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 .
DETAILED ACTION
Claims 6-9, 11-12, 27, 29-35, 39-44, 64-65, 75, 78, and 81-95 are currently pending in the application.
Priority
Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119(a)-(d) for foreign priority based on an application filed in England on 08/04/2022, which papers have been placed of record in the file.
IDS
The information disclosure statement (IDS) submitted 06/06/25, 08/12/25, 08/19/25, 01/02/26, and 02/03/26 are acknowledged and have been entered. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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 was pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicant(s) regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 33, 35, 44, 64-65, 91, and 93-94 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Specifically, the aforementioned claims recite the term “substantially” which is a term of degree and thus a relative term. Since no definition is proffered and the specification failed to provide a standard to measure a thermogram or XRPD spectrum, the examiner contends that the metes and bounds of the claims are not clearly defined.
Consequently, it is unclear to what extent those spectrum needs to be similar as shown in the figures. As a result, the examiner contends that all spectrums or thermograms recited in the claims need be similar to the ones shown in the figures.
As a result of the above inconsistencies, the aforementioned claims are unable to be examined as disclosed given that the scope of the claimed subject matter would not be able to be determined by one of ordinary skill in the art. For the sake of compact prosecution, the examiner will construe that the term “substantially” is cancelled in all claims.
Claim Rejections - 35 USC § 112
Notice of AIA Status
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.
Claims 11-12, 78, 81-83, and 87-88 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because inducing an agonist effect at the M1, M2, M3, and M4 receptors comprising administering the compound (ethyl-cis-2-{4-(1-methyl-1H-pyrazol-5-yl)piperidin-1-yl]-6-azaspiro[3,4]octane-6-carboxylate), does not reasonably provide enablement for preventing cognitive disorders or psychotic disorders comprising administering the aforementioned compounds including crystal salts such as citrate and/or hydrochloric salts. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The instant claims are drawn to a method of treating cognitive disorder or psychotic disorder or lessening the severity of acute, chronic, neuropathic, or inflammatory pain comprising administering the citrate salt of claim 6. The instant specification fails to provide information that would allow the skilled artisan to practice the prevention of any disorders comprising administering the citrate salt delineated in claim 6.
[In re Sichert, 196 USPQ 209 (CCPA 1977)]
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates a method of treating cognitive disorder or psychotic disorder or lessening the severity of acute, chronic, neuropathic, or inflammatory pain comprising administering the citrate salt of claim 6. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. The specification (pg. 63, lines 20-25) teaches the term treating encompasses prophylactic measures, i.e. prevention. As illustrative of the state of the art, the examiner cites Isaacson who teaches that Alzheimer, a type of cognitive disorder, cannot be prevented but rather risk reduction and early intervention to minimize the disease has been best applied (see last paragraph).Moreover, the specification fails to show actual treatment or alleviation of any disorder but rather agonist activity at the M1, M2, M3, and M4 receptors by administering the aforementioned compound (see spec. pgs. 141-142). The prior art, Isaacson et al. (J. Amer. Geriat. 2017, Vol. 65, No. 10, pgs. 2153-2154), teaches that current research seems to indicate that delay in onset and reduction in risk are seen as the type of options applicable to the treatment of cognitive disorders (see abstract). Nowhere in the specification or prior art, did applicant demonstrate prevention of any cognitive disorders or psychotic disorders, let alone Alzheimer’s disease. Additionally, the specification demonstrated that the compound, compound (ethyl-cis-2-{4-(1-methyl-1H-pyrazol-5-yl)piperidin-1-yl]-6-azaspiro[3,4]octane-6-carboxylate) was effective in inducing agonist effect at the M1-M4 receptors Nowhere in the specification was it demonstrated that the compound of the invention was effective in preventing any disorder. Thus, the examiner maintains that prevention of psychotic and cognitive disorders is unlikely and unpredictable.
2. The breadth of the claims
The claims are thus very broad insofar as they recite that the “prevention of every cognitive disorder or psychotic disorder with the compound of the invention delineated in claim 6”. While “reduction in risk or delay onset of such disorders” might theoretically be possible by administering the aforementioned compound, as a practical matter it is nearly impossible to achieve the prevention of tumor recurrence and metastasis with every single compound of the generic formula delineated in claim 6.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for the use of the compound of formula (I) of claim 6 in preventing cognitive or psychotic disorders. While specific guidance is provided concerning the use of said compound in inducing agonist activity at M1-M4 receptors as demonstrated in the specification, pgs. 141-142, no actual prevention was shown utilizing said compound of the generic formula as recited in claim 6.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence demonstrating the use of the compound of the generic formula in claim 6 in preventing cognitive disorder and psychotic disorder, no one skilled in the art would accept the assertion that said compound encompassed by the aforementioned generic formula of claim 6 could be predictably used for preventing cognitive and psychotic disorders as inferred by the claims and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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.
Claim(s) 6-9, 11-12, 27, 29-31, 75, and 81-89 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Brown et al. (WO2015/118342 A1, cited by applicant and filed on an IDS 1449).
Brown et al. teach bicyclic aza-compounds that are muscarinic M1 receptor agonists that are useful in the treatment of diseases mediated by M1 and M4 muscarinic receptors as well as pharmaceutical compositions comprising said compounds (see abstract and pg. 45; instant claim 9). Brown et al. specifically teach compound 1-21 (see pg. 48):
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as recited in clam 6 and wherein Brown teaches that various salts are envisaged including citric salts as well as hydrochloric salts and in acid or water as well as mono or di-salts (i.e. monohydrate salts are envisaged; see pgs. 30-31; instant claims 6-8). Additionally, Brown et al. teach monohydrates and formation of crystals using known standard techniques including TGE analysis, DSC and X-ray crystallography (see pg. 35). Brown further teaches that the compounds of the invention have muscarinic activity against M1 and M4 receptors with a pEC50 value of at least 6 and pEmax at greater than 80 (see pg. 37). Brown also teaches that the compounds of the invention are useful for treating cognitive and psychotic disorders including Alzheimer’s disease, dementia with Lewy bodies, etc.. (see pgs. 37-38).
Accordingly, the teachings of Brown et al. anticipate claims 6-9, 11-12, 27, 29-31, 75, and 81-89.
Objections
Claims 32, 34, 39-43, 90, 92, and 95 are objected to because of the following informalities: Claims are dependent upon rejected claims. Applicant is required to incorporate all of the limitations of said claims into the independent claims. Appropriate correction is required.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Director Bonnie Eyler whose telephone number is 571-272-1200. The Supervisory Primary Examiner can normally be reached on 12:00-8:00 PM EST M-F at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.
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