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
A. In the response filed 8/11/26, Applicants elected Group I and traversed and argued that the methods of using the antibody (Groups II, III, IV) should be considered to have unity. This argument has been considered. The Examiner will rejoin claim 40 in this Office Action (the restriction between Groups I and II is hereby withdrawn). Since Groups II, III and IV do not meet the criteria under section 2 as provided in the Restriction Requirement dated 6/11/26, Groups III and IV will not be examined in this Office Action. However, upon the allowance of the antibody claims, Groups III and IV will be considered for rejoinder. This restriction is deemed proper and is, therefore, made FINAL. However, upon further review, all species have been examined.
B. Claims 1, 3, 5, 8-11, 13, 16, 17, 19, 23, 26, 30, 32-35, 40-42, 46, 49 and 60 are pending. Claims 41, 42, 46, 49 and 60 are withdrawn as being drawn to non-elected inventions. Claims 1, 3, 5, 8-11, 13, 16, 17, 19, 23, 26, 30, 32-35 and 40 are the subject of this Office Action.
2. Specification
A. The specification is objected to since the Brief Description of the Figures (all Figures except Figure 17) should be amended to initially reflect the panels. In other words, “Figure 1 shows” should be amended to, for example, “Figures 1A-1C show” or “Figures 1A-C. Figure A shows”. The use of, for example, “A” and “B” later in the description may be retained.
B. According to 37 CFR 1.821(d) (MPEP § 2422), where the description or claims of a patent application discuss a sequence listing that is set forth in the "Sequence Listing" in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the assigned identifier, in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application. Sequences appear in at least paragraph [0314], of the specification, but are not identified by SEQ ID NO as required.
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
Claim 40 is objected to since there should be a comma between “disease” and “disorder”.
4. Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
No rejection is being made over the host cell of claim 35 not being “isolated” since the specification does not appear to contemplate gene therapy, only cultured cells.
5. Claim Rejections - 35 USC § 112(a) – scope of enablement
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.
Claim 40 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for the treating or alleviating conditions by inducing macrophage phagocytosis, does not reasonably provide enablement for (1) treating or alleviating conditions by inducing any other phagocytic cell, nor for (2) preventing any disease or disorder regardless of phagocytic cell. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The breadth of the claims is excessive with regard to claiming (1) treating or alleviating conditions by inducing any other phagocytic cell, nor for (2) preventing any disease or disorder regardless of phagocytic cell. In paragraph [002] of the specification, Applicants teach that the interaction of CD47 and SIRPa is involved in the regulation of macrophage-mediated phagocytosis. All that appears to have been known in the prior and current art is that various other phagocytic cells express SIRPa, but no evidence was found demonstrating this receptor mediates phagocytosis in these cells. Furthermore, the specification and claims do not provide any guidance or working examples of SIRPa mediating any other phagocytic cell.
Regarding “preventing”, the Examiner has interpreted this term to mean a condition will not occur in 100% of the subjects administered the intended antibody. Applicants provide no guidance or working examples of achieving this, nor is it predictable to one of ordinary skill in the art how to prevent any disease, disorder, or condition from occurring in 100% of the subjects. Regarding this issue, Applicants may, without adding new matter, consider using a limitation such as “reducing the likelihood”, or a similar phrase.
Given the above, it is also unpredictable to one of ordinary skill in the art how to mediate any disease, disorder, or condition by modulating any phagocytic cell other than a macrophage, as well as how to prevent any and all diseases in which phagocytosis plays a role.
These factors lead the Examiner to hold that undue experimentation is necessary to practice the invention as claimed.
6. Claim Rejections - 35 USC § 112(a) – written description
Claims 9 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are broadly drawn to antibodies comprising FR regions with up to 20% of the residues altered in up to all 8 regions. The Examiner takes no issue with the limited substitutions for X20-X22 in claim 9. However, the specification only teaches that antibodies with the wild-type (unaltered) FRs recited in claims 9 and 10 bind to human SIRPa The specification does not teach antibodies with framework regions comprising at little as 80% identity in one or more FR which have the desired binding specificity.
The nature of the invention is engineered antibodies where the relative level of skill of those in the art is deemed to be high. The state of the prior art is such that it is well-established in the art that the formation of an intact antigen-binding site of antibodies routinely requires the association of the complete heavy and light chain variable regions of a given antibody, the binding site of which can be influenced by the framework regions (Rhodes et al - Section 3 and Conclusion).
Thus, the state of the art recognized that it would be highly unpredictable that a specific binding member comprising an antibody comprising up to 20% alterations in one or more FR of a parental antibody with a desired specificity would retain the antigen-binding function of the parental antibody. One of ordinary skill in the art could not predictably extrapolate the teachings in the specification, limited to antibodies that comprise all 8 wild-type FRs to antibodies that comprise alterations in one or more FR from the parental antibody.
In summary, in view of the lack of the predictability of the art to which the invention pertains as evidenced by the above references, the lack of guidance and direction provided by applicant, and the absence of working examples, the Examiner concludes that undue experimentation would be required to practice the invention as claimed.
7. Conclusion
A. SEQ ID NO:2, 3, 8, 23, 24, 28, 29, 34, 44, 45 and 49-67 free of prior art.
B. Applicants’ elected species, SEQ ID NO:10, 11, 13, 15, 16 and 17, are all individually well-known in the prior art. However, no reference teaches the instant SIRPa antibody. Furthermore, as mentioned in section A of the Conclusion, SEQ ID NO:53 and 54 are novel.
C. Claims 1, 3, 5, 8, 11, 13, 16, 17, 19, 23, 26, 30 and 32-34 are allowable. Claim 35 is currently allowable.
D. Claims 9, 10 and 40 are not 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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