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 .
Priority
Instant application 19/034,034 filed on 01/22/2025 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1-13 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/22/2025 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant's election without traverse of Group I in the reply filed on 06/30/2026 is acknowledged.
Claims 4, 8, 9, 12 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/12/2025.
Regarding species election, Applicant's election of the compound of claim 10 in the reply filed on 06/30/2026 is acknowledged.
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It should be noted that Applicant also indicated species of Alzheimer’s disease. However, method claims are currently withdrawn from consideration.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
In the instant, case examiner determined that the elected species would have been obvious over prior art, therefore the search was not extended to additional species.
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.
Claim 7 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitations, for example, “liquid”, and the claim also recites “syrup”. A syrup is inherently a liquid, so syrup defines a specific a liquid and a specific formulation type.
Similarly, the claim recites “transmucosal vehicle” and “nasal spray” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 1-3, 5-7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Appendino (US-9802880-B2).
This rejection applies to the elected species.
Appendino teaches and claims cannabigerol quinone derivatives of formula (I)
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for treating PPARg related diseases (see abstract and claim 17).
Further, Appendino teaches pharmaceutical compositions comprising compounds of formula (I), and a method of treating diseases with said compounds (see abstract).
Specifically, Appendino teaches and claims compound (III) (see claim 2):
Appendino (US-9802880-B2; see claim 2):
Instant elected species:
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It should be noted that compound (III) is a homolog of the instant elected species that differs from the elected species only by a presence of one additional CH2 group in the diene chain (the additional CH2 moiety has been marked above).
However, MPEP 2144.09 states that “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
In the instant case, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare homologs of compound (III) disclosed by Appendino with a reasonable expectation of success.
Appendino teaches and claims that the disclosed compounds are useful for treatments of various PPARg mediated diseases, including cancer and neurodegenerative diseases:
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A skilled artisan would expect that changing the length of the diene chain in compound (III) would result in a homolog with a similar activity and in a retention of PPARg agonistic effect. Therefore, a person of ordinary skill would be motivated to prepare and use the homolog for the same purpose.
It should be noted that the instant specification does not present any experimental data. Applicant may consider presenting comparative data vs. compounds disclosed by Appendino.
Regarding the pharmacological compositions recited in instant claims 2, 3, 6, 7 and 11, Appendino teaches a pharmaceutical composition comprising the disclosed compounds (see claim 14):
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Further, Appendino teaches (see column 13, lines 32-36) tablets:
Furthermore, Appendino teaches syrups (see column 12, lines 8-10):
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Therefore, a skilled artisan would have been motivated to prepare pharmaceutical compositions comprising the elected species and an acceptable pharmaceutical vehicle wherein the pharmaceutically acceptable vehicle is a tablet or a syrup.
Conclusion
No Claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S./Examiner, Art Unit 1621
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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