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 .
Claim Status
Applicants’ amendments and arguments filed 08/28/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 4-5, 7, 9-18, 20, 22, 25-30, 35-36, 38, 40-41, 43-66, 68-103, 105-109, 111-121, and 123-129 are canceled.
Claims 1, 8, and 37 are amended.
Claims 130-131 are newly added.
Claims 67, 104, 110, and 122 remain withdrawn.
Claims 4-5, 7, 9-18, 20, 22, 25-30, 35-36, 38, 40-41, 43-66, 68-103, 105-109, 111-121, and 123-129 are canceled.
Claims 1-3, 6, 8, 19, 21, 23-24, 31-34, 37, 39, 42, and 130-131 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/30/2025 is being considered by the examiner.
Claim Interpretation
Claims 8, 19, 21, 23, 32, 34, 37, and 39 utilize the relative term "about". The term “about” is broadly defined by the specification as “"About" as used herein when referring to a measurable value is meant to encompass variations of + 20 % or + 10% , more preferably + 5% , even more preferably + 1%, and still more preferably + 0.1 % from the specified value” (paragraph 0088) which does not provide a clear standard for ascertaining the requisite degree, thus rendering the claims broad. Therefore, the term “about” in claims 8, 19, 21, 23, 32, 34, 37, and 39 will be broadly interpreted by the examiner to mean +/- 15%.
New Rejections Necessitated by Amendments
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.
Claim(s) 1, 6, 8, 19, 23-24, 31-34, 37, 39, 42, and 130-131 are rejected under 35 U.S.C. 103 as being unpatentable over Pollock et al (WO2014039607A1, found in ISR and written opinion, published 03/13/2014, hereafter Pollock) and as evidenced by TA Instruments (Flex, torsion or bend – every which way you can (or Close Encounters of the Third Kind. (2016, October)). TA Instruments, UK User Meeting National Space Research Centre., hereafter TA Instruments).
As evidenced by TA Instruments, elastic and storage modulus are the same thing (slide 13).
Pollock teaches hyaluronic acid/collagen dermal filler compositions and methods for making same (title). Pollock claims a crosslinked macromolecular matrix comprising a hyaluronic acid component and a collagen component derived from collagen type I or collagen type III (claim 1; according to the claim limitations of the instant claims 1, 24, and 42). Claim 1 of Pollock further teaches the hyaluronic acid component is crosslinked to the collagen component by a crosslinking component wherein the crosslinking component comprises a plurality of crosslink units to include an amide bond (according to the claim limitations of the instant claim 1). Pollock teaches the collagen to have specific binding sites and may be positively charged because of its high content of basic amino acid residues such as arginine, lysine, and hydroxylysine (paragraph 0028; according to the claim limitations of the instant claims 1 and 42). Pollock further teaches any type of collagen be used and provides the examples of collagen type I, collagen type III, collagen type IV, collagen type VI, or a combination thereof (paragraph 0049; according to the claim limitations of the instant claims 1, 24, and 31). Pollock teaches the concentration of the collagen to be from about 1 mg/mL up to about 40mg/mL (paragraph 0050; according to the claim limitations of the instant claim 32). Pollock teaches hyaluronan also known as hyaluronic acid (HA)(paragraph 004), originally was made from naturally occurring polymers that exist in an uncrosslinked state and exhibit excellent biocompatibility (paragraph 006; according to the claim limitations of the instant claims 6 and 8). Pollock teaches the storage modulus of the crosslinked macromolecular complex to be from about 1 Pa to 10,000 Pa (paragraph 0043; according to the claim limitations of the instant claim 19). Furthermore, Pollock teaches the concentration of hyaluronic acid to be present at about 3 mg/mL to about 100 mg/mL (paragraph 0048; according to the claim limitations of the instant claim 23). Claim 11 of Pollock teaches the comprises a salt and paragraph 0053 of Pollock teaches the salt may help to screen the negative charges of the hyaluronic acid from the positive charges of the collagen (according to the claim limitations of the instant claim 33). Pollock teaches the complex may further comprise an aqueous liquid to form a hydrogel (paragraph 0040; according to the claim limitations of the instant claim 42). The same paragraph of Pollock then teaches the liquid may comprise water with a salt dissolved in it, such as phosphate buffer, sodium chloride, potassium chloride, etc (paragraph 0040; according to the claim limitations of the instant claims 34 and 37). Pollock then provides an embodiment of this solution in which the concentration of sodium chloride is about 100-200nM, the concentration of potassium chloride is about 2-3mM, and the concentration of phosphate buffer is about 5-15mM which calculates to 0.005-0.015M (paragraph 0040; according to the claim limitations of the instant claims 34 and 37). Pollock teaches the hyaluronic acid to have a molecular weight of about 200,000 to about 10,000,000 daltons (paragraph 0047; according to the claim limitations of the instant claim 39). Pollock then teaches as a result of a crosslinking reaction, a crosslinked macromolecular matrix may comprise a crosslinking component that crosslinks or covalently connects the hyaluronic acid component to the collagen component ([0064]; according to the claim limitations of the instant claim 1). Further Pollock teaches a crosslink component comprises a plurality of crosslink units, or individual covalent bonding links, between the hyaluronic acid component and the collagen component ([0064]; according to the claim limitations of the instant claim 1). Pollock then teaches a crosslink unit may simply be a direct bond between a hyaluronic acid component and a collagen components, so that the coupling agent may not be incorporated into the crosslinked macromolecular matrix ([0064]; according to the claim limitations of the instant claim 1). Further, Pollock teaches a crosslink unit may contain additional atoms or groups from the coupling agent such that at least a portion of the coupling agent may become part of the crosslinked macromolecular matrix ([0064]; according to the claim limitations of the instant claim 1). Pollock teaches at least a portion of the crosslink units may comprise an ester bond or an amide bond. In some embodiments, at least a portion of the crosslink units may be -CON- or -CO2-, where the N is a nitrogen from an amino acid residue ([0064]; according to the claim limitations of the instant claim 1). Lastly, Pollock teaches that the concentration of hyaluronic acid pre-reaction (aka uncrosslinked) or in the crosslinking reaction is present at about 3 mg/ml to about 100mg/ml ([0048]; according to the claim limitations of the instant claims 6 and 8).
Pollock does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Yeo with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results. Further, in regards to claims 130-131, One of ordinary skill in the art would know how to optimize the ranges of Pollock, as the MPEP 2144.05 states “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Pollock et al (WO2014039607A1, found in ISR and written opinion, published 03/13/2014, hereafter Pollock) in view of Smith et al. (Smith L, Cockerham K. Hyaluronic acid dermal fillers: can adjunctive lidocaine improve patient satisfaction without decreasing efficacy or duration? Patient Prefer Adherence. 2011 Mar 14;5:133-9. doi: 10.2147/PPA.S11251. PMID: 21448297; PMCID: PMC3063660., hereafter Smith).
As outlined above, Pollock teaches a dermal filler comprising hyaluronic acid, collagen, lysine, and the desired crosslinking. Pollock fails to teach the addition of lidocaine at the desired concentration as claimed by instant claims 2 and 3.
Smith teaches hyaluronic acid dermal fillers and studies if lidocaine can improve patient satisfaction (title). Smith outlines that adjunctive lidocaine significantly decreases pain during injection and postinjection with corresponding increased patient satisfaction (abstract). Smith teaches four on the market hyaluronic acid dermal fillers that have preincorporated lidocaine at a concentration of 0.3% (page 135, paragraphs 2-5).
One skilled in the art before the effective filing date of the claimed invention would modify the dermal filler composition comprising lysine, hyaluronic acid, and collagen as outlined by Pollock by addition of lidocaine as outlined by Smith under TSM, see MPEP 2143(G). As outlined by Smith, adding lidocaine decrease pain during and after injection thus increasing patient satisfaction which would motivate someone skilled in the art to advantageously combine lidocaine with the composition of Pollock as it would have a reasonable expectation of success. Furthermore, one of ordinary skill in the art would know how to optimize the ranges of lidocaine further demonstrated by Smith, as the MPEP 2144.05 states “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Pollock et al (WO2014039607A1, found in ISR and written opinion, published 03/13/2014, hereafter Pollock) in view of Pavlovic et al. (US10154951B2, published 12/18/2018, hereafter Pavlovic).
As outlined above, Pollock teaches a dermal filler comprising hyaluronic acid, collagen, lysine, and the desired crosslinking. While Pollock does not specifically teach the compression force value of about 10 gmf-about 600 gmf, said compression force is known in the art.
Pavlovic teaches a cross-linked hyaluronic acid composition used as a dermal filler (title and abstract). Pavlovic teaches the ability or inability of a hydrogel to be easily compressed will affect its suitability for application (column 9, lines 20-22). Pavlovic then teaches the compositions to have a compression force of about 10 grams-force to about 3000 grams-force, more preferably a compression force of about 30-1000 grams-force (columns 17 and 18, lines 63-65 and 1-3 respectively).
One skilled in the art before the effective filing date of the claimed invention would claim a dermal filler comprising hyaluronic acid, collagen, lysine, and the desired crosslinking as outlined by Pollock ready for improvement with the known technique of optimizing the compression force of the crosslinked hyaluronic acid dermal filler to the known values of 30-1000 grams-force as outlined by Pavlovic. Adding the forementioned limitations to a dermal filler comprising hyaluronic acid, collagen, lysine, and the desired crosslinking as claimed by instant claim 21 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
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, 19, 23-24, 31-32, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6-7, and 10-15 of U.S. Patent No. US10434214B2 in view of Pollock et al (WO2014039607A1, found in ISR and written opinion, published 03/13/2014, hereafter Pollock), and as evidenced by TA Instruments (Flex, torsion or bend – every which way you can (or Close Encounters of the Third Kind. (2016, October)). TA Instruments, UK User Meeting National Space Research Centre., hereafter TA Instruments). Although the claims at issue are not identical, they are not patentably distinct from each other.
As evidenced by TA Instruments, elastic and storage modulus are the same thing (slide 13).
US10434214B2 claims a soft tissue aesthetic product comprising an injectable hydrogel composition comprising a hyaluronic acid crosslinked with a collagen view a plurality of crosslink units, wherein at least a portion of the crosslink units comprise an amide bond (claim 1; according to the claim limitations of the instant claim 1). Claim 3 of US10434214B2 claims the collagen is collagen type I, collagen type III, or a combination thereof and claim 4 of US10434214B2 claims the collagen is collagen type I (according to the claim limitations of the instant claims 24 and 31). Claim 6 of US10434214B2 claims the molecular weight of the hyaluronic acid to be about 1,000,000 Da to about 5,000,000 Da and claim 7 of US10434214B2 further limits this range to be about 1,000,000 Da to about 3,000,000 (according to the claim limitations of the instant claim 39). Claim 10 of US10434214B2 claims the hydrogel to have a storage modulus value of between 1,000 Pa and 5,000 Pa (according to the claim limitations of the instant claim 19). Claim 11 of US10434214B2 claims the concentration of hyaluronic acid to be 12 mg/ml or 16 mg/ml (according to the claim limitations of the instant claim 23). Claim 12 of US10434214B2 claims the concentration of collagen to be 6 mg/ml, 8 mg/ml, or 12 mg/ml (according to the claim limitations of the instant claim 32). Claim 13 of US10434214B2 further limits the concentrations to be the concentration of hyaluronic acid to be 12mg/ml and the concentration of collagen to be 6mg/ml (according to the claim limitations of the instant claims 23 and 32). Claim 14 of US10434214B2 claims concentration of hyaluronic acid to be 12 mg/ml and the concentration of collagen to be 12 mg/ml (according to the claim limitations of the instant claims 23 and 32). Lastly, claim 15 claims the concentration of hyaluronic acid to be 16 mg/ml and the concentration of collagen to be 8mg/ml (according to the claim limitations of the instant claims 23 and 32).
US10434214B2 fails to teach the addition of lysine to the composition as in instant claim 1.
As outlined above, Pollock teaches hyaluronic acid/collagen dermal filler compositions and methods for making same (title). Pollock claims a crosslinked macromolecular matrix comprising a hyaluronic acid component and a collagen component derived from collagen type I or collagen type III (claim 1; according to the claim limitations of the instant claims 1, and 24). Claim 1 of Pollock further teaches the hyaluronic acid component is crosslinked to the collagen component by a crosslinking component wherein the crosslinking component comprises a plurality of crosslink units to include an amide bond (according to the claim limitations of the instant claim 1). Pollock teaches the collagen to have specific binding sites and may be positively charged because of its high content of basic amino acid residues such as arginine, lysine, and hydroxylysine (paragraph 0028; according to the claim limitations of the instant claim 1).
One skilled in the art before the effective filing date of the claimed invention would claim a soft tissue aesthetic product comprising an injectable hydrogel composition comprising a hyaluronic acid crosslinked with a collagen view a plurality of crosslink units as claimed by US10434214B2 with the ready for improvement with the known technique of adding the limitation of lysine which is found in collagen at various amounts to have specific binding sites as outlined by Pollock. Adding the forementioned limitations to a hyaluronic acid-collagen crosslinked dermal filler as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicant’s arguments filed on 08/28/2025 have been considered by the examiner.
In regards to Applicant’s arguments over the 35 USC § 102 rejections over Pollock as evidenced by TA Instruments, Applicant argues that Pollock does not disclose a composition containing lysine, specifically a composition where lysine is crosslinked to hyaluronic acid. Applicant provides data suggesting that Pollock is silent to specific “surprising properties” as the instant invention.
In response to Applicant’s argument, it is first noted that instant claim 1 is not commensurate with the data outlined by Applicant. Applicant’s independent claim 1 provides no concentration of lysine, hyaluronic acid, or collagen. The data demonstrated in the tables of the instant specification (page 38-39) provide a variety of concentrations of lysine to HA to include 0, 0.166, 0.167. 0.320, 0.333, 0.334, 0.339, and 0.500. It is noted that these data points include 0% ratio of lysine to HA thus in light of the data the lack of range of concentration of lysine is to include 0%. Further, it is noted that these different concentrations of both HA and lysine demonstrate different properties, both beneficial and not. For instance, Applicant’s tables show that swelling is better for the 0.333 range, however is increased for the 0.500 range (page 38). Thus, the data of claims 130 and 131 are not commensurate with the claims. The examiner suggests incorporating a range, such as 0.33, to be added into instant claim 1 to make the data commensurate with the claims and further prosecution.
Overall, the examiner is not persuaded by Applicant’s arguments. However, the 35 USC § 102 rejections over Pollock as evidenced by TA Instruments is withdrawn do to claim amendments.
In regards to Applicant’s arguments over the 35 USC § 103 rejections over Pollock as evidenced by TA Instruments in view of Smith and separately in view of Pavlovic, Applicant argues the rejections should be withdrawn due to the reasons above.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, as demonstrated above, the examiner is not persuaded by Applicant’s arguments over Pollock.
Therefore, the 35 USC § 103 rejections over Pollock as evidenced by TA Instruments in view of Smith and separately in view of Pavlovic are maintained and updated for claim amendments.
In regards to Applicant’s arguments over the Double Patenting rejection over US10,434,214, Applicant argues that US10,434,214 does not disclose hyaluronic acid is crosslinked to lysine specifically, and is only directed towards hyaluronic acid crosslinked to collagen. Further, Applicant states that Pollock does not cure the deficiencies for the reasons listed above.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, it is noted that Pollock states the collagen to have specific binding sites and may be positively charged because of its high content of basic amino acid residues such as arginine, lysine, and hydroxylysine (paragraph 0028). Therefore, one skilled in the art would claim lysine bound as it commonly known to be part of the collagen as demonstrated in the double patenting rejection above. Lastly, as demonstrated above, the examiner is not persuaded by Applicant’s arguments over Pollock solely.
In summary, the examiner is not persuaded by Applicant’s arguments against the double patenting rejection of US10,434,214. Therefore, the double patenting rejection is maintained and updated for claim amendments.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./Examiner, Art Unit 1611