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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 8 is 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.
Claim 8 recites the limitation “p-SCN-Bn-DFO.” The meaning of this limitation is unclear, thereby causing claim 8 to be indefinite.
The examiner notes that the instant specification discloses the acronym p-SCN-Bn-DFO, and indicates that it is defined in US patent application publication US 2015/0017094 A1. In view of this, the examiner reviewed Gill et al. (US 2015/0017094 A1). Gill et al. (hereafter referred to as Gill) discloses “Df-Bz-SCN” as of paragraph 0372, but does not disclose p-SCN-Bn-DFO. Additionally, Gill does not appear to define the acronym “SCN.”
As such, the instant specification, as well as Gill, which is incorporated by reference therein, fail to adequately define the acronym p-SCN-Bn-DFO that is recited by claim 8.
No Indefiniteness Rejection of Claim 7
The examiner clarifies that claim 7 is not understood to be indefinite. Claim 7 recites acronyms in parentheses, such as “(DFO)” and “(NOTA).” However, it is clear from the context that these are acronyms of the chemical names which precede the acronyms. As such, these acronyms are not indefinite.
In the third to last line of claim 7, the claim recites “(i.e. DOPA).” The examiner clarifies that the phrase “i.e.” does not appear to render the claim indefinite as it is present only to show that a particular acronym applies to a particular chemical.
The examiner further notes that the description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. See MPEP 2173.05(d). With that being said, in this case, the term “i.e.” is not used to delineate examples or preferences but to show that 1,4,7,10-tetraazacyclododecante-1,4,7,10-tetraacetic acid is abbreviated as “DOPA.” As such, nothing in MPEP 2173.05(d) is understood to be sufficient to render claim 7 to be indefinite.
Claim Rejections - 35 USC § 102(a)(1) – Anticipation
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.
Claim(s) 1-3, 9, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chang et al. (US Patent 4,666,865).
Chang et al. (hereafter referred to as Chang) is drawn to immunoassays for human interferon gamma, as of Chang, title and abstract. Chang teaches a labeled soluble monoclonal anti human interferon gamma antibody, as of Chang, column 21, relevant text reproduced below.
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The term “labeled” refers to a radioactive 125I label, as of Chang, column 22 lines 8-9.
As to claim 1, Chang teaches an anti-human interferon gamma antibody that is labeled, as of Chang, above-reproduced text. This antibody appears to be conjugated to a 125I radioactive label.
As to claim 2, Chang teaches a monoclonal antibody. The skilled artisan would have understood this antibody to have been isolated from other antibodies because it is described as monoclonal rather than polyclonal.
As to claim 3, Chang teaches a monoclonal antibody, as of the above-reproduced text from column 21 of Chang.
As to claim 9, Chang teaches 125I, as of Chang, column 22 lines 8-9.
As to claim 11, Chang teaches an antibody that binds to natural or recombinant human interferon gamma, as of Chang, abstract.
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) 1-4 and 6-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez et al. (US 2016/0199524 A1).
Hernandez et al. (hereafter referred to as Hernandez) is drawn to labeled molecules comprising a fluorescent probe and a radionuclide, which may be antibodies, as of Hernandez, title and abstract. Hernandez teaches antibodies against interferon gamma, abbreviated as “IFN-γ”, as of paragraphs 0105, 0123 and claim 9 of Hernandez. Hernandez teaches a radionuclide detection label in the abstract.
As to claim 1, Hernandez is not anticipatory because Hernandez does not teach a specific example comprising an antibody against interferon-gamma; in contrast, Hernandez teaches an antibody against interferon gamma in a list of antibody targets. As such, while the prior art teaches all of the claimed components (namely a radioactive label and an anti-interferon gamma antibody), the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 2, Hernandez teaches isolated antibodies at least as paragraph 0126.
As to claim 3, Hernandez teaches a monoclonal antibody, abbreviated as “Mab” in paragraph 0126.
As to claims 3-4, Hernandez teaches a Fab fragment at least as of paragraph 0270.
As to claims 6-8, Hernandez teaches a NOTA-based bifunctional chelator in paragraphs 0042-0044.
As to claims 9-10, Hernandez teaches 18F imaging at least as of paragraph 0260, as well as elsewhere in the claim. Hernandez also teaches 89Zr in paragraph 0017.
As to claim 11, Hernandez teaches a human or humanized antibody in paragraphs 0076-0077.
Note Regarding Reference Date: The instant application has an earliest possible effective filing date of 23 August 2017, which is the filing date of provisional application 62/549,231, upon which the instant application ultimately claims benefit. Hernandez was published in July 2016. As such, Hernandez was published over a year earlier than the effective filing date of the instant application. Therefore, Hernandez is prior art under AIA 35 U.S.C. 102(a)(1). The exceptions under AIA 35 U.S.C. 102(b)(1)(A) or 102(b)(1)(B) would not appear to be applicable because Hernandez was published over a year earlier than the effective filing date of the instant application.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez et al. (US 2016/0199524 A1) in view of Holliger et al. (Proceedings of the National Academy of Sciences, Vol. 90, July 1993, pages 6444-6448).
Hernandez is drawn to antibodies attached to radionuclides, wherein the antibodies may be against interferon gamma. See the rejection above over Hernandez by itself. Hernandez teaches antibody fragments, at least as of the abstract. Hernandez teaches bispecific antibodies in the abstract and bivalent antibodies in paragraph 0083.
Hernandez does not appear to teach diabodies.
Holliger et al. (hereafter referred to as Holliger) is drawn to diabodies, which are small, bivalent antibody fragments, as of Holliger, page 6444, title and abstract. These appear to be useful as bivalent or bispecific antibodies, as of Holliger, page 6444, left column, end of abstract.
Holliger does not teach that the diabody is against interferon gamma, and does not teach that the diabody is radiolabeled.
It would have been prima facie obvious for one of ordinary skill in the art to have formulated the antibody fragment of Hernandez to have been in the form of a diabody, as of Holliger. Hernandez is drawn to an antibody, and teaches that the antibody may be bivalent and/or bispecific, and also teaches that the antibody may be in the form of an antibody fragment. Holliger teaches that a diabody is an antibody fragment which may be bivalent or bispecific. As such, the skilled artisan would have been motivated to have formulated the antibody fragment of Hernandez to have been in the form of a diabody to have predictably provided bivalency or bi-specificity, as desired by Hernandez, with a reasonable expectation of success.
Claim(s) 1-3, 9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US Patent 4,666,865).
Chang et al. (hereafter referred to as Chang) is drawn to immunoassays for human interferon gamma, as of Chang, title and abstract. Chang teaches a labeled soluble monoclonal anti human interferon gamma antibody, as of Chang, column 21, relevant text reproduced below.
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The term “labeled” refers to a radioactive 125I label, as of Chang, column 22 lines 8-9.
As to claim 1, for the purposes of this ground of rejection only, the examiner assumed that, purely en arguendo and in regard to this ground of rejection only, Chang teaches all of the claimed requirements but not in the same embodiment. While the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 2, Chang teaches a monoclonal antibody. The skilled artisan would have understood this antibody to have been isolated from other antibodies because it is described as monoclonal rather than polyclonal.
As to claim 3, Chang teaches a monoclonal antibody, as of the above-reproduced text from column 21 of Chang.
As to claim 9, Chang teaches 125I, as of Chang, column 22 lines 8-9.
As to claim 11, Chang teaches an antibody that binds to natural or recombinant human interferon gamma, as of Chang, abstract.
Claim(s) 1-7, 9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferlin et al. (US 2014/0186362 A1).
Ferlin et al. (hereafter referred to as Ferlin) is drawn to human anti-interferon gamma antibodies, as of Ferlin, title and abstract.
As to claim 1, the claim requires that the antibody be radio-labeled. Ferlin is not understood to be anticipatory because Ferlin does not appear to teach an example comprising a radiolabeled antibody. Nevertheless, Ferlin suggests radio-labeling of antibodies, as of Ferlin, at least paragraphs 0088-0089 and 0115. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 2, the antibody of Ferlin is isolated, as of claim 1 of Ferlin.
As to claim 3, Ferlin teaches monoclonal antibodies, as of at least paragraph 0006 of Ferlin.
As to claim 4, Ferlin teaches a Fab fragment as of at least paragraphs 0082-0083.
As to claim 5, Ferlin teaches a diabody, as of at least paragraph 0084.
As to claims 6-7, Ferlin teaches DOTA as a radionuclide chelator in paragraph 0086.
As to claim 9, Ferlin teaches various radionuclides including 125I and 111In in paragraph 0115.
As to claim 11, Ferlin teaches that the antibody binds to human interferon gamma, as of Ferlin, abstract.
Claim(s) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferlin et al. (US 2014/0186362 A1) in view of Hernandez et al. (US 2016/0199524 A1).
Ferlin is drawn to a human anti-interferon gamma antibody. Ferlin suggests various forms of radio-labeling, including using a chelator for said radiolabel. See the rejection above over Ferlin by itself.
Ferlin does not teach 18F as the radionuclide and does not teach NOTA as the chelator.
Hernandez et al. (hereafter referred to as Hernandez) is drawn to labeled antibodies, as of Hernandez, title and abstract. Hernandez teaches the use of 18F labeling with NOTA as the chelator, as of at least paragraph 0094 of Hernandez. See the rejection above over Hernandez by itself.
Hernandez is not anticipatory because Hernandez does not exemplify a formulation comprising an anti-interferon gamma antibody.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the antibody of Ferlin to have had an 18F radioactive label with NOTA as the chelator, as taught by Ferlin. Ferlin is drawn to an anti-interferon gamma antibody, and teaches various radioactive labels that can be included on said antibody. Hernandez teaches that the 18F radioactive label with a NOTA chelator is a known mode of labeling an antibody. As such, the skilled artisan would have been motivated to have modified the antibody of Ferlin in the manner taught by Hernandez in order to have predictably provided radioactive labeling to the antibody of Ferlin with a reasonable expectation of success, wherein radioactive labeling is desired by Ferlin.
As to claim 8, Hernandez teaches NOTA in paragraph 0094, which reads on the claimed requirement.
As to claim 10, Hernandez teaches 18F in paragraph 0094, which reads on the claimed requirement.
Conclusion
No claim is allowed.
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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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612