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 .
Applicant’s amendment, filed on 11/02/2023, is acknowledged.
Claims 1-31 are cancelled.
Claims 32-51 are currently pending.
Claims 32 and 47 are independent claims.
Election/Restrictions
Applicant’s election of Group I and the Species of the antibody with CDRL1-3 of SEQ ID NO: 1-3 and CDRH1-3 of SEQ ID NO: 4-6, respectively in the reply filed on 1/30/2026 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 § 818.01(a)).
In the Restriction Requirement mailed on 12/02/2025, Examiner noted that Groups I and II have Unity of Invention. Therefore, Group II is under examination as well.
Claims 50 and 51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
Claims 32-49 are under examination as reading on an antibody with the CDRs recited in claim 32 and methods of treating or preventing an opioid overdose comprising administration of the antibody to a subject in need.
Priority
Applicant’s claim for the benefit of a prior-filed U.S. Provisional Application 63/111,699, filed 11/10/2020, is acknowledged.
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.
Claims 32-49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
Claims 32 and 37 currently recites an antibody with defined CDR regions and no antigen/epitope in which it specifically binds. However, the current state of the art in epitope structure prediction is limited given the noncontiguous amino acid residues constitute most epitopes, and that the dynamics of binding is often not integrated into the epitope prediction equation, making epitope structure prediction a complex four-dimensional problem (see Van Regenmortel, page 464, abstract in particular; Methods: A Companion to Methods of Enzymology 9:465-472, 1996). Van Regenmortel notes that 90% of antibodies raised against intact proteins do not react with any peptide fragment derived from the parent protein indicating that these antibodies are directed to discontinuous epitopes (see page 466, column 1 in particular). In addition Van Regenmortel states that the low success rate of antigenic prediction is due to the fact that predictions concern only continuous epitopes and it is unrealistic to reduce the complexity of epitopes that always possess conformational features to one-dimensional, liner peptide models (see page 467, column 2 in particular). Dependent claims 33-49 do not resolve this issue and are also rejected under 35 U.S.C. § 112(a) WD.
A skilled artisan would require guidance, such as information regarding the specific epitope recognition of the antibodies successfully used in the instant invention in order to antibodies other than the specific clones in a manner reasonably commensurate with the scope of the claims. In the instant case, the specification discloses that the antibodies that were generated, including the instant claimed antibody, selectively binds to the following opioids: carfentanil, fentanyl, 3-methylfentanyl, acetylfentanyl, α-methylfentanyl, butrylfentanyl, and p-tolylfentanyl.
Amending claims 32 and 47 to recite the antigen(s) that the claimed antibody structure binds would resolve this issue.
Claim 46 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 methods of treating or preventing opioid-induced respiratory depression in a patient comprising administration of the claimed antibody structure, does not reasonably provide enablement for methods of treating or preventing opioid-induced respiratory depression or treating opioid use disorder in a patient comprising administration of the claimed antibody structure. 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.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
Breadth of claims and nature of invention:
Claim 46 encompasses a method treating or preventing opioid-induced respiratory depression or treating opioid use disorder in a patient comprising administration of the claimed antibody structure, which is the defined antibody structure claimed in instant claim 32.
The instant specification defines “opioid use disorder” (¶[00104]): “…"opioid use disorder" is characterized by signs and symptoms that reflect compulsive, prolonged self-administration of opioid substances that are used for no legitimate medical purpose or, if another medical condition is present that requires opioid treatment, they are used in doses greatly in excess of the amount needed for that medical condition…”
Amount of direction and existence of working examples:
The instant specification discloses identification of six monoclonal antibody clones that bind to fentanyl and derivatives such as carfentanil, which are JBZ-1, 2, 3, 4, 5, and 6 (Examples 1 and 2).
The instant specification further discloses a working example of a method of reducing the effects of fentanyl in a subject in need comprising administration of the antibodies after fentanyl administration (Example 3 and Fig. 1). The instant specification additionally discloses a working method of preventing the opioid effects of fentanyl via administration of the antibodies prior to fentanyl administration (Example 5 and Fig. 3).
Level of predictability, state of prior art, and quantity of experimentation needed:
Claim 46 encompasses methods of treating or preventing both opioid-induced respiratory depression and opioid use disorders comprising administration of the claimed antibody structure. However, the instant specification only provides methods of treating or preventing only opioid-induced effects. No guidance either in the instant specification or the prior art provide sufficient guidance to one with ordinary skill in the art to use a method of treating or preventing opioid use disorder, which includes a psychological component to the disorder, without undue experimentation.
The specification does not reasonably provide enablement to make and use the invention of instant claim 46. The specification does enable one with ordinary skill to make the antibody clone discussed supra.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Smith et al. (J Am Chem Soc. 2019 Jul 3;141(26):10489-10503. doi: 10.1021/jacs.9b04872. Epub 2019 Jun 25) teaches the following anti-opioid monoclonal antibodies: 2F12, 3H2, 6A4, 7A8, 12A1, and 15F4 (Table 1), which can rescue opioid induced effects in subjects (Fig. 6). However, Smith et al. does not teach the specific antibody structure in claims 32 and 47.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEC JON PETERS whose telephone number is (703)756-5794. The examiner can normally be reached Monday-Friday 8:30am - 6:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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