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 the amendment filed on February 11th, 2026. Claims 1-5 are currently pending and are under examination.
Any objections or rejections not reiterated below are hereby withdrawn.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application, filed on December 28, 2023. The priority document does not disclose the method currently claimed with reference to a 80% ethanol solvent to extract proanthocyanidin compounds from pine bark of Pinus roxburghii using the time frame of 100-140 minutes as currently claimed. The priority date is the instant filing date of November 21, 2023.
Withdrawal of Rejections
The rejections of claims 3 and 5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite are withdrawn based on applicant’s amendment to further clarify the method to extract proanthocyanidin compounds.
The rejection of Claim 5 under 35 U.S.C. 103 as being unpatentable over Singh et al. (J. Indian Chem. Soc. 2022, 99 (2), 100325.) in view of Phil et al. (KR 20070103213 A, 2007), Hellström and Mattila (J. Agric. Food Chem. 2008, 5 (17), 7617–7624), and Seewald (M.S. Thesis, UBC, 1998) as applied to claims 1, 2, and 4, and in further in view of Suzuki et al. (US 6,372,266 B1) (to address the limitations of claim 5) is withdrawn based on the remarks filed on February 11th, 2026 and reconsideration of Suzuki not disclosing preparation of a pine bark extract by the instantly disclosed process and analysis of the extract by HPLC. Applicant’s arguments, see page 14 lines 3-7, filed February 11th, 2026, with respect to claim 5 have been fully considered and are persuasive.
Information Disclosure Statement
The information disclosure statement filed November 21st, 2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because of certain illegible text and figures in the included copy of Singh, S. C. et al. Journal of the Indian Chemical Society 2022, 99, 100325. It has been placed in the application file, but the information referred to therein 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).
A legible copy of Singh et al. has been provided by the examiner and cited on the PTO-892 form.
Claim Objections
Claim 1 is objected to because of the following informalities:
step v) should be corrected to say "processing said obtained third residue ..." per the method steps disclosed in the instant specification (paragraph [0017]);
the applicant recites "adding 80% ethanol and RO (Reverse Osmosis) water" (step ii); if the RO water comprises the other 20% of the 80% ethanol, i.e. the applicant recites adding a single solvent mixture, then for clarity the applicant should recite 80% ethanol/20% RO (Reverse Osmosis) water.
Appropriate correction is required.
Response to Arguments
Pending Rejections
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5 are rejected under 35 U.S.C. 112(a) because the specification, while being
enabling for a method for the extraction and obtaining of compounds from the pine bark of
Pinus roxburghii comprising a mixture of components (see, for example, Figures 2-9 and
Tables 4-12), does not reasonably provide enablement for extracting any proanthocyanidin
compounds of pine bark of Pinus roxburghii. The specification does not enable any person
skilled in the art to which it pertains, or with which it is most nearly connected, to use the
invention commensurate in scope with these claims.
The rejection was explained in the office action mailed on November 13, 2025. Applicant respectfully submits that one of ordinary skill in the art would readily understand how to make and/or use the full scope of the claimed invention without undue experimentation, including extracting proanthocyanidins from Pinus roxburghii pine bark using the expressly disclosed sequential hydroalcoholic extraction steps and verifying proanthocyanidins content using the expressly disclosed HPLC methodology.
Applicant states support for each of the steps of preparing the instantly claimed composition and analyzing the instantly claimed composition for proanthocyanidins content (instant claim 1) in cited paragraphs of the instant specification (see pages 7-10 of Remarks filed February 11th, 2026).
Applicant's arguments filed February 11th, 2026 have been fully considered but they are not persuasive. The applicant has not provided evidence that the disclosed process extracts proanthocyanidins from pine bark of Pinus roxburghii, commensurate with the claims 1-5. Although the applicant has provided procedural guidance for obtaining and analyzing HPLC data, the data disclosed only demonstrates the presence of gallic acid, protocatechuic acid, catechin, and taxifolin (instant specification, Tables 4-12), none of which satisfy the structural requirements to be classified as proanthocyanidins, recited below:
"Proanthocyanidins are present in flowers, nuts, fruits, bark, and seeds of various plants, as a defense against biotic and abiotic stressors. … They are oligomeric and polymeric products of the flavonoid biosynthetic pathway. The building blocks of proanthocyanidins include catechin and epicatechin. … Proanthocyanidin degree of polymerization can range between 3 and 11. In these polymeric flavan-3-ols, the elementary units are linked by C—C and occasionally C—O—C bonds" (Rauf et al., Biomedicine & Pharmacotherapy 2019, 116, 108999, Introduction, paragraph 2).
Gallic acid, protocatechuic acid, catechin, and taxifolin are not polymeric flavan-3-ols having a degree of polymerization between 3 and 11; therefore, they are not proanthocyanidins. Therefore, the statement "After production of Pine bark extract (Pinorox®) from Pinus roxburghii, proanthocyanidins content in Pine bark Extract (obtained from Pinus roxburghii) was found to be ≥80% by HPLC" (instant specification, paragraph [0019]) lacks necessary supporting evidence in the instant disclosure. The instant disclosure does not recite evidence demonstrating the specific detection of proanthocyanidins in the product of the disclosed process. Therefore, there is insufficient support for the enablement of the disclosed process extracting proanthocyanidins from pine bark of Pinus roxburghii, commensurate with the claims 1-5.
The rejection of claims 1-5 under 35 U.S.C. 112 (a) is maintained.
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.
I. Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (J. Indian Chem. Soc. 2022, 99 (2), 100325. doi: 10.1016/j.jics.2021.100325) in view of Phil et al. (KR 20070103213 A, 2007) and Hellström and Mattila (J. Agric. Food Chem. 2008, 5 (17), 7617–7624. doi: 10.1021/jf801336s).
Applicant's arguments filed February 11th, 2026 have been fully considered but they are not persuasive. Singh .
Applicant has provided a submission in this file that the claimed invention and the subject matter disclosed in the prior art reference were owned by, or subject to an obligation of assignment to, the same entity as the inventive entity comprising Shashi Chandrama Singh, Kul Baskar Singh, and Harshpal Singh, not later than the effective filing date of the claimed invention, or the subject matter disclosed in the prior art reference was developed and the claimed invention was made by, or on behalf of one or more parties to a joint research agreement not later than the effective filing date of the claimed invention. However, although subject matter disclosed in the reference Singh et al. has been excepted as prior art under 35 U.S.C. 102(a)(2), it is still applicable as prior art under 35 U.S.C. 102(a)(1) that cannot be excepted under 35 U.S.C. 102(b)(2)(C).
Applicant may overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore, not prior art as set forth in 35 U.S.C. 102(b)(1)(A). Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
The applicant has not supported their assertion that even if Singh were properly considered prior art nowhere does Singh teach or suggest the noted features of amended claim 1.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's arguments that the Office Action's proposed combination would require selecting isolated features from references directed to different extraction paradigms and different analytical objectives, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that Phil and are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the references are .
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 understood that aqueous ethanol is an amphiphilic solvent like the 50% methanol recited by Singh, so both solvents would have reasonable success dissolving amphiphilic compounds such as proanthocyanidins. One of skill in the art would have been motivated to try aqueous ethanol as an alternative to 50% methanol to experimentally optimize the extraction procedure by testing known alternatives. Regarding HPLC analysis of proanthocyanidins content, one of skill in the art would understand that there is a reasonable expectation of success at detecting proanthocyanidins in a mixture using HPLC (Hellström, Proanthocyanidins in the Samples, paragraphs 1 and 2), and had teaching to apply this technique to determine proanthocyanidins in a mixture (Hellström, Materials and Methods).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The examiner’s obviousness analysis over Singh, Phil, and Hellström relies only upon knowledge which was within the level of ordinary skill at the time the claimed invention was made, from the teachings of the cited references, and general knowledge of solvent-solute interactions within the level of ordinary skill in the art.
The rejection of claims 1 and 4 under 35 U.S.C. 103 is maintained.
II. Claims 1, 3, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (J. Indian Chem. Soc. 2022, 99 (2), 100325.) in view of Hellström and Mattila (J. Agric. Food Chem. 2008, 5 (17), 7617–7624), and Phil et al. (KR 20070103213 A, 2007) as applied to claims 1 and 4 above, and further in view of Sarma et al. (J. Nat. Prod. 2020, 83 (4), 1334–1351; doi: 10.1021/acs.jnatprod. 9b01200) and Ferrari et al. (US 20110046215 A1).
Applicant's arguments filed February 11th, 2026 have been fully considered but they are not persuasive. The applicant has.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's arguments that the Office Action's proposed combination would require selecting isolated features from references directed to different extraction paradigms and different analytical objectives, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that Sarma and Ferrari are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the references are .
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, as of record above.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, the examiner’s obviousness analysis relies only upon knowledge which was within the level of ordinary skill at the time the claimed invention was made, from the teachings of the cited references.
The rejection of claims 1, 3, and 4 under 35 U.S.C. 103 is maintained.
III. Claims 1, 2, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (J. Indian Chem. Soc. 2022, 99 (2), 100325.) in view of Hellström and Mattila (J. Agric. Food Chem. 2008, 5 (17), 7617–7624), and Phil et al. (KR 20070103213 A, 2007) as applied to claims 1 and 4 above, and in further view of Hellström and Mattila (J. Agric. Food Chem. 2008, 5 (17), 7617–7624) and Seewald (The quantification of oligomeric proanthocyanidins in the inner and outer barks of selected B.C. conifers. M.S. Thesis, UBC, 1998).
Applicant's arguments filed February 11th, 2026 have been fully considered but they are not persuasive. The applicant has summarized differences between the teachings of Hellström.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's arguments that the Office Action's proposed combination would require selecting isolated features from references directed to different extraction paradigms and different analytical objectives, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that H are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the references are .
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, in the preparation of an extract comprising proanthocyanidins, as taught by Singh, one of skill in the art would have been motivated to select pine bark material with more extractable (and therefore more soluble) proanthocyanidin content. One would have had a reasonable expectation of success at doing so by selecting the inner pine bark (Hellström, Proanthocyanidins in the Samples, paragraph 6; Seewald, p. 100, under heading 4.4 Comparison Between Inner and Outer Barks).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, the examiner’s obviousness analysis relies only upon knowledge which was within the level of ordinary skill at the time the claimed invention was made, from the teachings of the cited references.
The rejection of claims 1, 2, and 4 under 35 U.S.C. 103 is maintained.
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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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655