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 species elections without traverse of A. a patient having genital psoriasis; and B. the regimen recited in claims 7 and 15, filed on 23 December 2025 are acknowledged.
Currently, claims 1-20 are pending, and claims 8-10 and 15-19 are under consideration. Claims 1-7, 11-14 and 20 are withdrawn from further consideration as being drawn to a non-elected species.
Formal Matters:
Information Disclosure Statement
Applicant's IDS submitted on 8/9/2022 is acknowledged and has been considered. A signed copy is attached hereto.
Priority acknowledgement
This application claims benefit of U.S. application 16/740,747 filed 01/13/2020, which is a national stage entry (371) of PCT/US2018/044080 with the international filing date of 07/27/2018; which claims benefit of U.S. provisional applications 62/549,321 filed 08/23/2017, 62/552,192 filed 08/30/2017, and 62/555,364 filed 09/07/2017, which is acknowledged.
Claims
Applicant is advised that should claim 9 be found allowable, claim 10 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. According to the specification, ixekizumab is an anti-IL17A antibody having a LC with the amino acid sequence of SEQ ID NO: 4 and a HC with the amino acid sequence of SEQ ID NO: 5 (page 12, last paragraph, lines 1-3, for example).
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 8, 9 and 15 are objected to for the following informalities, appropriate correction is required:
Claim 8 recites “wherein the LCVR is the amino acid sequence of SEQ ID NO: 2 and the HCVR is the amino acid sequence of SEQ ID NO: 3”; the following is suggested: “wherein the LCVR comprises the amino acid sequence of SEQ ID NO: 2, and the HCVR comprises the amino acid sequence of SEQ ID NO: 3”. Same is suggested for claim 9 (replacing “is” with “comprises”).
Claim 15 recites “an initial dose subcutaneous of about 160 mg”; the following is suggested: “an initial subcutaneous does of about 160 mg”.
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 8-10 and 15-19 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 8 is indefinite and confusing for the recitation “A method of achieving one of static physician's global assessment of genitalia 0, …, in a patient having genital psoriasis, comprising administering to the patient a therapeutically effective amount of an anti-IL17A antibody, … …, wherein following said step of administering, the patient achieves at least one of static physician's global assessment of genitalia 0, ...” because it is unclear what “A method of achieving one of static physician's global assessment of genitalia 0, …, in a patient having genital psoriasis” is meant, or who is the patient that would achieve the specifically defined one of said outcome measures, i.e., what the patient population is? For example, does it mean any or all patients having genital psoriasis, or only those who would achieve one of said outcome measures after the treatment as the claim requires? If the latter is meant, how such a patient can be selected prior to the treatment so that the patient would be guaranteed to achieve said treatment result as required by the claim (since treatment result or efficacy cannot be predicted or demanded as it is out of anyone’s control once the antibody is administered)? What about if a patient having genital psoriasis does not or never achieve said specific goal after the treatment? The metes and bounds of the claim, therefore, cannot be determined. The claim is further indefinite because it is unclear what “a therapeutically effective amount” here is meant, and how such an amount is related to the achievement recited in the preamble? For example, is “a therapeutically effective amount” the amount to achieve one of said specific outcome measures? If so, how such an amount is determined, i.e., how the amount to achieve one of said outcome measures is determined. The metes and bounds of the claim, therefore, cannot be determined. Claims 18 and 19 are similarly indefinite (for requiring or demanding the specific treatment result/efficacy).
Claim 15 is indefinite and confusing for the recitation “during a 12-week induction period administering an initial dose subcutaneous of about 160 mg of the anti-IL17 antibody … on day 0” because it seems that the induction regimen is incomplete since only an initial dose on day 0 is defined while the induction period lasts for 12 weeks. Such is also not supported by the specification.
The remaining claims are included in this rejection because they are dependent from the specifically mentioned claims without resolving the indefiniteness issue belonging thereto.
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 8 and 15 are indefinite for the reasons above, claim 1 is interpreted as drawn to a method of treating genital psoriasis with said anti-IL17A antibody. Claim 15 may not be evaluated accurately when comparing with the teachings of the prior art.
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 8-10 and 15-19 are [8-10 and 15-19] rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clinical Trial NCT02718898 (3/24/2016; provided by applicant), and as evidenced by Bolen et al. (WO 2015/105926 Al, 7/16/2015; provided by applicant); and by Ryan et al. ( J Am Acad Dermatol. 2015;72(6):978-83).
Clinical Trial NCT02718898 discloses a study of ixekizumab (LY2439821) in participants with moderate-to-severe genital psoriasis, wherein the Inclusion Criteria include, among others, patients having moderate-to-severe psoriasis in the genital area at screening and baseline (under “Inclusion Criteria”). Additionally, as evidenced by Bolen, ixekizumab comprises the heavy chain of SEQ ID NO:235 and the light chain of SEQ ID NO:236 (page 207, Table 48), which are 100% to the present SEQ ID NO:5 and 4, respectively. Therefore, NCT02718898 anticipates claims 8-10 and 17-19. Note, with respect to the limitations of “wherein following said step of administering, the patient achieves at least one of static physician's global assessment of genitalia 0, …” recited in claims 8, 18 and 19, such represent the treatment results or efficacy, therefore, they would be the inherent properties of the antibody treatment. Further, NCT02718898 teaches a specific regimen comprising two treatment periods: a blinded treatment period and an open label period; wherein in the blinded treatment, the patients were given 160 mg ixekizumab subcutaneously (SC) at baseline followed by 80 mg ixekizumab every 2 weeks (Q2W) SC from week 2 to week 10; and at week 12, 80 mg ixekizumab and placebo given SC; and in the open label period, 80 mg ixekizumab was given SC every 4 weeks (Q4W) with an option for Q2W dosing starting at week 24, week 28 or week 40 (3rd page), which meet the limitations of claim 12. Therefore, NCT02718898 also anticipates claim 15. With respect to claim 16, as evidenced by Ryan, in a study regarding genital psoriasis, affected genital areas and perigenital areas were recorded, and a modified genital PASI was calculated; this scoring index has previously been used to evaluate male genital psoriasis, which incorporates the degree of erythema, induration, and scaling or erosion of genital plaques as a product of the genital area involved (page 979, 1st column, 2nd paragraph), indicating that erosion is one of the characteristics of genital psoriasis. Therefore, NCT02718898 also anticipates claim 16.
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 8-10, 18 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-9 of U.S. Patent No. 11,634,485. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 6-9 of ‘485 patent are directed to a pharmaceutical formulation comprising an anti-IL-17A antibody, wherein the LCVR of the antibody comprises the amino acid sequence of SEQ ID NO. 7 and the HCVR comprises the amino acid sequence of SEQ ID NO. 8 (claims 6 and 9); wherein the LC of the antibody comprises the amino acid sequence of SEQ ID NO. 9 and the HC comprises the amino acid sequence of SEQ ID NO. 10 (claim 7); or wherein the anti-IL17A antibody is ixekizumab (claim 8). SEQ ID NO: 7-10 of the ‘485 patent are 100% identical to the present SEQ ID NO: 2-5, respectively. Additionally, '485 patent teaches that the pharmaceutical formulation can be used in the treatment of diseases including, among others, genital psoriasis (GenPs) (column 6, 2nd paragraph). Thus, it would be obvious to treat genital psoriasis with the pharmaceutical formulation comprising the anti-IL-17A antibody 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 8-10, 18 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-28 of copending Application No. 18/176,844. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 25-28 of the ‘844 application are directed to a method of treating diseases including, among others, GenPs, with a pharmaceutical formulation comprising an anti-IL-17A antibody, wherein the LCVR of the antibody comprises the amino acid sequence of SEQ ID NO. 7 and the HCVR comprises the amino acid sequence of SEQ ID NO. 8 (claims 25 and 28); wherein the LC of the antibody comprises the amino acid sequence of SEQ ID NO. 9 and the HC comprises the amino acid sequence of SEQ ID NO. 10 (claim 26); or wherein the anti-IL17A antibody is ixekizumab (claim 27). SEQ ID NO: 7-10 of the ‘485 patent are 100% identical to the present SEQ ID NO: 2-5, respectively. Thus, claims 25-28 of the ‘844 application anticipate the present claims 8-10, 18 and 19. Therefore, the conflicting claims are not patentably distinct from each other.
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:
Any inquiry concerning this communication should be directed to Examiner DONG JIANG whose telephone number is 571-272-0872. The examiner can normally be reached on Monday - Friday from 9:30 AM to 7:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DONG JIANG/
Primary Examiner, Art Unit 1674
1/22/26