DETAILED ACTION
Applicants’ arguments, filed 22 May 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
Claim 1 recites the following chemical structure, which is reproduced below with annotation by the examiner.
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As best understood by the examiner, the above-reproduced structure is drawn to the structure of the ligand prior to diabody conjugation. This structure becomes altered upon antibody conjugation. As such, a chemical structure that is within the scope of the above-reproduced structure prior to diabody conjugation but changes after diabody conjugation is understood to meet the claim requirements.
Evidence supporting this position is provided as of Vugts et al. (European Journal of Nuclear Medicine Molecular Imaging, Vol. 44, (2017) pages 286–295), page 290, relevant figure reproduced below.
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As such, the examiner understands the claimed chemical structure to be that of the ligand prior to conjugation with the diabody.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 2 and 11-15 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.
Claims 2 and 11-15 recite a labeled antibody conjugate. However, claims 2 and 11-15 ultimately depend upon claim 1. There is no antecedent basis for the phrase “a labeled antibody conjugate” in claim 1. In contrast, claim 1 recites a labeled diabody conjugate, not a labeled antibody conjugate.
For the purposes of examination under prior art, the examiner will examine claims 2 and 11-15 with the understanding that they are drawn to a labeled diabody conjugate.
Applicant may overcome this rejection by removing the phrase “a labeled antibody conjugate” and replacing this phrase with “a labeled diabody conjugate.”
Claim Rejections - 35 USC § 103 – Obviousness
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.
Claim(s) 1-2 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buyse et al. (US 2003/0099648 A1) in view of Vugts et al. (European Journal of Nuclear Medicine Molecular Imaging, Vol. 44, (2017) pages 286–295) and Bailly et al. (International Journal of Molecular Sciences, Vol. 18(57), 2017, pages 1-12).
Buyse et al. (hereafter referred to as Buyse) is drawn to an interferon gamma binding molecule, as of Buyse, title and abstract. Buyse appears to teach a diabody that binds to interferon as of paragraphs 0156 and 0187, as well as figure 26 of Buyse, which is reproduced below.
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Buyse teaches a tag on the antibody, as of Buyse, at least figure 1A, wherein the antibody may be a diabody.
Buyse does not teach 89Zr or the required ligand p-SCN-Bn-DFO. Buyse also does not specify that the tag is intended for positron emission tomography (PET), which is intended use of 89Zr.
Vugts et al. (hereafter referred to as Vugts) is drawn to 89Zr immuno-PET studies, wherein “PET” refers to positron emission tomography, as of Vugts, page 286, title and abstract. Vugts teaches the following manner of linking an antibody with 89Zr on page 290, relevant figure reproduced below.
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The teachings of Vugts include both 89Zr and p-SCN-Bn-DFO.
Vugts differs from the claimed invention because Vugts does not specify an interferon gamma binding diabody.
Bailly et al. (hereafter referred to as Bailly) is drawn to immuno-positron emission tomography (i.e. immune-PET), which is antibodies attached to PET radionuclides, as of Bailly, page 1, title and abstract. Bailly teaches that this is useful for studying the in vivo behavior of antibody based therapy, as of Bailly, page 8, “Conclusion” section.
Bailly does not teach interferon and does not suggest the specific ligand recited by the instant claims.
It would have been prima facie obvious for one of ordinary skill in the art to have used the 89Zr-DFO complex of Vugts as the tag to be attached to the diabody of Buyse. Buyse is drawn to a diabody that binds interferon gamma. This is used for therapeutic purposes, as of Buyse, abstract. Buyse suggests a tag to be attached to the antibody, as of figure 1A of Buyse. The 89Zr-DFO complex of Vugts is a tag for immune-PET imaging, and Bailly indicates that studying the in vivo behavior of antibody based therapy. As such, the skilled artisan would have been motivated to have attached the immuno-PET tag of Vugts to the diabody of Buyse in order to have predictably studied the in vivo behavior of the diabody of Buyse to have predictably evaluated its therapeutic potential and therapeutic properties of said diabody with a reasonable expectation of success.
As to claim 2, Buyse teaches isolating antibodies in paragraph 0183. As such, the skilled artisan would have been motivated to have isolated the diabody of Buyse as modified by Vugts and Bailly.
As to claim 11, Buyse suggests human interferon gamma in at least paragraph 0036.
Note Regarding Reference Dates: The instant application appears to have an earliest effective filing date of 23 August 2017. Vugts was published on 30 August 2016 and Bailly was published on 28 December 2016. As such, both Vugts and Bailly are prior art under AIA 35 U.S.C. 102(a)(1).
Response to Arguments
Applicant has presented arguments in applicant’s response on 22 May 2026. These arguments appear to relate to rejections which have been withdrawn. As such, the examiner has not addressed applicant’s arguments substantively as they appear to be moot in view of the withdrawal of the previously presented rejections.
Subject Matter Free of Prior Art
Claims 12-15 have not been subject to a prior art rejection. The examiner presents the following rationale for not subjecting these claims to a prior art rejection.
Claim 12 further modifies claim 1 to require a sequence with at least 90% similarity to Seq ID #11 or Seq ID #12. The examiner takes the position that a sequence having at least 90% similarity to Seq ID No. 11 was known prior to the effective filing date. See Gozzard et al. (WO 2010/103274 A1), specifically Sequence #19, which is reproduced below.
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This sequence appears to have over 90% similarity to the claimed Seq. ID #11; see the following analysis set forth below.
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With that being said, it appears that there would have been no motivation for the skilled artisan to have combined the sequence of Gozzard with the diabody of Buyse. This is because (a) the diabody of Buyse is drawn to a human composition, as of Buyse, abstract, whereas the sequence of Gozzard is a rat sequence, and (b) the sequence of Gozzard is intended for use in an anti-IL13 antibody, as of Gozzard, title, whereas the instant claims are drawn to an anti-interferon gamma diabody.
The examiner presents the following additional arguments related to item (b), the examiner notes that the sequence of Gozzard is taught as “(V + constant).” The examiner understands the letter “V” to refer to the variable domain of the antibody which varies dependent upon the antigen to which the antibody attaches, and “constant” to refer to a constant domain of the antibody, which does not vary dependent upon the antigen to which the antibody attaches. As such, the examiner best understands the above-reproduced sequence to include both a variable domain and a constant domain of an antibody. Therefore, even if, purely en arguendo, the skilled artisan would have been motivated to have modified the antibody of Gozzard to have attached to interferon gamma rather than IL-13, the result of this modification would have caused the sequence of Gozzard to have varied. Therefore, there would have been no reasonable expectation that, had the sequence of Gozzard been modified to have bound to interferon gamma rather than IL-13, that the resultant sequence would have successfully retained at least 90% similarity to Seq. ID #11 as required by the instant claims.
A statement that modifications of the prior art to meet the claimed invention would have been "‘well within the ordinary skill of the art at the time the claimed invention was made’" because the references relied upon teach that all aspects of the claimed invention were individually known in the art is not sufficient to establish a prima facie case of obviousness without some objective reason to combine the teachings of the references. See MPEP 2143.01(IV); the examiner notes that MPEP 2143.01(III) is also relevant. In this case, even if, purely en arguendo, there would have been a reason to have combined the teachings of Gozzard with the teachings of Buyse, Vugts, and Bailly, this combination would have necessitated changes to the sequences of Gozzard to result in an antibody attaching to interferon gamma rather than IL-13. There would have been a reasonable expectation that these changes would have caused the sequence of Gozzard to have lost its required similarity to that of the instant claimed invention. As such, the examiner has not combined the teachings of Gozzard with the teachings of Buyse, Vugts, and Bailly because there would have been no reasonable expectation of success without changing the sequence of Gozzard to have been outside the claim scope.
Conclusion
No claim is allowed at this time.
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 ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
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