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 .
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.
Current Status of 17/435,594
This Office Action is in response to the amended claims of 05/28/2026.
Claims 1, 5, 9, 13 and 17 are currently amended, claim 6 and 14 are original; 4, 7-8, 12 and 15-16 were previously amended.
Claims 1, 4-9 and 12-17 are examined in this office action.
Examiner has withdrawn 112 scope of enablement rejection.
Examiner has maintained 101 and 102 rejections.
New 112 rejection is made due to applicant’s amendments to the claim.
Priority
The effective filing date of March 1st, 2019 is based on provisional application no. 62/812,850.
Response to Arguments
Examiner acknowledges the receipt of applicants’ claim amendment and remarks of 05/28/2026. Examiner have reviewed these remarks and amendments.
Regarding 35 USC § 101-rejection: Applicant amended independent claims 1 and 9 by adding “wherein the isolated compound is isolated from a Castanea plant and is substantially free from other compounds from the Castanea plant” and deleted “liquid” and “particles” from the claims.
Applicant argues:
Some of the amendments to the claims allow for markedly different characteristics to the judicial exceptions. See explanation, below.
Examiner’s response:
The amended claims allow for markedly different characteristics from any found in nature for the limitations: “pills” or “beads” or “tablets, lotion, or gels”. The claimed formulation of compound
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in the form of “pills” or “beads” or “tablets, lotion, or gels” has particular structural/physical characteristics that are different from the naturally occurring
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. The person of ordinary skill in art would understand that these structural differences may result in the claimed natural compound having different characteristics. Formulation in the form of pills, beads or tablets may allow better solubility in physiological solutions. Natural compounds in the form of lotion and gel may result in better absorption through the skin (Step2A: YES). Hence the limitations “pills” or “beads” or “tablets, lotion, or gels” are viewed as subject matter eligible.
However, the claim limitations: “capsule” and “pharmaceutical formulations” or “salt of” or “pharmaceutically acceptable excipient” are added to claims 1, 4, 9, 12 and 17 are not markedly different characteristics from any found in nature. “Capsule” is considered to be a vehicle or container thus does not alter the natural state of the compound. Similarly, language such as “pharmaceutical formulations” or “salt of” or “pharmaceutically acceptable excipient” do not change characteristic of the compound and are found in nature (Step 2A: NO). Therefore, claim limitation of “capsule” and “pharmaceutical formulations” or “salt of” or “pharmaceutically acceptable excipient” do not include additional features that could add significantly more to the exception (Step 2B: NO).
Since these are drafting language which do not remedy the basis of the subject matter eligibility rejection, 101 rejection is maintained. At the minimum, Examiner recommends deleting “capsule” from claims 1 and 9.
Regarding 112 rejections, applicant amended claims 5 and 13 for treating “Staphylococcus aureus” bacterial infection. Applicant further deleted “preventing” from the claims. This narrowed the claims to one specific bacterial infection. Support for the amended claims is found on page 9-14. This renders moot the enablement rejection on record.
Regarding 102 rejection, applicant amended claims 1 and 9 by reciting “wherein the isolated compound is isolated from a Castanea plant and is substantially free from other compounds from the Castanea plant”. Applicant further amended claim 17 to recite “wherein the isolated compound is isolated from a Castanea plant, and wherein the pharmaceutical composition does not comprise any one of chlorogenic acid, ellagic acid, hyperoside, isoquercitrin, or rutin”.
Applicant argues
The method of extractions as stated in Henry et. al. is significantly different from the instant extraction method thus the compositions of the extractions cannot be considered the same.
Examiner’s Response
Applicant’s amendments to the claim does not change the scope of the rejections, because the pharmaceutical formulation comprises of other substance other than isolated hydroperoxy-cycloartane. The phrase “substantially free” does not translate to free from other compounds from the Castanea plant”. Furthermore amendments to claims 1, 9 and 17 constitute new matter. The specification does not support applicant assertion hydroperoxy-cycloartane is free from other compounds from castanea plant (claims 1 and 9) or composition does not comprise any one of chlorogenic acid, ellagic acid, hyperoside, isoquercitrin, or rutin” (claim 17).
The claims are directed to pharmaceutical formulation. The claims are not directed at the method of extraction. Therefore, applicant argument of the composition of instant claims is different from that of Henry et.al is considered to be attorney opinion and is not relevant to overcoming the anticipatory prior art rejection of record. Furthermore, the specification does not disclose composition to exclude compounds present in the extracts from Castanea plant or pharmaceutical composition does not comprise any one of chlorogenic acid, ellagic acid, hyperoside, isoquercitrin, or rutin.
Therefore 102 rejection is maintained.
Claim Rejections - 35 USC § 101(maintained)
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.
11. Claims 1, 4, 9, 12, and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product/phenomenon without significantly more. The claims recite a composition comprising a naturally-occurring compound found in the leaf of Castanea sativa Mill disclosed by Quave et.al (Frontiers in Pharmacology, June 2021, Volume 12, Article 640179, page 2, Material and Method section).
Step 1: Is the claim directed to a process, machine, manufacture, or composition of matter?
Yes, the claims 1, 4, 9, 12 and 17 are directed to pharmaceutical compositions which are compositions-of-matter claims.
Revised Step 2A:
Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claims 1, 4, 9, 12 and 17 are directed to a pharmaceutical composition comprising the compound:
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, which reference Quava (page 7, figure 1) describes as being a component compound extracted from the leaf of Castanea sativa Mill. (Quave et.al, page 2, Material and Method Section). Thus, the compounds of claims 1, 4, 9, 12 and 17 are interpreted as being naturally occurring/natural phenomenon (and hence a judicial exception (“JE”)). Any composition, such as the pharmaceutical composition of claims 1, 4, 9, 12 and 17 are also viewed as being naturally occurring/natural phenomena. As such, these claims are drawn to a judicial exception (JE)/naturally occurring phenomenon.
Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No. For limitation “capsule” and “pharmaceutical formulations” or “salt of” or “pharmaceutically acceptable excipient”. The claim limitation of “capsule” and “pharmaceutical formulations” or “salt of” or “pharmaceutically acceptable excipient” are added to claims 1, 4, 9, 12 and 17 are not markedly different characteristics from any found in nature. “Capsule” is considered to be a vehicle or container thus does not alter the natural state of the compound.
Similarly, language such as “pharmaceutical formulations” or “salt of” or “pharmaceutically acceptable excipient” of claim do not change characteristic of the compound and are found in nature (Step 2A: NO). See MPEP 2106.05(g).
Yes. For limitation with pills” or “beads” or “tablets, lotion, or gels”: The amended claims allow for markedly different characteristics from any found in nature for the limitation “pills” or “beads” or “tablets, lotion, or gels”. The claimed formulation of compound
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in the form of “pills” or “beads” or “tablets, lotion, or gels” has particular structural/physical characteristics that are different from the naturally occurring
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. “Pills”, “beads”, “tablets, lotion, or gels” are not naturally occurring therefore compound
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in form of “pill”, “beads”, “tablets”, lotion or gels will have markedly different characteristics from any found in nature.
The person of ordinary skill in art would understand that these structural differences may result in the claimed natural compound having different characteristic. Formulation in the form of pills, beads or tablet may allow better solubility in physiological condition. Formulation in the form of lotion or gel may result in better absorption through the skin or ease of application (Step2A: YES).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. For limitation and “pharmaceutical formulations” or “salt of” or “pharmaceutically acceptable excipient”: Claim limitation of “capsule” and “pharmaceutical formulations” or “salt of” or “pharmaceutically acceptable excipient” do not include additional features that could add significantly more to the exception (Step 2B: NO)
Since these are drafting languages which do not remedy the basis of the subject matter eligibility rejection, 101 rejection is maintained. Therefore, claims 1, 4, 9, 12 and 17 are not patent eligible subject matter under 35 USC 101.
Applicant can overcome 101 rejections against claims 1 and 9 by deleting “capsule” from claims 1 and 9.
Claim Rejections - 35 USC § 102 (maintained)
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-5, 7-9, 12-13, and 15-17 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Henry et.al (US 8067044) with evidentiary reference of Quave et. al . (Frontiers in Pharmacology, June 2021, Volume 12, Article 640179)
Henry et.al teaches the plant Castanea sativa is known as of published date of Nov. 29, 2011. Henry also teaches the extracts (extract would be in the form particles of many compounds, including compounds of independent claim 1, 9 and 17, liquid, proteinaceous material (gel) form) from leaves of the Castanea sativa have antimicrobial and allopathic activity (Henry et.al. column 1 lines 25-67, published Nov. 29, 2011), examiner interpret this as pharmaceutical composition comprising of antibiotic agent, anticipating claims 4, 8, 12-13 and 16. Henry et.al teaches the extract from castanea sativia can further contain additives for cosmetic and/or pharmaceutical purpose (column 4, lines 12-21), thus examiner interpret this as pharmaceutical excipient same as instant claims 1, 9 and 17. Henry et.al. further discloses a method of treatment with extract of Castanea Sativa by topical application (contact with skin) in derma pharmaceutical (Henry et.al. claims 16 and 20), thus anticipating claims 7 and 15. Henry further discloses use of extract of castanea sativa against gram positive and gram-negative bacteria (column 1 line 49-55) thus anticipating claim 5. Quave et. al discloses compounds
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of claims 1, 9 and 17 extracted from leave of Castanea sativa (page 7, Figure 1).
Henry is silent on the component of extract from Castanea Sativa, therefore using BRI, the extract from Castanea Sativa in prior art of Henry is considered to be substantially free of other component of Castanea Sativa (claims 1 and 9) the pharmaceutical composition does not comprise any one of chlorogenic acid, ellagic acid, hyperoside, isoquercitrin, or rutin (claims 17) . Therefore, Quave is relied upon for the beneficial teaching that the above illustrated compounds are part of the plant/leaves taught by Henry et. al, which anticipates claims 1,4-5, 7-9, 12-13, and 15-17.
Response to Amendment
Claim Rejections - 35 USC § 112
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, 4-9 and 12-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claims 1 and 9 recites “wherein the isolated compound is isolated from a Castanea plant and is substantially free from other compounds from the Castanea plant”; claim 17 recites “wherein the isolated compound is isolated from a Castanea plant, and wherein the pharmaceutical composition does not comprise any one of chlorogenic acid, ellagic acid, hyperoside, isoquercitrin, or rutin” ; in newly added by Applicants’ claim amendments. The full scope of these amendments do not have written description support in the original disclosure and thus constitutes new matter.
MPEP § 2163 states that, “[n]ew or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389,1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).” Further, the MPEP states, “[w]hile there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure.”
The specification does not provide description of composition to be substantially free of other component of Castanea Sativa (claims 1 and 9) or the absence of any one of chlorogenic acid, ellagic acid, hyperoside, isoquercitrin, or rutin (claims 17) in the formulation.
Thus, claims 1, 9 and 17 are rejected as lacking written description. Furthermore, claims 4-9 and 12-16 are similarly rejected as these claims refer to claim 1 and/or 9 but do not remedy the rationale underpinning the basis for rejections of claims 1 and 9.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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.
Claims 1, 4-9 and 12-17 are 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.
Claims 1 and 9 are rejected for reciting the term “substantially”. The term “substantially” is a relative term which renders these claims indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As drafted, the term “substantially” renders the metes and bounds of independent claims 1 and 9 undefined since the artisan has no idea by which objective standard “substantially” should be measured (since neither the claims nor Specification provide an objective standard or definition of “substantially”). Thus
Claims 4-9 and 12-16 are also rejected as indefinite because they refer back to claim 1 and 9 but do not remedy the bases for the rejection.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Conclusion
No claims are allowable as written.
Applicant's amendment necessitated the 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.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
