DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 27-30 are pending in this application.
This office action is in response to a claim set filed 9/12/2023.
This application is a divisional filing of U.S. serial 16/326,131 now U.S. Patent 11,591,613 which is a 371 filing of PCT/GB2017/052409 filed 8/16/2017 which claims priority to GB1614093.1 filed 8/17/2016. The certified copy in English has been provided.
Information Disclosure Statement
Information disclosure statements filed 5/31/2023 and 5/9/2023 have been identified and the documents considered. The corresponding signed and initialed PTO Form 1449 has been mailed with this action. The documents listed as Search Reports have been considered but have been crossed off the 1449 so that it will not appear on the face of any patent issuing from the instant application.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 16, lines 15, 17, 18, 19, 20, 21, 22. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112, first paragraph
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.
Claims 27 and 28 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 27-30 recites that the cell “expresses, at the cell surface, a mitogenic T-cell activating transmembrane protein”. In order to express, the cell must comprise a nucleic acid sequence encoding the transmembrane protein. As well, the sequence must be operably linedk to the coding sequence. However, even so, the expression would not be at the cell surface membrane. Expression is in nuclear spaces for cells that typically are used to produce or package lentivirus or retrovirus (mammalian cells). The transmembrane domain will relocate the processed protein to the cell surface but expression does not occur at the cell surface and certainly not without a promoter. The disclosure does not provide description of a cell “expresses, at the cell surface, a mitogenic T-cell activating transmembrane protein”.
To this end, the MPEP provides such guidance (emphasis added). If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Compare Fonar, 107 F.3d at 1549, 41 USPQ2d at 1805 (disclosure of software function adequate in that art). As recited, the method lacks critical elements that provide necessary function. What is necessary is 1) a promoter to express the protein and 2) language that correlates with the biology of expression of transmembrane proteins.
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 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 27-30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Frost et al (US 10,596,274).
Frost et al teach a cell expressing for example Cd30 binding domain (see figures 1 and col 73, line 55-57) wherein the activation domains are domains that bind to either CD3 or CD28 and comprise transmembrane domains (see col 41, line 35-36 and 74, lines 38-45). As defined by the disclosure, these binding molecules bind to mitogenic tetraspanin molecules (see e.g. ¶09126 of the instant disclosure).
Furthermore, the packaging system comprises sequences comprising the viral genome and encoding gag, pol and env (see bridging ¶ col 11-12).
This system represents a kit given the instructions provided for their combination in the above passages. As well, the kit is used to make retrovirus or lentivirus with the transmembrane protein which is not part of the viral envelope (see e.g. figure 1, 2 and col 7, line 45-55).
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
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. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970);and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 27-30 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-9 of copending U.S. Patent 10,954,530.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1-9 of copending U.S. Patent 10,954,530. The instant claims are drawn to host cells that are generic to those recited in claim 6 and 7 as well as packaging cells generic to claim 8. These cells are generic and anticipate the methods of making the cells and virus of the copending application. In fact, the instant disclosure is directed to using this cell as a starting block for multiple mitogenic transmembrane domains (see figures 1 and legend).
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the U.S. 10,954,530, then two different assignees would hold a patent to the claimed invention of U.S. 10,954,530, and thus improperly there would be possible harassment by multiple assignees.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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/MARIA MARVICH/Primary Examiner, Art Unit 1633
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