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
2. This Office Action is responsive to Applicant’s Amendment and Remarks, filed December 3, 2025. The amendment, filed December 3, 2025, is entered, wherein claim 12 is amended, claims 14 – 15 are new, and claims 1 – 8 and 15 are withdrawn.
Claims 1 – 15 are pending in this application and claims 9 – 14 are currently examined.
Priority
This application is a continuation application of 17/692,594, filed March 11, 2022, now issued as U.S. Patent No. 11,701,451.
The following are maintained / modified / new grounds of rejection necessitated by Applicant’s Amendment and Remarks, filed December 3, 2025, wherein claim 12 is amended and claim 14 is new. Previously and newly cited references have been used to establish the maintained / modified / new grounds of rejection.
Claim Interpretation
For purposes of examination, the phrase “50.0 to about 99.9 percent by weight of a first cross-linking polysaccharide material and from about 0.03 percent by weight to about 50.0 percent by weight of a second cross-linking polysaccharide material” will be interpreted to encompass any reference basis for the recited weight percentages.
New Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
a. Claim 13 depends from claim 12 and recites that “the malleable soft tissue filler includes at least one marker that is distinguishable from surrounding soft tissue using common medical imaging technologies.”, which may be reasonably interpreted in two ways. First, the “at least one marker” of claim 13 may be interpreted as the same marker in claim 12, further limited by the fact it must be distinguishable from surrounding soft tissue “using common medical imaging technologies”. Alternatively, the “at least one marker” of claim 13 is an additional marker to claim 12. Therefore, it is unclear because of the lack of indication of which interpretation claim 13 is referring to. Accordingly, claim 13 is ambiguous and indefinite. Claim 13 will be interpreted as encompassing any possible marker arrangement, wherein at least one marker in the filler is distinguishable from surrounding soft tissue using common medical imaging technologies, including embodiments, wherein the marker is the same as or additional to the marker recited in claim 12.
Maintained / Modified / New 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. Considering objective evidence present in the application indicating obviousness or
nonobviousness.
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.
Claims 9 – 11 are rejected under 35 U.S.C. 103 as being unpatentable over Barg (WO2012/022478A2, cited in the previous Office Action) in view of Lim (US10414833B2, cited in the previous Office Action).
Regarding claims 9 – 11, Barg teaches an invention pertains to a filler composition comprising β-glucan moieties and optionally a cosmetically and/or pharmaceutically acceptable carrier (Abstract), wherein the β-glucan moieties are cross-linked (para. [001]), wherein the carrier is hyaluronic acid (para. [0024] and claim 6). In certain embodiments, the β-glucan moieties are a mixture of different β-glucan moieties, wherein the β-glucan moieties are β-(1,3)-(1,4)-glucan, β-(1,3)-(1,6)-glucan, chitosan, chitin, and/or cellulose (para. [0018]). Barg teaches that β-glucan is extracted from oat in particular (para. [0058]). In one embodiment, the cross-linking β-glucan is made by combining a solution of at least one β-glucan moiety with an aqueous solution containing at least one cross-linking agent, wherein the concentration of the cross-linking agent is between about 2.5 wt-% and 30 wt-% and the concentration of β-glucan moieties the β-glucan moieties is between about 0.1 and about 5.0 wt% for β-glucans with greater than 100 kDa or between about 0.1 and about 10.0 wt% for β-glucans with less than 100 kDa, in each case of the final total weight of filler composition (para. [0042]).
However, Barg does not teach the recitation “50.0 to about 99.9 percent by weight of a first cross-linking polysaccharide material and from about 0.03 percent by weight to about 50.0 percent by weight of a second cross-linking polysaccharide material” as well as the density of the filler.
Lim teaches an invention directed to a biocompatible composition, wherein the composition comprising β-glucan and hyaluronic acid that is prepared by hybrid cross-linking and the composition is capable of being used as a medical material (Abstract), such as fillers (Col. 4, line 37). The β-glucan and the hyaluronic acid may be mixed in a mass ratio of 1:9 to 9:1 (Col. 2, lines 16 – 17).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine a filler composition comprising cross-linked β-glucan moieties and optionally a cosmetically and/or pharmaceutically acceptable carrier as taught by Barg with the weight ratio of β-glucan and hyaluronic acid in view of Lim because both reference teach the compositions that are used for the same purpose. One would have motivated to combine because of the predictable results. One would have performed routine experimentation to discover the best weight percentage of each components for optimal treatment characteristics. Although the density is not explicitly taught in the references, the density will still be expected to fall within the claimed range because of the weight ratio taught by Lim overlaps with the claimed percentage by weight of the cross-linking polysaccharides. Therefore, one would have had a reasonable expectation of success to combine a filler composition comprising cross-linked β-glucan moieties and optionally a cosmetically and/or pharmaceutically acceptable carrier as taught by Barg with the weight ratio of β-glucan and hyaluronic acid in view of Lim because Barg teaches all the components of the claimed composition, Lim teaches the possible weight ratio of the components, and both references teach the compositions that are used for the same purpose.
Claims 12 – 13 are rejected under 35 U.S.C. 103 as being unpatentable over Barg (WO2012/022478A2, cited in the previous Office Action) in view of Lim (US10414833B2, cited in the previous Office Action) as applied to claims 9 – 11 above, and further in view of Klein (US6394965B1) and Mundada et al. (Insights into Imaging, 2017, Vol. 8, Issue 6, page 557 – 572, Reference included with PTO-892).
b. Regarding claims 12 – 13, the references teach the limitations discussed above.
However, these references do not teach the filler includes at least one pyrolytic carbon-coated ceramic imaging marker.
Klein teaches tissue marking using biocompatible microparticles, wherein the microparticles has a pyrolytic carbon surface (Abstract) and biocompatible materials include ceramics, such as zirconium oxide (Col. 3, lines 25 – 31). The tissue may be marked for any reason, for example, to return to the same tissue site to monitor the process of a medical condition or a treatment (Col. 3, lines 58 – 60).
Mundada et al. teach that injectable fillers are widely used for facial rejuvenation, correction of disabling volumetric fat loss in HIV-associated facial lipoatrophy, Romberg disease, and post-traumatic facial disfiguring. Imaging can help in differential diagnosis when filler-related complications arise. Awareness of imaging features of facial fillers and their complications helps to avoid misinterpretation of MRI, and PET-CT scans and facilitates therapeutic decisions in unclear clinical cases.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the tissue filler as taught by Barg with a tissue marker that is a pyrolytic carbon-coated ceramic in view of Klein and Mundada et al. because Klein teaches that such pyrolytic carbon-coated ceramic tissue marker is biocompatible and it helps monitoring the process of a medical treatment and Mundada et al. provide the reason why a tissue marker is needed. One would have been motivated to combine the tissue filler as taught by Barg with a tissue marker that is a pyrolytic carbon-coated ceramic in view of Klein and Mundada et al. because Klein teaches that the pyrolytic carbon-coated ceramic tissue marker is biocompatible and Mundada et al. confirm that a marker is necessary for filler-related complications. One of the ordinary skill in the art would have had a reasonable expectation of success to combine the tissue filler as taught by Barg with a tissue marker that is a pyrolytic carbon-coated ceramic in view of Klein and Mundada et al. because Barg and Lim et al. teach the claimed tissue filler composition and Klein and Mundada et al. teach the pyrolytic carbon-coated ceramic tissue marker and the reason of including such marker.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Barg (WO2012/022478A2, cited in the previous Office Action) in view of Lim (US10414833B2, cited in the previous Office Action) as applied to claims 9 – 11 above, and further in view of Béduer et al. (bioRXiv, 2020, Reference included with PTO-892).
c. Regarding claim 14, the references teach the limitation discussed above.
However, these references do not teach that the soft tissue filler is a porous solid.
Béduer et al. teach that a novel type of injectable biomaterial with an elastic transition. It has irregular particle shape, which dramatically enhances yield strain for in-vivo stability against deformation, and friction and porosity provide the elastic softening transition as an emergent meta-material property (Abstract). This biomaterial consists of an interlocking suspension of highly irregular, sponge-like microparticles. Its unique material design enables both fluidic injection through a cannula and shapable three-dimensional stability (page 5, para. 2).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue filler composition as taught by Barg and Lim et al. into a filler that is porous in view of Béduer et al. because Béduer et al. teach that a porous biomaterial exhibits elastic softening transition. One would have been motivated to modify the tissue filler composition as taught by Barg and Lim et al. into a filler that is porous in view of Béduer et al. because Béduer et al. teach that the porous structure enhances the ability to be shaped. One of the ordinary skill in the art would have had a reasonable expectation of success to modify the tissue filler composition as taught by Barg and Lim et al. into a filler that is porous in view of Béduer et al. because such modification is known in the art to provide an enhanced tissue filler.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed December 3, 2025, have been fully considered and are found to be not persuasive.
Regarding Barg, Applicant argues that Barg discloses an injectable fluid, whereas the claimed invention is a substance that can be molded in a desired shape and retains that shape after removal from the mold. This argument is not persuasive because Barg does not disclose “fluid” as Applicant argued. Applicant asserts that a substance with injectability cannot be molded. However, there are materials, such as hyaluronic acid, that are injectable and moldable.
Regarding Lim, Applicant argues that Lim makes no mention of it being a porous solid structure or being malleable. This argument is not persuasive because the “porous solid structure” limitation is addressed by the addition of Béduer et al., wherein Béduer et al. provide motivation for the modification of the filler composition as taught by Barg. Applicant’s arguments rely on language solely recited in preamble recitations in claim 9. When reading the preamble in the context of the entire claim, the recitation “malleable” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Regarding Yeh, Applicant argues that Yeh does not disclose a tissue filler, but only addresses a comparison between hyaluronic acid and surgical clips for use in tumor bed delineation. This argument is moot because Yeh is no longer used as an evidence in the modified 103 rejection.
Finally, Applicant argues that Barg and Lim teach away from each other because Barg teaches that the hyaluronic acid may be less than about 10% and Lim teaches that hyaluronic acid is between 10% and 90% by weight. This argument is not persuasive because the ranges disclosed by Barg and Lim are not mutually exclusive and neither references criticize one another’s teachings. Therefore, Barg and Lim do not teach away from each other.
Maintained / Modified 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 9 – 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 – 5, 7, 9, 11, 14 – 15, and 17 – 18 of U.S. Patent No. 11701451B1. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘451B1 anticipate the claimed invention.
a. Independent claim 9 is directed to a malleable soft tissue filler, comprising: from about 50.0 to about 99.9 percent by weight of a first cross-linking polysaccharide material and from about 0.03 percent by weight to about 50.0 percent by weight of a second cross-linking polysaccharide material; wherein the density of the malleable soft tissue filler is from about 5.0 to about 300 mg/cubic centimeters (mg/cc); and wherein the first cross-linking polysaccharide material is a beta-D-glucan material and wherein the second cross-linking polysaccharide material is selected from the group consisting of chitin, chitosan, cellulose, and hyaluronic acid. Dependent claim 10 is directed to the filler, wherein the beta-D-glucan is (1-3),(1-4) beta-D-glucan and (1-3),(1-6) beta-D-glucan. Dependent claim 11 is directed to the filler, wherein the beta-D-glucan is oat-derived (1-3),(1-4) beta-D-glucan.
‘451B1 teaches a method of making a malleable soft tissue filler, wherein the malleable soft tissue filler comprises a first cross-linking polysaccharide material that is oat-derived (1-3),(1-4) beta-D-glucan in an amount of 50.0 to 99.9 percent by weight and a second cross-linking polysaccharide that is agarose in an amount of 0.03 to 50.0 percent by weight, wherein the density of the malleable soft tissue filler is from about 5.0 to about 300 mg/cubic centimeters (claims 1, 3 – 5, 7, 9, 11, 14 – 15, and 17 – 18).
For these reasons above, ‘451B1 anticipates the claimed invention.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed December 3, 2025, have been fully considered and are found to be not persuasive.
As Applicant does not file any terminal disclaimer and does not provide other remarks, the double patenting rejection is maintained.
Conclusion
No claim is found to be allowable.
Applicant's amendment necessitated the maintained / modified / 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 HOI YAN LEE whose telephone number is 571-270-0265. The examiner can normally be reached Monday - Thursday 7:30 - 17:30.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693