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 .
Current Status of 18 / 569850
Claims 1-11 filed 2023 December 13 are examined on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) of 2023 December 13, 2024 February 28, and 2025 December 2 were submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 6 and 8 are objected to because of the following informalities: each claim recites an intended use, “for use in treating a central nervous system disorder”.
In re Tuominen (213 USPQ 89) states the following:
The composition is the same no matter what its intended use is, and consequently, the appealed claims are not seen to distinguish over the art which also discloses a composition of the recited active ingredient. We will not construe the instant claims to be limited to compositions also containing other ingredients usually utilized in sunscreening compositions merely by the fact that the introductory clause of the claims recites a different contemplated utility for the claimed composition not taught by the art. Rather, as done by the Examiner, we interpret the claims to be drawn to a composition of the active ingredients, per se, and, as such, under the rationale of Pearson, they fail to distinguish over the references.
When Tuominen is applied to claims 6 and 8, the intended use does not limit the use of the compound.
Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement (IDS) filed 2023 December 13, 2024 February 28, and 2025 December 2 were submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 11 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for the treatment of a central nervous system disorder with a compound of [chemical formula 1] and non-enabling for the prevention of a central nervous system disorder with a compound of [chemical formula 1]. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Consideration of the relevant factors sufficient to establish a prima facie case for lack of enablement is set forth herein below:
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to treating and/or preventing a central nervous system disorder with a compound of [chemical formula 1]. Thus, the claims taken together with the specification imply a compound of [chemical formula 1] can treat or prevent a central nervous system disorder.
The state of the prior art and (4) the predictability or unpredictability of the art:
PULLEY (US 7067507, issued 2006 June 27) describes that Alzheimer’s disease cannot be prevented (column 2, line 40-45).
The relative skill of those in the art:
Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s, PhD’s, or those with advanced degrees and the requisite experience in INSERT METHOD HERE).
While the artisan generally would have an advanced degree in [area of claims], their high level of skill and knowledge is insufficient to overcome the lack of understanding as to how [disease] functions in the body or to overcome the art recognition that this disease is poorly understood and treatments have generally failed.
The amount of direction or guidance presented and the presence or absence of working examples:
The specification has provided guidance for the treatment of a central nervous system disorder with a compound of [chemical formula 1].
The specification does not provide guidance for the prevention of a central nervous system disorder with a compound of [chemical formula 1].
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to treating and/or preventing a central nervous system disorder with a compound of [chemical formula 1] and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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 9 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. Claim 9 does not recite an active step of for the manufacture of a medicament of a compound of claim 1 or for treating a central nervous system disorder.
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) 1, 2, and 6-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by TANAKA (US 20210087186, published 2021 March 25, cited in IDS). Tanaka describes compound 261 (page 152), a compound in which the following examined definitions apply: X-R is C(O)-1,5-dimethyl-1,5-dihydro-4H-pyrrolo[3,2-c]pyridine-4-one. A 1,5-dimethyl-1,5-dihydro-4H-pyrrolo[3,2-c]pyridine-4-one ring is a 9-membered heterocyclic group substituted with three methyl groups and an oxo group. Pharmaceutical compositions are described (paragraphs [2044]-[2049],page 178; claims 8-10, page 182). A method of treating a central nervous system disorder is described (claim 13, page 182).
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1, 2, and 6-11 are rejected under 35 U.S.C. 103(a) as being unpatentable over TANAKA (US 20210087186, published 2021 March 25, cited in IDS).
Determining the scope and contents of the prior art
Tanaka describes compound 262 (page 152), a compound in which the following examined definitions apply: X-R is C(O)-1,5-dimethyl-1,5-dihydro-4H-pyrrolo[3,2-c]pyridine-4-one. A 1,5-dimethyl-1,5-dihydro-4H-pyrrolo[3,2-c]pyridine-4-one ring is a 9-membered heterocyclic group substituted with three methyl groups and an oxo group. Pharmaceutical compositions are described (paragraphs [2044]-[2049],page 178; claims 8-10, page 182). A method of treating a central nervous system disorder is described (claim 13, page 182).
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Ascertaining the differences between the prior art and the claims at issue
In the prior art, the point of connection to a naphthyl ring is 1-position. In the claims, an azabicyclo[3.0]hexane ring is attached to the 2-position of naphthalene.
Resolving the level of ordinary skill in the pertinent art
Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s, PhD’s, or those with advanced degrees and the requisite experience in preparation of compounds of the elected group).
Considering objective evidence present in the application indicating obviousness or nonobviousness
Tanaka describes a compound that can treat a central nervous system disorder. This compound differs in the point of attachment to a naphthalene ring. Both compounds 261 and 262 are able to lower glucosylceramide (paragraphs [2037]-[2043], pages 177-178). Due to the combined teachings of Tanaka, a reasonable expectation of success is present to change the point of attachment to the naphthalene ring as an agent for the treatment of a central nervous system disorder.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Conclusion
Claims 1, 2, and 6-11 are not allowed.
Claims 3-5 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: TANAKA (US 20210087186, published 2021 March 25, cited in IDS). Tanaka describes compound 261 (page 152), a compound in which the following examined definitions apply: X-R is C(O)-1,5-dimethyl-1,5-dihydro-4H-pyrrolo[3,2-c]pyridine-4-one. A 1,5-dimethyl-1,5-dihydro-4H-pyrrolo[3,2-c]pyridine-4-one ring is a 9-membered heterocyclic group substituted with three methyl groups and an oxo group. This compound does not anticipate or render obvious a compound of claims 3-5 because an oxo group is not permitted as a substituent in claim 3. In claim 5, X cannot be a C(O) group.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699