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 1. Claims 1-17, 19, and 21 are pending. Priority 2. Application claims the priority of PCT/CN2022/072234 filed on 1/17/2022 which claims the benefit of CN202110060035.4 filed on 1/18/2021. However, foreign application has failed to provide the office with an English translation of the foreign patent. Therefore, priority is granted to the PCT application with the current effective filing date of 1/17/2022. Election/Restrictions 3. The Election filed 3/5/2026 , in response to the Office Action of 1/6/2026 , is acknowledged and has been entered. Applicants elected without traverse the species of : CDR1-HC, CDR2-HC, and CDR3-HC corresponding to SEQ ID NOs: 155, 156, 157; SEQ ID NOs: 158, 159, and 160; and SEQ ID NOs: 161, 162, and 163; CDR1-LC, CDR2- LC, and CDR3-LC corresponding to SEQ ID NOs: 164, 165, and 166; SEQ ID NOs: 167, 168, 169; and SEQ ID NOs: 170, 171, and 172 ; and the heavy chain variable region having the amino acid sequence of SEQ ID NO: 21 and the light chain variable region having the amino acid sequence of SEQ ID NO: 22 that aligns with the CDR sequences elected above . Claims 1-17, 19, and 21 are pending. Claims 1-17, 19, and 21 are currently under prosecution as drawn to the elected species. Claim Objections 4. Claims 2, 9 , 10, and 1 5 are objected to because of the following informalities: in claim 2 the phrase “comprises a combination of heavy chain CDR and a light chain CDR” then lists combinations of VH and VL regions. Please amend to remove “CDR.” in claim 9 the phrase “specifically binds to other antigens than CD22” please amend to state, “specifically binds to antigens other than CD22” in claim 10 the phrase “ and the extracellular antigen binding domain comprises…” please amend to state “ wherein the extracellular antigen binding domain comprises…” in claim 15 the phrase, “is cultured or cultured under appropriate conditions” please amend to “is cultured under appropriate conditions.” Appropriate correction is required. Claim Interpretation 5. The examiner’s broadest reasonable interpretation of the claims is set forth below. Claim 1 recite s : “An isolated antibody or an antigen-binding fragment that specifically binds to human CD22, characterized in that, the antibody or the antigen-binding fragment comprises a combination of heavy chain CDRs and a combination of light chain CDRs: (1) the combination of the heavy chain CDRs comprises: CDR1-VH, CDR2-VH and CDR3-VH; the CDR1-VH, CDR2-VH and CDR3-VH have any sequence combination selected from the following or a sequence combination with 1, 2, 3 or more amino acid insertions, deletions and/or substitutions compared to the sequence combination: and, (2) the combination of the light chain CDRs comprises: CDR1-VL, CDR2-VL, and CDR3-VL, the CDR1-VL, CDR2-VL and CDR3-VL have any sequence combination selected from the following, or a sequence combination with 1, 2, 3 or more amino acid insertions, deletions and/or substitutions compared to the sequence combination: each CDR1-VH, CDR2-VH, CDR3-VH, CDR1-VL, CDR2-VL and CDR3-VL is coded according to the prevailing analysis methods of KABAT, Chothia or IMGT. The phrase, “ or a sequence combination with 1, 2, 3 or more amino acid insertions, deletions and/or substitutions compared to the sequence combination: ” is reasonably interpreted as an isolated antibody or antigen-binding fragment that binds CD22 comprising a combination of heavy chain CDRs and a combination of light chain CDRs comprising CDR1-VH, CDR2-VH, CDR3-VH, CDR1-VL, CDR2-VL, and CDR3-VL having the sequences from the elected SEQ ID NOs with any number of insertions, deletions, and substitutions, including where the amino acid sequence has no resemblance to the listed SEQ ID NO. Claim 2 recites: “The antibody or the antigen-binding fragment of claim 1, characterized in that, the antibody or the antigen-binding fragment comprises a combination of a heavy chain CDR and a light chain CDR selected from: VH13+VL13, VH14+VL14, or VH15+VL15, and a combination of CDRs with insertions, deletions and/or substitutions of 1, 2, 3 or more amino acids compared to the sequence of the heavy chain CDR and the light chain CDR in these combinations. ” The phrase, “ and a combination of CDRs with insertions, deletions and/or substitutions of 1, 2, 3 or more amino acids compared to the sequence of the heavy chain CDR and the light chain CDR in these combinations ” is reasonably interpreted as the antibody or antigen-binding fragment of claim 1 comprising a combination of a heavy chain CDR and l ight chain CDR selected from VH13+VL13, VH14+VL14, VH15+VL15 and a combination of CDRs with any number of insertions, deletions, or substitutions including where the amino acid sequence has no resemblance to the sequence of the heavy chain CDR and the light chain CDR. Claim 3 recites: “ The antibody or the antigen-binding fragment of any one of claims claim 1, characterized in that, the antibody or the antigen-binding fragment comprises: (1) a heavy chain variable region having a sequence as shown in SEQ ID NO: 21 ; a light chain variable region having a sequence as shown in SEQ ID NO: 22 ; (2) an amino acid sequence having at least 90% identity, preferably at least 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99% identity with the sequence shown in (1) above; or, (3) a framework region of the antibody or the antigen-binding fragment having at least 90% identity, preferably at least 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% identity with the framework region of the amino acid sequence as shown in (1) above. ” The phrase “a heavy chain variable region having a sequence as shown in SEQ ID NO: 21 ” and a light chain variable region having a sequence as shown in SEQ ID NO: 22 ” is reasonably interpreted as a heavy chain or a light chain comprising a sequence of amino acids from SEQ ID NO: 21 or 22 , as few as two consecutive amino acids long. 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 appl icant regards as his invention. 6 . Claims 2-3, 5-9, 11, 14, 17, and 19 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. In regards to claim 2 the phrase “ and a combination of CDRs with insertions, deletions and/or substitutions of 1, 2, 3 or more amino acids compared to the sequence of the heavy chain CDR and the light chain CDR in these combinations” makes this claim indefinite because the claim already encompasses an antibody or antigen-binding fragment with a defined VH and VL region , the addition of another “combination of CDRs” is unclear how that would fit into the already disclosed heavy and light variable chains of the antibody. A person of ordinary skill in the art could not reasonably ascertain the scope of claim 2 with the phrase above included. In regard to claims 3, 5-6, 8-9, 11, 14, 17, and 19 the use of the word “preferably” renders the claim indefinite because it is not clear whether preferably indicates the following limitation is required or optional . For continued compact prosecution, the examiner is interpreting all uses of the word “preferably” to be the same as “optionally.” In regard to claim 6 , the phrase “comprises a sequence of the constant region of human or murine antibody IgG1, IgG2, IgG3 or IgG4” is indefinite because it is not clear what limitation is being further defined by the phrase . In regard to claim 7 , the phrase “antibody minimum recognition unit” is indefinite because this is not a term known to the art and not defined by the specification. Therefore, it is unclear what the claim is referring to in this limitation. 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. 7. Claims 1-17, 19 and 21 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention. This is a WRITTEN DESCRIPTION rejection. Claim 1 is drawn to an isolated antibody or antigen-binding fragment that specifically binds human CD22 comprising a combination of heavy chain CDRs comprising CDR1-VH, CDR2-VH, and CDR3-VH having the sequence combination of VH13, VH14, or VH15 and a combination of light chain CDRs comprising CDR1-VL, CDR2-VL, and CDR3-VL having the sequence combinations selected from VL13, VL14, or VL15 or a sequence of any of the above VH or VL sequences with any number of insertions, deletions, and substitutions including a sequence that does not resemble the listed sequences. Claims 10 - 11 and 16 are drawn to a CAR protein comprising an extracellular antigen-binding domain comprising the CD22 antibody or antigen-binding fragment of claim 1 , an immune effector cell comprising the nucleic acid fragment encoding the CAR protein, and a method for preparing the immune effector cell comprising introducing a nucleic acid fragment encoding the CAR protein . Claims 12-15 are drawn to an isolated nucleic acid molecule that encodes the antibody or the antigen-binding fragment of claim 1 , the use of the nucleic acid in an expression vector , the use of the nucleic acid in an isolated host cell, and a method for preparing the antibody or antigen-binding fragment of claim 1 by expression of the nucleic acid in the isolated host cell. Claim s 1 and 10 identif y the antibody or antigen-binding fragment by the function of binding human CD22 and a partial sequence structure of a combination of heavy chain CDRs and light chain CDRs having the sequence any sequence structure. Thus, the claims encompass a vast genus of antibody and CAR protein variants comprising a heavy chain CDR region and a light chain CDR region. Claims 1 1 -16 identify the antibody or antigen-binding fragment or the CAR cells by the function of binding human CD22 and by the partial sequence structure of nucleic acid fragments of the antibody or CAR protein that encode the partial amino acid sequence structure given in claim 1 for the CDR regions of the antibody as discussed above. Thus, the claims encompass a vast genus of antibody , antigen-binding fragments and CAR cell variants that bind human CD22 and the partial sequence structure of nucleic acid molecules that encode the amino acid sequences of the CDRs disclosed in claim 1. The instant specification discloses 35 heavy chain region amino acid sequences and 35 light chain amino acid sequences that bind to human CD22 . (See pgs. 46-50, Table 9). The instant specification further discloses 35 different combinations for heavy chain CDRs including CDR1-HC, CDR2-HC, and CDR3-HC and 35 different combinations for light chain CDRs including CDR1-LC, CDR2-LC, and CDR3-LC analyzed by Kabat, Chothia, and IMGT analysis that bind to human CD22 . (See pgs. 50-59, Table 10). Thus, the instant specification discloses identifying 35 different structurally distinct heavy chain and light chain amino acid sequence combinations and the corresponding heavy and light chain regions. The instant specification fails to disclose the structures of all CDR regions with any number of amino acid insertions, deletions, or substitutions that could be used to bind to human CD22. To provide adequate written description and evidence of possession of the claimed antibody and CAR genus, the instant specification can structurally describe representative antibody and CAR variants that function to bind human CD22 , or describe structural features common to the members of the genus, which features constitute a substantial portion of the genus. Alternatively, the specification can show that the claimed invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics (see University of California v. Eli Lilly and Co ., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) and Enzo Biochem, Inc. V. Gen-Probe Inc.) . A disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product. In this case, the only factor present in the claims is a recitation of the antibody function, “ binds to human CD22 ” or the CAR function of an “extracellular antigen-binding domain comprising the CD22 antibody” , and partial sequence structure as stated above. The instant specification fails to describe structural features common to the members of the antibody or CAR binding a human CD22 genus, which features constitute a substantial portion of the genus because the instant specification fails to disclose a representative antibody or CAR variant sequences that function as claimed. A definition by function does not suffice to define the genus because it is only an indication of what the antibody does, rather than what it is. Other than for the heavy and light chain sequences disclosed in Tables 9, 10 and the sequences on pages 59-60 , the specification fails to provide CDR1-VH, CDR2-VH, CDR3-VH, CDR1-VL, CDR2-VL, and CDR3-VL structural features coupled to the claimed functional characteristics. The instant specification fails to describe a representative number of antibody sequence variants for the genus of antibodies that function as claimed. The instant specification further fails to describe a representative number of CAR protein sequence variants. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus required to make the claimed antibodies. The claims broadly encompass any sequence variant that functions to bind human CD22 . Applicants have not established any reasonable structure-function correlation with regards to the sequences in the CDRs that can be altered and still maintain CD22 binding function . Further, applicants have not established a reasonable structure-function correlation with regards to a nucleotide sequence encoding for an entire antibody to bind to human CD22. Given the well-known high level of polymorphism of antibody CDR sequences and structure, the skilled artisan would not have been in possession of the vast repertoire of antibodies or CAR cells encompassed by the claimed invention. One could not reasonably or predictably extrapolate the structure of a single human CD22 antibody comprising the sequences of the VH13, VH14, VH15, VL13, VL14, and VL15 combination of CDRs or the sequences of the above structures with any number of insertions, deletions, or substitutions to the structure of any variants required to bind human CD22 as broadly claimed. Further, one could not reasonably or predictably extrapolate the structure of a single nucleic acid sequence encoding for the antibody to human CD22 or the CAR cell expressing the antibody to human CD22 as broadly claimed. Therefore, one could not readily envision members of the broadly claimed genus. Although Applicants may argue that it is possible to screen for antibodies and CAR cells that bind human CD22 and function as claimed, the court found in ( Rochester v. Searle , 358 F.3d 916, Fed Cir., 2004) that screening assays are not sufficient to provide adequate written description for an invention because they are merely a wish or plan for obtaining the claimed chemical invention. “As we held in Lilly , “[a]n adequate written description of a DNA … ‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” 119 F.3d at 1566 (quoting Fiers , 984 F.2d at 1171). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions.” Knowledge of screening methods provides no information about the structure of any future antibodies or CAR cells yet to be discovered that may function as claimed. The human CD22 antigen provides no information about the structure of an antibody or a CAR cell that binds to it. Given the lack of representative examples to support the full scope of the claimed variant antibodies and CAR proteins , and lack of reasonable structure-function correlation with regards to the unknown variable sequences in the CDRs that provide human CD22 -binding function , the present claims lack adequate written description. Thus, the specification does not provide an adequate written description of antibody and CAR variants that bind human CD22 and comprise any CDR amino acid sequence capable of binding human CD22 that is required to practice the claimed invention. Examiner Suggestion: Examiner suggests amending claim 1 to recite: “An isolated antibody or an antigen-binding fragment that specifically binds to human CD22, characterized in that, the antibody or the antigen-binding fragment comprises a combination of heavy chain CDRs and a combination of light chain CDRs: (1) the combination of the heavy chain CDRs comprises: CDR1-VH, CDR2-VH and CDR3-VH; the CDR1-VH, CDR2-VH and CDR3-VH have any sequence combination selected from the following or a sequence combination with 1, 2, 3 or more amino acid insertions, deletions and/or substitutions compared to the sequence combination: and, (2) the combination of the light chain CDRs comprises: CDR1-VL, CDR2-VL, and CDR3-VL, the CDR1-VL, CDR2-VL and CDR3-VL have any sequence combination selected from the following, or a sequence combination with 1, 2, 3 or more amino acid insertions, deletions and/or substitutions compared to the sequence combination: . ” each CDR1-VH, CDR2-VH, CDR3-VH, CDR1-VL, CDR2-VL and CDR3-VL is coded according to the prevailing analysis methods of KABAT, Chothia or IMGT. Examiner further suggests amending claim 2 to recite: The antibody or the antigen-binding fragment of claim 1, wherein the antibody or the antigen-binding fragment comprises a combination of a heavy chain variable region and light chain variable region selected from: VH13+VL13, VH14+VL14, and VH15+VL15. Examiner further suggests amending claim 3 to recite: The antibody or the antigen-binding fragment of claim 1, wherein the antibody or the antigen-binding fragment comprises a heavy chain variable region having the sequence as shown in SEQ ID NO: 21, and a light chain variable region having the sequence as shown in SEQ ID NO: 22. Examiner suggests amendments to any of the remaining claims to limit the antibody and antigen-binding fragment thereof to comprising the six completely defined C DR sequences recited in claim 1 that are critical to the CD22 binding function. 8. Claim s 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The claim is drawn to an antibody or antigen-binding fragment that is characterized as a fully human antibody or a fragment thereof. The specification discloses producing the antigen-binding fragments in murine models and describes testing only human/murine chimeric antibodies. Given the claimed antibody sequences are murine , they are not enabled to be human. Examiner suggestion: Delete “ (c) a fully human antibody or a fragment thereof ” from claim 5. 9. Claim 19 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for a method of producing antibodies that bind to human CD22 , does not reasonably provide enablement for a method of treating and preventing a B-cell disease which includes tumors or an autoimmune disease . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. The claims as currently constituted encompass methods of treating and preventing B-cell diseases including tumors and autoimmune diseases b y administering an antibody or antigen-binding fragment that specifically binds to human CD22 . The instant specification does not demonstrate that the claimed antibody binding to human CD22 can treat or prevent B-cell disease s including tumors and autoimmune diseases . A search of relevant art does not support that antibodies binding to human CD22 is evidence of the treat ment or prevent ion of B cell disorders including tumors and autoimmune disorders. For example, Carter (Mayo Clin. Proc., 81(3):377-384, March 2006) teaches that the essential outcome for monoclonal antibody treatment of B cell malignancies is the depletion of B cells . (See Carter, pg. 381 column 2, last paragraph) Further, Carter, teaches that predicting the development of autoimmune disorders is difficult because of the complex nature of the development of B cells within the immune system that involves the production of antibodies that react to self-antigens and several checkpoints that involve testing reaction to self-antigens in the process called tolerance. (See Carter, pgs. 379-381, “B cells and Disease States”). One cannot extrapolate the disclosure of the specification to the scope of the claims because the specification lacks the critical steps necessary in presenting some type of predictable response in a population of hosts deemed necessary to treat or prevent B cell disorders . Reasonable guidance with respect to treating or preventing any B cell disease relies on quantitative analysis from defined populations which have been successfully pre-screened and are predisposed to particular types of cancer or autoimmune disorders . The essential element towards the validation of a preventive therapeutic is the ability to test the drug on subjects monitored in advance of clinical diagnosis and Iink those results with subsequent histological confirmation of the presence or absence of disease. This irrefutable link between antecedent drug and subsequent knowledge of the prevention of the disease is the essence of a valid preventive agent. All of this underscores the criticality of providing workable examples which are not disclosed in the specification. A high quantity of experimentation would be required to determine if and what antibodies disclosed through the specification are capable of depleting B cells in response to either malignancy or autoimmune disease. Reasonable correlation must exist between the scope of the claims and scope of enablement set forth, and it cannot be reasonably predicted that the claimed antibody or antigen-binding fragment that binds human CD22 will predictably function to prevent cancer as claimed. Further, pharmaceutical therapies in the absence of in vivo clinical data are unpredictable for the following reasons; (1) the protein may be inactivated before producing an effect, i.e. such as proteolytic degradation, immunological inactivation or due to an inherently short half-life of the protein; (2) the protein may not reach the target area because, i.e. the protein may not be able to cross the mucosa or the proteins may be adsorbed by fluids, cells and tissues where the protein has no effect; and (3) other functional properties, known or unknown, may make the protein unsuitable for in vivo therapeutic use, i.e. such as adverse side effects prohibitive to the use of such treatment. See page 1338, footnote 7 of Ex parte Aggarwal, 23 USPQ2d 1334 (PTO Bd. Pat. App. & Inter. 1992). Therefore, in view of the state of the art, the quantity of experimentation necessary, the breadth of the claims, lack of guidance in the specification, and the absence of working examples, it would require undue experimentation for one skilled in the art to practice the invention as broadly claimed. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 10. Claims 2, 5 , and 7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In regards to claim 2 , the claims recite “comprises a combination of a heavy chain CDR and a light chain CDR.” Claim 2 depends from claim 1 which requires a combination of 3 CDRs for the heavy chain and a combination of 3 CDRs for the light chain. The limitation of a single heavy chain CDR and a single light chain CDR improperly broadens claim 2. In regard to claim s 5 and 7 , the claims recite “a single domain antibody” (claim 5) and “a nanobody” (claim 7 ) . Claim 5 is dependent on claim 1 which recites an antibody comprising a VH region and a VL region. A single domain antibody and a nanobody comprise just a VH region which makes the dependence from claim 1 improper. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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. (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. 11. Claims 1, 3 -9, 12-1 5 , 17, 19, and 21 are rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated by Cheung (WO2020/185763, pub. 9/17/2020) . In regard to claim 1, Cheung discloses an antibody, or antigen-binding fragment that binds to CD22 comprising a combination of heavy chain CDRs and a combination of light chain CDRs that have any sequence combination disclosed by the instant application with more than one amino acid insertions, deletions, or substitutions including sequences that have no resemblance to the sequences of the present application. (See Cheung, pgs. 1-2 [0005]) See examples from Figures 6 and 7 reproduced below with CDR regions underlined: In regard to claim 3 Cheung discloses a heavy chain variable region having a sequence, SEQ ID NO:1, that aligns with SEQ ID NO: 21 for sequences of 2 or more consecutive amino acids at multiple locations. (See Cheung, Fig. 6, also see alignment below). Cheung further discloses a light chain variable region having a sequence, SEQ ID NO: 17, that aligns with SEQ ID NO: 22 for sequences of 2 or more consecutive amino acids. (See Cheung, Fig. 7, also see alignment below). SEQ ID NO: 21 aligns with SEQ ID NO: 1 from Cheung: SEQ ID NO: 22 aligns with SEQ ID NO: 17 from Cheung: In regard to claim 4 , Cheung discloses anti-human CD22 antibodies comprising the same sequence structures instantly claimed, and teaches the antibodies have a dissociation constant (KD) of less than 10 -6 M ([0187]), therefore the antibodies inherently perform the same functions claimed including having the same dissociation constants claimed. Cheung does not specifically teach that antibodies have a KD no more than 10 -8 M to rhesus monkey CD22. However, the claimed antibodies appear to be the same as the prior art antibodies, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989). In regard to claims 5-9 , Cheung discloses that the antibody can be chimeric or humanized, and can be bispecific. (See Cheung, pg. 3, [0010]). Cheung further discloses the bispecific antibody with one binding domain binding to CD22 and the other binding to a second immunoglobulin including CD3, CD16, CD4, CD8, CD14, CD15, CD20, CD19, CD21, CD23, CD46, CD74, CD80, and HLA-DR. (See Cheung, pg. 5, [0016]). Cheung further discloses that the antibody can be comprised of a constant region from the group of IgG1, IgG2, IgG3, IgG4, IgA, IgM, and IgD and the antigen-binding fragment could be from the group of F(ab)2, Fab’, Fab, Fv, and scFv. (See Cheung, pgs. 1-2 [0005]). Cheung further discloses the antibody or antigen-binding fragment further coupled to a radionuclide. (See Cheung, pg. 7 [0025]). In regards to claims 12-1 4 , Cheung discloses a recombinant nucleic acid sequence encoding the antibody or antigen-binding fragment and a host cell or vector to express the nucleic acid sequence. (See Cheung, pgs. 5 [[0016]-[0017]). In regard to claim 15 , Cheung discloses preparing the antibody or the antigen binding fragment, characterized in that the host cell is cultured under appropriate conditions and the antibody is isolated . These methods include isolating the host cell and introducing an isolated nucleic acid molecule that encodes the antibody or antigen-binding fragment. (See Cheung, pg. 52, [00223]). In regard to claim 17 , Cheung discloses a composition comprising an antibody or antigen binding fragment and a pharmaceutically acceptable carrier. (See Cheung, pg. 5 [0018]). In regard to claim 19 and 21 , Cheung discloses a method for treating CD22-associated cancer and CD22-associated autoimmune disease in a subject by administering an effective amount of the antibody or antigen-binding fragment . (See Cheung, pg. 6 [0020]). Cheung further discloses kits including the antibody or antigen binding fragment. (See Cheung, pg. 7 [0026]). 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. 1 2 . Claims 1, 10-11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Cheung (WO2020/185763, pub. 9/17/2020) in view of Trinklein (WO2020/252366 Pub. 12/17/2020) . Cheung discloses the l imitations of claim 1 as disclosed above. Cheung does not disclose a CAR cell that expresses CD22 on its extracellular binding domain. Che u ng also does not disclose a method for making the C AR cell or the antibody or antigen-binding fragment by introducing a nucleic acid fragment into the CAR cell or the host cell and culturing it in appropriate conditions. Trinklein teaches using a CAR-T cell that comprises a heavy chain anti- CD22 antibody fragment to treat CD22 related disorders . (See Trinklein, pg. 5 [0022]). It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date to apply the antibody of Cheung to the CAR protein of Trinklein to create the antibody of the present claim invention. It would have been obvious because the CAR disclosed by Trinklein was successful with just a heavy chain variable region to treat CD22-related disorders and using a full antibody with a variable heavy chain and variable light chain would provide more specificity for the CAR protein . Therefore, one of ordinary skill in the art would have been motivated to improve the CAR cell of Trinklein by applying the antibody of Cheung to create the present claimed invention to treat CD22 related disorders with a reasonable expectation of success. Conclusion 1 3 . Claims 1-17, 19, and 21 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LINDSAY DUNN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-5825 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 8-4:30 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Samira Jean-Louis can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-3503 . 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. /LINDSAY DUNN/ Examiner, Art Unit 1644 /Laura B Goddard/ Primary Examiner, Art Unit 1642