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 1-9 are pending.
Claim 1 is newly amended.
Claims 8 and 9 are newly added.
Claims 5-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/25/2025.
Claims 1-4 and 8-9 have been examined on their merits.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application. Any objections or rejections not specifically reiterated are hereby withdrawn.
The rejection claims 1-4 under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Chang et al. (WO2018148445A1, 2018, on IDS 03/22/2023, previously cited) as evidenced by Arora et al. (MABS, 2016) is withdrawn due to amendment of the claims and in order to address those amendments.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-4 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (WO2018148445A1, 2018, on IDS 03/22/2023, previously cited) as evidenced by Arora et al. (MABS, 2016, previously cited) and Spaner et al. (EBioMedicine, 2018).
In regards to claims 1-2 and 8-9, Chang teaches methods comprising contacting (mixing) NK cells with a fusion proteins (a substance) (claim 22).
In regards to the composition of the substance, Chang teaches that the substance (the fusion protein) comprises a first antigen-binding site (a first region or “region I”) and at least a second region (a “region II”) that is an antigen-binding site that can bind to CD16 (claim 1, 19, 22; paragraphs [0007-0008]).
In regards to region I, Chang teaches that the region (the first antigen binding site) binds to (NK cell surface protein) NKG2D (Claims 1 and 22; paragraphs [0007-0008]).
In regards to region II, Chang teaches that in embodiments, that this region can be a human IgG1 antibody (claim 19; paragraphs [00121, 00197]).
As evidenced by Arora, it is known in the art that IgG1 (an antibody) undergoes self-association (Abstract, p1561; Fig. 7, 1570), and therefore, the region II, as disclosed by Chang is capable of binding to antibodies.
In regards to “a substance which is not the antibody”, it is noted that while IgG1s are the same species of antibodies, they are still different individual molecules, and therefore, binding of an IgG1 to the IgG1-comprising region II of the fusion protein as taught by Chang is still a binding of an antibody to the substance which is not the antibody.
Continuing, Chang teaches that the fusion protein can be administered to a tumor or cancer and natural killer cells (claim 22; paragraph [00139) to treat disease including at least chronic lymphocytic leukemia (CLL) (paragraph [00148]). As taught by Chang, natural killer cells also make up the innate immunity (paragraph [0005]), and a person of ordinary skill in the art would have recognized that a patient with CLL would also have these cells. Furthermore, as evidenced by Spaner, IgG (which would include IgG1) is found in the blood CLL patients (Abstract, p222). Therefore, administering the fusion protein to a CCL patient would result in the same arrangement of NK cells, the substance (the fusion polypeptide), and an antibody (IgG1). As a result, the method of Chang carriers the same methods steps as claimed.
In regards to the specific ordering of steps, whether the substance and the NK cell population is first mixed and then an antibody added or mixing the antibody and the substance and then adding this mixture to a NK cell population, Applicant should note that according to MPEP 2144(IV)(C), the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946); see also In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.). Again, as above, the method of Chang results in the same mixture of arrangement of NK cells, the substance (the fusion polypeptide), and an antibody (IgG1).
Additionally, in regards to specifically stabilizing the antibody, Applicant should note that this is a property or natural consequence of the substance (the fusion protein) and an antibody when contacted, and since the method of Chang carries out these same steps, it would result in the same stabilization, absent evidence to the contrary.
In regards to claim 3, Chang discloses that the antigen binding sites (corresponding to either first or second regions) can form an scFV (paragraphs [0012, 0015, 0106]; Fig. 2).
In regards to claim 4, Chang discloses that the protein comprising IgG1 can be used to treat cancers (Claims 23-24). It is also well-known in the art that the antibody IgG1 itself binds to cancer cells.
Therefore, Chang anticipates the invention as claimed.
Response to Arguments
In regards to the claims as amended, Applicant argues that the substance is not an antibody itself, pointing to paragraphs [0104-0106], Example 1 of the specification (Remarks, p8-9).
Relatedly, Applicant argues that the Examiner correlated IgG1 with the claimed region II of the substance but that the substance and the antibody are different elements as recited in the claims (Remarks, p9).
Applicant’s arguments filed 02/17/2026 have been fully considered but are not found persuasive.
The claims as amended do not disallow the substance to be (or comprise) and antibody, only that it is different from the antibody being stabilized.
Specifically, the claims states “A method for stabilizing binding of an antibody which is not the antibody.” As discussed above, this only means that the substance and the antibody are different individual molecules. However, the plain language of this clause does not suggest that the substance itself cannot be (or does not comprise) an antibody.
Applicant argues that Chang does not teach the specific sub-steps (i) or (ii) (Remarks, p9). Specifically, Applicant argues that even if the multi-specific binding protein reads on the claimed antibody, this substance is not mixed with an additional substance which binds to both the NK cell and the multi-specific binding protein (Remarks, p9).
Applicant’s arguments filed 02/17/2026 have been fully considered but are not found persuasive.
In regards to sub-steps (i) or (ii), as above, Chang teaches that the fusion protein can be administered to a tumor or cancer and natural killer cells (claim 22; paragraph [00139) to treat disease including at least chronic lymphocytic leukemia (CLL) (paragraph [00148]). As taught by Chang, natural killer cells also make up the innate immunity (paragraph [0005]), and a person of ordinary skill in the art would have recognized that a patient with CLL would also have these cells. Furthermore, as evidenced by Spaner, IgG (which would include IgG1) is found in the blood CLL patients (Abstract, p222). Therefore, administering the fusion protein to a CCL patient would result in the same arrangement of NK cells, the substance (the fusion polypeptide), and an antibody (IgG1). As a result, the method of Chang carriers the same methods steps as claimed.
In regards to the specific ordering of steps, whether the substance and the NK cell population is first mixed and then an antibody added or mixing the antibody and the substance and then adding this mixture to a NK cell population, Applicant should note that according to MPEP 2144(IV)(C), the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946); see also In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.). Again, as above, the method of Chang results in the same mixture of arrangement of NK cells, the substance (the fusion polypeptide), and an antibody (IgG1).
Additionally, in regards to specifically stabilizing the antibody, Applicant should note that this is a property or natural consequence of the substance (the fusion protein) and an antibody when contacted, and since the method of Chang carries out these same steps, it would result in the same stabilization, absent evidence to the contrary.
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 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 JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
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