DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 25-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,485,813. Although the claims at issue are not identical, they are not patentably distinct from each other because the methods of treatment herein would be prima facia obvious in view of the methods in ‘813. ‘813 is drawn to treating a herpes viral infection (including CMV – see claim 4) comprising administering maribavir in an amount of greater than 200mg/day and up to 6400 mg/day (see claims 2-3). Claim 7 provides an adjuvant, excipient, or carrier is included and clam 8 provides for an immediate release composition. A skilled artisan would see these methods in ‘813 would render obvious the present claims as the present dosage of 800 mg 2x/day would be prima facia obvious as this is fully embraced by the claims therein and is set forth as an exemplified embodiment in ‘813. See table and dosing protocol 06 and 28 therein which is an 800mg immediate release tablet administered orally at 2x/day. Immediate release is defined therein as “to mean release of the drug from drug formulation by dissolution in less than 60 min or is otherwise release from the drug formulation in less than 60 min – see column 6, lines 49-52 therein.
The above rejection is, in part, based on the specification of a previously issued patent, rather than the claims. In support of the use of this material, the examiner notes the following excerpt from MPEP section 804:
When considering whether the invention defined in a claim of an application is an obvious variation of the invention defined in the claim of a patent, the disclosure of the patent may not be used as prior art. This does not mean that one is precluded from all use of the patent disclosure.
The specification can always be used as a dictionary to learn the meaning of a term in the patent claim. In re Boylan, 392 F.2d 1017, 157 USPQ 370 (CCPA 1968). Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined."
Thus, the courts have held that it is permissible to use the specification in determining what is included in, and obvious from, the invention defined by the claim on which the rejection is based. This is true even where elements are drawn from the specification describing the claimed invention which are not elements in the claim itself.
Claims 25-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,684,632. Although the claims at issue are not identical, they are not patentably distinct from each other because the methods of treatment herein would be prima facia obvious in view of the methods in ‘632. ‘632 is drawn to treating a herpes viral infection (including CMV – see claims 2, 7, and 12) comprising administering maribavir in an amount of 400mg 2x/day. It is noted that the present application provides for administration of 800mg 2x/day instead of the 400mg 2x/day as in ‘632. However, this dosage would be obvious to a skilled artisan who is optimizing the dosages of ‘632 and determining other active doses. See table and dosing protocol 06 and 28 therein which is an 800mg immediate release tablet administered orally at 2x/day. Claims 5, 11, and 15 provide that the composition is optionally an immediate release compositions. Immediate release is defined therein as “to mean release of the drug from drug formulation by dissolution in less than 60 min or is otherwise release from the drug formulation in less than 60 min – see column 6, lines 61-64 therein. As such, the methods of treating CMV with the same drug in the same amount via the dame dosage form is claimed in both applications and a skilled artisan would see they are substantially overlapping and the present claims being obvious in view of ‘632.
The above rejection is, in part, based on the specification of a previously issued patent, rather than the claims. In support of the use of this material, the examiner notes the following excerpt from MPEP section 804:
When considering whether the invention defined in a claim of an application is an obvious variation of the invention defined in the claim of a patent, the disclosure of the patent may not be used as prior art. This does not mean that one is precluded from all use of the patent disclosure.
The specification can always be used as a dictionary to learn the meaning of a term in the patent claim. In re Boylan, 392 F.2d 1017, 157 USPQ 370 (CCPA 1968). Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined."
Thus, the courts have held that it is permissible to use the specification in determining what is included in, and obvious from, the invention defined by the claim on which the rejection is based. This is true even where elements are drawn from the specification describing the claimed invention which are not elements in the claim itself.
Claims 25-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,447,169. Although the claims at issue are not identical, they are not patentably distinct from each other because the methods of treatment herein would be prima facia obvious in view of the methods in ‘169. ‘169 is drawn to treating a CMV infection comprising orally administering maribavir in an amount of 400mg 2x/day. It is noted that the present application provides for administration of 800mg 2x/day instead of the 400mg 2x/day as in ‘169. However, this dosage would be obvious to a skilled artisan who is optimizing the dosages of ‘169 and determining other active doses. See table and dosing protocol 06 and 28 therein which is an 800mg immediate release tablet administered orally at 2x/day. Claim 4 provides the compound is administered as a composition comprising a therapeutically acceptable adjuvant, excipient, or carrier medium. Claim 5 provides the composition is an immediate release composition. Immediate release is defined therein as “to mean release of the drug from drug formulation by dissolution in less than 60 min or is otherwise release from the drug formulation in less than 60 min – see column 6, lines 26-29 therein. As such, the methods of treating CMV with the same drug in the same amount via the dame dosage form is claimed in both applications and a skilled artisan would see they are substantially overlapping and the present claims being obvious in view of ‘169.
The above rejection is, in part, based on the specification of a previously issued patent, rather than the claims. In support of the use of this material, the examiner notes the following excerpt from MPEP section 804:
When considering whether the invention defined in a claim of an application is an obvious variation of the invention defined in the claim of a patent, the disclosure of the patent may not be used as prior art. This does not mean that one is precluded from all use of the patent disclosure.
The specification can always be used as a dictionary to learn the meaning of a term in the patent claim. In re Boylan, 392 F.2d 1017, 157 USPQ 370 (CCPA 1968). Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined."
Thus, the courts have held that it is permissible to use the specification in determining what is included in, and obvious from, the invention defined by the claim on which the rejection is based. This is true even where elements are drawn from the specification describing the claimed invention which are not elements in the claim itself.
Claims 25-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-26 of copending Application No. 19/347,325 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are drawn to the same methods of treating CMV with the same drug in an immediate release formulation releasing the compound in less than 60 minutes. The difference is the present application administers 800mg 2x/day and the ‘325 application administers 400mg 2x/day. However, this dosage difference would be prima facia obvious when optimizing dosages. Modifying dosages is seen to be obvious when looking for improved therapies, and applicants have shown nothing surprising or unexpected about the present 800mg 2x/day dosages compared to 400 mg 2x/day as in ‘325.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 25-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-24, 26-28, 30, 32, 35-47, and 69-70 of copending Application No. 18/678,709 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the methods in ‘709 would anticipate the present claims. ‘709 is drawn to methods of treating CMV with an immediate release maribavir composition having dosages of from 50-400mg 2x/day (see claims 41-47 therein). The difference is the present application administers 800mg 2x/day and the ‘709 application administers 400mg 2x/day. However, this dosage difference would be prima facia obvious when optimizing dosages. Modifying dosages is seen to be obvious when looking for improved therapies, and applicants have shown nothing surprising or unexpected about the present 800mg 2x/day dosages compared to 400 mg 2x/day as in ‘709.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. ViroPharma Press release dates 3/29/06 – NPL reference 15 from applicant’s IDS dated 10/1/25; who teaches to orally administer 400mg 2x/day maribavir to patients to test efficacy in preventing CMV infections, which is different than the present methods of treating the disease in a patient having CMV. ViroPharma noted that if an active CMV infection was detected, the study drug (maribavir or placebo) would to be discontinued and the subject managed according to current standards of care (see pages 1-2). As such, the present methods of treatment would not have been rendered obvious by the art’s testing of prophylactic use.
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/TRAVISS C MCINTOSH III/ Primary Examiner, Art Unit 1693