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 .
DETAILED ACTION
Claims 1, 5, 7-11, 17-20, 23, 25, 26 and 29-45 are pending in the application. Claims 1, 5, 7-9, 17, 18, 23, 25, 26 and 29-31 are rejected. Claims 10, 11, 19, 20 and 32-45 are withdrawn.
Election/Restrictions
In view of Applicant’s amendment, filed on July 28, 2025, the restriction requirement as set forth in the Office action mailed on October 1, 2024 has been reconsidered. Specifically, claims 9, 17 and 18 are no longer withdrawn from consideration because the claims now apply to Applicant’s elected species (shown below).
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However, claims 10, 11, 19, 20 and 32-45, directed to a separate invention/species remain withdrawn from consideration. The claim(s) and subject matter that do not read on Applicant’s elected species have NOT been examined and searched.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on October 10, 2022, September 6, 2023, February 6, 2025 and August 28, 2025 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Response to Amendments
Objections and rejections made in the Office Action mailed February 27, 2025 that do not appear below have been overcome by Applicant’s amendments to the disclosure and have been withdrawn.
Drawings
The drawings remain objected to because it is impossible to distinguish between various data points, for instance, in Figures 23D, 23F, 26F, 26G and 33E. It is recommended Applicant incorporate shape markers to differentiate data lines/points in the provided figures. To further improve the clarity and reproducibility of the aforementioned figures, Applicant should submit replacement drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the Applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Response to Arguments - 35 USC § 102
The claim rejection under 35 U.S.C. § 102 as presented in the Nonfinal Rejection mailed February 27, 2025 is rendered moot by Applicant’s amendment filed on July 28, 2025 and the rejection is hereby withdrawn.
Response to Arguments - 35 USC § 103
The claim rejection under 35 U.S.C. § 103 as presented in the Nonfinal Rejection mailed February 27, 2025 is rendered moot by Applicant’s amendment filed on July 28, 2025 and the rejection is hereby withdrawn. The newly applied rejections under 35 U.S.C. § 103 of claims 1, 5, 7-9, 17, 18, 23, 25, 26 and 29-31 were necessitated by Applicant’s amendment filed on July 28, 2025. Applicant’s arguments relevant to the newly applied rejection is discussed below.
Applicant argues that the prior art (i.e., PCT Publication No. WO 2018/027175 A1) “compounds of I, II, III, and IV have significantly different core structures” and that the prior art “does not suggest to one of skill in the art that one should have selected DCPIB as the lead compound for modification in comparison to the claimed invention.” See pages 11 and 15 of Applicant’s Remarks dated July 28, 2025. For reference, compounds of formula I, II, III and IV of the prior art each refer to a distinct genus of SWELL1 inhibitor compounds while DCPIB (structure shown below) is taught on page 10 as a species of a compound of formula I.
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Applicant’s reference to compounds of formula II, III and IV provides no meaningful value in the instant situation as the instant claims and relevant rejections thereof have been limited to discussions regarding compounds of formula I (e.g., DCPIB) as taught in the prior art. Applicant argues on page 14 of the response that the prior art “discloses several different compounds having significantly different core structures including DCPIB, clomiphene, nafoxidine, or tamoxifen...[and] [t]hus, a person of ordinary skill would not have selected DCPIB as the lead compound for further experimentation.” However, it would be well within the ability of a skilled artisan to choose DCPIB from this limited list of “several different compounds” especially since the prior art teaches “[i]n certain embodiments, the SWELL1 inhibitor is DCPIB.” See e.g., page 3. Notwithstanding, the rejected claims (as indicated in the Nonfinal Rejection mailed February 27, 2025) do not even fall into the paradigm established by the lead compound analysis. The rejected claims are drawn towards a generic formula with variable Markush groups as opposed to a specific compound(s) having a defined chemical structure. Therefore, the fact patterns in the instant situation are different from those referenced by Applicant in the response.
Applicant further argues that the prior art “does not provide either a motivation to modify the compounds as disclosed in the instant application or a reasonable expectation that such a modification would have been successful.” See page 14 of Applicant’s Remarks dated July 28, 2025. However, “[t]he rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law.” In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988). As discussed below in the rejection under 35 U.S.C. § 103 (1 of 2), homologues are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue because the homologue is expected to be preparable by the same method and to possess the same general properties. Applicant argues on page 14 of the response that, in the instant situation, the compounds should “be considered analogs or derivatives of each other” instead of homologs as “[h]omologs are not usually applied to compounds like those of the instant claims since the compounds have several substituents.” This argument is not persuasive as compounds differing only in the number of methylene group(s) are considered to be homologs of each other. Furthermore, even if the terminology was adjusted to replace the word “homolog” with either “analog” or “derivative” as Applicant suggests, this change would not be sufficient to overcome the underlying issues of obviousness stated in the record. It also appears that Applicant’s position is that as long as the “length of the linker between the phenyl group and the carboxylic acid” is maintained, a hypothetical reference disclosing any substituent in the variable positions of the prior art genus (i.e., formula I) would render the instant invention obvious over the hypothetical reference. See page 14 of response. This, however, is not the standard for determining obviousness.
Accordingly, for the reasons discussed above, the instant claims are prima facie obvious over the prior art.
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.
(1 of 2) Claims 1, 5, 7-9, 17, 18, 23, 25, 26, 30 and 31 are rejected under 35 U.S.C. § 103 as being unpatentable over Sah (PCT Publication No. WO 2018/027175 A1; February 8, 2018).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Regarding instant claims 1, 5, 7-9, 17, 25, 26 and 30, Sah teaches the following generic chemical formula on e.g., page 10:
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Regarding instant claim 31, the expression “...wherein the compound has a higher potency at modulating or inhibiting...” is considered a characteristic that would necessarily be present in the instantly claimed compound and is, therefore, nonlimiting. See MPEP § 2112.01 which states: 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. “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).
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
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Applicant’s elected species (shown above) requires instant variable “Y” to be defined as an unsubstituted alkylene having 5 carbons. However, the prior art genus (i.e., compound of formula I) does not teach this 5-carbon linker (it instead teaches a 3-carbon linker in the position corresponding to instant variable “Y”). See e.g., page 10. The prior art also does not teach a 4-carbon linker for instant variable “Y” as required by newly amended instant claim 18. In addition, newly amended claim 23 does not recite an alternative for variable “Y” [i.e., when R3 is -Y-C(O)R4], wherein variable “Y” is an unsubstituted alkylene having 3 carbons (as seen in the prior art genus).
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
With respect to Applicant’s elected species, it would have been obvious to a person of ordinary skill in the art to arrive at the elected species based on the prior art genus. For instance, Applicant’s elected species is encompassed by variable definitions of the prior art genus when R1a is 5-membered cycloalkyl; R2a is hydrogen; R3a is C4 alkyl; X1a is halo; and X2a is halo. See e.g., page 10 of the prior art. As indicated before, the prior art genus does not teach the 5-carbon linker as seen in Applicant’s elected species; however, it would have been obvious to a person of ordinary skill in the art to arrive at this 5-carbon linker from the 3-carbon linker taught in the prior art. Compounds that differ only by the presence or absence of an extra methyl group are considered to be homologues. Homologues are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue because the homologue is expected to be preparable by the same method and to possess the same general properties. Notwithstanding, “[p]rior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979). As stated in MPEP § 2144.09: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). Therefore, at least in the interest of providing additional SWELL1-modulating compounds, a person of ordinary skill would have been motivated to provide homologues derived from the prior art genus.
Regarding instant claims 18 and 23, it would also have been obvious to a person of ordinary skill in the art to select, for instance, the fourth or fifth recited moiety corresponding to instant variable “R3” (as recited in instant claim 23) for the same reasons discussed above (i.e., homologues are considered obvious embodiments of each other).
(2 of 2) Claim 29 is rejected under 35 U.S.C. § 103 as being unpatentable over Cragoe et al. (U.S. Patent No. 4,465,850; August 14, 1984).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
The broadest disclosure of the prior art genus corresponds to the following generic chemical formula as seen, for instance, in claim 1 of the prior art (see e.g., column 16, lines 58-68 and column 17, lines 1-7):
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The prior art also teaches 4-[(2-butyl-6,7-dichloro-2-cyclopentyl-2,3-dihydro-1-oxo-1H-inden-5-yl)oxy]butanoic acid (structure depicted below) as a compound representative of the above prior art genus (see e.g., column 2, lines 60-61):
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Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
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The prior art does not specifically teach or provide an example of one of the compounds recited in instant claim 29. However, the prior art genus encompasses, for instance, the third recited structure (reproduced above) of instant claim 29 when the prior art variables are defined as such: X1 and X2 are halo; R is butyl; R1 is cyclopentyl; and R2 is hydrogen. See e.g., column 16, lines 58-68 and column 17, lines 1-7. Accordingly, when X1 and X2 of the prior art are each defined, for instance, as fluoro, the resulting structure (depicted below) would read on the third recited structure of instant claim 29.
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Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
It would, therefore, have been obvious to a person of ordinary skill in the art to arrive at, for instance, the third recited structure of instant claim 29 based on the prior art genus. Moreover, it would be further obvious to a person of ordinary skill to arrive at the third recited structure of instant claim 29 based on the prior art which teaches 4-[(2-butyl-6,7-dichloro-2-cyclopentyl-2,3-dihydro-1-oxo-1H-inden-5-yl)oxy]butanoic acid (as indicated above). This representative prior art compound differs from the third compound of instant claim 29 only in the presence of chloro (i.e., instead of fluoro) substituents in the positions corresponding to prior art variables X1 and X2. However, considering that the prior art genus does not limit variables X1 and X2 to only chloro substituents but instead encompasses any halogen (e.g., fluoro), it would be within the ability of a skilled artisan to substitute the chlorine atoms present in the prior art representative compound with fluorine atoms. At least in the interest of developing additional bioisosteres for routine testing, a person of ordinary skill would be motivated to modify the prior art representative compound and arrive at, for instance, the third compound as recited in instant claim 29.
Response to Arguments – Double Patenting
The Double Patenting rejection as presented in the Nonfinal Rejection mailed February 27, 2025 is rendered moot by Applicant’s amendment (i.e., namely the inclusion of a proviso regarding instant variable “Y”) filed on July 28, 2025 and the rejection is hereby withdrawn.
Conclusion
No claims are allowed.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 DAVID M SHIM whose telephone number is 571-270-1205. The examiner can normally be reached Monday - Friday, 8 am - 4 pm EST. The examiner can also be reached via email (david.shim@uspto.gov) once an Authorization for Internet Communications form PTO/SB/439 has been filed by Applicant.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOSEPH K MCKANE can be reached on 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.M.S./Examiner, Art Unit 1626
/JOSEPH K MCKANE/Supervisory Patent Examiner, Art Unit 1626