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 .
Claim Status
2. Applicant's election of Group I, claims (1, 2, 4-8, 11, 18, 20, 23, 31, 33, 34, 36, 59, 72, and 83) and species: (i) treatment with a neutralizing antibody for human IL-17A and IL-17F; and (ii) ACR response in the reply filed on March 6, 2026 is acknowledged. Since the elected species does not include (i) methotrexate or (ii) PAS response, claims 18 and 23 are directed to non-elected species. Therefore, claims: 1-2, 4-11, 18, 20, 23, 31, 33-34, 36-38, 42, 44, 59, 72, 83, and 113 are presently pending; claim 18 and 23 are directed to a non-elected species of invention and presently withdrawn; claims 9-10, 18, 23, 37-38, 42, 44, and 113 are therefore presently withdrawn; and claims 1-2, 4-8, 11, 20, 31, 33-34, 36, 59, 72, and 83 are presently subject to examination.
Information Disclosure Statement
3. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objection to the Specification
4. The instant specification is objected to for the following reasons:
a. There are trademarks in this application that do not meet the requirements.
The use of the term (e.g., “Biacore,” pg. 35, ln. 11), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; 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.
Applicant should review the specification for other trademarks and make corrections as required.
b. There are references in this specification that should be placed on an information disclosure statement if application would like them considered.
Double Patenting
5. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/proces/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 4-8, and 36 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 10-11, 13-14, 20, 21, 23-24 and 26 of U.S. Patent No. 9,988,446, filed April 20, 2015 (instant claim 2 and 4 directed to epitope binding and claim 7 directed to the antibody’s name are necessarily present in Adams et al., discussed in the below prior art rejections). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1, 3-4, 10-11, 13-14, 20, 21, 23-24 and 26 of the ’446 patent are directed to methods for treating a pathological disorder that is mediated by IL-17A and/or IL-17F, comprising administering to a subject a therapeutically effective amount of a neutralising antibody which binds human IL-17A and human IL-17F comprising a heavy chain comprising the sequence given in SEQ ID NO:15 and a light chain comprising the sequence given in SEQ ID NO:11. SEQ ID NOs: 15 and 11 are 100% identical to instant SEQ ID NOs 11 and 10 respectively (alignments are presented below for applicant’s convenience). Furthermore, e.g., claims 3 and 21 further discloses that the pathological condition relates to arthritis (encompassing psoriatic arthritis) or is psoriatic arthritis. The claims therefore encompass the indicated claims of instant application by encompassing methods of treatment of psoriatic arthritis with the same antibody.
Therefore, the conflicting claims are not patentably distinct from each other.
Instant SEQ ID 10 alignment with US 9988446 SEQ ID NO: 11.
US-14-690-892-11
Filing date in PALM: 2015-04-20
Sequence 11, US/14690892
Patent No. 9988446
GENERAL INFORMATION
APPLICANT: UCB Biopharma SPRL
TITLE OF INVENTION: Antibody molecules which bind IL-17A and IL-17F
FILE REFERENCE: CELL0010-101
CURRENT APPLICATION NUMBER: US/14/690,892
CURRENT FILING DATE: 2015-04-20
PRIOR APPLICATION NUMBER: 14/074,880
PRIOR FILING DATE: 2013-11-08
PRIOR APPLICATION NUMBER: 13/348456
PRIOR FILING DATE: 2012-01-11
PRIOR APPLICATION NUMBER: 61/432814
PRIOR FILING DATE: 2011-01-14
NUMBER OF SEQ ID NOS: 19
SEQ ID NO 11
LENGTH: 214
TYPE: PRT
ORGANISM: Artificial
FEATURE:
OTHER INFORMATION: Light chain of antibody CA028_496g3
ALIGNMENT:
Query Match 100.0%; Score 564; Length 214;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AIQLTQSPSSLSASVGDRVTITCRADESVRTLMHWYQQKPGKAPKLLIYLVSNSEIGVPD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AIQLTQSPSSLSASVGDRVTITCRADESVRTLMHWYQQKPGKAPKLLIYLVSNSEIGVPD 60
Qy 61 RFSGSGSGTDFRLTISSLQPEDFATYYCQQTWSDPWTFGQGTKVEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFRLTISSLQPEDFATYYCQQTWSDPWTFGQGTKVEIK 107
Instant SEQ ID 11 alignment with US 9988446 SEQ ID NO: 15.
US-14-690-892-15
Filing date in PALM: 2015-04-20
Sequence 15, US/14690892
Patent No. 9988446
GENERAL INFORMATION
APPLICANT: UCB Biopharma SPRL
TITLE OF INVENTION: Antibody molecules which bind IL-17A and IL-17F
FILE REFERENCE: CELL0010-101
CURRENT APPLICATION NUMBER: US/14/690,892
CURRENT FILING DATE: 2015-04-20
PRIOR APPLICATION NUMBER: 14/074,880
PRIOR FILING DATE: 2013-11-08
PRIOR APPLICATION NUMBER: 13/348456
PRIOR FILING DATE: 2012-01-11
PRIOR APPLICATION NUMBER: 61/432814
PRIOR FILING DATE: 2011-01-14
NUMBER OF SEQ ID NOS: 19
SEQ ID NO 15
LENGTH: 455
TYPE: PRT
ORGANISM: Artificial
FEATURE:
OTHER INFORMATION: Heavy chain of antibody CA028_496g3
ALIGNMENT:
Query Match 100.0%; Score 669; Length 455;
Best Local Similarity 100.0%;
Matches 125; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSDYNMAWVRQAPGKGLEWVATITYEGRNTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSDYNMAWVRQAPGKGLEWVATITYEGRNTYY 60
Qy 61 RDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCASPPQYYEGSIYRLWFAHWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCASPPQYYEGSIYRLWFAHWGQGTL 120
Qy 121 VTVSS 125
|||||
Db 121 VTVSS 125
Claim Rejections - 35 USC § 112
6. 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.
Written Description
7. Claims 1-2, 6-8, 11, 20, 31, 33-34, 36, 59, 72, and 83 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 inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-2, 6-8, 11, 20, 31, 33-34, 36, 59, 72, and 83 are directed to a method of treating psoriatic arthritis with a neutralizing antibody which binds human IL-17A and human IL-17F, which encompasses any or all antibodies that binds human IL-17A and IL-17F (Note: claim 6 only specifically claims a light chain without a corresponding specific heavy chain). However, the specification merely discloses the use of one specific monoclonal antibody to IL-17A/F, i.e., CA028_0496.g3 (UCB4940 or Bimekizumab) (Examples 1 and 2, for example); no other anti-human IL-17A and IL-17F were ever identified or particularly described.
The first paragraph of 35 U.S.C. § 112 "requires a 'written description of the invention' which is separate and distinct from the enablement requirement." "[A]pplicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the "written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 1111, 1116, 1117 (Fed. Cir. 1991).
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. Sufficient description of a genus requires the disclosure of either (1) a representative number of species falling within the scope of the genus or (2) description of structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus. In the instant case, only one antibody that binds human IL-17A and IL-17F is disclosed in the specification, i.e., only one species disclosed for the broad genus claimed. Antibody variable regions especially CDRs are responsible for antigen binding specificity, which structures are unpredictable, and are sensitive to sequence changes with respect to the retention of the desired functional property. See, Rudikoff et al. (Proc. Natl. Acad. Sci. USA, 1982, 79:1979-1983), for reference. Additionally, there is no information in the specification about the structure and function relationship for CA028_0496.g3 (UCB4940 or Bimekizumab). Thus, with the exception of the antibody CA028_0496.g3, one of skill in the art cannot "visualize or recognize" the members of the claimed genus. "A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F.3d at 923; Eli Lilly, 119 at 1568. Instead, the "disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described." Id. Accordingly, the specification does not provide adequate written description of the claimed genus. Due to the limited species disclosed (one) that meets the limitations of the claims; the broad breadth of the claimed genus, and the lack of structural limitation and/or lack of predictability for the encompassed anti-IL-17A and IL-17F antibodies, one skilled in the art would not conclude that the applicant was in possession of the claimed genus.
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes V. Baird, 30 USPQ2d 1481 at 1483.
Therefore, only the anti-human IL-17A and IL-17F neutralizing antibody CA028_0496.g3 (UCB4940 or Bimekizumab), but not the full breadth of the claims ("a neutralizing antibody which binds human IL-17A and human IL-17F") meets the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
8. 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 31 and 33-34 are rejected under 35 U.S.C 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention.
Claims 31 and 33-34 recite methods for “reducing joint effects.” It is unclear if this term encompasses joint effects specifically caused by psoriatic arthritis and/or other “joint effects.” Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 102
9. 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.
Claim interpretation: The metes and bounds of the term “reducing joint effects” is unclear, as discussed in the 35 USC § 112(b) rejection above. However, for the purposes of examination, this term is interpreted as including the treatment of psoriatic arthritis.
Note: Adams et al. does not explicitly disclose that the antibody is named “bimekizumab” (e.g., instant claim 7), however the instant specification indicates at pg. 34, ln. 14-15 that the IL-17A/F antibody of Adams et al. is bimekizumab.
Claims 1-2, 4-8, 31, 33, and 36 are rejected under 35 U.S.C 102(a)(2) as being anticipated by Adams et al. (US20120183558A1; published July 19, 2012; Patent No. 8580265).
Claim 1 is drawn to a method of treating psoriatic arthritis in a human comprising the step of administering to the human a neutralizing antibody which binds human IL-17A and human IL-17F.
Claim 2 is drawn to the method of claim 1, wherein the antibody specifically binds (a) an epitope of human IL-17F, the epitope comprising one or more residues selected from ARG47, ARG73, LEU75 and ILE86 of SEQ ID NO: 27; and/or (b) epitope of human IL-17A, the epitope comprising one or more residues selected from TYR44, ASN45, ARG46, TRP51, ASN52, HIS54 and ASP84 of SEQ ID NO: 28.
Claim 4 is drawn to the method of claim 1, wherein the antibody binds to the same epitope on human IL-17A, human IL-17F, or IL-17 A/F heterodimer as a neutralising antibody that has a heavy chain comprising the sequence given in SEQ ID NO: 11 and a light chain comprising the sequence given in SEQ ID NO: 10.
Claim 5 is drawn to the method of claim 1, wherein the antibody cross-blocks a neutralising antibody that has a heavy chain comprising the sequence given in SEQ ID NO: 11 and a light chain comprising the sequence given in SEQ ID NO: 10 and binds human IL-I7A and human IL-I7F.
Claim 6 is drawn to the method of claim 1, wherein the antibody comprises a light chain variable domain and a heavy chain variable domain, wherein the variable domain of the light chain comprises the sequence given in SEQ ID NO:10.
Claim 7 is drawn to the method of claim 1, wherein the antibody is bimekizumab.
Claim 8 is drawn to the method of any one of claims 1 through 7, wherein the antibody is administered as a pharmaceutical composition.
Claim 31 is drawn to a method of reducing joint effects in a human comprising the step of administering to the human a neutralizing antibody which binds human IL-17A and human IL-17F.
Claim 33 is drawn to a method of reducing psoriasis and reducing joint effects in a human comprising the step of administering to the human a neutralizing antibody which binds human IL-17A and human IL-17F.
Claim 36 is drawn to a method of treating psoriatic arthritis in a human, comprising the step of administering to the human at least one dose of a neutralizing antibody which binds human IL-17A and human IL-17F.
Adams et al. is directed to antibody molecules which bind IL-17A and IL-17F. Adams et al. at title. Adams et al. teaches the antibody molecule may be used to treat psoriatic arthritis at para. [0120]. Adams et al. teaches the antibody is a neutralizing antibody binding to human IL 17A and ILF and having a light chain variable domain of SEQ ID NO: 9 (e.g., Adams et al. claim 1) and a heavy chain variable domain of SEQ ID NO: 7 (e.g., Adams et al. claim 3). SEQ ID NOs: 7 and 9 of Adams et al. are identical to instantly claimed SEQ ID NOs: 10 and 11, respectively. An alignment of the sequences is provided below for Applicant’s convenience:
Instant SEQ ID 10 alignment with Adams et al. SEQ ID NO: 7.
US-13-348-456A-7
(NOTE: this sequence has 6 duplicates in the database searched.
See complete list at the end of this report)
Sequence 7, US/13348456A
Patent No. 8580265
GENERAL INFORMATION
TITLE OF INVENTION: Antibody molecules which bind IL-17A and IL-17F
FILE REFERENCE: G0141
CURRENT APPLICATION NUMBER: US/13/348,456A
CURRENT FILING DATE: 2012-03-23
NUMBER OF SEQ ID NOS: 19
SEQ ID NO 7
LENGTH: 107
TYPE: PRT
ORGANISM: Artificial
FEATURE:
OTHER INFORMATION: Light chain variable region
Query Match 100.0%; Score 564; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AIQLTQSPSSLSASVGDRVTITCRADESVRTLMHWYQQKPGKAPKLLIYLVSNSEIGVPD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AIQLTQSPSSLSASVGDRVTITCRADESVRTLMHWYQQKPGKAPKLLIYLVSNSEIGVPD 60
Qy 61 RFSGSGSGTDFRLTISSLQPEDFATYYCQQTWSDPWTFGQGTKVEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFRLTISSLQPEDFATYYCQQTWSDPWTFGQGTKVEIK 107
Instant SEQ ID 11 alignment with Adams et al. SEQ ID NO: 9.
US-13-348-456A-9
Filing date in PALM: 2012-01-11
Sequence 9, US/13348456A
Patent No. 8580265
GENERAL INFORMATION
TITLE OF INVENTION: Antibody molecules which bind IL-17A and IL-17F
FILE REFERENCE: G0141
CURRENT APPLICATION NUMBER: US/13/348,456A
CURRENT FILING DATE: 2012-03-23
NUMBER OF SEQ ID NOS: 19
SEQ ID NO 9
LENGTH: 125
TYPE: PRT
ORGANISM: Artificial
FEATURE:
OTHER INFORMATION: Heavy chain variable region
Query Match 100.0%; Score 669; Length 125;
Best Local Similarity 100.0%;
Matches 125; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSDYNMAWVRQAPGKGLEWVATITYEGRNTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSDYNMAWVRQAPGKGLEWVATITYEGRNTYY 60
Qy 61 RDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCASPPQYYEGSIYRLWFAHWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCASPPQYYEGSIYRLWFAHWGQGTL 120
Qy 121 VTVSS 125
|||||
Db 121 VTVSS 125
Adams et al. further teaches the antibody may be administered as a pharmaceutical composition at para. [0088] (the pharmaceutical composition must necessarily be administered in at least one dose); and that the antibody may also treat psoriasis at para. [0120]. (Claims 1, 6-8, 31, 33, and 36)
The claim limitations “ the antibody binds to the same epitope on human IL-17A, human IL-17F, or IL-17 A/F heterodimer as a neutralising antibody that has a heavy chain comprising the sequence given in SEQ ID NO: 11 and a light chain comprising the sequence given in SEQ ID NO: 10 (e.g., instant claim 4); specific epitopes that are bound (e.g., instant claim 2); or that the antibody cross-blocks a neutralising antibody that has a heavy chain comprising the sequence given in SEQ ID NO: 11 and a light chain comprising the sequence given in SEQ ID NO: 10 and binds human IL-I7A and human IL-I7F (e.g., instant claim 5)” are inherently present in the disclosure of Adams et al. since Adams et al. teaches the same antibody, as discussed above.
Accordingly, Adams et al. anticipates claims 1-2, 4-8, 31, 33, and 36.
Claim Rejections - 35 USC § 103
10. 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.
11. 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.
12. Claims 1-2, 4-11, 20, 31, 33-34, 36-38, 42, 44, 59, 72, 83, and 113 are rejected under 35 U.S.C. 103 as being unpatentable over Adams et al. in view of Mpofu et al. (US20170281762A1, filed September 8, 2015; Patent No. 11278618).
Claim 1 is drawn to a method of treating psoriatic arthritis in a human comprising the step of administering to the human a neutralizing antibody which binds human IL-17A and human IL-17F.
Claim 2 is drawn to the method of claim 1, wherein the antibody specifically binds (a) an epitope of human IL-17F, the epitope comprising one or more residues selected from ARG47, ARG73, LEU75 and ILE86 of SEQ ID NO: 27; and/or (b) epitope of human IL-17A, the epitope comprising one or more residues selected from TYR44, ASN45, ARG46, TRP51, ASN52, HIS54 and ASP84 of SEQ ID NO: 28.
Claim 4 is drawn to the method of claim 1, wherein the antibody binds to the same epitope on human IL-17A, human IL-17F, or IL-17 A/F heterodimer as a neutralising antibody that has a heavy chain comprising the sequence given in SEQ ID NO: 11 and a light chain comprising the sequence given in SEQ ID NO: 10.
Claim 5 is drawn to the method of claim 1, wherein the antibody cross-blocks a neutralising antibody that has a heavy chain comprising the sequence given in SEQ ID NO: 11 and a light chain comprising the sequence given in SEQ ID NO: 10 and binds human IL-I7A and human IL-I7F.
Claim 6 is drawn to the method of claim 1, wherein the antibody comprises a light chain variable domain and a heavy chain variable domain, wherein the variable domain of the light chain comprises the sequence given in SEQ ID NO:10.
Claim 7 is drawn to the method of claim 1, wherein the antibody is bimekizumab.
Claim 8 is drawn to the method of any one of claims 1 through 7, wherein the antibody is administered as a pharmaceutical composition.
Claim 11 is drawn to the method of claim 1, wherein the human (a) has a diagnosis of adult-onset psoriatic arthritis; (b) has active arthritis; (c) has active psoriatic lesions or a history of psoriatic lesions; and/or (d) is an inadequate responder to at least one non-biologic disease-modifying antirheumatic drug ("DMARD") and/or one approved biologic DMARD.
Claim 20 is drawn to the method of claim 1, wherein the antibody is administered in an amount that is effective to provide an ACR20 response at week 8, an ACR50 response at week 8, or an ACR70 response at week 8 in a population of patients in need of treatment.
Claim 31 is drawn to a method of reducing joint effects in a human comprising the step of administering to the human a neutralizing antibody which binds human IL-17A and human IL-17F.
Claim 34 is drawn to the method of claim 33, wherein the psoriasis is plaque psoriasis.
Claim 36 is drawn to a method of treating psoriatic arthritis in a human, comprising the step of administering to the human at least one dose of a neutralizing antibody which binds human IL-17A and human IL-17F.
Claim 59 is drawn to the method of claim 1, wherein the method comprises administering a dose comprising between 40 and 640 mg of the antibody.
Claim 72 is drawn to the method of claim 1, comprising administering to the human a loading dose of the neutralizing antibody followed by at least one maintenance dose of the antibody.
Claim 83 is drawn to the method of treating psoriatic arthritis of claim 1, wherein the method comprises administering (a) 16 mg of antibody every four weeks, (b) 160 mg of antibody every four weeks, (b) 320 mg loading dose of antibody followed by a maintenance dose of 160 mg of antibody every four weeks, or (d) 320 mg of antibody every four weeks.
Adams et al. is directed to antibody molecules which bind IL-17A and IL-17F. Adams et al. at title. Adams et al. teaches the antibody molecule may be used to treat psoriatic arthritis at para. [0120]. Adams et al. teaches the antibody is a neutralizing antibody binding to human IL 17A and ILF and having a light chain variable domain of SEQ ID NO: 9 (e.g., Adams et al. claim 1) and a heavy chain variable domain of SEQ ID NO: 7 (e.g., Adams et al. claim 3). SEQ ID NOs: 7 and 9 of Adams et al. are identical to instantly claimed SEQ ID NOs: 10 and 11, respectively. An alignment of the sequences is provided below for Applicant’s convenience:
Instant SEQ ID 10 alignment with Adams et al. SEQ ID NO: 7.
US-13-348-456A-7
(NOTE: this sequence has 6 duplicates in the database searched.
See complete list at the end of this report)
Sequence 7, US/13348456A
Patent No. 8580265
GENERAL INFORMATION
TITLE OF INVENTION: Antibody molecules which bind IL-17A and IL-17F
FILE REFERENCE: G0141
CURRENT APPLICATION NUMBER: US/13/348,456A
CURRENT FILING DATE: 2012-03-23
NUMBER OF SEQ ID NOS: 19
SEQ ID NO 7
LENGTH: 107
TYPE: PRT
ORGANISM: Artificial
FEATURE:
OTHER INFORMATION: Light chain variable region
Query Match 100.0%; Score 564; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AIQLTQSPSSLSASVGDRVTITCRADESVRTLMHWYQQKPGKAPKLLIYLVSNSEIGVPD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AIQLTQSPSSLSASVGDRVTITCRADESVRTLMHWYQQKPGKAPKLLIYLVSNSEIGVPD 60
Qy 61 RFSGSGSGTDFRLTISSLQPEDFATYYCQQTWSDPWTFGQGTKVEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFRLTISSLQPEDFATYYCQQTWSDPWTFGQGTKVEIK 107
Instant SEQ ID 11 alignment with Adams et al. SEQ ID NO: 9.
US-13-348-456A-9
Filing date in PALM: 2012-01-11
Sequence 9, US/13348456A
Patent No. 8580265
GENERAL INFORMATION
TITLE OF INVENTION: Antibody molecules which bind IL-17A and IL-17F
FILE REFERENCE: G0141
CURRENT APPLICATION NUMBER: US/13/348,456A
CURRENT FILING DATE: 2012-03-23
NUMBER OF SEQ ID NOS: 19
SEQ ID NO 9
LENGTH: 125
TYPE: PRT
ORGANISM: Artificial
FEATURE:
OTHER INFORMATION: Heavy chain variable region
Query Match 100.0%; Score 669; Length 125;
Best Local Similarity 100.0%;
Matches 125; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSDYNMAWVRQAPGKGLEWVATITYEGRNTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSDYNMAWVRQAPGKGLEWVATITYEGRNTYY 60
Qy 61 RDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCASPPQYYEGSIYRLWFAHWGQGTL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCASPPQYYEGSIYRLWFAHWGQGTL 120
Qy 121 VTVSS 125
|||||
Db 121 VTVSS 125
Adams et al. further teaches the antibody may be administered as a pharmaceutical composition at para. [0088] (the pharmaceutical composition must necessarily be administered in at least one dose); and that the antibody may also treat psoriasis at para. [0120]. (Claims 1, 6-8, 31, 33, and 36)
The claim limitations “ the antibody binds to the same epitope on human IL-17A, human IL-17F, or IL-17 A/F heterodimer as a neutralising antibody that has a heavy chain comprising the sequence given in SEQ ID NO: 11 and a light chain comprising the sequence given in SEQ ID NO: 10 (e.g., instant claim 4); specific epitopes that are bound (e.g., instant claim 2); or that the antibody cross-blocks a neutralising antibody that has a heavy chain comprising the sequence given in SEQ ID NO: 11 and a light chain comprising the sequence given in SEQ ID NO: 10 and binds human IL-I7A and human IL-I7F (e.g., instant claim 5)” are necessarily present in the disclosure of Adams et al. since Adams et al. teaches the same antibody, as discussed above.
Adams et al. does not explicitly disclose the claim limitations “, i.e., more specific diagnostic and administration criteria: wherein the human (a) has a diagnosis of adult-onset psoriatic arthritis; (b) has active arthritis; (c) has active psoriatic lesions or a history of psoriatic lesions; and/or (d) is an inadequate responder to at least one non-biologic disease-modifying antirheumatic drug ("DMARD") and/or one approved biologic DMARD (claim 11); wherein the antibody is administered in an amount that is effective to provide an ACR20 response at week 8, an ACR50 response at week 8, or an ACR70 response at week 8 in a population of patients in need of treatment (claim 20); wherein the psoriasis is plaque psoriasis (claim 34); wherein the method comprises administering a dose comprising between 40 and 640 mg of the antibody (claim 59); administering to the human a loading dose of the neutralizing antibody followed by at least one maintenance dose of the antibody (claim 72); and wherein the method comprises administering (a) 16 mg of antibody every four weeks, (b) 160 mg of antibody every four weeks, (b) 320 mg loading dose of antibody followed by a maintenance dose of 160 mg of antibody every four weeks, or (d) 320 mg of antibody every four weeks (claim 83).
Mpofu et al. is directed to the use of IL-17 antagonists (i.e., anti-IL-17 antibody Secukinumab) to inhibit the progression of structural damage in psoriatic arthritis patients. Mpofu et al. at title. Mpofu et al. provides specific diagnostic and administration criteria. Mpofu et al. teaches treating an inadequate responder to at least one non-biologic disease-modifying antirheumatic drug ("DMARD") (e.g., “Patients with moderate to severe PsA fulfilling the following criteria were enrolled: […]; (iv) disease is inadequately controlled on least one DMARD given for at least three months at the maximum tolerated dose” at para. [0108]) (Claim 11); wherein the antibody is administered in an amount that is effective to provide an ACR20 response at week 8, an ACR50 response at week 8, or an ACR70 response at week 8 (see e.g., FIG. 4 showing ACR 20/50/70 responses to Secukinumab at week 8) (Claim 20); wherein the psoriasis is plaque psoriasis (see e.g., claim 32: “wherein patient has concomitant moderate-to severe plaque psoriasis”) (Claim 34); administering a dose comprising between 40 and 640 mg of the antibody (see e.g., claims 34-35: wherein the patient is administered about 150 or 300 mg of the antibody) (Claim 59); administering loading dose and maintenance dose (see e.g., para. [0175] “The objective was to evaluate the efficacy and safety of s.c. loading and maintenance dosing with secukinumab in FUTURE 2 (NCT01752634), a randomized, double-blind, placebo (PBO)-controlled phase 3 study in patients with active PsA.”) (Claim 72); and treating psoriatic arthritis by administering 160 or 320 mg of the antibody every four weeks (see e.g., claim 48 “A method of inhibiting the progression of structural damage in a patient having psoriatic arthritis (PsA), administering the patient about 150 mg-about 300 mg of Secukinumab by subcutaneous injection every 4 weeks”; Mpofu defines “about” as +/- 10% at para. [0031], thereby encompassing 160 or 320 mg of the antibody) (Claim 83).
It was prima facie obvious at the time of the claimed invention to modify the method of treating psoriatic arthritis as taught by Adams et al. with the diagnostic and administration criteria as taught by Mpofu et al. because both Adams et al. and Mpofu et al. teach the use of an anti-IL-17 antibody for the treatment of psoriatic arthritis; Adams et al. also teaches that the dose of the antibody depends on the nature of the condition at para. [0094] but does not provide specific dosage information; Mpofu et al. provides the missing information, e.g., dose information, for treating rheumatoid arthritis. A person of ordinary skill in the art would also be motivated to look to similar treatments for the same indication, i.e., Mpofu et al., to obtain dosage information. A person of ordinary skill in the art would have a reasonable expectation of success that using the diagnostic and administration criteria as taught by Mpofu et al. would result in a beneficial treatment for psoriatic arthritis because Mpofu et al. also uses anti-IL-17 antibody for treatment of psoriatic arthritis. It is also obvious to substitute one know element for another to obtain predictable results. Here, the diagnostic and administration criteria as taught by Mopfu et al. can easily be substituted into Adams et al. because both references treat the same condition (psoriatic arthritis) with anti-IL-17 antibody. The substituted diagnostic and administration criteria of Mpofu et al. perform the same function in Adams et al. as they do in Mopfu et al., e.g., providing specific guidance on dosing the anti-IL-17 antibody. One of ordinary skill in the art could have easily applied the e.g., dosing information of Mopfu et al. to the anti-IL17 antibody of Adams et al., and it would have been predictable the e.g., anti-IL-17 antibody doses would have resulted in beneficial treatment of psoriatic arthritis.
Accordingly, Adams et al. in view of Mpofu et al, renders claims 1-2, 4-11, 20, 31, 33-34, 36-38, 42, 44, 59, 72, 83, and 113 obvious.
Conclusion
13. No claim is allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON R SCHWECHTER whose telephone number is (571)272-1270. The examiner can normally be reached M-Th 7-5 EST.
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/BRANDON R SCHWECHTER/
Examiner, Art Unit 1674
/VANESSA L. FORD/ Supervisory Patent Examiner, Art Unit 1674
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