DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
Status of the Claims
The listing of claims filed 3 May 2024 has been examined. New claims 20–43 are pending. Claims 1–19 are canceled.
Benefit of Earlier Filing Date
The instant application was filed 11 May 2023; is a national stage application of PCT/EP2021/081522, filed 12 November 2021, and claims the benefit of U.S. Prov. Pat. App. Serial No. 63/113,662, filed 13 November 2020. Acknowledgment is made of Applicant’s claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 28 August 2023; 30 April 2024; and 3 April 2025 are acknowledged and have been considered.
Objections to the Specification
The abstract of the disclosure is objected to because it recites legal phraseology (“comprising”). Appropriate correction is required.
For guidelines for the preparation of patent abstracts, see MPEP § 608.01(b) (Explaining: The abstract should be in narrative form and avoid legal phraseology (e.g., means, said), terms referring to purported merits of the invention (e.g., new, novel), and phrases that can be implied (e.g., The disclosure concerns, The disclosure defined by this invention,). The language should be clear and concise, and not repeat information given in the title. It should not compare the invention with the prior art. The abstract is generally limited to a single paragraph within the range of 50 to 150 words in length.).
Claim Rejections - 35 U.S.C. § 112
The following is a quotation 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.
Claim 20–43 are rejected under 35 U.S.C. § 112(a) because 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 the claims.
MPEP § 2164.01(a) explains how enablement for the claimed invention can be analyzed:
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue.” . . . These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The Wands factors are analyzed with respect to the claimed invention in turn below.
The breadth of the claim is broad in scope, as it is drawn to treating over a dozen different diseases with a compound of Formula (I). The claim recites: “A method of treating a disease . . .” Claims are read in light of the specification. In relevant part, the specification states:
The terms “treat,” “treating” or “treatment”, as used herein, include alleviating, abating or ameliorating a disease or condition symptoms, preventing additional symptoms, ameliorating or preventing the underlying metabolic causes of symptoms, inhibiting the disease or condition, e.g., arresting the development of the disease or condition, relieving the disease or condition, causing regression of the disease or condition, relieving a condition caused by the disease or condition, or stopping the symptoms of the disease or condition. The terms “treat,” “treating” or “treatment”, include, but are not limited to, prophylactic and/or therapeutic treatments.
(Spec., ¶36) (emphasis added).
The term “treating” includes prophylactic use, which is synonymous with preventing. The claim therefore encompasses preventing pain, epilepsy/seizure disorder, Alzheimer’s disease, Huntington’s chorea, Huntington’s disease, spasticity, multiple sclerosis, obsessive-compulsive disorder, Parkinson’s disease, depression, post-traumatic stress disorder, generalized anxiety disorder, and dystonia.
The nature of the invention generally relates to the pharmaceutical art and more specifically to a method of administering a compound of Formula (I) for the purpose of “treating” diseases.
The state of the prior art does not support preventing the claimed diseases. In general, to treat a disease, one of skill in the art must identify a biological target for affecting the disease, demonstrate a first drug candidate some way modulates the normal processes of the biological target, and demonstrate that a subject would benefit from such modulation without detrimental side effects. Typically, the process includes in vitro laboratory screening, in vivo testing, and clinical testing. Once that process has been successfully completed by the first drug candidate, subsequent drug candidates can benefit from the established proof of concept if a substantial correlation can be established between the first drug candidate and the subsequent drug candidates.
In order to prevent a disease, one of skill in the art would need to identify the subjects likely to acquire such as disease, carry out the claimed invention (e.g., administer the claimed compound/composition), and demonstrate the subject did not have any cells infected by the pathogen and/or demonstrate the subject did not develop the disease as a result of the administration of the compound/composition.
Examiner is not aware of any evidence a compound of Formula (I) can prevent a disease, and it’s not credible that certain diseases, such as Alzheimer’s disease, can be prevented.
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
The level of predictability in the art is generally unpredictable. The relevant art requires each potential drug candidate to be assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18, 24 (CCPA 1970). The more unpredictable an area is the more specific disclosure is necessary to satisfy the statutory requirement. MPEP § 2164.02(II) explains that a correlation between the claimed invention and the evidence provided in an application, along with a correlation between the evidence and the models recognized in the art, are required:
“Correlation” as used herein refers to the relationship between in vitro or in vivo animal model assays and a disclosed or a claimed method of use. An in vitro or in vivo animal model example in the specification, in effect, constitutes a “working example” if that example “correlates” with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute “working examples.” In this regard, the issue of “correlation” is also dependent on the state of the prior art. In other words, if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate. Even with such evidence, the examiner must weigh the evidence for and against correlation and decide whether one skilled in the art would accept the model as reasonably correlating to the condition. In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995) (reversing a USPTO decision based on finding that in vitro data did not support in vivo applications).
Further, treatments may be effective for some subjects and ineffective for other subjects. Thus, each candidate for pharmaceutical medicine must be evaluated on its own even when a nexus to an existing drug or class of drugs has been established.
The amount of direction provided by the inventor relates to in vitro and in vivo evaluations of compounds of Formula (I) to assess their MAGL activity. (Spec., pp.153–167).
The existence of working examples relate to the in vitro and in vivo evaluation of compounds of Formula (I) to assess their MAGL activity. There are no working examples demonstrating a compound can prevent a specific disease.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure is extensive, as it includes in vitro and in vivo screening for each specific disease or disorder.
Scope of Enablement Conclusion
In view of the Wands factors discussed above, the disclosure of the instant application does not reasonably enable a person having ordinary skill in the art to use the full scope of the claimed invention. The breadth of the claims is broad in scope; the nature of the invention is sophisticated; the state of the prior art is in its infancy for preventing any disease; the level of skill in the art is high; the pharmaceutical art is unpredictable; the direction provided by the inventor is limited to in vitro and in vivo evaluations of the compounds of Formula (I); there are no working examples showing a compound of Formula (I) can prevent a disease; and the quantify of experimentation needed to practice the claimed invention is extensive. Thus, when the evidence is considered as a whole, undue experimentation would be required to practice the full scope of the claimed invention.
Examiner recommends amending the claim to recite “A method of treating a subject having a disease or disorder . . .”
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 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993); In re Longi, 759 F.2d 887 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937 (CCPA 1982); In re Vogel, 422 F.2d 438 (CCPA 1970); In re Thorington, 418 F.2d 528 (CCPA 1969).
Please note the following information regarding terminal disclaimers:
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(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.
(i) Claims 20–43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1–12 of U.S. Pat. No. 11,434,222 (reference claims) [IDS].
18/252,611
11,434,222
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The instant claims are directed to a method of treating a disease by administering a compound of Formula I (above left).
Claims 1–12 of the reference claims are directed to a compound of Formula I and a pharmaceutical composition thereof (above right). The reference claims do not disclose the utility of the compounds.
The specification can be reviewed to see what the utility of a claimed product is when it is not apparent from the claims. MPEP § 804(II)(B)(1) (“The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed.”). In this case, the specification for the reference claims discloses the compounds are useful as MAGL inhibitors for the treatment of the same diseases listed in the instant claims. (1:11–51; 2:41–67) (col:lines).
Although the claims at issue are not identical, they are not patentably distinct from each other because they cover the same or many of the same compounds and the compounds are characterized as having the same utility. As such, the instant claims would have been prima facie obvious in view of the reference claims. Furthermore, an infringer of a patent granted based on the instant claims would also be an infringer of the reference claims.
(ii) Claim 27 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Pat. No. 12,378,219 (reference claims).
Claim 27 is directed to a method of treating a disease by administering a compound of Formula I, wherein the compound 1,1,1,3,3,3-hexafluoropropan-2-yl (S)-1-(pyridazin-3-ylcarbamoyl)-6- azaspiro [2.5]octane-6-carboxylate is explicitly recited in the claim (below left).
Claim 9 of the reference claims is directed to a method of treating a disease by administering a crystalline form 3 of 1,1,1,3,3,3-hexafluoropropan-2-yl (S)-1-(pyridazin-3-ylcarbamoyl)-6- azaspiro [2.5]octane-6-carboxylate, which is a compound with the same structure and formula (below right).
18/252,611
12,378,219
20. A method of treating a disease or disorder selected from the group consisting of
pain, epilepsy/seizure disorder, Alzheimer's disease, Huntington's chorea, Huntington's disease, spasticity, multiple sclerosis, obsessive-compulsive disorder, Parkinson's disease, depression, post-traumatic stress disorder, generalized anxiety disorder, and dystonia, in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a
compound of Formula (I) . . .
27. The method of claim 20, wherein the compound is . . . 1,1,1,3,3,3-hexafluoropropan-2-yl (S)-1-(pyridazin-3-ylcarbamoyl)-6- azaspiro [2.5]octane-6-carboxylate . . . or a pharmaceutically acceptable salt thereof.
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Although the claims at issue are not identical, they are not patentably distinct from each other because they cover a method of treating the same diseases with the “same” compound. The instant claim 27 refers to the compound name, which is considered a genus and that genus includes all crystalline forms capable of being formed. The reference claim 9 is directed to a specific crystalline form of the compound in instant claim 27 (i.e., a species of the genus). Thus, the instant claim would have been prima facie obvious in view of the reference claim based on a theory of anticipation. And, an infringer of the reference claims would also be an infringer of a patent granted based on the instant claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623