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 Application, Amendments and/or Claims
The amendment, filed 29 November 2022, has been entered in full. Claims 2 and 6 are canceled. Claims 1 and 4 are amended. The amendment, filed 27 June 2025, has been entered in full. The amendment, filed 09 July 2025, has been entered in full.
Applicant's election with traverse of Group II (claims 9-13, drawn to a method for treating an opioid use disorder, an opioid overdose or inhibiting the effects of opioids comprising administering the adjuvanted conjugate opioid vaccine, in the reply filed on 18 December 2025, is acknowledged.
The traversal is on the ground(s) that the claimed adjuvanted conjugate opioid vaccine is inventive in view of the combined teachings of Janda and Valli. Applicant argues that there is no teaching or suggestion in either Janda or Valli that the selection of the claimed adjuvants with the claimed protein-hapten conjugate would produce the significantly effective and unexpected benefits achieved through the use of the adjuvanted conjugate opioid vaccine. Applicant argues that the specification and figures include data and associated explanatory material that fully support the highly unexpected and beneficial effectiveness of the claimed vaccine. Applicant submits that no reference having a publication date prior to the effective priority date of the current claims is at all suggestive of such efficacy. Applicant argues that there is significant commentary in the relevant art at the time of the present application's filing date that cast doubt on the potential effectiveness of such a vaccine and would have discouraged a person of skill in the art from pursuing such a combination.
Applicant’s arguments have been fully considered but are not found persuasive. Claim 1 is drawn to a composition. The combined references (Janda et al. and Valli et al.) teach the adjuvanted conjugate opioid vaccine that is recited in claim 1 and thus would have the associated properties argued by Applicant. Chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 3, 4, 5, 7 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 18 December 2025. Claims 9-13 are under examination.
Information Disclosure Statement
The information disclosure statement(s) (IDS) (filed 08 February 2024) was received and complies with the provisions of 37 CFR §§1.97, 1.98 and MPEP § 609. It has been placed in the application file and the information referred to therein has been considered as to the merits.
Claim Objections
Claims 9-11 are objected to because of the following informalities:
Claims 9 and 10 are objected to because they depend from a Non-elected claim (i.e. claim 8).
Claims 10 and 11 are objected to because of a typo; “..on a subject..” should be
“..in a subject..” (see line 1 of claims 10 and 11).
Appropriate correction is required.
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 9 is 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:
“A method of treating opioid use disorder or preventing or treating opioid overdose..”
does not reasonably provide enablement for:
“A method of preventing opioid use disorder..”
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 specification teaches naloxone is the standard medication to reverse fentanyl (FEN) effects and because of FEN’s potency, reversing an overdose requires very high and quickly administered doses of naloxone (para 0005).
The instant specification teaches FEN-CRM conjugate vaccine as a protectant whether to prevent overdose or for individuals that are unintentionally exposed to potent synthetic opioids (e.g. first responders, police). The specification teaches rats either received no vaccine or (5 μg) with dmLT (1 μg) at 0, 3 and 6 weeks (IM). The specification teaches one week after analgesic tests, all rats were administered an additional high dose of FEN (0.1 mg/kg) and then processed. The specification teaches that within 30 minutes, 33% of the rats that did not receive the vaccine unexpected perished. The specification teaches that none of the vaccinated rats (Male=30, Female=30) perished. The specification teaches that both male and female rats showed enduring anti-FEN antibody levels at 6 months post-initial vaccination and that these levels were adequate to provide 100% protection against the high dose of FEN (0.1 mg/kg)(para 0058).
The specification is not enabling for the full scope for the following reasons:
“Opioid use disorder” appears to encompass many symptoms such as chronic use of opioids, an overpowering desire to use opioids, increased opioid tolerance, withdrawal syndrome when opioids are discontinued.
For example, Rice et al. teach that individuals with an opioid use disorder (OUD) have increased psychosocial distress and healthcare utilization. Rice et al. teach that the societal implications of OUD are also substantial and that a variety of approaches have been used to aid in OUD management, including cognitive–behavioral therapy, motivational interviewing, contingency management, supportive counselling and other strategies. Rice et al. teach examining behaviors such as illicit drug use, alcohol use, HIV risk behaviors, changes in mental health symptoms (depression, anxiety and suicidality), measures of craving and changes in patients’ quality of life (Rice et al. Evaluating comparative effectiveness of psychosocial interventions for persons receiving opioid agonist therapy for opioid use disorder: protocol for a systematic review. BMJ Open 8:e023902, pages 1-6; 2018).
Given this guidance, one of ordinary skill in the art could reasonably predict that administering the recited vaccine would be useful in methods of treating an opioid use disorder. However, “prevent” means to completely stop a condition from occurring. “Prevention” is not a relative term, it is total. The specification is not enabled for a method of preventing or fully stopping the varied psychological effects encompasses by opioid use disorders. A very high degree of evidence is required, which is accepted in the art, that an absolute protection from the pathology exists over an extended period of time. It could not be predicted that administering the recited vaccine would completely stop an opioid use disorder from ever occurring.
Due to the inherent unpredictability and the large quantity of experimentation necessary to show that the onset of an opioid use disorder has been prevented or fully stopped; the lack of direction/guidance presented in the specification to same; the absence of working examples to same, the complex nature of the invention and the prior art which teaches the different facets of opioid use disorder, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Janda et al. (US 2022/0081400; published March 17, 2022, priority date July 16, 2018) and Valli et al. (Reference of record; LTA1 is a safe, intranasal enterotoxin-based adjuvant that improves vaccine protection against influenza in young, old and B-cell-depleted (µMT) mice. Scientific Reports Volume 9:15128, 2019).
Janda et al. teach an adjuvanted conjugate opioid vaccine comprising a protein-hapten conjugate, wherein the protein-hapten conjugate comprises a protein carrier, wherein the protein carrier is CRM197, and at least one opioid backbone hapten conjugated to the protein carrier, wherein the opioid backbone hapten is fentanyl; and at least one adjuvant admixed with the protein-hapten conjugate (abstract, paras 0005, 0006, 0070, 0088 and 0089). Janda et al. teach the structure wherein P is CRM197, attached to a fentanyl hapten (para 0070 and Figure 1 and Figure 2B)(applies to claim 11). Janda et al. teach adjuvants (paras 0090, 0166-00169). Janda et al. teach the adjuvanted conjugate opioid vaccine can comprise excipients, stabilizers and buffers (para 0088). Janda et al. teach a method of treating an opioid use disorder, opioid overdose or inhibiting the effect of opioids comprising administering said adjuvanted conjugate opioid vaccine (abstract and para 0161)(applies to claims 9-11).
Janda et al. teach adjuvants but do not teach adjuvants dmLT or LTA1.
Valli et al. teach intranasal (IN) vaccination is an attractive delivery route due to the ease of administration (including possibility of self-administration), lack of injection-related infections, low antigen doses, and induction of robust systemic and mucosal immunity. Valli et al. teach more recently, another mutant adjuvant, dmLT (LT-R192G/L211A), has exhibited success in Phase 1 and 2 clinical trials by non-intranasal (IN) mucosal and parenteral delivery routes. Valli et al. teach LT adjuvants are potent mucosal adjuvants, but there is no candidate being considered for intranasal (IN) use. Valli et al. teach that the LTA1 protein is a safe and effective intranasal adjuvant. Valli et al. teach LTA1 as a mucosal adjuvant, which has broad potential for flu and other vaccines (pages 1 and 10)(applies to claims 12 and 13).
It would have been obvious for one of ordinary skill in the art before the effective filling date to modify a method of treating an opioid use disorder, opioid overdose or inhibiting the effect of opioids in a subject comprising administering an adjuvanted conjugate opioid vaccine comprising a protein-hapten conjugate, wherein the protein-hapten conjugate comprises a protein carrier, wherein the protein carrier is CRM197, and at least one opioid backbone hapten conjugated to the protein carrier, wherein the opioid backbone hapten is fentanyl; and at least one adjuvant admixed with the protein-hapten conjugate, as taught by Janda et al., by using dmLT and/or LTA1 as adjuvants, as taught by Valli et al. One of ordinary skill in the art before the effective filing date, would have been motivated to make such modifications and expect success because Valli et al. teach intranasal (IN) vaccination is an attractive delivery route due to the ease of administration and that LTA1, as a mucosal adjuvant, has broad potential for flu and other vaccines. Valli et al. also teach that dmLT adjuvants have exhibited success in Phase 1 and 2 clinical trials by non-IN mucosal and parenteral delivery routes.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M DEBERRY whose telephone number is (571)272-0882. The examiner can normally be reached M-F 9:00-6:30 pm (alt Fri).
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/R.M.D/Examiner, Art Unit 1647 1/29/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647