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 .
Status of the Application
Claims 1-2, 7, 11-15, 17, 20-21, 37-38, 41-42, 49 and 51-54 are pending in the application as of the response submitted 06/09/2026. Claims 3-6, 8-10, 16, 18-19, 22-36, 39-40, 43-48 and 50 are cancelled. Claims 1-2, 7, 11-15, 17, 20-21, 37-38, 41-42, 49 and 51-54 are examined herein.
Applicant’s submission of an English translation of the foreign priority document on 06/09/2026, is acknowledged. The subject matter of the instant claims is supported in the foreign priority application, JAPAN 2021-079820 filed 05/10/2021. Therefore, the instant claims have been afforded an effective filing date of 05/10/2021.
The 35 U.S.C. 112(b) rejection of previous record is rendered moot in consideration of the cancellation of claim 47.
Applicants have perfected the foreign priority claim by submitting an English translation. Therefore, the Nishimura reference published 03 February 2022, is no longer available as prior art (Pg. 7 of Applicant’s remarks dated 06/09/2026). The 35 U.S.C. 102 rejection of previous record over Nishimura is hereby withdrawn.
Applicants submit that the Hasumi reference is not available as prior art (Pg. 7 of Applicant’s remarks dated 06/09/2026). Applicant’s declaration submitted 06/09/2026 indicates that the Hasumi reference is a grace period inventor originated disclosure and that the additional co-author named in the Hasumi reference is not an inventor. Therefore, the Hasumi reference is excepted as prior art under the 35 U.S.C. 102(b)(1)(A) exception. The 35 U.S.C. 102 rejection of previous record over Hasumi is hereby withdrawn in consideration of the declaration.
The 35 U.S.C. 102 rejection of claims 20-21, 37-38 and 54 over Honda is withdrawn in consideration of the claim amendments.
The 35 U.S.C. 103 rejection of claims 46-47 over Honda in view of Koyanagi is rendered moot in consideration of the cancellation of claims 46-47.
Applicant’s arguments have been carefully considered and was not found to be persuasive, as elaborated below.
In view of the pending claims, the statutory class of the rejection of claims 20-21, 37-38 and 54 is changed to a 35 U.S.C. 103 rejection over Honda, necessitated by the claim amendments. All other 35 U.S.C. 103 rejections of record over Honda are maintained and modified to address the claim amendments. The title of the rejection is edited to include claim 49 which was included in the body of the Non-final rejection and to include the joint inventor paragraph that was inadvertently missed.
The nonstatutory double patenting rejection of record is maintained and updated to reflect the claim amendments.
37 C.F.R. 1.121
The following claims have not been provided with the proper status identifier, which is improper.
It is brought to Applicant’s attention that claim 22 is noted as cancelled in the remarks (page 6) dated 06/09/2026. However, claim 22 is not accounted for in the claim set dated 06/09/2026.
See MPEP 714(II)(C) for further explanation of the amendment format required by 37 CFR 1.121.
Information Disclosure Statement
The information disclosure statements submitted on 07/07/2026 and 06/09/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 103 – Maintained and modified
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 1-2, 7, 11-15, 17, 20-21, 37-38, 41-42, 49 and 51-54 are rejected under 35 U.S.C. 103 as being unpatentable over the Honda et al. (EP 2452679 A1, 16 May 2012, hereinafter Honda, in the IDS).
Regarding instant claim 1 and 49, Honda teaches a method of treatment of ischemic damage including administration of a drug containing a triprenyl phenol compound according to the present invention to a patient 3 or more hours after the onset of a symptom, especially for the treatment of cerebral infraction (Para. [0081]). Honda teaches the subject can be a human (Para. [0076]). Honda teaches a single effective dose for an adult of the triprenyl phenol compound to preferably be 0.1 to 30 mg/kg (Para. [0068]). Honda exemplifies the treatment of cerebral infarction in various animal models comprising administering an exemplary triprenyl phenol compound, SMTP-7 (Paras. [0085]-[00173]). SMTP-7 is taught to be a cryoprotective agent for the treatment of ischemic damage having the following structure (Paras. [0008]-[0010]; Paras. [0060]-[0061], Table 5).
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Honda teaches the triprenyl phenol compounds to have plasminogen activation activity which allows for thrombolysis, as well as cryoprotective effect for inhibiting dysfunction caused by ischemia (Paras. [0006]-[0007]; Para. [0017]). SMTP-7 is Compound I of instant claim 1 as evidenced by Para. [0008] of the instant specification. Honda teaches a test dose of 10 mg/kg of SMTP-7 administered intravenously as a bolus over 5 sec followed by continuous administration over 30 min in a crab-eating monkey cerebral infarction model (Paras. [0154]-[0173]). Honda teaches the administration of SMTP-7 (10 mg/kg) resulted in significant reduction in infraction size in the crab-eating monkey model (Paras. [0172]-[0173]).
According to MPEP 2144.05(II)(A), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed human dose of 1 to 6 mg of SMTP-7 (i.e., Compound I), more specifically 1 mg/kg, 3 mg/kg and 6 mg/kg, in the absence of any criticality of the recited doses.
The teachings of Honda render the limitations of instant claims 1-2, 11, 13 prima facie obvious.
Regarding instant claims 7 and 20-21, the teachings of Honda render the method of treating cerebral infarction in a human as in instant claim 1, , i.e., a method of treating a human subject with cerebral infarction, comprising administering to the human subject in need thereof a pharmaceutical composition comprising Compound I having the structure of formula (I) at a dose of 1 to 6 mg/kg of said Compound I prima facie obvious. Honda teaches administration of the agent up to 12 hours after the onset of the symptom (Para. [0069]).
According to MPEP 2144.05(II)(A), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to optimize the treatment window, to arrive at the 3 to 12 hours or 4.5 to 12 hours after onset of cerebral infarction of the instant claims with a reasonable expectation of success, absent any criticality of the recited administration window. This is because Honda teaches administering the agent 3 or more hours after the onset of a symptom and up to 12 hours after the onset of the symptom.
Regarding instant claim 12, the teachings of Honda render the method of treating cerebral infarction in a human as in instant claim 1, prima facie obvious. Honda teaches that there is no particular restriction on the number of administrations, and the use by any of one-time administration, multiple administrations, and a continuous administration is acceptable (Para. [0068]). This renders the limitation drawn to once daily administration, prima facie obvious.
Regarding instant claim 14, the teachings of Honda render the method of treating cerebral infarction in a human as in instant claim 1, prima facie obvious. Honda teaches SMTP-7 administered intravenously as a bolus over 5 sec followed by continuous administration over 30 min in a crab-eating monkey cerebral infarction model. Honda teaches rapid intravenous injection for 10% of a single dose, and a drip infusion over 30 min to 1 hour for 90% thereof (Para. [0070]). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have optimized the intravenous administration schedule to arrive at the schedule of the instant claims with a reasonable expectation of success. See MPEP 2144.05(II)(A) cited above.
Regarding instant claim 15, the teachings of Honda render the method of treating cerebral infarction in a human as in instant claim 1, prima facie obvious. Honda teaches in the case of cerebral infarction, it is effectual to use a drug containing a triprenyl phenol compound according to the present invention for a patient to whom alteplase cannot be administered because 3 or more hours have passed since the onset of a symptom (Para. [0081]; Paras. [0074]-[0075]). This renders the limitations of claim 15 prima facie obvious.
Regarding instant claim 17, the teachings of Honda render the method of treating cerebral infarction in a human as in instant claim 1, prima facie obvious. Honda teaches the cryoprotective agent is effective in treating cerebral infarction associated with cerebral thrombosis, cerebral embolism pathologies (i.e., pathologies causing atherothombotic/embolic cerebral infarction) (Para. [0024]). This renders the limitations of claim 17 prima facie obvious.
Regarding instant claims 41-42 and 51-53, the teachings of Honda render the method of treating cerebral infarction in a human as in instant claim 1, prima facie obvious. Here, the limitations with respect to “wherein the administering of the pharmaceutical composition improves a life of independence after cerebral infarction, wherein an index of the improvement of a life of independence is outcome of mRS (modified Rankin Scale) of 0-1 on Day 90 after administration; wherein the administering of the pharmaceutical composition improves a life of independence after cerebral infarction, wherein an index of the improvement of a life of independence is outcome of mRS (modified Rankin Scale) of 0-2 on Day 90 after administration; wherein the administering of the pharmaceutical composition dissolves a thrombus of a cerebral infarction patient; wherein the administering of the pharmaceutical composition has a low risk of a hemorrhagic side effect; wherein the administering of the pharmaceutical composition reduces the risk of causing hemorrhage in cerebral infarction”, are related to the mechanism of action of the drug, Compound I, in treating cerebral infarction. Honda teaches the active step of administering a pharmaceutical composition of the same drug (Compound 1) to the same patient population (a subject with cerebral infarction). Therefore, the method of Honda, when practiced in treating a human subject with cerebral infarction, would have necessarily produced the same treatment effects. Therefore, the limitations of instant claims 41-42 and 51-53 are rendered obvious by the teachings of Honda.
Regarding instant claim 37, Honda renders obvious the method of treating a human subject with cerebral infarction, comprising administering to the human subject in need thereof a pharmaceutical composition comprising Compound I having the structure of formula (I) at a dose of 1 to 6 mg/kg of said Compound I (see rationale used for rejection of instant claim 1 above). The limitation with respect to “wherein the administering of the pharmaceutical composition recanalizes occluded vessel in cerebral infarction”, is related to the mechanism of action of the drug, Compound I, in treating cerebral infarction. Honda teaches the active step of administering a pharmaceutical composition of the same drug (Compound 1) to the same patient population (a subject with cerebral infarction) in doses that are encompassed by the disclosure of Honda.
According to MPEP 2112.02 (II), “The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978)”. In the instant case, the method of Honda, when practiced in treating a human subject with cerebral infarction, would have necessarily produced the same treatment effects, i.e., resulted in recanalizing the occluded vessel in cerebral infarction.
Regarding instant claims 38 and 54, Honda renders obvious the method of treating a human subject with cerebral infarction, comprising administering to the human subject in need thereof a pharmaceutical composition comprising Compound I having the structure of formula (I) at a dose of 1 to 6 mg/kg of said Compound I (see rationale used for rejection of instant claim 1 above). Honda teaches in case of cerebral infarction, it would be effective to use the cryoprotective agent for a patient to whom a thrombolytic drug cannot be administered, because the risk of intracranial hemorrhage would be increased (Para. [0074]; Para. [0082]). Therefore, the teachings of Honda renders obvious the limitations of instant claims 38 and 54.
Response to Arguments
Applicants argue on page 8 of the response dated 06/09/2026 that “Neither Honda nor Koyanagi, taken alone or in combination, teaches or suggests the claimed human doses recited in the present claims … As discussed further below, this disclosure does not teach, suggest, or provide guidance as to an effective and safe dose in humans, nor would it direct a person of ordinary skill in the art to the claimed human dose range. Therefore, Honda has not provided any teachings of human doses of SMTP-7, let alone any clinical data indicating such a broad range is safe and efficacious in humans”.
Applicant's arguments have been fully considered but they are not persuasive.
Contrary to Applicant’s contention that Honda does not teach or suggest the claimed human doses, as discussed in the 103 rejection above, Honda teaches a method of treatment of ischemic damage including administration of a drug containing a triprenyl phenol compound to a patient 3 or more hours after the onset of a symptom, especially for the treatment of cerebral infraction. Honda teaches the subject can be a human. Honda teaches a single effective dose for an adult of the triprenyl phenol compound to preferably be 0.1 to 30 mg/kg. Honda exemplifies SMTP-7 as a triprenyl phenol compound of choice (Table 5, Para. [0062]) (i.e., Compound I of the instant claims). The dosage disclosed by Honda clearly encompasses the claimed 1 to 6 mg/kg of SMTP-7. Applicants have not established any criticality of the claimed dosages, as further elaborated below.
According to MPEP 2123 (I), A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). In the instant case, the teachings of Honda provide sufficient motivation to pursue SMTP-7 for the treatment of cerebral infarction in humans. Therefore, the rejection of record over Honda has not been overcome.
Applicants argue on pages 8-11 of the response dated 06/09/2026 that “Translation from animal doses into human doses is highly unpredictable and there is no reasonable expectation of success to arrive at human doses based on disclosure of doses tested in an animal model”. Applicants have cited various references to support unpredictability with respect to dose conversion from animal models to humans.
Applicant's arguments have been fully considered but they are not persuasive.
Applicant’s submission of various references is acknowledged and has been carefully considered. While there is general unpredictability with respect to translating therapies of neuroprotectants from animal models to human stroke trials, none of the cited references provide any direct evidence of failure to translate acute ischemic stroke therapies in a crab-eating monkey model to humans. Narayanan et al. (cited by Applicant), in fact, teach that models involving larger and more evolved animal species more closely resemble human strokes (Pg. 112, first column, last paragraph). The examiner notes that the crab-eating monkey is known to share close anatomical, physiologic and cerebrovascular homology to humans, making it a robust model to study cerebral infarction. Narayanan et al. state that STAIR guidelines recommend using two different species of animals for studying the efficacy of a drug, with initial studies preferably on rodents and further studies on larger animals, before going to clinical trials (Pg. 111, second column, last paragraph). Honda shows experimental results regarding the effectiveness of SMTP-7 in both a mouse model of cerebral infarction and a crab-eating model of cerebral infarction, rendering it reliable. Ferriera et al. (cited by Applicant), state that while standard reporting quality of preclinical studies is generally poor, specific pharmacokinetic parameters effectively predict human responses (Abstract). Ferriera et al. teaches predicting clinical active dose ranges from animal data is generally reliable—with Human Equivalent Dose (HED) and Area Under the Curve (AUC) serving as top predictors (Pg. 9, second column, second paragraph). Ferriera et al. conclude that integrated data presentation improves translation (Pg. 11, second column, last paragraph – first column, continued paragraph).
Overall, while it may be true that several therapies have failed to translate from animal models to human clinical trials, doses can be and routinely are translated using validated pharmacological frameworks.
Moreover, according to MPEP 2143.02, “The reasonable expectation of success requirement refers to "the likelihood of success" in combining or modifying prior art disclosures to meet the limitations of the claimed invention. See Elekta Ltd. v. ZAP Surgical Sys., Inc., 81 F.4th 1368, 1375, 2023 USPQ2d 1100 (Fed. Cir. 2023) and Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367, 119 USPQ2d 1171, 1176 (Fed. Cir. 2016) … Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019)”. In the instant case, Honda teaches the triprenyl phenol compounds (including SMTP-7) to have plasminogen activation activity which allows for thrombolysis, as well as cryoprotective effect for inhibiting dysfunction caused by ischemia. Honda teaches that SMTP-7 directly reduces the volume of cerebral infarction and limits subsequent brain damage when administered after ischemia. Honda teaches that SMTP-7 can be administered hours after the onset of the ischemic event, i.e., has a wider therapeutic window. Thus, the teachings of Honda provide sufficient evidence to support a reasonable expectation of success in translating the results from the animal models into human dosages.
Applicants argue on pages 11-12 of the response dated 06/09/2026 that “The claimed human doses of SMTP-7 demonstrate unexpected benefits of achieving both safety and efficacy at the same time in human subjects”. Applicants reference Example 1 and Example 2 in the specification and state that these examples establish that SMTP-7 at 1, 3 and 6 mg/kg doses was safe with no indication of hemorrhagic risk in healthy persons, SMTP-7 at 1 mg/kg, 3 mg/kg, and 6 mg/kg demonstrates that SMTP-7 does not promote symptomatic intracranial hemorrhage with NIHSS score worsening of 4 or more points up to 24 hours after administration compared to the placebo group, and that the mRS values of these dosage groups were statistically significantly lower than the placebo group.
Applicant's arguments have been fully considered but they are not persuasive. While the examiner appreciates the Applicants’ discussion of unexpected results, the examiner respectfully disagrees a sufficient showing of unexpected results for the following reasons.
According to MPEP 716.02. “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected.”
According to MPEP 716.02(b)(I): The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."). In the instant case, although Applicants assert that the claimed 1 mg/kg, 3 mg/kg, and 6 mg/kg of SMTP demonstrated a good safety profile without inducing toxicity versus placebo, Applicants have not established any criticality of these claimed dosages. Applicants have not provided any data to demonstrate that at dosages outside this range there were some adverse side effects, i.e., induced hemorrhagic risk or that the neuroprotective effect was not observed. Applicants have not provided any data showing why the 1 to 6 mg/kg doses perform better or differently in a surprising way compared to the rest of Honda's broad range. The range of 0.1-30 mg/kg taught by Honda overlaps with and encompasses the claimed narrower dosages of 1 to 6 mg/kg, establishing a prima facie case of obviousness. Thus, the evidence provided by Applicants is not sufficient to overcome the obviousness rejection of record.
According to MPEP 716.02(b)(II), “"[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). As such, Applicants have not established evidence of unexpected results.
Therefore, the 35 U.S.C. 103 rejection of record over Honda is maintained.
Double Patenting – Maintained and updated
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 7, 11-15, 17, 20-21, 37-38, 41-42, 49 and 51-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 8, 10-14, 16-18, 21-29 and 31-48 of co-pending Application No 18/287,489 in view of Honda et al. (EP 2452679 A1, 16 May 2012, hereinafter Honda, in the IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both set of claims are drawn to a method of treating a subject with cerebral infarction comprising administering a composition comprising the same active compound, a compound represented by formula (I) (SMTP-7).
The instant claims are drawn to a method of treating a human subject with cerebral infarction, comprising administering to the human subject in need thereof a pharmaceutical composition comprising Compound I having the structure of formula (I) (i.e., SMTP-7) or a salt thereof at a dose of 1 to 6 mg/kg as of said Compound I and other embodiments.
The claims of the reference ‘489 application are drawn to a method for preventing or treating an ischemic disorder in a subject in need thereof, wherein the method comprises administering a therapeutically effective amount of a pharmaceutical composition according to claim 1 to the subject, wherein the pharmaceutical composition comprises a compound represented by formula (1) (i.e., SMTP-7).
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Claims 10-12, 35-38 of the reference ‘489 application anticipates treating cerebral infraction as in instant claim 1. Claims 13 and 39 of the reference ‘489 application anticipates treating acute ischemic stroke as in instant claim 49. Claims 16 and 40 of the reference ‘489 application anticipates the intravenous administration as in instant claim 11. Claims 21-24 and 41-44 of the reference ‘489 application anticipates the patient population as in instant claims 15, 38 and 54. The remaining claims of the reference ‘489 application drawn to specific pharmaceutical composition anticipates the generic pharmaceutical composition of the instant claims (since a species always anticipates a genus, MPEP 2131.02(I)).
The reference ‘489 application does not teach the specific dosages of SMTP-7, the administration schedule, the window of administration of the active agent after the onset of cerebral infarction as in instant claims 7 and 20-21 and the intended treatment effects as in instant claims 41-42 and 51-53.
Honda teaches a single effective dose for an adult of the triprenyl phenol compound to preferably be 0.1 to 30 mg/kg (Para. [0068]). Honda exemplifies the treatment of cerebral infarction in various animal models comprising administering an exemplary triprenyl phenol compound, SMTP-7 (Paras. [0085]-[00173]). Honda teaches a test dose of 10 mg/kg of SMTP-7 administered intravenously as a bolus over 5 sec followed by continuous administration over 30 min in a crab-eating monkey cerebral infarction model (Paras. [0154]-[0173]). Honda teaches the administration of SMTP-7 (10 mg/kg) resulted in significant reduction in infraction size in the crab-eating monkey model (Paras. [0172]-[0173]). Honda teaches administration of the triprenyl phenol compound according to the present invention to a patient 3 or more hours after the onset of a symptom, especially for the treatment of cerebral infraction (Para. [0081]).
According to MPEP 2144.05(II)(A), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed human dose of 1 to 6 mg of SMTP-7, more specifically 1 mg/kg, 3 mg/kg and 6 mg/kg, in the absence of any criticality of the recited doses and the claimed administration schedule.
Regarding the intended treatment effects as in instant claims 41-42 and 51-53, performing the active step of administering a pharmaceutical composition of SMTP-7 to a subject with cerebral infarction, as taught by the reference ‘489 application, would have necessarily resulted in the intended treatment effects.
Therefore, claims 1, 4-6, 8, 10-14, 16-18, 21-29 and 31-48 of the reference ‘489 application in view of Honda renders the instant compounds of claims 1-2, 7, 11-15, 17, 20-21, 37-38, 41-42, 49 and 51-54 prima facie obvious.
The instant claims 1-2, 7, 11-15, 17, 20-21, 37-38, 41-42, 49 and 51-54 and claims 1, 4-6, 8, 10-14, 16-18, 21-29 and 31-48 of co-pending Application No 18/287,489 are therefore not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants argue on page 12 of the response dated 06/09/2026 that “Applicant submits that the Office's ODP rejection rests entirely on the allegation that Honda teaches the claimed human doses of"1 to 6 mg/kg" as recited in the instant claims. However, as explained above in the response to 103 rejections, Honda does not teach or suggest the claimed human doses of "1 to 6 mg/kg”.
Applicant's arguments have been fully considered but they are not persuasive.
For the reasons of record and discussion above, the disclosure of the broad numerical range of 0.1 to 30 mg/kg in Honda establishes a prima facie case of obviousness for a narrower claimed sub-range of 1 to 6 mg/kg. Applicants have not established any criticality of the claimed 1 to 6 mg/kg dosage range. Therefore, the nonstatutory double patenting rejection is maintained.
Conclusion
Claims 1-2, 7, 11-15, 17, 20-21, 37-38, 41-42, 49 and 51-54 are rejected.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached on 9:00-5:30pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (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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/PADMAJA S RAO/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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