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 .
The Restriction Requirement (Species Election) dated 4/8/26 has been VACATED in favor of this Office Action.
1. Formal Matters
Claims 1-15 are pending and are the subject of this Office Action.
2. Specification
A. If applicable, the first line of the specification should be updated to reflect the status (e.g. “now U.S. Patent No.”, or “now abandoned”) of any parent applications. Similarly, though none could be found, any U.S. or Foreign Applications cited in the specification which have since issued should be updated with the corresponding Patent No.
B. The use of at least the terms AlexaFluor® (page 88, line 33; page 89, lines 27 and 28) and Fluoromount G® (page 89, lines 34-35), which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
C. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors, embedded hyperlinks, or improperly referenced trademarks. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware.
3. Claim Objections
Claims 1-15 are objected to since “high affinity” should be hyphenated in all occurrences.
4. Claim Rejections - 35 USC § 112(a) – written description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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.
A. Claims 1-3, 5 and 15 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
These are genus claims. Other than being a high-affinity PD-1 mimic, the specification and claims do not indicate what distinguishing attributes are shared by the members of the genus. Thus, the scope of the claims includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between/among genus members is permitted. The specification and claims do not provide any guidance as to what changes should be made. Structural features that could distinguish compounds in the genus from others in the protein class are missing from the disclosure. No common structural attributes identify the members of the genus. In other words, the specification and claims only provide limited written description regarding the substitutions at each position, with most having only one to three identified substitutions. Only 7 of the 29 amino acid positions describe more than 3 substitutions out of a possible 19, with only one having up to 6 (G65).
The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, the mimics recited in claim 4, alone, are insufficient to describe the genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus at the time the invention was made.
B. Claim 2 is rejected under 35 U.S.C. 112(a) as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims do not provide a lower limit for the KD values. Therefore, the claims read on “superbinders”, which can have affinity values in the femptomolar range, or lower (i.e. higher affinity).
5. Nonstatutory 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.
A. Claims 1-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-16 and 18 of U.S. Patent No. 11,814,419 (16/883,396). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to the identical polypeptides used in the method claims of the patent. It is noted that the instant application is not a DIV of ‘419 and, therefore, does not receive safe-harbor protection. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
Instant claims 1 and 3-8 are met by patent claims 4-10 and 18.
Instant claim 2 is met by patent claim 2.
Instant claims 9-14 are met by patent claims 11-16.
B. Claims 1-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 8, and 11-13 of U.S. Patent No. 10,800,830 (15/502,439) in view of U.S. Patent No. 11,814,419. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to the identical polypeptides used in the method claims of the patent. It is noted that the instant application is not a DIV of ‘830 and, therefore, does not receive safe-harbor protection. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
Instant claim 1 is met by patent claims 1 and 4.
Instant claim 2 is met by patent claim 3.
Instant claims 3-8 are met by patent claims 5, 8 and 11.
Instant claims 9-14 are met by patent claims 12 and 13.
None of the ‘830 claims teach instant claim 15. However, ‘419 does teach the PD-1 mimetic of ‘830 further comprising an Fc region (claim 18).
C Claims 1-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-14 of U.S. Patent No. 9,546,206 (14/821,589). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to the identical polypeptides used in the method claims of the patent. It is noted that the instant application is not a DIV of ‘206 and, therefore, does not receive safe-harbor protection. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
Instant claims 1 and 9-14 are met by patent claims 1, 5-11 and 14.
Instant claim 2 is met by patent claim 3.
Instant claims 3-8 are met by patent claims 5-11.
D Claims 1-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-10, 13, 16, 23, 25, 26 and 28-30 of U.S. Patent No. 9,562,087 (14/931,725). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to the identical polypeptides used in the method claims of the patent. It is noted that the instant application is not a DIV of ‘087 and, therefore, does not receive safe-harbor protection. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
Instant claims 1 and 9-14 are met by patent claims 1, 13, 16 and 26.
Instant claim 2 is met by patent claim 2.
Instant claims 3-8 are met by patent claims 4-10, 25, 28 and 29.
Patent claim 30 is drawn to method of using instant PD-1 mimic polypeptide.
6. Conclusion
No claim is allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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, Joanne Hama, can be reached at 571-272-2911. 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 http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
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