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 24-37 are the subject of this Office Action.
2. Information Disclosure Statement
It appears that Applicants intended to file an IDS with the 9/29/26 response. However, no PTO-1449 / SB08 was provided. Based on the NPL document provided (Fridman), the Examiner believes that this was the only intended reference. Therefore, the Examiner cited Fridman on the PTO-892 accompanying this Office Action.
3. Specification
Both objections have been withdrawn in view of Applicants’ amendments to the Brief Description and to the trademarks.
4. Claim Objections
The objection has been withdrawn in view of Applicant’s amendment.
5. Claim Rejections - 35 USC § 103
All rejections have been withdrawn in view of Applicants’ arguments.
6. Claim Rejections - 35 USC § 112(a) – scope of enablement
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 24-35 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for the specific antibody recited in claim 36, does not reasonably provide enablement for any other antibody which meets the claimed limitations. 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 a method for treating fibrotic disease by administering any antibody that binds DDR2. Applicants have only provided guidance and a working example of at most 2 antibodies DAB0048 and DAB0065) that functions as claimed. However, only one is recited in claims (36/37).
In their response to overcome the rejections under 35 USC 103, Applicants discussed the lack of understanding and predictability of not only antibodies binding to DDR2, but of their effects (see, e.g. Friedman et al.). Furthermore, Applicants argued that Examples 4 and Figure 3 of their specification show the unpredictability of antibody effects upon binding to DDR2 by stating that only two of the tested antibodies act as desired. Given this, the specification and claims provide only minimal guidance and working examples of antibodies able to bind DDR2 and which have the desired function. Applicants do provide some guidance by identifying residues to be bound by a DDR2 antibody. However, not only is this range (residues 22-191 of SEQ ID NO:78) only recited in one of the independent claims, but, again, given the argued complexity of the relationship between DDR2 antibodies and their intended function, it is not predictable to one of ordinary skill in the art how to make antibodies meeting the claimed functional limitations other that, at most, DAB0048 and DAB0065.
These factors lead the Examiner to hold that undue experimentation is necessary to practice the invention as claimed.
7. Claim Rejections - 35 USC § 112(a) – written description
Claims 24-35 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 treating a fibrotic disease, 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. Although these types of changes are routinely done in the art, neither the specification, nor the claims provide any guidance as to what changes should be made, especially in view of the unpredictable nature of these antibodies (e.g. Friedman; Example 4, Figure 3 of the instant specification). 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.
Applicants do provide some limitation as to the binding location of the antibodies (residues 22-191). However, due to the apparent unpredictable structure-function relationship between antibody/DDR2 binding and desired or expected effects, 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, DAB0048 and DAB0065, at most, 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.
8. Conclusion
A. Claims 24-35 are not allowable.
B. Claims 36 and 37 are objected to since they depend from rejected base claims, but are otherwise allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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
