DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 12/22/2025 wherein claims 1, 6, 11, 13 and 20 have been amended and claims 10 and 16 have been cancelled.
Claims 1, 3, 4, 6, 11-15, 17, 18 and 20 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s arguments filed 12/22/2025 regarding the rejection of claims 1, 3, 4, 11-13, 15, 17, 18 and 20 made by the Examiner under 35 USC 103 over Chu (US 2008/0107744) in view of Asius et al. (US 2010/0221684) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 9/30/2025. It is noted that the previous rejection rejected ‘25-15’, this was a typo and should have read ’15-18’ instead.
Applicant’s arguments filed 12/22/2025 regarding the rejection of claim 14 made by the Examiner under 35 USC 103 over Chu (US 2008/0107744) in view of Asius et al. (US 2010/0221684) further in view of Peterson (US 2002/0150550) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 9/30/2025.
In regards to the 103 rejections, Applicant asserts the following:
A) Chu and Asius fail to teach component C as being within a range of 1-5% and comprising hydroxyapatite microparticles. Chu describes ‘hollow particles’ that may include hydroxyapatite but Chu is silent how they are made and instead prefer PMMA for the hollow particles.
In response to A, as noted in Applicant’s response, Chu teaches that their composition comprises hollow particles comparable to the carrier so as to avoid clumping and palpable masses at the injection site. These particles have a particle size of 20-500 microns (see [0044]) and may be made from a variety of materials including hydroxyapatite (see [0046]). Although PMMA may be a preferred material of the hollow particle, as alluded to in the response, such a preference is not considered limiting. Preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments. See MPEP 2123(II). In the current case, the prior art suggests that hydroxyapatite may be used as the material for the hollow particles and this suggestion alone is sufficient to obviate the instantly claimed composition.
Regarding the water content and concentration of hydroxyapatite in the composition, Chu teaches that the hydroxyapatite microparticles may be present in an amount of 10% and water in an amount of at least 50%. Manipulating the contributions of these so as to result at values such as that claimed would have been obvious as a) obviousness exists where claimed ranges do not overlap but are merely close and b) where the general differences conditions of a claimed are described by the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation. See MPEP 2144.05(I) and 2144.05(II)(A).
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, 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.
Claims 1, 3, 4, 11-13, 15, 17, 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 2008/0107744; of record) in view of Asius et al. (US 2010/0221684).
Chu describes an injectable tissue filler composition. It is taught that as skin ages the skin loses volume leading to uneven skin surfaces, e.g. wrinkles. The uneven skin can be repaired by injecting an appropriate amount of the tissue filler composition underneath the skin so as to restore smoothness to the treated area (see abstract and [0005]). The smoothing out uneven skin described by Chu obviates the instant limitation of ‘optically improving the facial contour and shape of a human face”. The composition is to be injected via a fine (i.e. sharp) needle so as to be precise and leave no scar on the skin during administration (see [0006]) (see instant claim 12).
Chu’s composition for treating the skin is to comprise a major amount of water (see [0051]), 0.01-6% by weight of an anesthetic (component D) (see [0052]) (see instant claims 1d and 20), microspheres of hydroxyapatite, PLA and/or PMMA (component C) having a diameter of between 20-500 microns (see [0044]) (see instant claims 1c, 6 and 13) and between 0.1-20% of a thickening agent(s) such as glucose (component A), mannitol (component A), sorbitol (component A), hydroxypropylmethylcellulose (component B) and hyaluronic acid (component B) (see [0048]) (see instant claims 1a and 1b, 4, 11, 13 and 20). Although Chu is silent with respect to the amount of water in the composition, given that Chu describes water as being a present in a ‘major amount’ would reasonably suggest water be present in an amount of 50% or more of the compositions mass (see instant claims 1, 11, 13 and 20). Regarding the obviousness of the ranges of Chu in relation to those claimed more broadly (e.g. anesthetic, thickening agent), MPEP 2144.05(II)(A) states that where the general conditions of a claim are described by the prior art, it is not considered inventive to discover the optimum/workable ranges by routine experimentation. Such a rationale is applicable to the claimed ranges in the current case.
Regarding claims 1, 11 and 20, wherein the components of the composition are “dissolved or suspended in the excipient”, Chu teaches the thickening or suspension agents are mixed with the biocompatible carrier (see [0048]), and the anesthetic is used with the aqueous base and mixed with the composition prior to administration (see [0052]). Therefore, while Chu does not explicitly state that the components are “dissolved or suspended”, the skilled artisan would recognize such from use of the term “mixed”.
Chu’s microspheres are taught to be present in in a concentration from about 10-80% of total volume of the composition (see [0018]) wherein the microspheres possess a void volume between 0.1-74% (see [0043]). Applying the void volume to the volume concentration results in a net of 2.6-79.9% by volume. Chu teaches that the density (m/v) of the microspheres is to match that of the composition (carrier) and so the % volume would convert directly to % mass, e.g. 2.6-79.9% weight. The lower end of the manipulated range would overlap with the claimed range of instant claims 11 and 20c. See MPEP 2144.05 regarding obviousness of ranges.
Regarding the osmotic concentration (osmolarity), assuming a concentration of glucose of 40% would equate to a concentration of about 400g/1000 mL (or 400g/L) which results in a molarity of 2.2M (MW glucose 180 g/mol). As glucose does not dissociate the osmolarity would equate to 2200 mOsm/L. Because osmotic pressure is a colligative property, the osmotic pressure of the solution comprising does not depend on the chemistry of the solute (the polyol or saccharide) but rather the quantity of solute dissolved in the solvent. In the instant case, the concentration of the solute taught by Chu would result in an osmotic concentration of 500-5000 mOsm/L which is encompassed by the prior art and would reasonably be expected to overlap. A similar analysis can be performed with other claimed components and yield the same result (e.g. sorbitol, mannitol, etc.)
Regarding claim 3, it is noted that the limitation “for improving the ligamentous laxity of the face” recites an intended result of the claimed method, and does not recite any additional method steps or structural components apart from what is already claimed. Chu teaches an improved composition for processes of filling contour deficiencies including skin lines or wrinkles, or placing in the hollows of the cheeks (see [0005, 0014, 0015]), which include areas where ligaments are located. Since the same composition is injected into the same area for the areas of the face where ligaments are located, one skilled in the art would reasonably expect the composition may be injected into or close to the ligaments of the face, absent a teaching otherwise. Regarding the step of cleaning “specific skin areas above the ligaments of the face” (claim 13), it is noted that, while Chu does not specifically state cleaning the area of skin first, Chu teaches the composition is for internal administration (see [0002]), and is injected with a sterile syringe (see [0054]), and thus the skilled artisan would reasonably expect the area of injection to be cleaned first. Regarding the limitations of repeating the injecting step more than once (see instant claim 13) or wherein the injecting step is repeated from 1 to 10 times (see instant claim 15), it is noted that repeating the step of injecting amounts to performing the same step for the same purpose, which would be within the purview of the ordinarily skilled artisan. Such a modification of Chu’s methods would be similar to the duplication of parts described by MPEP 2144.04(VI)(B). Accordingly, the limitation of repeating the injecting step from 1 to 10 times does not impart patentability to the claim, absent a showing of the criticality and/or unexpected results from repeating the injecting step.
Chu fails to teach the water of their composition as being ‘sterile’ water.
Asius is directed to compositions for subcutaneous or intradermal injection so as to fill wrinkles, skin cracks, and smooth out acne scars (see [0002]). The composition is to be aqueous and comprise sterile water (see [0024]). It would have been obvious to modify Chu’s method such that the water used for injection was sterile so as to avoid any risk of infection. See MPEP 2143(I)(A).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 2008/0107744; of record) in view of Asius et al. (US 2010/0221684) as applied to claims 1, 3, 4, 11-13, 15, 17, 18 and 20 above, and further in view of Petersen (US 2002/0150550; of record).
Chu fails to teach the volume of composition applied by the method as being between 0.01-1.2 mL.
Petersen is in the field of composition for soft tissue augmentation and soft tissue correction of the body (see [0001]), and generally teaches the gel to be injected is typically stored in a syringe suitable for injecting the required amount for a single session treatment; depending on the afflicted area, the volume of the syringe may vary, such as a syringe with a volume of 0.25-25 mL, with amounts provided in a syringe for facial surgery being typically lower in volume than those for body contouring (see [0041]). This range overlaps that instantly claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I)(A).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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