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 1-33 are pending.
Due to reconsideration of the claims, in view of the amendments and resultant cited art, the species requirements for types of co-stimulatory ligands (corresponding to claims 3-5) and compositions comprising nucleic acids (corresponding to claims 24-25, 29, and 32 has been withdrawn.
Claims 26-27, 30-31, and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.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 08/29/2025.
Claims 1-25, 28-29, and 32 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Withdrawn Objections & Rejections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 Any objections or rejections not specifically reiterated are hereby withdrawn.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 of claims 1-2, 4-5, 8-9, 11-12, 14-16, 18, 20-22, and 28 under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Baeuerle et al. (US20170166622A1, 2017) as evidenced by Jonker et al. (Transplantation, 2002) is withdrawn due to amendment of the claims and Applicant’s persuasive arguments.
The rejection of claims 6 and 7 under 35 U.S.C. 103 as being unpatentable over Baeuerle et al. (US20170166622A1, 2017) in view of Swanson et al. (WO2017181152A2, 2017, hereafter “Swanson”) as evidenced by Jonker et al. (Transplantation, 2002) is withdrawn due to amendment of the claims and Applicant’s persuasive arguments.
The rejection of claims 10 and 17 under 35 U.S.C. 103 as being unpatentable over Baeuerle et al. (US20170166622A1, 2017) in view Swanson et al. (WO2017181148A2, 2017, hereafter “Swanson ICOSL”) as evidenced by Jonker et al. (Transplantation, 2002) is withdrawn due to amendment of the claims and Applicant’s persuasive arguments.
The rejection of claims 13 and 19 under 35 U.S.C. 103 as being unpatentable over Baeuerle et al. (US20170166622A1, 2017) in view Swanson et al. (WO2017181152A2, 2017, hereafter “Swanson”) and Swanson et al. (WO2017181148A2, 2017, hereafter “Swanson ICOSL”) as evidenced by Jonker et al. (Transplantation, 2002) is withdrawn due to amendment of the claims and Applicant’s persuasive arguments.
The rejection of claim 23 under 35 U.S.C. 103 as being unpatentable over Baeuerle et al. (US20170166622A1, 2017) in view of Glatzová et al. (Frontiers in Immunology, 2019) and Brannetti et al. (US20180125892A1, 2018) as evidenced by Jonker et al. (Transplantation, 2002) is withdrawn due to amendment of the claims and Applicant’s persuasive arguments.
Response to Arguments – persuasive
Applicant argues that Baeuerle does not anticipate the claims as amended (Remarks, p6-7). Specifically, Applicant argues that the fusion polypeptide as disclosed by Baeuerle does not “consist” of an extracellular domain of a co-stimulatory molecule (Remarks, p6).
Relatedly, Applicant argues that none of Swanson CD28, etc. cures the deficiencies of Baeuerle (Remarks, p9-10).
Applicant’s arguments, see p6-10, filed 03/24/2026 with respect to the claims under 35 USC 102 or 25 USC 103 over Baeuerle have been fully considered and are persuasive. Specifically, it is noted that since the fusion polypeptide as taught by Baeuerle comprises an extracellular domain with an anti-CD19 binding domain (thus, an antigen domain which is not a co-stimulatory domain), it is not a “fusion polypeptide consisting of a) an extracellular domain of a co-stimulatory ligand.” As required by the claim.
Therefore, the rejection has been withdrawn. However, upon further consideration, in light of amendment to the claims a new grounds of rejection is made in view of Noessner et al. (WO2017162797A1, on IDS 05/29/2025) as discussed below.
Response to Arguments – not persuasive
Applicant argues that the double-patenting rejection over co-pending Application No. 18/306,890 should be withdrawn citing recent decisions in Allergan USA, Inc. v MSC Laboratories, 11 F.4th 1358 (Fed. Cir. 2004) and Ex Parte Baurin (PTAB 2024) (Remarks, p10).
Applicant’s arguments filed 03/24/2026 have been fully considered but are not found persuasive.
The MPEP does not cite or provide guidance in reference to Allergan USA, Inc. v MSC Laboratories or Ex Parte Baurin.
Indeed, since MPEP 804(I)(B)(1)(b)(iii)) directs that if a provisional non-statutory double-patenting rejection is the only remaining in an application with an earlier patent term date, the provisional double-patenting rejection would be withdrawn, it suggests that provisional non-statutory double-patenting rejections should be made over co-pending applications with a later patent term date when appropriate (as it is here).
Indeed, the Federal Circuit has sustained non-statutory double patenting rejections where the reference patent has a later priority and patent-term filing date than the application under examination. For example, In re Fallaux, 564 F.3d 1313 (Fed. Cir. 2009), where the Federal Circuit affirmed the Board's ODP rejection based on these later-priority reference patents. Id. at 1319. The court acknowledged that “the unjustified patent term extension justification for obviousness-type double patenting has limited force in this case,” but it identified a “second justification for obviousness-type double patenting-harassment by multiple assignees.” Id. at 1318-19 (citing In re Van Ornum, 686 F.2d 937, 944-48 (C.C.P.A. 1982)).
Therefore, the provisional non-statutory double patenting rejection over co-pending Application No. 18/306,890 is maintained as discussed below.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Dependent claim 22 is “The fusion polypeptide of claim 1, further comprising a signaling domain of a cytokine receptor.
Dependent claim 23, is “The fusion polypeptide of claim 22, wherein the cytokine receptor is selected from the group consisting of CD121a, etc.”
Dependent claims 22 and 23 ultimately depend on claim 1 which is a fusion polypeptide “consisting of” a) an extracellular domain of a co-stimulatory ligand, b) a transmembrane domain comprising a transmembrane domain of a co-stimulatory ligand, and c) and intracellular domain comprising an intracellular domain of a first co-stimulatory molecule.
Because claim 1 is closed-ended, the fusion polypeptide may not further comprise structural elements beyond those recited in claim 1. Thus, the fusion polypeptide may structurally only have a) an extracellular domain of a co-stimulatory ligand, b) a transmembrane domain comprising a transmembrane domain of a co-stimulatory ligand, and c) and intracellular domain comprising an intracellular domain of a first co-stimulatory molecule.
In regards to the transmembrane and intracellular domains, these specific domains may themselves comprise other structural elements (as long as they minimally have respective co-stimulatory domains). However, the extra-cellular domain is limited only to an extracellular domain of a co-stimulatory ligand.
It is noted that the specification does not define a cytokine receptor as a species of co-stimulatory ligand. Furthermore, even if it did, it would contradictory to how the terms are used in the art, as it is well known that a cytokine receptor is a receptor that binds to a cytokine (a type of ligand), while a co-stimulatory ligand is a type of ligand that binds to co-stimulatory receptors.
Under the written description guidelines (see MPEP 2163) the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. “Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.” Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
Actual Reduction to Practice
In regards to claims 22-23 the specification does not provide working examples of a fusion polypeptide that “consists” of an extracellular, transmembrane, and intracellular domains as discussed above but that also comprises a signaling domain of a cytokine receptor. As above, because claim 1 is closed-ended, the fusion polypeptide may not further comprise features other than the extracellular, transmembrane, or intracellular domains as in claim 1. While the transmembrane domain and intracellular domains themselves comprise other elements (although the extracellular domain may not), the claim does not suggest that the cytokine receptor is a further limitation of the transmembrane or intracellular domains. Explicitly, the cytokine receptor is a further structural limitation of fusion polypeptide itself and does not necessarily imply a further structural element of the transmembrane or intracellular domains.
Additionally, while the specification states that a cytokine receptor may be added to the N- or C-terminus of the fusion polypeptide (paragraph [0142]), this does not necessarily suggest a cytokine receptor in the intracellular domain because an intracellular domain may be either N- or C-terminal. Additionally, the same is true for the extracellular domain, which again, is disallowed from further structural features. Moreover, the only cited examples, CD122, CD122, CD126 (IL-6R), etc. (see claim 23; paragraph [0142]), only have receptor function in the extracellular domain (see Deng et al., Journal of Cellular Immunology, 2021 (Fig. 1, p388) and Chen et al., Kidney Disease, 2023 (Fig. 2, p241)).
Accordingly, Applicant does not demonstrate a reduction to practice a fusion polypeptide that “consists” of an extracellular, transmembrane, and intracellular domains as discussed above but that also comprises a signaling domain of a cytokine receptor.
State of the Art and Quantity of Experimentation
The art is completely silent as to a fusion polypeptide that “consists” of an extracellular, transmembrane, and intracellular domains as discussed above but that also comprises a signaling domain of a cytokine receptor.
As above, while CD122, CD122, CD126 (IL-6R), etc. (see claim 23; paragraph [0142]), are known cytokine domains, they only have receptor function in the extracellular domain (see Deng et al., Jounral of Cellular Immunology, 2021 (Fig. 1, p388) and Chen et al., Kidney Disease, 2023 (Fig. 2, p241)), which is disallowed by the claims.
Therefore, one of skill in the art would neither expect nor predict the appropriate functional change of a fusion polypeptide that “consists” of an extracellular, transmembrane, and intracellular domains as discussed above but that also comprises a signaling domain of a cytokine receptor
Conclusion
Applicant has claimed a fusion polypeptide that “consists” of an extracellular, transmembrane, and intracellular domains as discussed above but that also comprises a signaling domain of a cytokine receptor, yet the specification has not disclosed a fusion polypeptide that “consists” of an extracellular, transmembrane, and intracellular domains as discussed above but that also comprises a signaling domain of a cytokine receptor. Indeed, the fusion polypeptide is disallowed to comprise other structural elements beyond those to the co-stimulatory domains of the transmembrane and intracellular domains, but the claims and specification do not indicate that cytokine receptor is a part of these domains.
Therefore, the Examiner concludes that there is insufficient written description of the instantly claimed fusion polypeptide that “consists” of an extracellular, transmembrane, and intracellular domains (claim 1) but that also comprises a signaling domain of a cytokine receptor (claims 22-23).
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 8-10, 20-21, 24-25, 28-29, and 32 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(1) as being anticipated by Noessner et al. (WO2017162797A1, on IDS 05/29/2025).
In regards to claims 1-3 and 8-9, Noessner discloses a fusion protein consisting of an extracellular domain, a transmembrane domain, and an intracellular domain (paragraphs [01, 06, 11]). In embodiments, Noessner discloses that the transmembrane and extracellular domains are derived from 4-1BB or CD28 (paragraphs [01, 06, 11]), which are both well-known “co-stimulatory molecules.” In embodiments, Noessner discloses that the extracellular domain can be co-stimulatory CD40L (paragraphs [01, 06, 09, 035]) (a well-known TNF family molecule).
In regards to claim 10, Noessner discloses 4-1BB SEQ ID NO: 4, which has 100% identity with the claimed SEQ ID NO: 3.
In regards to claim 20-21, Noessner discloses that the fusion polypeptide is capable of supporting T cell activity (paragraph [09]) which augments TCR signaling (paragraph [07]).
In regards to claims 24-25 and 32, Noessner discloses a nucleic acid encoding the fusion polypeptide, a vector comprising the nucleic acid, and a kit comprising the nucleic acid (paragraph [01]).
In regards to claim 28, as above, Noessner discloses the fusion polypeptide as in claim 1. Noessner also discloses that it can be expressed on at least T cells expressing antigen-recognizing receptors (e.g., TCRs) (paragraphs [07, 09]).
In regards to claim 29, as above, Noessner discloses a nucleic acid encoding the fusion polypeptide (paragraph [01]). Also as above, Noessner also discloses that it can be expressed on at least T cells expressing antigen-recognizing receptors (e.g., TCRs) (paragraphs [07, 09]), which necessarily requires a second polynucleotide encoding an antigen-recognizing receptor that minds to an antigen.
Therefore, Noessner anticipates the invention as claimed.
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 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Noessner et al. (WO2017162797A1, on IDS 05/29/2025).
Noessner anticipate claim 1 as discussed above.
In regards to claims 14-16, while Noessner is silent regarding embodiments of a second co-stimulatory molecule, as discussed above, Noessner teaches that the transmembrane and extracellular domains are derived from 4-1BB “or” CD28 (paragraphs [01, 06, 11]). Since the word “or” is disjunctive, it necessarily suggests that either 4-1BB or CD28 or both 4-1BB and CD28 may be selected as co-stimulatory molecules. Therefore, a person of ordinary skill in the art would have recognized that a second co-stimulatory molecule was within the breadth of fusion polypeptide as taught by Noessner.
Furthermore, Applicant should note that the duplication of parts is prima facie obvious absent new and unexpected results (see MPEP 2144.04(VI)(B), citing In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), “the mere duplication of parts has no patentable significance unless a new and unexpected result is produced”).
Moreover, a person of ordinary skill in the art would have been motivated to use a second co-stimulatory molecule in order to provide greater and more dynamic co-stimulation. Furthermore, because as above, Noessner teaches that the transmembrane and extracellular domains are derived from 4-1BB “or” CD28 (paragraphs [01, 06, 11]), which necessarily suggests that both CD28 and 4-1BB may be selected, it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 17, Noessner also teaches a CD28 ICD (SEQ ID NOs: 14) which has 100% identity with the claimed CD28 ICD of SEQ ID NO: 5.
Therefore, the teachings of Noessner renders obvious the invention as claimed.
Claims 4-7, 11-13, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Noessner et al. (WO2017162797A1, on IDS 05/29/2025) in view of Williams et al. (Crit Rev Immunol, 2015) and Swanson et al. (WO2017181152A2, 2017, previously cited).
Noessner discloses claims 1 and 2 as discussed above.
In regards to claims 4-5, as discussed above, Noessner teaches that extracellular co-stimulatory domain is CD40L, not CD80 specifically. However, Williams teaches that both CD80 and CD40L are involved in interactions that promote central tolerance of T cells, specifically through CD28-CD80 and CD40-CD40L costimulatory interactions between T cells and antigen presenting cells (APCs) (Title, Abstract, p1; Introduction, p1-2). Williams also teaches that CD28 and CD40 are usually constitutively expressed on T cells an APCs respectively, but that CD40L (on T cells) and CD80 (on APCs) is upregulated upon activation (Introduction, p2). Continuing, Williams teaches that this results in a dialogue between T cell and APC that, for optimal co-stimulation, requires both cell types to have been stimulated (Introduction, p2). Therefore, a person of ordinary skill in the art would have been motivated to modify the extracellular domain as at taught by Noessner and engineer a fusion polypeptide with an extracellular CD80 domain in order to optimize co-stimulation of T cells and APCs, and promote central tolerance of T cells. Furthermore, because Swanson teaches a recombinant CD80 extracellular domain (Claims 1, 4; paragraph [0033) for modulating the interaction between APCs and T cells and specifically to modulate self-tolerance (paragraphs [0004, 0076]), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 6, Swanson teaches a CD80 polypeptide (Claims 1, 4) comprising a CD80 ECD with 100% query match with the claimed sequence (SEQ ID NO: 1; see Search Result 10 duplicate, BEM78218, 20250915_094607_us-17-578-989-2.rag).
Applicant should note that the successful cloning and sequencing of the cDNA encoding a known protein is obvious, and thus unpatentable, if (1) there was some suggestion or motivation in the prior art to clone the cDNA, and (2) there was a “reasonable expectation of success,” based on "detailed enabling methodology" in the prior art. Ex parte Kubin, 83 U.S.P.Q.2d (BNA) 1410 (B.P.A.I. 2007), aff'd, 561 F.3d 1351 (Fed. Cir. 2009).
In the instant case, a person of ordinary skill in the art would have been motivated to clone the CD80 TMD because Swanson teaches that CD80 is useful for modulating the interaction between APCs and T cells and specifically to modulate self-tolerance (paragraphs [0004, 0076])
Furthermore, because the CD80 TMD is a known sequences with 100% homology as taught in the prior art, because Swanson teaches a CD80 cDNA (paragraph [0038]) which can be cloned into an expression vector (paragraph [0345]), and because Swanson and Noessner are both in same technical field of utilizing engineering fusion proteins for stimulating lymphocytes for therapeutic purposes, it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 7, Swanson teaches a CD80 polypeptide (Claims 1, 4) comprising a TMD with 100% query match with the claimed sequence (SEQ ID NO: 1, claim 92; see Search Result 1 duplicate, BEM78698, 20250915_094607_us-17-578-989-2.rag).
Applicant should note that the successful cloning and sequencing of the cDNA encoding a known protein is obvious, and thus unpatentable, if (1) there was some suggestion or motivation in the prior art to clone the cDNA, and (2) there was a “reasonable expectation of success,” based on "detailed enabling methodology" in the prior art. Ex parte Kubin, 83 U.S.P.Q.2d (BNA) 1410 (B.P.A.I. 2007), aff'd, 561 F.3d 1351 (Fed. Cir. 2009).
In the instant case, a person of ordinary skill in the art would have been motivated to clone the CD80 TMD because Swanson teaches that CD80 is useful for modulating the interaction between APCs and T cells and specifically to modulate self-tolerance (paragraphs [0004, 0076])
Furthermore, because the CD80 TMD is a known sequences with 100% homology as taught in the prior art, because Swanson teaches a CD80 cDNA (paragraph [0038]) which can be cloned into an expression vector (paragraph [0345]), and because Swanson and Noessner are both in same technical field of utilizing engineering fusion proteins for stimulating lymphocytes for therapeutic purposes, it could have been done with predictable results and a reasonable expectation of success.
In regards to claims 11 and 12, as above, Noessner teaches that the co-stimulatory molecule can be CD28 or 4-1BB (paragraphs [01, 06, 11]).
In regards to claim 13, in regards to a fusion polypeptide with at least 85% homology with SEQ ID NO: 4, it is noted that the polypeptide comprises a CD80 ECD and TMD, and a 4-1BB ECD.
In regards to these sequences, as discussed above, Swanson teaches a CD80 polypeptide (Claims 1, 4) comprising a ECD and a TMD with 100% query match (SEQ ID NO: 1, claim 92; see Search Result 1 duplicate, BEM78698, 20250915_094607_us-17-578-989-2.rag) with the claimed CD80 ECD and TMD of SEQ ID NO: 4.
Additionally, as discussed above, Noessner teaches a 4-1BB ECD (SEQ ID NO: 4), which has 100% identity with the claimed 4-1BB ICD of SEQ ID NO: 4.
As above, Applicant should note that the successful cloning and sequencing of the cDNA encoding a known protein is obvious, and thus unpatentable, if (1) there was some suggestion or motivation in the prior art to clone the cDNA, and (2) there was a “reasonable expectation of success,” based on "detailed enabling methodology" in the prior art. Ex parte Kubin, 83 U.S.P.Q.2d (BNA) 1410 (B.P.A.I. 2007), aff'd, 561 F.3d 1351 (Fed. Cir. 2009).
In the instant case, a person of ordinary skill in the art would have been motivated to clone the CD80 ECD or TMD because Swanson teaches that CD80 is useful for modulating the interaction between APCs and T cells and specifically to modulate self-tolerance (paragraphs [0004, 0076])
Furthermore, because the CD80 TMD is a known sequences with 100% homology as taught in the prior art, because Swanson teaches a CD80 cDNA (paragraph [0038]) which can be cloned into an expression vector (paragraph [0345]), and because Swanson and Noessner are both in same technical field of utilizing engineering fusion proteins for stimulating lymphocytes for therapeutic purposes, it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 18, as above, Noessner teaches that the transmembrane and extracellular domains are derived from 4-1BB “or” CD28 (paragraphs [01, 06, 11]), which necessarily suggests 4-1BB and CD28 as first and second co-stimulatory molecules.
In regards to claim 19, in regards to a fusion polypeptide with at least 85% homology with SEQ ID NO: 6, it is noted that the polypeptide comprises a CD80 ECD and TMD, a 4-1BB ECD and a CD28 ECD.
In regards to these sequences, as discussed above, Swanson teaches a CD80 polypeptide (Claims 1, 4) comprising a ECD and a TMD with 100% query match (SEQ ID NO: 1, claim 92; see Search Result 1 duplicate, BEM78698, 20250915_094607_us-17-578-989-2.rag) with the claimed CD80 ECD and TMD of SEQ ID NO: 6.
Additionally, as discussed above, Noessner teaches a 4-1BB ECD (SEQ ID NO: 4), which has 100% identity with the claimed 4-1BB ICD of SEQ ID NO: 6.
Furthermore, as discussed above, Noessner also teaches a CD28 ICD (SEQ ID NOs: 14) which has 100% identity with the claimed CD28 ICD of SEQ ID NO: 6.
As above, Applicant should note that the successful cloning and sequencing of the cDNA encoding a known protein is obvious, and thus unpatentable, if (1) there was some suggestion or motivation in the prior art to clone the cDNA, and (2) there was a “reasonable expectation of success,” based on "detailed enabling methodology" in the prior art. Ex parte Kubin, 83 U.S.P.Q.2d (BNA) 1410 (B.P.A.I. 2007), aff'd, 561 F.3d 1351 (Fed. Cir. 2009).
In the instant case, a person of ordinary skill in the art would have been motivated to clone the CD80 ECD or TMD because Swanson teaches that CD80 is useful for modulating the interaction between APCs and T cells and specifically to modulate self-tolerance (paragraphs [0004, 0076])
Furthermore, because the CD80 TMD is a known sequences with 100% homology as taught in the prior art, because Swanson teaches a CD80 cDNA (paragraph [0038]) which can be cloned into an expression vector (paragraph [0345]), and because Swanson and Noessner are both in same technical field of utilizing engineering fusion proteins for stimulating lymphocytes for therapeutic purposes, it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Noessner, Williams, and Swanson renders the invention unpatentable as claimed.
Double Patenting
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(d) 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.
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Claims 1-5, 8-9, 11-12, 14-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26 and 27 of copending Application No. 18/306,890.
Claims 1, 6-7, 10, 13, 16-21, 24-25, 28-29, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26 and 27 of copending Application No. 18/306,890 in view of Noessner et al. (WO2017162797A1, on IDS 05/29/2025) and Swanson et al. (WO2017181152A2, 2017, previously cited).
Although the conflicting claims of Application No. 18/306,890 are not identical to the currently prosecuted claims 1-21, 24-25, 28-29, and 32, they are not patentably distinct from each other because said claims of both inventions are drawn to compositions that can consist of a fusion polypeptide comprising: a) an ECD and a TMD of a co-stimulatory ligand, and b) an ICD of a co-stimulatory molecule. Furthermore, in both inventions the co-stimulatory ligand can be CD80 and the first co-stimulatory molecule can be 4-1BB specifically.
Furthermore, the various embodiments were all known in the art before the effective filing date.
Specifically, Noessner teaches a similar fusion polypeptide that can a nucleic acid encoding the fusion polypeptide, a vector comprising the nucleic acid, and a kit comprising the nucleic acid (paragraph [01]). Noessner teaches that the fusion polypeptide can be expressed on at least T cells expressing antigen-recognizing receptors (e.g., TCRs) (paragraphs [07, 09]). It would have been predictably obvious to incorporate these teachings for the purpose of developing lymphocyte therapies.
Additionally, the claimed sequences were all known in the art before the effective filing date as well.
Specifically, Noessner teaches 4-1BB ECD (SEQ ID NO: 4), which has 100% identity with the claimed 4-1BB ICD of SEQ ID NOs: 4 and 6 and a CD28 ICD (SEQ ID NOs: 14) which has 100% identity with the claimed CD28 ICD of SEQ ID NO: 6, while Swanson teaches a CD80 polypeptide (Claims 1, 4) comprising a ECD and a TMD with 100% query match (SEQ ID NO: 1, claim 92; see Search Result 1 duplicate, BEM78698, 20250915_094607_us-17-578-989-2.rag) with the claimed CD80 ECD and TMD of SEQ ID NOs: 2 and 6.
As above, Applicant should note that the successful cloning and sequencing of the cDNA encoding a known protein is obvious, and thus unpatentable, if (1) there was some suggestion or motivation in the prior art to clone the cDNA, and (2) there was a “reasonable expectation of success,” based on "detailed enabling methodology" in the prior art. Ex parte Kubin, 83 U.S.P.Q.2d (BNA) 1410 (B.P.A.I. 2007), aff'd, 561 F.3d 1351 (Fed. Cir. 2009).
In the instant case, a person of ordinary skill in the art would have been motivated to clone the CD80 ECD or TMD because Swanson teaches that CD80 is useful for modulating the interaction between APCs and T cells and specifically to modulate self-tolerance (paragraphs [0004, 0076]). They would have been motivated to clone the ICDs of CD28 and 4-1BB because Noessner teaches they are useful for improving stimulation and proliferation of T cells (paragraphs [07-011]). Furthermore, because these are all known sequences in the art, and because Swanson and Noessner are both in same technical field of utilizing engineering fusion proteins for stimulating lymphocytes for therapeutic purposes, it could have been done with predictable results and a reasonable expectation of success.
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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