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 .
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 7-12 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. There is no description in the application of methods or protocols to carry out the method of claim 7 across the scope of “a condition or disease in a tissue and/or an organ” by administering the compound as defined in claim 1. A condition or disease in a tissue and/or an organ encompasses thousands of conditions or diseases, and the application has not described methods or protocols for carrying out the invention over the thousands of conditions that fall under the scope of the claims. Regarding claim 8, there is no disclosure of how to carry out step (iv), specificalyy how the susceptibility of the tumor tissue to the immunotherapy is detemirnedf “based” on the ratio obtained in step (III), and how this calculation is carried out, nor description of how this calculation is carried out across the scope of the invention.
Further regarding claim 11, there is no description of what is encompassed by involving “subjecting a subject to a therapeutic treatment regfiment based on the result obtained by the method. There is no description of in what way the involving step is “based” on the results obtained by the the method.”
Claim Rejections - 35 USC § 112
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 and 7-12 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 the recitation” “or a pharmaceutically acceptable salt or solvate thereof,” it’s unclear if only the salt is pharmaceutically acceptable or if the “solvate thereof” is also pharmaceutically acceptable. If the intention is that the solvate is also pharmaceutically acceptable, the examiner recommends reciting “or a pharmaceutically acceptable salt or pharmaceutically acceptable solvate thereof. Further regarding claim 2, it’s unclear why the formulas are surrounded by rectangles and in what way the rectangles limit the claim. Further regarding claim 7, it’s unclear what is encompassed by “a subject in need of diagnosis and determining the presence of absence of a condition or disease in a tissue and/or an organ using near-infrared fluorescence.” It’s unclear what patient populations are in need and or not in need of diagnosis and determining the presence of absence of a condition or disease in a tissue and/or an organ, and further it’s not clear in what way near-infrared fluorescence is used. Further regarding claim 7, the claim recites “the method comprising the steps of administering a compound as defined in claim 1,” however, there is no method comprising the steps of administering a compound of claim 1. There is therefore insufficient antecedent basis for in claim 7 for “the method… in claim 1.” Further regarding claim 8, the term “a desired course of immunotherapy” is indefinite as it depends on the preferences of the practionier. Further regarding claim 8, “after a period of time” is indefinite because it’s unclear what period of time is encompassed by the term. A period of time could be less than a second, and a period of time can be many years. There’s no clarification in the reference as to what periods of time are encompassed by the claim.
Further regarding claim 11, it’s unclear in what way the method “further involves” subjecting a subject to a therapeutic treatment regimen based on the results obtained by the method. It’s unclear what it means to involve subjecting a subject and how the term “involves” limits the claim. It’s further unclear how what it means to subject a subject to a therapeutic treatment regimin based on the results obtained by the method, and what aspects or characteristics in the results are used in the basis and how this basis is used to qualify the step of subjecting a subject to a therapeutic treatment regimen. There is further no description of how to carry this out across the scope of the invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
9/2/2026
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