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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 25, 2023 has been entered.
Response to Amendment
2. Claim 2 has been amended and claim 6 canceled as requested in the amendment filed on August 25, 2023. Following the amendment, claims 2, 9 and 11-18 are pending in the instant application.
3. Claims 11-18 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in Paper filed on April 28, 2021.
4. Claims 2 and 9 are under examination in the instant office action.
5. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
6. Applicant’s arguments filed on August 25, 2023 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 2 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention for reasons of record at section 4 of Paper mailed on October 12, 2022.
8. Claim 2 stands vague and indefinite for reasons of record in section 6 of Paper mailed on June 07, 2022. Applicant submits at p. 4 of the Response that amendment to the claim obviates the rejection. While this has been fully considered, the argument is not persuasive because claim 2, as currently presented, encompasses a method for inhibiting neuronal activity in a subject without any point of reference to evaluate the degree of inhibition. Providing a point of reference or comparison within the claim would obviate this ground of rejection.
9. Next, claim 2, as amended, is indefinite insofar as it recites the term “neural membrane bound proteasome (NMP) associated disease or disorder” as a limitation. This term is not known within the relevant art of record as being specifically associated with a well-defined genus of pathologies. Moreover, because the instant specification fails to set forth any definitive limitations on “neural membrane bound proteasome (NMP) associated disease or disorder,” an artisan would not know whether a disease or disorder which meets all other limitations of the claim would be included or excluded from the claimed invention.
10. Finally, claim 2 specifically requires inhibition of “neuronal activity” in a subject, and it is not obvious what particular activity is intended by the claim. It is especially critical in view of the fact that inhibition of all neuronal activity ultimately kills the subject under treatment.
11. Claim 9 is rejected under 35 U.S.C. 112, second paragraph, as being incomplete for being dependent from a cancelled claim. See MPEP § 608.01(n), V.
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.
12. Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 2 is directed to a method of treatment of a neural membrane bound proteasome (NMP) associated disease or disorder by administration of biotin-epoxomicin. However, the specification does not provide sufficient guidance to enable practice the full scope of the claimed invention without undue experimentation.
The enablement requirement is met when one skilled in the art, having read the specification, could practice the invention without “undue experimentation.” Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d at 1336 (Fed. Cir. 2013). The factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and, (8) the breadth of the claims. In re Wands, 8 USPQ2d, 1400 (CAFC 1988).
The specification discloses a set of experiments, specifically Examples at pp. 72-83, to study the effect of an NMP-specific inhibitor (biotin-epoxomicin) on NPM-dependent production of extracellular peptides; NMP-mediated co-translational degradation of ribosome-associated nascent polypeptides, and to study activity-dependent nascent NMP substrates. The instant specification does not provide any further information directly supporting and enabling what is currently claimed—a method of administration of biotin-epoxomicin for a specific clinical benefit. There appears neither enough guidance for such a method of treatment, nor working examples, which would show that the claimed method was successfully achieved, thus, requiring undue experimentation on part of one skilled in the art to discover how to practice the claimed invention.
The nature of the invention involving biological molecules and their effect on a physiological system is complex and unpredictable. As was found in Ex parte Hitzeman, 9 USPQ2d 1821 (BPAI 1987), a single embodiment may provide broad enablement in cases involving predictable factors such as mechanical or electrical elements, but more will be required in cases that involve unpredictable factors such as most chemical reactions and physiological activity. This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology", Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970); Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991).
The prior art does not recognize the term a “neural membrane bound proteasome associated disease or disorder.” Moreover, finding of biotin-epoxomicin being suitable for immediate effect to “inhibit neuronal activity,” as in claim 2, has not been reported. Also, as explained earlier, it is not even clear what stands for the specific neuronal activity intended to be inhibited, see earlier in sections 8-10. The prior art undeniably recognizes that neuronal activity is essential to life of a subject under treatment for any pathology; therefore, a method of inhibiting of neuronal activity must be meaningfully enabled.
With respect to claim breadth, the standard under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. In addition, when analyzing the enablement scope of the claims, the teachings of the specification are to be taken into account because the claims are to be given their broadest reasonable interpretation that is consistent with the specification (see MPEP 2111 [R-1], which states that claims must be given their broadest reasonable interpretation“During patent examination, the pending claims must be "given *>their< broadest reasonable interpretation consistent with the specification." In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).”
As such, the broadest reasonable interpretation of the claimed method is that it allows inhibition of neuronal activity and treatment of any disease that is “associated” with NMP by administration of biotin-epoxomicin, and is not particularly limited to specific diseases or to a particular neuronal activity. Thus, the claims encompass an unreasonable number of pathological conditions, which the skilled artisan would not know how to evaluate, to be treated by inhibiting neuronal activity. However, the specification fails to teach any factual evidence directly supporting the claimed subject matter. No methods of treatment of any diseases can be envisioned because the experiments provided within the specification do not directly relate to any of the limitations recited in the claims. In fact, he specification does not describe a single embodiment that satisfies the claim limitations.
A mere wish or plan of obtaining the claimed invention is not sufficient. The standard of an enabling disclosure is not the ability to make and test if the invention worked but one of the ability to make and use with a reasonable expectation of success.
A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. In the decision of Genentec, Inc, v. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997), the court held that:
“[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” and that “[t]ossing out the mere germ of an idea does not constitute enabling disclosure.” The court further stated that “when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art,” “[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement.”
The instant specification is not enabling because one cannot follow the guidance presented therein and practice the claimed methods without first making a substantial inventive contribution to perfect the method and complete the invention.
Conclusion
13. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
August 4, 2026
Prosecution Insights