12, 15 and 16 as amended now have been changed and claim 20 has been newly added. Therefore, rejections from the previous Office Action, dated 08 August 2025, have been modified and are listed below.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-12, 15 and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lebreton (US Patent Application Publication No. 2006/0194758, cited in previous Office Action) in view of Kablik et al. (Dermatol. Surg., February 2009, vol. 35, S1, pp. 302-312, cited in previous Office Action), and Clark et al. (Plast. Reconstr. Surg., 2007, vol. 120, suppl. 27S-32S, cited in previous Office Action).
Lebreton teach the preparation of an injectable hydrogel for use as a filling material, including in cosmetic surgery (para [0005]). Lebreton teaches preparing high molecular weight hyaluronic acid (HMW-HA) crosslinked with 1,4-butanediol diglycidyl ether (BDDE), (example 1). The crosslinked HMW-HA has an injection force after sterilization is 25 N. The HMW-HA has a Mw average of 1,100,000 to 5,000,000 Da (or 1.1 MDa to 5 MDa), and an intrinsic viscosity of 2800 mL/g (claim 5; example 1). The LMW-HA has a MW of less 990,000 Da, or a range of from 10,000 to 990,000 Da (or 0.01 MDa to about 0.990 MDa (para [0037]). Lebreton teaches preparing low molecular weight hyaluronic acid (LMW-HA) crosslinked with BDDE, (example 2). The crosslinked LMW-HA has an injection force of 24 N. The LMW-HA has a Mw of 300,000 Da (or 0.30 MDa), and an intrinsic viscosity of 600 mL/g (para [0020]; example 2). The exemplified HMW-HA is 3.3 times higher (i.e. at least twice) that of the exemplified LMW-HA. The LMW-HA is mixed with the HMW-HA, such that the mixture contains more than 50% by weight, preferably more than 70% by weight of at least one LMW-HA. Lebreton teaches examples having 77% or 90% w/w LMW-HA (examples 3 and 4; and para [0041]). The mixture results in an injectable hydrogel having an HA concentration of between 10-40 mg/g, preferably 20-30 mg/g (para [0049]). The HA gels are sterilized in an autoclave (para [0070], [0076], [0081], [0087]). Thus, Lebreton also teaches a sterile, injectable soft tissue filler.
Lebreton does not expressly disclose “an uncrosslinked HA gel” component (claim 1).
Kablik et al. characterize the physical properties of hyaluronic acid dermal fillers (title). Figure 2 shows uncrosslinked HA is a liquid, while crosslinked HA is a gel (p.304). The gel to fluid ratio refers to the {[total HA conc] - [soluble HA conc]}/[soluble HA conc] (p.309). Kablik et al. teach manufacturers add soluble (uncrosslinked) fluid HA to the gel component to facilitate the extrusion of the filler through fine-bore needles (p.305, first para). Because the soluble fluids are quickly degraded, it is important to consider how much of the filler’s HA concentration is gel (cross-linked) and how much is soluble (uncrosslinked). Kablik also teaches gel concentration affects the modulus of the gel, and the gels overall hardness or softness (p.306).
Table 1 summarizes the physical properties of six commercially available dermal fillers. Hylaform, Hylaform Plus and Prevelle had a total HA concentration of 5.5 mg/mL, and a 98:2 gel-to-fluid ratio. Restylane and Perlane had a total HA concentration of 20 mg/mL, and a 75:25 gel-to-fluid ratio. And Juvederm 30 HV had a total HA concentration of 24 mg/mL, and a 60:40 gel-to-fluid ratio. “The data on the modulus G’, presented in Table 1, shows that Juvederm 30 HV is the softest of the HA fillers reviewed (G’ 105 Pa), closely followed by Hylaform/Hylaform Plus (G’ 140-220 Pa) and Prevelle (G’ 220-260 Pa). The modulus for Restylane/Perlane (G’ 600-700 Pa) is six times as great as that of Juvederm 30 HV and three times as great as Hylaform, Hylaform Plus, and Prevelle. The FDA has approved all of these products for the same indication, but these differences in the modulus may be used as a guide to physicians to refine the use of each product to better suit the needs of their patients.” (p.311).
Clark also describes the physical characteristics of known hyaluronic acid dermal filler products (title). Clark estimates there is about 4% by weight soluble HA in Hylaform, Hylaform Plus and Captique; and about 25% by weight soluble HA in Perlane and Restylane. The MW of Hylaform and Hylaform plus are 4-6 MDa (table 1). The MW of Captique, Perlane and Restylane are 1.5-2 MDa. The starting MW of HA from rooster combs used for Hylaform was two to three times that of HA from bacterial source used for Restylane (p.28S, The Significance of the Hyaluronic Acid Source). Clark teaches HA’s viscoelastic properties are determined by its size (MW), its concentration, the cross-linking and particle size (p.28S, Rheology and Cross-Linking of Hyaluronic Acids). HA has non-Newtonian characteristics, wherein HA has decreasing viscosity with increasing applied force, i.e. HA becomes less viscous when it’s pushed through a syringe. The G’ modulus of the HA gels inform one of the gel hardness, wherein “the harder the gel, the greater its ability to resist shear, and the greater its ability to exert a deformational force on the surrounding tissues for the correction of defects” (p.28S, last para). HA concentration also affects longevity, where soluble (uncrosslinked) HA degrades quickly, so that a product having too high a concentration of soluble HA may degrade too quickly as well (p.29S, first para).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the crosslinked HA gel mixture of Lebreton with about 2-4% soluble uncrosslinked HA.
One having ordinary skill in the art would have been motivated to combine soluble (uncrosslinked) HA with the HMW-HA/LMW-HA crosslinked HA gel mixture of Lebreton because it is a commonly employed technique to improve the extrusion of crosslinked HA gels through fine-bore needles.
Since soluble (uncrosslinked) HA degrades too quickly, one having ordinary skill in the art would have known from the combined teaching of Kablik and Clark to optimize the concentration to ensure the HA gel has good viscosity and G’ modulus to push it through a syringe and optimize biodegradability. The ordinary artisan would have been motivated to include about 4% soluble (uncrosslinked HA) because Clark and Kablik teach commercially available crosslinked HA gels with about 4% by weight soluble (uncrosslinked HA) were FDA approved for use as a dermal filler. One having ordinary skill in the art would have been motivated to further optimize the amount of soluble (uncrosslinked HA) because it is a recognized result-effective variable. Using less soluble (uncrosslinked HA) would have expected to decrease the viscosity of the HA gel.
The ordinary artisan would have been motivated to use soluble (uncrosslinked) HA having a Mw of about 2.0 MDa, because Clark teaches the starting MW of HA from bacterial sources is around 1.5-2.0 MDa, which has been used for the preparation of commercially available and FDA approved dermal fillers having uncrosslinked and crosslinked HA.
As discussed above, Lebreton teaches a total HA concentration of 10-40 mg/g, preferably 20-30 mg/g; and Kablik and Clark teaches products having a total HA concentration of 4.5-6.0 mg/mL, 20 mg/mL or 24 mg/mL. The prior art as a whole suggests an operable working range of 4.5-24 mg/mL. The total HA concentration taught by Lebreton, Kablik and Clark overlap with the claimed range recited in present claim 1. The ordinary artisan would have been motivated to optimize the total HA concentration because Clark teaches it is one of the physical properties that affects the viscoelastic property of the dermal filler, i.e. it’s a result-effective variable. Similarly, Kablik teaches the concentration affects the hardness/softness of the gel and their utility as a dermal filler.
See MPEP 2144.05, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Thus, the combined teaching of the prior art is prima facie obvious over the combined teaching of the prior art.
Claims 13, 14, and 17-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lebreton, Kablik and Clark as applied to claims 1-12, 15 and 16 above, and further in view of Gavard Molliard (US Patent No. 8,455,465, cited in previous Office Action).
Lebreton, Kablik and Clark teaches as discussed above.
Lebreton does not expressly disclose lidocaine (present claims 13, 14, 17 and 18).
Gavard Molliard teaches a heat sterilized injectable hyaluronate containing composition further comprising lidocaine (title). The presence of lidocaine in the gel improves patient comfort during and after injection (col.3: 39-41). The HA can be crosslinked or uncrosslinked (col.2: 30-35). Gavard Molliard teaches first preparing the crosslinked HA gel, and then subsequently adding lidocaine to it (Example 1, Gel B). The resulting mixture was then heat sterilized.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include lidocaine with the composition of Lebreton to improve patient comfort during and after injection with HA.
With respect to the order of steps recited in renumbered claim 18, the claimed process is no more than a selective combination of prior art teachings done in a manner obvious to one of ordinary skill in the art since each step of the process appears to be relatively complete in itself and there is no indication of an interaction between steps of such a type that would lead one of ordinary skill in the art to doubt that a substitution of alternative steps known to the art could be made. In re Mostovych, 144 USPQ 38 (1964).
The skilled artisan would have had a reasonable expectation of success because like Lebreton, Gavard Molliard teach lidocaine can be combined with crosslinked or uncrosslinked HA, and heat sterilized.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lebreton, Kablik, Clark and Gavard Molliard as applied to claims 1-19 above, and further in view of David (WO 2007/106457, cited in PTO-892).
Lebreton, Kablik and Clark teaches as discussed above.
Lebreton does not expressly disclose mepivacaine (present claim 20).
Gavard Molliard teaches as discussed above.
David teaches a kit comprising two prefilled syringes, where the second prefilled syringe contains at least one dermal filler (claim 1). The at least one dermal filler comprises hyaluronic acid (claim 5). The kit further comprises at least one analgesic selected from lidocaine, mepivacaine and others (claim 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include lidocaine or mepivacaine with the composition of Lebreton to improve patient comfort during and after injection with HA, because lidocaine and mepivacaine are recognized as suitable alternative analgesic agents used in combination with HA-based dermal fillers.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Response to Arguments
Applicant's arguments, filed 09 February 2026, have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the priority date are not found persuasive as discussed above.
With respect to Kablik, Applicant argues the data in Table 1 suggests “increasing the HA concentration from 5.5 mg/ml (e.g., Hylaform/Hylaform Plus) to 20 mg/ml (e.g. Restylane/Perlane) increased the dermal filler’s modulus from between 140-220 Pa to 588-660 Pa. Applicant argues this increase in modulus was observed even though Restylane had an increased amount of soluble HA compared to Hylaform (75:25 Restylane, 98:2 Hylaform), and a decreased percentage of crosslinked HA compared to Hylaform (1.5% Restylane, 12% Hylaform). Thus, Applicant contends one of ordinary skill in the art would need at least 25% soluble HA “to have a comparably increased modulus as Kablik’s dermal fillers (e.g. Restylane) and an even higher percentage in order to achieve a modulus closer to Hylaform”.
The above arguments have been carefully considered but are not found persuasive when Kablik is considered with the teaching of Lebreton. In the table disclosed by Lebreton, four gels having 26 mg/g NaHA were prepared. Their elastic modulus (G’) and ejection force(F) were measured through a 27 G1/2 needle.
Gel no. 1 was prepared from 100% high MW HA, had a G’ of 143 Pa, but the ejection force was high at 25 N. Gel no. 2 was prepared from 100% low MW HA, had a G’ of 1300 Pa, and a similar ejection force of 24 N. Gel no. 3 was prepared from 77:23 ratio of low:high MW HA, and it had a G’ of 262 Pa, but with a much lower ejection force of 15 N. And finally, gel no. 4 was prepared from a 90:10 ratio of low:high MW HA, and it had a G’ of 571 Pa, and ejection force of 14 N.
Thus, one of ordinary skill in the art would have known the mixed MW HA gels of Lebreton could be prepared with an elastic modulus of 262 Pa, which is similar to the elastic modulus of Prevelle (see Kablik et al.), even at a much higher concentration of HA (26 mg/g) than the concentration of HA present in Prevelle (5.5 mg/mL). Additionally, the mixed MW HA gels of Lebreton could be prepared with an elastic modulus of 571 Pa, similar to that of Perlane and Restylane. While Perlane and Restylane have 25% soluble HA, respectively, the mixed MW HA gel of Lebreton does not have any soluble HA.
Accordingly, the ordinary artisan would have had a reasonable expectation of success in adding 2-4% soluble HA to give a gel having a good elastic modulus and good extrusion force, similar to those of commercially available HA, with a reasonable expectation of success.
Applicant further argues there is no reason to alter the HA concentration or the percentage of soluble HA in any of the dermal fillers of Kablik and Clark to arrive at the present claims. Applicant argues none of the cited references provide any suggestion that modifying the HA concentration and/or soluble HA percentage would provide any advantage or benefit.
The above arguments have been carefully considered, but are not found persuasive. As discussed above, Kablik et al. teach manufacturers add soluble (uncrosslinked) fluid HA to the gel component to facilitate the extrusion of the filler through fine-bore needles. This goal is similar to that of Lebreton, where HA of different MWs were mixed together to lower the extrusion force needed to push the mixture through a 27 G1/2 needle.
The ordinary artisan would have been motivated to include about 4% soluble (uncrosslinked HA) because Clark estimates there is about 4% by weight soluble HA in Hylaform, Hylaform Plus and Captique; and about 25% by weight soluble HA in Perlane and Restylane. Thus, the prior art suggests a working range of 4-25%. One having ordinary skill in the art would have been motivated to further optimize the amount of soluble (uncrosslinked HA) because it is a recognized result-effective variable. Clark teaches it is one of the physical properties that affects the viscoelastic property of the dermal filler and Kablik teaches the concentration affects the hardness/softness of the gel and their utility as a dermal filler. See MPEP 2144.05, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
For the above stated reasons, said claims are properly rejected under 35 U.S.C. 103(a). Thus, the rejection is hereby maintained.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 8,450,475 in view of Kablik, Clark and David.
The ‘475 Patent is directed towards a stable, sterile soft tissue filler comprising HA crosslinked with BDDE and 10% by volume uncrosslinked HA; the composition further comprising lidocaine. The HA material includes a HMW and LMW component (claim 19). The HMW-HA has a MW of about 1.0 MDa and about 4.0 MDa (claim 20). The LMW-HA has a MW of between about 0.2 MDa and less than 1.0 MDa (claim 24). The HA material comprises about 90% by wt. LMW-HA material (claim 26). The total HA concentration is between about 20 mg/mL to about 30 mg/mL (claim 32).
The reference Patent does not expressly disclose the molecular weight of uncrosslinked HA, or the claimed amount of uncrosslinked HA, or mepivacaine.
Kablik, Clark, and David teach as discussed above.
Since soluble (uncrosslinked) HA degrades too quickly, one having ordinary skill in the art would have known from the combined teaching of Kablik and Clark to optimize the concentration to ensure the HA gel has good viscosity and G’ modulus to push it through a syringe while not degrading too quickly. The ordinary artisan would have been motivated to include about 4% soluble (uncrosslinked HA) because Clark and Kablik teach commercially available crosslinked HA gels with about 4% by weight soluble (uncrosslinked HA) were FDA approved for use as a dermal filler. One having ordinary skill in the art would have been motivated to further optimize the amount of soluble (uncrosslinked HA) because it is a recognized result-effective variable.
The ordinary artisan would have been motivated to use soluble (uncrosslinked) HA having a Mw of about 2.0 MDa, because Clark teaches the starting MW of HA from bacterial sources is around 1.5-2.0 MDa, which has been used for the preparation of commercially available and FDA approved dermal fillers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include mepivacaine to improve patient comfort during and after injection with HA, because lidocaine and mepivacaine are recognized as suitable alternative analgesic agents used in combination with HA-based dermal fillers.
Thus, the claimed invention as a whole is prima facie obvious over the claims of the reference Patent in view of the prior art.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent No. 8,357,795 in view of Lebreton, Kablik, Clark and David.
The ‘795 Patent is directed towards a sterile, soft tissue filler composition comprising HA crosslinked with BDDE, and lidocaine. The composition further comprises 1-10% uncrosslinked HA. The crosslinked HA contains HMW-HA and LMW-HA (claim 20). The HMW-HA has a molecular weight of at least 1 MDa (claim 21). The total HA concentration is about 22 mg/mL (claim 29).
The reference Patent does not expressly disclose the MW of the LMW-HA, the MW of uncrosslinked HA, or the ratio of LMW-HA to HMW-HA, or mepivacaine.
Lebreton, Kablik, Clark and David teaches as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include about 2-4% soluble uncrosslinked HA with the crosslinked HA gel mixture of Lebreton.
One having ordinary skill in the art would have been motivated to include soluble (uncrosslinked) HA with the HMW-HA/LMW-HA crosslinked HA gel mixture of Lebreton because it is a commonly employed technique to improve the extrusion of crosslinked HA gels through fine-bore needles.
Since soluble (uncrosslinked) HA degrades too quickly, one having ordinary skill in the art would have known from the combined teaching of Kablik and Clark to optimize the concentration to ensure the HA gel has good viscosity and G’ modulus to push it through a syringe while not degrading too quickly. The ordinary artisan would have been motivated to include about 4% soluble (uncrosslinked HA) because Clark and Kablik teach commercially available crosslinked HA gels with about 4% by weight soluble (uncrosslinked HA) were FDA approved for use as a dermal filler. One having ordinary skill in the art would have been motivated to further optimize the amount of soluble (uncrosslinked HA) because it is a recognized result-effective variable.
The ordinary artisan would have been motivated to use soluble (uncrosslinked) HA having a Mw of about 2.0 MDa, because Clark teaches the starting MW of HA from bacterial sources is around 1.5-2.0 MDa, which has been used for the preparation of commercially available and FDA approved dermal fillers.
As discussed above, Lebreton teaches a total HA concentration of 10-40 mg/g, preferably 20-30 mg/g; and Kablik and Clark teaches products having a total HA concentration of 4.5-6.0 mg/mL, 20 mg/mL or 24 mg/mL. The prior art as a whole suggests an operable working range of 4.5-24 mg/mL. The total HA concentration taught by Lebreton, Kablik and Clark overlap with the claimed range recited in present claim 1. The ordinary artisan would have been motivated to optimize the total HA concentration because Clark teaches it is one of the physical properties that affects the viscoelastic property of the dermal filler, i.e. it’s a result-effective variable. Similarly, Kablik teaches the concentration affects the hardness/softness of the gel and their utility as a dermal filler.
See MPEP 2144.05, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include mepivacaine to improve patient comfort during and after injection with HA, because lidocaine and mepivacaine are recognized as suitable alternative analgesic agents used in combination with HA-based dermal fillers.
Thus, the claimed invention as a whole is prima facie obvious over the claims of the reference Patent in view of Kablik and Clark.
Conclusion
In view of the rejections to the pending claims set forth above, 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.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699