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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/19/25 has been entered.
Applicant’s response to the Final Action dated 22 July 2025 is acknowledged. In the amendment filed therein claims 23, 30, 31, 36, 40, 41, 42, and 43 were modified. Claims 1-22 and 24 have been canceled without prejudice or disclaimer. Claims 23 and 25-42 are pending.
Election/Restrictions
3. Applicant's election without traverse of Group I (claims 23-42) and the species of: nucleic acid comprising SEQ ID NO. 1, which encodes the CAR of SEQ ID NO. 24, wherein said CAR comprises the 5B9 peptide epitope tag, extracellular hinge and transmembrane domain of CD28, a signal transduction domain comprising the cytoplasmic region of CD28 and CD3 chains; a tag binding domain comprising SEQ ID NOs. 30-31 as VH and VL respectively, which bind 5B9 epitope, and a binding moiety comprising SEQ ID Nos. 38-39 which are VH and VL respectively which bind CD123; and T cell as cell type, in the reply filed on 08/07/2023 is acknowledged.
4. Claims 32, 34-35 and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/07/2023.
5. Currently, claims 23, 35-31, 33, and 36-42 are under consideration.
6. Rejections and/or objections of record not reiterated herein have been withdrawn.
NEW GROUNDS OF REJECTIONS NECESSITATED BY AMENDMENTS
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.
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.
8. Claims 23, 25-31, 33, and 36-42 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.
A. The claims rejected above recite a sequence selected from a Markush group of sequence identifiers. This language gives the claims multiple interpretations since the claims could be interpreted to mean just any dipeptide/subsequence from the list of sequences or it could also be that the full sequences of each identifier are required to meet the claim limitation.
The presence of multiple interpretations renders the claims indefinite. Furthermore, claim 23 requires SEQ ID NO. 28 or SEQ ID NO. 29 while claim 27 requires SEQ ID NO. 24 to be a nucleic acid sequence. However, sequence identification numbers 28, 29, and 24 are a protein sequence (amino acid sequences). Therefore, it is not clear what exact nucleic acid sequence is being claimed and this renders the claim indefinite. A similar rejection is made for claim 36 which requires SEQ ID NO. 3 to be a peptide, but it is a nucleic acid. Therefore, it is not clear which peptide sequence is actually being claimed here and this makes the claim indefinite. The same rejection is made for claim 40.
B. Claim 41-42 are also rejected here for having multiple interpretations. These claims could be interpreted such that the cells express both the reversed universal chimeric antigen receptor and the adapter molecule. On the other hand, they could be interpreted such that the compositions comprise the cells and the adapter molecule as separate ingredients mixed and the cells need not express the adapter. The presence of multiple interpretations renders the claims indefinite. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
C. Claims 23, 29 , 36, and 41 are vague and indefinite because it is not clear as to what the isolated nucleic acid will encode. As recited the claims reads on “an isolated nucleic acid encoding a reversed universal chimeric antigen receptor that is capable of specifically binding to an adapter module when expressed by an effector cell, wherein the receptor comprises a first domain, a second domain, and a third domain”. However, it is ambiguous as to what the encoding nucleic acid sequence will entail. Is it Applicant’s intent to mean the nucleic acid will encode the entire receptor – comprising the 1st domain, 2nd domain, and the 3rd domain? Or will the nucleic acid encode a portion of the receptor? This is additionally unclear as the specification (page 4) and claim 29 appear to claim nucleic acid constructs that do not include the entire receptor. Please clarify the nucleic acid composition. It is suggested that the nucleic acid sequence encoding for the full receptor is included in the claims in order to obviate the rejection. Appropriate correction is required.
D. Claims 23, 30, and 40 are indefinite because the claims recite, "according to SEQ ID NO: 28 [...]". This recitation of this phrase renders the claim indefinite because it cannot be ascertained how it is intended to limit the subject matter to which the claim is drawn. Is a La/SSB antigen "according to SEQ ID NO: 28" or any of the other recited amino acid sequences) a polypeptide consisting of the amino acid sequences of SEQ ID NO: 28, a polypeptide fragment found within SEQ ID NO:28, or a polypeptide having a certain relationship/association [i.e. percent homology] to SEQ ID NO:28 (or the recited amino acid sequence selected) or a polypeptide comprising the amino acid sequence of SEQ ID NO: 28 (or the recited amino acid sequence selected)?
Claim Rejections - 35 USC § 103
9. 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.
10. Claim(s) 23, 25-31, 33, and 36-42 are rejected under 35 U.S.C. 103 as being unpatentable over Bachmann (WO2016/030414, published 03/03/2016, on IDS and previously cited) in view of Powell (WO2017/112784, published 06/29/2017).
Bachmann teaches immune cell-based anticancer therapeutics and methods for using them to treat cancer (Abstract). To this end, they teach a universal chimeric antigen receptor and immune cells expressing the same that target various antigens and that can treat cancer (Title, Pg. 1). They state that conventional CAR technology comes along with several critical issues which need to be solved before this treatment modality can be widely applied in the clinic (Pg. 2, Paragraph, second).
Immune responses of T cells engineered with conventional CARs are difficult to control, in particular that against healthy tissue, which can cause severe side effects (Pg. 2, Paragraph, second). Also, conventional CAR technology causes restriction of the engineered T cell to a single antigen, which can allow for tumor escape variants that have lost the target antigen and such has been observed in the clinic (Pg. 2, Paragraph, second). They provide a genetically modified immune cell that allows redirection against diverse disorders in a safe and efficient manner using endogenous tags based on nuclear proteins (Pg. 2, Paragraph, final). They teach an isolated nucleic acid encoding a universal chimeric antigen receptor (UniCAR) wherein the receptor comprises three domains, the first domain being a tag- binding domain, the second domain is a linking peptide chain that includes an extracellular hinge and transmembrane domain and the third domain is a signal transduction domain, wherein the tag-binding domain binds a tag derived from any human nuclear protein (Pg. 3, Paragraph, second).
Use of a peptide from a human nuclear protein as the tag above means the native proteins cannot be accessed and bound by the receptor in the context of the native protein under physiological conditions (Pg. 3, Paragraph, second). An optional fourth domain is a short peptide linker in the extracellular portion of the UniCAR which forms a linear epitope for an antibody that binds the fourth domain (Pg. 3, Paragraph, second). They further teach a target module (adapter module) comprising a binding moiety specific for a certain human cell surface protein and a tag, wherein the tag is derived from any human nuclear protein (Pg. 3, Paragraph, third) and an isolated nucleic acid encoding said target module (Pg. 3, Paragraph, fourth).
The binding moiety can be an antibody or fragment thereof against CD123 (Pg. 11, Paragraph, first). Since the binding moiety is an antibody it is a protein complex or fragment thereof. They also teach a cell comprising the nucleic acid encoding the UniCAR above (Pg. 3-4, Paragraph, spanning). A vector comprising said nucleic acid is taught (Pg. 4, Paragraph, second). They teach a kit comprising said vector and a target module according to their invention and/or a vector encoding said target module (Pg. 4, Paragraph, third). They also teach pharmaceutical compositions comprising the cells and target modules of their invention with a carrier for intravenous administration (Pg. 4, Paragraph, fourth). Cells of these formulations can be immune cells (claim 17).
The first domain of the UniCAR, which binds the tag, is typically an antibody or fragment thereof such as an scFv (Pg. 7-8, Paragraph, spanning). In a preferred embodiment the tag is a short linear epitope from the human nuclear La protein (Pg. 9, Paragraph, third). To bind this tag, the UniCAR can have an scFv against 5B9 epitope of La, encoded by their SEQ ID NO. 1 (Pg. 24, Paragraph, third).
The 5B9 epitope is their SEQ ID NO. 44 (Pg. 25, Paragraph, fourth). For the second domain of the UniCAR the hinge and transmembrane domain above can be those of human CD28 (Pg. 9, Paragraph, penultimate). The third UniCAR domain for signal transduction can be the cytoplasmic domains of CD28 and CD3 chains (Pg. 9-10, Paragraph, spanning). These domains are immune cell activating or costimulatory and so are signaling domains (Pg. 10, Paragraph, first).
With these components taught, they further provide an illustration of how their system functions in Figure 2 against cancer. A T cell expresses the UniCAR (Pg. 9, Paragraph, third, and claim 15), the scFv of which binds the target module (TM1) by the tag derived from the human nuclear protein. The scFv of the TM1 will then bind the tumor cell, crosslinking the T cell and tumor cell (Pg. 9-10, Paragraph, spanning), leading to lysis of said tumor cell (Figure 2 and its legend on page 6). Figure 7 presents data of use of this system against prostate tumor antigens (Pg. 6, Figure 7 legend). Specific lysis of tumor cells is shown in this figure.
Bachmann does not teach a reversed UniCAR in which the peptide tag, like 5B9 epitope, replaces the 5B9 binding scFv of the UniCAR of their invention and the target module (adapter module), rather than the 5B9 tag, comprising the anti-5B9 scFv taught by Bachmann.
However, such a switch in domains or domain exchange is immediately obvious to one of ordinary skill in this art. The key to Bachmann's invention is simply that the UniCAR bind the adapter module and the adapter module bind the target tumor cell. This will occur whether the anti-5B9 scFv is present on the adapter module or on the UniCAR when its target epitope is on the second member of the system.
Said another way, this exchange is just moving to known elements of the prior art to different positions of a system to arrive at predictable results. Thus, for at least this reason, all claims above are obvious here as this switch will generate the corresponding immune cells, nuclear acids, and vectors, recited in all instant claims.
Further support for the obviousness of this domain exchange is found in Powell. Powell teaches compositions and methods for adoptive T cell therapy in treating cancer by providing a universal immune receptor that comprising a peptide tag such as a SpyTag moiety bound to an extracellular hinge region and transmembrane domain and an intracellular domain for T cell activation (Abstract).
Therefore, Powell teaches a similar invention as the UniCAR of Bachmann above. Importantly, Figure 1A shows that their invention also functions the same, with the CAR variant expressed in a cell and the adapter module with the antigen specific antibody that will bind the target cell of the T cell above is bound by said CAR variant. Figure 1A also illustrates that the binding domain and tag of this system, SpyCatcher and SpyTag are interchangeable in position within the system. Both can be on the CAR variant as the first domain and both can be on the adapter module with antigen specific antibody.
Thus, one of ordinary skill in this art would prior to the effective filing date of the invention would readily see such flexibility in the system of Bachmann above, owed to the strong similarity in the two systems of the references and also the flexibility of recombinant DNA technology and recombinant protein generation in which a peptide tag can be added to any protein of interest as evidenced by the references above. Also, scFv molecules share such versatility.
This is evidenced also by the references above. See or example Powell at page 3, Paragraph, first in which an scFv can be linked to their SpyCatcher or SpyTag.
Taken together, one of ordinary skill in this art enjoys a reasonable expectation of success in exchanging the scFv against 5B9 in Bachmann and the 5B9 epitope in Bachmann with respect to their positions in the system taught to arrive at all the products of the instant claims above with a reasonable expectation of success.
With respect to claim 27, it requires the nucleic acid sequence encode the obvious UniCAR above with first domain as the 5B9 tag and having a sequence from SEQ ID NO. 24 which comprising KPLPEVTDEY at residues 23-32. This is the 5B9 tag. As stated above in the indefiniteness rejection, SEQ ID NO. 24 is not a nucleic acid and so the claim is indefinite but the nucleic acid of claim 27 can comprise the nucleic acid encoding the 5B9 tag obviously which is taught by Bachmann as their SEQ ID NO. 14 (Pg. 25, Paragraph, fourth). Since this tag is known, all nucleic acid sequences that encode it are known to one of ordinary skill in this art as codon/ amino acid correspondence is known. Thus, the obvious nucleic acid encoding the obvious CAR variant with 5B9 epitope as the first domain will comprise such a 5B9 encoding sequence and thus comprise a sequence of a nucleic acid that would be present in the nucleic acid that encodes SEQ ID NO. 24. Therefore, the claim is obvious here. With respect to claim 29, SEQ ID NO. 1 was elected by Applicant and so encodes their elected 5B9 tag. Thus, one of the obvious 5B9 encoding nucleic acid sequences above will be present in SEQ ID NO. 1 and so the obvious nucleic acid has a sequence from instant SEQ ID NO. 1. Thus, this claim too is obvious here.
It should also be noted that one of ordinary skill in this art would see an advantage to replacing the anti-5B9 scFv of the UniCAR of Bachmann with the 5B9 peptide. Said peptide is not a binding domain and so the reversed UniCAR obvious here will have less possibility of unwanted interactions on healthy cells. Thus, the T cells that express the reversed UniCAR should have less possibility of side effects. On the other hand, non- specific or off-target binding of the anti-5B9 scFv carrying UniCAR could occur, leading to side effects. This would be clear of one of ordinary skill in this art. Thus, the combined teachings of the art render the claims above obvious.
Response to Arguments
Applicant’s arguments filed 12/19/25 have been carefully considered but were not found persuasive for the following reasons:
I. Sequence modifications to a UniCAR would not be obvious to a PHOSITA
Applicant argues that, as would be understood by a PHOSITA, sequence modifications can lead to changes in expression, stability, and/or function of a chimeric antigen receptor (CAR) (see the Response to Non-Final Office Action dated May 16, 2025; the "May 2025 Response"). And a RevCAR of the instant application differs from a UniCAR described in Bachmann in that the N-terminal extracellular domain of a RevCAR comprises a short linear epitope tag from a human nuclear La protein, whereas the N-terminal extracellular domain of a UniCAR comprises a large tag-binding domain (e.g., scFv) that specifically binds to a short linear epitope tag of a target module (see May 2025 Response at p.9).
This argument was carefully considered but not found persuasive because a PHOSITA would understand that either member of a specific binding pair could be utilized to construct the nucleic acids presently claimed. Applicant contends that the instantly claimed RevCAR comprises a short linear epitope tag from a human nuclear La protein, whereas the N-terminal extracellular domain of a UniCAR (as taught by Bachmann) comprises a large tag-binding domain (e.g., scFv) that specifically binds to a short linear epitope tag. Absent evidence to the contrary it would have been obvious to design a binding construct with either member of a known binding pair.
II. Examiner mischaracterized the state of the art known by a PHOSITA
Applicant argues that the unpredictable influence of structural changes to a CAR was known to a PHOSITA based on the teachings of Krug et al. and continued to persist at the time of publication of Fujiwara et al. and Landoni et al. Thus, Krug et al., Fujiwara et al., and Landoni et al. all support Applicant's argument that, given the state of knowledge at the time of filing of the instant application, it would not be obvious to a PHOSITA that substituting a UniCAR scFv with a short linear epitope tag from a human nuclear La protein would result in an expressed, stable, and functional CAR.
In response to Applicant’s argument it is noted that the substitution of a UniCAR scFV with a short linear epitope tag from a human nuclear La protein was an established binding interaction taught by the prior art. Although the predictability of the substitution within a CAR was not known, it would have been obvious to try since the binding interaction of the compositions were already taught in the prior art.
In particular, the N-terminal extracellular domain of a UniCAR (as taught by Bachmann) comprise a large tag-binding domain (e.g., scFv) that specifically binds to a short linear epitope tag. While the RevCAR, reversed the binding entity and places the short linear epitope tag in the CAR construct (the claimed RevCAR comprises a short linear epitope tag from a human nuclear La protein). It would have been prima facie obvious at the effective filing date of the instant invention to choose from a finite number of identified, predictable solutions, with a reasonable expectation of success – “Obvious to try”;
The Supreme Court in KSR reaffirmed the familiar framework for determining obviousness as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), but stated that the Federal Circuit had erred by applying the teaching-suggestion-motivation (TSM) test in an overly rigid and formalistic way. KSR, 550 U.S. at 404, 82 USPQ2d at 1391. Specifically, the Supreme Court stated that the Federal Circuit had erred in four ways: (1) "by holding that courts and patent examiners should look only to the problem the patentee was trying to solve " (Id. at 420, 82 USPQ2d at 1397); (2) by assuming "that a person of ordinary skill attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem" (Id.); (3) by concluding "that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘obvious to try’" (Id. at 421, USPQ2d at 1397); and (4) by overemphasizing "the risk of courts and patent examiners falling prey to hindsight bias" and as a result applying "[r]igid preventative rules that deny factfinders recourse to common sense" (Id.). See also Novartis Pharms. Corp. v. West-Ward Pharms. Int'l Ltd., 923 F.3d 1051, 1059, 2019 USPQ2d 171676 (Fed. Cir. 2019); Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1047-48, 120 USPQ2d 1400, 1410 (Fed. Cir. 2016); and Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324, 1332,
102 USPQ2d 1445, 1449 (Fed. Cir. 2012).
III. Examiner's rationale failed to establish a link between the facts and a conclusion of obviousness
Applicant contends that predictable results" (see MPEP 2143(I)), as described in Bachmann, wherein a UniCAR functions to bind to a tag conjugated to a target module, which in turn binds to a cellular surface protein or an extracellular structure (see Bachmann at p.7) were not known for the claimed RevCAR.
And In the context of a UniCAR system, a substitution of one known element (e.g., a UniCAR scFv) for another (e.g., a short linear epitope from a human nuclear protein) would result in a non-functional substituted CAR construct because such a substituted CAR construct would not be able to bind to a target module comprising a short linear epitope tag (i.e., a short linear epitope tag cannot bind another short linear epitope tag). Thus, it would not be obvious to a PHOSITA to substitute a UniCAR scFv of Bachmann with a short linear epitope from a human La nuclear protein as presently claimed in the instant application. This argument was carefully considered but not found persuasive because although the short linear tag would not bind another short linear epitope tag, it would bind a molecule of interest (tag binding domain) to produce the expected expression, stability and/or function. It is noted that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
IV. Examiner failed to consider the invention as a whole
Applicant argues that while all the domains of a RevCAR maybe taught, the mere teaching of the individual domains by the cited references does not establish that their specific combination and arrangement as presently claimed would be predictable by a PHOSITA, expressed by cells, stable, and/or functionally operative.
Therefore, the Examiner's stated position ignores the technical complexities and interrelated dependencies among the domains of a CAR construct, which are not trivially interchangeable. Accordingly, the Examiner failed to account for the non-obvious nature of a RevCAR as a whole.
This argument was carefully considered but not found persuasive because the claims as currently recited, broadly read on isolated nucleic acid constructs encoding a reverse universal chimeric antigen receptor comprising various known binding domains. There is no specific novel sequence identification number(s) presented in the claims, no distinction regarding the positioning of the binding domains (N-terminal to C-terminal) and no specific combination allowing for distinction from the prior art.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., specific combinations and/or arrangements of the claimed nucleic acids) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
V. Examiner failed to provide a rationale for why a PHOSITA would be motivated to substitute domains of a UniCAR
Applicant argues that a UniCAR and a RevCAR are both capable of being cross-linked to the same target antigen (e.g., TAA) on a target cell via a target module (as described in Bachmann) or an adapter module (as described in the instant application), respectively.
The fact that a UniCAR and a RevCAR are capable of being cross-linked to the same target antigen (e.g., TAA) expressed by a target cell, underscores that it would not be obvious to a PHOSITA that exchanging a UniCAR scFv with a target module's short linear epitope tag would result in a reduced immune response against healthy tissues expressing the target antigen (e.g., TAA). This argument was carefully considered but not found persuasive because a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
VI. Examiner engaged in impermissible hindsight analysis
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
VII. The claims as presently amended are not reasonably predicted by a PHOSITA
Applicant argues that the Examiner alleged that "Applicant in their claims asserts broader predictability than they argue exists" (see Final Action at p.6).
Applicant respectfully disagrees with the Examiner's assertion, however, for the sole purpose of advancing the instant application to allowance, pending claim 23 has been amended to recite intended use or binding characteristics and SEQ ID Nos. 28 & 29.
The amendments have been carefully considered but are not found persuasive because sequence identification number 28 and 29 are taught in the prior art. See US Patent #9,540,446 wherein SEQ ID NO: 83 is identical to the instantly claimed SEQ ID NO:28 and SEQ ID NO:97 is identical to the instantly claimed SEQ ID NO:29.
In response to applicant's argument related to the utility of the claimed compositions a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Double Patenting
11. 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 conflicting claims 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); 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( may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used.
Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apphv/applving- online/eterminal-disclaimer.
12. Claims 23, 25-31, 33, and 36-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,611,814 in view of Bachmann (WO2016/030414, published 03/03/2016, on IDS and previously cited) and Powell (WO2017/112784, published 06/29/2017).
The combined teachings of Bachmann and Powell already render obvious all claims above and the addition of the patented claims only further supports this obviousness. The 103 above is incorporated here. The patented claims are the result of the Bachmann international application above. Therefore, all the products therein relate to UniCARs (Patented claim 1 is a nucleic acid that encodes a UniCAR) which are obvious to "reverse" for the reasons in the 103 above. This reversal of the patented claims' elements (tag and anti-tag scFv domain exchange) leads one of ordinary skill in this art to the instant claims and so the instant claims are all rejected here. Said another way, the instant claims are an obvious variant of the patented claims.
13. Claims 23, 25-31, 33, and 36-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14-18, 20-23, and 25-27 of copending Application No. 16/798,255 in view of Bachmann (WO2016/030414, published 03/03/2016, on IDS and previously cited) and Powell (WO2017/112784, published 06/29/2017).
The combined teachings of Bachmann and Powell already render obvious all claims above and the addition of the copending claims only further supports this obviousness. The 103 above is incorporated here. Copending claim 1 is drawn to an isolated nucleic acid that encodes a UniCAR as in Bachmann above. A cell that expresses the same is taught (copending claim 14). However, in view of the art above and reasons in the 103, it is obvious to reverse this UniCAR to arrive at the claimed invention through domain exchanges discussed supra. In this way, one arrives at the instant claims and so the claims above are rejected here.
This is a provisional nonstatutory double patenting rejection.
14. Claims 23, 25-31, 33, and 36-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 17/911,678 in view of Bachmann (WO2016/030414, published 03/03/2016, on IDS and previously cited) and Powell (WO2017/112784, published 06/29/2017, previously cited).
The combination of Bachmann and Powell render all claims rejected here obvious. All reasons for this of record are incorporated here. The addition of the copending claims over related subject matter only further supports this obviousness. Copending claim 1 can be a reversed UniCAR system like that instantly claimed as the CAR can contain a peptide tag and the targeting module can carry a binding domain for the tag. Thus, combined with Bachmann and Powell the copending claims render all instant claims obvious and so this rejection is made.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant traverses the ODP rejections for at least the same reasons that the present claims are non-obvious over Bachmann and Powell as discussed in the reply filed on 12/19/25. Accordingly, Applicant has respectfully requested that the non-statutory obviousness-type double patenting rejections be reconsidered and withdrawn. The obviousness rejections are addressed herein and were not found persuasive. Therefore, the ODP rejections are maintained.
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Lisa Cook
Patent Examiner
Art Unit 1642
571-272-0816
5/16/26
/LISA V COOK/Primary Examiner, Art Unit 1642
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