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 12/16/25, Applicants elected SEQ ID NO:39, 79, 119 and 159 as the species. However, upon further review, all species have been examined.
B. Claims 1-12, 17, 18, 20, 22, 24, 25 and 30-33 are pending and are the subject of this Office Action.
2. Claim Objections
A. Claim 4 is objected to since it is unclear why “urelumbab” and “utomilumab” are capitalized.
B. Claim 9 is objected to since there is a comma after “or” before the phrase “the Fc fragment”.
C. Though not incorrect, but to maintain parallel sentence structure, it is suggested that the word “to” be added before “the fusion protein” in claim 18.
D. Claim 24 is objected to since there is a comma after “in that”.
E. Claim 24 is objected to since the phrase “or, with an amino acid sequence” is unclear in the context of the claim. It is believed that the phrase should instead recite “or has an amino acid sequence”.
F. Claim 24 is objected to since “anyone” should be worded as “any one”.
G. Claim 30 is objected to since it should recite “of a detectable”.
H. Claim 32 is objected since it recites “characterized in that, which comprises”, which is unclear.
I. Claim 33 is objected to since there is a comma after “in that”.
J. While not incorrect, it is noted that claim 30 recites “(a)” and “(b)”, whereas claims 32 and 33 recite “(i)” and (ii)”.
3. 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 22 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for the treating malignant tumors and autoimmune disease, does not reasonably provide enablement for preventing malignant tumors and autoimmune disease. 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 preventing malignant tumors and autoimmune disease. The Examiner has interpreted “preventing” as a condition will not occur in 100% of the subjects administered the intended compound. 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 malignant tumors and autoimmune disease from occurring in 100% of the subjects.
Applicants may, without adding new matter, consider using a limitation such as “reducing the likelihood”, or a similar phrase.
These factors lead the Examiner to hold that undue experimentation is necessary to practice the invention as claimed.
4. Claim Rejections - 35 USC § 112(a) – written description
Claim 3 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. Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
A. Claims 1-3, 11, 17, 18, 22, 24 and 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The phrase "preferably" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is noted that claim 18 also recites “such as”, which raises the same issues.
B. Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The metes and bounds of the claim is unclear since it recites measuring affinity by using “ForteBio”. While ForteBio is not a trademark, it is the name of a company which uses bio-layer interferometry in systems such as Octet®. Therefore, it is unclear to what technology/procedure/assay “ForteBio” refers.
7. Conclusion
A. Claims 1-3, 11, 17, 18, 22, 24 and 25 are not allowable.
B. Claims 4, 9, 30, 32 and 33 are objected to as discussed in section 2.
C. Claims 5-8, 10, 12, 20 and 31 are objected to since they depend from rejected claims.
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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