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 .
Application Status
The preliminary amendment filed on 3/21/2023 is acknowledged. Claims 1-8 are currently pending and under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The effective filing date of the application is 3/18/2021 because applicants have not filed an English translation of the priority document and there is intervening art (see below).
Information Disclosure Statement
The information disclosure statement filed on 4/6/2023 has been considered expect where lined through.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 recites the acronym ODS. It is suggested that applicants first refer to the actual name, octadecylsilane, followed by the acronym in parenthesis. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 6-8 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.
Claim 6 recites a method of use without reciting active steps. As such, it is unclear what applicants are attempting to claim.
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 2-5 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.
It is apparent that Penicillium allii-sativi having an collection number of MCCC 3A00580 is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 USC 112, first paragraph, may be satisfied by a deposit of the biological strain. The process disclosed in the specification (preparation of benziothiazole meroterpenoid compound (page 16, example 1)) does not appear to be repeatable, and it is not apparent if the biological material considered necessary to make and use the invention is both known and readily available to the public. The invention requires the use of this specific material, so it cannot be practiced without the strain. Therefore, a deposit at a recognized depository may be made to obviate this rejection.
It is noted that applicants have indicated where and when the biological material was deposited, but there is not indication in the specification as to public availability.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance or a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
The deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
Provide evidence of the test of the viability of the biological material at the time of deposit (see CFR 1.807)
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim(s) 1 does not recite something significantly different than a judicial exception.
The analysis has been conducted in accordance with the most recent 2014 Interim Guidelines for Subject Matter Eligibility, published by USPTO in the Federal Register on 12/16/2014, http://www.gpo.gov/fdsys/pkg/FR-2014-12-16/pdf/2014-29414.pdf. See information about the Interim Guidelines at http://www.uspto.gov/patents/law/exam/interim_guidance_subject_matter_eligibility.jsp.
Based upon an analysis with respect to the claims as a whole, Claims 1 is directed to a judicial exception (i.e., law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1 recites natural products and as such are directed towards a law of nature and a natural phenomenon. The claimed compounds do not have markedly different characteristics from what occurs in nature, and are a “product of nature” exception. Further, the claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exceptions.
The rationale for this determination is explained below:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
The elected subject matter, within the scope of the instant claims is construed as a benzothiazole meroterpenoid.
So the answer to Step 1 is: Yes, the claims are drawn to a composition of matter.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea?
The claimed subject matter is a compound.
Because each compound is prepared by fermenting Penicillium allii-sativi (see claim 2), the compounds are considered a “product of nature,” which falls within each of the categories: “laws of nature” and “natural phenomena”. Thus, the claims are drawn to judicially recognized exceptions. See p74623, left column, of the Federal Registry notice: …Courts have held that naturally occurring products and some man-made products that are essentially no different from a naturally occurring product are ‘‘products of nature’’ that fall under the laws of nature or natural phenomena exception. (Section I (3); pp. 74622-4, of the Federal Registry notice discusses Natural Products.).
The next question within step 2A is: does the nature based product show “markedly different characteristics” from any naturally occurring counterpart(s) in their natural state, based on structure, function and/or properties?
Claim 1recites a benzothiazole meroterpenoid compounds which appear to be natural products.
See p. 74623 of the Federal registry notice, middle column:
“The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. When there is no naturally occurring counterpart to the nature based product, the comparison should be made to the closest naturally occurring counterpart. In the case of a nature-based combination, the closest counterpart may be the individual nature-based components that form the combination, i.e., the characteristics of the claimed nature-based combination are compared to the characteristics of the components in their natural state”.
Establishment of a marked difference cannot be based on some inherent or innate characteristic of the naturally occurring counterpart. See p. 74623, footnote 28:
“To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (‘‘[The inventor did] not create a state of inhibition or of non-inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not patentable.’’); In re Marden, 47 F.2d 958 (CCPA 1931) (eligibility of a claim to ductile vanadium held ineligible, because the ‘‘ductility or malleability of vanadium is . . . one of its inherent characteristics and not a characteristic given to it by virtue of a new combination with other materials or which characteristic is brought about by some chemical reaction or agency which changes its inherent characteristics’’). Further, a difference in a characteristic that came about or was produced independently of any effort or influence by applicant cannot show a marked difference. Roslin, 750 F.3d at 1338 (Because ‘‘any phenotypic differences came about or were produced ‘quite independently of any effort of the patentee’ ’’ and were ‘‘uninfluenced by Roslin’s efforts’’, they ‘‘do not confer eligibility on their claimed subject matter’’ (quoting Funk Bros.)).
In the instant case, there seems to be no indication in the specification that the combination of all of the above natural products has any characteristics (structural, functional or other properties) that are different from the naturally occurring compounds, individually.
Thus the composition does not have markedly different characteristics from what occurs in nature, and is a “product of nature exception”.
So the answer to Step 2A is: Yes, the claims are drawn to a natural compound.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exemption?
The claims have no additional elements. Because the claim does not include any additional features that could add “significant more” to the exception the answer to Step B is: No, the claims do not recite additional elements that amount significantly more than the judicial exception.
The claims do not qualify as eligible subject matter, and are properly rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (CN109942658A, 2019-06-28, IDS, English translation attached).
Yang et al. teach a method of preparing meroterpenoid compounds comprising culturing Penicillium allii-sativi having a preservation number of MCCC 3A00589 for 3 days at 25 degrees centigrade on the PDA flat plate. Then the fresh mycelium is inoculated in to 50 triangular flask of 1 L at 28 degrees centigrade under static culture, in each bottle with 80g of rice and 120mL of distilled water, culturing for 30 days to obtain a fermentation product. The fermentation product was extracted with ethyl acetate three times and isolating and purifying the resulting extract (See preparing meroterpenoid compounds section). While the prior art does not specifically teach that the claimed benzothiazole meroterpenoid is obtained, the preparation taught in the prior art appears to be identical to the process steps claimed in claim 2.
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 2 and 4-5 is/are rejected under 35 U.S.C. 103 as being obvious over Xie et al. (Bioorganic Chemistry (2021), 108, 104671, published online 2021-01-27) in view of Yang et al. (CN109942658A, 2019-06-28, IDS, English translation attached).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) 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 thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Xie et al. teach the discovery of andrastones from the deep-sea-derived Penicillium allii-sativi MCCC 3A00589 (title). In particular, Xie et al. teach a large scale fermentation of Penicillium allii sativi was carried out in 1L Erlenmyer flasks each containing oats (80g) and tap water (3% marine salt), wherein after incubating for 30days, the fermented broth was extracted with EtOAc three times to give a crude extract and purifying the resulting extract (Section 2.2).
Xie et al. do not teach culturing the penicillium to form a mycelium prior to the fermentation.
Yang et al. teach a method of preparing meroterpenoid compounds comprising culturing Penicillium allii-sativi having a preservation number of MCCC 3A00589 for 3 days at 25 degrees centigrade on the PDA flat plate. Then the fresh mycelium is inoculated in to 50 triangular flask of 1 L at 28 degrees centigrade under static culture, in each bottle with 80g of rice and 120mL of distilled water, culturing for 30 days to obtain a fermentation product. The fermentation product was extracted with ethyl acetate three times and isolating and purifying the resulting extract (See preparing meroterpenoid compounds section).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Xie et al. to include an initial culturing in view of the teachings of Yang et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Yang et al. teaches preparing meroterpenoid compounds comprising culturing Penicillium allii-sativi having a preservation number of MCCC 3A00589 for 3 days at 25 degrees centigrade on the PDA flat plate. Then the fresh mycelium is inoculated in to 50 triangular flask of 1 L at 28 degrees centigrade under static culture
Conclusion
Therefore, No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626