DETAILED 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 response and amendments received December 16, 2025 are acknowledged.
Claims 1-8, 11, 13, 19, and 22-37 have been canceled.
Claims 9, 10, 12, 15-18, 20, and 21 have been amended.
Claims 38-45 are newly presented.
Claims 9, 10, 12, 14-18, 20, 21, and 38-45 are pending in the instant application.
Information Disclosure Statement
The IDS form received 12/16/2025 is acknowledged and the references cited therein have been considered.
Claim Rejections - 35 USC § 103
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.
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.
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.
The rejection of claims 9-21, 24-27, and 32-34 under 35 U.S.C. 103 as being unpatentable over US 2014/0072583 in view of US 2014/0356372 (of record) and in view of Wachholz et al. (of record) has been withdrawn in view of applicant’s claim amendments received December 16, 2025.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
The rejection of claims 9-21, 25-27, and 32-34 on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,771,743 as evidenced by US 2014/0356372 has bene withdrawn in view of applicant’s claim amendments received December 16, 2025.
The rejection of claim 24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,771,743 as applied to claims 9-21, 25-27, and 32-34 above in view of US 2014/0072583 and in view of Wachholz et al. is moot as claim 24 was canceled as part of the December 16, 2025 response.
The rejection of claims 9-21, 24-27, and 32-34 on the ground of nonstatutory double patenting as being unpatentable over claims 1-57 of U.S. Patent No. 10,485,844 in view of US 2014/0072583 in view of US 2014/0356372 and in view of Wachholz et al. has been withdrawn in view of applicant’s claim amendments received December 16, 2025 which differentiate between the patient population of the instant claims relative to those previously issued.
The rejection of claims 9-21, 24-27, and 32-34 on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,137,193 in view of US 2014/0072583 in view of US 2014/0356372 (of record) and in view of Wachholz et al. (of record) has been withdrawn in view of applicant’s claim amendments received December 16, 2025 which differentiate between the patient population of the instant claims relative to those previously issued.
The rejection of claims 9-21, 24-27, and 32-34 on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. Patent No. 11,034,768 in view of US 2014/0072583 in view of US 2014/0356372 (of record) and in view of Wachholz et al. (of record) has been withdrawn in view of applicant’s claim amendments received December 16, 2025 which differentiate between the patient population of the instant claims relative to those previously issued.
The rejection of claims 9-21, 24-27, and 32-34 on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,090,201 in view of US 2014/0072583 in view of US 2014/0356372 and in view of Wachholz et al. has been withdrawn in view of applicant’s claim amendments received December 16, 2025 which differentiate between the patient population of the instant claims relative to those previously issued.
The following are new grounds of rejection necessitated by applicant’s claim amendments received December 16, 2025.
Claims 9, 10, 12, 14-18, 20, 21, and 38-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,771,743 in view of US 2014/0356372 (of record)
The issued claims of the ‘743 patent recite methods of administering anti-IL-4R antibodies that have the same biological sequences (including dupilumab itself) as those recited in the instant claims to subjects comorbid with asthma and perennial allergic rhinitis wherein said subject has anti-perennial allergen antibodies of the IgE isotype at a titer to greater than 0.35 kU/L at a dose of 75-600 mg once a week or every two weeks for at least 16 weeks (see all issued claim , particularly issued claims 1 and 15). Specific doses of 300 mg (compare issued claim 4 to instant claim 15) and 200 mg (compare issued claim 5 to instant claim 16) as well as subcutaneous administration (compare issued claim 10 to instant claim 25). Notably, perennial allergens are recited as including cat dander, D. farina, D. pteronyssinus, German cockroach, and the mold species Aspergillus fumigatus (compare issued claim 3 and instant claim 12). Repeating dosing after 1 or 2 weeks is also claimed (compare instant claims 17, 18, 20 and 21 to issued claims 6-9). Administration at an initial does of 600 mg followed by secondary doses at 300 mg ever two weeks is also claimed (compare issued claim 6 to instant claim 38) as is an initial dose of 400 mg followed by subsequent dosing at 200 mg (compare issued claim 7 to instant claim 40). Such issued claims differ from what is presently claimed in that the administration methods of the ‘743 claims are not explicitly recited as being subcutaneous nor do they explicitly recite the intended results of the instant claimed anti-IL-4R antibody administrations, namely reductions in allergy symptoms such as runny noses and sneezing even though the issued claim do explicitly state the administrations are for the purpose of “reducing the severity of an allergic reaction in a subject”.
The ‘372 document discloses and claims methods of administering antibodies that bind the IL-4R for the purpose of treating and reducing the severity of allergic reactions (see entire document, particularly the abstract, claims, and paragraph [0004]). Notably the antibodies disclosed by the ‘372 document match those recited in the instant claims and are the sequences found in the commercially available antibody known as dupilumab (see particularly sequence alignments previously provided as well as claim 7). The claims indicate that such administrations are useful in inhibiting allergic reactions to a wide variety of structurally diverse allergens including dust, birch pollen, animal dander and mold (see for example claims 19 and 45, and paragraph [0026]). It is disclosed that subjects given the recited anti-IL-4R antibody can have reductions in serum IgE of more than 50% as compared to the untreated patient (see particularly paragraphs [0006] and [0024]). The anti-IL-4R antibodies are disclosed as being administered in a variety of routes including subcutaneous (see for example paragraphs [0054-0060]). Numerous doses including 200 mg, 400 mg, and 600 mg (see for example paragraphs [0061-0062]) and time intervals between doses including weekly, biweekly, and monthly are also disclosed (see for example paragraphs [0027-0031]). Notably, the ‘372 document teaches that “a subject in need thereof” upon whom the disclosed methods are practiced exhibit allergic responses when exposed to allergen (see particularly paragraph [0023]) and that allergic reactions encompass one or more signs and symptoms encompassing of rhinitis, asthma, and increased IgE production (total and/or allergen specific, see particularly paragraph [0025] as well as claims 12 and 14). Such administrations are disclosed as being carried out using devices including autoinjectors and pen delivery devices (see particularly paragraphs [0055-0060]).
Therefore, it would have been obvious to ordinary artisans that the administration methods of the ‘743 patent could be delivered subcutaneously, such as by a pen injector. This is because the ‘372 publication discloses administering dupilumab subcutaneously using such devices to treat the symptoms of allergy in patients suffering from allergies including mold and pet dander. Note that runny noses and sneezing are extremely obvious manifestations of allergy obvious to non-clinicians and are even explicitly disclosed as being reduced by dupilumab administration in the ‘372 publication (see paragraph [0025] in particular). Artisans would have more than a reasonable expectation of success in making such modifications based on the teachings and working examples of the ‘372 publication.
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached on Monday-Friday 8:30-5:00.
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, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1644