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 .
Claim Status
Applicants’ amendments and arguments filed 09/26/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claims 13-20 are amended.
Claims 1-12 remain withdrawn.
Claims 13-20 are examined on the merits.
Claim Interpretation
Claim 13 recites “an effective amount” in which Applicant’s instant specification fails to define what an “effective amount” constitutes. Therefore, Examiner broadly interprets “effective amount” to encompass any amount administered.
Maintained 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 (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.
Claims 13-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Han Dong et al. (KR20210106796A, published 08/31/2021, hereafter Han).
Han claims a composition for a filler comprising microparticles of biodegradable polymer and basic ceramic particles in which the filler has enhanced anti-inflammatory or anti-aging effects (claims 13-16, according to the claim limitations of the instant claim 13). Han teaches that human skin tissue maintains its structure by the extracellular matrix (ECM) containing proteins such as collagen and glycosaminoglycans (paragraph 0002; according to the claim limitations of the instant claims 13 and 15). Furthermore, Han teaches that damage to the skin tissue due to external shock, disease, or aging may leave a defect which can be treated by inserting a living tissue or synthetic polymer into the relevant area, such as a filler (paragraph 0002; according to the claim limitations of the instant claims 13 and 17-18). Han then teaches most domestic and foreign fillers, specifically hyaluronic acid fillers, exist in the form of a gel (paragraph 0004; according to the claim limitations of the instant claim 20). Furthermore, Han teaches the biodegradable polymer to be polycaprolactone (PCL) which Han further designates as a biocompatible material (paragraphs 0024 and 0027; according to the claim limitations of the instant claim 13). Han defines “biocompatible material” as a material that is substantially non-toxic to the human body, chemically inert, has no immunogenicity, and can be decomposed in vivo by body fluids or microorganisms (paragraph 0026; according to the claim limitations of the instant claim 13). Han further teaches polycaprolactone to decompose slowly over a long period of time thereby maintaining the effect of the filler (paragraph 0029; according to the claim limitations of the instant claim 19). Furthermore, Han teaches that when polycaprolactone exists for a long time in the body, it may be decomposed into 6-hydroxycaproic acid (HCA) (paragraph 0029; according to the claim limitations of the instant claim 13). In order to confirm the effects of the composition, Han treated human dermal fibroblasts (HDF) with the final decomposition forms of bioabsorbable polymers, HCA and magnesium hydroxide (paragraphs 0117 and 0121; according to the claim limitations of the instant claims 13 and 14). Han’s Table 1 demonstrates that PCL (as mentioned above degrades to HCA) and magnesium hydroxide control inflammation (paragraphs 0128-0129; according to the claim limitations of the instant claim 13). Furthermore, Han demonstrated that the composition of HCA and magnesium hydroxide demonstrated low inflammation inducing factor even after 24 hours, thus having anti-inflammatory ability (paragraph 0125; according to the claim limitations of the instant claim 13).
A reference is analyzed using its broadest teachings. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen 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.” Therefore, claims 13-15 and 18-20 of the instant application would be of obviousness.
Claim 13 and 16 is rejected under 35 U.S.C. 103 as being unpatentable over Weitao et al. (CN1691929A, published 11/02/2005, hereafter Weitao) as evidenced by Wolters et al. (Wolters, W. J., Duncan, H. F., Tomson, P. L., Karim, I. E., McKenna, G., Dorri, M., Stangvaltaite, L., & van der Sluis, L. W. (2017). Minimally Invasive Endodontics: A new diagnostic system for assessing pulpitis and subsequent treatment needs. International Endodontic Journal, 50(9), 825–829. https://doi.org/10.1111/iej.12793, hereafter Wolters).
As evidenced by Wolters, in the majority of cases of mature teeth diagnosed with irreversible pulpitis or apical periodontitis, root canal treatment is the therapy of choice to save the tooth (page 825, introduction, paragraph 1).
Weitao claims a filling for a pocket or root canal comprising a thermoplastic polymer having adhesion strength when attached to a root catheter sealant (claim 1; according to the claim limitations of the instant claim 13). Claim 2 of Weitao claims the polymer to be a biodegradable polymer (according to the claim limitations of the instant claim 13). Weitao further teaches the polymer to be polylactides, polyglycolides, or polyacetones which have excellent biocompatibility which reduces tissue rejection, inflammation, necrosis, or toxicity (page 3, paragraph 4; according to the claim limitations of the instant claim 13). Furthermore, Weitao teaches these polymers, in the presence of water produce lactic acid, glycolic acid, and hydroxycaproic acid (page 3, paragraph 4; according to the claim limitations of the instant claim 13). Weitao teaches that a root canal is used for dental tissue diseases, specifically infection at the root and the removal of diseased pulp tissue (page 1, paragraph 4; according to the claim limitations of the instant claim 16). Lastly, Weitao treatment of the root canal indicates that even a tooth with a healthy external structure may be sick, necrotic or necrotic (page 1, paragraph 4; according to the claim limitations of the instant claim 16).
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[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”. Therefore claims 13 and 16 of the instant application are of obviousness.
Response to Applicant’s Arguments
Applicant’s arguments filed on 09/26/2025 have been considered by the examiner.
In regards to Applicant’s arguments against the 35 U.S.C. 103 over Han Dong, Applicant first argues that Han fails to teach or suggest administering an “effective amount” of free hydroxy(C1-10)(COOH) (e.g. HCA) as the instant claims require. Furthermore, Applicant argues that Han does not teach “delivering a pharmacologically active dose of the free acid itself”. Secondly, Applicant argues that Han has “no step treating inflammatory diseases” and is directed towards a purely aesthetics. Lastly, Applicant argues that instant dependent claims 16-20 are directed towards systemic or local inflammation, specifically referencing osteoarthritis, obesity-related inflammation, periodontitis, gingivitis, pulpitis, etc.
In regards to Applicant’s argument that Han fails to teach an “effective amount”, it is first noted that Applicant’s instant specification and claims fails to define “effective amount” and teaches a very broad range of HCA to encompass 1-1500gm including +/- 25% of these values (page 15, lines 17-28). Therefore, absent evidence to the contrary, any amount being administered will satisfy this limitation. In regards to Applicant’s claim that Han does not disclose a step of treating inflammatory diseases, it is first noted that the instant claims are not directed towards treating an inflammatory disease either. Instant claim 13 recites “a method to prevent, inhibit, or treat inflammation” broadly and makes no mention to disease. Furthermore, the instant claim 13 also encompasses preventing or inhibiting inflammation, thus treating inflammation is an optional requirement. Further as outlined in the previous office action, in the 103 rejection over Han above, and reiterated here, Han claims “the filler has enhanced anti-inflammatory or anti-aging effects” (claim 16). Lastly, in regards to Applicant’s argument that the dependent claims are directed towards osteoarthritis, obesity-related inflammation, periodontitis, gingivitis, and pulpitis, it is noted that these limitations are only found in dependent instant claim 16 and are thus not a requirement of the instant claim 13 nor 17-20 which dependent upon claim 13. It is noted that claim 16 is not rejected to over Han and since claim 16’s limitations are not in any other claim, this is not a requirement of the remaining claims.
Overall, Examiner is not persuaded by Applicant’s arguments and the 35 U.S.C. 103 over Han Dong is maintained.
In regards to Applicant’s arguments against the 35 U.S.C. 103 over Weitao as evidenced by Wolters, Applicant first argues that the instant claim 1 recites an “effective amount” and argues that Weitao does not disclose free hydoxy(C1-10)-carboxylic acid (e.g. HCA) in an anti-inflammatory “effective” amount. Furthermore, Applicant argues that Weitao does not explicitly state how much HCA is released and if the amount released ever enters the systemic circulation. Applicant then argues that Weitao teaches an intact polymer and not free HCA. Finally, Applicant additionally argues that Weitao does not teach treating the specific inflammatory conditions of claim 16.
As mentioned above, it is noted that Applicant’s claims and specification fail to define what constituents an “effective amount” and teaches a very broad range of HCA to encompass 1-1500gm including +/- 25% of these values (page 15, lines 17-28). It is further noted that Applicant’s instant claims also do not claim how much is released or if the amount enters the circulation system, thus this is not a limitation of the claims. In response to Applicant’s arguments that Weitao does not teach “free” HCA, it is noted that the instant claims make no mention of “free” HCA, but merely hydoxy(C1-10)-carboxylic acid. Therefore, the free HCA or HCA used alone (i.e. not in a polymer) is not a current limitation of the instant claims. Lastly, in regards to Applicant’s argument that Weitao does not teach treating the inflammatory conditions of instant claim 16, it is again noted that the instant claims are not narrowed to “treat” alone and instead encompass “prevent, inhibit, or treat inflammation”. As outline about in the 103 rejection, Weitao teaches their invention reduces tissue rejection, inflammation, necrosis, or toxicity in root canals (page 3, paragraph 4) and further teaches a root canal is used for dental tissue diseases, specifically infection at the root and the removal of diseased pulp tissue (page 1, paragraph 4) which as evidenced by Wolters is pulpitis or apical periodontitis (page 825, introduction, paragraph 1).
Overall, Examiner is not persuaded by Applicant’s arguments and the 35 U.S.C. 103 over Weitao as evidenced by Wolters. Therefore the rejections over Weitao as evidenced by Wolters is maintained.
Conclusion
No claims allowed.
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 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.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./Examiner, Art Unit 1611