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 .
Claims 1, 2, 4, 9, 23, 24, 26, 32, 44, 45, 53, 57, 63-65. 72, 73, 83, 85-86 are pending.
Election/Restrictions
Applicant’s election without traverse of the specie,
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, in the reply filed on 8/17/2026 is acknowledged.
As the elected specie is found to be free of art, the search has been extended to all of the species in the claims.
Claim Rejections - 35 USC § 112
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, 2, 4, 9, 23, 24, 26, 32, 44, 45, 53, 57, 63-65. 72, 73, 83, 85-86 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 instant claims recite “M is, at each occurrence, independently a moiety comprising two or more double bonds and at least one degree of conjugation, …” and “L1, L2, and L3 are, at each occurrence, independently optional linkers …” in claim 1.
The claims at issue recite minimal structure in the body of the claims. It is not even clear what structure of the moieties that can be encompassed by the language recited in the claims. A structure that has two or more double bonds and at least one degree of conjugation is not describing what the structure is. As such, all means or methods of resolving the problem or achieving the result are encompassed by the claims. See Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010) (en banc). When claims depend on a recited property or result, the claim covers every conceivable structure (means) for achieving the stated property or result while the specification discloses at most only those known to the inventor. See MPEP 2164.08(a).
The purpose of the written description requirement is to “ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 920 (Fed. Cir. 2004), (quoting Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000)). To determine whether there is adequate written description support for the genus of methods and means of achieving the claimed properties, the Specification is reviewed for species that achieve the claimed results. "[T]he specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Ariad, 94 USPQ2d at 1170-1171.
In University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 927-28 (Fed. Cir. 2004), the court reasoned that because the specification did not describe any specific compound capable of performing the claimed method and the skilled artisan would not be able to identify any such compound based on the specification's function description, the specification did not provide an adequate written description of the claimed invention. Ariad, 94 USPQ2d at 1173. Therefore, instant Specification does not provide adequate written description support for the invention of Claims 1-because it is not clear what “linker” being capable of achieving the claimed function. As such, the Specification would not reasonably convey to a person of ordinary skill in the art that Applicant had possession of the claimed invention.
Only a limited example of what M and L are disclosed in the instant specification. In other words, Applicant has not disclosed a sufficient number of species to support the claims as drafted in full scope. Reciting partial structural features of a moieties does not inform the skilled artisan what the moieties may be. With limited examples disclosed in the specification, the claims extend beyond what is disclosed.
Thus, while one of ordinary skill in the art would conclude that the Applicant would have been in possession of some examples of what was disclosed in the specification, at the time of filing, one of ordinary skill in the art would not conclude that the Applicant described a sufficient number of pharmaceutical compositions to be in possession of the claimed invention as a whole at the time of filing.
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.
Claims 1, 2, 4, 9, 23, 24, 26, 32, 44, 45, 53, 57, 63-65. 72, 73, 83, 85-86 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 limitations “M is, at each occurrence, independently a moiety comprising two or more double bonds and at least one degree of conjugation, …” and “L1, L2, and L3 are, at each occurrence, independently optional linkers …” recited in claim 1 render the claims indefinite because it is not clear what the moiety M and L1, and L3 may be. Therefore, it is not clear what compounds are encompassed by the claims. Since L1, L2, and L3 is optionally linkers as recited in the claim, it is not clear what linker moieties are encompassed by the claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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