DETAILED OFFICE ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s preliminary amendment filed on 11 October 2022 is acknowledged and entered. Following the amendment, the original claims 1-25, 31-83, 85-88 and 90-124 are canceled.
Currently, claims 26-30, 84 and 89 are pending and under consideration.
Formal Matters:
Information Disclosure Statement
Applicant's IDS submitted on 10/11/2022 is acknowledged and has been considered. A signed copy is attached hereto.
Priority acknowledgement
This application claims benefit of U.S. application 15/771,310 filed on 3/19/02, which is a national stage entry (371) of PCT/EP2016/075821 with the international filing date of 10/26/2016; which claims benefit of U.S. provisional applications 62/405,546 filed 10/07/2016; 62/346,826 filed 06/07/2016; 62/303,230 filed 03/03/2016; and 62/246,989 filed 10/27/2015, which is acknowledged.
Specification
The specification is objected to because the status of U.S. Application 15/771,310,
which has been issued as U.S. Patent No. 11,492,396, has not been updated.
Rejections under 35 U.S.C. §112:
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION. - The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 28-30 and 84 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 pre-AIA the applicant regards as the invention.
Claim 28 recites the limitation "wherein the reduction of plaque psoriasis is measured …". There is insufficient antecedent basis for this limitation in the claim.
Claim 29 is indefinite for the recitation “administering an amount of antibody that achieves at least a 75% or 90% change in lesion severity score (LSS) compared to pre-treatment at four, six, or eight weeks following administration of the antibody” because it is unclear how such an amount (resulting in 75% or 90% change) can be determined prior to the treatment, and how anyone would be able to predict “a 75% or 90% change”, and how to know what it is like pre-treatment at four, six, or eight weeks, especially when no treatment duration is indicated? Said achievement represents efficacy or result of the treatment, which cannot be requested or demanded as such is out of anyone’s control once the antibody is administered. The metes and bounds of the claim, therefore, cannot be determined. The claim is further indefinite for the recitation “achieves at least a 75% or 90% change in …” because of the following: a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 29 recites the broad recitation “achieves at least 75% change”, and the claim also recites “achieves ... 90% change”, which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. also, it is unclear as to why “achieves ... 90% change” is needed since “achieves ... 75% change” would necessarily encompass “90% change”. Claim 30 is similarly indefinite.
Claim 84 is incomplete because it is dependent on canceled claims (claims 33-35).
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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
Claims 26-30, 84 and 89 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 claim(s) contains 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 26-30, 84 and 89 are directed to a method of treating psoriasis 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. 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).
Rejections Over Prior Art:
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 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.
Claim interpretation: as claims 29 and 30 are indefinite for the reasons above, the recited “an amount of antibody that achieves at least a 75% or 90% change” is interpreted as an effective amount for treating psoriasis; thus, claims 29 and 30 are interpreted as being directed to a method of treating psoriasis with an effective amount of said antibody.
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.
Claims 26-30 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Clinical Trial NCT02529956 (8/20/2015).
Clinical Trial NCT02529956 discloses a clinical trial study evaluating the safety, pharmacokinetics, and pharmacodynamics of UCB4940 in patients with mild to moderate psoriasis (1st page, under “Study Overview”), wherein the patients have mild to moderate plaque-type psoriasis (4th page, under “Inclusion criteria”). Note, UCB4940 is also known as bimekizumab, the same antibody as that of the present application, which is an anti-IL-17A/F antibody. Therefore, the reference anticipates claims 26 and 27. In addition, NCT02529956 teaches that, regarding outcome measures, percentage change from baseline to week 12 is measured in Psoriasis Area and Severity Index (PASI) (14th page). Therefore, the reference also anticipates claim 28.
Claims 26 and 28-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams et al. (US 2012/0183558, 7/19/2012; or its patent US 8,580,265, 11/12/2013, provided by applicants).
Adams discloses a neutralising antibody having specificity for human IL-17A and human IL-17F, and comprising the VH sequence of SEQ ID NO:9 and the VL sequence of SEQ ID NO:7 (page 6, [0076], and Fig. 1). Additionally, Adams teaches a method of using of the antibody in the treatment a pathological disorder that is mediated by IL-17A and/or IL-17F or is associated with an increased level of IL-17A and/or IL-17F, wherein the pathological condition includes, among others, psoriasis (page 9, [0120] and [0121], for example). Therefore, the reference anticipates claims 26 and 28. Note, with respect to “wherein the reduction of plaque psoriasis is measured by PASI criteria” in claim 28, such is not considered an active method step, thus, does not carry patentable weight in the claim.
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 of this title, 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.
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.
Claims 26-30, 84 and 89 are rejected under 35 U.S.C. 103 as being unpatentable over Adams et al. (US 2012/0183558, 7/19/2012; or its patent US 8,580,265, 11/12/2013; provided by applicants), as applied to claims 26 and 28 above, and further in view of Guettner et al. (US 2013/0202610, 8/8/2013; provided by applicant).
The teachings of Adams are reviewed above. Additionally, Adams teaches that the dose at which the antibody molecule of the present invention is administered depends on the nature of the condition to be treated, the extent of the inflammation present and on whether the antibody molecule is being used prophylactically or to treat an existing condition (page 7, [0094], for example).
Guettner teaches regimens for treating psoriasis with a therapeutically effective amount of an IL-17 antagonist, such as an IL-17 antibody secukinumab (abstract, for example), which comprise: a) administering an IL-17 antagonist during an induction regimen or a loading regimen comprises administering the patient five doses of about 75 mg-about 300 mg (e.g., about 150 mg-about 300 mg) weekly; and b) thereafter, administering the IL-17 antagonist during a maintenance regimen (page 2, [0011], for example); that in preferred embodiments, the induction regimen employs dosing weekly for five weeks (week 0, 1, 2, 3, and 4), followed by a monthly dose during week 8; and the maintenance regimen employs monthly dosing beginning on week 12 (page 13, [0113] and [0114], for example). Additionally, teaches that the appropriate dosage will, of course, vary depending upon, for example, the particular IL-17 binding molecule to be employed, the host, the mode of administration and the nature and severity of the condition being treated, and on the nature of prior treatments that the patient has undergone; ultimately, the attending physician will decide the amount of the IL-17 binding molecule with which to treat each individual subject, and may administer low doses of the IL-17 binding molecule and observe the subject's response; and the dosage of secukinumab used in the disclosed induction and/or maintenance regimens is based on the patient's weight (page 18, [0164]; and page 19, [0172], for example); and that the frequency of dosing may be in the range from about once per week up to about once every three months, e.g., in the range from about once every 2 weeks up to about once every 12 weeks, e.g., once every four to eight weeks; and will depend on, inter alia, the phase of the treatment regimen (page 19, [0166]). Further, Guettner teaches the use of the PASI scoring system in evaluating treatment response of psoriasis patients (page 8, [0085] - [0090], for example). Furthermore, Guettner teaches a clinical trial using similar regimens to treat psoriasis patients (page 24, Example 2).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat psoriasis with Adams anti-IL-17A/F antibody using Guettner’s psoriasis treatment regimen following the teachings of Adams and Guettner, wherein about 150 mg-about 300 mg (such as 160 mg or 320 mg) anti-IL-17A/F antibody is used weekly during the loading regimen, and monthly thereafter at week 12 during the maintenance regimen, depending on the individual patient’s condition such as body weight, and severity of the condition being treated, which can be readily determined by the attending physician. The person of ordinary skill in the art would have been motivated to do so for effective disease treatment (treating psoriasis), and reasonably would have expected success because Adams teaches the use of the anti-IL-17A/F antibody for treating psoriasis, and Guettner has demonstrated the success of the regimen in treating psoriasis.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Double Patenting Rejections:
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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 26-30 and 84 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,492,396. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1-12 of the ‘396 patent are directed to a method of treating psoriasis with an antibody which binds human IL-17A and IL-17F, comprising a first treatment period comprising administering the antibody at a dose of 320 mg once every four weeks for sixteen weeks; and a second treatment period comprising administering the antibody at a dose of 320 mg once every four or eight weeks (claims 1, 4, 5, 7, 10 and 11, for example), wherein the psoriasis is plaque psoriasis (claims 2, 3, 8 and 9, for example); and wherein a reduction of plaque psoriasis after the first treatment is measured by PASI criteria (claims 6 and 12). Thus, claims 1-12 of the ‘396 patent anticipate the present claims 26-30 and 84 (part (c)) or render the claims obvious. Therefore, the conflicting claims are not patentably distinct from each other.
Claims 26 and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12 and 14 of U.S. Patent No. 9,890,219. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 12 and 14 of ‘219 patent are directed to a method of treating an IL-17A and/or IL-17F mediated pathological disorder with a pharmaceutical composition comprising a monoclonal neutralising antibody which binds human IL-17A and human IL-17F, wherein the disorder comprises, among others, psoriasis. Thus, claims 12 and 14 of the ‘219 patent anticipate the present claims 26 and 28-30. Therefore, the conflicting claims are not patentably distinct from each other.
Claims 26 and 28-30 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 9 of U.S. Patent No. 10,308,723; over claims 4, 14 and 24 of U.S. Patent No. 9,988,446; and over claim 7 of U.S. Patent No. 9,771,420. Although the claims at issue are not identical, they are not patentably distinct from each other for the similar reasons above (over 9,890,219).
Claims 26 and 28-30 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8,679,494. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-6 of ‘494 patent are directed to a monoclonal antibody or a chimeric or humanized antibody that specifically binds to human IL-17A and IL-17F, and a composition thereof, wherein the antibody is further defined by its epitope on human IL-17A of SEQ ID NO:21. Additionally, '494 patent teaches the use of the antibody of the invention in the treatment of a pathological disorder that is mediated by IL-17A and/or IL-17F, including, among others, psoriasis (column 18, lines 36-61, esp. line 47, for example). Thus, it would be obvious to treat psoriasis with a pharmaceutical composition comprising the neutralising antibody binding to human IL-17A and IL-17F as that of the patent. Therefore, the conflicting claims are not patentably distinct from each other. See also Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010).
Claims 26 and 28-30 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 9,045,537; over claims 1-12 of U.S. Patent No. 8,303,953; and over claims 1-10 of U.S. Patent No. 8,580,265. Although the claims at issue are not identical, they are not patentably distinct from each other for the similar reasons above (over 8,679,494).
Claims 26 and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-38 of copending Application No. 18/422,323. Although the claims at issue are not identical, they are not patentably distinct from each other for the similar reasons above.
Claims 7-38 of copending Application ‘323 are directed to a monoclonal antibody comprising the HCDR1-3 of SEQ ID NO: 1-3, respectively, and the VL of SEQ ID NO: 7 (claim 7, for example); the VH and VL of SEQ ID NO: 9 and 7, respectively (claims 7, 8, 17, 21, 26 and 27, for example); a pharmaceutical composition thereof, and a container comprising the pharmaceutical composition (claims 31-38). The claimed monoclonal antibody binds to both IL-17A and IL-17F. Additionally, the ‘323 application teaches the use of the antibody of the invention in the treatment of a pathological disorder that is mediated by IL-17A and/or IL-17F, including, among others, psoriasis (page 24, [0118], for example). Thus, it would be obvious to treat psoriasis with a pharmaceutical composition comprising the neutralising antibody binding to human IL-17A and IL-17F as that of the patent. Therefore, the conflicting claims are not patentably distinct from each other. See also Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion:
No claim is allowed.
Advisory Information:
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/DONG JIANG/
Primary Examiner, Art Unit 1674
12/26/25