DETAILED ACTION
In view of the Appeal Brief filed on 06/15/2026, PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/Andrew D Kosar/ Supervisory Patent Examiner, Art Unit 1625
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 1-8, 22-24 and 25 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 subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 and claim 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being vague and indefinite and incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01.
The omitted elements are: structural identity of starting materials, reagents, intermediates and products as explained below.
The structural make-up of the starting material, recited with its function, is unclear. The phrase ‘COX-2 inhibitor’ is a generic term used for any molecule (singular) that is an inhibitor of the enzyme cyclooxygenase-2, hitherto known and unknown, such that the metes and bounds of the claim is unclear.
There is no definition in the specification of what this phrase means. Examples are not explicit definition. It is one of commonsense that nonsteroidal anti-inflammatory drugs (NSAIDs) bind to and inhibit both COX-1 and COX-2 enzymes, for example NSAIDS ibuprofen and naproxen block both types equally or with minor preference. See more on this in the context of limitations of claim 22. As such the metes and bounds of the (starting material in) base claim 1 is unclear.
The lack of clarity with regards to the chemical structure renders claim interpretation thorny because, the first bond forming step requires that the COX-2 inhibitor has a functional group that is nucleophilic so as to remove the chlorine from the amino protected aminoalkyl chloroformate. The most common nucleophilic functional groups are OH containing alcohols, phenol or primary and secondary amino group containing amines or SH containing thiols, and occasionally carboxylates, which means the COX-2 inhibitor has to have one or more of these functionalities. That said, some of the COX-2 inhibitors contemplated do not have any of these nucleophilic functionalities; such as Nabumetone (see dependent claim 22). More on this later.
As if to address such problems of the base claim, dependent claims 4-6 suggest additional essential chemical steps. For example, dependent claim 6 recites further chemistry for generating an intermediate that could be useful to generate the ‘nucleophile’.
The term ‘primary’ in claim 1 is interpreted to mean ‘first’.
Claim language
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is confusing and does not set forth the metes and bounds of starting materials and intermediates of the claimed process as explained below.
With respect to the term ‘including’:
According to MPEP 2111.03 Transitional Phrases [R-01.2024], the transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. This open-ended comprising language, renders the scope of the claim 1 indefinite. “Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising" leaves "the claim open for the inclusion of unspecified ingredients even in major amounts").
On top of this, with respect to the phrase
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:
It is unclear the above phrase means,
because,
there is no compound that has ‘chloroformate’ group that could be considered as cannabinoid. There is nothing in the specification to support such a possibility. If the intended intermediate is a compound that is a derivative of a cannabinoid that contains chloroformate functionality, the claim needs to recite as such.
Further, according to Ruhaak ( "Evaluation of the Cyclooxygenase Inhibiting Effects of Six Major Cannabinoids Isolated from Cannabis sativa",
BIOLOGICAL AND PHARMACEUTICAL BULLETIN, vol. 34, no. 5, 2011, pages 774-778), cannabinoids are cox-2 inhibitors. This raises additional 112-2 problem of ‘section within claim’ issue.
Such broadest interpretation of claim limitations of the starting materials and intermediates renders the boundaries of unclear. Again the issue is not ‘breadth’ rather ‘clarity’.
Consider dependent claim 22 which depends on claim 1:
The listed compounds have degrees of
That the cox-2 inhibitor nabumetone which has the structure
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can be conjugated to cannabinoid using the method steps of claim 1 is incomprehensible,
because
there is no nucleophile present in this ‘cox-2’ inhibitor for reacting the aminoalkyl chloroformate with a COX-2 inhibitor
That Examiner has to interpret claim 1 and 22 by ‘reaching through’ to the limitations of claim 6, just does not make much sense and needs support from MPEP.
Further, as per the teachings of Matsumoto Xenobiotica (2021), 51(2), 155-166, page 3, column A, section under Discussion, the active metabolite of nabumetone is 6-MNA, 6-methoxy-2-naphthylacetic acid, which has the methoxy group. That is for the claim term ‘conjugate’ (of nabumetone) to be interpreted properly, the conjugate needs to have the structural elements of the cox-2 inhibitor that actually does the biochemical inhibition. There is nothing in the specification to suggest that the compound with hydroxy group is a cox-2 inhibitor. (Since the pharmaceutical utility of drug-conjugates, is fundamentally based on the controlled release of the active drug payload once the conjugate reaches its intended target site, what medical condition is contemplated here for nabumetone derived conjugate is unclear).
Claim 22 is rife with such many chemical/biological fallacies and logical inconsistencies for interpretation. Similar problems are present in limitations of claim 24 formula (IV-b). Here, the moiety conjugated to COX2 inhibitor is not a cannabinoid at all. As such claim 24 lacks antecedent basis. In the alternate, this claim 24 is a ‘reach through claim’ as it requires essential chemistry steps of deoxygenation of the cannabinoid Cannabigerol.
Such considerations of chemistry (and biology) creates a situation akin to ‘impossible substituent’ in claims with listed alternative molecules, functional groups, or structural variations that are chemically impossible, nonsensical, or incapable of being synthesized. As per Examination guidelines such claims can properly be rejected under 35 USC 112 paragraph 1 or 2. A compound with an impossible substituent clearly cannot be made, and hence a paragraph1 rejection is proper. Applicant is reminded of the following though relevant in the not-made 112-1 enablement rejection, MPEP 2166 R [R-10.2019]
"patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" is a famous quote from the landmark Federal Circuit case Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997)
Dependent claims do not resolve all the problems of the base claim. As such all claims are rejected.
Response to Applicants Remarks in papers filed 06/15/2026. Applicant Remarks reiterate that ‘breadth is not indefinite’. The Remarks also focus on the knowledge of one of skill in the art with respect to what (the structure of) cox-2 inhibitor, intermediate, chloroformate etc. in the context of the disclosure in the specifications, further explained in the affidavit. Applicants arguments are considered and specifically responded to in the reformatted rejection above, supported by prior art citations (not ‘assertions’).
The affidavit full of speculations
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‘believe’, ‘opinion’, ‘could be’, ‘would be’ and ‘should be’ not supported by citations would not be persuasive to this Examiner. It is also interesting to note that the recurring utterances of
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language in the affidavit is not signed by any of the inventors of record.
In short, a comprehensive patent search cannot be done with the claims as recited.
Note that the claims are interpreted in light of the specification, however limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The significance of process parameters such as starting materials, reagents and intermediates (in the claims) is also evidenced by the following at pages 26-27 in the specification.
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In re Zletz, 13 USPQ2d 1320, 1322. “An essential purpose of patent examination is to fashion claims that are precise, clear, correct and unambiguous.”
This is consistent with MPEP 2173 Claims Must Particularly Point Out and Distinctly Claim the Invention [R-10.2019]
Optimizing patent quality by providing clear notice to the public of the boundaries of the inventive subject matter protected by a patent grant fosters innovation and competitiveness. Accordingly, providing high quality patents is one of the agency’s guiding principles. The Office recognizes that issuing patents with clear and definite claim language is a key component to enhancing the quality of patents and raising confidence in the patent process.
The following references (found in WO2023150057 which is document corresponding to the instant applications) are not relied upon, considered pertinent to applicant's disclosure and are not included.
WO 2019/159168 A1 (BEETLEBUNG PHARMA LTD [IL]) 22 August 2019 (2019-08-22)
WO 2021/076197 A1 (DIVERSE BIOTECH INC [US]) 22 April 2021 (2021-04-22)
WEINER B-Z ET AL: "Monomers and polymers of delta 1(6)-tetrahydrocannabinol and cannabidiol",
EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY, vol. 10, no. 1, 1975, pages 79-83, XP009109254, ISSN: 0223-5234
WO 2021/243467 A1 (LONDON PHARMACEUTICALS AND RES CORPORATION [CA]) 9 December 2021 (2021-12-09)
US 2011/052694 A1 (STINCHCOMB AUDRA LYNN [US] ET AL) 3 March 2011 ( 2011-03-03)
TAKEDA SHUSO ET AL: "Cannabidiol Acid as a Selective Cyclooxygenase-2 Inhibitory Component in Cannabis",
DRUG METABOLISM AND DISPOSITION, vol. 36, no. 9, 12 June 2008
(2008-06-12), pages 1917-1921, XP055899537, ISSN: 0090-9556, DOI: 10.1124/dmd.108.020909
CASTILLO A ET AL: "The neuroprotective effect of cannabidiol in an in vitro model of newborn hypoxic-ischemic brain damage in mice is mediated by CB"2 and adenosine receptors",
NEUROBIOLOGY OF DISEASE, vol. 37, no. 2, February 2010 (2010-02),
pages 434-440, XP026822437, ISSN: 0969-9961 [retrieved on 2009-11-06]
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 1-8, 22-24 and 25 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 19555053 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant base claims 1 and 25 and that of the conflicting claims of 19555053 have the genus (instant)- species (conflicting) relationship as shown seen below:
Claim 1 of 19555053:
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wherein Formula (II) is the same Formula (II) of instant dependent claim 24.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
Prosecution Insights