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
Applicant's election (03/11/2026) and follow-up amendment (05/11/2026) to incorporate the elected species have been received and entered. Applicants elected with traverse Group I. Applicants have further identified the election of species to a “Chimeric Antigen Receptor” targeting “CD19”. The ZAP70 kinase domain species is “ZAP327”, the co-stimulatory domain species is “4-1BB”, the transmembrane domain species is “CD28” and the chemokine receptor species is “CCR5”.
The traversal is on the ground(s) that the compositions and methods are similar and thus a search for the composition will likely encompass search results for methods of treating disease and prolonging T cell persistence. This is not found persuasive. MPEP 802.01 provides that restriction is proper between inventions which are independent or distinct. Here, the inventions of Group I (compositions) versus the methods of Groups III-IV were identified as distinct for the reasons set forth in the action mailed 01-13-2026 (paragraph 4). Further, should the product compositions of Group I be found allowable, the restriction requirement will be reconsidered (See paragraph 32, “Notice of Potential Rejoinder” in action mailed 01/13/2026).
As to the question of burden of search, the inventions are classified differently, necessitating different searches in a variety of databases. Further, classification of subject matter is merely one indication of the burdensome nature of the search involved. The literature search, particularly relevant in this art, is not coextensive and is much more important in evaluating the burden of search. Different searches and issues are involved in the examination of each group.
Applicants further request that the examiner review MPEP 808.01(a) as it relates to the species election. MPEP 808.01(a) states that “where there is no disclosure of a relationship between species, they are independent inventions. A requirement for restriction is permissible if there is a patentable difference between the species as claimed and there would be a serious search and/or examination burden on the examiner if restriction is not required. In conjunction with this, applicants further refer to MPEP 806.04(b) which states species may be either independent or related under the particular disclosure. Where species under a claimed genus are not connected in any of design, operation, or effect under the disclosure, the species are independent inventions. However, where inventions as disclosed and claimed are both (A) species under a claimed genus and (B) related, then the question of restriction must be determined by both the practice applicable to election of species and the practice applicable to other types of restrictions such as those covered in MPEP § 806.05 - § 806.05(j). If restriction is improper under either practice, it should not be required.
In the instant case, applicants argue that there is a disclosure of a relationship between the claimed species in that the claims are all drawn to specific functional domains operating cohesively within CAR or TCR constructs. Applicants point out that a search focused on the novel ZAP70 amino acid sequences will capture the relevant art for the generic claims regardless of the which specific tumor antigen the CAR is directed toward. Thus, applicants argue that the requirement of a species election is not proper. These arguments have been considered but are not found persuasive as applicants concerns regarding MPEP 808.01(a) and MPEP 806.04(b) appear to suggest that the examiner’s species requirement was along the lines of an “intraclaim” restriction or a holding that each species within the Groups were drawn to separate and distinct inventions. That is not the case here. The election of species was based on the Markush-style of claim presentation (See MPEP 803.02). Thus, following an election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious. Thus, the examiner fully recognizes that the species requirement can be removed should the generic ZAP70 sequences be found free of the art. But, the species requirement for Markush claims is a proper species practice.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-38 are pending.
Claims 4-14, 16, 25-28, 31, and 35-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions or non-elected species, there being no allowable generic or linking claim.
Claims 1-3, 15, 17-24, 29-30, 32-34, and 37-38 are pending and are under consideration.
Information Disclosure Statement
The information disclosure statements filed 11/15/2023, 08/16/2024, and 09/26/2024 have been considered. It should be noted that reference 95 (Wolfel et al.) of the IDS filed 11/15/2023 was only one page and thus only the abstract was considered.
Specification
The disclosure is objected to because of the following informalities: The specification filed 06/20/2023 is objected on page 71, para 0213 for recitation of two amino acids sequences in the absence of a sequence identifier. See 37 CFR 1.821(c). 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825.
Claim Objections
Claim 17 is objected to because of the following informalities: Claim 17 recites “wherein the intracellular T-cell activation moiety comprising a costimulatory signaling domain fused with a signaling domain, wherein the costimulatory signaling domain selected from”. To better understand the entirety of the claimed composition applicant may wish to rewrite the claim as:
“wherein the intracellular T-cell activation moiety comprisesis selected from”
Claim Rejections - 35 USC § 112
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.
Claims 1-3, 15, 23 and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1 (step a), the recitation of “optionally” is ambiguous because the claim does not recite any other antigen recognition moieties other than a ScFv. Thus, it’s not clear what other options the claim language is attempting to cover. Dependent claims 2-3, and 15 are included in this rejection since their dependencies do not cure this issue.
Claim 2 recites the limitation "or a mutant" in 1. There is insufficient antecedent basis for this limitation because Claim 1 (step b) only refers to a Zap70 kinase or a variant thereof.
Claim 23 contains the trademark/trade name Nanobodies. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an antigen recognition moiety and, accordingly, the identification/description is indefinite.
Claim 24 recites the limitation "by ScFv" in claim 22. There is insufficient antecedent basis for this limitation because Claim 22 does not reference a ScFv.
Claim 38 is rejected for reciting a signaling domain comprising “ZAP255, ZAP280, ZAP300, ZAP308, ZAP327, or ZAP338” as there are no structures associated with these laboratory designations. Since the specification teaches that all of these ZAP kinases can comprise variants or mutants, it would be unclear what the scope of the claim encompasses. Further, others in the art may use similarly named ZAP kinases that have different functions and different structures. Thus, in the absence of a specifically claimed structure in conjunction with the laboratory designation, Claim 38 is indefinite.
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 1-3, 15, 17-24, 29-30, 32-34, 37-38 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. This is a Written Description rejection.
The claims are broadly drawn to chimeric antigen receptors inclusive of an intracellular T-cell activation moiety that comprises a “signaling” domain wherein said signaling domain comprises a “Zap70 kinase domain or a variant thereof” (Claim 1, part b); alternatively, the Zap70 kinase domain can comprise mutants, variants, or sequences with at least 70% identity to one of SEQ ID Nos: 64, 65, 16, 17, and 52 (Claims 2-3). Mutants or variants of ZAP70 kinases are also encompassed in Claims 17-18. Further, claim 19 comprises mutants or variants of a ZAP70 kinase domain “derivatized” from a “functional wild type ZAP70 or a mutant or a variant thereof”.
Thus, the claims are broadly inclusive of a genus of enzymatic ZAP70 kinase polypeptides with or without functional activity. For example, the specification teaches [0032] that in some embodiments, the functional ZAP70 kinase domain, or signaling component, can include or exclude ZAP255 (SEQ ID NO: 64), ZAP280 (SEQ ID NO: 65), ZAP327 (SEQ ID NO: 17) or ZAP300 (SEQ ID NO: 16) or ZAP338 (SEQ ID NO: 52). Thus, in some instances, the ZAP70 kinase is not defined by a particular structure. See also claim 38. One of ordinary skill in the art would understand that the protein sequence, and/or proper folding/assembly are responsible for the function of enzymes and functional domains thereof (e.g., ZAP70 kinase domains), including acting as a signaling domain in a CAR construct. Fischer et al. (Seminars in Immunopathology, “ZAP70: a master regulator of adaptive immunity”,Vol.32, 2010) teach that recognition of specific MHC-peptide by the TCR at the surface of antigen-presenting cells (APC) leads to the phosphorylation of tyrosine residues present in the intracellular tail of the CD3 and ζ subunits. In quiescent T lymphocytes, ZAP70 is a cytosolic protein, and it is recruited at the plasma membrane of T cells following TCR stimulation. This recruitment is mediated by binding of the two SH2 domains of ZAP70 to the doubly phosphorylated ITAMs of ζ, which serve to dock the kinase at the stimulated TCR complex. The reference further teaches that certain domains and residues are critical to the function of the kinase. For example, interdomain B is a critical region of ZAP70 containing three tyrosine residues (Y292, Y315, and Y319) that are phosphorylated upon TCR signaling. Thus, deletions or mutations of this domain could affect kinase activity. As such, the instant disclosure does not provide a structure-function correlation that would allow for a person of ordinary skill in the art to envision all possible ZAP70 protein sequence derivatives, mutants, and/or variants, such that the obtained structure would result in the claimed functions.
As set forth above, the written description of ZAP70 kinase domains with functional activity includes ZAP300 (SEQ ID NO:16), ZAP327 (SEQ ID NO:17), ZAP338 (SEQ ID NO:52), ZAP255 (SEQ ID NO:64) and ZAP280 (SEQ ID NO:65). At the time of filing, the functionality of enzymes and/or domains thereof (e.g., ZAP70 kinase domains) was/were known to depend on the protein sequence, proper folding, and post-translational modifications. Further, the instant disclosure acknowledges that “…derivatization may alter the function of the protein…” [0183], and therefore require function testing. No structure-activity relationship was found in the prior art, nor provided in the instant specification that would allow for prediction of all of the possible derivatives, mutants, and/or variants of ZAP70 kinase domain that retain function/signaling activity.
A description of a genus of may be achieved by means of a recitation of a representative number of species, defined by structure, falling within the scope of the genus. However, the instant specification fails to provide sufficient descriptive information, such as definitive structural or functional features of the claimed genus of variants, mutants, or derivatized mutants of the ZAP70 kinase that would distinguish the claimed proteins from other molecules that do not have the claimed biological properties. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, the disclosure of only several species of ZAP70 kinase domains with functional activity is insufficient to describe the large genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe and enable the genus as broadly claimed.
Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of second polypeptides, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed. See, e.g., . An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). 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 inventor was in possession of the claimed invention.
At present, the disclosure fails to describe the common attributes or characteristics that identify members of the genus. Thus, because the genus is highly variant, the contemplation of a world of variants and mutants is insufficient to describe the genus and one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
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, 17-24, and 37-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pule et al. US 2019/0023761, published January 24, 2019 (Applicant’s IDS).
Applicants elected species were to a composition comprising “chimeric antigen receptors” that recognizes “CD19” (target antigen), comprising a CD28 (transmembrane domain), an intracellular signaling domain comprising ZAP327 (SEQ ID NO:17), a “41-BB” domain (co-stimulatory domain) and a CCR5 receptor (chemokine receptor).
As to claims 1-3, 17, 19-24, and 37-38, Pule et al. teach [0012, 0399] chimeric antigen receptors (CARs) targeting CD19 via single-chain variable fragments (scFv), and transmembrane domain comprising CD28 [0417] and a 41-BB co-stimulatory domain [0072] inclusive of a ZAP70 kinase domain comprising SEQ ID NO:17. See Figure 5 for example:
PNG
media_image1.png
434
662
media_image1.png
Greyscale
ZAP327 (SEQ ID NO:17) is 100% identical to Zap70 kinase domain of the prior art:
PNG
media_image2.png
390
524
media_image2.png
Greyscale
PNG
media_image3.png
506
638
media_image3.png
Greyscale
As to claim 18, wherein the intracellular T-cell activation moiety comprises “the replacement of CD3ζ with a ZAP70 kinase domain”, the broadest reasonable interpretation of the claim is simply a CAR construct not requiring CD3ζ but that still contains a ZAP70 kinase. Pule et al. teach that the immunoreceptor tyrosine-based activation motif (ITAM) such as those associated with CD3ζ, may be “bypassed”. (See also Figure 5). For example, the reference teaches [0279] that a fusion between ZAP70 and another signaling molecule not typically activated with an ITAM containing receptor may act to bypass signal from one pathway into another. A fusion between ZAP70 and the endodomain of CD28 may transmit a CD28 co-stimulatory signal as well as an ITAM activatory signal. Similarly, a fusion between ZAP70 and the endodomain of 41 BB or OX40 may transmit a 41 BB or OX40 co-stimulatory signal. Other pathways may also be recruited, for instance a fusion between ZAP70 and AKT kinase domain may result in transmission of an AKT signal upon ITAM phosphorylation.
As to claim 30, Pule et al. teach [0463] pharmaceutical compositions comprising the claimed chimeric antigen receptors with acceptable carriers.
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.
Claim(s) 15, 29, and 32-34 are further rejected under 35 U.S.C. 103 as being unpatentable over Pule et al. US 2019/0023761 in view of Tokarew et al. (British Journal of Cancer (2019) 120:26–37 and McColl (US20200054677, earliest filing date 2017)
Pule et al. teach as set forth above with regard to CARs comprising all of the elected species. However, Pule et al. does not teach that the CAR further comprises a chemokine receptor selected from CCR5.
Tokarew et al. teach the further engineering of CAR T cells to comprise expression of a chemokine receptor to increase CAR T cell recruitment (e.g., trafficking). For example, the reference specifically teaches (page 29, 1st column) that approaches by the author and others have sought to utilize the tumor chemokine signaling network to drive T cell recruitment by engineering the expression of a cognate chemokine receptors such as CCR2, CCR2b, CCR4, CCR7, CXCR258 or CXCR459 on the surface of CAR T cells (see Fig. 1).
Similarly, McColl also taught [0009] methods of enhancing the recruitment of T cells to a tumor comprising expressing in the T cells a receptor to a chemokine expressed by the tumor including within CAR-T cells. Specifically, McColl’s application claims (see claim 39-40): A chimeric antigen T cell engineered to express a chemokine receptor wherein the chemokine receptor comprises one or more of CCR2, CXCR3, CCR6, CCR9, CCR10, CXCR4, CXCR6, CXCR5, XCR1 and CCR5.
It would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to combine the pharmaceutical composition comprising a CD19 directed CAR comprising CD28 transmembrane domain, a 4-1BB domain, and a ZAP70 domain as taught by Pule with a chemokine receptor (e.g. CCR5) as taught by Tokarew and McColl, to arrive at a pharmaceutical composition comprising a CD19 directed CAR comprising transmembrane domain, a 4-1BB domain, and a ZAP70 domain, further comprising a CCR5 chemokine receptor. A PHOSITA would have been motivated to include the chemokine receptors because Tokarew teaches engineering CAR T cells to further express chemokine receptors is known and employed in the art to increase CAR T cell trafficking. There would have been a reasonable expectation of success for a PHOSITA to combine the pharmaceutical composition comprising a CD19 directed CAR comprising transmembrane domain, a 4-1BB domain, and a ZAP70 domain as taught by Pule with the chemokine receptor as taught by Tokarew and McColl, because Pule teaches the composition and CAR T cells, and Tokarew teaches engineering CAR T cells to further express chemokine receptors is known and employed in the art to increase CAR T cell trafficking. Further, McColl also taught [0009] methods of enhancing the recruitment of T cells to a tumor comprising expressing in the T cells a receptor to a chemokine (including CCR5) expressed by the tumor including within CAR-T cells. This rationale aligns with the principle of applying a known technique to a known method to yield predictable results, supporting a conclusion of obviousness (see MPEP § 2143).
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.
Claims 1-3, 15, 17-24, 29-30, 32-34, and 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 44-50, 52, 59-61, 65, 70-71 of copending Application No. 18002969 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim the same or overlapping subject matter.
Claim 44 of the ‘969 application (which is a continuation in part of the current application) is drawn the same CARs as currently claimed with the only difference being that the antigen recognition moiety is not claimed:
PNG
media_image4.png
208
666
media_image4.png
Greyscale
However, the “targets” of any of the antigen recognizing moieties are defined in the specification and include CD19. Further, the portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.
Claim 45 of ‘969 application is drawn to the replacement of CD3ξ with a ZAP70 which encompasses Claim 18 of the current application.
Claims 46-48 of the ‘969 application depend from claim 44 and recite:
PNG
media_image5.png
458
662
media_image5.png
Greyscale
The above claims are nearly the same as currently pending claims 19, 20, and 21.
Claims 49-50 of the ‘969 application are also nearly the same or identical to claims 22 and 23 of the current application.
Claim 70 of the ‘969 application is specifically inclusive of the currently elected CD19 targeting species:
PNG
media_image6.png
484
654
media_image6.png
Greyscale
The above claim is similar in scope to current claim 32.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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, Julie Wu can be reached at 571-272-5205. 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.
/GARY B NICKOL/Primary Examiner, Art Unit 1643
Prosecution Insights