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 .
This office action is in response to an amendment filed on May 15th, 2026.
Any objections or rejections not reiterated below are hereby withdrawn.
The applicant has cancelled claim 2.
Claims 1 and 5-13 are pending and are under examination.
Withdrawal of Objections and Rejections
Applicant’s arguments, filed May 15th, 2026, with respect to the rejection of claims 1, 5, and 11-13 under 35 U.S.C. 112(a) have been fully considered and are persuasive. The rejection of claims 1, 5, and 11-13 under 35 U.S.C. 112(a) has been withdrawn. The applicant has amended claims 1 and 11-13 to remove the limitation of preventing periodontal disease. Instant claim 5 (original) contains no limitation of preventing periodontal disease.
The rejection of claim 2 under 35 U.S.C. 101 is withdrawn, this claim having been cancelled by the applicant.
The rejection of claim 2 under 35 U.S.C. 103 is withdrawn, this claim having been cancelled by the applicant.
Information Disclosure Statement
The information disclosure statement filed April 20th, 2026 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because non-patent literature document 1 is partly illegible and the examiner did not to find a legible copy on the internet with trivial effort, and non-patent literature document 3 has neither an English translation, nor an English language explanation of relevance. It has been placed in the application file, but the information referred to therein for non-patent literature documents 1 and 3 has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a). Regarding non-patent literature document 1 on the IDS, the examiner suggests sending a copy with a larger text size to avoid illegibility caused by inadequate resolution.
The information disclosure statement filed April 20th 2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein for non-patent literature document 3 has not been considered.
Pending Objections and Rejections
Specification
The use of the terms CAPCELL PAK, SHISEIDO, Sigma-Aldrich, Duksan, Corning, and Molecular
Devices, which are trade names or a mark used in commerce, has been noted in this application. Each
term should be accompanied by the generic terminology; furthermore, the term should be capitalized
wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as
™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks,
certification marks, and collective marks) are permissible in patent applications, the proprietary nature
of the marks should be respected and every effort made to prevent their use in any manner which might
adversely affect their validity as commercial marks.
The examiner recognizes the applicant’s attempt to amend the specification to recite trademarks and/or tradenames according to the guidelines above; however, the applicant appears to have made typographical errors in the amendment paragraph numbering as follows. Certain amendments, recited as for paragraph [0140], appear applicable to specification paragraphs [0160]-[0165]. Moreover, the applicant’s amendments, recited for paragraph [0152], instead appear applicable to paragraph [0175]. The applicant’s amendments, recited for paragraph [0153], instead appear applicable to paragraph [0179]. The applicant is advised to review their amendments in view of the paragraph numbering of most recent copy of the full specification, and make appropriate corrections to the paragraph numbering recited in the amendments.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 5-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a horse chestnut extract without significantly more.
Applicant's arguments filed May 15th , 2026 have been fully considered but they are not persuasive. The specific and controlled concentration profile of active components and a physical and chemical form resulting from purification and enrichment are not markedly different characteristics distinguishing the instantly claimed composition from a product of nature. The claims are drawn to a pharmaceutical composition, so appropriate markedly different characteristics would relate to the pharmaceutical function of the composition, for instant its biological effects when administered to a subject. The applicant has recited “enhanced functional properties, including enhanced effects in inhibiting the osteoclast marker TRAP, which is not observed in natural extracts or simple admixtures of components”. However, in arguing against this rejection over 35 U.S.C. 101, the applicant did not recite support for this assertion of enhanced functional properties not observed in natural extracts or simple admixtures of components, either in cited references or the instant disclosure. It is also not clear how the “natural extracts or simple admixtures of components” recited in the applicant’s remarks materially differ from the instantly claimed composition.
If the applicant intends to overcome this rejection under 35 U.S.C 101, any markedly different characteristics must be recited in the claims. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673 (unclaimed characteristics could not contribute to eligibility) (MPEP § 2106.04(c) II. B.).
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:
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.
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 1 and 5-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (J
Vet Sci 2017, 18 (2), 245-251), and further in view of Zhang et al. (Front. Pharmacol., Sec. Inflammation Pharmacology 2021, 11, 596230), Ha et al. (Molecules 2014, 19 (4), 3940-3954), Hienz et
al. (Journal of Immunology Research 2015, 2015, 615468), and Wu et al. (Analytical Biochemistry 2013, 433 (1), 48-55).
Applicant's arguments filed May 15th, 2026 have been fully considered but they are not persuasive.
In arguing that the cited references fail to disclose all elements, the applicant asserts in response to the examiner's statement "Even if avicularin and juglanin are not inherently present in a horse chestnut extract, one of skill in the art could have added them to a horse chestnut extract" that inherency cannot he established in this case. However, the examiner's argument cited by the applicant explicitly does not rely inherency. Rather the examiner's argument relies on the prior art and using compounds with known biological effects to improve a product: "Even if avicularin and juglanin are not inherently present in a horse chestnut extract, one of skill in the art could have added them to a horse chestnut extract already known to treat periodontal disease, with the predictable effect of enhancing the activity of the extract against periodontal disease (Kim et al., Abstract; instant claims 1, 2, 9, and 10)" (previous office action, March 10th 2026, page 13); the recitation of avicularin and juglanin having activity useful for treating periodontal disease, as supported by prior art, is on page 13 of the previous office action dated March 10th, 2026.
In arguing that the cited references fail to disclose all elements, the applicant states “The composition of claim 1 comprises "0.1 to 4.0% by weight" of avicularin and "0.1 to 3.0% by weight" of juglanin, and those amounts do not exist in a natural product as this requires a processing as described in the specification”.
Although Kim et al. does not recite a pharmaceutical composition comprising "0.1 to 4.0% by weight" of avicularin and "0.1 to 3.0% by weight" of juglanin (instant claim 1), such a composition would be obvious to make to one of skill in the art over routine optimization. One of skill in the art could weigh the avicularin and juglanin and other components of the pharmaceutical composition to be combined to control the content of horse chestnut extract by weight in the pharmaceutical composition. Compositions with differing content of horse chestnut extract, in terms of weight percent, could be tested for their efficacy for treating periodontal disease in a subject (Kim et al., Materials and Methods).
Kim et al., Zhang et al., Ha et al., Hienz et al., and Wu et al. are relied upon for the reasons discussed above and in the previous office action. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the utilities of horse chestnut extract, avicularin, and juglanin for treating periodontal disease, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the avicularin and juglanin components of the instantly claimed compositions), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Kim et al. in view of Zhang et al., Ha et al., Hienz et al., and Wu et al., the invention as a whole, drawn to a composition comprising horse chestnut extract, in which avicularin and juglanin are active ingredients, as described in Claim 1, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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, one of skill in the art would have been motivated to combine materials known in the art to have activity that would treat periodontal disease (horse chestnut extract, avicularin, and juglanin) to treat periodontal disease, and with the predictable effect of making a composition useful for treating periodontal disease. One of skill in the art would have been able to concentrate specific compounds in the extract by adding them to the extract.
The applicant argues that there is no reasonable expectation of success, specifically disagreeing with the assertion that the weight ranges of avicularin and juglanin are obvious over routine optimization. The applicant supports their disagreement stating that the cited references fail to describe that horse chestnut extracts contain avicularin or juglanin. However, one of skill in the art would have reasonable expectation of success at measuring and manipulating the weight percents of avicularin and juglanin by weighing these components and horse chestnut extract before combining them.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the feature of avicularin and juglanin, at the recited weight ranges, exhibiting significantly greater reduction of TRAP (compared to avicularin and juglanin individually, as implied by context) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The applicant has argued that Kim does not disclose avicularin and juglanin in a horse chestnut extract. However, Kim does disclose treating periodontal disease with a horse chestnut extract that necessarily contains the active ingredient because the applicant’s currently pending claim recites the extract comprising the active ingredients. The applicant has not distinguished the horse chestnut extract disclosed by Kim as having different active ingredients from the instantly claimed composition. One of skill in the art would have been motivated to understand the mechanism of action of the horse chestnut extract disclosed by Kim and identify any compounds as active ingredients necessarily present in the horse chestnut extract, including avicularin and juglanin. Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571) 272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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