DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03 November 2025 has been entered.
Priority
The instant application was filed on 13 May 2022 and claims domestic benefit to provisional application no. 63/188,295 filed on 13 May 2021. Therefore, the effective filing date of the instant application is 13 May 2021.
Examiner’s Note
Applicant's amendments and arguments filed 03 November 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed
03 November 2025, it is noted that claims 1-4 have been amended, claim 9 has been canceled, claims 11-16 remain withdrawn, and claim 27 has been newly added. Support for the amendment and new claims are found in pg. 8 of the instant specification. No new matter has been added.
Declaration
The declaration under 37 CFR 1.132 filed 03 November 2025 is insufficient to overcome the rejection of claims 1-8 and 10, 17-27 based upon Robinson, Champion, Shimojo, and Guo as set forth in the last Office action because:
The Applicant argues that Robinson’s composition does not include any ophthalmic treatment (Declaration, pg. 2).
Applicant’s argument is not found persuasive. Robinson et al. teach a composition for treating ocular conditions that may comprise an anesthetic (para. 74), PLGA or PLA microspheres (para. 50, 59), and 0.5-95% (para. 95) of crosslinked hyaluronic acid, sodium hyaluronate (para. 99), or a dermal filler (para. 16) as a carrier (para. 49).
The Applicant argues that the composition is partially reversible because the hyaluronic acid can be digested by hyaluronidase injected in the implantation site. Therefore, the microspheres allegedly do not restore volume by themselves (Declaration, pg. 2).
Applicant’s argument is not found persuasive. The instant claims recite a hyaluronic carrier with slowly resorbable particles. The composition for use in soft tissue augmentation is interpreted as intended use and is given minimal patentable weight (see MPEP 2111.02(II)).
The Applicant argues that the microspheres in Robinson’s composition are used as drug carriers and hyaluronic acid is used to prevent the inflammation caused by microspheres (Declaration, pg. 2).
Applicant’s argument is not found persuasive. The instant claims recite a hyaluronic carrier with slowly resorbable particles. Robinson et al. teach a composition for treating ocular conditions that may comprise an anesthetic (para. 74), PLGA or PLA microspheres (para. 50, 59), and 0.5-95% (para. 95) of crosslinked hyaluronic acid, sodium hyaluronate (para. 99), or a dermal filler (para. 16) as a carrier (para. 49). Therefore, Robinson’s composition addresses the limitations of the instant claims.
The Applicant argues that collagen stimulation was not mentioned in Robinson’s teaching (Declaration, pg. 3).
Applicant’s argument is not found persuasive. As stated above, the instant claims recite a hyaluronic carrier with slowly resorbable particles. Robinson et al. teach a composition for treating ocular conditions that may comprise an anesthetic (para. 74), PLGA or PLA microspheres (para. 50, 59), and 0.5-95% (para. 95) of crosslinked hyaluronic acid, sodium hyaluronate (para. 99), or a dermal filler (para. 16) as a carrier (para. 49). Therefore, Robinson’s composition addresses the limitations of the instant claims.
The Applicant argues that they have found significant benefits of using crosslinked hyaluronic acid and microspheres (Declaration, pg. 3).
Applicant’s argument is not found persuasive. The Applicant seemingly refers to unexpected results and is encouraged to expand upon these alleged surprising results or benefits.
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) 1-3, 5-8, 10, 17, 21-23, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US 20150147406 A1).
Robinson et al. teach a composition for treating ocular conditions that may comprise an anesthetic (para. 74), PLGA or PLA microspheres (para. 50, 59), and 0.5-95% (para. 95) of crosslinked hyaluronic acid, sodium hyaluronate (para. 99), or a dermal filler (para. 16) as a carrier (para. 49), addressing claims 1, 5, 6, 8, 10, 17, and 23. The hyaluronic acid used may have a molecular weight of about 1.3 million Daltons or about 2 million Daltons (para. 99) and formulated at a concentration of 24 mg/mL (para. 97), addressing claim 1. The crosslinked hyaluronic acid may form a homogenized gel, which is interpreted as cohesive in claim 1. The composition may also comprise other bioerodible or biodegradable polymers in the form of microspheres (para. 45, 89, 107) with a size of about 50 nm to 200 microns, addressing claims 7 and 21. The polymer matrix of these microspheres may take up at least about 10% of the entire implant (para. 80), which is interpreted as addressing the percentage of microspheres in claim 1. The active agent may be lidocaine (para. 74) in an amount of about 10-90% (para. 79), which can vary by +/- 10% of the claimed range (para. 23), which addresses claims 22 and 26. The limitations of the HA carrier derived from animal tissue or formed through crosslinking specific agents in claims 2 and 3 are interpreted as product-by-process limitations (see MPEP 2113(I)). The composition may include a sodium chloride or phosphate buffer (para. 102) and is homogeneously dispersed (para. 80), which is interpreted as addressing the limitation of a white precipitate solubilized in a buffer to form a homogeneous gel in claim 1. The composition may be injected in tissue (para. 3, 21), addressing the limitation in claim 1.
Robinson et al. do not teach an exact combination with PLA/PLGA microspheres, lidocaine, and crosslinked hyaluronic acid in claim 1.
In regards to selecting the combination of crosslinked hyaluronic acid, PLA/PLGA microspheres, and an anesthetic, “[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)). “When 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 at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Robinson teaches compositions for treating ocular conditions comprising lidocaine, PLGA or PLA microspheres, and crosslinked hyaluronic acid or sodium hyaluronate as a carrier, whereas the claimed invention is directed towards a composition for use in soft tissue augmentation comprising a mixture of a hyaluronic acid carrier and slowly resorbable particles. Since Robinson teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Claim(s) 1-8, 10, 17-23, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US 20150147406 A1) and Champion et al. (US 20090022808 A1).
In regards to claim(s) 1-3, 5-8, 10, 17, 21-23, 26, Robinson et al., as applied supra, is herein applied in its entirety for its teachings of a composition comprising PLA microspheres, crosslinked hyaluronic acid, and an anesthetic.
Robinson et al. do not teach coated crosslinked hyaluronic acid microspheres in claims 4 and 18-20.
Champion et al. teach a composition that may comprise crosslinked hyaluronic acid (para. 12) in the form of microspheres (para. 14) and suspended in a crosslinked hyaluronic acid gel (para. 8). The microspheres may be coated with a biocompatible material such as PLGA or PLA (para. 30). In some embodiments, the PLGA coated particles may have a size of about 10-500 microns (para. 53), addressing claims 4 and 20.
Since Robinson does not teach coated crosslinked hyaluronic acid microspheres in claims 18 and 19, one of ordinary skill in the art would have been motivated to use the composition of a PLGA coated crosslinked hyaluronic acid microsphere described in Champion et al. to address the deficiencies in Robinson’s teachings. One of ordinary skill in the art would have been motivated to combine the teachings since both references are directed towards using a microsphere composition for tissue delivery. Robinson’s teaching utilizes a dermal filler as a suitable carrier (para. 97), and Champion also teaches that a coating comprising a biodegradable polymer help to protect the hyaluronic acid from degradation and allow for the hyaluronic acid to degrade over time (para. 11). Therefore, Champion provides a reason and motivation to combine and enhance the compositions taught by Robinson.
Claim(s) 1-8, 10, 17-24, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US 20150147406 A1), Champion et al. (US 20090022808 A1), and Shimojo et al. (The Performance of Crosslinking with Divinyl Sulfone as Controlled by the Interplay Between the Chemical Modification and Conformation of Hyaluronic Acid, J. Braz. Chem. Soc., 2015).
In regards to claim(s) 1-8, 10, 17-23, 26, Robinson et al. and Champion et al., as applied supra, is herein applied in its entirety for its teachings of a composition comprising coated hyaluronic acid microspheres, crosslinked hyaluronic acid, and an anesthetic.
Robinson et al. do not teach that the hyaluronic acid is crosslinked with divinyl sulfone in claim 24.
Shimojo et al. teach that crosslinked hyaluronic acid that are crosslinked with divinyl sulfone are primarily used in viscosupplementation (abs). It is also suggested that hyaluronic acid crosslinked with divinyl sulfone helps to retain the biocompatibility and physical functionality of unmodified hyaluronic acid (pg. 506).
Since Robinson does not teach crosslinking hyaluronic acid with divinyl sulfone in claim 24, one of ordinary skill in the art would have been motivated to use the teaching of using divinyl sulfone to crosslink hyaluronic acid described in Shimojo et al. to address the deficiencies in Robinson’s teachings. One of ordinary skill in the art would have been motivated to combine the teachings since Robinson’s composition comprises crosslinked hyaluronic acid and Shimojo teaches that crosslinking hyaluronic acid with divinyl sulfone is a common and well-known method in injectable and biomedical applications. Shimojo also teaches that crosslinking with this agent may retain favorable physical properties. Therefore, Shimojo provides a reason and motivation to combine and enhance the compositions taught by Robinson.
Claim(s) 1-8, 10, 17-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US 20150147406 A1), Champion et al. (US 20090022808 A1), Shimojo et al. (The Performance of Crosslinking with Divinyl Sulfone as Controlled by the Interplay Between the Chemical Modification and Conformation of Hyaluronic Acid, J. Braz. Chem. Soc., 2015), and Guo et al. (An in situ mechanical adjustable double crosslinking hyaluronic acid/poly-lysine hydrogel matrix: Fabrication, characterization and cell morphology, International Journal of Biological Macromolecules, 2021).
In regards to claim(s) 1-8, 10, 17-24, 26, Robinson, Champion, and Shimojo, as applied supra, is herein applied in its entirety for its teachings of a composition comprising coated hyaluronic acid microspheres, crosslinked hyaluronic acid, and an anesthetic.
Robinson et al. do not teach crosslinked hyaluronic acid microspheres with polylysine and 4-methylmorpholine hydrochloride in claim 25.
Guo et al. teach crosslinking hyaluronic acid with polylysine and DMTMM provides favorable electrostatic interaction (pg. 235) and mechanically strong and tough properties (pg. 241) for targeted drug delivery, tissue engineering, and regenerative medicine (pg. 235).
Since Robinson and Champion do not teach crosslinking hyaluronic acid microspheres with polylysine and DMTMM in claim 25, one of ordinary skill in the art would have been motivated to use the teaching of using polylysine and DMTMM to crosslink hyaluronic acid described in Guo et al. to address the deficiencies in Robinson’s teachings. One of ordinary skill in the art would have been motivated to combine the teachings since Champion’s composition comprises crosslinked hyaluronic acid microspheres and Guo teaches that crosslinking hyaluronic acid with polylysine and DMTMM provides favorable physical properties and electrostatic interactions in hyaluronic acid compositions. Therefore, Guo provides a reason and motivation to combine and enhance the compositions taught by Robinson and Champion.
Claim(s) 1-8, 10, 17-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US 20150147406 A1), Champion et al. (US 20090022808 A1), Shimojo et al. (The Performance of Crosslinking with Divinyl Sulfone as Controlled by the Interplay Between the Chemical Modification and Conformation of Hyaluronic Acid, J. Braz. Chem. Soc., 2015), Guo et al. (An in situ mechanical adjustable double crosslinking hyaluronic acid/poly-lysine hydrogel matrix: Fabrication, characterization and cell morphology, International Journal of Biological Macromolecules, 2021), and Belalcazar-Rey et al. (Efficacy and Safety of Sodium Hyaluronate/chondroitin Sulfate Preservative-free Ophthalmic Solution in the Treatment of Dry Eye: A Clinical Trial, Current Eye Research, 2020).
In regards to claim(s) 1-8, 10, 17-26, Robinson, Champion, Shimojo, and Guo, as applied supra, is herein applied in its entirety for its teachings of a composition comprising coated hyaluronic acid microspheres, crosslinked hyaluronic acid, and an anesthetic.
Robinson does not specifically teach chondroitin sulfate sodium in their composition in claim 27.
Belalcazar-Rey teaches that chondroitin sulfate may be helpful in treating dry eye symptoms (abs, pgs. 919, 927).
Since Robinson does not specifically teach use of chondroitin sulfate sodium in their ocular composition in claim 27, one of ordinary skill in the art would have been motivated to use Belalcazar-Rey’s teaching of using chondroitin sulfate to treat dry eyes. A skilled artisan would have recognized an added benefit of using chondroitin sulfate to treat dry eyes or other ocular conditions in Robinson’s ocular composition with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed 03 November 2025 have been fully considered but they are not persuasive.
The Applicant argues that the prior art cited do not teach the limitations of the newly amended claim 1, such as the limitation of the white precipitate and soft tissue limitation (Remarks, pg. 11).
Applicant’s argument is not found persuasive. In regards to the newly presented limitations in claim 1, Robinson et al. teach a composition for treating ocular conditions that may comprise an anesthetic (para. 74), PLGA or PLA microspheres (para. 50, 59), and 0.5-95% (para. 95) of crosslinked hyaluronic acid, sodium hyaluronate (para. 99), or a dermal filler (para. 16) as a carrier (para. 49). The hyaluronic acid used may have a molecular weight of about 1 million Daltons (para. 49, 97) and formulated at a concentration of 24 mg/mL (para. 97). The crosslinked hyaluronic acid may form a homogenized gel, which is interpreted as cohesive in claim 1. The polymer matrix of these microspheres may take up at least about 10% of the entire implant (para. 80), which is interpreted as addressing the percentage of microspheres in claim 1. The composition may include a sodium chloride or phosphate buffer (para. 102) and is homogeneously dispersed (para. 80), which is interpreted as addressing the limitation of a white precipitate solubilized in a buffer to form a homogeneous gel in claim 1. The composition may be injected in tissue (para. 3, 21), addressing the limitation in claim 1.
The limitation of a white precipitate that is then solubilized is examined in its final form of a homogenous solution. The composition for soft tissue limitation is interpreted as intended use and is given minimal patentable weight (see MPEP 2111.02(II)).
The Applicant argues that the inventor identified a problem others did not and that Robinson is silent on providing a proposed solution for soft tissue (Remarks, pgs. 12-13).
Applicant’s argument is not found persuasive. The arguments of counsel cannot take the place of evidence in the record. MPEP 2145(I). Furthermore, Robinson’s composition may be used for eyeball tissue and the limitation of soft tissue augmentation is interpreted as intended use.
The Applicant argues that a person of ordinary skill in the art would not have been motivated to combine the teachings to reach the claimed invention (Remarks, pgs. 13-14). It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Since Robinson does not teach coated crosslinked hyaluronic acid microspheres in claims 18 and 19, one of ordinary skill in the art would have been motivated to use the composition of a PLGA coated crosslinked hyaluronic acid microsphere described in Champion et al. to address the deficiencies in Robinson’s teachings. One of ordinary skill in the art would have been motivated to combine the teachings since both references are directed towards using a microsphere composition for tissue delivery. Robinson’s teaching utilizes a dermal filler as a suitable carrier (para. 97), and Champion also teaches that a coating comprising a biodegradable polymer help to protect the hyaluronic acid from degradation and allow for the hyaluronic acid to degrade over time (para. 11). Therefore, Champion provides a reason and motivation to combine and enhance the compositions taught by Robinson.
Since Robinson does not teach crosslinking hyaluronic acid with divinyl sulfone in claim 24, one of ordinary skill in the art would have been motivated to use the teaching of using divinyl sulfone to crosslink hyaluronic acid described in Shimojo et al. to address the deficiencies in Robinson’s teachings. One of ordinary skill in the art would have been motivated to combine the teachings since Robinson’s composition comprises crosslinked hyaluronic acid and Shimojo teaches that crosslinking hyaluronic acid with divinyl sulfone is a common and well-known method in injectable and biomedical applications. Shimojo also teaches that crosslinking with this agent may retain favorable physical properties. Therefore, Shimojo provides a reason and motivation to combine and enhance the compositions taught by Robinson.
Since Robinson and Champion do not teach crosslinking hyaluronic acid microspheres with polylysine and DMTMM in claim 25, one of ordinary skill in the art would have been motivated to use the teaching of using polylysine and DMTMM to crosslink hyaluronic acid described in Guo et al. to address the deficiencies in Robinson’s teachings. One of ordinary skill in the art would have been motivated to combine the teachings since Champion’s composition comprises crosslinked hyaluronic acid microspheres and Guo teaches that crosslinking hyaluronic acid with polylysine and DMTMM provides favorable physical properties and electrostatic interactions in hyaluronic acid compositions. Therefore, Guo provides a reason and motivation to combine and enhance the compositions taught by Robinson and Champion.
Since Robinson does not specifically teach use of chondroitin sulfate sodium in their ocular composition in claim 27, one of ordinary skill in the art would have been motivated to use Belalcazar-Rey’s teaching of using chondroitin sulfate to treat dry eyes. A skilled artisan would have recognized an added benefit of using chondroitin sulfate to treat dry eyes or other ocular conditions in Robinson’s ocular composition with a reasonable expectation of success.
The Applicant refers to unexpected results in Examples 4 and 5 (Remarks, pgs. 14-16).
Applicant’s argument is not found persuasive. Examples 4 and 5 allegedly show that the effect of HA and PLA implants are better than just hyaluronic acid alone. Any alleged evidence of a better effect does not have a causal relationship with the merits and scope of the claimed invention, which is, broadly, a hyaluronic acid carrier with a wide range of concentration, molecular weight, and amount, as well as any slowly resorbable particles. As such, the data are not commensurate in scope with the claims, as the data presented do not appear to demonstrate the full range of the claims.
“For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” Wyers v. Master Lock Co., 616 F.3d 1231, 1246 [95 USPQ2d 1525] (Fed. Cir. 2010) (quotation omitted). Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 [97 USPQ2d 1673] (Fed. Cir. 2011) (“If commercial success is due to an element in the prior art, no nexus exists.”); Ormco Corp., 463 F.3d at 1312 (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”); In re Woodruff, 919 F.2d 1575, 1578 [16 USPQ2d 1934] (Fed. Cir. 1990).
The Applicant argues that the dependent claim and new claim 27 are allowable (Remarks, pgs. 16-17).
Applicant’s argument is not found persuasive. The rejections of the dependent claims are maintained for reasons stated in the rejection above. In regards to claim 27, Belalcazar-Rey teaches that chondroitin sulfate may be helpful in treating dry eye symptoms (abs, pgs. 919, 927). Since Robinson does not specifically teach use of chondroitin sulfate sodium in their ocular composition in claim 27, one of ordinary skill in the art would have been motivated to use Belalcazar-Rey’s teaching of using chondroitin sulfate to treat dry eyes. A skilled artisan would have recognized an added benefit of using chondroitin sulfate to treat dry eyes or other ocular conditions in Robinson’s ocular composition with a reasonable expectation of success.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613