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 .
Preliminary claims filed February 25, 2025 is entered.
Claims 1-15 are pending.
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.
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 1-15 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.
Regarding claim 1, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 2-15 encompass the terms.
Claim 3 recite (when untreated) which is confusing because it is not clear why the term is in parenthesis. It is not clear what the meaning of the parenthesis adds to the terms within the parenthesis. Claims 1-2, 4-15 encompass the terms.
Claim 5 recite (hypothalamus) which is confusing because it is not clear why the term is in parenthesis. It is not clear what the meaning of the parenthesis adds to the terms within the parenthesis. Claims 1-4, 6-15 encompass the terms.
Claim 13 recite prefably which is confusing because it is not clear which claim limitations is to be considered. Claims 1-12, 14-15 encompass the terms.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating cluster headache in a patient as claimed, does not reasonably provide enablement for a method for prevention of cluster headache in a patient in need of preventative treatment of cluster headache as claimed. 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 and use the invention commensurate in scope with these claims.
The first paragraph of § 112 requires that the patent specification enable "those skilled in the art how to make and use the full scope of the claimed invention without `undue experimentation."' Genentech, Inc. v. Novo Nordisk AIS, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)); see also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). ("[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art."). Whether making and using the invention would have required undue experimentation, and thus whether the disclosure is enabling is a legal conclusion based upon several underlying factual inquiries. See In re Wands, 858 F.2d 731, 735, 736-37, 8 USPQ2d 1400, 1402, 1404 (Fed. Cir. 1988). As set forth in Wands, the factors to be considered in determining whether a claimed invention is enabled throughout its scope without undue experimentation include the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims.
Likewise, in Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991), the court affirmed the holding of invalidity of claims to analogs of the EPO gene under § 112 for lack of enablement where applicants had claimed every possible analog of the EPO gene but had disclosed only how to make EPO and a very few analogs. "[D]espite extensive statements in the specification concerning all analogs of the EPO gene that can be made, there is little enabling disclosure of the particular analogs and how to make them .... There may be many other genetic sequences that code for EPO-type products. Amgen has told how to make and use only a few of them and is therefore not entitled to claim all of them." Id., 927 F.2d at 1213-14, 18 USPQ2d at 1027.
Claims encompass a method for prevention of cluster headache in a patient in need of preventative treatment of cluster headache by administering the claimed anti-CGRP antibody claimed. However, one skilled in the art cannot prevent cluster headaches in a patient by administering the antibody to the patient. The specification teaches the treatment of patient with the antibody but no prophylactic prevention. The term “prevention” encompass never having the headache for all patients administered the claimed antibody. The amount of direction provided in the specification is limited to the treatment of patient with headache. The state of the art is such that one skilled in the art is not aware of prevention of cluster headache in a patient by administering the antibody. The state of the art was such that Bigal (US 2018/0111984) teach the treatment of cluster headache with anti-CGRP antibody which differs from the claimed antibody CDRs by the difference in the heavy chain CDR2 sequence. No working example is provided for prevention of cluster headache in a patient by administering the antibody to the patient. Thus, the claims encompass a method of prevention which is not enabled. In view of the extent and the unpredictability of the experimentation required to practice the invention as claimed, one skilled in the art could not make the invention without undue experimentation.
Therefore, based on the above Wands analysis, a preponderance of the evidence supports a conclusion that one skilled in the art would not have been enabled to make and use the invention of claims without undue experimentation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) s 1-2, 6-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over FDA (2019, IDS) in view of Bigal et al. (US 2018/0111984) .
FDA teach the method of FDA trail results of treating cluster headache with eptinezumab. Eptinezumab inherenly comprises the CDRs SEQ ID NO: and heavy and light chain SEQ ID NO: sequences claimed. FDA does not teach the dosage of 400 mg.
Bigal teach the method of treating chronic and episodic and chronic cluster headache by administering monoclonal antibody directed to CGRP at about 225 mg to 1000 mg including 400 mg (abstract, para 2-10, 160-161, 168-177). Bigal teach the method administration every 12 weeks (paragraph 165). Bigal teach the assessment of pain relief within hours of administration (paragraph 187-191).
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the 400 mg dosage of Bigal in the treatment of FDA with eptinezumab of cluster headache patients. One of ordinary skill in the art would be motivated to improve the FDA teaching by using a well know skill of determining of dosage to find the optimal treatment of cluster headache.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on 571-272-0857. 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). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL D PAK/Primary Examiner, Art Unit 1674
