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 Claims
Claims 1-5, 7-12, 14-16, and 18 are pending in the instant application.
Claims 6, 13, 17, and 19-20 have been canceled.
Withdrawn Objections/Rejections
Applicant’s cancellation of Claim 19 renders the rejection thereof under 35 U.S.C. 112(b) moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claim 20 renders the rejection thereof under 35 U.S.C. 112(d) moot. This rejection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection of Claims 15-16, 18, and 20 under 35 U.S.C. 102(a)(1). Applicant’s cancellation of Claim 20 renders the rejection thereof moot. This rejection is hereby withdrawn.
Election/Restrictions
Claims 15-16 and 18 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 1-5, 7-12, and 14, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on March 13th 2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
The following rejections are necessitated by amendment:
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 1-5, 7-12, and 14 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 a method of treating atherothrombosis and/or ischemic stroke, does not reasonably provide enablement for the treatment of any thrombotic disease. 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 use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a method of inhibiting ERO1α in a subject having thrombotic disease comprising administering at least one ERO1α inhibitor comprising B12-5.
Breadth of the invention:
The scope of the claimed invention is very broad, as it is drawn to inhibiting ERO1α in a subject having thrombotic disease. This includes numerous thrombotic diseases, including not only those presently known, but also extends to thrombotic diseases that are discovered years from now. Can Applicant simply “reach through” and obtain patent protection over methods of inhibiting ERO1α in diseases that are either not presently known, or those diseases that are known presently, but are later classified as thrombotic diseases?
State of the prior art and predictability in the art:
With respect to inhibiting ERO1α in subjects having thrombotic disease, Wang et. al. (“The extracellular Ero1α/PDI electron transport system regulates platelet function by increasing glutathione reduction potential”, Redox Biology, 2022; hereinafter referred to as Wang) represents the state of the prior art.
At the Abstract, Wang states, “targeting the functional interplay between PDI and Ero1α by small molecule inhibitors may be a novel strategy for antithrombotic therapy.”
At Page 4, Second Paragraph of Second Column, Wang discloses results validating an Ero1α inhibitor as an inhibitor of the Ero1α-PDI axis, and at Page 10, Second Paragraph of Second Column, Wang states, “The critical role of the Ero1α/PDI electron transport system in platelet aggregation makes it a promising target for antithrombotic therapy.” Further, “future drug development targeting the functional interplay between Ero1α and PDI could kill two birds with one stone for both anticancer and antithrombotic therapy, which is especially important for the clinical treatment of cancer patients with high risk of thrombosis.”
Taken together, Wang establishes inhibition of ERO1α in subjects with a thrombotic disease for the treatment thereof is speculative and unpredictable.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
Beginning at Page 46 of the instant specification, disclosure is provided detailing the identification of B12-5 and other B12 derivatives as inhibitors of ERO1α, and validated in vivo administration of B12-5 in treating atherothrombosis and ischemic stroke.
Beyond this, no examples of inhibition of ERO1α in a subject with thrombotic disease have been disclosed.
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation. As alluded to above, a person having ordinary skill in the art would need to identify and/or develop methods by which to evaluate the instantly claimed method for inhibition of ERO1α in subjects having thrombotic disease wherein the disease is a thrombotic disease other than atherothrombosis and/or ischemic stroke. Based on the instant disclosure, the breadth of the claims could not be practiced by a person having ordinary skill in the art with reasonable expectation of success.
Genentech Inc. v Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 states 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 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 and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person having ordinary skill in the art would have to engage in undue experimentation to practice the full scope of the claimed invention.
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.
Claims 4 and 11 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.
The phrase “does not significantly affect” recited in Claims 4 and 11 renders each claim indefinite, as “does not significantly affect” is not defined in the specification such that a person having ordinary skill in the art would be able to reasonably ascertain the metes and bounds of this limitation.
Allowable Subject Matter
Claims 15-16 and 18 are allowed.
Conclusion
Claims 1-5, 7-12, and 14 are rejected.
Claims 15-16, and 18 are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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