DETAILED ACTION
The Examiner is reopening prosecution. Please refer to Pre-Appeal Brief Review mailed 18 July 2025.
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 03/10/2025.
Examiner attempted 3 times to contact attorney on record via telephone. Examiner was not able to reach the attorney or leave a message.
Claims 1, 4-5, 7-9 and 12-16 are currently amended, claim 6 is original and claim 17 is new.
Claims 1, 4-9 and 12-17 are examined in this office action.
Priority
The effective filing date of March 1st, 2019 based on provisional application no. 62/812,850.
Response to Arguments
Examiner acknowledges the receipt of applicants claim amendment and remarks of 11/15/2024.Examiner have reviewed these remarks and amendments.
Regarding 35 USC § 101-rejection: Applicant amended independent claims 1 and 9 by adding language such “pills” or “beads” or “particles, tablets, capsules, lotion, liquid, or gels”
Applicant argues:
The amended claims allow for markedly different characteristics to the judicial exceptions.
Examiners response:
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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. The person of ordinary skill in the art would understand that these structural differences may result in the claimed natural compound to have different characteristic. Formulation in the form of pills, beads or tablet may allow better solubility in physiological solution. Natural compound in the form of lotion and gel may result in better absorption through the skin (Step2A: YES). Hence are the limitations “pills” or “beads” or “tablets, lotion, or gels” are viewed as subject matter eligible.
The claim limitation of “particles, liquid, or 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 “Particles” are considered to be aggregates of the natural compound in claims 1, 4, 9, 12 and 17. “Liquid” is considered to be a natural state of matter does not add significantly more the exception. “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 “particles, liquid, or 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 eligbility rejection, 101 rejection is maintained
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.
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 phenomenona.
Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No. For limitation “particles, liquid, or capsule” and “pharmaceutical formulations” or “salt of” or “pharmaceutically acceptable excipient”. The claim limitation of “particles, liquid, or 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. “Particles” are considered to be aggregates of the natural compound in claims 1, 4, 9, 12 and 17. “Liquid” is considered to be a natural state of matter does not add significantly more to the exception. “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). 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 the art would understand that these structural differences may result in the claimed natural compound to have 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 “particles, liquid, or capsule” and “pharmaceutical formulations” or “salt of” or “pharmaceutically acceptable excipient”: Claim limitation of “particles, liquid, or 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 eligbility rejection, 101 rejection is maintained. Therefore, claims 1, 4, 9, 12 and 17 are not patent eligible subject matter under 35 USC 101.
New Rejection
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 5-8 and 13-16 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Factors to be considered in making the determination as to whether one skilled in the art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include:
(a) Breadth of the claims:
(b) Nature of the invention;
(c) State of the prior art;
(d) Level of one of ordinary skill;
(e) level of predictability art
(f) amount of direction provided by the inventor;
(g) existence of working examples;
(h) and Quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth and nature of the claims and Nature of the Invention
Claims 5-8 and 13-16 are directed to method of treating plurality of bacterial infection comprising of administering compound of claims 1. Claims 6 and 14 lists numerous infections that are difficult to treat and each infections/conditions would require different treatment regimens. For example, septic arthritis requires prolong treatment with oral antibiotics and surgeries whereas blood stream infection would require intravenous administration of antibiotics.
State of the prior art:
The extraction from Castenea sativa plant is known in the prior art (Henry et.al, US 8067044). Henry discloses extracts from Castenea sativa leaves (the extract would be in the form particles of many compounds, including compounds of independent claim 1, 9 and 17, as liquid and/or proteinaceous material (gel)) have antimicrobial and alleopathic activity (Henry et.al. column 1 lines 25-67, published Nov. 29, 2011).
The specification discloses extractions form Castenea plant is used in cosmetic composition for cosmetic treatment. The specification further provides various formulation comprising of extracts of one or more compound of claims 1, 9 and 17 and provides experiments for Quorum quenching assay.
Prior art does not teach the application of extracts from castenea sativa for treating condition recited in claims 6 and 14. There is no evidence in the prior art for the use of extract from Castenea sativa for treating conditions disclosed in claims 6 and 14.
Level of one of ordinary skill
A person of ordinary skill will have to navigate various treatment and diagnosis method for treating infections/conditions stated in claims 6 and 14. For example, treatment of septic arthritis may requires prolong treatment with oral antibiotics and removal of purulent material by arthrocentesis or surgical method. (Horowitz et.al, Am Fam Physician. 2011;84(6):653-660, abstract).
Level of predictability art
A person skilled in the around would not be able to envision treatment of the infections/conditions with the experiments disclosed in the specification (Wands factor (d)) because specification does not provide guidance for method of treatment of conditions with extracts from Castanea Sativa (wand faction (e)). Moreover, treatment of conditions in claims 6 and 14 are unpredictable because no one compound can treat all the infections/conditions (wand factor (e)).
Amount of direction provided by the inventor:
The specification does not disclose a method of treating any bacterial infections. The specification or prior art do not provide guidance for treating infections/conditions of claims 6 and 14 with extracts from Castenea plant (wand factor (g)) and there is no prior art that envision using extracts from Castenea sativa plant for treating infections/conditions of claims 6 and 14. Moreover, treatment of bacterial infections is unpredictable because no one method of treatment can treat all the infections/conditions of claims 6 and 14 (wand factor (e)). For example, toxic shock syndrome is a severe complication associated with invasive infections. Early recognition and multidisciplinary management are key to the care of patients with streptococcal toxic shock syndrome, with intensive and appropriate intensive support of failing organs, rapid diagnosis of infectious source(s), and surgical management (Schmitz, M., Roux, X., Huttner, B. et al. Streptococcal toxic shock syndrome in the intensive care unit. Ann. Intensive Care 8, 88 (2018). https://doi.org/10.1186/s13613-018-0438-y, abstract).
Therefore, method claims 5-8 and 13-16 are rejected for lacking enablement.
Claim Rejections - 35 USC § 102
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 alleopathic 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 dermapharmaceutical (Henry et.al. claims 16 and 20), thus anticipating claims 7 and 15. Henry further disclose 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). 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.
Conclusions
No claims are allowable as written.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625