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 .
Priority
This application was filed 11/13/2023 and is a 371 of PCT/JP2022/006876 (02/21/2022) which has a PRO of 63/151107 (02/19/2021). Claims 1-22 are before the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 19-21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 19-21 are improper dependent claims from claim 18 because they do not further limit the pharmaceutical composition claim from which they depend. Limitations of use do not further limit a composition claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Specifically, claim 22 is drawn to a method for (1) diagnosing, (2) treating or (3) diagnosing and treatment of a disease or a symptom that may cause the disease. The disease is not defined. The symptom is not defined. The claim contains no steps towards diagnosing a disease/symptom. The only steps given in the claim could (might) be seen as treatment of said unknown disease/symptom due to administering a drug and then irradiation of the target tissue. However, there are no teachings in the specification as to what tissue is targeted or how to target a tissue or why to target a tissue. There are no diagnosing steps. There are no blood tests. Due to this, it is not seen how claim 22 can diagnose a disease. As far as treatment, the specification does not support how giving the instantly claimed composition and then irradiation gives treatment of a disease/symptom. Further, what disease? What symptom?
Thus, the specification fails to provide sufficient support of the broad use of the compounds of claim 1 for the treatment of any disease or symptom. As a result necessitating one of ordinary skill to perform an exhaustive search for which diseases can be treated by which compound of claim 1 in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, one of ordinary skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compounds of the instant claims, with no assurance of success.
Claims 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while possibly being enabling for compounds wherein X is F or -OC(O)-R’, Y = structures of claim 10, R1 and R2=H or F, R3 = X, alkyl or alkoxy, Z being alkyl or -ethyl-O- and B = O-Carborane, does not reasonably provide enablement for B being any group containing 10B, Z being any linking group or a bond, R1-3 being any monovalent substituent, L’ being a saccharide or partial structure of a saccharide or other group listed in claim 1. 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 or use the invention commensurate in scope with these claims. Claim 1 paints a broad landscape for the compound (I). However, the actual structures made are very small and appear to be only two specific structures EP-4OCB-MA and EP-4OCB-FMA. These two structures differ by only a F atom. However, the instant claim 1 is very broad. The specification provides no support for compounds treating any condition with compounds other than the two specified above much less with a phosphoric acid ester group or a peptide having a self-cleaving linker. Correction is required.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625
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