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 Claims
Claims 1 and 5-10 are pending in this application. Claims 2-4 have been cancelled by Applicant. Claim 9 remains withdrawn from consideration as being drawn to a non-elected invention. Claims 1, 5-8, and 10 are under examination herein.
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.
Claim 1, 5-8, and 10 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1, 8, and 10 recite the broad recitation as a proviso “when R1 is linear O-C3-6 alkyl optionally substituted with R8”, and the claims also recite: “R1 is selected from . . . -O-(CH2)3-4-R8” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 5-7 are rejected for depending upon the limitations of an indefinite claim.
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.
Claims 1, 6-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Youssefyeh et al. (J. Med. Chem., 1990, 33, 1186-1194 – cited in IDS – previously cited) (“Youssefyeh”).
Regarding claims 1 and 8, Youssefyeh discloses the compounds below as Leukotriene receptor antagonists for treating inflammatory conditions - which reads on the intended uses presented in the instant disclosure (abstract; and Table 1, page 1187). Youssefyeh’s compounds read on the instant compounds of Formula I and Ia when instant R1 (corresponding to substitution in position 3 of the phenyl ring below) is –(CH2)3-R, wherein R (corresponding to instant R8) can be -COOH (as in Youssefyeh’s compound 22 below) or -COOEt (as in compound 21 below). Further regarding claim 8, which requires the compounds for use as a medicament, Youssefyeh discloses their compounds as medicaments for leukotriene inhibition.
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While instant claims have the proviso that “when R1 is linear -OC-3-6 alkyl optionally substituted with R8, at least one between R2 and R3 is not H”; Applicant is advised that H vs. Me is considered an obvious modification in the absence of superior, unexpected results. Note In re Wood 199 USPQ 137; In re Lohr 187 USPQ 548 and In re Bowers 149 USPQ 573. Note also In re Fauque 121 USPQ 425 in which differences were 2H’s vs 2 methyl groups. Also see MPEP 2144.09. Therefore, it would be obvious to one of ordinary skill to replace one of the H groups on the Youssefyeh’s X group with a methyl, thus making a branched -OC-3-6 alkyl and circumventing the proviso of the instant claims. Thus, Youssefyeh discloses a narrow subgenus which is encompassed genus of the instant claims.
Regarding claims 1 and 6-7, particularly when the instant R1 group is -O-iPr, -O-n-propyl, or -O-n-pentyl and R2-3 are H; Youssefyeh’s disclosure of their compound 51, wherein the group corresponding to instant R1 is -O-n-butyl; Applicant is advised that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Furthermore, a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In re Norris, 179 F.2d. 970, 84 USPQ 458 (CCPA 1970). Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results. In re Finely, 81 USPQ 383 (CCPA 1949); 84 USPQ 458 (CCPA 1950).
Therefore, regarding instant claims 1 and 6-8, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by the disclosed formula; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2144.08. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of leukotriene receptor agonist compounds disclosed by Youssefyeh. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Further regarding claim 6, Youssefyeh’s compound 51, renders the compound below obvious when R1 is -OiPr and R3 is H; and when R1 is -O-2-methylbutyl and R3 is H; for the reasons outlined above.
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Further regarding claim 7, Youssefyeh’s compound 51, renders the compounds below obvious for the reasons outlined above:
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Regarding claim 10, Youssefyeh discloses their compounds administered intraduodenally with PEG400 as vehicle (page 1194, col. 1, para. 2).
Claims 1, 5-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Jayyosi et al. (WO 99/20275 – cited in IDS – previously cited) (“Jayyosi”).
Regarding claims 1 and 8, Jayyosi discloses the compounds of Formulae I and V below (pages 4-5 and 22), reading on the instant compounds when, in Formula V; d, e, and f are 0; C is -CH2-; c is 1-5; n = 0; D is a bond; E is a bond; R can be H, alkyl, alkoxy, etc.; and Z is -CO2R1, wherein R1 can be H or alkyl. Jayyosi’s disclosure reads on the instant compounds of Formula I and Ia when: R1 or 2 is H; R1 or 2 is C1-6 alkyl substituted with one R7, wherein R7 is
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or
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, wherein R4-6 can independently be H, COOH, or COO-C1-6 alkyl. Further regarding claim 8, which requires the compounds for use as a medicament, Jayyosi discloses their compounds as medicaments for PPAR-ɣ inhibition for the treatment of metabolic conditions like diabetes, obesity and certain malignancies (abstract; and page 1, lines 23-30).
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Jayyosi particularly discloses the compound below as a preferred embodiment (page 25, line 6, row 1). While this compound has the methylene and oxygen (circled groups) in the opposite position compared to the instant substrates corresponding to instant R1 or 2 being a C1 alkyl substituted with an R7 group, Jayyosi’s disclosure allows for c to be 1-5 (corresponding to R1 or 2 being C1-5 alkyl) and d to be 0 when B is -O- (in Formula V). Thus, Jayyosi discloses a broad genus of compounds, which encompass the compounds of the instant invention.
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In view of Jayyosi’s general structures I and V, and further in view of the preferred embodiment shown above, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by the disclosed formula. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Jayyosi. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Regarding claim 5, Jayyosi discloses their compounds above, wherein the groups corresponding to instant R4/ 6 can independently be H, COOH, or COO-C1-6 alkyl; and their preferred embodiment above, wherein the group corresponding to R6 is COOH; R3 is H; R4 is H; and R5 is H.
Regarding claim 6-7, Jayyosi discloses their compounds above, wherein c and d can be 0; B can be a chemical bond; D and E are a bond (as in the preferred embodiment shown above) and Z is -CO2R1, wherein R1 can be H or alkyl; reading on the compounds below when B and A are independently H, -COOH, or -COOMe.
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Jayyosi’s compounds also read on the compounds below when c is 1; D is -O-; d, e, and f are 0; R is alkoxy (reading on instant groups being -OiPr, -OnBu, etc.); D and E are a bond (as in the preferred embodiment shown above) and Z is -CO2R1, wherein R1 can be H or alkyl.
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Applicant is reminded that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. Furthermore, Applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Regarding claim 10, Jayyosi discloses their compounds may be administered with an inert diluent or with an edible carrier, and that the active compound may be incorporated with an excipient (page 104, para. 3, lines 1-4).
Response to Arguments
Specification
Applicant’s arguments, see page 16, filed 01/28/2026, with respect to objections to the specification have been fully considered and are persuasive. The objection of the specification has been withdrawn.
Claim Rejections - 35 USC § 102
Applicant’s arguments, see page 16, filed 01/28/2026, with respect to the 35 USC § 102 rejection of the claims have been fully considered and are persuasive. The 35 USC § 102 rejection of the claims has been withdrawn
Claim Rejections - 35 USC § 103
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive.
Applicant argues that the Office’s conclusion is obvious because Jayyosi allows c to be 1-5 and d to be 0 when B is O, cannot be sustained on the teachings of the reference; that the “position swapping rationale is technically problematic” and conflates generic variable ranges with specific structural guidance. Applicant argues Jayyosi provides no teaching, suggestion, or motivation to reverse the structural connectivity in a manner required to arrive at the instant claims. Applicant further argues that Jayyosi’s compounds are disclosed for the treatment of different diseases with different mechanism of action (PPAR-ɣ agonists vs CysLTR in the instant invention) and that the skilled person would not be motivated to make modifications or change the mechanism of action of Jayyosi’s compounds.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Jayyosi discloses the preferred embodiment compound below (page 25, line 6, row 1). While this compound has the methylene and oxygen (circled groups) in the opposite position compared to the instant substrates corresponding to instant R1 or 2 being a C1 alkyl substituted with an R7 group, Jayyosi’s disclosure allows for c to be 1-5 (corresponding to R1 or 2 being C1-5 alkyl) and d to be 0 when B is -O- (in Formula V).
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Applicant is reminded that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. Furthermore, Applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Furthermore, Jayyosi discloses their compounds as medicaments for PPAR-ɣ inhibition for the treatment of metabolic conditions like diabetes, obesity and certain malignancies (abstract; and page 1, lines 23-30) – which coincide with some of the conditions referenced in the instant application (diabetes, for instance). Thus, in response to Applicant’s arguments that one of ordinary skill would not be motivated to modify Jayyosi’s compounds because they target a different pathway; Applicant is advised that, per MPEP 2112 (I): "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel."
Applicant further argues that a skilled person would not have been motivated to prepare the instant compounds in view of Youssefyeh because they focus on leukotriene receptors and there is no teaching or suggestion to modify.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
In this case, Youssefyeh discloses the compounds below as Leukotriene receptor antagonists for treating inflammatory conditions - which reads on the intended uses presented in the instant disclosure (abstract; and Table 1, page 1187). Youssefyeh’s compounds read on the instant compounds of Formula I and Ia when instant R1 (corresponding to substitution in position 3 of the phenyl ring below) is –(CH2)3-R, wherein R (corresponding to instant R8) can be -COOH (as in Youssefyeh’s compound 22 below) or -COOEt (as in compound 21 below). Further regarding claim 8, which requires the compounds for use as a medicament, Youssefyeh discloses their compounds as medicaments for leukotriene inhibition.
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While instant claims have the proviso that “when R1 is linear -OC-3-6 alkyl optionally substituted with R8, at least one between R2 and R3 is not H”; Applicant is advised that H vs. Me is considered an obvious modification in the absence of superior, unexpected results. Therefore, it would be obvious to one of ordinary skill to replace one of the H groups on the Youssefyeh’s X group with a methyl, thus making a branched -OC-3-6 alkyl and circumventing the proviso of the instant claims. Thus, Youssefyeh discloses a narrow subgenus which is encompassed genus of the instant claims.
Youssefyeh also discloses their compound 51, wherein the group corresponding to instant R1 is -O-n-butyl; Applicant is reminded that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. Furthermore, a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by the disclosed formula. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of leukotriene receptor agonist compounds disclosed by Youssefyeh. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Conclusion
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 JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627