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
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1, 4, 13-21, 27-38, 43-44, and 46-54 have an effective filing date of 04MAY2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2/1/2024, 5/10/2024, 6/18/2026, and 7/15/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
In the response filed on 6/18/2026, Applicant elected, without traverse:
A distinct species of autoimmune disease
Discoid lupus erythematosus (DLE)
A distinct species of ILT7-binding protein
A binding protein comprising SEQ ID NOs: 3-5 and 6-8
Status of Claims
Claims 1, 4, 13-21, 27-38, 43-44, and 46-54 are currently pending and presented for examination on the merits.
Claims 1, 21, 27, 29, and 33 are amended.
Claims 46-54 are new.
Claims 2-3, 5-12, 22-26, 39-42, and 45 are canceled.
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 28 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 28, which depends from claim 21, recites an ILT7 binding protein is an antibody that comprises heavy chain Complementarity-Determining Regions (HCDRs) HCDR1, HDR2, HCDR3, and light chain Complementarity Determining Regions (LCDRs) LCDR1, LCDR2, and LCDR3 comprising the amino acid sequences of SEQ ID NOs: 3, 4, 5, 6, 7, and 8, respectively, and this ILT7 binding protein does not appear to limit the ILT7 binding protein of claim 1.
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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 4, 13-21, 27-38, 43-44, and 46-54 are rejected under 35 U.S.C. 103 as being unpatentable over Cao et al (WO 2010065536 A2 A1, IDS 2/1/2024), and further in view of Vousden et al (WO 2017156298 A1, IDS 2/1/2024).
In regards to claims 1 and 21, Cao et al teaches a method of treating an autoimmune disease comprising Bone Marrow Stromal Antigen-2 (BST2) protein agent [0138]. Cao et al further teaches BST2 protein agent is capable of binding an ILT7 receptor and stimulating ILT7 receptor [0013]. Cao et al further teaches the chronic autoimmune disease cutaneous or discoid lupus erythematosus (CLE) [0108]. Cao et al further teaches a method of treating CLE comprising administering a BST2 protein agent [0113]. Cao et al further teaches the dosage to be administered depends on individual needs [0144]. Cao et al further teaches BST2 binds ILT7 expressed on plasmasytoid dendritic cells (pDCs), and initiate a signaling cascade which can result in the strong inhibition of interferon production by pDCs [0029].
Cao et al does not specifically teach the ILT7 binding protein is an antibody comprising SEQ ID NOs: 3-8. However, this deficiency is made up in the teachings of Vousden et al.
Vousden et al teaches a method of treating an autoimmune disease comprising ILT7 binding molecules [Abstract]. Vousden et al further teaches a decrease in incidence or severity of diseases associated with ILT7 expression, including autoimmune diseases like lupus [0161]. Vousden et al further teaches that the dosage can be titrated to optimize safety and efficacy [0229]. Vousden et al teaches an antibody comprising SEQ ID NO: 202. A comparison of instant SEQ ID NO: 3,4,5 and SEQ ID NO:202 of Vousden et al are shown below.
Instant SEQ ID NOs: 3,4,5 and SEQ ID NO: 202 of Vousden et al.
Query Match 87.7%; Score 175.4; Length 122;
Best Local Similarity 43.2%;
Matches 35; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 SYGIS--------------WISAYNGNTNYAQKLQG------------------------ 22
||||| |||||||||||||||||
Db 31 SYGISWVRQAPGQGLEWMGWISAYNGNTNYAQKLQGRVTMTTDTSTSTAYMELRSLRSDD 90
Qy 23 --------NGLWGWDSDAFDI 35
|||||||||||||
Db 91 TAVYYCARNGLWGWDSDAFDI 111
Vousden et al teaches an antibody comprising SEQ ID NO: 207. A comparison of instant SEQ ID NO: 6,7,8 and SEQ ID NO:207 of Vousden et al are shown below.
Instant SEQ ID NOs: 6,7,8 and SEQ ID NO: 207 of Vousden et al.
Query Match 84.1%; Score 130.3; Length 110;
Best Local Similarity 39.7%;
Matches 31; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 TGTSSDVGGYNYVS---------------DVSNRPS------------------------ 21
|||||||||||||| |||||||
Db 23 TGTSSDVGGYNYVSWYQQHPGKAPKLMIYDVSNRPSGVSNRFSGSKSGNTASLTISGLQA 82
Qy 22 --------SSYTSSSTVV 31
||||||||||
Db 83 EDEADYYCSSYTSSSTVV 100
One of ordinary skill, before the effective filing date, would have been motivated to combine Cao’s method of treating discoid lupus erythematosus comprising administering an ILT7 binding protein, with Vousden’s method of treating autoimmune diseases that express ILT7, such as lupus, comprising administering an ILT7 antibody comprising SEQ ID NOs: 3,4,5 and 6,7,8. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Cao and Vousden’s methods for a methods of treating discoid lupus erythematosus comprising administering a ILT7 antibody comprising SEQ ID NOs: 3,4,5 and 6,7,8, because Cao teaches a method of treating discoid lupus erythematosus using an ILT7 binding protein and Vousden teaches an ILT7 antibody comprising SEQ ID NOs: 202 and 207 to treat autoimmune diseases such as lupus.
In regards to claims 1, 17-21, 27, 34-38, 43-44, and 53-54, with regard to an effective amount from about 100-350 mg and dosage frequency, the amount of the antibody in a composition and frequency of delivery is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."(Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 4, Cao et al teaches BST2 binds ILT7 expressed on plasmasytoid dendritic cells (pDCs), and initiate a signaling cascade which can result in the strong inhibition of interferon production by pDCs [0029].
In regards to claims 13-15, Cao et al teaches administering the additional therapeutic agent prednisone [0157].
In regards to claim 16, the additional therapies are tapered is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."(Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claim 28, Vousden et al teaches an antibody comprising SEQ ID NO: 202. A comparison of instant SEQ ID NO: 3,4,5 and SEQ ID NO:202 of Vousden et al are shown above. Vousden et al teaches an antibody comprising SEQ ID NO: 207. A comparison of instant SEQ ID NO: 6,7,8 and SEQ ID NO:207 of Vousden et al are shown above.
In regards to claims 29-30, and 47, Vousden et al teaches an ILT7 antibody comprising SEQ ID NOs: 202. A comparison of instant SEQ ID NO: 1 and SEQ ID NO:202 of Vousden et al are shown below.
Instant SEQ ID NO: 1 and SEQ ID NO: 202 of Vousden et al.
Query Match 100.0%; Score 654; Length 122;
Best Local Similarity 100.0%;
Matches 122; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLQQSGAEVKKPGASVKVSCKASGYTFTSYGISWVRQAPGQGLEWMGWISAYNGNTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLQQSGAEVKKPGASVKVSCKASGYTFTSYGISWVRQAPGQGLEWMGWISAYNGNTNY 60
Qy 61 AQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARNGLWGWDSDAFDIWGRGTLVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARNGLWGWDSDAFDIWGRGTLVTV 120
Qy 121 SS 122
||
Db 121 SS 122
Vousden et al teaches an ILT7 antibody comprising SEQ ID NOs: 207. A comparison of instant SEQ ID NO: 2 and SEQ ID NO:207 of Vousden et al are shown below.
Instant SEQ ID NO: 2 and SEQ ID NO: 207 of Vousden et al.
Query Match 100.0%; Score 568; Length 110;
Best Local Similarity 100.0%;
Matches 110; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QSALTQPASVSGSPGQSITISCTGTSSDVGGYNYVSWYQQHPGKAPKLMIYDVSNRPSGV 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QSALTQPASVSGSPGQSITISCTGTSSDVGGYNYVSWYQQHPGKAPKLMIYDVSNRPSGV 60
Qy 61 SNRFSGSKSGNTASLTISGLQAEDEADYYCSSYTSSSTVVFGGGTKVTVL 110
||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SNRFSGSKSGNTASLTISGLQAEDEADYYCSSYTSSSTVVFGGGTKVTVL 110
In regards to claims 31, and 49-50, Vousden et al teaches the ILT7 binding protein is afucosylated [0302, Example 7].
In regards to claims 33, and 51-52, Cao et al teaches the ILT7 binding protein is administered subcutaneously [0162].
Applicant teaches in specification pg. 17, clone ILT70137 in PCT Publication No. WO 2017/156298, US Patent No. US8084585B2, PCT Publication No. WO 2021/113702 all of which are incorporated by reference herein in their entirety.
Furthermore, Applicant teaches in Table 1 pg. 17, anti-ILT7 antibody clone ILT70137 comprising SEQ ID NOs: 1-10.
In regards to claims 32, 46, and 48, Vousden et al teaches the anti-ILT7 antibody ILT70137, which comprises the heavy and light chains of SEQ ID NO(s): 10 and 9, respectively, [0291].
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, 4, 13-21, 27-38, 43-44, and 46-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 18-19 of U.S. Patent No. 11072652 ('652) in view of Cao et al (WO 2010065536 A2 A1, IDS 2/1/2024) and Vousden et al (WO 2017156298 A1, IDS 2/1/2024).
The teachings of Cao et al and Vousden et al are discussed above.
Claims 1, 4, 21, 28-30, and 47 are not patentably distinct from claims 1, and 18-19 of ‘652. Specifically, a method of treating an autoimmune disease comprising contacting a pDC with an anti-ILT7 antibody comprising anti-ILT7 antibody ILT70137. Although the claims at issue are not identical, they are not patentably distinct from each other, because both sets of claims recite a) a method of treating an autoimmune disease comprising the anti-ILT7 antibody ILT70137 (claims 1, 21, 28-30, and 47), and b) administering is effective in reducing a type I interferon gene signature (claim 4).
In regards to claims 1, 17-21, 27, 34-38, 43-44, and 53-54, with regard to an effective amount from about 100-350 mg and dosage frequency, the amount of the antibody in a composition and frequency of delivery is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."(Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claims 13-15, Cao et al teaches administering the additional therapeutic agent prednisone [0157].
In regards to claim 16, the additional therapies are tapered is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."(Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claims 31, and 49-50, Vousden et al teaches the ILT7 binding protein is afucosylated [0302, Example 7].
In regards to claims 32, 46, and 48, Vousden et al teaches the anti-ILT7 antibody ILT70137 [0291].
In regards to claims 33, and 51-52, Cao et al teaches the ILT7 binding protein is administered subcutaneously [0162].
Claims 1, 4, 13-21, 27-38, 43-44, and 46-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 44-47, and 74-84 of copending Application No. 17/831,784 ('784) in view of Cao et al (WO 2010065536 A2 A1, IDS 2/1/2024) and Vousden et al (WO 2017156298 A1, IDS 2/1/2024).
The teachings of Cao et al and Vousden et al are discussed above.
Claims 1, 17-21, 27-31, 33-34, 38, 43, 47, and 49-54 are not patentably distinct from claims 44-47, and 74-84 of ‘784. Specifically, a method of treating an autoimmune disease comprising contacting a pDC with an anti-ILT7 antibody comprising anti-ILT7 antibody ILT70137. Although the claims at issue are not identical, they are not patentably distinct from each other, because both sets of claims recite a) a method of treating an autoimmune disease comprising administering an afucosylated anti-ILT7 antibody ILT70137 at 150-500 mg, subcutaneously, every four weeks (claims 1, 17-21, 27-31, 33-34, 36, 38, 43, and 49-54).
In regards to claim 4, Cao et al teaches BST2 binds ILT7 expressed on plasmasytoid dendritic cells (pDCs), and initiate a signaling cascade which can result in the strong inhibition of interferon production by pDCs [0029].
In regards to claims 13-15, Cao et al teaches administering the additional therapeutic agent prednisone [0157].
In regards to claim 16, the additional therapies are tapered is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."(Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claims 32, and 46-48, Vousden et al teaches the anti-ILT7 antibody ILT70137 [0291].
In regards to claims 35, 37, and 44, with regard to an effective amount from about 100-350 mg and dosage frequency, the amount of the antibody in a composition and frequency of delivery is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."(Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4, 13-21, 27-38, 43-44, and 46-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34, 37-38, and 51 of copending Application No. 18/997,755 ('755) in view of Cao et al (WO 2010065536 A2 A1, IDS 2/1/2024) and Vousden et al (WO 2017156298 A1, IDS 2/1/2024).
The teachings of Cao et al and Vousden et al are discussed above.
Claims 1, 17-18, 20-21, 27-31, 33-34, 38, 43, 47, and 49-54 are not patentably distinct from claims 34, 37-38, and 51 of ‘755. Specifically, a method of treating an autoimmune disease comprising contacting a pDC with an anti-ILT7 antibody comprising anti-ILT7 antibody ILT70137. Although the claims at issue are not identical, they are not patentably distinct from each other, because both sets of claims recite a) a method of treating an autoimmune disease comprising administering an anti-ILT7 antibody ILT70137, wherein the autoimmune disease is discoid lupus erythematosus from about 150-450 mg (claims 1, 17-18, 20-21, 27-30, 33, 36, 38, 47, and 51-52).
In regards to claim 4, Cao et al teaches BST2 binds ILT7 expressed on plasmasytoid dendritic cells (pDCs), and initiate a signaling cascade which can result in the strong inhibition of interferon production by pDCs [0029].
In regards to claims 13-15, Cao et al teaches administering the additional therapeutic agent prednisone [0157].
In regards to claim 16, the additional therapies are tapered is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."(Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claims 19, 34-35, 37, 43-44, and 53-54, with regard to an effective amount and dosage frequency, the amount of the antibody in a composition and frequency of delivery is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."(Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In regards to claims 31, and 49-50, Vousden et al teaches the ILT7 binding protein is afucosylated [0302, Example 7].
In regards to claims 32, 46, and 48, Vousden et al teaches the anti-ILT7 antibody ILT70137 [0291].
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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