DETAILED ACTION
This office action is in response to applicant’s filing dated January 11, 2024.
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 Claims
Claims 1-15 are pending in the instant application.
Priority
The present application is a CON of US Application No. 16/642,722 filed on February 27, 2020, which is a 371 of PCT/US2018/048126 filed on August 27, 2018, which claims benefit of US Application No. 62/550,847 filed on August 28, 2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 5, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, except where marked with a strikethrough.
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Drawings
Acknowledgement is made of the drawings received on January 11, 2024.
The drawings are objected to because:
New Fig 1A, 1B, 1C, 4A, 4B, 5A, and 5B are pixelated and the lettering in the legends and axis are blurry.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
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. In the instant claims, the abstract contains implied language.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 recites the phrase “the at least one high molecule weight polyethylene glycol.” The phrase should be written “the at least one high molecular weight polyethylene glycol.” Appropriate correction is required.
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,813,333 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of increasing the circulation half-life of at least one pegylated therapeutic composition to be repeatedly administered to a subject, the method comprising: administering from 0.1 to 2500 milligrams per kilogram of at least one high molecular weight polyethylene glycol composition to a subject that has previously been administered at least one pegylated therapeutic composition and/or to a subject that is known to possess a high titer of pre-existing anti-PEG antibodies, wherein the high molecular weight polyethylene glycol composition comprises high molecular weight polyethylene glycol having a molecular weight of between 20 kDa to 200 kDa, and further wherein the high molecular weight polyethylene glycol composition is administered prior to or simultaneously with any subsequent or further administration of the at least one pegylated therapeutic composition to the subject.
The previously allowed claims are directed to a method of reducing accelerated blood clearance of at least one pegylated therapeutic composition by anti-PEG antibodies in a subject suffering from a disease and in need of treatment thereof, the method comprising the steps of: administering from 0.1 to 500 milligrams per kilogram of at least one high molecular weight polyethylene glycol composition to a subject suffering from a disease and in need of treatment with at least one pegylated therapeutic composition, wherein the high molecular weight polyethylene glycol composition comprises high molecular weight polyethylene glycol having a molecular weight of between 20 kDa to 200 kDa, and further wherein the high molecular weight polyethylene glycol composition is administered 30 minutes prior to or simultaneously with the administration of the at least one pegylated therapeutic composition.
The instant claims differ from the previously allowed claims in that the instant claims are directed to a method of increasing circulation half-life of at least one pegylated therapeutic composition to be repeatedly administered to a subject that has previously been administered at least one pegylated therapeutic composition and/or to a subject that is known to possess a high titer of pre-existing anti-PEG antibodies, while the previously allowed claims are directed to a method of reducing accelerated blood clearance of at least one pegylated therapeutic composition by anti-PEG antibodies wherein the high molecular weight polyethylene glycol composition is administered 30 minutes prior to or simultaneously with the administration of the at least one pegylated therapeutic composition. The instant claims require repeated administration of the pegylated therapeutic, while the previously allowed claims require that the subject be administered at least one pegylated therapeutic composition. It would have been prima facie obvious to one of ordinary skill in the art to utilize the method of the previously allowed claims to reduce accelerated blood clearance of at least one pegylated therapeutic composition to increase circulation half-life of at least one pegylated therapeutic composition. One of ordinary skill in the art would recognize that reducing accelerated blood clearance of at least one pegylated therapeutic composition would also increase circulation half-life of at least one pegylated therapeutic composition.
Even though the previously allowed claims are silent regarding “increasing circulation half-life of at least one pegylated therapeutic composition,” by practicing the method of the previously allowed claims: "the administration of a high molecular weight polyethylene glycol having a molecular weight of between 20 kDa to 200 kDa to a subject prior to or simultaneously with the administration of the at least one pegylated therapeutic composition to reduce accelerated blood clearance of the at least one pegylated therapeutic composition, one will also be increasing circulation half-life of at least one pegylated therapeutic composition.”
Apparently, Applicant has discovered a new property or advantage (“increasing circulation half-life of at least one pegylated therapeutic composition ) of the method of the previously allowed claims. MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Conclusion
Claims 1-15 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/Primary Examiner, Art Unit 1628
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