DETAILED ACTION
The amendment submitted on September 25, 2025 has been entered. Claims 97-104 and 106-118 are pending in the application and remain rejected for the reasons set forth below. No claim is allowed.
This application, filed on or after March 16, 2013, is being examined under the first-inventor-to-file provisions of the Leahy-Smith America Invents Act (AIA ), Pub. L. No. 112-29, 125 Stat. 284 (2011). In the event that 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 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.
Withdrawn Rejections
The rejection of claim 105 under 35 U.S.C. 112(d) being of improper dependent form is withdrawn because this claim has been cancelled.
Response to Arguments
Applicant acknowledges that Weg teaches that racemic ketamine can be administered to treat addiction to an extremely broad range of addictive substances, including narcotics and opioids. Applicant argues, however, that one of ordinary skill in the art “would be aware that the neurotransmitter systems that mediate addiction are different, depending on the substance.” See applicant’s Remarks, submitted September 25, 2025, at p. 7. In applicant’s view, “the person of ordinary skill in the art would turn to the working examples of Weg for guidance regarding specific substance abuse disorders that could be treated with ketamine.” Remarks at p. 8. Applicant further argues that the working examples of Weg are limited to “racemic ketamine for addiction to cigarettes,” but “nicotine acts through different neurotransmitter receptors than opioids.” Remarks at p. 8. “Thus, the person of ordinary skill in the art, provided the teachings of Weg, with its sole working Example directed to racemic ketamine for nicotine addiction, would have little expectation of predictable results or success in administering racemic ketamine, much less R(-)-ketamine, for the treatment of opioid abuse in a subject.” Remarks at p. 8. Applicant’s argument is not persuasive because “[a] reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art.” See MPEP 2123 (Rejection Over Prior Art’s Broad Disclosure Instead of Preferred Embodiments). The examiner is therefore required to take the teachings of Weg at face value, absent specific evidence to the contrary. Weg discloses, in its broadest teachings, that ketamine is useful for treating addiction to opioid analgesics (Weg at col. 6, ll. 23-30). The fact that nicotine may also exert its effects through other neurotransmitters does not change the fact that Weg clearly links using ketamine and treating opioid addiction. The examiner understands that there may be other neurotransmitters involved in this process, but the prior art clearly informs the artisan that opioid addiction is treatable with racemic ketamine, which necessarily includes both enantiomers.
Applicant further argues that Hashimoto “is directed to treating depressive symptoms in a variety of psychiatric diseases” but “provides no teaching or suggestion the R(-)-ketamine would be effective in treating opioid abuse.” Remarks at p. 8. However, “[o]cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.” See MPEP 2145(IV) (ARGUING AGAINST REFERENCES INDIVIDUALLY). The examiner acknowledges that neither of the references specifically discloses the claimed invention, but maintains that it would have been prima facie obvious when their teachings would have been read in light of each other. As explained in the rejection below, the motivation for doing so would have been the desire to reduce the psychotomimetic side effects of (S)(+)-ketamine (Hashimoto at para. 0007) when treating opioid addiction (Weg).
Finally, applicant argues that “R-ketamine was unexpectedly effective at treating symptoms of withdrawal from a representative opioid,” specifically “R-ketamine did not produce anhedonia, a well known side-effect of S-ketamine.” Remarks at p. 8-9. But this appears to be yet another inherent property (i.e., the subject matter of claims 99-100, 111, and 114-116) of an otherwise prima facie obvious treatment method. The mere recognition of such latent properties in the prior art does not render nonobvious an otherwise known invention. Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. The fact that applicant has apparently recognized other advantages that “would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” See MPEP 2145(II) (Prima Facie Obviousness Is Not Rebutted by Merely Recognizing Additional Advantages or Latent Properties Present But Not Recognized in the Prior Art).
Applicant’s arguments have been fully considered but are not persuasive. The rejection is therefore maintained.
Maintained RejectionsClaim Rejections – 35 USC § 103
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; and (4) considering objective evidence present in the application indicating obviousness or nonobviousness. See MPEP 2141 et seq.
Claims 97, 99-100, 106-112, and 114-117 remain rejected under 35 U.S.C. 103 as being unpatentable over Weg (US 5,989,582) in view of Hashimoto (US 2016/0220513 A1).
Weg (cited in the prior action) discloses “a method for assisting detoxification and treat-ment of substance addiction in a subject comprising administering a dose of ketamine,” presum-ably racemic ketamine, “effective to assist in detoxification and treatment of the addiction” (col. 2, ll. 14-17), including addiction to narcotics, opioid analgesics, and so forth (col. 6, ll. 27-31). “[T]he patient can safely administer an amount of drug effective for assisting in withdrawal and treatment of substance addiction by controlling the amount and frequency of administration of a formulation according to the invention” (col. 5, ll. 28-40), which suggests the subject matter of claim 100. With respect to claims 106 and 108, Weg discloses (col. 4, l. 61 – col. 5, l. 14):
The invention provides for administration of a therapeutically effective dose of ketamine, i.e., a dose effective facilitate detoxifi-cation and assist in treatment of substance addiction. The actual dose will vary, depending on the body weight of the patient, the severity of the or substance addiction, the route of administration, the nature of medications administered concurrently, the number of doses to be administered per day, and other factors generally considered by the ordinary skilled physician in the administration of drugs. … [T]he dose of ketamine is about 0.01 mg per kg of body weight (0.01 mg/kg) to about 1 mg/kg, preferably about 0.05 mg/kg to about 0.7 mg/kg. In yet another embodiment, the total dose ranges from about 1 mg to about 30 mg. Preferably, the effective dose is titrated under the supervision of a physician or medical care provider, so that the optimum dose for the particular application is accurately determined. Thus, the present invention provides a dose suited to each individual patient.
One would therefore have viewed the particular dosage regimen on claims 106 and 108 as being a matter of routine experimentation within the general teachings of Weg. It is Office policy, in such situations, to regard these parameters as being prima facie obvious; where the general conditions of a claim are disclosed in the prior art, “it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP 2144.05(II) (Optimization Within Prior Art Conditions or Through Routine Experimentation). Weg further discloses (col. 6-10) a variety of different pharmaceutical compositions within the meaning of instant claim 107. The reference also acknowledges the hydrochloride salt of ketamine (col. 1, ll. 39-41), which suggests the subject matter of claim 109. Weg also discloses intravenous administration and other routes of administration within the meaning of claim 110. Weg also recognizes assisting in withdrawal symptoms (col. 5, ll. 28-31), such as “nervousness, shakiness, difficulty concentrating, impa-tience, and ill tempered behavior” (col. 1, ll. 50-52), which suggests the subject matter of claims 114-116.
The difference between the prior art and the claims at issue is that Weg does not specifi-cally disclose using the (R)(−)-enantiomer of ketamine.
Hashimoto (cited in the prior action), however, discloses that the ketamine referred to in Weg is a racemic mixture containing equal amounts of (R)(−)-ketamine and (S)(+)-ketamine, and that (S)(+)-ketamine produces undesirable psychotomimetic side effects (para. 0007). On the other hand, (R)(−)-ketamine does not produce psychotic symptoms but a state of relaxation and a feeling of wellbeing (para. 0007). Hashimoto further teaches that ketamine is useful in the treatment of a variety of psychiatric conditions (para. 0009). Importantly, Hashimoto cautions that administration of (S)(+)-ketamine induces adverse side effects such as “hyperlocomotion, prepulse inhibition deficit, and drug dependence,” while administration of (R)(−)-ketamine did not (para. 0033).
It would have been prima facie obvious to one of skill in the art as of the effective filing date to use (R)(−)-ketamine as taught by Hashimoto instead of the racemic ketamine as taught by Weg in the treatment of addiction and thereby arrive at subject matter within the scope of the instant claims. Clearly, when treating a substance abuse disorder as taught by Weg, it would have been desirable to avoid medication that may cause “drug dependence” (Hashimoto at para. 0033). This observation would have suggested the use of (R)(−)-ketamine instead of racemic ketamine. By using (R)(-)-ketamine in this manner, one would avoid (S)(+)-ketamine, which is necessarily present in the racemate.
The subject matter of claims 99-100, 111, and 114-116 appear to be inherent in the fore-going treatment. See MPEP 2112. When read in light of each other, the cited references would have suggested the use of the same drug ((R)(−)-ketamine) for treating the same disorder (substance abuse withdrawal), so it is a reasonable conclusion that the outcomes recited in claims 99-100, 111, and 114-116 would necessarily follow.
Claims 97-102 and 104-118 remain rejected under 35 U.S.C. 103 as being unpatentable over Weg and Hashimoto as applied above, and further in view of Patel (US 2014/0271766 A1).
The disclosures of Weg and Hashimoto are relied upon as set forth above. The first difference between the prior art and the claims at issue is that, although Weg discloses treating opioid addiction (col. 6, l. 28), it does not specifically disclose the opioids recited in claims 98, 113, or 118. One would therefore look to the prior art for this missing information, and Patel (see, e.g., para. 0027) provides an answer to this question, namely, that heroin, codeine, and so forth were known in the prior art as being opioids that are susceptible to addiction. The second difference between the prior art and the claims at issue is that Weg does not specifically disclose medication-assisted therapy with buprenorphine within the meaning of claims 101-102 and 104-105. Again, however, Patel (cited in the prior action) recognizes that combination therapy, or medication-assisted treatment particularly with buprenorphine (para. 0025) was known in the prior art. As a general matter, one would have viewed the combination treatment of (R)(−)-ketamine (Weg/Hashimoto) with buprenorphine therapy (Patel) for treating opioid addiction as being prima facie obvious for the reasons discussed in MPEP 2144.06(I) (COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE).
Claims 97-104 and 106-118 remain rejected under 35 U.S.C. 103 as being unpatentable over Weg Hashimoto, and Patel as applied above, and further in view of Carroll (Am. J. Psychiatry 2005;162(8):1452-60).
The disclosures of Weg, Hashimoto, and Patel are relied upon as set forth above. The difference between the prior art and the claims at issue is that neither of these two references discloses behavioral therapy as recited in claim 103. Weg does teach, however, that “[l]ong term treatment, to be successful, must provide strong physical and psychological reinforcements to avoid the addi[c]tion” (col. 1, ll. 53-55). Because Weg does not specifically disclose what these “reinforcements” might be, one would necessarily look to the prior art for this missing infor-mation, and Carroll (cited in the prior action) provides an answer to this question. Specifically, Carroll teaches the importance of behavioral therapy in the treatment of addiction. Carroll also recognizes methadone (p. 1453) medication-assisted treatment, which meets the limitations of claims 104. See MPEP 2144.06(I).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The examiner can normally be reached Monday - Thursday, 7:00 am - 6:00 pm (Eastern Time).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
November 18, 2025