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 1-20 are pending in the instant application.
Election/Restrictions
This action is in response to an election from a restriction requirement filed on March 13th, 2026. There are 20 claims pending and 5 claims under consideration. This is the first action on the merits. The present invention relates to a composition comprising at least one ERO1α inhibitor as recited at instant Claim 15.
Applicant’s election of Group II and B12-5 as a single species of ERO1α in the reply received May 13th, 2026 is acknowledged. Claims 1-14 are withdrawn as claims directed to a non-elected invention. Applicant did not indicate whether the elections were made with or without traverse. To this end, the examiner has construed the lack of traversal as elections without traverse. Therefore, this restriction is considered proper and thus made FINAL.
The elected species of B12-5 was found to be free of the prior art. To this end, search and examination was extended to B12-22, a species of ERO1α inhibitor recited, for example, at Claim 16.
Domestic Benefit
Acknowledgement is made of Applicant’s claim for domestic benefit on the basis of U.S. Provisional Application No. 63/486,680. Claims 15-20, presently under examination are fully supported by this application and will be evaluated with an effective filing date of February 24th, 2023.
Information Disclosure Statement
The Information Disclosure Statement received June 20th, 2024 has been fully considered by the examiner, except where marked with a strikethrough.
Specification
The abstract of the disclosure is objected to because while the use of claimed compositions are disclosed, their nature referred to only as comprising an ERO1α inhibitor without further comment on the structure of these inhibitors is insufficient. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which Applicant may become aware of in the specification.
Drawings
Acknowledgement is made of the drawings filed February 24th, 2024. These drawings are acceptable.
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.
Claim 19 is 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.
Claim 19 is indefinite due to the recitation of the limitation that “at least one ERO1α inhibitor has an IC50 value of less than about 13 µM.” Applicant acknowledges at Page 15, Lines 23-24 that “IC50 can be determined with functional assays or with competition binding assays.” It is appreciated by a person having ordinary skill in the art that the conditions by which an IC50 value is determined impact the IC50 value. In other words, results from a given assay are not directly comparable to the results of an assay run under different conditions, even when measuring inhibition of the same assay. Therefore, this claim is indefinite, as the conditions by which the IC50 value is to be determined are unclear.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 20 depends from Claim 15, which is drawn to a composition comprising at least one ERO1α inhibitor. The recitation of “for treating a thrombotic disease” at Claim 15 is a statement of intended use, and is not given patentable weight. Per MPEP 2111.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” Therefore, Claim 15 is drawn to a composition comprising at least one ERO1α inhibitor. Because the phrase “for treating a thrombotic disease” is not given patentable weight, the specific diseases recited at instant Claim 20 fail to further limit Claim 15, from which it depends, as no additional limitations are recited with respect to the composition are recited.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 15-16, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Selwood et. al. (WO 2008/009935 A1; hereinafter referred to as Selwood) as evidenced by CAS Registry File (332019-59-7; entered into STN April 23rd, 2021; hereinafter referred to as CAS Registry File).
At the abstract, Selwood teaches the general structural formula (I):
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At Page 70, Claim 31, Selwood teaches 2-(benzo[d]thiazol-2-yloxy)-1-(10H-phenothiazin-10-yl)ethenone. As evidenced by CAS Registry File, this compound has the formula:
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This is compound B12-22 as noted, for example, at Page 63 of the instant specification.
At Page 72, Claim 38, Selwood teaches a pharmaceutical composition comprising a phenothiazine derivative which is a compound of formula (I) and a pharmaceutically acceptable carrier. This includes compound B12-22, as noted above.
Regarding the recitation of “for treating a thrombotic disease” as recited at instant Claim 15, this is a statement of intended use that does not carry patentable weight. Per MPEP 2111.02, II., “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the body of the claim sets forth the limitation that the composition comprises at least one ERO1α inhibitor. Therefore, the instant claims are drawn to a composition comprising at least one ERO1α inhibitor.
Taken together, Selwood teaches a composition comprising B12-22. Therefore, Claims 15-16, 18, and 20 are anticipated.
Allowable Subject Matter
Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 15-16 and 18-20 are rejected.
Claim 17 is objected to.
No claim is allowed.
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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