DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-18 are pending.
Claims 1, 2, 4-6, 8, 10-13 and 18 are examined herein.
Claims 3, 7, 9, and 14-17 are withdrawn (see restriction/election below).
Priority
This application is filed on 08/28/2024 and claims the benefit of domestic priority as below:
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Information Disclosure Statements
Two IDS(s) received on 06/18/2025 and 06/25/2026 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicants elect Group I, claims 1-13, and 16-18, is drawn to a method for treatment or prophylaxis of ageing or ageing-associated disorders comprising administering a compound by formula (I) or (II), or a hydroquinone analogue of formula (II), or a pharmaceutically acceptable salt thereof, without traverse in the reply field on 08/18/2026 is acknowledged. Claims 14-15 (Group II) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of use, there being no allowable generic or linking claim.
Applicants elect the SUL-138 (S-(6-hydroxy-2,5,7,8-tetramethylchroman-2-yl)(4-(2-hydroxyethyl)piperazin-l-yl)methanone)one compound as the species, without traverse in the reply field on 08/18/2026 is acknowledged. The applicants assert that claims 1-13 and 16-18 are readable on the elected species.
The elected species was not identified in the art. If Applicant drafted an independent claim drawn to only the elected specie that claim would be allowable. Examiner expanded his search to a new specie pursuant to MPEP 803.02. The expanded species, SUL-121 in claim 8, reads on claims 1, 2, 4-6, 8, 10-13 and 18. Claims 3, 7, 9, 16, are 17 from Group I are withdrawn from consideration because these claims do not read on the elected species. It should be noted that the full scope of claims 3, 7, 9, 16, are 17 have not yet been searched. Accordingly, the readable claims 1, 2, 4-6, 8, 10-13 and 18 will be examined on their merits.
With respect to the expanded species, the art is rejected under 35 USC 103, 35 USC 112(a) and 35 USC 112(b) below.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because:
The lines, numbers and lettering are not clean, well-defined, sufficiently dense and dark, and uniformly thick and well defined in Figure(s) 1. See 37 CFR 1.84(l) and (q).
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepare new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claim(s) 1 and 5 is/are objected to because of the following informalities:
Claim 1 is objected to because the phrase “…3-12 carbon atoms; ii. or R2 is a hydrogen atom…” should be ““…3-12 carbon atoms; or ii. R2 is a hydrogen atom…”.
Claim 5 is objected to because the term “formula I” should be “formula (I)”.
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 1, 2, 4-6, 10-13 and 18 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.
Regarding claim 1, the phrases "can be removed ", "may comprise", and “may contain” render the claim indefinite because the scope of the recited limitations is unclear. In particular, it is unclear whether these phrases define specific optional alternatives within the claimed structures or merely describe possible characteristics without defining the boundaries of the claimed subject matter. These phrases create uncertainty as to which structural features are required, and which may be omitted from the claimed compound. Claims 2, 4-6, 10-13, and 18 do not resolve the indefiniteness identified in claim 1 because they retain at least one of the ambiguous limitations of claim 1 that discussed above.
Regarding claim 6, the phrase “R2 and R3 together with the N atom to which they are attached form a 5-7 membered ring comprising one additional amine group” renders the claim indefinite because it is unclear whether the limitation “comprising one additional amine group” encompasses a ring in which the additional amine nitrogen is incorporated into the ring, such as a piperazinyl group, or whether it requires the ring to be substituted with an amine containing substituent. For this office action, the Examiner interprets claim 6 as encompassing compounds with unsubstituted piperazinyl groups that are formed from R2 and R3 together with the N atom to which they are attached.
Regarding claim 11, the phrase "substantially the whole of the period” renders the claim indefinite because the scope of this limitation is unclear. The specification permits continuous administration, intermittent administration, and drug holidays, including an exemplary schedule of three weeks of administration followed by one week without administration (paragraph [0077]-[0078]). Therefore, it is unclear what minimum frequency or proportion of the recited period satisfies “substantially the whole of the period”. Claim 18 does not resolve the indefiniteness identified in claim 11 because they retain the ambiguous limitation of claim 11 that discussed above.
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, 2, 4-6, 8, 10-13 and 18 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 the use of certain chromanol compounds in particular ageing models, does not reasonably provide enablement for the full scope of the claimed genus of compounds and the claimed therapeutic uses for the treatment or prophylaxis of ageing or ageing-associated disorder. 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.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited 8 factors: 1) the quantity of experimentation necessary; 2) the amount of direction or guidance provided; 3) the presence or absence of working examples; 4) the nature of the invention; 5) the state of the prior art; 6) the relative skill of those in the art; 7) the predictability of the art; and 8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
Nature of the invention:
The invention is drawn to a method for treatment or prophylaxis of ageing or ageing-associated disorders comprising administering to a subject a compound according to formula (I) or (II), or a hydroquinone analogue of formula (II), or a pharmaceutically acceptable salt thereof. The claimed compounds encompass structurally diverse R1, R2, and R3 substituents, including prodrug moieties.
Breadth of the claims:
The claims are broadly directed to the use of the compounds of Formula (I) and Formula (II) for the treatment or prophylaxis of ageing or ageing-associated disorders. Claims 2 and 4-6 further define portions of the genus of Formula (I) and Formula (II) but remain subject to the broad therapeutic use recited in claim 1.
The specification describes ageing related disorders including vascular ageing, reduced kidney function, loss of memory, reduced lung-function and the like (paragraph [0063]). Thus, the claims encompass therapeutic effects in physiologically distinct tissues and organ system.
The breadth of claim 1 also encompasses an R1 substituent defined functionally as a “prodrug moiety that can be removed in living tissue”. Although the specification provides certain examples of prodrug forms (paragraph [0041]), it does not provide sufficient guidance to predict which prodrug moieties across the full claimed scope would be suitably converted in vivo to the active compounds. Accordingly, additional experimentation would be required to identify operative prodrug embodiments throughout the claimed scope.
Moreover, claim 8 encompasses compounds or a pharmaceutically acceptable salt thereof, as a racemic mixture or as one of its enantiomers. Although claim 8 recites specific compounds, the claim retains the broad therapeutic uses of claim 1, and the specification does not provide experimental evidence commensurate with that full therapeutic scope for each recited compound. Claims 10 and 12 further extend the scope of Claim 1 by applying the broad classes of compounds encompassed by Formulas (I) and (II) to additional therapeutic indications and disease states. Claims 11 and 18 cover the range of chronic administration from a minimum period of two months up to a maximum of 60 years. The specification does not present experimental data commensurate with such a wide range of administration durations.
Level of ordinary skill in the art:
The artisans using applicant’s method would have knowledge and experience in medicinal chemistry, pharmacology, ageing biology, and the relevant therapeutic area, and would be capable of conducting routine in vitro and in vivo testing.
State of the prior art and predictability in the art:
It is known in the art that ageing is a complex biological process involving tissue and organ dependent changes. Schaum et al. (Nature, 583, 596–602, pub’d 07/15/2020) shows that ageing-associated molecular changes exhibit distinct temporal patterns among different organs and tissues (abstract and discussion). Thus, efficacy demonstrated for a particular compound in one aging model or organ system would not, without further evidence, reasonably establish efficacy of structurally different compounds across other ageing-associated conditions or organ systems.
In addition, Harrison et al. (Nature, 460, 7253, 392-5, pub’d 7/8/2009) shows that rapamycin extended lifespan in genetically heterogeneous mice after long-term administration at three independent test sites (abstract). Thus, Harrison teaches that a pharmacological effect on ageing may require compound- and regimen-specific testing and cannot reasonably be predicted merely from antioxidant activity or short-term improvement in a particular tissue or experimental model.
Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The amount of direction provided and working examples:
The specification provides a Drosophila lifespan study using SUL-109 and SUL-121. The specification also provides an accelerated ageing EC-KO mouse study in which SUL-138 is administered for 8 weeks and evaluated primarily for vascular and renal effects. While these examples provide evidence regarding three specific compounds under certain experimental conditions, they do not offer sufficient guidance to predict which compounds within the claimed genus would be effective against the other aging-related diseases encompassed by Claim 1.
The specification does not establish that effects observed in a lifespan, vascular or renal model are predictive of efficacy in neurological, pulmonary, or other ageing-associated disorders. Additoinaly, for claim 8, the specification does not establish the represented compounds’ salts, racemic mixture and/or individual enantiomer recited in the claim for the full range of claimed ageing-associated disorders. See MPEP 2164.02 (“Compliance with the enablement requirement of 35 USC 112, first paragraph, does not turn on whether an example is disclosed ... Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”).
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation. A PHOSITA would need to select compounds from the claimed genus and experimentally determine which compounds provide the claimed therapeutic effect for the different ageing-associated conditions. Such testing would require compound by compound and condition specific pharmacological evaluation rather than routine verification of results reasonably predictable from the disclosure.
For claim 11 and 18, additional experimentation would be needed to determine whether the compounds remain effective and suitable over the broad range of chronic administration periods encompassed by the claims.
In view of the breadth of the claimed compounds and therapeutic uses, the limited representative experimental data, the organ specific nature of ageing, and the unpredictability of pharmacological activity, the experimentation required to practice the full scope of the claimed invention would be undue.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Claim Rejections - 35 USC § 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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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, 4-6, 8, 10-12, and 18 is/are rejected under 35 U.S.C. 103 as being obvious over Lambooy et al. (Scientific Reports, 7(1), 11165, pub'd 09/11/2017, made of recode in the IDS) in view of Tümer et al. (Physiol Rep., 2(6), e12031, pub’d 06/06/2014), and further in view of Gioscia-Ryan et al. (J Physiol., 592(12), 2549-61, pub’d 06/15/2014).
With respect to independent claim 1, the claim recites that a method for treatment or prophylaxis of ageing or ageing-associated disorders comprising administering to a subject a compound according to formula (I) or (II), or a hydroquinone analogue of formula (II), or a pharmaceutically acceptable salt thereof.
Lambooy teaches 1) administering SUL-121, a species encompassed by Formula (I), to mice at 2.2 mg/kg/day by subcutaneous osmotic pumps administration from infusion for 10 to 18 weeks (abstract); 2) SUL-121 inhibits mitochondrial ROS production, restores endothelium mediated vasorelaxation through increased nitric oxide and prostaglandin-mediated components, and preserves endothelial function (introduction, and results section); and 3) inhibits the progression of kidney damage (Discussion and Conclusion section).
Lambooy fails to teach administering SUL-121 for treatment or prophylaxis of ageing or an ageing-associated disorder.
Tümer teaches that ageing causes vascular dysfunction characterized by structural remodeling, increased oxidative stress, reduced nitric oxide availability, and impaired endothelium dependent and endothelium independent vascular relaxation (introduction and discussion section). Tümer further teaches that the age-related impairment indicates a deficient NO/cGMP-mediated mechanism (discussion section).
The combination of Lambooy and Tümer fails to teach administering a mitochondrial ROS inhibiting compound to an aged subject to restore nitric oxide bioavailability and endothelium dependent vasodilation.
Gioscia-Ryan teaches that mitochondria derived oxidative stress is an important mechanism underlying vascular endothelial dysfunction in primary ageing (abstract). Gioscia-Ryan further teaches that administration of the mitochondria targeted antioxidant MitoQ to old mice restores endothelium dependent dilation by improving nitric oxide bioavailability (abstract, results, and Fig. 1-2.)
It would have been obvious to a PHOSITA at the time of the invention to administer SUL-121, as taught by Lambooy for treating or preventing age-related vascular dysfunction, as taught by Tümer and Gioscia-Ryan. Lambooy establishes that SUL-121 inhibits mitochondrial ROS and restores nitric oxide associated endothelial vasorelaxation, while Tümer and Gioscia-Ryan establish that oxidative stress, reduced nitric oxide bioavailability, and impaired vascular relaxation are associated with age-related vascular dysfunction, and Gioscia-Ryan specifically identifies mitochondria derived oxidative stress as a therapeutic target in ageing. A PHOSITA would have been motivated to administer SUL-121 for treating or preventing age-related vascular dysfunction and would have had a reasonable expectation of success because the compound is already known to produce the mitochondrial and endothelial effects identified as therapeutic targets in ageing.
With respect to claims 2, 4-6 and 8, the claims recite the structural limitations for the method of claim 1.
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Lambooy teaches SUL-121 compound, as required in claim 8 that 1) has R1 is hydrogen, as required in claim 2; 2) has R2 and R3 together to form unsubstituted piperazine, as required in claims 4 and 6; and 3) belongs to formula (I), as required in claim 5 (chemicals and compounds section).
Instant Formula (I) SUL-121
With respect to claim 10, the claim recites that the method according to claim 1 for the treatment or prophylaxis of vascular aging, for delaying ageing, and/or for the treatment or prophylaxis of reduced kidney function due to aging.
Tümer and Gioscia-Ryan teach that ageing causes vascular endothelial dysfunction through increased mitochondrial oxidative stress, reduced nitric oxide bioavailability, and impaired vasodilation (Tümer’s introduction and discussion, and Gioscia-Ryan’s abstract and results, Fig. 1-2). Therefore, claim 10 would have been obvious for the same reasons discussed with respect to claim 1.
With respect to claims 11 and 18, the claims recite that the compound is administered chronically, comprising administration of the active over a period of at least 2 months wherein an effective amount of compound is administered for substantially the whole of the period in claim 11; and administration of the active over a period of 60 years or less in claim 18.
Lambooy teaches administering SUL-121, a species encompassed by Formula (I), to mice at 2.2 mg/kg/day by continuous subcutaneous infusion for 8 weeks by subcutaneous osmotic pump administration (abstract, and introduction). The 8 weeks administration period satisfies the “60 years or less” in claim 18 and closely approaches the “at least 2 months” in claim 11.
However, Extending Lambooy’s 8-week treatment regimen by a few days to a minimum of two months would have been a routine optimization of the treatment duration. Lambooy characterized such 8 weeks regimen as long-term administration, reporting beneficial effects on the vasculature and kidneys without any observable major adverse effects (Abstract and Discussion). Therefore, a person having ordinary skill in the art (PHOSITA) would have had a basis for extending the treatment duration to at least two months and could have reasonably expected the treatment to remain effective and well-tolerated. Absent evidence demonstrates that the specific regiment is critical or yields unexpected results of a different nature, the claimed minimum treatment period would not have rendered the otherwise obvious treatment method nonobvious. (see MPEP 2144.05)
With respect to claim 12, the claim recites that the treatment and prophylaxis of disease conditions are associated with a reduced endothelium-dependent NO-cGMP vasodilation.
Tümer teaches that ageing causes vascular dysfunction characterized by structural remodeling, increased oxidative stress, reduced nitric oxide availability, and impaired endothelium dependent and endothelium independent vascular relaxation (discussion). Tümer further teaches that the age-related impairment indicates a deficient NO/cGMP-mediated mechanism (discussion).
Therefore, claim 12 would have been obvious for the same reasons discussed with respect to claim 1.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lambooy et al. (Scientific Reports, 7(1), 11165, pub'd 09/11/2017, made of recode in the IDS), Tümer et al. (Physiol Rep., 2(6), e12031, pub’d 06/06/2014), and Gioscia-Ryan et al. (J Physiol., 592(12), 2549-61, pub’d 06/15/2014), as applied to claim 1 above, and further in view of Dunn et al. (Physiol Rep., 5(23), e13502, pub'd 12/07/2017).
With respect to claim 13, the claim recites that the treatment and prophylaxis of disease conditions are associated with the preservation of vascular function through EDHF rescue.
The combination of Lambooy, Tümer, and Gioscia-Ryan fails to teach the preservation of vascular function through EDHF rescue.
Dunn teaches that decreased EDHF mediated relaxation is a major mechanism of endothelial dysfunction in aged mice subjected to a prolonged high fat sucrose diet (abstract and results). Dunn further teaches that treatment with the antioxidant ebselen restores EDHF mediated relaxation and normalizes endothelial responses (abstract, results, Fig. 7 and conclusion).
It would have been obvious to a PHOSITA at the time of the invention to use the mitochondrial ROS inhibiting SUL-121 taught by Lambooy to preserve vascular function through EDHF rescue in an ageing-associated vascular condition. A PHOSITA would have been motivated to take such measures because Dunn teaches that oxidative stress contributes to impaired EDHF mediated relaxation and that antioxidation treatment rescues the EDHF response, while Lambooy teaches that SUL-121 reduces mitochondrial ROS and shows an increased EDHF component following treatment. A PHOSITA would have had a reasonable expectation of success because both Lambooy and Dunn demonstrated that reducing oxidative stress is associated with improved endothelium-dependent vasorelaxation, notably, Dunn showed that antioxidant treatment could restore the EDHF component of the response.
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, 2, 4-6, 8, 10-13, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of U.S. Patent No. 12,156,862 B2 in view of Lambooy et al. (Scientific Reports, 7(1), 11165, pub'd 09/11/2017, made of recode in the IDS), Tümer et al. (Physiol Rep., 2(6), e12031, pub’d 06/06/2014), Gioscia-Ryan et al. (J Physiol., 592(12), 2549-61, pub’d 06/15/2014), and Dunn et al. (Physiol Rep., 5(23), e13502, pub'd 12/07/2017).
The claims 1 and 10 of the ‘862 patent are directed to administering SUL-150, as the (R)-enantiomer of SUL-121, for the prophylaxis or treatment of a vasoconstriction related disorder or condition.
The instant claims are directed to administration of the same or overlapping chromanol compound, with additional limitations relating to treatment or prophylaxis of ageing or an ageing associated disorder, vascular ageing, reduced NO-cGMP vasodilation, preservation of vascular function through EDHF rescue, and the administration periods recited in claims 11 and 18.
The teachings of Lambooy, Tümer, Gioscia-Ryan, and Dunn are as discussed supra in the 35 U.S.C. 103 rejection and are herein incorporated by reference in their entirety.
The ageing-related therapeutic use limitations, vascular function limitations and administration period limitations recited in the instant claims 1, 2, 4-6, 8, 10-13, and 18 would have been prima facie obvious to one of ordinary skill in the art to variations of the SUL-150 treatment claimed in the ‘862 patent in view of the combined teachings of Lambooy, Tümer, Gioscia-Ryan, and Dunn for the same reasons discussed supra in the 35 U.S.C. 103 rejection, which reasons are herein incorporated by reference in their entirety.
Claims 1, 2, 4-6, 8, 10-13, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,730,741 B2 in view of Lambooy et al. (Scientific Reports, 7(1), 11165, pub'd 09/11/2017, made of recode in the IDS), Tümer et al. (Physiol Rep., 2(6), e12031, pub’d 06/06/2014), Gioscia-Ryan et al. (J Physiol., 592(12), 2549-61, pub’d 06/15/2014), and Dunn et al. (Physiol Rep., 5(23), e13502, pub'd 12/07/2017).
The claims 1-4 of the ‘741 patent are directed to a method of treating a disorder requiring long systemic treatment by administering the (S)-enantiomeric 6-chromanol derivative SUL-151, with claims 2-4 further recite concentration and treatment duration limitations.
The instant claims are directed to administration of the same or overlapping chromanol compound, with additional limitations relating to treatment or prophylaxis of ageing or an ageing associated disorder, vascular ageing, reduced NO-cGMP vasodilation, preservation of vascular function through EDHF rescue, and the administration periods recited in claims 11 and 18.
The teachings of Lambooy, Tümer, Gioscia-Ryan, and Dunn are as discussed supra in the 35 U.S.C. 103 rejection and are herein incorporated by reference in their entirety.
The ageing-related therapeutic use limitations, vascular function limitations and administration period limitations recited in the instant claims 1, 2, 4-6, 8, 10-13, and 18 would have been prima facie obvious to one of ordinary skill in the art to variations of the SUL-150 treatment claimed in the ‘741 patent in view of the combined teachings of Lambooy, Tümer, Gioscia-Ryan, and Dunn for the same reasons discussed supra in the 35 U.S.C. 103 rejection, which reasons are herein incorporated by reference in their entirety.
Claims 1, 2, 4-6, 8, 10-13, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, and 9-11 of copending Application No. 17/783,671 in view of Lambooy et al. (Scientific Reports, 7(1), 11165, pub'd 09/11/2017, made of recode in the IDS), Tümer et al. (Physiol Rep., 2(6), e12031, pub’d 06/06/2014), Gioscia-Ryan et al. (J Physiol., 592(12), 2549-61, pub’d 06/15/2014), and Dunn et al. (Physiol Rep., 5(23), e13502, pub'd 12/07/2017).
The claims 1, 2, 4, 5, and 9-11 of the ‘671 application are directed to substantially the same Formula (I) and Formula (II) chromanol genus and structural limitations for treating Alzheimer’s disease, improving memory function, and/or reducing plaque load. Claims 9 and 10 recite the specific compounds, including SUL-121, SUL-13, SUL-109, and SUL-138.
The instant claims are directed to administration of the same or overlapping chromanol compound, with additional limitations relating to treatment of prophylaxis of ageing or an ageing associated disorder, vascular ageing, reduced NO-cGMP vasodilation, preservation of vascular function through EDHF rescue, and the administration periods recited in claims 11 and 18.
The teachings of Lambooy, Tümer, Gioscia-Ryan, and Dunn are as discussed supra in the 35 U.S.C. 103 rejection and are herein incorporated by reference in their entirety.
The ageing-related therapeutic use limitations, vascular function limitations and administration period limitations recited in the instant claims 1, 2, 4-6, 8, 10-13, and 18 would have been prima facie obvious to one of ordinary skill in the art to variations of the SUL-150 treatment claimed in the ‘671 application in view of the combined teachings of Lambooy, Tümer, Gioscia-Ryan, and Dunn for the same reasons discussed supra in the 35 U.S.C. 103 rejection, which reasons are herein incorporated by reference in their entirety.
Claims 1, 2, 4-6, 8, 10-13, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9-12 of copending Application No. 18/026,834 in view of Lambooy et al. (Scientific Reports, 7(1), 11165, pub'd 09/11/2017, made of recode in the IDS), Tümer et al. (Physiol Rep., 2(6), e12031, pub’d 06/06/2014), Gioscia-Ryan et al. (J Physiol., 592(12), 2549-61, pub’d 06/15/2014), and Dunn et al. (Physiol Rep., 5(23), e13502, pub'd 12/07/2017).
The claims 1-6 and 9-12 of the ‘834 application are directed to substantially the same Formula (I) and Formula (II) chromanol genus and structural limitations for the treatment or prophylaxis of heart failure with reduced ejection fraction. Claims 9 and 10 recite the specific compounds including SUL-121, SUL-13, SUL-109, and SUL-150.
The instant claims are directed to administration of the same or overlapping chromanol compound, with additional limitations relating to treatment or prophylaxis of ageing or an ageing associated disorder, vascular ageing, reduced NO-cGMP vasodilation, preservation of vascular function through EDHF rescue, and the administration periods recited in claims 11 and 18.
The teachings of Lambooy, Tümer, Gioscia-Ryan, and Dunn are as discussed supra in the 35 U.S.C. 103 rejection and are herein incorporated by reference in their entirety.
The ageing-related therapeutic use limitations, vascular function limitations and administration period limitations recited in the instant claims 1, 2, 4-6, 8, 10-13, and 18 would have been prima facie obvious to one of ordinary skill in the art to variations of the SUL-150 treatment claimed in the ‘834 application in view of the combined teachings of Lambooy, Tümer, Gioscia-Ryan, and Dunn for the same reasons discussed supra in the 35 U.S.C. 103 rejection, which reasons are herein incorporated by reference in their entirety.
Claims 1, 2, 4-6, 8, 10-13, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9-11, and 13-14 of copending Application No. 17/928,645 in view of Lambooy et al. (Scientific Reports, 7(1), 11165, pub'd 09/11/2017, made of recode in the IDS), Tümer et al. (Physiol Rep., 2(6), e12031, pub’d 06/06/2014), Gioscia-Ryan et al. (J Physiol., 592(12), 2549-61, pub’d 06/15/2014), and Dunn et al. (Physiol Rep., 5(23), e13502, pub'd 12/07/2017).
The claims 1, 6, 9-11, and 13-14 of the ‘645 application are directed to substantially the same Formula (I) and Formula (II) chromanol genus and structural limitations for treating or preventing sepsis associated organ dysfunction. Claims 9-11 recite the specific compounds including SUL-121, SUL-13, SUL-109, and SUL-138.
The instant claims are directed to administration of the same or overlapping chromanol compound, with additional limitations relating to treatment of prophylaxis or ageing or an ageing associated disorder, vascular ageing, reduced NO-cGMP vasodilation, preservation of vascular function through EDHF rescue, and the administration periods recited in claims 11 and 18.
The teachings of Lambooy, Tümer, Gioscia-Ryan, and Dunn are as discussed supra in the 35 U.S.C. 103 rejection and are herein incorporated by reference in their entirety.
The ageing-related therapeutic use limitations, vascular function limitations and administration period limitations recited in the instant claims 1, 2, 4-6, 8, 10-13, and 18 would have been prima facie obvious to one of ordinary skill in the art to variations of the SUL-150 treatment claimed in the ‘645 application in view of the combined teachings of Lambooy, Tümer, Gioscia-Ryan, and Dunn for the same reasons discussed supra in the 35 U.S.C. 103 rejection, which reasons are herein incorporated by reference in their entirety.
Conclusion
Claims 1, 2, 4-6, 8, 10-13, and 18 are rejected.
Claims 1, and 5 are objected to.
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/SEONG JONG KIM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
