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 Claims
Claims 1-18 are pending in the instant application.
Election/Restriction
This action is in response to an election from a restriction requirement filed on October 2nd, 2025. There are 18 claims pending and 9 claims under consideration. Claims 1-9 have been withdrawn as claims drawn to a non-elected invention. This is the first action on the merits. The present invention relates to a conjugate of formula FG0-1-L-Q2-8 as recited at instant Claim 10.
Applicant’s election of Group II, Claims 10-18 and species election of a single species of conjugate of formula FG0-1-L-Q2-8 of N-[2-[2-(cyclooctylamino0-3,5,6-trifluoro-4-sulfamoyl-phenyl]sulfonylethyl]-3-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[3-[2-[2-(cyclooctylamino)-3,5,6-trifluoro-4-sulfamoyl-phenyl]sulfonylethylamino]-3-oxo-propoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy] propenamide in the reply filed December 1st, 2025 is acknowledged. Applicant did not indicate whether or not these elections were made with traverse. As such, the examiner has construed this as an election without traverse.
The requirement for restriction is deemed proper and therefore made FINAL.
The elected species was found to be free of the prior art. Therefore, examination has been extended to all species of a conjugate of formula FG0-1-L-Q2-8.
Domestic Benefit
The present application claims domestic benefit to US Provisional Application No. 63/120,734, filed on December 3rd, 2020. Instant Claims 10-18, presently under examination, are fully supported by this application and will be evaluated with an effective filing date of December 3rd, 2020.
Information Disclosure Statement
The Information Disclosure Statement filed on September 13th, 2023 has been fully considered by the examiner, except where marked with a strikethrough.
Specification
The abstract of the disclosure is objected to because the abstract must be presented on a separate sheet. Per MPEP 608.01(b), I., C., “The abstract must commence on a separate sheet, preferably following the claims, under the heading "Abstract" or "Abstract of the Disclosure." The sheet or sheets presenting the abstract may not include other parts of the application or other material.” 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).
The 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 of the errors of which Applicant may become aware of in the specification.
Drawings
The drawings are objected to because the axes and peak labels in Figure 2 are illegible. 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.
Claim Objections
Claim 11 is objected to because of the following informalities:
The acronym “CA” is used without being previously defined. The examiner is construing this to mean carbonic anhydrase. This objection could be overcome by adding “(CA)” after carbonic anhydrase at the second line of Claim 10, from which Claim 11 depends. Appropriate correction is required.
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 10-13 and 15-17 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.
The metes and bounds of Claim 10 are indefinite, as Claim 10 is drawn to a conjugate of Formula FG0-1-L-Q2-8. FG, L, and Q are not defined such that a person having ordinary skill in the art would be able to reasonably ascertain the metes and bounds of these claim limitations. While the instant specification provides exemplary compounds, no definition of “binding ligand of carbonic anhydrase IX”, linker, or functional group, therapeutical agent, or imaging agent is provided such that a person having ordinary skill in the art would reasonable be able to envisage a finite set of moieties to which the claim is limited. Per MPEP 2173.05(h), I., “In certain circumstances, however, a Markush group may be so expansive that persons skilled in the art cannot determine the metes and bounds of the claimed invention. For example, if a claim defines a chemical compound using one or more Markush groups, and that claim encompasses a massive number of distinct alternative members, the claim may be indefinite under 35 U.S.C. 112(b) if one skilled in the art cannot determine its metes and bounds due to an inability to envision all of the compounds defined by the Markush group(s). In such a circumstance, a rejection of the claim for indefiniteness under 35 U.S.C. 112(b) is appropriate.”
While dependent Claims 11-13 further limit the definition of Q, L, and FG, respectively, the variability of the variables not limited in each claim remain too expansive for a person having ordinary skill in the art to reasonably determine the metes and bounds of the compounds intended to be encompassed by these claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 16-18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 16 and 17 recite an intended use of the pharmaceutical composition of Claim 15. No additional elements, however, are recited in Claims 16 and 17 that further limit the composition of Claim 15. Therefore, these claims are not further limiting of Claim 15, from which they depend.
Analogously Claim 18 recites an intended use of the compound of Claim 14 without reciting an additional claim limitation that distinguishes the compound of Claim 18 from the compound of Claim 14, from which Claim 18 depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 10-11 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kleemann et. al. (US 2004/0044081 A1; cited on Applicant’s Information Disclosure Statement filed September 13th, 2013; hereinafter referred to as Kleemann).
At Page 9, Kleemann teaches compounds of the following formula:
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147
315
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At Page 19, Example 10 in the table defines the above variables as follows:
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127
473
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For clarity, this results in a compound having the structure:
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393
580
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This compound reads on a conjugate as claimed at instant Claim 10 when the variables are defined as follows:
Each of the 2 Q moieties are
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137
139
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, as recited at Claim 11, wherein A is NH and R is aryl.
The two Q moieties are joined by the linker:
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209
170
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This compound differs in that R, defined as noted above by aryl, is substituted with two methyl groups. The specification is silent with respect to whether or not substitution on an aryl group is permitted.
While the exact compound of Claims 10-11 is not disclosed by Kleemann, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S. P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963); In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S. P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.PA.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O.B.A. 1960). Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the “methyl” group for a hydrogen.
Regarding Claims 15-17, at Page 16, Paragraphs 6936-694, Kleemann teaches the inclusion of the aforementioned compound in pharmaceutical formulations.
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 10-13 and 15-18 are rejected.
Claim 14 is objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624