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 .
Priority
This application, filed 10/19/2023 is a National Stage entry of PCT/US2022/025462, International Filing Date: 04/20/2022. PCT/US2022/025462 claims foreign priority to 2021070892, filed 04/20/2021. A certified copy of the foreign priority application is of record.
Status of Claims
Claims 1, 3-8, 10-14, and 16-26 are currently pending, claims 2, 9, and 15 have been canceled.
Claims 1, 3-8, 10-14, and 16-26 were examined and are rejected.
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.
Claims 3-6 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 claims recite the term “comprises” followed by “one or more selected from the group consisting of”. The inclusion of both “comprises” and “one or more selected from the group consisting of” is confusing because “comprises” is open-ended while “one or more selected from the group consisting of” requires selection from a closed group. The claims are indefinite, as the metes and bounds aren’t clear.
To provide compact prosecution, the claims were given the narrower scope, i.e., limited to the species following “one or more selected from the group consisting of”.
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.
Claim(s) 1, 5, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koyanagi et. al., Blood Coagulation & Fibrinolysis, vol. 25, pp. 316-321, publ. 2014.
Koyanagi discloses the compound SMTP-7 as a modulator of plasminogen activation, and that this agent has shown excellent therapeutic activity in treating thrombotic stroke in rodent models (title & abstract). SMTP-7 has the following structural formula, as defined by Applicants’ specification (para [0008]):
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Koyanagi discloses combining SMTP-7 in a composition with the surfactant Tween 80, and that Tween 80 performed as a cofactor for the plasminogen activation of SMTP-7 (p. 318, see paras under Results section, and Fig. 1). Tween 80 is also known as polyoxyethylene sorbitan monooleate, as shown by Koyanagi (p. 318, see Fig. 1(a), for chemical structure of Tween 80). Therefore, Koyanagi discloses a pharmaceutical composition comprising SMTP-7 with an amphipathic additive, polyoxyethylene sorbitan monooleate, and anticipates the claims.
Claim Rejections-35 USC § 103
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.
Claim(s) 7, 10-13, 16-17, 20-24, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koyanagi et. al., Blood Coagulation & Fibrinolysis, vol. 25, pp. 316-321, publ. 2014 as applied to claims 1, 5, and 14 as discussed previously, in view of Honda et. al., EP 2452679 A1, publ. 5/16/2012, cited in an IDS.
The disclosure of Koyanagi as discussed previously is incorporated herein. Furthermore, as Koyanagi teaches SMTP-7 has shown excellent therapeutic activity in treating thrombotic stroke in rodent models, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have treated the ischemic disorder, ischemic stroke and acute ischemic stroke, comprising administering to a subject in need thereof a pharmaceutical composition comprising SMTP-7 and the amphipathic additive, Tween 80, since Tween 80 is taught to enhance the plasminogen activating activity of SMTP-7, and have had a reasonable expectation of success.
Koyanagi doesn’t explicitly teach or suggest intravenous administration or the concentration of SMTP-7 between about 0.5 mg/mL to about 20 mg/mL; Koyanagi also doesn’t explicitly teach or suggest administering to a subject within the time period recited by instant claim 20, or to a subject for whom treatment with a thrombolytic drug is contraindicated.
Honda teaches triphenyl phenol compounds as cytoprotective agents for the treatment of ischemic damage (title & abstract; para [0008-0010]):
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. Honda teaches when a thrombolytic drug is administered to treat a thrombus, ischemia reperfusion damage may result, leading to enhancement of cerebral edema or intracranial hemorrhage (para [0005]). Honda teaches the triphenyl phenol compounds as described above have plasminogen activation activity which allows for thrombolysis, as well as a cytoprotective effect for inhibiting dysfunction caused by ischemia (para [0006-0007], [0017]). Honda teaches thrombosis is involved in pathologies such as transient ischemic attack, disseminated intravascular coagulation syndrome, thrombotic microangiopathy, thrombosis phlebitis, deep vein thrombosis, idiopathic thrombosis, cerebral infarction, myocardial infarction, and pulmonary thromboembolism (para [0024]). Honda exemplifies the compound SMTP-7 (para [0061], Table 5). Administration of a triphenyl phenol compound at a dose between 0.01-100 mg/kg for treating ischemic damage is taught, as well as intravenous administration from once to multiple times daily; additionally, administration of the compound immediately after the onset of symptoms up to 12 hours after symptom onset is preferable (para [0068-0070]). Honda further teaches administration of a triphenyl phenol compound to a patient to whom a thrombolytic drug is no longer applicable due to the passage of time after symptom onset, as well as administration to a patient to whom a thrombolytic drug is contraindicated, including patients at risk of intracranial hemorrhage (para [0073-0074]). Honda exemplifies preparing a composition comprising SMTP-7 at a concentration of 10 mg/mL (para [0093]), and administration of this composition to gerbils 1 hr, 3 hrs, or 6 hrs after initiation of ischemia in a model of cerebral infarction (para [0096]). Honda teaches SMTP-7 in particular had a significant effect on reducing infarct size and mitigated hemorrhagic infarction; furthermore, SMTP-7 inhibited an increase in inflammation parameters IL-1β, TNF-α, and IL-6 (para [0174]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims, to have treated an ischemic condition, such as cerebral infarction, ischemic stroke, or transient ischemic attack comprising administering the composition comprising SMTP-7 and the amphipathic additive, Tween 80, in consideration of the combined teachings of Koyanagi and Honda. Koyanagi teaches SMTP-7 has shown excellent therapeutic activity in treating thrombotic stroke in rodent models, and teaches combining SMTP-7 with the surfactant Tween 80 allowed for enhancement of plasminogen activation. Honda teaches triphenyl phenol compounds, of which SMTP-7 is exemplified, for treating ischemic conditions, and in particular cerebral infarction and transient ischemic attack. Honda further teaches intravenous delivery and administration within the time period recited by instant claim 20, as well as treatment in a patient for whom therapy with a thrombolytic drug is contraindicated, including patients at risk for intracranial hemorrhage. As such, one of ordinary skill in the art would have been motivated to have applied the method of treatment as taught by Honda, by administering the pharmaceutical composition taught by Koyanagi, with the reasonable expectation that treatment would have been enhanced by the presence of Tween 80 in the composition. As Honda also teaches SMTP-7 inhibited an increase in inflammation parameters IL-1β, TNF-α, and IL-6, it would have been prima facie obvious to have administered the SMTP-7 composition taught by Koyanagi to treat an inflammatory disease in a subject as recited by instant claim 26, and have had a reasonable expectation of success.
Regarding instant claim 7, Honda further teaches the triphenyl phenol compound can be in the form of a pharmaceutically acceptable salt, including a basic amine or basic amino acid (para [0066]). Therefore, it would have been prima facie obvious to have arrived at the composition of instant claim 7, comprising a basic amine or basic amino acid as an additive to form a salt of SMTP-7, and the amphipathic additive, Tween 80, from the combined teachings of Koyanagi and Honda.
Claim Rejections-Nonstatutory 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, 3-8, 10-14, and 16-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7, 11-15, 17, 20-22, 37-38, 41-42, 46-47, 49, and 51-54 of copending Application No. 18289399 (reference application) in view of Honda et. al., EP 2452679 A1, publ. 5/16/2012. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of treating a subject with cerebral infarction comprising administering a composition comprising the same active compound, SMTP-7, and either or both of a basic additive or amphipathic additive:
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; particularly, see copending claims 1 & 46, and instant claims 1 and 10-11. Additionally, both sets of claims recite the basic additive as being selected from amino sugars, alkanolamines, and trometamol; and the amphipathic additive selected from polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitan monolaurate, sorbitan fatty acid ester, and polysorbate (see copending claim 47 & instant claims 4-5). Both sets of claims further recite administering within an overlapping time period after onset of cerebral infarction, e.g., within 12 hours (see copending claim 7 & instant claim 20); intravenous administration (copending claim 11 & instant claim 16); as well as administration to a subject to whom administration of a thrombolytic agent is contraindicated (copending claim 15 and instant claims 22-24). While the copending claims recite administering the compound at a dose of 1-6 mg/kg, which is not recited by the instant claims, this dose range would have been prima facie obvious in view of Honda. Honda teaches triphenyl phenol compounds as cytoprotective agents for the treatment of ischemic damage (title & abstract; para [0008-0010]):
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. Honda teaches when a thrombolytic drug is administered to treat a thrombus, ischemia reperfusion damage may result, leading to enhancement of cerebral edema or intracranial hemorrhage (para [0005]). Honda teaches the triphenyl phenol compounds as described above have plasminogen activation activity which allows for thrombolysis, as well as a cytoprotective effect for inhibiting dysfunction caused by ischemia (para [0006-0007], [0017]). Honda teaches thrombosis is involved in pathologies such as transient ischemic attack, disseminated intravascular coagulation syndrome, thrombotic microangiopathy, thrombosis phlebitis, deep vein thrombosis, idiopathic thrombosis, cerebral infarction, myocardial infarction, and pulmonary thromboembolism (para [0024]). Honda exemplifies the compound SMTP-7 (para [0061], Table 5). Administration of a triphenyl phenol compound at a dose between 0.01-100 mg/kg for treating ischemic damage is taught, as well as intravenous administration; additionally, administration of the compound immediately after the onset of symptoms up to 12 hours after symptom onset is preferable (para [0068-0070]). Honda further teaches administration of a triphenyl phenol compound to a patient to whom a thrombolytic drug is no longer applicable due to the passage of time after symptom onset, as well as administration to a patient to whom a thrombolytic drug is contraindicated, including patients at risk of intracranial hemorrhage (para [0073-0074]). Honda exemplifies preparing a composition comprising SMTP-7 at a concentration of 10 mg/mL (para [0093]), and administration of this composition to gerbils 1 hr, 3 hrs, or 6 hrs after initiation of ischemia in a model of cerebral infarction (para [0096]). Honda teaches SMTP-7 in particular had a significant effect on reducing infarct size and mitigated hemorrhagic infarction; furthermore, SMTP-7 inhibited an increase in inflammation parameters IL-1β, TNF-α, and IL-6 (para [0174]). Therefore, one of ordinary skill in the art would have arrived at the dose of 1-6 mg/kg as recited by the copending claims, in view of the guidance provided by Honda. For these reasons, the instant and copending claims are obvious variants of each other and are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Information Disclosure Statement
The IDS filed on 1/9/24 and 10/21/25 have been considered.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627