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 .
Status of the Application
This Office Action is in response to Applicant's Restriction Requirement remarks filed on August 4, 2026. Claim(s) 1, 3-10, and 21-30 are pending. Applicant's election of ACPD (aPKC inhibitor) and Alzheimer’s disease (neurodegenerative disease) of the restriction requirement in the reply is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The requirement is deemed proper and is therefore made FINAL. Claim(s) 1, 3-10, and 21-30 are examined herein insofar as they read on the elected invention and species.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1, 3-10, and 21-30 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3-5, 9, 13-14, 16-19, 21-22, 25-31 of copending Application No. 18/704,415. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are drawn to a method of treating a neurodegenerative disorder in a subject in need thereof, the method comprising: administering an amount of an aPKC inhibitor capable of crossing the blood brain barrier to the subject in need thereof. The copending claims are drawn to a method of treating a neurodegenerative disorder in a subject in need thereof, the method comprising: administering an effective amount of a PKC inhibitor, wherein the PKC inhibitor is capable of crossing the blood brain barrier, and wherein the administered PKC inhibitor decreases BACE1 levels in the subject in need thereof.
The limitation of “decreases BACE1 levels” is considered a property inherent in the disclosed active agent. "Products of identical chemical composition cannot have mutual exclusive properties." Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
The instant claims are deemed anticipated over the copending claims.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 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.
Claims 1, 3-10, and 21-30 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of treating Alzheimer’s disease comprising administering ACPD, does not reasonably provide enablement for the treatment of any neurodegenerative disease with the administration of any aPKC inhibitor as instantly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. The specification does not provide sufficient information that all conditions embraced by the umbrella term “neurodegenerative disease” are treatable by any aPKC inhibitor as described in the methods claimed.
The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation 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 breadth of the claims
The breadth of the instant claims is seen to encompass methods for treating any neurodegenerative disease with the administration of any aPKC inhibitor. Thus, the claims are extremely broad.
The nature of the invention
The nature of the invention is the treatment of any neurodegenerative disease with the administration of any aPKC inhibitor. Currently, there are no known agents that treat neurodegenerative disorders inclusively.
The state of the prior art and level of predictability in the art
Verma (Journal of Molecular Neuroscience, 2026) teaches, even as most recently, that neurodegeneration is a "systems biology" problem rather than a single- protein problem. The reference explains that because Alzheimer's and other neurodegenerative disorders are multifactorial and complex a "one-size-fits-all" approach is insufficient to encompass the full range of disease mechanisms (page 1).
Thus, the treatment of these disorders is highly unpredictable. It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved," and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The amount of direction provided by the inventor and existence of working examples
The specification does not provide guidance for the treatment of the scope of disorders embraced by umbrella terms or any symptom of any neurodegenerative disease by administering any aPKC inhibitor of the claims.
In the instant case, applicant demonstrates ACPD rescues memory and CNS markers in HFF mice, namely Ab1-40/42 (Figures 27A-27F) and ACPD metabolic testing in the presence of metformin (Figures 29A-29B).
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 27 USPQ2d 1510 (CAFC). The disclosure does not demonstrate sufficient evidence to support the Applicant's claim to the treatment. There are not sufficient working examples or data from references of the prior art to provide a nexus between those examples and a method of treating the embraced disorders with the claimed compound.
The level of one of ordinary skill
The level of skill is that of one with a doctoral understanding of treating any neurodegenerative disease with the administration of any aPKC inhibitor. Applicant’s data is not convincing as to make the production and use of pharmaceutical compositions comprising the broad scope of compounds treating the wide array of diseases without undue and unpredictable experimentation.
The quantity of experimentation
A great deal of experimentation is required. In order for there to be a method of treating any neurodegenerative disorders generally, as claimed by the applicant, it would be necessary to show that there is a vast range of any aPKC inhibitor associated diseases. Furthermore, direction, in the form of examples, must be shown to determine what an effective dose may be. The references submitted do not demonstrate this. Therefore, one of ordinary skill in the art would require a significant amount of experimentation in order to determine the effective dosage to treat the multitudes of different types of neurodegenerative disorders with the broad class of drugs embraced by any aPKC inhibitor individually or in combination with other therapeutic agents.
Genentech, 108 F.3d at 1366 states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent 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." Thus, it can be safely concluded that the instant case fails to provide an enabling disclosure for the treatment of treating any neurodegenerative disease with the administration of any aPKC inhibitor as discussed above.
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.
Claims 1, 3-8, 10, 21-23, and 28-30 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Eveleth (US 5,622,981).
Examiner notes that the limitation regarding ability to cross the blood brain barrier (claim 1) and the inhibition of protein activity (i.e., decrease phosphorylation of Akt (claim 4); decrease activity of b-secretase (claim 5); decrease amount of Ab1-40/42 (claims 6 and 21); decrease amount of Thr-231-phospho-tau (claims 7 and 22-23); decrease activity of 70k PKC (claim 8)) are considered properties inherent in the disclosed active agent. "Products of identical chemical composition cannot have mutual exclusive properties." Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Eveleth teaches a method of treating a mammal with a neurodegenerative disease which is caused at least in part by β-amyloid protein neurotoxicity, comprising administering to said mammal a pharmacologically effective dose of a metabotropic receptor agonist. (abstract; claim 1).
Eveleth teaches wherein the metabotropic receptor agonist is ACPD (claim 3).
Eveleth teaches wherein the mammal has Alzheimer’s disease (claim 6; example 2).
Eveleth teaches that the metabotropic receptor agonists may be administered orally, parenterally, or intravenously (column 7, lines 50-62).
Eveleth teaches doses of 0.001 to 100 mg/kg (column 8, lines 9-18).
Eveleth teaches other subjects who exhibit indicia of AD and are thus at risk for coming down with this disease, can be administered a dose of a metabotropic agonist which is pharmacologically effective for preventing AD (column 6, lines 30-36).
Based on the foregoing reasons, the instant claims are deemed anticipated over the cited art.
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.
Claims 9 and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Eveleth (US 5,622,981) as applied to claims 1, 3-8, 10, 21-23, and 28-30 in the 102(a)(1) rejection above in view of Luchsinger (Eur J Pharmacol, 2008).
Eveleth is discussed above.
Eveleth does not teach the patient population suffering from hyperinsulinemia, as required by claim 9, as well as an insulin-resistant disorder, as required by the limitations of claims 26-27.
Luchsinger teaches there is a clinical and epidemiological overlap between Alzheimer’s disease and metabolic disorders including type 2 diabetes, hyperinsulinemia.
Luchsinger cites numerous studies in the review paper illustrating that patients with Alzheimer’s disease or cognitive impairment have a significantly higher prevalence of type 2 diabetes, hyperinsulinemia, and components of metabolic syndrome compared to cognitively healthy control populations (entire document).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the administration of ACPD in the treatment of Alzheimer’s disease as taught by Eveleth and envisioned that many of said patients will also be suffering from hyperinsulinemia and other insulin-resistant disorders. The motivation, provided by Luchsinger, teaches the clinical and epidemiological overlap between Alzheimer’s disease and metabolic disorders including type 2 diabetes and hyperinsulinemia. Thus, it is well established that patients with Alzheimer’s disease or cognitive impairment have a significantly higher prevalence of type 2 diabetes, hyperinsulinemia, and components of metabolic syndrome compared to cognitively healthy control populations.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1, 3-10, and 21-30 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
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