DETAILED ACTION
The present application is a national stage entry of PCT/US2022/032120, filed 03 June 2022, which claims priority to US Provisional Application No. 63/197,015, filed 04 June 2021.
The preliminary amendment filed 01 December 2023 is acknowledged. Claims 1-6, 9 and 30-38 are pending in the current application. Claims 33 and 36-38 are withdrawn as being drawn to a non-elected invention, see below. Claims 2, 3, 6, 34 and 35 are withdrawn as being drawn to a non-elected species, see below. Claims 1, 4, 5, 9 and 30-32 are examined on the merits herein.
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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-6, 9, 30-32, 34 and 35 in the reply filed on 08 May 2026 is acknowledged. The traversal is on the ground(s) that a search of Group I would not impose a serious burden, because a search concerning the patentability of the methods of Group I, would likely uncover art relevant to the kit of Group II. This is not found persuasive because a search burden is not a requirement when making a restriction between multiple inventions in a 35 U.S.C. §371 application.
The requirement is still deemed proper and is therefore made FINAL.
Claims 33 and 36-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08 May 2026.
Applicant's election with traverse of “a cognitive deficit disorder” as a specific disorder, censavudine as the specific LINE-1 inhibitor, and donepezil as the second optional therapeutic agent in the reply filed on 08 May 2026 is acknowledged. The traversal is on the ground(s) that a search of the elected species would likely uncover art of interest to other species recited in the instant claims. Any additional searches that would be needed would not be an undue burden on the Examiner. This is not found persuasive because a search burden is not a requirement when making a restriction between multiple inventions in a 35 U.S.C. §371 application.
It is noted “cognitive deficit disorder” is not a specific species as laid out in the restriction requirement mailed 08 May 2026. Rather, claim 5 lists specific types of cognitive deficit disorder Applicant was supposed to elect from.
Claims 2, 3, 6, 34 and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08 May 2026.
Claim Interpretation
The recitation “prevent a cognitive deficit disorder” in claim 1, is broadly and reasonably interpreted to include administering the LINE-1 inhibitor to any individual.
The recitation “treat…a cognitive deficit disorder” in claim 1 is broadly and reasonably interpreted to include the disorders listed in claim 5. These include “a learning disorder, a memory disorder, a sensory perception disorder, an attention deficit/hyperactivity disorder, associated with autism or Asperger’s syndrome, mild cognitive impairment, age-related cognitive decline, associated with traumatic, tumor-related, or ischemic brain injury, a drug-related cognitive impairment, or an alcohol-related cognitive impairment”.
The “memory disorder” is broadly and reasonably interpreted as including Alzheimer’s disease.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1, 4, 5, 9, and 30-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for enhancing cognition, , does not reasonably provide enablement for treating or preventing any cognitive deficit disorder, or preventing Creutzfeldt-Jakob disease (CJD). 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 Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth 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 nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
The nature of the invention: The nature of the invention is administering one of three compounds identified as a LINE-1 inhibitor for enhancing cognition, inhibiting cognitive decline, treating or preventing a cognitive deficit disorder, or treating or preventing CJD.
The state of the prior art: Prevent is defined as “keep from happening or existing”. See provided definition of prevent (definition of prevent, Merriam-Webster, cited in PTO-892). There is no prior art disclosing how to keep heart failure and kidney disease from happening.
Regarding the treatment of Alzheimer’s disease, it is known in the art that there is no known cure or prevention for Alzheimer’s disease and that there are only four medications available in the United States to temporarily slow the progression of the early stages of Alzheimer’s disease. The current drugs for the treatment of Alzheimer’s disease (Aricept, Exelon, Reminyl, and Cognex) treat early stages of Alzheimer’s disease by delaying the breakdown of acetylcholine. Memantine, which blocks excess amounts of glutamate, treats late stage Alzheimer’s disease (i.e., see URL: http://www.cnn.com/2003/HEALTH/conditions/09/24/alzheimers.drug.ap/index.html).
The relative skill of those in the art: The relative skill of those in the art in preventing the claimed conditions is low, since there is no prior art teaching how to prevent the claimed conditions.
The predictability or unpredictability of the art: Each of the claimed conditions have multiple possible causes.
Risk factors for CJD include age, genetics and/or exposure to contaminated tissue (Mayo Clinic, “Creutzfeldt-Jakob disease”, p.4, cited in PTO-892). According to the Mayo Clinic, CJD can be caused for no apparent reason (sporadically), (p.3). Furthermore, they teach there is no known way to prevent sporadic CJD (p.5).
Alzheimer’s disease (AD) has traditionally been very difficult or impossible to prevent or treat effectively. See e.g. Damasio (Cecil Textbook of Medicine, 20th edition (1996), Vol. 2, cited in PTO-892) wherein it is stated that “[t]here is no cure for Alzheimer’s disease, and no drug tried so far can alter the progress of the disease” (p. 1994). Maczurek et al. (Advanced Drug Delivery Reviews, 2008, vol. 60, pp.1463-1470, cited in PTO-892) teaches that glucose metabolism is decreased in patients having AD, and that lipoic acid (LA) can ameliorate impaired glucose metabolism in type II diabetics (p.1466, 4.6. LA—a stimulator of glucose uptake and utilization). Maczurek et al. suggests that because the R form of lipoic acid (RLA) can increase glucose metabolism in vivo, it may be a contributing factor in the treatment of neurodegenerative disorders (p.1466, 4.6. LA—a stimulator of glucose uptake and utilization). Maczurek et al. teaches increased glucose metabolism may increase metabolites like acetyl-CoA wherein increasing production of acetyl-CoA by increasing glucose uptake is believed to be useful as a therapeutic strategy in treating AD (p. 1466, 4.6. LA—a stimulator of glucose uptake and utilization and p.1464, sections 3 and 4; see 4B).
Thus, the risk factors for some of the claimed disorders/conditions vary. They include additional factors that cannot necessarily be changed or controlled, e.g. including age and genetics. Furthermore, there is no known way to prevent CJD, or any drug that can prevent the claimed conditions from occurring.
The breadth of the claims: The breadth of the claims includes preventing any cognitive deficit disorder, or preventing Creutzfeldt-Jakob disease (CJD).
The amount of direction or guidance presented: The presence or absence of working examples: There is no teaching or guidance on how one would administer the claimed composition to treat or prevent any of the claimed conditions.
The quantity of experimentation necessary: In order to practice the invention with the full range of all possible treatment methods beyond those known in the art, one skilled in the art would undertake a novel and extensive research program to show any and all forms of cognitive deficit disorder, or Creutzfeldt-Jakob disease (CJD) could be treated or prevented.
In order to determine the efficacy of the claimed therapies in the absence of any existing in vivo data, one skilled in the art would undertake animal testing in order to practice the invention. Animal experiments include, induction of the disease state, administration of the potential pharmaceutical compound and collection and analysis of data, additional burdens associated with compliance with animal welfare regulations, care, feeding and other maintenance of the animals, dissection of dead animals to collect data, and dispose of the dead animals after the research is finished. These trials would need to be run separately and repeatedly for each disorder to be treated, and success in treating each and every disorder would still not be definitive. The experimentation involved would therefore be significant, undue and unpredictable.
Genentech, 108 F.3d at 1366, sates that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “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.”
Therefore, in view of the Wands factors, as discussed above, particularly the breadth of the claims, Applicants fail to provide information sufficient to practice the claimed invention for preventing any cognitive deficit disorder, or preventing Creutzfeldt-Jakob disease (CJD).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, 5, 9 and 30-32 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Sedivy et al. (US Patent Application Publication No. 2021/0106586, cited in PTO-892).
Sedivy et al. is drawn towards the use of a reverse transcriptase inhibitor (RTI) for preventing, delaying or reversing age associated inflammation (abstract). Sedivy et al. found three RTI drugs: islatravir, censavudine, and elvucitabine, displayed unexpected ability to inhibit mouse and human line-1 activity (para [0009]). The pathophysiological line-1 processes that can be prevented, treated, or reversed include Alzheimer’s disease, Parkinson’s disease, peripheral degenerative disease, frontotemporal dementia (FTD), and/or autism spectrum disorder (claim 24; para [0011]). Sedivy et al. disclose administering at least one second therapeutic agent for treating symptoms of Alzheimer’s disease, wherein the at least one second therapeutic agent is donepezil (para [0017]). The method also includes administering the composition to a patient suspected of having mild cognitive impairment (e.g. para [0021]).
The recitation “prevent a cognitive deficit disorder” in claim 1, is broadly and reasonably interpreted to include administering the LINE-1 inhibitor to any individual.
Furthermore, Sedivy et al. disclose administering the composition to treat patients with cognitive deficit disorders, including mild cognitive impairment and autism spectrum disorder.
Thus, the disclosure of Sedivy et al. anticipates claims 1, 4, 5, 9 and 30-32 of the present application.
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, 4, 5, 9 and 30-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 13, 17-19, 21, 22, 25 and 29-32 of copending Application No. 18/550,498 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn towards administering the same compounds recited in the present claims to any patient population.
The recitation “prevent a cognitive deficit disorder” in claim 1, is broadly and reasonably interpreted to include administering the LINE-1 inhibitor to any individual.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAHAR A CRAIGO whose telephone number is (571)270-1326. The examiner can normally be reached M-F: Noon-8pm ET.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
Prosecution Insights