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 .
Claim status
In the interest of compact prosecution, this office action is examining the claims filed 12 December 2025, where Applicant has previously presented claims 3-6, 14-18, 20, 26, 29, 32 and 40-45. Claims 1-2, 7-13, 19, 21-25, 27-28, 30, 33-39 are cancelled. Therefore, claims 3-6, 14-18, 20, 26, 29, 31-32, and 40-45 claims are herein pending.
Election/Restrictions
Applicant previously elected of Group 1, claims 3-6, 14-18, 20, 26, 29, and 31-32 drawn to a chimeric cytokine receptor, which comprises two polypeptides (a) a first dimerization domain and (b) a second dimerization domain in the reply filed on 13 January 2025 is acknowledged.
Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, therefore, the response filed on 13 January 2025 will be treated without traverse (MPEP § 818.01(a)). The examiner was able to provide art which satisfied the limitations of product of group I, thereby demonstrating that the special technical feature lacks novelty. Therefore, a lack of unity exists between the restricted groups and the election response filed on 13 January 2025 will be treated without traverse (MPEP § 818.01(a)).
Furthermore, applicant has canceled claims 7-8, 21, 38, and 39 of Group 2.
Therefore, claims 3-6, 14-18, 20, 26, 29, 31-32, and 40-45 are herein under examination.
Priority
This application was filed 01/19/2022 and is a 371 application of PCT/GB2020/ 051865 filed on 08/04/2020, which claims benefit to the foreign application foreign priority to 1911187.1 filed on 08/05/2019. Thus, the earliest possible priority for the instant application is 08/05/2019.
Withdrawn Claim Rejections - 35 USC § 102/103.
Applicant discloses in the remark that Figure 2 from Pule as depicting chimeric cytokine receptors in which the ectodomains were being changed (replaced). In other words, the "delta" symbol would have been understood to refer to ectodomain changes that are described in detail when the application discusses Figure 2. Furthermore, a generic teaching of "variants" at p. 20 of Pule. Applicant notes that, a few paragraphs earlier, variants are discussed in the context of having less than 100% sequence identity but retaining wildtype function and no specific deletions of endodomains are described here or elsewhere in Pule. Therefore, Applicant argues that the POSITA who read the specific teachings of Pule would not have gleaned a suggestion to truncate cytokine receptor endodomains in the manner taught in the current application and presently claimed. Applicant's arguments have been fully considered but they are persuasive, and therefore, prior rejection of claims 3-6, 14-18, 20, 26, 29, and 31-32, 42, 44-45 under 35 U.S.C. 102(a) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Pule et al. (WO2017029512A1) is withdrawn.
Withdrawn Claim Rejections - 35 USC § 103
Applicant remarks that Tanaka appears to discuss the importance of retaining IL2R [Symbol font/0x62]-chain amino acids 530-551 (see, e.g., col. 16, lines 26-35; col. 29, lies 5-7). As discussed in greater detail in the present application presents unexpected results ¶ (see remark filed 12 December 2025 p. 10 E ¶), Applicant has shown that deletion of these amino acids enhanced T cell proliferation, a surprising and unexpected result. Applicant's arguments have been fully considered but they are persuasive, and therefore, prior rejection of Claims 3-6, 14-18, 20, 26, 29, 31-32, and 40-45 under 35 U.S.C. 103 as being unpatentable over Pule et al. (WO2017029512A1), in view of Tanaka et al. (US10336810B2) is withdrawn.
Response to Arguments
Applicant's arguments filed on 12 December 2025 are acknowledged.
The rejection under 102/103 over by Pule has been withdrawn in view of Applicant’s persuasive arguments as discussed above to the claims. Therefore, Applicant’s arguments are moot.
Title Objection
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. See MPEP 606.01
The following title is suggested:
“A truncated chimeric cytokine receptor (IL-2) [Symbol font/0x62]-chain to increase the proliferation of T cells.”
New Claim Rejections - 35 USC § 112(a)
(Scope of Enablement)
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 3-6, 14-15, 17-18, 20, 26, 29, and 31-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while enabling truncated specific chimeric cytokine receptor (CCR) (truncated IL-2 receptor β-chain) effective to increase proliferation of T cells (See the ¶ [0570-0572] of SPEC US20220289820A1); does not reasonably provide enablement any CCR as recited in claim 3 or any [Symbol font/0x67]-chain CCR as recited in 15. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with this claim.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The Court in Wands states: “Enablement is not precluded by the necessity for some 'experimentation.'” Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The office has analyzed the specification in direct accordance to the factors outlined in In re Wands. MPEP 2164.04 states: "[W]hile the analysis and conclusion of a lack of enablement are based on factors discussed in MPEP 2164.01(a) and the evidence as whole, it is not necessary to discuss each factor in written enablement rejection." These factors will be analyzed, in turn, to demonstrate that one of ordinary skill in the art would have had to perform "undue experimentation" to make and/or use the invention and therefore, Applicant's claims are not enabled commensurate with the scope of the invention.
Furthermore, MPEP 2164.03 as set forth in In re Fisher, 166 USPQ 18 (CCPA 1970), compliance with 35 USC 112, first paragraph requires: “That scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved.” Moreover, the courts have also stated that reasonable correlation must exist between scope of exclusive right to patent application and scope of enablement set forth in the patent application (27 USPQ2d 1662 Ex parte Maize).
The Breadth of The Claims
The breadth of the claim 3 broadly encompasses any CCR, wherein the first and/or second chain of the cytokine receptor endodomain is/are truncated in amount effective to increase proliferation of T cells.
Claim 15 encompasses a genus of any [Symbol font/0x67]-chain CCR to increase the proliferation of T cells.
The Nature of The Invention
The nature of the invention is truncated any CCR and/or any [Symbol font/0x67]-chain CCR to increase proliferation of T cells.
The State of The Prior Art
In the prior art Pule et al. (WO2017029512A1; IDS filed on 04/27/2022; published on 23 February 2017; hereinafter “Pule”) teaches a CCR, which comprises two polypeptides: (i) a first polypeptide which comprises: (a) a first dimerization domain; and (b) a first chain of the cytokine receptor endodomain; and (ii) a second polypeptide which comprises: (a) a second dimerization domain, which dimerizes with the first dimerization domain; and (b) a second chain of the cytokine-receptor endodomain (p. 7 lns 1-10; p. 12 lns 19-27); wherein the first and/or second chain of the cytokine-receptor endodomain comprising endodomains labelled [Symbol font/0x44]IL2-Rβ, [Symbol font/0x44][Symbol font/0x67]c and [Symbol font/0x44]IL7-Rα (Fig. 2). Furthermore, Pule teaches that the truncated CCR increases the T cells proliferation that express the CCR under dimerization conditions, compared to T cells that express a CCR that comprises the same domains, without endodomain truncation (Fig. 8 (first panel), p. 61 lns 20-24; p. 8 lns 11-16). Therefore, it is not obvious that prior art does not support to identify any truncated CCR or any truncated [Symbol font/0x67]-chain CCR increases the T cells proliferation that express the CCR under dimerization conditions.
With these additional evidences, the any CCR or any [Symbol font/0x67]-chain CCR wherein the first and/or second chain of the cytokine receptor endodomain is/are truncated in amount effective to increase proliferation of T cells is not well established at the time of filling and the ordinary artisan cannot predictably identify any CCR or any [Symbol font/0x67]-chain CCR in a subject. Therefore, Therefore, the prior art does not provide any evidence that truncated any CCR or any [Symbol font/0x67]-chain CCR can increase the T cell proliferation for treating cancer. It is only teaching, specific truncated CCR (i.e., IL-2) to increase the T cell proliferation for treating cancer.
The Level of Ordinary Skill in The Art
An ordinary artisan in the area of cell biology and immunotherapy development would have experience in genetically engineer T cells with specific truncated CCR for particular activities. Genetically engineering of specific cells, while complex, is routine in the art. The process of finding new product for treating tumor with truncated specific CCR that have in vitro activity against a particular biological target, (i.e., cancer cell) is well known. Additionally, while high throughput screening assays can often be employed, developing truncated specific CCR T cells for treating cancer, however truncated any CCR with T cells, as claimed, is generally not well-known or routine, given the complexity of certain biological systems.
Thus, the level of ordinary skill in the art of preparing T cells with truncated any CCR is high, as an ordinary artisan in this art needs specialized knowledge of the complex nature of the biology.
The Level of Predictability in The Art
While the preparation of T cell with truncated specific CCR (e.g., IL-2) for treatment of cancer disease is well known, the preparation of such T cells with truncated any CCR within the scope of the claim is not predictable. For instance, while Pule indicates the first and/or second chain of the cytokine-receptor endodomain comprising endodomains labelled [Symbol font/0x44]IL2-Rβ, [Symbol font/0x44][Symbol font/0x67]c and [Symbol font/0x44]IL7-Rα (Fig. 2 of Pule). Therefore, the truncated CCR increases the T cells proliferation that express the CCR under dimerization conditions, compared to T cells that express a CCR that comprises the same domains, without endodomain truncation (Fig. 8 (first panel), p. 61 lns 20-24; p. 8 lns 11-16 of Pule).
Thus, it is unpredictable whether preparing T cell with any truncated CCR would have same capability with specific truncated CCR (i.e., IL-2) for treating disease. The predictability of T cell with any CCR encompassed by the instant claim would be low given that there doesn’t appear to a link between engineered T cells and the claimed conditions.
The Amount of Guidance and Working Examples Discussion
The specification discloses that the product IL2Rβ is a truncated or full-length IL-2 receptor β-chain endodomain. Constructs were generated with the series of truncated IL-2 receptor β-chain endodomain shown in FIG. 10a and the key for FIG. 10b. Further, T cells were transduced with vectors expressing each construct and cultured for 4 days in absence of exogenous cytokines (starvation assay). The absolute number of viable, transduced cells was assessed by flow cytometry. The results are shown in FIG. 10b. Truncation of the IL-2 receptor β-chain endodomain by 20 or 40 amino acids (i.e. from amino acids 266-551 to 266-531 and 266-511 respectively) increased proliferation, with the highest level of proliferation observed for the IL2Rbeta aa266-511. Further truncation of the IL-2 receptor β-chain endodomain results in a step-wise reduction in proliferation from aa266-471>aa266-451>aa 266-411>aa266-391>aa266-371, at which point it plateaued with further deletions having no significant effect of the level of proliferation. It is therefore possible to reduce the activity of CCRs by truncation of one or both cytokine receptor endodomains. It is also possible to “tailor” CCRs to have a desired level of cytokine production (in this case IL-2) by selecting an endodomain truncation which gives the desired level of activity. See the ¶ [0570-0572] of SPEC US20220289820A1. However, specification does not disclose that any truncated of any CCR can be increased the T cell proliferation.
The specification discloses that the CCR, one or more chains may have a truncated sequence. For example, in a CCR with and IL-2 receptor endodomain comprising the IL-2 receptor β-chain and/or the IL-2 receptor (i.e. common) γ-chain, the IL-2 receptor β-chain and/or the common γ-chain may be truncated [0239]. In the preferred embodiment, SPEC discloses that truncation of the IL-2 receptor β-chain endodomain by 20 or 40 amino acids (i.e. from amino acids 266-551 to 266-531 and 266-511 respectively) increased proliferation, with the highest level of proliferation observed for the IL2Rbeta aa266-511. Therefore, it is possible to “tailor” CCRs to have a desired level of cytokine production (in this case IL-2) by selecting an endodomain truncation which gives the desired level of activity [0572]. Accordingly, SPEC has specific adequate support for specific truncated IL-2 receptor β-chain (i.e. from amino acids 266-551 to 266-531 and 266-511 respectively) associated with increase T cell proliferation.
Further, SPEC discloses the CCR of the present invention may comprise the IL-7 receptor α-chain and/or the IL-7 receptor (i.e. common) γ-chain, or a variant thereof [0218]. The endodomain of IL-15Rα is shown as SEQ ID No. 60 and has 38 amino acids [0237]. However, the specification does not show any embodiments that meet all the limitations of the claim reduced to practice. Therefore, an actual reduction to practice of an invention directed to a product of any CCR or any y-chain CCR is not established at the time of filling. The successful testing of the product of the current invention is not shows reduced to practice, therefore, it is not established that the product made is satisfactory. See MPEP 2163(I)-(II) and 2163.02.
The specification does not provide any additional examples or guidance on how to prepare any truncated CCR to enhance T cell proliferation as recited in the claim. Therefore, POSITA can prepare truncated specific CCR (i.e., IL-2 receptor β-chain from amino acids 266-551 to 266-531 and 266-511 respectively) to enhance T cell proliferation at the time of filling as disclosed in specification [0572]. However, POSITA cannot prepare any truncated CCR to enhance T cell proliferation as claimed in claim 3.
Thus, the specification and the prior art provide sufficient teachings only for the enablement for preparing truncated CCR (i.e., IL-2 receptor β-chain from amino acids 266-551 to 266-531 and 266-511 respectively [0572] to enhance T cell proliferation.
Conclusion
Since both the instant specification and the prior art at the effective filing date of the present application provide a guide to preparing truncated CCR (i.e., IL-2 receptor β-chain from amino acids 266-551 to 266-531 and 266-511 respectively [0572]¶) to enhance T cell proliferation of claim 3, and since does not appear to be any other teaching in the specification and/or prior art that support to preparing truncated -any CCR or any [Symbol font/0x67]-chain CCR to enhance T cell proliferation, it would therefore be unpredictable to practice the invention to preparing truncated -any CCR or any [Symbol font/0x67]-chain CCR to enhance T cell proliferation. The prior art provides no compensatory guidance, and since attempts to preparing truncated -any CCR or any [Symbol font/0x67]-chain CCR to enhance T cell proliferation have been unsuccessful. In view of the foregoing, due to the lack of sufficient guidance provided by the specification regarding the issues set forth above, the state of the relevant art, and the breadth of the claims, it would have required undue experimentation for one skilled in the art to make and use the instant broadly claimed invention as recited.
In conclusion, given the breadth of the claims and the limited scope of the specification, an undue quantity of experimentation is required to make and use the invention beyond the scope of preparing truncated -any CCR or any [Symbol font/0x67]-chain CCR to enhance T cell proliferation.
Accordingly, the instant application has not fully enabled the entire scope of the invention as claimed in claim 3 and dependent claims 4-6, 14-15, 17-18, 20, 26, 29, and 31-32.
New Claim Rejections - 35 USC § 112(a)
(Written description)
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 3-6, 14-15, 17-18, 20, 26, 29, and 31-32 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 contains subject matter that 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 pre-AIA the inventor, at the time the application was filed, had possession of the claimed invention.
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 so 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.
REQUIREMENTS TO ESTABLISH ACTUAL REDUCTION TO PRACTICE
"In an interference proceeding, a party seeking to establish an actual reduction to practice must satisfy a two-prong test: (1) the party constructed an embodiment or performed a process that met every element of the interference count, and (2) the embodiment or process operated for its intended purpose." Eaton v. Evans, 204 F.3d 1094, 1097, 53 USPQ2d 1696, 1698 (Fed. Cir. 2000).
The same evidence sufficient for a constructive reduction to practice may be insufficient to establish an actual reduction to practice, which requires a showing of the invention in a physical or tangible form that shows every element of the count. Wetmore v. Quick, 536 F.2d 937, 942, 190 USPQ 223, 227 (CCPA 1976). For an actual reduction to practice, the invention must have been sufficiently tested to demonstrate that it will work for its intended purpose, but it need not be in a commercially satisfactory stage of development. See, e.g., Scott v. Finney, 34 F.3d 1058, 1062, 32 USPQ2d 1115, 1118-19 (Fed. Cir. 1994) (citing numerous cases wherein the character of the testing necessary to support an actual reduction to practice varied with the complexity of the invention and the problem it solved). If a device is so simple, and its purpose and efficacy so obvious, construction alone is sufficient to demonstrate workability. King Instrument Corp. v. Otari Corp., 767 F.2d 853, 860, 226 USPQ 402, 407 (Fed. Cir. 1985).
For additional cases pertaining to the requirements necessary to establish actual reduction to practice see DSL Dynamic Sciences, Ltd. v. Union Switch & Signal, Inc., 928 F.2d 1122, 1126, 18 USPQ2d 1152, 1155 (Fed. Cir. 1991) ("events occurring after an alleged actual reduction to practice can call into question whether reduction to practice has in fact occurred"); Fitzgerald v. Arbib, 268 F.2d 763, 765-66, 122 USPQ 530, 531-32 (CCPA 1959) ("the reduction to practice of a three-dimensional design invention requires the production of an article embodying that design" in "other than a mere drawing"); Birmingham v. Randall, 171 F.2d 957, 80 USPQ 371, 372 (CCPA 1948) (To establish an actual reduction to practice of an invention directed to a method of making a product, it is not enough to show that the method was performed. "[S]uch an invention is not reduced to practice until it is established that the product made by the process is satisfactory, and [ ] this may require successful testing of the product."). See MPEP 2138.05.
Claim 3 encompasses a genus of truncated any chimeric cytokine receptor (CCR), However, the specification doesn't have adequate support in the disclosure for the any CCR, the specification discloses that the product IL2Rβ is a truncated or full-length IL-2 receptor β-chain endodomain. Constructs were generated with the series of truncated IL-2 receptor β-chain endodomain shown in FIG. 10a and the key for FIG. 10b. Further, T cells were transduced with vectors expressing each construct and cultured for 4 days in absence of exogenous cytokines (starvation assay). The results are shown in FIG. 10b. Truncation of the IL-2 receptor β-chain endodomain by 20 or 40 amino acids (i.e. from amino acids 266-551 to 266-531 and 266-511 respectively) increased T cell proliferation, with the highest level of proliferation observed for the IL2Rbeta aa266-511. Further truncation of the IL-2 receptor β-chain endodomain results in a step-wise reduction in proliferation from aa266-471>aa266-451>aa 266-411>aa266-391>aa266-371, at which point it plateaued with further deletions having no significant effect of the level of proliferation. It is therefore possible to reduce the activity of CCRs by truncation of one or both cytokine receptor endodomains. It is also possible to “tailor” CCRs to have a desired level of cytokine production (in this case IL-2) by selecting an endodomain truncation which gives the desired level of activity. See the ¶ [0570-0572] of SPEC US20220289820A1. However, specification does not disclose that truncated any CCR can be treated in a subject with instant method. Therefore, the specification fails to identify the truncated any CCR.
Claim 15 encompasses a genus of truncated any [Symbol font/0x67]-chain CCR to increase the proliferation of T cells. However, the specification doesn't have adequate support in the disclosure for the generic species that characterize the genus of truncated any [Symbol font/0x67]-chain CCR. The specification discloses that the CCR, one or more chains may have a truncated sequence. For example, in a CCR with and IL-2 receptor endodomain comprising the IL-2 receptor β-chain and/or the IL-2 receptor (i.e. common) γ-chain, the IL-2 receptor β-chain and/or the common γ-chain may be truncated [0239]. In the preferred embodiment, SPEC discloses that truncation of the IL-2 receptor β-chain endodomain by 20 or 40 amino acids (i.e. from amino acids 266-551 to 266-531 and 266-511 respectively) increased proliferation, with the highest level of proliferation observed for the IL2Rbeta aa266-511. Therefore, it is possible to “tailor” CCRs to have a desired level of cytokine production (in this case IL-2) by selecting an endodomain truncation which gives the desired level of activity [0572]. Accordingly, SPEC has specific adequate support for specific truncated IL-2 receptor β-chain endodomain by 20 or 40 amino acids (i.e. from amino acids 266-551 to 266-531 and 266-511 respectively) associated with increase T cell proliferation.
Further, SPEC discloses the CCR of the present invention may comprise the IL-7 receptor α-chain and/or the IL-7 receptor (i.e. common) γ-chain, or a variant thereof [0218]. The endodomain of IL-15Rα is shown as SEQ ID No. 60 and has 38 amino acids [0237]. However, the specification does not show any embodiments that meet all the limitations of the claim reduced to practice. Therefore, an actual reduction to practice of an invention directed to a product of truncated any CCR or any [Symbol font/0x67]-chain CCR is not established at the time of filling. The successful testing of the product of the current invention is not shows reduced to practice, therefore, it is not established that the product made is satisfactory. See MPEP 2163(I)-(II) and 2163.02.
In the prior art Pule et al. (WO2017029512A1; IDS filed on 04/27/2022; published on 23 February 2017; hereinafter “Pule”) teaches a CCR, which comprises two polypeptides: (i) a first polypeptide which comprises: (a) a first dimerization domain; and (b) a first chain of the cytokine receptor endodomain; and (ii) a second polypeptide which comprises: (a) a second dimerization domain, which dimerizes with the first dimerization domain; and (b) a second chain of the cytokine-receptor endodomain (p. 7 lns 1-10; p. 12 lns 19-27); wherein the first and/or second chain of the cytokine-receptor endodomain comprising endodomains labelled [Symbol font/0x44]IL2-Rβ, [Symbol font/0x44][Symbol font/0x67]c and [Symbol font/0x44]IL7-Rα (Fig. 2). Furthermore, Pule teaches that the truncated CCR increases the T cells proliferation that express the CCR under dimerization conditions, compared to T cells that express a CCR that comprises the same domains, without endodomain truncation (Fig. 8 (first panel), p. 61 lns 20-24; p. 8 lns 11-16). Therefore, it is not obvious that prior art does not support to identify any truncated CCR or any truncated [Symbol font/0x67]-chain CCR increases the T cells proliferation that express the CCR under dimerization conditions.
With these additional evidences, the any truncated CCR or any truncated [Symbol font/0x67]-chain CCR wherein the first and/or second chain of the cytokine receptor endodomain is/are truncated in amount effective to increase proliferation of T cells is not well established at the time of filling and the ordinary artisan cannot predictably identify any truncated CCR or any truncated [Symbol font/0x67]-chain CCR in a subject. Therefore, one of skill in the art would neither expect nor predict the appropriate method of developing the instantly claimed genus of any truncated CCR or any truncated y-chain CCR to increase the T cell proliferation.
Therefore, it concludes that the claimed genus of any truncated CCR or any truncated y-chain CCR to increase the T cell proliferation doesn't have an adequate written description. It concludes that a skilled artisan would find the specification inadequately described.
Accordingly, the Applicant did not sufficiently possess the broader invention as claimed in claim 3 and dependent claims 4-6, 14-15, 17-18, 20, 26, 29, and 31-32.
Allowable Subject Matter
Claims 16, 40-45 are objected to as being dependent upon a rejected base claim 3, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claims 16, 40-45 is objected because art does not teach or reasonably suggest the chimeric cytokine receptor according to claim 3, which comprises a truncated IL-2 receptor [Symbol font/0x62]-chain endodomain by 20 or 40 amino acids (i.e. from amino acids 266-551 to 266-531 and 266-511 respectively).
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684