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 .
Election/Restrictions
Applicant's election with traverse of Group I, drawn to physiological coolants, a physiological coolant mixture, and a physiological coolant in encapsulated form in the reply filed on 06/28/2026 is acknowledged. The traversal is on the grounds that there would be no undue search burden to examine both groups together. This is not found persuasive because, per PCT rule 13.1 and 13.2, search burden is not a criterion for lack of unity of invention. As set forth in the Requirement for Restriction mailed 04/27/2026, the groups of inventions do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical feature, as the shared technical feature does not make a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election of the species of compound B-01 in Table A in claim 3:
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as the physiological coolant, and the species of physiological coolant mixture that does not comprise the optional at least one other physiological coolant of (b) in the reply filed on 06/28/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the election of species requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Upon further search and consideration, the elected physiological coolant is being rejoined with Compound B-44 in Table A of claim 3:
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Claims 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 06/28/2026.
Claims 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/28/2026.
Claims 21-28 are cancelled.
Claims 1-13, 16, and 20 are under current examination.
Priority
This application is a national stage entry of PCT/EP2023/052047, filed 01/27/2023. Foreign priority has been claimed to PCT/EP2022/052139, filed 01/28/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is fewer than 50 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at paragraph [0445]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 1 is objected to because of the following informalities: for consistency in the claim language, chemical formulae should be written with appropriate subscripts; for example, -N(CH3)-phenyl at pg. 4 should be written as -N(CH3)-phenyl, and -OC2H5 and -OC(CH3)3 at pg. 4 should be written as -OC2H5 and -OC(CH3)3, respectively.
Claim 3 is objected to because of the following informalities: it is suggested that “(Via)” in line 2 should be written as “(VIa)”, consistent with the formatting of claim 1.
Claim 16 is objected to because of the following informalities: it is suggested that “Benzyl alcohol” in line 2 should be written as the lowercase “benzyl alcohol”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-13, 16, and 20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 (see pgs. 6 and 10), claim 2, claim 3 (see pgs. 19 and 24), claim 4 (see pg. 29), claim 6 (see pg. 33 and 37), claim 8, claim 11 (see pgs. 54 and 72), and claim 12 recite the term “preferably”. This term renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 1 (see pgs. 4, 5, 6, 9, 10, and 11), claim 3 (see pgs. 19 and 24), claim 4 (see pgs. 28, 29, and 30), claim 6 (see pgs. 32, 33, 34, 36, 37, and 38), claim 7 (see pg. 39), claim 11 (see pgs. 54 and 72), and claim 12 recite the phrase “in particular”. This phrase renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 1 at pg. 4 and claim 6 at pg. 32 recite that “the group Q is a radical selected from the group consisting of…-S(O)2a,… -OS(O)2a,…” without defining the meaning of the superscripted “a”, rendering the metes and bounds of the claims uncertain.
Claims 10, 13, 16, and 20 are rejected under 35 U.S.C. 112(b) by virtue of their dependency on indefinite claim 1 and failure to cure the deficiencies noted above.
Claims 5 and 9 are rejected under 35 U.S.C. 112(b) by virtue of their dependency on indefinite claim 4 and failure to cure the deficiencies noted above.
Claim 7 recites “Physiological coolant according to claim 1, wherein furthermore the optionally substituted groups mentioned above have one or more substituents, such that: (i) when in the aforementioned substituted groups the substitution occurs on a saturated…”. As the claim recites both “the optionally substituted groups…have one or more substituents” and “when in the aforementioned substituted groups the substitution occurs”, it is unclear if the claim is meant to a) require that at least one of the optionally substituted groups has one or more substituents; b) require that every optionally substituted group has one or more substituents; c) further limit the identity of the substituents should the optional substitution occur. For purposes of examination and applying prior art, the Examiner interprets that the claim is intended to limit the identity of the substituents should the optional substitution occur.
Claim 7 defines substituents in terms of “Y” and “Z”, with definitions that are distinct from those provided in instant claim 1 (from which claim 7 depends) for the “Y” and “Z” present in the general formulae (Va)-(VIIIa). The claim is therefore indefinite as to how variables “Y” and “Z” are to be interpreted. It is suggested that Applicant use distinct variables in defining the substituents in claim 7.
Claim 8 recites, “Physiological coolant according to claim 1, wherein in the general formulae (I) to (VIII) and (Va) to (VIIIa)…”. There is insufficient antecedent basis for the general formulae (I) to (VIII) in the claim, as claim 1 recites only formulae (Va) to (VIIIa).
Claim 9 recites, “Physiological coolant according to claim 4, wherein in the general formulae (I) to (VIII)…”. There is insufficient antecedent basis for the general formulae (V) to (VIII) in the claim, as claim 4 recites only formulae (I) to (IV).
Claim 10 recites, “Physiological coolant according to claim 1, wherein in the general formulae (I) to (VIII) and (Va), (VIIa) and (VIIIa)…”. There is insufficient antecedent basis for the general formulae (I) to (VIII) in the claim, as claim 1 recites only formulae (Va) to (VIIIa).
Claim 11 recites, “Physiological coolant according to claim 4, wherein in the general formulae (I) to (II), (V), or (VI) is selected from…” and “wherein the physiological coolant of the general formulae (III), (IV), (VII) or (VIII) is selected from…”. There is insufficient antecedent basis for the general formulae (V), (VI), (VII), and (VIII) in the claim, as claim 4 recites only formulae (I) to (IV).
Claim 20 recites, “Physiological coolant according to claim 1 or a physiological coolant mixture comprising one, two, three or more coolant(s) according to claim 1 and optionally at least one other physiological coolant and/or optionally at least one solvent or a flavoring preparation comprising the physiological coolant or the physiological coolant mixture and at least one flavoring substance in encapsulated form.” It is unclear from the multiple alternative phrasings of the claim language what is required to be in encapsulated form in order to satisfy the claim.
Herein, the Examiner reads the claim as requiring one of
A physiological coolant according to claim 1 or
a physiological coolant mixture comprising one, two, three or more coolant(s) according to claim 1 and optionally at least one other physiological coolant and/or optionally at least one solvent or
a flavoring preparation comprising the physiological coolant or the physiological coolant mixture and at least one flavoring substance
in encapsulated form. That is, a physiological coolant according to claim 1 in encapsulated form satisfies the claim.
Claim Rejections – Improper Markush Grouping
Claims 1-2, 4-10, 12-13, 16, and 20 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 1-2, 4-10, 12-13, 16, and 20 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
Independent claims 1 and 4 recite four separate core structures. While each of these cores is substituted with R1, R2, and -S-(Y)m-C(=O)-Z, these substituents do not constitute a single structural similarity, as each of these variables encompass a vast number of possibilities, leading to a nearly infinite number of permutations encompassing different physical and chemical classes of molecules. The alternatives cannot be said to share a substantial structural feature. Dependent claims 2, 5-10, 12-13, 16, and 20 do not limit the scope of the claimed compounds to a proper Markush group.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claims 1-13 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhalla et al. (“Synthesis and pharmacological evaluation of 1,2,4-triazine and its congeners” Boll. Chim. Farmaceutico 1995, 134(1), 9-15), hereafter “Bhalla”.
Regarding instant claim 1, Bhalla discloses the following compound (II) (see entire document, particularly Fig. 1 at pg. 10):
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consistent with the claimed general formula (Va):
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wherein R1 and R2 are each an aryl group, Y is a branched alkyl group, m is 1, and Z is OH. Regarding the recitation of a “physiological coolant”, given that the compound disclosed by Bhalla is the same as that instantly claimed, it must necessarily possess the same properties and is therefore capable of functioning as a physiological coolant. Per MPEP 2112.01 II., “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
Regarding instant claim 2, as shown above, the compound of Bhalla is consistent with the recited Y of a substituted methylene group.
Regarding instant claim 3, the compound of Bhalla is the same as compound B-44 in Table A.
Regarding instant claim 4, the compound of Bhalla is consistent with claimed general formula (I):
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wherein R1 and R2 are each an aryl group, X is S, Y is a branched alkyl group, m is 1, n is 1, and Z is OH.
Regarding instant 5, as noted above, the compound of Bhalla is consistent with the recited X stands for S, Y is a branched alkyl group, and m stands for 1.
Regarding instant claim 6, the compound of Bhalla is consistent with claimed general formula (V):
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wherein R1 and R2 are each an aryl group, Y is a branched alkyl group, m is 1, n is 1, and Z is OH.
Regarding instant claim 7, as noted above, the scope of compounds that satisfy the claim are indefinite. As set forth above, the Examiner interprets that the claim is intended to limit the identity of the substituents should the optional substitution occur, and the compound of Bhalla is interpreted as consistent with the optional substitution of the claim.
Regarding instant claim 8, the compound of Bhalla is consistent with the recited R1 and R2 are identical and are both phenyl groups.
Regarding instant claim 9, the compound of Bhalla is consistent with the recited Y stands for a methyl group substituted with a methyl group.
Regarding instant claim 10, the compound of Bhalla is consistent with the recited Z is selected from -OH.
Regarding instant claim 11, the compound of Bhalla is the same as compound B-44 in Table 1.
Regarding instant claim 12, the claim further limits the identity of the salt in the recited Markush alternatives of claim 1; as set forth above, the compound of Bhalla is consistent with the claimed compound of general formula (Va).
Regarding instant claim 13, as noted above, the compound of Bhalla is consistent with (a) one coolant according to claim 1. Components (b) and (c) are optional, and thus not required by the claim.
Regarding instant claim 16, the claim further limits the optional solvent recited in instant claim 13. As set forth above, Bhalla anticipates the limitations of claim 13, which does not require the presence of the optional solvent.
Claim Rejections - 35 USC § 103
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 1-13, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bhalla et al. (“Synthesis and pharmacological evaluation of 1,2,4-triazine and its congeners” Boll. Chim. Farmaceutico 1995, 134(1), 9-15), hereafter “Bhalla”, in view of Gullo et al. (GB 1604084A, published December 2nd, 1981), hereafter “Gullo”.
Regarding instant claim 1, Bhalla discloses the following compound (II) (see entire document, particularly Fig. 1 at pg. 10):
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consistent with the claimed general formula (Va):
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wherein R1 and R2 are each an aryl group, Y is a branched alkyl group, m is 1, and Z is OH. Regarding the recitation of a “physiological coolant”, given that the compound disclosed by Bhalla is the same as that instantly claimed, it must necessarily possess the same properties and is therefore capable of functioning as a physiological coolant. See MPEP 2112.01 II., “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
Regarding instant claim 2, as shown above, the compound of Bhalla is consistent with the recited Y of a substituted methylene group.
Regarding instant claim 3, the compound of Bhalla is the same as compound B-44 in Table A.
Regarding instant 4, the compound of Bhalla is consistent with claimed general formula (I):
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wherein R1 and R2 are each an aryl group, X is S, Y is a branched alkyl group, m is 1, n is 1, and Z is OH.
Regarding instant 5, as noted above, the compound of Bhalla is consistent the recited X stands for S, Y is a branched alkyl group, and m stands for 1.
Regarding instant claim 6, the compound of Bhalla is consistent with claimed general formula (V):
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wherein R1 and R2 are each an aryl group, Y is a branched alkyl group, m is 1, n is 1, and Z is OH.
Regarding instant claim 7, as noted above, the scope of compounds that satisfy the claim are indefinite. As set forth above, the Examiner interprets that the claim is intended to limit the identity of the substituents should the optional substitution occur, and the compound of Bhalla is interpreted as consistent with the optional substitution of the claim.
Regarding instant claim 8, the compound of Bhalla is consistent with the recited R1 and R2 are identical and are both phenyl groups.
Regarding instant claim 9, the compound of Bhalla is consistent with the recited Y stands for a methyl group substituted with a methyl group.
Regarding instant claim 10, the compound of Bhalla is consistent with the recited Z is selected from -OH.
Regarding instant claim 11, the compound of Bhalla is the same as compound B-44 in Table 1.
Regarding instant claim 12, the claim further limits the identity of the salt in the recited Markush alternatives of claim 1; as set forth above, the compound of Bhalla is consistent with the claimed compound of general formula (Va).
Regarding instant claim 13, as noted above, the compound of Bhalla is consistent with (a) a coolant according to claim 1. Components (b) and (c) are optional, and thus not required by the claim.
Regarding instant claim 16, the claim further limits the optional solvent recited in instant claim 13. As set forth above, Bhalla anticipates the limitations of claim 13, which does not require the presence of the optional solvent.
Bhalla does not teach the limitation of instant claim 20 that the physiological coolant is in encapsulated form.
Gullo teaches compositions containing 1,2,4-triazine compounds (see entire document, particularly pg. 1, lines 7-9) which can be administered to promote an anti-inflammatory effect (pg. 3, lines 19-21). Gullo teaches that compositions are formatted in dosage unit form with a pharmaceutical carrier and can be formatted with additional active compounds; diluents, carriers, and excipients can be suitably selected with respect to the intended route of administration, and compositions for oral administration can be formulated as capsules with conventional excipients (pg. 3, lines 52-65).
It would have been prima facie obvious to one of ordinary skill in the art to formulate the triazine compound of Bhalla to be contained in a capsule (encapsulated), as suggested by Gullo. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to achieve a dosage form suitable for administering a 1,2,4-triazine compound which has an anti-inflammatory effect, and which can achieve a desired dosage amount in combination with conventional pharmaceutically acceptable excipients, as suggested by Gullo. There is a reasonable expectation of success as Bhalla similarly teaches 1,2,4-triazine compounds with anti-inflammatory activity (see “Introduction” at pg. 9) and that compounds can be orally administered (pg. 13, column 1, paragraph 1).
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 1-13, 16, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-10, 13, 16, and 29 of copending Application No. 19/506,473 in view of Gullo et al. (GB 1604084, published December 2nd, 1981), hereafter “Gullo”.
The claims of copending Application 19/506,473 recite compounds and physiological coolants consistent with the instant claims: compare compounds B-01-R and B-01-S of copending claim 1 and compound B-01 of copending claim 9 to compounds B-01 of instant claims 3 and 11, respectively (the elected species). The claims of copending Application 19/506,473 further recite the same physiological cooling mixture and solvent. The claims of copending Application 19/506,473 further recites a pharmaceutical preparation comprising the compound which is used for the prevention or treatment of inflammatory conditions.
The claims of copending Application 19/506,473 do not recite the limitation of instant claim 20 that the physiological coolant is in encapsulated form.
Gullo teaches compositions containing 1,2,4-triazine compounds (see entire document, particularly pg. 1, lines 7-9) which can be administered to promote an anti-inflammatory effect (pg. 3, lines 19-21). Gullo teaches that compositions are formatted in dosage unit form with a pharmaceutical carrier and can be formatted with additional active compounds; diluents, carriers, and excipients can be suitably selected with respect to the intended route of administration, and compositions for oral administration can be formulated as capsules with conventional excipients (pg. 3, lines 52-65).
It would have been prima facie obvious to one of ordinary skill in the art to formulate the triazine compound of copending Application 19/506,473 to be contained in a capsule (encapsulated), as suggested by Gullo. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to achieve a dosage form suitable for administering a 1,2,4-triazine compound to achieve an anti-inflammatory effect, and which can achieve a desired dosage amount in combination with conventional pharmaceutically acceptable excipients, as suggested by Gullo.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
Prosecution Insights