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 .
1. Formal Matters
Claims 1-3, 5, 7-9, 11-13, 19 and 20 are pending and are the subject of this Office Action.
2. Specification
A. The use of at least the terms Millipore® (page 35, line 24), Alexa 488 and 647 (page 37, line 14; which are believed to be Alexa Fluor® 488 and 647), FreestyleTM (page 45, line 4) and GibcoTM (page 37, line 13 and page 45, line 4), 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.
B. 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 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.
Claims 1-3, 5, 7-9, 11-13, 19 and 20 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.
Claims 1-3, 5, 12 and 13 are drawn to Fc domain variants. Claims 7-9, 11, 19 and 20 are drawn to the variant of claim 1, but recite functions. While claims 1-3, 5, 12 and 13 appear to not raise an issue of written description, since the artisan would be able to envision all possible combinations of variants, the intended use is that the variants have a function (such as altered binding capacity in claim 7).
These are genus claims. The only written description appears to be those Fc positions and specific substitutions disclosed in Table 1; Examples 4, 5, 7 and 8 and Table 2. These Examples not only use fewer than the 14 positions recited in claim 1, but are limited in the specific substitutions described.
Therefore, other than claims 1-3, 5, 12 and 13 requiring a variant, and claims 7-9, 11, 19 and 20 requiring specific functions, 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 only provide minimal guidance (Tables and Examples discussed above) as to what changes should be made. Structural features that could distinguish compounds in the genus from others in the antibody class are missing from the disclosure. No common structural attributes identify the members of the genus.
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 embodiments in the Tables and Examples discussed above, 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.
4. Closest Prior Art
A. U.S. Patent No. 12,565,538 teaches all of the positions in claim 1; however, the reference does not teach all instant positions as being altered together and teaches far more mutations included with those of the instant claims.
B. U.S. 2013/0122001 (cited on the IDS filed 4/17/24) teaches the S239D and I332E mutations as discussed in the PCT/ISA/237 dated 4/17/24.
5. 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.
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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
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