Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of the Claims
1. Claims 1-20 are the original claims filed on 12/6/2023. In the preliminary amendment of 5/14/2024, claims 1-20 are canceled and new claims 21-23 are added.
Claims 21-23 are all the pending claims.
Priority
2. USAN 18/530,387, filed 12/06/2023, is a Continuation of 16/985,868, filed 08/05/2020, now U.S. Patent # 11858999, 16/985,868 is a Continuation of 16/229,716, filed 12/21/2018, now U.S. Patent # 11180564, 16/229,716 is a Continuation of 15/058,738, filed 03/02/2016, now U.S. Patent # 10/208,122 and having 1 RCE-type filing therein, 15/058,738 is a Continuation of 14/304,472, filed 06/13/2014, now abandoned, 14/304,472 is a Continuation of 13/472,074, filed 05/15/2012, now U.S. Patent # 8790648, 13/472,074 is a Divisional of 12/443,962, filed 04/01/2009, now abandoned, 12/443,962 is a National Stage entry of PCT/US2007/021174, International Filing Date: 10/01/2007, PCT/US2007/ 021174 Claims Priority from Provisional Application 60/969,895, filed 09/04/2007,
PCT/US2007/021174 Claims Priority from Provisional Application 60/873,072, filed 12/05/2006, PCT/US2007/ 021174 Claims Priority from Provisional Application 60/827,882, filed 10/02/2006.
The priority filing date for a method of treating psoriasis, plaque psoriasis, guttate psoriasis, inverse psoriasis, pustular psoriasis, and erythrodermic psoriasis is 10/02/2006.
Information Disclosure Statement
3. As of 7/17/2026, a total of one (1) IDS is filed: 7/11/2024. The corresponding initialed and dated 1449 form is considered and of record.
Objections
Specification
4. The abstract of the disclosure is objected to because it contains legal phraseology (“said”). Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
5. The disclosure is objected to because of the following informalities:
The use of the term, i.e., Alexa, Octet, Triton, Tris, ATCC, Oregon green, LC Red 705, Cascade Blue, BODIPY, GenBank, Bio-Plex, EMBL, 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.
Appropriate correction is required.
Claim Rejections - 35 USC § 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.
6. Claim 23 is 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 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 23 recites the broad recitation “psoriasis”, and the claim also recites “plaque psoriasis, guttate psoriasis, inverse psoriasis, pustular psoriasis, and erythrodermic psoriasis”, which is the narrower statement of the range/limitation. See www.mayoclinic.org/diseases-conditions/psoriasis/symptoms-causes/syc-20355840 teaching the species of psoriasis: plaque psoriasis, guttate psoriasis, inverse psoriasis, pustular psoriasis, and erythrodermic psoriasis.
The claim(s) are 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.
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.
Scope of Enablement
7. Claims 21-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating psoriasis using the anti-IL-17 RA antibody (brodalumab; AMG827; KHK4827), in vivo, does not reasonably provide enablement for treating any “disease state” with the same antibody, in vivo. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required, are summarized in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). They include the nature of the invention, the state of the prior art, the relative skill of those in the art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the predictability of the art, the breadth of the claims, the quantity of experimentation which would be required in order to practice the invention as claimed.
Claim interpretation
Claims 21-22 are drawn to the treatment of any disease state in any patient by administration of Amgen anti-IL-17 RA antibody clone, AML14/AMH14 (Brodalumab; AMG827; KHK4827), to the patient in need thereof, where the treatment effect is observed for the combination of functional properties: binds hIL-17RA; inhibits binding of IL-17A to IL-17RA; and treatment of any disease state, in vivo.
“disease state”: the breadth and scope of the disease state encompassed by the instant claim scope is beyond that taught, supported and enabled in the specification as filed:
[0931] Embodiment 152: the method of embodiment 151, wherein said disease state selected from the group consisting of: inflammation, autoimmune disease, cartilage inflammation, and/or bone degradation, arthritis, rheumatoid arthritis, juvenile arthritis, juvenile rheumatoid arthritis, pauciarticular juvenile rheumatoid arthritis, polyarticular juvenile rheumatoid arthritis, systemic onset juvenile rheumatoid arthritis, juvenile ankylosing spondylitis, juvenile enteropathic arthritis, juvenile reactive arthritis, juvenile Reiter's Syndrome, SEA Syndrome (Seronegativity, Enthesopathy, Arthropathy Syndrome), juvenile dermatomyositis, juvenile psoriatic arthritis, juvenile scleroderma, juvenile systemic lupus erythematosus, juvenile vasculitis, pauciarticular rheumatoid arthritis, polyarticular rheumatoid arthritis, systemic onset rheumatoid arthritis, ankylosing spondylitis, enteropathic arthritis, reactive arthritis, Reiter's Syndrome, SEA Syndrome (Seronegativity, Enthesopathy, Arthropathy Syndrome), dermatomyositis, psoriatic arthritis, scleroderma, vasculitis, myolitis, polymyolitis, dermatomyolitis, osteoarthritis, polyarteritis nodossa, Wegener's granulomatosis, arteritis, polymyalgia rheumatica, sarcoidosis, scleroderma, sclerosis, primary biliary sclerosis, sclerosing cholangitis, Sjogren's syndrome, psoriasis, plaque psoriasis, guttate psoriasis, inverse psoriasis, pustular psoriasis, erythrodermic psoriasis, dermatitis, atopic dermatitis, atherosclerosis, lupus, Still's disease, Systemic Lupus Erythematosus (SLE), myasthenia gravis, inflammatory bowel disease (IBD), Crohn's disease, ulcerative colitis, celiac disease, multiple sclerosis (MS), asthma, COPD, Guillain-Barre disease, Type I diabetes mellitus, Graves' disease, Addison's disease, Raynaud's phenomenon, autoimmune hepatitis, and graft versus host disease (GVHD).
Claim 23 is drawn to the genus and species of psoriasis for the disease state using the AML14/AMH14 clone, AMG827 or Brodalumab, that is enabled for use in the treatment of psoriasis. See Clinicaltrials.gov: NCT01101100; NCT00975637; NCT01708603; NCT01937260; NCT01708590; NCT00867100; NCT01708629; NCT01708603 (PTO 892).
Disclosure in the Specification
The specification provides limited examples of the clone being tested for in vitro and/or in vivo bioassay activities, i.e., binds, hIL-17RA, inhibits binding of hIL-17A to hIL-17RA and treatment of just any disease state, in vivo, that correspond to the specific disease in a human subject in order to establish that the claims are enabled by the original disclosure at the time of filing.
Examples 1-2, 5-6 demonstrate therapeutic use in collagen induced arthritis (CIA); and
Example 3-4 demonstrates therapeutic use in MOG-EAE model.
Evidentiary standard
MPEP 706 stating in part “The standard to be applied in all cases is the preponderance of the evidence test. In other words, an examiner should reject a claim if, in view of the prior art and evidence of record, it is more likely than not that the claim is unpatentable.”
The scope of the claims must bear a reasonable correlation with the scope of enablement. See In re Fisher, 166 USPQ 19, 24 (CCPA 1970). "[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.'" Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)). See In re Fisher, 166 USPQ 19 24 (CCPA 1970). Without such guidance, the amount of in vitro and in vivo animal model testing for any given much less the combination of antibodies, is unpredictable and the experimentation left to those skilled in the art is unnecessarily and improperly extensive and undue. See Amgen, Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F,2d 1200, 18 USPQ 1016 (Fed. Cir. 1991) at 18 USPQ 1026 1027 and Ex parte Forman, 230 USPQ 546 (BPAI 1986).
Prior art status of IL-17 pathway inhibition in any disease state, for example, sclerosis/scleroderma
Wei (PTO 892) teaches the complexities of monoclonal antibody use in treating IL-17/IL-17 RA pathways: “Dual role of IL-17A and the subtle balance over its control raises concerns over the use of antibodies against IL-17 whether it will abrogate fibrosis or antagonize the protective role of IL-17 remains an issue and requires further investigations into it. It is worthy of consideration the protective role of IL-17A in host defense against infection when blocking IL-17 pathway, as it could bring detrimental harm.”
Roofeh (PTO 892) teaches the challenges of treating a systemic disease like scleroderma from even a clinical trial standpoint is because SSc is a multifaceted disease with a complex pathogenesis (Figure 1). “Clinical trials in SSc are challenged by relatively low prevalence, clinical heterogeneity in terms of which organs are involved and to what extent, and the presence of unique disease subsets present with the same clinical phenotype according to current definitions. This last feature, identifying a molecular pattern that portends differing rates of progression and response, is a critical focus of the research agenda in improving outcomes. The identification of 4 subsets (fibroproliferative, inflammatory, limited, and normal-like) holds the promise of the path towards personalized medicine [81]. The identification of accurate and highly reliable biomarkers in SSc is critical to the next phase of rational drug design and optimizing targeted therapy. Gene-expression based biomarkers of skin disease progression and response is a promising avenue in this regard [82]. Detection of treatment effect in a clinical trial may be hampered by clinical heterogeneity and variation in treatment response. Intrinsic gene expression profiling, as instituted in the ASSET trial, has the capability to categorize patients based on disease pathogenesis in addition to clinical features present at the time of evaluation. In sum, gene expression analysis may allow for a more effective risk stratification and treatment selection, although this is yet to be demonstrated.”
See Clinicaltrials.gov Study of KHK4827 (AMG827); NCT03957681; 5/21/2019 (PTO 892)) Phase III trial for treating systemic sclerosis, in vivo.
Rafael-Vidal (PTO 892) teaches “…targeting IL-17 signaling might be a potential option in the treatment of systemic rheumatic diseases, which is highly important due to the need for new therapeutic options for these diseases, as an effective therapy is lacking for SLE, SSc and SS patients. The most common therapies are broad-spectrum immunosuppressive drugs, which have moderate to severe side effects and therapies that only treat organ manifestations or simply relieve the clinical symptoms [49,130–133]. However, the ongoing clinical trials with different IL-17 inhibitors need to be finished before concluding whether IL-17 blocking is an effective therapeutic strategy for these diseases.”
Therefore, due to the unpredictability of immunotherapeutics in general and in view of the insufficient guidance and/or working examples concerning the use of the claimed human antiIL-17RA antibody as immunotherapeutic agent, in vivo, in treating any disease state, one skilled in the art would reasonably conclude that the broadly claimed invention was not fully supported in the specification, and thereby removing applicants from full possession of the invention.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
8. Claims 21-22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Budelesky et al (20140234330; 14/234,064) as evidenced by Clinicaltrials.gov (Study of KHK4827 (AMG827); NCT03957681; 5/21/2019 (PTO 892)).
The applied reference has a common assignee (Amgen Inc.) with the instant application. Based upon the earlier effective U.S. filing date of the reference, it constitutes prior art under pre-AIA 35 U.S.C. 102(e). This rejection under pre-AIA 35 U.S.C. 103(a) might be overcome by: (1) a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor of this application and is thus not an invention “by another”; (2) a showing of a date of invention for the claimed subject matter of the application which corresponds to subject matter disclosed but not claimed in the reference, prior to the effective U.S. filing date of the reference under 37 CFR 1.131(a); or (3) an oath or declaration under 37 CFR 1.131(c) stating that the application and reference are currently owned by the same party and that the inventor or joint inventors (i.e., the inventive entity) named in the application is the prior inventor under pre-AIA 35 U.S.C. 104 as in effect on March 15, 2013, together with a terminal disclaimer in accordance with 37 CFR 1.321(c). This rejection might also be overcome by showing that the reference is disqualified under pre-AIA 35 U.S.C. 103(c) as prior art in a rejection under pre-AIA 35 U.S.C. 103(a). See MPEP §§ 2146 et seq.
The claimed method invention for treating any disease state, e.g., generic sclerosis (systemic), using the AM14 clone (brodalumab; AMG827; KHK4827) is prima facie obvious over Budelesky as evidenced by NCT03957681.
Budelesky teaches and claims methods for treating sclerosis:
Claim 64: A method of treating inflammation and autoimmune disorders in a patient in need thereof, comprising administering to said patient an isolated monoclonal antibody that specifically binds human IL-17RA that inhibits the biological activity of IL- 17A, IL-17B, IL-17C, IL-17D, IL-17E (IL-25), IL-17F, and IL-17A/F wherein the disorders include…sclerosis…”
The anti-human IL-17RA antibody in Budelesky is the same instant claimed antibody, AMH14/AML14, comprising the identical VL CDR1-3:
PNG
media_image1.png
653
655
media_image1.png
Greyscale
And comprising the identical VH CDR1-3:
PNG
media_image2.png
653
662
media_image2.png
Greyscale
As evidenced by NCT03957681, the treatment of sclerosis is reduced to practice and enabled for the AM14 clone. The POSA would have found more than sufficient support and motivation to have introduced the AM14 clone into a method of treating sclerosis in humans for as broad-spectrum a disease.
9. Claims 21-22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Martin et al (20120308566; 13/501,430) as evidenced by NCT03957681.
The applied reference has a common inventor with the instant application. Based upon the earlier effective U.S. filing date of the reference, it constitutes prior art under pre-AIA 35 U.S.C. 102(e). This rejection under pre-AIA 35 U.S.C. 103(a) might be overcome by: (1) a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor of this application and is thus not an invention “by another”; (2) a showing of a date of invention for the claimed subject matter of the application which corresponds to subject matter disclosed but not claimed in the reference, prior to the effective U.S. filing date of the reference under 37 CFR 1.131(a); or (3) an oath or declaration under 37 CFR 1.131(c) stating that the application and reference are currently owned by the same party and that the inventor or joint inventors (i.e., the inventive entity) named in the application is the prior inventor under pre-AIA 35 U.S.C. 104 as in effect on March 15, 2013, together with a terminal disclaimer in accordance with 37 CFR 1.321(c). This rejection might also be overcome by showing that the reference is disqualified under pre-AIA 35 U.S.C. 103(c) as prior art in a rejection under pre-AIA 35 U.S.C. 103(a). See MPEP §§ 2146 et seq.
The claimed method invention for treating any disease state, e.g., generic sclerosis (systemic), using the AM14 clone (brodalumab; AMG827; KHK4827) is prima facie obvious over Martin as evidenced by NCT03957681.
Martin teaches methods for treating sclerosis at [0936]: method of treating a disease in a patient in need thereof, comprising administering to said patient an isolated monoclonal antibody for AM-14 VH/VL CDR 1-3 wherein the disorders include…sclerosis…”
The anti-human IL-17RA antibody in Martin is the same instant claimed antibody, AMH14/AML14, comprising the identical VL CDR1-3:
PNG
media_image3.png
624
667
media_image3.png
Greyscale
The anti-human IL-17RA antibody in Martin is the same instant claimed antibody, AMH14/AML14, comprising the identical VH CDR1-3:
PNG
media_image4.png
623
661
media_image4.png
Greyscale
As evidenced by NCT03957681, the treatment of sclerosis is reduced to practice and enabled for the AM14 clone. The POSA would have found more than sufficient support and motivation to have introduced the AM14 clone into a method of treating sclerosis in humans for as broad-spectrum a disease.
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.
10. Claims 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 9096673. Although the claims at issue are not identical, they are not patentably distinct from each other because ref patent claims drawn to methods of treating COPD using the VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab, anticipate or render obvious the instant method claims drawn to treating any disease state with the same VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab. The ref patent species for COPD anticipates or renders obvious the genus for any disease state.
11. Claims 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-59 of U.S. Patent No. 8790648. Although the claims at issue are not identical, they are not patentably distinct from each other because ref patent claims drawn to methods of treating psoriatic arthritis using the VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab, anticipate or render obvious the instant method claims drawn to treating any disease state with the same VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab. The ref patent species for psoriatic arthritis anticipates or renders obvious the genus for any disease state.
12. Claims 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 10208122. Although the claims at issue are not identical, they are not patentably distinct from each other because ref patent claims drawn to methods of treating psoriasis using the VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab, anticipate or render obvious the instant method claims drawn to treating any disease state with the same VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab (Claims 21-22). As regards claim 23, the ref patent species for psoriasis anticipates or renders obvious the method of treatment for psoriasis.
13. Claims 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11858999. Although the claims at issue are not identical, they are not patentably distinct from each other because ref patent claims drawn to methods of treating scleroderma using the VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab, anticipate or render obvious the instant method claims drawn to treating any disease state with the same VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab. The ref patent species for scleroderma anticipates or renders obvious the genus for any disease state.
14. Claims 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 7833527. Although the claims at issue are not identical, they are not patentably distinct from each other because ref patent claims drawn to methods of treating psoriasis using the VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab, anticipate or render obvious the instant method claims drawn to treating any disease state with the same VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab (Claims 21-22). As regards claim 23, the ref patent species for psoriasis anticipates or renders obvious the method of treatment for psoriasis.
15. Claims 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-65 of U.S. Patent No. 8435518. Although the claims at issue are not identical, they are not patentably distinct from each other because ref patent claims drawn to methods of treating plaque psoriasis using the VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab, anticipate or render obvious the instant method claims drawn to treating any disease state with the same VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab (Claims 21-22). As regards claim 23, the ref patent species for plaque psoriasis anticipates or renders obvious the method of treatment for plaque psoriasis.
16. Claims 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10072085. Although the claims at issue are not identical, they are not patentably distinct from each other because ref patent claims drawn to methods of treating psoriasis using the VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab, anticipate or render obvious the instant method claims drawn to treating any disease state with the same VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab (Claims 21-22). As regards claim 23, the ref patent species for psoriasis and plaque psoriasis anticipates or renders obvious the method of treatment for psoriasis and plaque psoriasis.
17. Claims 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11505612. Although the claims at issue are not identical, they are not patentably distinct from each other because the ref patent claims drawn to methods of treating Sjorgen’s syndrome, dermatomyositis or systemic lupus erythematosus using the VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab, anticipate or render obvious the instant method claims drawn to treating any disease state with the same VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab. The ref patent species for Sjorgen’s syndrome, dermatomyositis or systemic lupus erythematosus anticipates or renders obvious the genus for any disease state.
18. Claims 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-28 of copending Application No. 18/045,534 (reference application US 20230192873). Although the claims at issue are not identical, they are not patentably distinct from each other because the ref claims drawn to methods of treating scleroderma, sclerosis or multiple sclerosis using the VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab, anticipate or render obvious the instant method claims drawn to treating any disease state with the same VH/VL CDR1-3 or the VH/VL of the anti-IL-17RA clone, AMH14 or AMG827 or brodalumab. The ref species for scleroderma, sclerosis or multiple sclerosis anticipates or renders obvious the genus for any disease state.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
19. No claims are allowed.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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, Wu Julie can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
Prosecution Insights