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 .
DETAILED ACTION
This Office Action is in response to Applicants’ Amendment and Remarks filed on 1/30/2026, in which claims 1, 7 and 8 are amended and claims 9-12 are newly added.
Claims 1-12 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/EP2021/078065, filed on 10/11/2021. The instant application claims foreign priority to EP 2020118632 filed on 10/9/2020. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 4/7/2023.
Withdrawn Rejections
Applicant’s amendment, filed on 1/30/2026, with respect to the rejection of claims 1-8 under 35 U.S.C. 112(b), has been fully considered and is persuasive. Applicant amended the claims to: 1) amended step d) of claim 1 to clearly define the scope of the step; 2) removed recitations to “notably” and “preferably”; and amended claim 8 o clearly define the scope of the claim. The rejection is hereby withdrawn.
Rejections Necessitated by Amendment
The following are new ground(s) or modified rejections necessitated by Applicants' amendment, filed on 1/30/2026, wherein instant claims 9-12 are newly added. Therefore, rejections from the previous Office Action have been modified.
Modified Rejections
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over LaGatta et al. (Poly. Deg. Stab., 2011, reference of record), in view of Masi et al. (US 11,058,640 B1, filed 4/2020, reference of record).
LaGatta discloses a process for comparative analysis of commercial dermal filler gels, which comprise crosslinked hyaluronic acid and soluble hyaluronic acid (HA), where the analysis examined filler swelling properties, soluble HA fraction and rheological behavior. (Abstract) The process of LaGatta comprises: 1) Extraction of the soluble HA portion of each filler via dilution in PBS, stirring, centrifugation and filtering, to obtain permeate comprising soluble HA, lacking insoluble crosslinked HA; 2) The permeate was then analyzed by size exclusion chromatography (SEC); 3) the eluate from the SEC was analyzed to determine sample molecular weight (Mw, Mn, Mw/Mn), molecular size (hydrodynamic radius-Rh) and intrinsic viscosity ([h]). (Sec. 2.2) Rheological measurements were also performed, using an oscillatory rheometer, on each dermal filler, to determine shear thinning, storage modulus and loss modulus values. (Sec. 2.4) The data obtained by LaGatta for the SEC analysis is as follows, where it is noted that the soluble HA fraction ranges from 7-33% meaning the insoluble crosslinked HA fraction ranges from 67-93%: (Table 2)
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LaGatta does not teach a step where the dermal fillers are selected based on the amount of soluble HA having a molecular weight of less than or equal to 50kDa.
Masi et al. discloses a process for evaluating properties of commercial dermal fillers comprising HA, using SEC to determine molecular weight and soluble HA fraction amount, where it was discovered that the amount of soluble HA with molecular weight less than 50 kDa was 24.4%. (Example 1, Table 2) Masi then performed a purification procedure using centrifugation, resulting in the amount of soluble HA with molecular weight less than 50 kDa being 0%. (Example 2, Table 4) Masi also discloses that commercial dermal fillers include a large percentage of low molecular weight HA which the FDA has determined to be undesirable, because low molecular weight HA may be inflammatory and/or profibrotic. (Col. 2 and 8) The process of Masi enables the selection of dermal fillers where the amount of soluble HA is less than 4% by weight of the total amount of hyaluronic acid. (Claim 1)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the procedure of LaGatta and add a purification by centrifugation step, to remove all soluble HA with molecular weight less than 50 kDa, thereby arriving at the instant invention. One would be motivated to modify LaGatta in this manner because Masi teaches that low molecular weight HA is undesirable in dermal fillers because the FDA has documented concerns regarding the inflammatory and/or profibrotic effects of low molecular weight HA.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the rejection over LaGatta/Masi, has been fully considered but is not persuasive.
Applicant argues that LaGatta does not teach the selection of a composition where the amount of soluble hyaluronic acid having a molecular weight less than or equal to 50kDa, is 5% or less. Applicant argues that Masi does not remedy the deficiency of LaGatta because Masi suggests selecting a composition where the amount of soluble hyaluronic acid having a molecular weight less than or equal to 250kDa, is 4% or less. The molecular weight cutoff of 250 kDa claimed by Masi is significantly higher than the 50 kDa of the instant claims, thus the combination of LaGatta/Masi does not render the instant claim obvious. Applicants’ argument is not persuasive because the disclosure of Masi is not limited to the teaching of selecting a composition where the amount of soluble hyaluronic acid having a molecular weight less than or equal to 250kDa, is 4% or less, but includes the exemplified embodiments as well. In Example 2 of Masi, there is detailed a procedure for purifying HA dermal filler compositions by centrifugation, such that all soluble HA with a molecular weight of 50 kDa or less is eliminated. Masi goes on to teach that removal of such low molecular weight HA, specifically those with molecular weight less than 50 kDa, is advantageous because the FDA has reported that such low molecular weight HA may be inflammatory and/or profibrotic. (Col. 2, Ln. 57-61) Hence, one would be motivated to employ the purification procedure of Masi on the dermal fillers analyzed by the process of LaGatta to reap the advantages of removing low MW soluble HA as taught by Masi. In combining LaGatta with Masi, the purified HA fillers being analyzed would necessarily be such that all soluble hyaluronic acid having a molecular weight less than 50 kDa (including those having molecular weight less than 30 kDa and those less than 20 kDa) are absent (i.e. 0%, as per Table 4 of Masi). The culmination of the comparative analysis of the combination of LaGatta/Masi would then be used to “assist physician in selecting the most appropriate product for a specific clinical treatment”, as per LaGatta. (Sec. 5), thereby arriving at the instant invention.
The rejection is still deemed proper and is maintained.
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over LaGatta et al. (Poly. Deg. Stab., 2011, reference of record), in view of Masi et al. (US 11,058,640 B1, filed 4/2020, reference of record), further in view of Burdon et al. (WO 2016/150974, reference of record).
The disclosure of LaGatta/Masi is referenced as discussed above. The combined prior art does not teach the rheological characterization of creep measurement to determine slope of deformation or G’ integration score.
Burdon discloses that there is an advantage in having tools for characterizing and selecting gels in the laboratory, making it possible to avoid resorting to in vivo tests at the selection stage in the development of a product… The invention achieves this objective owing to a process for evaluating the mechanical performance of a filler gel, comprising the step consisting in subjecting a sample of this gel to oscillating mechanical stresses making it possible to determine the elastic modulus G’ and to deliver a score representative of the integration of G” over the stress and/or the deformation strain within a stress and/or deformation strain interval that includes values of the modulus G’ encountered beyond the linear viscoelasticity plateau. The integration interval is wide enough to include values of the modulus G’ encountered beyond the linear viscoelasticity plateau. The lower limit of the integration interval is preferably taken, for the lowest stress and/or deformation strain values of the measurement, within the linear viscoelasticity range of the modulus G’… Accordingly, the score is derived from the integration of G’ over the stress and/or the deformation strain within a stress and/or deformation strain interval that includes values of the modulus G’ encountered beyond the linear viscoelasticity plateau. Knowledge of the G” integration score based on the integration of the modulus G’ proves to be invaluable for comparing several gels and thus facilitating the selection thereof as a function of the applications…Preferably, a complementary creep measurement is also carried out. This measurement makes it possible to differentiate gels for which the G” integration scores are similar, having clinical performances and resistance to degradation performances which are quite similar. The gel which has a significantly higher slope of the creep offers the advantage of being more easily injectable and malleable, may improve the comfort of the patient and give a more natural effect by adapting to the dynamics of the face. Thus, taking into account both the G’ integration score and the creep gives information on the behaviour of the gel not only in situ, especially in terms of durability, firmness and mechanical power, but also on its behaviour in the positioning situation, especially in terms of placement of the implant during the injection, and of deformation forced by the dynamics of the face. (pp. 1-3)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the gels evaluated by LaGatta/Masi could be further evaluated using the rheological characterization techniques of Burdon, thereby arriving at the invention. One would be motivated to select gels with the highest G’ integration score or the highest slope of deformation because Burdon teaches that such gels are more easily injectable and malleable and may improve the comfort of the patient.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant argues that the combined prior art does not render the independent claims prima facie obvious for the reasons outlined above, thus the rejection of dependent claims that reply on the teachings of said combined prior art, should be withdrawn. Applicants' arguments are not persuasive because the rejection of the independent claims is maintained as prima facie obvious over said combined prior art, as per the response to arguments above.
The rejection is still deemed proper and is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new and/or modified 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 extension fee 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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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693