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 .
1. Formal Matters
A. In the response filed 12/23/25, Applicants elected the indicated species. However, upon further review, all species have been examined.
B. Claims 1, 6-9, 15, 18-21, 24, 26, 31, 33, 40, 41, 43-46, 49, 50, 62, 66-69, 75, 78-83, 85-89, 91 and 92 are pending and are the subject of this Office Action.
2. Specification
The use of at least the terms Yervoy®, Opdivo® and others in paragraph [0288], which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
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. The Examiner performed a cursory review, but Applicants are urged to perform a more thorough review of the specification.
3. Claim Objections
A. Claim 7 is objected to since “disulfide linked” and “single chain” should both be hyphenated.
B. Claims 9 and 69 are objected to since part (a) should say “the” before “heavy chain”.
C. Claim 21 is objected to since it is unclear why “mono-specific” is hyphenated, whereas “bispecific” is not. See also claim 67.
4. 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 9, 15, 43, 69, 75 and 85 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.
A. Claims 9(c) and 69(c) recite the limitation "the IgG1 heavy chain". There is insufficient antecedent basis for this limitation (IgG1) in the claims.
B. Claims 15(b) and 75(b) recite the limitation "the kappa light chain". There is insufficient antecedent basis for this limitation (kappa) in the claims.
C. Claims 43 and 85 recite “urothelial cancer”; however, “bladder” is recited in parentheses. Though many bladder cancers are urothelial, they are not the same (i.e. genus/species); therefore, the parentheses make the claims unclear.
5. Claim Rejections - 35 USC § 102
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 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.
Claims 1, 6-9, 15, 19, 21, 40, 41, 43, 49, 50, 62, 66-69, 75, 79-83, 85, 91 and 92 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Freytag et al. (U. S. Patent No. 9,309,30).
Freytag teaches that chondroitin sulfate proteoglycan 4 (CSPG4 – instant term) is also known as melanoma-associated chondroitin sulfate proteoglycan (MCSP – patent term). See column 11, lines 21-22).
Freytag teaches a heavy chain variable region of SEQ ID NO:29 (corresponds to instant SEQ ID NO:25) and light chain variable region of SEQ ID NO:26 (corresponds to instant SEQ ID NO:30). The CDRs are 100% identical. The framework region of SEQ ID NO:29 has 7 alterations, whereas the framework region of SEQ ID NO:26 has 8, meeting instant claims 1 and 62. Freytag also teaches a linker and cytotoxic agent (column 38, line 31 to column 39, line 38).
Freytag also teaches the monoclonal and multispecific antibodies of claims 7 and 67 (column 19, lines 5-12; column 23, line 12).
Claims 8 and 68 are taught in column 19, lines 10-12. Claims 9 and 69 are taught in column 1, line 57; column 19, lines 10-12 and column 33, lines 29-31). Claims 15 and 75 are taught in column 10, lines 9-12. Claim 21 is taught in column 23, lines 24-27.
Claim 19 (engineered cysteine) is taught in column 35, lines 45-61. Claims 40 and 79 are taught in column 40, line 53. Claims 41, 43, 83 and 85 are taught in column 4, lines 1-9). Claims 49 and 91 are taught in column 42, line 53. Claim 50 and 92 are taught in column 43, line 23.
Regarding claim 80, while the nucleic acid of light chain, which includes the variable region, is taught (SEQ ID NO:40), the nucleic acid of the heavy chain M4-1 encoding nucleic acid does not appear to be taught. However, given the amino acid sequence, the artisan would immediately envision the sequence. See also Table A of the patent; column 36, lines 60-67; Example 2. Claims 81 and 82 are taught in column 36, line 32 – column 37, line 27.
SEQ ID NO:25
Patent No. 9309306
GENERAL INFORMATION
APPLICANT: Freytag, Oliver, et al.
TITLE OF INVENTION: Anti-MCSP Antibodies
FILE REFERENCE: P4932US
CURRENT APPLICATION NUMBER: US/13/590,904
CURRENT FILING DATE: 2012-08-21
PRIOR APPLICATION NUMBER: EP 11178393.2
PRIOR FILING DATE: 2011-08-23
SEQ ID NO 29
LENGTH: 112
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: LC007 Humanized Antibody M4-1 VH
Query Match 93.7%; Score 565; Length 112;
Best Local Similarity 93.8%;
Matches 105; Conservative 3; Mismatches 4; Indels 0; Gaps 0;
Qy 1 EVQLQESGPGLVKPSQTLSLTCTVSGYSITSGYYWNWIRQFPGNKLEWMGYITYDGSNNY 60
:||||||||||||||||||||||||||||||||||||||| || |||:|||||||||||
Db 1 QVQLQESGPGLVKPSQTLSLTCTVSGYSITSGYYWNWIRQHPGKGLEWIGYITYDGSNNY 60
Qy 61 NPSLKNRVTISRDTSKNQFSLKLSSVTAADTAVYYCADFDYWGQGTTVTVSS 112
|||||:|||||||||||||||||||||||||||||||||||||||| |||||
Db 61 NPSLKSRVTISRDTSKNQFSLKLSSVTAADTAVYYCADFDYWGQGTLVTVSS 112
SEQ ID NO:30
Patent No. 9309306
GENERAL INFORMATION
APPLICANT: Freytag, Oliver, et al.
TITLE OF INVENTION: Anti-MCSP Antibodies
FILE REFERENCE: P4932US
CURRENT APPLICATION NUMBER: US/13/590,904
CURRENT FILING DATE: 2012-08-21
PRIOR APPLICATION NUMBER: EP 11178393.2
PRIOR FILING DATE: 2011-08-23
SEQ ID NO 26
LENGTH: 107
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: LC007 Chimeric Antibody VL
Query Match 94.1%; Score 531; Length 107;
Best Local Similarity 92.5%;
Matches 99; Conservative 6; Mismatches 2; Indels 0; Gaps 0;
Qy 1 DIQLTQSPSSLSASVGDRVTITCSASQGIRNYLNWYQQKPDGTVKLLIYYTSSLHSGVPS 60
|| |||||||||||:||||||:||||||||||||||||:|||||||||||||||||||||
Db 1 DIVLTQSPSSLSASLGDRVTISCSASQGIRNYLNWYQQRPDGTVKLLIYYTSSLHSGVPS 60
Qy 61 RFSGSGSGTDYTLTISSLQPEDFATYYCQQYSKLPWTFGGGTKLEIK 107
|||||||||||:||||:|:||| ||||||||||||||||||||||||
Db 61 RFSGSGSGTDYSLTISNLEPEDIATYYCQQYSKLPWTFGGGTKLEIK 107
6. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
A. Claims 20, 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Freytag et al. (U. S. Patent No. 9,309,30) in view of Govindan (U.S. Patent No. 7,585,491 - cited as reference 23 on the IDS filed 2/15/24).
The teachings of Freytag are taught above. Freytag does not teach the drug loading of claim 20, nor the agents of claims 24 and 26. However, Govindan does teach a target moiety linked to a chemotherapeutic moiety wherein the drug loading which overlaps the instant range (column 5, line 54 to column 6, line 15).
Freytag does not teach the cytotoxic agents in claims 24 or 26. However, Govindan teaches camptothecin (column 5, line 36) and SN-38 (column 6, line 14).
B. Claims 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Freytag et al. (U. S. Patent No. 9,309,30) in view of Govindan (U.S. Patent No. 9,375,489).
The teachings of Freytag are taught above. Freytag does not teach CL2A. However, Govindan does teach the linker CL2A attached to SN-38 (Example 10) which is used for essentially the same purpose as the instant invention.
C. Claims 44, 45, 46 and 86-89 are rejected under 35 U.S.C. 103 as being unpatentable over Freytag et al. (U. S. Patent No. 9,309,30) in view of Tapalian et al.
The teachings of Freytag are taught above. Freytag does not teach the immunotherapy compounds of claims 46, 88 and 89 (e.g. pembrolizumab). However, Tapalian does (Abstract; Table 1).
7. Prior Art of Interest Not Relied Upon
Instant SEQ ID NO:31 (claim 1) is also taught by Freytag et al.
SEQ ID NO:31
Patent No. 9309306
GENERAL INFORMATION
SEQ ID NO 26
LENGTH: 107
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: LC007 Chimeric Antibody VL
Query Match 94.1%; Score 530; Length 107;
Best Local Similarity 92.5%;
Matches 99; Conservative 6; Mismatches 2; Indels 0; Gaps 0;
Qy 1 DIQLTQSPSSLSASVGDRVTITCSASQGIRNYLNWYQQKPDGTVKLLIYYTSSLHSGVPS 60
|| |||||||||||:||||||:||||||||||||||||:|||||||||||||||||||||
Db 1 DIVLTQSPSSLSASLGDRVTISCSASQGIRNYLNWYQQRPDGTVKLLIYYTSSLHSGVPS 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFATYYCQQYSKLPWTFGGGTKLEIK 107
||||||||||::||||:||||| ||||||||||||||||||||||||
Db 61 RFSGSGSGTDYSLTISNLEPEDIATYYCQQYSKLPWTFGGGTKLEIK 107
8. Conclusion
A. Claims 1, 6-9, 15, 19-21, 24, 26, 31, 33, 40, 41, 43-46, 49, 50, 62, 66-69, 75, 79-83, 85-89, 91 and 92 are not allowable.
B. Claims 18 and 78 are objected to since they depend from rejected claims, but are otherwise allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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, Joanne Hama, can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647