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 .
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The disclosure is objected to because of the following informalities: the specification includes “acillin” and “disulfram,” but also includes “allicin,” and “disulfiram.” Please ensure that the compounds listed in the specification are correctly spelled and consistent with the invention.
Appropriate correction is required.
Claim Objections
Claims 2 and 8 are objected to because of the following informalities: both claims include “acillin,” and “disulfram;” this appears to be a typographical error for “allicin,” and “disulfiram.” Appropriate correction is required.
Claim Interpretation
The claimed “hydrogen sulfide donor” is interpreted to mean a compound, that once administered to a subject, releases hydrogen sulfide, in vivo. This interpretation appears consistent with the instant specification.
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 1-7 and 15 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 claim(s) 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 inventor(s), at the time the application was filed, had possession of the claimed invention. The claims provide for “synthetic mRNA coded to increase CSE expression.” There are no sequences provided, or specific examples of these compounds in the specification. As such, the instant specification does not comply with the written description requirement, with respect to the cited claim limitation.
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 1-16 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.
Claims 1, 8 and 14 are indefinite because, given the grammar of the claim, it is unclear what a “hydrogen sulfide… salt, ester, amide, clathrate, stereoisomer, enantiomer, or analog” would comprise. For example, since hydrogen sulfide is a molecular compound, it has no salt associated with it; similarly, it is unclear what sort of hydrogen sulfide “amides,” “clathrates,” “stereoisomers,” enantiomers,” or “analogs” could entail. Since there are no examples in the instant specification, it is unclear what compounds should be considered when interpreting the claim language. The claims “prodrug” is the only clear limitation, since the specification has provided allicin and disulfiram as acceptable examples of a “hydrogen sulfide prodrug.”
Claims 1 and 15 are indefinite because, although it is clear what cystathionine gamma lyase (CSE) is, it is unclear what salts, esters, amides, clathrates, stereoisomers, enantiomers, prodrugs, and analogs could entail. CSE is a well-known and widely used enzyme of classification EC4.4.1.1. Its structure is known. However, it is unclear what salts, esters, amides, clathrates, stereoisomers, enantiomers, prodrugs, and analogs the claims are referring to, as there are no examples of these in the instant specification. For the sake of examining the claims on their merit, it will be assumed that any enzyme that is capable of performing the same lytic reaction as CSE will be considered an “analog.”
Claims 2-7, 9-13 and 16 are rejected insofar as they are dependent on one of the above-rejected claims, and does not cure the described indefiniteness.
Claim Rejections - 35 USC § 102/103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8-14 and 16 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wall (WO 2019/094383 [IDS Reference]) and evidenced by Kafri, et al (Biochemical Pharmacology, 85, 689-703, 2013 [IDS Reference]). Wall provides a method of treating methamphetamine-induced oxidative stress by administering N-acetyl cysteine (NACA) based compounds, including cardiac myopathies. See page 1, lines 6-17.
Although Wall does not state that NACA compounds are hydrogen sulfide donors, they would have inherently been consistent with the claimed hydrogen sulfide donor. See Kashfi, page 689, “Abstract” section. Since the method of Wall inherently performs the claimed function, it appears as though it anticipates the claims; however, if it can be shown that Wall does not anticipate the claimed invention, the claimed invention would be an obvious variant of Wall’s method.
With respect to claims 8 and 14, Wall provides a hydrogen sulfide donor/prodrug that appears consistent with the claimed donors. See page 3, top. If it can be shown that Wall’s compound is not consistent with the claimed donors, then it can be reasoned that the claimed donors are obvious variants to Wall, since Kashfi shows that Wall’s compound is a hydrogen sulfide donor.
With respect to claims 9 and 16, Wall provides for the same administration methods. See page 11, lines 6-15.
With respect to claims 10, 11, and 13, Wall teaches a number of different dosing regimens that would be consistent with the claimed dosing. See page 27 and 28. If it can be shown that Wall does not explicitly teach the claimed dosing range, it would be reasonable to suggest that the ordinary artisan would be capable of optimizing the dosing regimen and scheduling based upon the instruction provided in Wall.
With respect to claim 12, Wall teaches enteric coatings. See page 14, lines 18-26.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,883,426. Although the claims at issue are not identical, they are not patentably distinct from each other because the inventions provide for embodiments with overlapping scope.
The claims to the patent are drawn to a method of treating/preventing methamphetamine-related endothelial dysfunction by administering a hydrogen sulfide donor, which must specifically be sugammadex. Claims 10 and 16 provide for methods that further include the administration of cystathionine gamma lyase (CSE).
Claims 1-7 and 15 of the instant claim-set provide for methods of treating/preventing methamphetamine-related endothelial dysfunction by administering a hydrogen sulfide donor and CSE, wherein the hydrogen sulfide can be any compound that provides hydrogen sulfide, in vivo, including sugammadex. As such, claims 1-7 and 15 directly read upon claims 10 and 16 of the patent, wherein even though the instant claims are broader, the patent claims would anticipate the claims of the instant invention.
Claims 8-14 and 16 provide for methods of treating/preventing methamphetamine-related endothelial dysfunction by administering a hydrogen sulfide donor, wherein the hydrogen sulfide can be any compound that provides hydrogen sulfide, in vivo, including sugammadex. The instantly claimed embodiments provide for a broader claim that is anticipated by claims 1-9, and 11-15 of the cited patent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhang, et al (Brain Research, 1275, 87-95, 2009).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651