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 .
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1, 3, 4, 10 and 19, drawn to A cell comprising a CAR/TCR and a FasL-binding receptor (FLBR) with a Fas ectodomain and a CD40 or CD27 endodomain.
Group II, claim(s) 11, 12, 13, drawn to a FLBR with a Fas ectodomain and a CD40 or CD27 endodomain.
Group III, claim(s) 14, 15, 17, 18, drawn to A nucleic acid construct encoding CAR/TCR and FLBR with a Fas ectodomain and a CD40 or CD27 endodomain.
Group IV, claim(s) 21-24, 26, drawn to A method of treating/preventing any disease using the cell of claim 1
Group V, claim(s) 27, 28, drawn to A method of making cell of claim 1
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-V lack unity of invention because even though the inventions of these groups require the technical feature of FLBR with a Fas ectodomain and a CD40 or CD27 endodomain, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Oda et al (WO 2018/170475 A1, Sep 20, 2018; in IDS 2/9/2023) that teaches fusion proteins comprising Fas extracellular/ecto-domain and CD28 or CD40 intracellular/endodomain (=claimed FLBR; Page 31-lines 8-15; page 59-lines 20-25; Figure 23A, Figure 11, Example 11, 22)
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Greta Noland on 6/18/2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1, 3, 4, 10 and 19. Affirmation of this election must be made by applicant in replying to this Office action. Claims 11-15, 17-18, 21-24, 26-28 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims status
Applicants preliminary claim amendments filed 9/29/2022 is acknowledged.
Claims 2, 5-9, 16, 20, 25 is/are cancelled. Claims 1, 3, 4, 10-15, 17-19, 21-24, 26-28 is/are currently pending with claims 11-15, 17-18, 21-24, 26-28 is/are withdrawn. Claims 1, 3, 4, 10 and 19 is/are under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
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.
The following title is suggested: An immune cell expressing modified FasL-binding receptor.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 12. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the terms such as GlutaMAX, GeneJuice, Gibco, Retronectin etc. on pages 45 and 46, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112(b)
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.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 is vague and indefinite in the use of parenthesis, since it is unclear whether the parenthetical material is or is not intended to be part of the claim. Thus, claim 10 could be interpreted as reciting the SEQ IDs as optional limitations or wherein the recited SEQ IDs are required. In case, the recited SEQ IDs are required, the following interpretation is followed when applying art: “Fas-CD27 comprising the sequence set forth in SEQ ID NO: 39comprising the sequence set forth in SEQ ID NO:41
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.
Claim 1, 3, 4, 10 and 19 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.
In making a determination of whether the application complies with the written description requirement under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant is claiming and what Applicant has possession of.
Claims 1, 3, 10 and 19 are directed to a cell expressing a CAR or TCR and a FasL-binding receptor (FLBR) which comprises a Fas ectodomain and a CD40 or CD27 endodomain. Therefore, the claim embraces FLBRs that comprise any variant or fragment of Fas ectodomain, any variant or fragment of CD40 endodomain and/or any variant or fragment of CD27 endodomain. Claim 4 limits the CD40 endodomain to SEQ 4 but does not limit the Fas ectodomain that continues to embrace any variant or fragment of Fas ectodomain.
The specification teaches a human Fas protein sequence as SEQ 49. Further, it teaches the sequence of the extracellular/ecto-domain of human Fas protein as SEQ 50. The specification teaches the sequence of CD40 endodomain as SEQ 4 and CD27 endodomain as SEQ 45. The specification does not teach any variants or fragments of the Fas ectodomain other than the full-length human Fas ectodomain. Similarly the specification does not teach any variants or fragments of the CD27 or CD40 endodomain other than the full-length human CD27 and CD40 ectodomain
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. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish it).
There are no drawings, or structural formulas disclosed of any variants or fragments of Fas ectodomain, CD27 endodomain and CD40 endodomain. Further, the variants and fragments of these polypeptides can vary substantially. Although the specification teaches the full length sequence of these polypeptides that function as expected i.e. appropriate ecto/endodomain, it does not indicate which amino acid residues within the full length sequences confer the requisite function. There is no teaching in the specification fragments or variants of SEQ 49, 4 or 5 could function as Fas ectodomain, CD40 endodomain or CD27 endodomain respectively. Consequently, a skilled artisan cannot readily envision the variant sequences embraced by the claims.
Therefore, the claimed invention, as a whole, is not adequately described. The claims require essential or critical elements which are not adequately described in the specification, and are not conventional in the art before the effective filing date.
Further, the breadth of the genus of sequences, fragments, or variations of Fas ectodomain, CD40 endodomain and CD27 endodomain lack a written description.
According to the MPEP § 2163, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").”
In the instant case, the only species described are the full length sequences of SEQ 49 (Fas ectodomain), SEQ 4 (CD40 endodomain) and SEQ 5 (CD27 endodomain). There is not even identification of any particular portion of the structure that must be conserved. It is not even clear what region of the sequence has the activity clearly associated with SEQ ID NOs: 49, 4 and 5. The specification does not provide a complete structure of those variants embraced and fails to provide a representative number of species for the encompassed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the recited genus.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3, 10 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oda et al (WO 2018/170475 A1, Sep 20, 2018; in IDS 2/9/2023).
For claim 10, in view of the 112b issue noted above, the interpretation wherein recited SEQ IDs are optional is applied for the instant rejection.
Oda discloses a cell comprising a CAR or TCR and fusion proteins (page 73:lines 15-20, page 74:line 20-21; Example 11, 22).
Oda discloses fusion proteins comprising Fas extracellular/ecto-domain and CD28 or CD40 intracellular/endodomain (= claimed FLBR of instant claim 1, CD40 endodomain of instant claim 3, Fas-CD28 of instant claim 10, Fas-CD40 of instant claim 10; Page 31-lines 8-15; page 59-lines 20-25; Figure 23A, Figure 11, Example 11, 22).
Oda discloses pharmaceutical compositions comprising the cells disclosed (required for instant claim 19, page 12-lines 5-7; page 81:line 1-10).
Therefore, Oda anticipates the claimed invention.
Claim Rejections - 35 USC § 103
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oda as applied to claim 1, 3 above, and further in view of Hartmut (US7642046, Jan 5, 2010).
Oda discloses FLBR with CD40 endodomain (Page 31-lines 8-15; page 59-lines 20-25). Oda does not teach the exact sequence of the CD40 endodomain. However the sequence of CD40 endodomain was known in the art. Hartmut teaches SEQ ID NO:1 as the sequence for CD40 intracellular domain (=100% identical to instant SEQ ID NO: 4; see alignment below and in PTO-892; Figure 3A).
PNG
media_image1.png
182
985
media_image1.png
Greyscale
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the sequence taught by Hartmut to generate the FLBR of Oda comprising CD40 endodomain. An artisan would be motivated to use Hartmut’s CD40 endodomain sequence to generate Oda’s FLBR with CD40 endodomain (i.e. Fas-CD40) because Oda does not disclose this known sequence. An artisan would reasonably expect to generate a FLBR with CD40 endodomain because Oda teaches the general structure of FLBR comprising Fas ectodomain and a TNFRSF endodomains such as from CD28 or CD40 (Figure 11, 23, Example 11) and Hartmut teaches the sequence of CD40 endodomain that would be used to generate a Fas-CD40 (SEQ ID NO: 1).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oda as applied to claim 1 above, and further in view of Hartmut (US7642046, Jan 5, 2010) and Yu et al (US 2018/0118838 A1, May , 2018) as evidenced by O’Neill et al (Protein-Specific Signal Peptides for Mammalian Vector Engineering. ACS Synth. Biol. 2023, 12, 2339−2352).
For claim 10, in view of the 112b issue noted above, the interpretation wherein recited SEQ IDs are required is applied for the instant rejection.
Instant SEQ ID NO: 41 for Fas-CD40 is a 246 amino acid polypeptide sequence that comprises a well-known signal peptide sequence (residues 1-19) followed by Fas ectodomain and transmembrane domains (20-184) followed by CD40 endodomain (residues 185-246).
Oda discloses FLBR with Fas signal peptide, ectodomain and transmembrane domains followed by CD40 endodomain (Page 31-lines 8-15; page 59-lines 20-25).
Oda teaches the sequence of Fas ectodomain and transmembrane in SEQ 186 (=100% identical to residues 20-184 of instant SEQ ID NO: 41; see alignment in IDS 2/9/2023 cited as “DATABASE genetic sequence [Online] 15 November 2018 (2018-11-15), "Human FAStm-41BB fusion construct SEQ: 186," Retrieved from EBI accession no. GSP:BFR47856 Database accession no. BFR47856 abstract, XP055816915, 1 page”).
Oda does not teach a FLBR with a non-Fas signal peptide and the exact sequence of the CD40 endodomain. However the signal peptide and the sequence of CD40 endodomain was known in the art.
Yu teaches SEQ ID NO: 43 as one of alternative signal peptides that could be used to direct expression of fusion receptors to the cell membrane (=100% identical to residues 1-19 of instant SEQ ID NO: 41; see alignment below and in PTO-892; [0269-0273]).
PNG
media_image2.png
63
334
media_image2.png
Greyscale
Hartmut teaches SEQ ID NO:1 as the sequence for CD40 intracellular domain (=100% identical to instant SEQ ID NO: 4 which is 100% identical to residues 185-246 of instant SEQ ID NO:41; see alignment in the rejection above and in PTO-892; Figure 3A).
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the sequences taught by Yu (for signal peptide), Oda (for Fas ectodomain and transmembrane domain) and Hartmut (for CD40 endodomain) to generate the Fas-CD40 of SEQ ID NO: 41. An artisan would be motivated to use Hartmut’s CD40 endodomain sequence to generate Oda’s FLBR with CD40 endodomain (i.e. Fas-CD40) because Oda does not disclose this known sequence. Furthermore, an artisan would be substitute the Fas signal peptide of Oda with the well-known alternative signal peptide of Yu because these are alternatives known to perform the same function (see MPEP 2144.06). Both Oda’s and Yu’s signal peptide perform the function of allowing membrane translocation of fusion receptor proteins. Further, O’Neill evidences that Yu’s signal peptide is a well-known industry standard (Table 1 designates Yu’s sequence as “C” which the legend describes as “industrially relevant standard reference signal peptide”). An artisan would reasonably expect to generate a Fas-CD40 with a sequence of SEQ ID No: 41 as claimed because the sequences that comprise SEQ ID No: 41 were taught by Yu, Oda and Hartmut which an ordinary artisan could combine using standard molecular biology techniques such as used by Oda to generate their fusion proteins (see at least Example 11).
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.
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/apply/applying-online/eterminal-disclaimer.
Claim 1, 3, 10 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 25, 27, 48, 1, 4-6 of copending Application No. 17/915, 689 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1, 3, 10 are directed to a cell comprising a CAR and a FLBR with a Fas ectodomain and a CD27 or CD40 endodomain.
Claim 27 in `689 is directed to a cell comprising a CAR and a dominant negative Fas (recited in claim 25 of `689). Claims 1, 4-6 in `689 teach a dominant negative Fas as comprising a Fas ectodomain (recited in claim 4 of `689) and an endodomain from a TNF receptor such as CD27 or CD40 (recited in claims 5 and 6 of `689).
Instant claims 19 is directed to a pharmaceutical composition comprising the cell of instant claim 1.
Claim 48 of `689 is directed to a pharmaceutical composition comprising the cell of claim 25.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 4 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 25, 27, 48, 1, 4-6 of copending Application No. 17/915, 689 in view of Hartmut (US7642046, Jan 5, 2010).
Instant claims 4 is directed to a cell comprising a CAR and a FLBR with a Fas ectodomain and a CD40 endodomain of SEQ ID No: 4.
Claim 27 in `689 is directed to a cell comprising a CAR and a dominant negative Fas (recited in claim 25 of `689). Claims 1, 4-6 in `689 teach a dominant negative Fas as comprising a Fas ectodomain (recited in claim 4 of `689) and an endodomain from a TNF receptor such as CD40 (recited in claims 5 and 6 of `689).
Claims in `689 does not teach the exact sequence of the CD40 endodomain.
Hartmut teaches SEQ ID NO:1 as the sequence for CD40 intracellular domain (=100% identical to instant SEQ ID NO: 4; see alignment below and in PTO-892; Figure 3A).
PNG
media_image1.png
182
985
media_image1.png
Greyscale
Therefore, it would be obvious to a person of ordinary skill in the art to use the sequence taught by Hartmut to provide the sequence for CD40 endodomain for the dominant negative Fas of `689. An artisan would be motivated to use Hartmut’s CD40 endodomain sequence because claims in `689 do not teach this exact sequence. An artisan would reasonably expect to generate the claimed FLBR with CD40 endodomain of SEQ ID NO: 4 because Hartmut teaches this sequence.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATASHA DHAR whose telephone number is (571)272-1680. The examiner can normally be reached M-F 8am-4pm (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras Jr. can be reached at (571)272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATASHA DHAR/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632