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 file don 7/03/2023 is acknowledged. Claims 13-25 are currently pending and under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements filed on 10/02/2023 and 8/12/2025 have been considered except where lined through.
Specification
There are multiple uses of a trade name or mark within the specification. For example, the use of the term Protaandim ®, which is a trade name or a mark used in commerce, has been noted in this application. The 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.
Claim Interpretation
Claims 13-24 are drawn to a composition comprising anatabine or a salt thereof. The claims further attempt to limited the composition by reciting an intended use “for treating”, as well as, the daily dose administered of the composition and/or the route of administration. Since the intended use does not appear to limit the structure or content of the composition, the intended use has not been giving any patentable weight consistent with MPEP 2111.02.
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 13-25 are 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) 13-25 do 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 13-25 are directed to a judicial exception (i.e., law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 13-25 recite a compositing or a compound comprising anatabine which read on natural products and as such are directed towards a law of nature and a natural phenomenon. The claimed composition does 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 claimed subject matter encompasses anatabine or a salt thereof and/or a composition comprising anatabine or a salt thereof.
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 describes anatabine or a salt thereof and/or a composition comprising anatabine, wherein according to the specification, anatabine is a minor alkaloid found in plants of the family Solanaceae (page 2 of the specification as originally filed).
Because each compound is naturally occurring 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?
Claims 13-25 recite a compound or composition comprising a natural product in a single formulation. In this case, the combination is compared to the individual components as they occur in their natural state. 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 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 composition.
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) 13-25 is/are rejected under 35 U.S.C. 102a(1) as being anticipated by Williams, Jonnie (US2012/0196899A1, 2012-08-02, IDS) referred to herein as Williams.
Williams teaches compositions and pharmaceutical compositions comprising R-(+)-anatabine useful for treating a variety of diseases including, but not limited to, neurodegenerative diseases such as Alzheimer’s (paragraph 0145). Moreover, the PG Pub teaches that the compositions are administered by numerous routes including, but not limited to, orally, wherein daily doses typically range from about 1 mg/kg to about 7 mg/kg (paragraph 0137 and 0154).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 13-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-24, 27, 29-34 and 36-37 of copending Application No. 17/622,001(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a method of reducing an infestation of ectoparasites comprising applying anatabine including racemic mixtures which falls within the scope of the instantly claimed composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/008,793 (reference application) or claims 1-20 of copending Application No. 18/022,638. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a composition comprising anatabine which falls within the scope of the instantly claimed composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-35 of copending Application No. 18/022,795 (reference application) or claims 16-35 of copending Application 18/022,619. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a method of forming a composition comprising anatabine which falls within the scope of the instantly claimed composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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