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. DETAILED ACTION Claims 1-20 are pending in the application and are under examination. Information Disclosure Statement The information disclosure statement ha s been considered. Claim Ob jections Claim 18 is objected to for reciting “ the multispecific antibody according to claim 6 or 7, the chimeric antigen receptor according to claim 10” . It is suggested that this be amended to recite “ the multispecific antibody according to claim 6 or 7, or the chimeric antigen receptor according to claim 10” . Claim 20 is objected to for reciting “ subjectan ” It is suggested that this be amended to recite “ subject an ” . Claim Rejections - 35 USC § 112 The following is a quotation 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 35 U.S.C. 112 (pre-AIA), first paragraph: 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 20 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for using methods for treating B-cell lymphoma comprising administering to a subjec t an effective amount of the engineered immune cell according to claim 14 does not reasonably provide enablement for using the full scope of the claimed methods such as preventing, treating or diagnosing all diseases associated with CD19 expression . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. MPEP § 2164.01 states: The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde , 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands , 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands , 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988). There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors, which have been outlined in the Federal Circuit decision of In re Wands , 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), include, but are not limited to, the nature of the invention, the state of the prior art, the relative skill of those in the art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, the breadth of the claims, and the quantity of experimentation which would be required in order to practice the invention as claimed. See also Ex parte Forman , 230 USPQ 546 (BPAI 1986). The amount of guidance, direction, and exemplification disclosed in the specification, as filed, would not be sufficient to enable the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue and/or unreasonable experimentation. With respect to treating all CD19 associated diseases , it is noted that the art of Zelm et al (NEJM, 354:1901-1912, 2006) teach an antibody-deficiency disease due to altered CD19 expression (see abstract) which would not be expected to be treatable with the claimed engineered immune cell . Furthermore, the specification o nly establish es that B-cell lymphoma would be expected to be treatable by the claimed engineered immune cell (see pages 23 and 26 ). Therefore, one of skill in the art would be subject to undue experimentation to determine how to treat any and all diseases associated with CD19 expression , because CD19 expression in altered in a variety of diseases where it is unlikely the claimed agent would be effective . Then with respect to diagnosing all diseases associated with CD19 expression , the claimed e ngineered immune cell s are designed to kill cells expressing CD19, and the specification does not identify how to diagnose any disease with such immune cells, so one of skill in the art would be subject to undue experimentation to determine how to diagnose any and all diseases associated with CD19 expression using the claimed engineered immune cell , Finally, w ith respect to preventing diseases associated with CD19 expression, it is noted that the prevention of the antibody-deficiency disease due to altered CD19 expression disclosed by Zelm et al would not appear to be able to be prevented by the claimed engineered cell. Furthermore, with respect to preventing B-cell lymphomas by prophylactically administering the engineered cells, it is noted that preventing hyperproliferative disorders, including cancers and tumors, i.e., keeping individuals free of any such disorders indefinitely, is an intractable proposition, if not now wholly impossible, given, for example, that cancers are widely heterogeneous diseases, having widely varying pathologies and etiologies, and with causes that are multifactorial and as yet only partially characterized and poorly understood. It is generally recognized that a disease cannot be prevented unless and until its causes are fully appreciated and understood to a degree that it becomes possible to intercede effectively to block its onset or development by any cause. Notably, in this case, the specification presents merely prophetic examples that the recited compositions would be effective to prevent B-cell lymphomas . As such, the specification, which lacks any specific non-general guidance, direction, and exemplification that is reasonably commensurate in scope with the intended use of preventing diseases associated with CD19 expression or B-cell lymphomas , would not reasonably enable the artisan to prevent such diseases without undue and/or unreasonable experimentation. Here, there is no disclosure of testing using any model to determine if any engineered cell as claimed can prevent diseases associated with CD19 expression in any mammal; again, the assertion that the invention is useful is based solely upon merely prophetic examples . Applicant is reminded that reasonable correlation must exist between the scope of the claims and scope of enablement set forth. In deciding In re Fisher , 166 USPQ 18, 24 (CCPA 1970), the Court indicated the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. “Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Genentech Inc. v. Novo Nordisk A/S , 42 USPQ2d 1001, 1005 (CA FC 1997). In conclusion, upon careful consideration of the factors used to determine whether undue experimentation is required, in accordance with the Federal Circuit decision of In re Wands , 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988), the amount of guidance, direction, and exemplification disclosed in the specification, as filed, is not deemed sufficient to have enable the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue and/or unreasonable experimentation. 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. Claims 1, 3, 5, 8-15 and 20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Huang, Wen-Jin ( CN107226867-A ) (machine translation attached as Exhibit A for disclosure reference s ) . With respect to claim 1 , Huang discloses a humanized CD19 antibody comprising SEQ ID NO:1 that comprises a light chain variable region and a heavy chain variable region, wherein the light chain variable region comprises CDR-L1 as set forth in SEQ ID NO: 1, CDR-L2 as set forth in SEQ ID NO: 2, and CDR-L3 as set forth in SEQ ID NO: 3, and the heavy chain variable region comprises CDR-H1 as set forth in SEQ ID NO: 4, CDR-H2 as set forth in SEQ ID NO: 5, and CDR-H3 as set forth in SEQ ID NO: 6, and the light chain variable region has at least 90% identity to the amino acid sequence as set forth in SEQ ID NO: 10, and the heavy chain variable region has at least 90% identity to the amino acid sequence as set forth in SEQ ID NO : 13 (see alignments and claims and page 3 ). RESULT 525 BEY22203 (NOTE: this sequence has 2 duplicates in the database searched. See complete list at the end of this report) ID BEY22203 standard; protein; 245 AA. XX AC BEY22203; XX DT 08-MAR-2018 (first entry) XX DE Anti-CD19 ScFv humanized antibody, SEQ ID 1. XX KW B-lymphocyte antigen CD19; antibody therapy; cancer; cytostatic; KW humanized antibody; single chain antibody; therapeutic. XX OS Unidentified. XX CC PN CN107226867-A. XX CC PD 03-OCT-2017. XX CC PF 25-JUL-2017; 2017CN-10613317. XX PR 25-JUL-2017; 2017CN-10613317. XX CC PA (CHON-) CHONGQING PRECISION BIOTECH CO LTD. XX DR WPI; 2017-71127R/79. XX CC PT New Chimeric antigen receptor of anti-human CD19 antigen useful for CC PT preparing of medicine for treating B cell malignancies comprises CC PT polypeptide ( scFv ). XX CC PS Claim 1; SEQ ID NO 1; 53pp; Chinese. XX CC The present invention relates to a novel anti-human CD19 antigen chimeric CC antigen receptor (CAR) useful for preparing a medicine for treating B CC cell malignancies. The invention further provides: a method for preparing CC lentivirus vector; and T cells comprising lentivirus vector. The present CC sequence represents an anti-CD19 single chain variable fragment ( ScFv ) CC humanized antibody, which is used in the invention for preparing a CC medicine for treating B cell malignancies. XX SQ Sequence 245 AA; Query Match 95.7%; Score 532; Length 245; Best Local Similarity 94.3%; Matches 100; Conservative 4; Mismatches 2; Indels 0; Gaps 0; Qy 1 DIQMTQSPSSLSASVGDRVTITCRASQDISKYLNWYQQKPGKAPKLLLYHTSRLHSGVPS 60 ||||||||||||||||||||||||||||||||||||||||||||:||:|||||||||||| Db 1 DIQMTQSPSSLSASVGDRVTITCRASQDISKYLNWYQQKPGKAPRLLIYHTSRLHSGVPS 60 Qy 61 RFSGSGSGTDYTLTISSLQQEDFATYYCQQGNTLPYTFGQGTKVEI 106 ||||||||||||||||||| ||||||||||||||||||| ||::|| Db 61 RFSGSGSGTDYTLTISSLQPEDFATYYCQQGNTLPYTFGGGTRLEI 106 RESULT 45 BEY22203 (NOTE: this sequence has 2 duplicates in the database searched. See complete list at the end of this report) ID BEY22203 standard; protein; 245 AA. XX AC BEY22203; XX DT 08-MAR-2018 (first entry) XX DE Anti-CD19 ScFv humanized antibody, SEQ ID 1. XX KW B-lymphocyte antigen CD19; antibody therapy; cancer; cytostatic; KW humanized antibody; single chain antibody; therapeutic. XX OS Unidentified. XX CC PN CN107226867-A. XX CC PD 03-OCT-2017. XX CC PF 25-JUL-2017; 2017CN-10613317. XX PR 25-JUL-2017; 2017CN-10613317. XX CC PA (CHON-) CHONGQING PRECISION BIOTECH CO LTD. XX DR WPI; 2017-71127R/79. XX CC PT New Chimeric antigen receptor of anti-human CD19 antigen useful for CC PT preparing of medicine for treating B cell malignancies comprises CC PT polypeptide ( scFv ). XX CC PS Claim 1; SEQ ID NO 1; 53pp; Chinese. XX CC The present invention relates to a novel anti-human CD19 antigen chimeric CC antigen receptor (CAR) useful for preparing a medicine for treating B CC cell malignancies. The invention further provides: a method for preparing CC lentivirus vector; and T cells comprising lentivirus vector. The present CC sequence represents an anti-CD19 single chain variable fragment ( ScFv ) CC humanized antibody, which is used in the invention for preparing a CC medicine for treating B cell malignancies. XX SQ Sequence 245 AA; Query Match 91.7%; Score 586; Length 245; Best Local Similarity 90.0%; Matches 108; Conservative 7; Mismatches 5; Indels 0; Gaps 0; Qy 1 QVTLKESGPVLVKPTETLTLTCTVSGVSLPDYGVSWIRQPPGKALEWLAVIWGSETTYYN 60 || |:|||| ||||::||:||||||||||||||||||||||||||||| ||||||||||| Db 126 QVQLQESGPGLVKPSQTLSLTCTVSGVSLPDYGVSWIRQPPGKALEWLGVIWGSETTYYN 185 Qy 61 SALKSRLTISKDTSKSQVVLTMTNMDPVDTATYYCAKHYYYGGSYAMDYWGQGTMVTVSS 120 ||||:||||||| ||:|||||||||||||||||||||||||||||||||||||: ||||| Db 186 SALKTRLTISKDNSKNQVVLTMTNMDPVDTATYYCAKHYYYGGSYAMDYWGQGSSVTVSS 245 With respect to claim 3 , the humanized CD19 antibody comprising SEQ ID NO:1 comprises a linker of SEQ ID NO:22 (see SEQ ID NO:1). With respect to claim s 5 and 8-9 , Huang discloses a cell comprising a vector comprising a nucleic acid that encodes SEQ ID NO:1 to express the antibody (see page 5). With respect to claims 10-1 5 , Huang discloses a chimeric antigen receptor comprising the humanized antibody, a CD28 transmembrane domain and a CD3 intracellular signaling domain further comprising a CD137 co-stimulatory domain and engineered T cells comprising the chimeric antigen receptor (see pages 3-5). With respect to claim 20, Huang discloses treating B cell malignant tumors by administering the engineered T cells to subjects (see pages 2-4). Accordingly, Huang anticipate s the claims absent a showing otherwise. 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 set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 . Claims 1, 3 and 5-20 are rejected under 35 U.S.C. 103 as being unpatentable over Huang, Wen-Jin ( CN107226867-A ) (machine translation attached as Exhibit A for disclosure references) and Damschroder et al ( US 2016/0145335 A1 ). With respect to claim 1 , Huang discloses a humanized CD19 antibody comprising SEQ ID NO:1 that comprises a light chain variable region and a heavy chain variable region, wherein the light chain variable region comprises CDR-L1 as set forth in SEQ ID NO: 1, CDR-L2 as set forth in SEQ ID NO: 2, and CDR-L3 as set forth in SEQ ID NO: 3, and the heavy chain variable region comprises CDR-H1 as set forth in SEQ ID NO: 4, CDR-H2 as set forth in SEQ ID NO: 5, and CDR-H3 as set forth in SEQ ID NO: 6, and the light chain variable region has at least 90% identity to the amino acid sequence as set forth in SEQ ID NO: 10, and the heavy chain variable region has at least 90% identity to the amino acid sequence as set forth in SEQ ID NO: 13 (see alignments and claims and page 3). RESULT 525 BEY22203 (NOTE: this sequence has 2 duplicates in the database searched. See complete list at the end of this report) ID BEY22203 standard; protein; 245 AA. XX AC BEY22203; XX DT 08-MAR-2018 (first entry) XX DE Anti-CD19 ScFv humanized antibody, SEQ ID 1. XX KW B-lymphocyte antigen CD19; antibody therapy; cancer; cytostatic; KW humanized antibody; single chain antibody; therapeutic. XX OS Unidentified. XX CC PN CN107226867-A. XX CC PD 03-OCT-2017. XX CC PF 25-JUL-2017; 2017CN-10613317. XX PR 25-JUL-2017; 2017CN-10613317. XX CC PA (CHON-) CHONGQING PRECISION BIOTECH CO LTD. XX DR WPI; 2017-71127R/79. XX CC PT New Chimeric antigen receptor of anti-human CD19 antigen useful for CC PT preparing of medicine for treating B cell malignancies comprises CC PT polypeptide ( scFv ). XX CC PS Claim 1; SEQ ID NO 1; 53pp; Chinese. XX CC The present invention relates to a novel anti-human CD19 antigen chimeric CC antigen receptor (CAR) useful for preparing a medicine for treating B CC cell malignancies. The invention further provides: a method for preparing CC lentivirus vector; and T cells comprising lentivirus vector. The present CC sequence represents an anti-CD19 single chain variable fragment ( ScFv ) CC humanized antibody, which is used in the invention for preparing a CC medicine for treating B cell malignancies. XX SQ Sequence 245 AA; Query Match 95.7%; Score 532; Length 245; Best Local Similarity 94.3%; Matches 100; Conservative 4; Mismatches 2; Indels 0; Gaps 0; Qy 1 DIQMTQSPSSLSASVGDRVTITCRASQDISKYLNWYQQKPGKAPKLLLYHTSRLHSGVPS 60 ||||||||||||||||||||||||||||||||||||||||||||:||:|||||||||||| Db 1 DIQMTQSPSSLSASVGDRVTITCRASQDISKYLNWYQQKPGKAPRLLIYHTSRLHSGVPS 60 Qy 61 RFSGSGSGTDYTLTISSLQQEDFATYYCQQGNTLPYTFGQGTKVEI 106 ||||||||||||||||||| ||||||||||||||||||| ||::|| Db 61 RFSGSGSGTDYTLTISSLQPEDFATYYCQQGNTLPYTFGGGTRLEI 106 RESULT 45 BEY22203 (NOTE: this sequence has 2 duplicates in the database searched. See complete list at the end of this report) ID BEY22203 standard; protein; 245 AA. XX AC BEY22203; XX DT 08-MAR-2018 (first entry) XX DE Anti-CD19 ScFv humanized antibody, SEQ ID 1. XX KW B-lymphocyte antigen CD19; antibody therapy; cancer; cytostatic; KW humanized antibody; single chain antibody; therapeutic. XX OS Unidentified. XX CC PN CN107226867-A. XX CC PD 03-OCT-2017. XX CC PF 25-JUL-2017; 2017CN-10613317. XX PR 25-JUL-2017; 2017CN-10613317. XX CC PA (CHON-) CHONGQING PRECISION BIOTECH CO LTD. XX DR WPI; 2017-71127R/79. XX CC PT New Chimeric antigen receptor of anti-human CD19 antigen useful for CC PT preparing of medicine for treating B cell malignancies comprises CC PT polypeptide ( scFv ). XX CC PS Claim 1; SEQ ID NO 1; 53pp; Chinese. XX CC The present invention relates to a novel anti-human CD19 antigen chimeric CC antigen receptor (CAR) useful for preparing a medicine for treating B CC cell malignancies. The invention further provides: a method for preparing CC lentivirus vector; and T cells comprising lentivirus vector. The present CC sequence represents an anti-CD19 single chain variable fragment ( ScFv ) CC humanized antibody, which is used in the invention for preparing a CC medicine for treating B cell malignancies. XX SQ Sequence 245 AA; Query Match 91.7%; Score 586; Length 245; Best Local Similarity 90.0%; Matches 108; Conservative 7; Mismatches 5; Indels 0; Gaps 0; Qy 1 QVTLKESGPVLVKPTETLTLTCTVSGVSLPDYGVSWIRQPPGKALEWLAVIWGSETTYYN 60 || |:|||| ||||::||:||||||||||||||||||||||||||||| ||||||||||| Db 126 QVQLQESGPGLVKPSQTLSLTCTVSGVSLPDYGVSWIRQPPGKALEWLGVIWGSETTYYN 185 Qy 61 SALKSRLTISKDTSKSQVVLTMTNMDPVDTATYYCAKHYYYGGSYAMDYWGQGTMVTVSS 120 ||||:||||||| ||:|||||||||||||||||||||||||||||||||||||: ||||| Db 186 SALKTRLTISKDNSKNQVVLTMTNMDPVDTATYYCAKHYYYGGSYAMDYWGQGSSVTVSS 245 With respect to claim 3 , the humanized CD19 antibody comprising SEQ ID NO:1 comprises a linker of SEQ ID NO:22 (see SEQ ID NO:1). With respect to claims 5 and 8-9 , Huang discloses a cell comprising a vector comprising a nucleic acid that encodes SEQ ID NO:1 to express the antibody (see page 5). With respect to claims 10-15 , Huang discloses a chimeric antigen receptor comprising the humanized antibody, a CD28 transmembrane domain and a CD3 intracellular signaling domain further comprising a CD137 co-stimulatory domain and engineered T cells comprising the chimeric antigen receptor (see pages 3-5). With respect to claim 20, Huang discloses treating B cell malignant tumors by administering the engineered T cells to subjects (see pages 2-4). Huang does not disclose CD19 bispecific antibodies, CD19 antibody conjugates or kits and compositions. Damschroder et al disclose s that CD19 bispecific antibodies that bind C D19 and another antigen are desirable and that the second antibody can be a sdAb (see pages 6 and 28). Damschroder et al disclose CD19 antibody conjugates are desirable and a CD19 antibody conjugated to a detectable marker that is a fluorescent protein (bioluminescent compound ) or fluorophore (see pages 1 and 10 -11 ) . and CD19 Damschroder et al disclose that kits can be acquired to run experiments (see page 10) and pharmaceutical aqueous compositions comprising CD19 antibodies that would comprise an excipient such as water (see abstract). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to modify the antibody of Huang to make CD19 bispecific antibodies with a sdAb that binds another antigen , CD19 antibody conjugates conjugated to a detectable marker that is a fluorescent protein or fluorophore , kits comprising the antibody or other products and compositions comprising CD19 antibodies compris ing water because Damschroder et al disclose s that such CD19 products are commonly made in the art and desirable depending on the need of one of ordinary skill in the art. Here these additional CD19 products would be seen as combining prior art elements according to known methods to yield predictable results and simple substitution of one known element for another to obtain predictable results . Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, absent a showing otherwise. Conclusion No claims are allowed. Claims 2 and 4 are objected to for depending upon rejected claim 1 . Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner works a flexible schedule. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Respectfully, Brad Duffy 571-272-9935 /Brad Duffy/ Primary Examiner, Art Unit 1643 December 17, 2025