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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/18/2026 has been entered.
Status of Application
Applicants' arguments/remarks filed 05/15/2026 are acknowledged. Claims 16, 18, 22 and 31 are currently amended. Claims 23-24 are newly canceled. Claims 25-28, 30 and 32-33 are currently withdrawn. Claims 16-18, 20-22, 29, 31, and 34-35 are examined on the merits within and are currently pending.
Withdrawn Rejections
With applicants' amendment, filed 08/21/2025 and with respect to the applicant’s arguments/remarks:
the 35 U.S.C. § 103 rejection of Claims 22-23 has been withdrawn in view of the cancelation of the claims;
the 35 U.S.C. § 103 rejection of Claims 16-18, 20-23, 29, 31 and 34-35, over Altman et al. has been withdrawn in view of the amendment of the claims;
the 35 U.S.C. § 103 rejection of Claims 16 and 24 over Altman et al. and Gavard Molliard Kettenberger et al. has been withdrawn in view of the amendments.
Modified Rejections
Claim Rejections - 35 USC § 103
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.
The factual inquiries 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 non-obviousness.
Claim(s) 16-18, 20-22, 29, 31 and 34-35 is/are rejected under 35 U.S.C. 103 as being obvious by Altman et al. (US 12296067 B2) in view of Kettenberger et al. (US 20180264175 A1).
Claims 16-18 and 20-21,
Altman et al. teach in some embodiments, a tissue filler disclosed is injectable. (Col. 2, lines 24-25), comprising an organic compound and/or an inorganic compound. (Col. 5, lines 42-44).
The inorganic compound comprises calcium hydroxyapatite. (Col. 5, lines 42-44). In some embodiments, the calcium hydroxyapatite is formulated as particles having a diameter between about 1 µm and about 100 µm. (Col. 5, line 45-47). (A).
In one embodiment, the invention relates to a biocompatible tissue filler comprising: a glycosaminoglycan selected from the group consisting of hyaluronic acid (HA). (Col. 6, lines 16-18). (B). In an embodiment, the percent HA by weight in the tissue filler composition is less than 99%-0.1% (Col. 94, lines 20-67-Col. 95 lines 1-38). In some embodiments, all of the HA is non-crosslinked. (Col. 12, lines 23-24, 33-34, or 47-48; or Col. 44, lines 36-37).
In some embodiments, the HA incorporated (Col. 93, line 67) in the tissue fillers described has a high molecular weight (e.g., an HA molecular weight of about 1 MDa to about 4 MDa). (Col. 94, lines 2-3). (B1).
In some embodiments, the dermal fillers are made by a process described by using HA having a low MW of about 50 kDa, about 100 kDa. (Col. 42, lines 36-38). (B2).
In some embodiments, the dermal fillers are made by a process described by using HA having a MW of between about 5 kDa and about 5 MDa. (Col. 42, lines 32-34). (B). B comprises a combination of components B1 and B2. Any of the above MW of HA can be mixed with any other of the above MW of HA, in any possible proportion. In some embodiments, a dermal filler is made by mixing a high MW HA with a low MW HA. (Col. 42, lines 61-65). Because B1 and B2 can be mixed in any possible proportion, it would be obvious that they include B1 50-100% by weight and B2 0-50% by weight.
In some embodiments, a composition of the invention comprises a carrier phase. (Col. 46, lines 3-4). Potential carriers could include protein solutions, gels composed of polymers including proteins, glycoproteins, proteoglycans, or polysaccharides. (C). (Col. 46, lines 21-25). Tissue filler comprising silk protein or silk protein fragments (SPF). In some embodiments, the silk protein is silk fibroin. (Col. 7, lines 7-8). Silk protein, silk protein fragments or silk fibroin can be carrier. In some embodiments, the percent SPF content, by weight, in the tissue fillers described herein is at least 0.01 % - 99.9%. (Col. 57, lines 32-67-Col. 58, lines 1-29).
In one embodiment, the invention relates to a biocompatible tissue filler comprising: an anesthetic agent. (Col. 3, line 61– Col. 4, line 1). (D). In certain embodiments, the tissue fillers
can include one or more anesthetic agents in an amount effective to ameliorate or mitigate pain
like lidocaine or others. In some embodiments, the tissue fillers described herein may include lidocaine or other anesthetic at a concentration, by weight, of at least 0.01 %-10%. (Col. 166, lines 4-27).
Additional Agents: In some embodiments, the tissue fillers include an active agent, different from anesthetic agents, can be one or more of enzyme inhibitors, medicinal neurotoxins, antioxidants, anti-infective agents, anti-inflammatory agents, vasodilators, ultraviolet (UV) light blocking agents, dyes ( e.g., tattoo dye, ink or pigment), a reflective agent, hormones, immunosuppressants, and combinations thereof. (Col. 6, lines 7-12). In some embodiments, the tissue fillers include an active agent at a concentration, by weight, of 0.01%-50%. (Col. 163, lines 28-44 – Col. 164, lines 32-46). (E).
Altman et al. do not teach (A) 60 to 80% by weight, referred to dry matter, based on the composition, of one or more types of calcium hydroxyapatite particles having a mean particle size of 1 to 150 µm as component A.
Kettenberger et al. teach preparation of the first phase:
(A) 400 mg of hydroxyapatite particles (rounded shape, average diameter of 5 µm) were mixed with 0.1 ml NaOH 5M and 1.873 ml of H2O,
(B) 200 mg of hyaluronic acid sodium salt ( molecular weight 2MDa ) were added to the particle suspension. (0083).
(A) hydroxyapatite particles: 400mg/(400+200mg)*100= 67%
(B) hyaluronic acid: 33% of dry weight
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to prepare an injectable composition comprising
Calcium Hydroxyapatite, with a mean diameter between about 1 µm and about 100 µm.
hyaluronic acid, the percent HA by weight in the tissue filler composition is less than 99%-0.1%. The dermal fillers are made by a process described by using HA having a MW of between about 5 kDa and about 5 MDa. In some embodiments, the HA incorporated (Col. 93, line 67) in the tissue fillers described has a high molecular weight (e.g., an HA molecular weight of about 1 MDa to about 4 MDa). In some embodiments, the dermal fillers are made by a process described by using HA having a low MW of about 50 kDa, about 100 kDa. B comprises a combination of components B1 and B2. Any of the above MW of HA can be mixed with any other of the above MW of HA, in any possible proportion. In some embodiments, a dermal filler is made by mixing a high MW HA with a low MW HA. In some embodiments, all of the HA is non-crosslinked. In some embodiments, all of the HA is non-crosslinked.
In some embodiments, a composition of the invention comprises a carrier, which include a protein, like silk protein fragments, with 0.01 % - 99.9% by weight.
In one embodiment, the invention relates to a biocompatible tissue filler comprising: an anesthetic agent, like lidocaine or other anesthetic at a concentration, by weight, of at least 0.01 %-10%.
In some embodiments, the tissue fillers include an active agent, different from anesthetic agents, can be one or more of enzyme inhibitors, medicinal neurotoxins, antioxidants, anti-infective agents, anti-inflammatory agents, vasodilators, ultraviolet (UV) light blocking agents, dyes ( e.g., tattoo dye, ink or pigment), a reflective agent, hormones, immunosuppressants, at a concentration, by weight, of 0.01%-50%. All taught by Altman et al., and A, hydroxyapatite, 5µm at a concentration of 67%, taught by Kettenberger, since they have proven it would be possible to do so.
With regard to claim 22,
Altman et al. teach in some embodiments that the invention relates to a tissue filler further comprising an organic compound and/or an inorganic compound. In some embodiments, the inorganic compound comprises calcium hydroxyapatite. In some embodiments, the calcium hydroxyapatite is formulated as particles having a diameter between about 1 µm and about
100 µm, between about 1 µm and about 10 µm, between about 2 µm and about 12 µm, between about 3 µm and about 10 µm, between about 4 µm and about 15 µm, between about 8 µm and about 12 µm, between about 5 µm and about 10 µm, between about 6 µm and about 12 µm, between about 7 µm and about 20 µm, between about 9 µm and about 18 µm, or between about 10 µm and about 25 µm. (Col. 5, lines 42-54).
With regard to claim 29,
Altman et al. teach hyaluronic acid (hyaluronan) is a glycosaminoglycan that is distributed throughout the body and is found in connective and epithelial tissues. Due to its biocompatibility and structural benefits, it is a useful component in medical devices and implantable materials. Soft tissues of the human body owe their structures in part to an extracellular matrix that includes collagen, elastin, and glycosaminoglycan. Soft tissue defects may occur, which distort, deform, or otherwise alters soft tissue structures. Such structure may be restored through the use of tissue fillers that may be deposited at the defect site remedy the
defect. For example, tissue fillers may be placed at the site of a facial wrinkle to remedy the wrinkle. However, new tissue fillers are needed in the field that remedy a number of tissue defects while providing tunable properties, which may allow for tailoring of the tissue filler
to the specific tissue defect. (Col. 1, lines 11-28).
With regard to claim 31
Altman et al. teach in some embodiments, a composition of the invention comprises a carrier phase. (Col. 46, lines 3-4). Potential carriers could include but are not limited to polysaccharides (Col. 46, lines 21, 25). Suitable biocompatible polymers include polysaccharides (e.g., HA, chitosan, chondroitin sulfate, alginate, carboxymethylcellulose), poly( ethyleneglycol), poly(lactic acid), poly (hydroxyethylmethacrylate ), poly(methylmethacrylate ),
With regard to claims 34 and 35
Altman et al. teach in some embodiments, the condition treated by the tissue fillers may include a soft tissue condition. Soft tissue conditions include, augmentations, reconstructions, diseases, disorders, defects, or imperfections of a body part, region or area: a face, skin, lip, urethra defect, breast, cheeks, arm, hand, shoulder, back, torso, abdomen, buttocks, leg, calves, foot, eye, genitals; urinary incontinence, fecal incontinence, other forms of incontinence; and gastroesophageal reflux disease. (Col. 188, lines 13-53).
Response to Arguments
Rejections Under 35 U.S.C. § 103
Applicant argues that claim 16 is amended and Altman does not disclose each and every feature of claim 16. Further, the Office and Altman fail to provide any reason or rationale for one of ordinary skill in the art to have modified Altman to have included, inter alia, a mixture of 50 to 100% by weight of Bl and 0 to 50% by of B2 and an amount of calcium hydroxyapatite particles in the range of 60 to 70% by weight, as recited in claim 16, without the benefit of Applicant's specification. A person of ordinary skill in the art would not have had a reasonable expectation of success in looking to Altman to arrive at the claimed invention. Claims, 17-18, 20-22, 31, and 34-35 either directly or indirectly depend from claim 16 and, likewise, would not have been rendered obvious Altman.
Applicant's arguments have been fully considered and they are persuasive according to the previous Office Action of the Final Rejection. However, with the amendment of claims 16, the office action is modified. Please see the rejection of claim 16 above. Because rejection of claim 16 is modified, so the rejection of all dependent claims is maintained.
Applicant argues that the Office acknowledges that Altman does not teach (A) 10-80% by
weight, based on the composition, of one or more types of calcium hydroxyapatite particles having a mean particle size of 1 to 150 µm as component A. Gavard-Molliard is cited to cured this deficiency in Altman. However, the presently claimed range of 60-80% by weight. Gavard-Molliard discloses hydroxyapatite concentrations of 10-60% (mass/volume), with preferred ranges of 20-40% and does not teach or suggest concentrations exceeding 60%. The claimed invention recites a high concentration of hydroxyapatite which enables powerful biostimulation due to the high collagen production. Additionally, hydroxyapatite degrades more slowly than hyaluronic acid, providing that when it is utilized in higher amounts the results can last for 1 to 2 years. Neither Altman nor Gavard-Molliard, alone or in combination, teaches or suggests at least the presently claimed high concentration of calcium hydroxyapatite, which increased collagen production and prolonged persistence resulting from the slower degradation of hydroxyapatite relative to hyaluronic acid which are not achievable to the same extent at the lower concentrations disclosed in the cited art. A person of ordinary skill in the art would not have had motivation, or a reasonable expectation of success in looking to Altman and Gavard-Molliard, alone or in combination, to arrive at the instant claims.
Applicant's arguments have been fully considered and they are persuasive according to the previous Office Action of the Non-Final Rejection, but they are not persuasive according to this new modified office action. Please see details above. Regarding the arguments that applicant shows increased collagen production and prolonged persistence resulting from the slower degradation of hydroxyapatite relative to hyaluronic acid which are not achievable to the same extent at the lower concentrations disclosed in the cited art in the specification, (Table 3, pg. 36), applicant does not have this limitation in the claim, does not provide this high CaHA concentrations in relation to the 60-80% by weight and does not prolonged persistence resulting from the slower degradation of hydroxyapatite relative to hyaluronic acid which are not achievable to the same extent at the lower concentrations disclosed in the cited art. In response to applicant' s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case Altman teaches about injectable composition including calcium hydroxyapatite CaHA, and hyaluronic acid, with different options of non-crosslinked, high and low molecular weight as applicant does and Kettenberger teaches a higher percentage of CaHA 67% and HA at 33%. Prior arts teach different options and one with skill in the art, is known for solving the same problem, is represented with design choices, may modify the teachings of the prior arts until they can achieve better outcome results.
Conclusion
No claim is allowed
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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