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
This action is in response to papers filed September 9, 2025. Applicant’s reply to the restriction/election requirement of July 16, 2025 has been entered. Claims 3, 17-20, and 24-29 have been canceled. Claims 1, 2, 4-16, 21-23, 30, and 31 are pending.
Priority
Applicant’s claim for the benefit as a continuation-in-part (CIP) of prior-filed WIPO International Application No. PCT/US2021/063846, filed December 16, 2021 under 35 U.S.C. 365(c), which claims the benefit of prior-filed U.S. Provisional Patent Application Nos. 63/126,380, 63/173,869, and 63/174,085, filed December 16, 2020, April 12, 2021, and April 13, 2021, respectively, under 35 U.S.C.119(e), is acknowledged.
Election/Restrictions – Non-Compliant Response
Applicant’s election without traverse of Group I, claims 1, 2, and 4-16, is acknowledged. Applicant’s elections of i) “tricarbonyldichlororuthenium(II) dimer (CORM-2)” as the species of ruthenium-based agent, ii) “enhancing coagulation” as the species of method, and iii) “human” as the species of subject are all also acknowledged. The Examiner has determined that claims 1, 2, 7, 8, and 14 read on the elected subject matter.
Applicant’s response filed September 9, 2025 is non-compliant. First, Applicant failed to elect a single disclosed species of “source of the venom”, and also failed to elect a single disclosed species of “underlying mechanism of treatment”, as required. Second, Applicant elected “human” as the single disclosed species of subject, but this election remains incomplete. This species election more specifically required Applicant to elect whether the subject is, in fact, suffering from venom poisoning, or rather is “at risk” of suffering from venom poisoning. However, despite the non-compliant response, as a courtesy, and in the interest of furthering compact prosecution, Applicant’s reply has been entered. Nevertheless, Applicant should provide the missing species elections in their next response.
Accordingly, claims 4-6, 9-13, 15, 16, 21-23, 30, and 31 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on September 9, 2025. Claims 1, 2, 7, 8, and 14 are under examination.
Claim Objections
Claims 1 and 8 are objected to because of the following:
i). In claim 1, there should be a semicolon rather than a comma between “agents” and “wherein”.
ii). In claim 8, there should be a closing parenthesis after “(CORM-3)”
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 7, and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claims recite compositions comprising ruthenium-based agents, which are nature-based compositions that, without question, are found in nature. This judicial exception is not integrated into a practical application because the claims are directed to the natural compositions themselves and not to methods of using the compositions. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not necessarily require the ruthenium-based agent to be limited to a synthetic ruthenium-based agent, or require the further inclusion of any non-natural compounds in the composition.
Claim Rejections - 35 USC § 112(b)
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 1, 2, 7, 8, and 14 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.
Claim 1 is indefinite for the following reasons:
1. Claim 1 is directed to a composition comprising a “ruthenium-based agent”. The limitation “ruthenium-based agent” is not defined by the claim. One of ordinary skill cannot definitively ascertain the metes and bounds of the limitation. For example, does a “ruthenium-based agent” necessarily contain ruthenium? Does a “ruthenium-based agent” further include any compound that e.g. can be synthesized from a reaction in which ruthenium is a catalyst, but which compound need not necessarily contain ruthenium? Or what?
2. Claim 1 stipulates in a wherein clause that “in vitro or in vivo exposure of the composition to a biological sample results in inhibition of venom related procoagulant activity, inhibition of venom related PLA2 activity, and/or inhibition of venom related thrombus generation”. One of ordinary skill in the art cannot make heads or tails out of “exposure of the composition to a biological sample” resulting in inhibition of all the recited venom related effects. What “biological sample”? How is this “biological sample” connected, if at all, to venom, to procoagulant activity, to PLA2 activity, and to thrombus generation. Moreover, humans and other organisms are known to contain at least trace amounts of “ruthenium-based agents”, and one of ordinary skill in the art cannot definitively ascertain if this phrase about “in vitro or in vivo exposure of the composition to biological samples” which results in the recited effects is somehow supposed to limit the ruthenium-based agent to those naturally found in humans or other organisms. Or, alternatively, is the ruthenium-based agent being administered to a human or to a biological sample? One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 8 stipulates in a wherein clause that the ruthenium-based agent is a ruthenium-based carbon monoxide releasing molecule, then in parentheses provides by way of example, CORM-2 and CORM-3, which renders the claim indefinite. One of ordinary skill cannot definitively ascertain whether the limitations in parentheses following the e.g. are part of the claimed invention. See MPEP § 2173.05(d). If so, one of ordinary skill in the art cannot definitively ascertain whether the claim is necessarily limited to the ruthenium-based agent being CORM-2 and/or CORM-3.
Claims 2, 7, 8, and 14 are (also) indefinite for depending from an indefinite claim.
Claim Rejections - 35 USC § 112(d)
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 14 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 14, which depends from claim 1, stipulates in a wherein clause that “the composition is a pharmaceutical composition”. Claim 1 is directed to a composition comprising a ruthenium-based agent, and stipulates in a wherein clause that “in vitro or in vivo exposure of the composition to a biological sample results in inhibition of venom related procoagulant activity, inhibition of venom related PLA2 activity, and/or inhibition of venom related thrombus generation”. One of ordinary skill in the art, therefore, would no doubt understand that the composition of claim 1 is a pharmaceutical composition. Claim 14 thus does not appear to further limit claim 1 from which it depends.
Claim Rejections - 35 USC § 102(a)(1) and 102(a)(2)
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 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.
I. Claims 1, 2, 7, 8, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nielsen et al. (Anesthesia and Analgesia. 2010; 111(6): 1347-1352).
Applicant’s elected subject matter is directed to a pharmaceutical composition comprising tricarbonyldichlororuthenium(II) dimer (CORM-2).
Nielsen et al. disclose a pharmaceutical composition comprising tricarbonyldichlororuthenium(II) dimer (CORM-2).
Nielsen et al., therefore, anticipate the elected subject matter.
II. Claims 1, 2, 7, 8, and 14 are rejected under 35 U.S.C. 102(a)(1) and 35 USC 102(a)(2) as being anticipated by Nielsen et al. (U.S. Patent Application Pub. No. 2018/0177826).
Applicant’s elected subject matter is directed to a pharmaceutical composition comprising tricarbonyldichlororuthenium(II) dimer (CORM-2).
Nielsen et al. disclose a pharmaceutical composition comprising tricarbonyldichlororuthenium(II) dimer (CORM-2) (see e.g. examples).
Nielsen et al., therefore, anticipate the elected subject matter.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617