DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Restriction/Election
Applicant’s election without traverse of Group I, drawn to a pharmaceutical composition comprising an antibody that binds to human CD38 and excipients and corresponding to claims 1, 4, 7, 11-12, 14-16, 19, 25, 27-28, 33-34, 36-37, 45, 52-53, and 57 in the reply filed 12/22/2025 is acknowledged.
Applicant has further elected examination of the following species of pharmaceutical composition: (a) antibody concentration about 20 mg/mL, (b) human IgG1 Fc region with an E430G substitution, (c) about 20 mM histidine, about 250 mM sorbitol, and about 0.04% w/v of polysorbate 80.
Claim Status
Claims 1, 4, 7, 11-12, 14-16, 19, 25, 27-28, 33-34, 36-37, 45, 52-53, 57, 60, 62-63, 65-67, 70, and 74 are pending. Claims 60, 62-63, 65-67, 70, and 74 are withdrawn for being directed to a non-elected invention.
Claims 1, 4, 7, 11-12, 14-16, 19, 25, 27-28, 33-34, 36-37, 45, 52-53, and 57 are under examination.
Specification
The use of the term Darzalex®, which is a trade name or a mark used in commerce, has been noted in this application (see, for example, Pgs. 7, 96, and 97). The term should be accompanied by the generic terminology (daratumumab); furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 7, 25, 34, 36-37, and 52-53 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 claims 25 and 34, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Regarding claims 4, 7, 36, and 37, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Regarding claims 37, 52, and 53, the phrases "consists essentially of" and “consisting essentially of” render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Regarding claims 37, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(d)
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.
Claim 12 is 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.
Claim 12 recites human IgG1 as the base sequence of the Fc region. However, this limitation is already required under one interpretation of claim 1 and so, under this interpretation, this limitation of claim 12 does not further limit the claim on which claim 12 depends. For at least this reason, the claim is rejected here.
Claim 12 also recites wherein the Fc region is an IgG2, IgG3, IgG4, or mixed isotype. However, in one interpretation of claim 1, the Fc region must be a human IgG1. Therefore, these limitations of claim 12, under this interpretation, cannot contain all the limitations of the claim on which claim 12 depends. For at least this reason, the claim is rejected here.
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 § 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.
Claims 1, 4, 7, 12, 14-16, 19, 25, 27-28, 33-34, 36-37, 45, 52, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over De Weers (US2018/0298106A1, published 10/18/2018, effectively filed 06/09/2010) in view of Kuipers (WO2017/1987231A1, published 11/23/2017, effectively filed 05/18/2016) and Jansson (US2017/0121414A1, published 05/04/2017, effectively filed 11/03/2015).
The disclosure of De Weers is directed to isolated monoclonal antibodies which bind to human CD38 and related antibody-based compositions. The disclosure is also directed to pharmaceutical compositions comprising the antibodies (Abstract).
Regarding the pharmaceutical composition of claims 1, 16, 33-34, and 36-37, pertaining to an antibody composition comprising an antibody which binds to human CD38, De Weers teaches a pharmaceutical composition comprising an anti-CD38 antibody formulated with pharmaceutical [0461], and that pharmaceutical composition may include salts, buffers, detergents (polysorbate 80/Tween-80TM) and stabilizers such as protein-free amino acids [0464] and sugars such as sorbitol [0475].
Regarding the anti-CD38 antibody of claims 1, 4, 16, 19, 25, and 52, pertaining to an antibody which binds to human CD38, comprising a VH CDRs set forth in SEQ ID NO:2, CDR2 set forth in SEQ ID NO:3, CDR3 in SEQ ID NO:4 and VL CDR1 SEQ ID NO:6, VL CDR2 sequence AAS, and CDR3 SEQ ID NO:7 (claim 1) and VH region comprising SEQ ID NO:1 and VL region comprising SEQ ID NO:5, De Weers discloses the antibody comprising VH SEQ ID NO:2 identical to instant SEQ ID NO:1 and VL SEQ ID NO:27 identical SEQ ID NO:5. The VH and VL comprise the claimed CDRs. The alignment is set forth below:
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[AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector]De Weers SEQ ID NO:2; Instant SEQ ID NO:1 (CDRs underlined)
De Weers SEQ ID NO:27; Instant SEQ ID NO:27 (CDRs underlined)
[AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector]
Regarding claim 12, wherein the Fc region, is, except for the recited mutations, a human IgG1, DeWeers teaches the antibody is a full length, IgG1 (Pg. 61, claim 95).
Regarding claim 27, wherein the pharmaceutical composition according to claim 16 is a bivalent antibody, DeWeers teaches the anti-CD38 antibodies of the disclosure may be bivalent ([0388], Line 16).
Regarding claim 45, wherein the antibody of the pharmaceutical composition according to claim 1 induces ADCC, DeWeers teaches the anti-CD38 antibodies of the disclosure induce ADCC mediated lysis in Daudi cells (Pg. 44, Example 6 and Fig. 4).
Regarding claim 57, wherein the composition is for intravenous or subcutaneous use, De Weers teaches in one embodiment the pharmaceutical composition of the disclosure is administered by intravenous or subcutaneous injection or infusion ([0470]).
The disclosure of De Weers does not teach: (1) the Fc region of the antibody comprises the mutation E430G, (2) the CL kappa region set forth in SEQ ID NO:37 or (3) the specific formulation of excipients of the instant disclosure.
These deficiencies are taught by Kuipers and Jansson.
The teachings of Kuipers:
The disclosure of Kuipers is directed to antibody molecules of the IgG isotype having a mutation in the Fc domain that enhances clustering of IgG molecules after target binding (see Abstract).
Regarding the Fc region of claims 1, 7, 16, and 19, wherein the Fc region comprises a mutation E430 and specifically E430G, Kuipers teaches the introduction of the mutation E430G into an IgG1 antibody (Pg. 83, Lines 25-28) and teaches the mutation enhances hexamerization resulting in enhanced efficacy of neutrophil-mediated phagocytic uptake using the mutated antibody compared to the wildtype (Pg. 86, Lines 3-7, Figs. 5D and 5E).
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Regarding claim 14, wherein the Fc region is an human IgG1 Fc region comprising, except for the recited mutations, amino acid residues 99 to 329 of SEQ ID NO:20, Kuipers discloses SEQ ID NO:15, identical to instant SEQ ID NO:20 with the exception of the E430G mutation. The alignment is shown below:
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Regarding the IgG1 Fc region of claims 15, 25, and 52, wherein the Fc region comprises the amino acid residues 99 to 329 of SEQ ID NO:24 or comprises SEQ ID NO:46, Kuipers SEQ ID NO:15 which anticipates the sequences of SEQ ID NO:24 and SEQ ID NO:46 and comprises the Fc E430G mutation. The alignment is shown below:
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Regarding the CL region of claims 25 and 52, wherein the CL region comprises SEQ ID NO:37, Kuipers discloses light chain SEQ ID NO:41, which comprises the kappa CL identical to instant SEQ ID NO:37. The alignment is shown below:
Regarding claim 28, wherein the antibody is, except for the recited mutation(s), a human monoclonal full-length monospecific bivalent IgG1m(f), κ antibody, Kuipers SEQ ID NO:15 represents the IgG1 allotype IgG1m(f), κ as evidenced by the instant specification which teaches that the corresponding instant SEQ ID NO:46 is human HC IgG1m(f), κ (instant specification, Pg. 80, Table 1).
The teachings of Jansson:
The disclosure of Jansson is directed to pharmaceutical compositions comprising subcutaneous formulations of anti-CD38 antibodies and their uses (see Abstract).
Regarding the specific pharmaceutical composition of claims 1, 16, 33-34, and 36-37, Jansson teaches a pharmaceutical composition comprising:
about 1 mg/mL to 180 mg/mL anti-CD38 antibody (Pg. 39, claim 25)
about 5 mM to about 50 mM histidine (Pg. 39, claim 25)
about 50 mM to about 400 mM sorbitol (Pg. 39, claim 25)
about 0.01% to about 0.1% polysorbate-20 (Pg. 39, claim 26)
the pH of the pharmaceutical composition is at pH 5.0 to 6.0 ([262])
In light of these teachings, it would have been prima facie obvious to one having ordinary skill in the art to modify the anti-CD38 pharmaceutical composition of De Weers with the teachings of Kuipers and Jansson by (1) modifying the Fc region of the antibody with the mutation E430G and (2) using the known CL kappa region set forth in SEQ ID NOs: 37 as taught by Kuipers and by (3) formulating the composition using the excipients and concentrations as taught by Jansson. One would have been motivated to do so because Kuipers teaches (1) the E430G mutation enhances neutrophil-mediated phagocytosis and (2) discloses the wild-type CL kappa sequence and Jansson (3) provides a stable pharmaceutical composition comprising anti-CD38 antibodies. Doing so constitutes combining prior art elements according to known methods to yield predictable results (see MPEP 2143 (I)). There would be an expectation of success in combining the prior art elements because De Weers provides for a pharmaceutical composition comprising the disclosed anti-CD38 antibody, Kuipers provides known heavy and light chain constant regions, and Jansson provides stable formulations for antibodies.
Claims 1, 4, 7, 11-12, 14-16, 19, 25, 27-28, 33-34, 36-37, 45, 52, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over De Weers (US2018/0298106A1) in view of Kuipers (WO2017/1987231A1) and Jansson (US2017/0121414A1) as applied to claims 1, 4, 7, 12, 14-16, 19, 25, 27-28, 33-34, 36-37, 45, 52, and 57 above, and further in view of van den Bremer (MAbs. 2015;7(4):672-80).
The combined teachings of De Weers, Kuipers, and Jansson teach a pharmaceutical composition comprising an antibody which binds to human CD38, comprising an Fc mutation E430 in a human IgG1 heavy chain, and pharmaceutical excipients as taught above. Jansson additionally teaches that removal of the C-terminal lysine from the antibody heavy chain is a well-known antibody alteration ([0033], Lines 3-5).
The combined teachings of De Weers, Kuipers, and Jansson do not teach that the antibody of the pharmaceutical composition the Lys at position 447 in human IgG1 heavy chain is absent.
This deficiency is taught by van den Bremer.
The disclosure of van den Bremer is directed to the investigation of the effect of the cleavage of C-terminal lysine that occurs in human IgG in circulation (Abstract, Lines 1-2). Van den Bremer teaches that that efficient C1q binding and complement-dependent cytotoxicity (CDC) requires IgG hexamerization at the cell surface and demonstrates that C-terminal lysines may interfere with this process, leading to suboptimal C1q binding and CDC of cells opsonized with C-terminal lysine-containing IgG (Abstract, Lines 2-5).
Regarding claim 11, wherein the lysine at position 477 in a human IgG1 heavy chain is absent, van den Bremer teaches that C-terminal lysine cleavage from both heavy chains via post-translational modification increased IgG-induced complement activation and CDC by >2–3 fold (Pg. 676, Discussion, Lines 1-4).
In light of these teachings, it would have been prima facie obvious to one having ordinary skill in the art to modify the anti-CD38 pharmaceutical composition of De Weers, Kuipers, and Jansson by using anti-CD38 antibodies wherein the C-terminal lysine is absent or “clipped” as taught by van den Bremer. One would have been motivated to do so because van den Bremer teaches that optimal complement activation requires the absence of the C-terminal lysine. There would be an expectation of success in modifying the antibody of De Weers, Kuipers, and Jansson by the absence of the K477 because van den Bremer teaches post-translational methods of removing the C-terminal lysine.
Claims 1, 4, 7, 12, 14-16, 19, 25, 27-28, 33-34, 36-37, 45, 52-53, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over De Weers (US2018/0298106A1) in view of Kuipers (WO2017/1987231A1) and Jansson (US2017/0121414A1) as applied to claims 1, 4, 7, 12, 14-16, 19, 25, 27-28, 33-34, 36-37, 45, 52, and 57 above, and further in view of Singh (J Pharm Sci. 2017 Dec;106(12):3486-3498).
The combined teachings of De Weers, Kuipers, and Jansson teach a pharmaceutical composition comprising an antibody which binds to human CD38, comprising an Fc mutation E430 in a human IgG1 heavy chain, and pharmaceutical excipients as taught above. Jansson additionally teaches the pharmaceutical composition comprises about 0.01% to about 0.1% polysorbate 20 (Pg. 39, claim 26) and lists polysorbate 80 as an exemplary surfactant ([-163], Line 2).
The combined teachings of De Weers, Kuipers, and Jansson do not teach the pharmaceutical composition comprises polysorbate 80.
This deficiency is taught by Singh.
The disclosure of Sing is directed to the effect of polysorbate 20 and polysorbate 80 on the higher order structure of a monoclonal antibody, and its antigen-binding (Fab) fragments and Fc fragments (Abstract, Lines 1-3). Singh teaches in the mAb-IgG1 of the disclosure that both polysorbate 20 and polysorbate 80 protect mAb against agitation induced aggregation (Pg. 3490, Left columm, Full paragraph 3) and determined in their particular antibody that polysorbate 80 is preferred over polysorbate 20 because polysorbate 80 offered higher protection against aggregation and caused lesser structural perturbations (Pg. 3497, Right column, Lines 1-5).
Regarding claim 53, wherein the pharmaceutical composition requires polysorbate 80, Singh teaches polysorbate 80 protects antibodies against agitation induced aggregation (Pg. 3497, Right column, Lines 1-5).
In light of these teachings, it would have been prima facie obvious to one having ordinary skill in the art to modify the anti-CD38 pharmaceutical composition of De Weers, Kuipers, and Jansson by substituting polysorbate 80 into the composition. One would have been motivated to do so because Singh teaches of the protective effects of polysorbate 80 and that in some conditions it is preferable over polysorbate 20. Doing so constitutes simple substitution of one known element for another to obtain predictable results (see MPEP 2143(I)). There would be an expectation of success in using polysorbate 80 in the formulation because Singh provides evidence of its efficacy in protecting monoclonal antibodies as part of a formulation.
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.
Copending Application No. 19/125,633
Claims 1, 4, 7, 11-12, 14-16, 19, 25, 27-28, 45, and 57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 12-13, 16-17, 19, 21-22, 26, 28, 34, 41, 54, 63-64, 71, 76, 81, 88, 90-91, 93, and 98-99 of copending Application No. 19/125,633 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending applicaiton teaches the instant antibody comprised in a composition comprising the pharmaceutically acceptable excipients of the instant invention.
Regarding the pharmaceutical composition of instant claims 1, 4, 7, 12, 16, 19, and 27, ‘633 teaches the following:
The anti-CD38 antibody comprising instant VH CDRs SEQ ID NO:2-4, VL CDRS SEQ ID NO:6, AAS, and SEQ ID NO:7 (‘633, claim 1)
The anti-CD38 antibody comprising VH SEQ ID NO:1 and VL SEQ ID NO:5 (‘633, claim 71)
The Fc region of the antibody comprises a mutation E430 (‘633, claim 1), specifically E430G (‘633 claim 76)
The antibody is a bivalent antibody (‘633, claim 93)
The antibody is comprised in a composition comprising:
Antibody concentration 1 to 200 mg/mL
5-40 mM histidine
100-400 mM sorbitol; and
A surfactant (‘633 claim 99)
Regarding instant claim 11, ‘633 claim 90 teaches wherein Lys at position 447 according to EU numbering is deleted.
Regarding instant claims 14, 15, 25, 28, pertaining to the Fc region of the antibody of the instant pharmaceutical composition, ‘633 claims the CH region instant SEQ ID NOs: 24 and 46
Regarding instant claim 45, ‘633 claim 63 teaches the antibody has an inhibitory effect on CD38 cyclase activity in a subject.
Regarding instant claim 57, ‘633 claim 19 teaches the antibody of the disclosure is administered by intravenous injection or infusion.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 7, 11-12, 14-16, 19, 25, 27-28, 33-34, 36-37, 45, 52-53, and 57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 12-13, 16-17, 19, 21-22, 26, 28, 34, 41, 54, 63-64, 71, 76, 81, 88, 90-91, 93, and 98-99 of copending Application No. 19/125,633 as applied to claims 1, 4, 7, 11-12, 14-16, 19, 25, 27-28, 45, and 57 above and further in view of Jansson (US2017/0121414A1), Singh (J Pharm Sci. 2017 Dec;106(12):3486-3498), and Kuipers (WO2017/1987231A1).
‘633 does not teach (1) the pharmaceutical composition comprises about 0.04% w/v polysorbate 80, (2) the pH of the composition is 5.9 to 6.1, or (3) the CL of the antibody comprises SEQ ID NO: 37.
These deficiencies are taught by Jansson, Singh, and Kuipers.
Regarding instant claims 33, 34, 36, and 53, pertaining to the pharmaceutical composition comprising 0.04% w/v polysorbate 80, Jansson teaches about 0.01% to about 0.1% of a surfactant (Pg. 39, claim 26) and Singh teaches polysorbate 80 protects antibodies against agitation induced aggregation (Pg. 3497, Right column, Lines 1-5).
Regarding instant claim 37, pertaining to the pharmaceutical composition having a pH of 5.9 to 6.1, Jansson teaches the pH of the pharmaceutical composition is 5.0 to 6.0 ([262]).
Regarding instant claims 52 and 53, pertaining to the anti-CD38 antibody comprising the CL SEQ ID NO:37, Kuipers SEQ ID NO:15 comprises CL kappa set forth in instant CL SEQ ID NO:37.
In light of these teachings, it would have been prima facie obvious to one having ordinary skill in the art to modify the anti-CD38 pharmaceutical composition of ‘633 by (1) using 0.04% w/v polysorbate 80, (2) formulating at a pH of 5.9 to 6.1, or (3) using the known CL kappa SEQ ID NO: 37 as taught by Jansson, Singh and Kuipers. One would have been motivated to do so because Jansson and Singh provide known pharmaceutical components and Kuipers provides the known CL kappa sequence. Doing so constitutes combining prior art elements according to known methods to yield predictable results (see MPEP 2143 (I)). There would be an expectation of success in combining the prior art elements because ‘633 provides for a pharmaceutical composition comprising the disclosed anti-CD38 antibody, and Jansson, Singh and Kuipers provide evidence of use of the known prior art elements.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROL ANN CHASE whose telephone number is (571)270-0934. The examiner can normally be reached Monday-Friday 9:00am-6:00pm.
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/CAROL ANN CHASE/Examiner, Art Unit 1646
/HONG SANG/Primary Examiner, Art Unit 1646