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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on September 21, 2023 and February 13, 2026 in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS document was considered and signed copies of the 1449 form are attached.
Election/Restrictions
Applicant’s election with traverse of Group I (i.e. a pharmaceutical composition comprising a derivatized peptide of formula (II)), claims 1, 2, 10, 11, 14-16, 20,24, 25, 28, 31, 33, 39 and 44, in the reply filed on February 13, 2026 is acknowledged. Further, Applicant’s election of the compound
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in the same reply is acknowledged.
Applicant’s traversal is on the grounds that the claims would not pose an undue burden to search each invention. In view of the traversal, the restriction requirement was reconsidered and is withdrawn herein.
Status of Claims
Currently, claims 1-2, 10-11, 14-16, 20, 24-25, 28, 31, 33, 39, 44, 50-51 and 54-61 are pending and under consideration herein.
Claim Rejections – 35 U.S.C. § 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 50-51 and 54-60 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 treating ischemia-reperfusion injury, myocardial infarction, hind limb ischemia, critical limb ischemia, renal ischemia or kidney injury, does not reasonably provide enablement for prevention of the same. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In evaluating the enablement question, several factors are to be considered. Note In re Wands, 8 USPQ2d 1400 and Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed.
The Nature of the Invention and Breadth of the claims
The invention is drawn to a method for preventing, delaying the progression of, or for treating a wide variety of diseases including heart failure, renal failure, myocardial infarction (MI), restenosis or stroke. Further, claim 11 is drawn to a pharmaceutical combination which includes a “pharmaceutical form” which is an active ingredient having any “cardiovascular effect.” This is extremely broad in that it encompasses any substance having any effect on the entire cardiovascular system, including adverse effects which would not be reasonably expected to have the claimed effect.
The State of the Prior Art and Predictability or lack thereof in the artThe state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific diseases by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic preventative regimen on its face.
The instantly claimed invention is highly unpredictable as discussed below. It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instantly claimed invention is highly unpredictable since one skilled in the art would not recognize which particular compounds of the claimed formula, out of the millions of possible compounds encompassed by the claim, would be effective in treating the entirety of conditions encompassed by the claims.
Additionally, because the claims also include “preventing” the claimed diseases as well as delaying their progression, a person of ordinary skill would have to determine a patient population of healthy individuals to administer the compounds to, determine whether or not that patient population would have acquired any of the claimed conditions, and further determine whether or not the administration of the instant compound(s) prevented said patient population from acquiring said condition(s).
Herr et al. (cited on 9/21/23 IDS) provides that “The ability of certain drugs to precondition the myocardium against ischemia reperfusion injury has led to multiple clinical trials, with little success” (Abstract). The art therefore recognizes that difficulty in prevention of the claimed ischemic conditions. To date, there is no known way to practice this method based on what is known in conventional medicine with respect to the entire scope of claimed conditions.
The Amount of Direction or Guidance Present
Applicants have not provided any competent evidence or disclosed tests that are highly predictive for the broadly claimed pharmaceutical use of the instant compounds for treating the entirety of conditions listed in the claim.
The scope of the claims is not adequately enabled solely based on the mitochondrial targeting activity provided in the specification. First, the instant claims prevention of the claimed diseases, for which there is no direction or guidance provided beyond statements that the compounds can be used for said purpose. Test procedures and assays are provided in the specification at pages 186-199 only for 5 compounds and it is concluded that the compounds of examples 31, 37, 42, 33 and 82 treat the claimed conditions; however, there is nothing in the disclosure regarding how the provided in vitro data reasonably correlates to the prevention of the disorders and conditions embraced the instant claims. The disorders encompassed by the instant claims include, for example, prevention of myocardial infarction. There is no reasonable basis for assuming that the myriad of compounds embraced by the claims will all share the same physiological properties since they are so structurally dissimilar as to be chemically non-equivalent and there is no basis in the prior art for assuming the same. Note In re Surrey, 151 USPQ 724 regarding sufficiency of disclosure for a Markush group.
In regard to the prevention, to this day the only means available is the treatment of patients already suffering from the claimed conditions, but not preventing the same conditions in a healthy patient.
The Quantity of Experimentation Needed and the Level of Skill in the Art
While the level of skill in the pharmaceutical arts is high, it would require undue experimentation for one of ordinary skill in the pertinent art to use the entire genus of claimed compounds for the instantly claimed method. This rejection can be overcome by amending the claims to include treatment of only specific diseases for which a reasonable nexus has been demonstrated between the in vitro activity demonstrated and the treatment of the disease.
Thus, factors such as “sufficient working examples”, “the level of skill in the art” and “predictability”, etc. have been demonstrated to be sufficiently lacking in the use of the invention. In view of the breadth of the claim, the chemical nature of the invention, the unpredictability of ligand-receptor interactions in general, and the lack of working examples regarding the activity of the claimed compounds, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims.
To overcome this rejection, it is recommended that applicants amend the claims to delete the term “preventing” from the method of treatment claims.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-2, 10-11, 14-16, 20, 24-25, 28, 31, 33, 39, 44, 50-51 and 54-61 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-18 of US Patent 11,795,196.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claim(s) because the examined 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).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the instantly claimed compositions and methods are anticipated by those in the patented claims. In particular, the conflicting claims recite compounds of an identical formula
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, including a list of anticipatory patented compounds (claim 17) and most specifically the compound
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.
It is noted that the instant claims are drawn to methods of treating and preventing ischemia-reperfusion injury, myocardial infarction, hind limb ischemia, critical limb ischemia, renal ischemia or kidney injury, as well as pharmaceutical compositions of the compounds of formula (I), while the conflicting claims are directed to the compounds themselves. To this end, the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent.
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
Section 804 IIb of the M.P.E.P. states
...those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
In the instant case, the specification and title of the conflicting patent identifies the compounds as having efficacy as mitochondrial targeting substances for the treatment of diseases associated with mitochondrial dysfunction, including ischemia-reperfusion injury or myocardial infarction. Further, the utility in pharmaceutical compositions is necessarily met by the description of treating the diseases as claimed.
Since the patented claims are drawn to compounds with a utility identical to that encompassed by the instantly claimed methods and compositions, a double patenting rejection is appropriate.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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