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
Receipt of applicant’s remarks and claim amendments filed on 05/29/2026 are acknowledged.
In light of applicants clarifications and arguments, previous 112(b) and 103 rejections are withdrawn.
However, a new non-statutory double patenting rejections are made over the copending applications, viz., 18/021802, 18/121490 and 18/751087.
Nonstatutory Double Patenting Rejection
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(i) Claims 25, 28-31, 35-41 and 43-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US copending application#18/021,802.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claims are drawn to a method of treating neovascular age-related macular degeneration by administering 8 mg of aflibercept by intravitreal injection with recited dosing intervals.
Claims of copending application are drawn to a method of treating angiogenic eye disorder by administering 8 mg of aflibercept by intravitreal injection with recited dosing intervals. Claim 12 define angiogenic eye disorder is neovascular age-related macular degeneration.
Both applications are directed to treating same disorder by administering 8 mg of aflibercept with a similar dosing regimen comprising an initial dosage followed by one or more secondary doses followed by one or more tertiary dosages.
Difference is in the timing of the tertiary dose. Claims of copending application requires tertiary dose about 4, 8 or 12 weeks after the immediately preceding dose, whereas it is about 13-16 (+5 days) weeks in the instant claims.
However, the term “about” and/or “13th week with +5 days” overlap with 12th week of copending application.
The difference, however, does not constitute a patentable distinct, because the subject matter overlaps with each other, and therefore claims are obvious over the claims of copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(ii) Claims 25, 28-31, 35-41 and 43-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US copending application#18/121,490 in view of Yancopoulos (WO 2012/097019).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claims are drawn to a method of treating neovascular age-related macular degeneration by administering 8 mg of aflibercept by intravitreal injection with recited dosing intervals.
Claims of copending application are drawn to a method of treating diabetic macular edema by administering 8 mg of aflibercept by intravitreal injection with recited dosing intervals.
Both applications are directed to treating the recited disorder by administering 8 mg of aflibercept with a same dosing regimen comprising an initial dosage followed by one or more secondary doses followed by one or more tertiary dosages.
Difference is that claims of copending application is silent on treating neovascular age-related macular degeneration.
The above can be cured with Yancopoulos, which teaches that angiogenic eye diseases in general and including both diabetic macular edema and neovascular age-related macular degeneration can be treated by administration of a VEGF antagonist, such as aflibercept [see 0001]. Therefore, a skilled person in the art would be motivated to treat, using the same drug, other angiogenic eye diseases with a reasonable expectation of success, because art provided enough guidance or description to treat angiogenic eye diseases and its related diseases.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(iii) Claims 25, 28-31, 35-41 and 43-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US copending application#18/751,087.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claims are drawn to a method of treating neovascular age-related macular degeneration by administering 8 mg of aflibercept by intravitreal injection with recited dosing intervals.
Claims of copending application are drawn to a method of treating angiogenic eye disorder by administering 8 mg of aflibercept by intravitreal injection with recited dosing intervals [see dependent claims]. Claim 83 defines angiogenic eye disorder is neovascular age-related macular degeneration.
Both applications are directed to treating same disorder by administering 8 mg of aflibercept with a similar dosing regimen comprising an initial dosage followed by one or more secondary doses followed by one or more tertiary dosages.
Difference is in the timing range for secondary and tertiary dose. However, these ranges are overlap with each other.
The difference, however, does not constitute a patentable distinct, because the subject matter overlaps with each other, and therefore claims are obvious over the claims of copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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