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
2. The election with traverse filed on 07/30/2026 in response to the Office Action of 05/26/2026 is acknowledged and has been entered.
Applicant has elected Group I, claims 1-14, drawn to a hybrid ligand molecule comprising a first antibody combining site that binds to an effector cell receptor complex structure of an effector cell linked to a second antibody combining site which is a target cell-specific antibody combining site.
Additionally, Applicant has elected species of αβ T cell and FcᵞRI (CD64).
Claims 1-19 are pending in the application. Claims 15-19 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/30/2026.
4. Claims 1-14 are currently under prosecution.
Election/Restrictions
5. Applicant's traversal of the propriety of the restriction and election requirement set forth in the Office action mailed 05/26/2026 is acknowledged.
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
For the reasons set forth in the preceding Office action mailed 05/26/2026, the different inventions or different species thereof listed, as listed therein, do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2.
Then, in light of the grounds of rejection of the claims directed to the elected invention that follow, it is apparent that although the inventions appear to be linked by a common concept, or special technical feature, namely a hybrid ligand molecule comprising a first antibody binds to a CD3 complex on a surface of the T lymphocyte and a second antibody binds to a protein encoded by a virus which is expressed on a surface of the target cell, because Ast et al. (WO 2013026833, published on 28 February 2013) (of record) teaches a T cell activating bispecific antigen binding molecule comprising a first and a second antigen binding moiety, wherein the first and the second antigen binding moiety are fused to each other via a peptide linker, wherein the first antigen binding moiety binds to CD3 and the second antigen binding moiety binds to an antigen presented on a virus-infected cell (and any minor differences in the subject matter claimed in the instant application would be seen as an obvious variation of subject matter described by the prior art), this technical feature that appears to link the inventive concepts of the different inventions does not constitute a special technical feature as defined by PCT Rule 13.1, as it does not define a contribution over the prior art.
Accordingly, the restriction and election requirement set forth in the Office action mailed 05/26/2026 is deemed proper and therefore made FINAL.
Priority
6. Applicant’s claim under 35 U.S.C. §§ 119(e) and 365(c) for benefit of the earlier filing date of applications, is acknowledged.
Claim Rejections - 35 USC § 112
7. 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.
8. 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.
9. Claim 14 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 pre-AIA the applicant regards as the invention.
Claim 14 recites the limitation " the fluid" in line 7. There is insufficient antecedent basis for this limitation in the claim.
10. 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 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 § 102
11. 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.
12. Claims 1-5 and 7-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ast et al. (WO 2013026833, published on 28 February 2013) (of record).
Claims 1-5 and 7-14 are herein drawn to a hybrid ligand molecule comprising a first antibody binds to a CD3 complex on a surface of the T lymphocyte and a second antibody binds to a protein encoded by a virus which is expressed on a surface of the target cell.
Ast et al. teach a T cell activating bispecific antigen binding molecule comprising a first and a second antigen binding moiety, wherein the first and the second antigen binding moiety are fused to each other via a peptide linker, wherein the first antigen binding moiety binds to CD3 and the second antigen binding moiety binds to an antigen presented on a virus-infected cell; see entire document, e.g., claims 1-3, pages 49-51.
For claims 11-12, Ast et al. teach that activating Fc receptor includes FcᵞRIIIa (CD16a), FcᵞRI (CD64), or FcᵞRIIa (CD32); see page 30.
For claim 14, Ast et al. teach a method for inducing lysis of a target cell, comprising contacting a target cell with the T cell activating bispecific antigen binding molecule in the presence of a T cell; see claim 41.
Claim Rejections - 35 USC § 103
13. 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 of this title, 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.
14. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
15. Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ast et al. (WO 2013026833, published on 28 February 2013) (of record).
Claim 6 is herein drawn to the hybrid ligand molecule of claim 1, wherein the second antibody binds to a viral protein encoded within a coronavirus and expressed on the surface of the target cell.
The teachings of Ast et al. have been set forth in the above rejection of claims 1-5 and 7-14 under 35 U.S.C. 102(a)(1).
Although Ast et al. teach the second antigen binding moiety binds to an antigen presented on a virus-infected cell, Ast et al. do not teach the virus is a coronavirus.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the reference so as to substitute the virus of Ast et al. for another virus (e.g., a coronavirus), because simple substitution of the virus of Ast et al. for another virus (e.g., a coronavirus) would obtain predictable results.
Given the examination guidelines for determining obviousness under 35 U.S.C. 103 in view of the Supreme Court decision in KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007) and the Examination Guidelines set forth in the Federal Register (Vol. 72, No. 195, October 10, 2007) and incorporated recently into the MPEP (Revision 9, March 2014), the following rationales to support rejection under 35 U.S.C. 103(a) are noted:
A) Combining prior art elements according known methods to yield predictable results.
B) Simple substitution of one known element for another to obtain predictable results.
C) Use of known technique to improve similar devices (methods, or products) in the same way.
D) Applying known technique to a known device (method, or product) ready for improvement to yield predictable results.
E) “Obvious to try” --- choosing form a finite number of identified, predictable solutions, with a reasonable expectation of success.
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art.
G) Some teachings, suggestion, or motivation in the prior art that would lead to one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In this case, simple substitution of the virus of Ast et al. for another virus (e.g., a coronavirus) would obtain predictable results.
Obviousness is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007). From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Double Patenting
16. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
17. Claims 1-14 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 5,078,998. Although the conflicting claims are not identical, they are not patentably distinct from each other because for the following reasons:
Claims 1-14 are herein drawn to a hybrid ligand molecule comprising a first antibody combining site that binds to an effector cell receptor complex structure of an effector cell linked to a second antibody combining site which is a target cell-specific antibody combining site.
Claims 1-10 of U.S. Patent No. 5,078,998 are drawn to a hybrid ligand molecule comprising one antibody combining site that binds to a T cell receptor complex structure and is capable of activating cytotoxic effector T lymphocytes linked to a second target cell-specific antibody combining site.
Conclusion
18. No claims are allowed.
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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