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 .
Status of the Application
Applicant's election with traverse of the species: rash (disease), tofacitinib (JAK inhibitor, and afatinib (anti-tumor agent), in the reply filed on 2/9/26 is acknowledged. Upon further consideration, the species requirement for the anti-tumor agent is hereby withdrawn. The traversal is on the grounds that there is no search burden and that the claims are part of an overlapping search area. This is not found persuasive because a search for one species will not lead to information regarding another. For example, the dependent claims recite that rash and cancer are species of a cutaneous disease. These two diseases have different etiologies, symptoms, and treatment regimens, therefore are not considered overlapping search areas. The requirement is still deemed proper and is therefore made FINAL.
Claims 162-181 are pending. Claims 164-171, 174-175, 179 have been withdrawn from further consideration as being drawn to a non-elected species. Claims 162-163, 172-173, 176-178, 180-181 are examined herein insofar as they read on the elected invention and species.
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.
Claims 162, 165, 172-181 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 87-106 of copending Application No. 18/259,532.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating a cutaneous disease associated with an antitumor agent by administering a JAK inhibitor, wherein the disease is a rash, the antitumor agent is a EGFR inhibitor, and JAK inhibitor is the compound in claim 93.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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.
Claims 162-163, 172-173, 176-178, 180-181 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification, while being enabled for the method of treating a cutaneous disease or disorder by administering a JAK inhibitor, does not reasonably provide enablement for preventing. The specification does not enable any person skilled in the art to which it pertains to practice the invention commensurate in scope with these claims.
The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547, the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the breadth of the claims; (4) the amount of direction or guidance presented; (5) the predictability or unpredictability of the art; (6) the relative skill of those in the art; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The Nature of the Invention: The rejected claims are drawn to an invention which pertains to a method of preventing and treating a cutaneous disease or disorder by administering a JAK inhibitor.
(2) State of the Prior Art: The state of the art regarding treating a cutaneous disease or disorder is relatively high, however the state of the art for the prevention of a cutaneous disease or disorder is non-existent.
(3) Breadth of Claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The claims encompass the prevention, inhibition, and treatment of any and all cutaneous diseases or disorders.
(4) Guidance of the Specification: The guidance of the specification as to the prevention of a cutaneous disease or disorder is completely lacking. The specification discloses preventing the onset of a cutaneous disease or disorder. However, the specification fails to mention how one is able to determine whether the onset of a cutaneous disease or disorder in a subject would have occurred in the absence of treatment, thus being unable to confirm that prevention has indeed taken place. Moreover, the specification fails to mention the complete prevention or cessation of a cutaneous disease or disorder once the onset of preclinically evident stage is determined.
(5) The Predictability or Unpredictability of the Art: The invention is directed to a method of treating, inhibiting, and preventing a cutaneous disease or disorder by administering a JAK inhibitor. The specification does not disclose how one of ordinary skill in the art at the time of the invention would be able to prevent a cutaneous disease or disorder, nor does the prior art reveal any type of prevention associated with a cutaneous disease or disorder.
(6) The Relative Skill of those in the Art: One of ordinary skill in the art does not know how to prevent a cutaneous disease or disorder by administering a JAK inhibitor. Moreover, one is unable to determine whether a subject will ever develop a cutaneous disease or disorder should this subject be administered the JAK inhibitor.
(7) Working Examples: The specification does not give any data for the prevention of a cutaneous disease or disorder.
(8) The Quantity of Experimentation Necessary: The specification fails to provide support for the prevention of a cutaneous disease or disorder by administering a JAK inhibitor. Nor does it provide information to practice the claimed invention, absent undue experimentation. Genetech, 108 F. 3d at 1366 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Claim Rejections - 35 USC § 102
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 162-163, 172-173, 176-178, 180-181 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arkin et al. (US Patent Application 2020/0197397, of record).
Arkin et al. teach methods of treatment of skin disorders by administration of a composition comprising at least one EGFR inhibitor, such as topical compositions comprising erlotinib (abstract). Treatment of EGFR inhibitors, in general and erlotinib in particular, is known to induce cutaneous conditions like acneiform rash and papulopustular rash (paragraph 0037). The composition can also comprise a JAK inhibitor in a concentration of 0.01 to 5% w/w (paragraphs 0012, 0026, 0083, claims 78-79), for example tofacitinib (paragraph 0072).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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