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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 9/8/2023 wherein claims 5, 11, 15, and 17 were amended and claim 21 was canceled.
Note(s): Claims 1-20 are pending.
Priority
This application is a 371 of PCT/US2022/019517 filed 3/9/2022 and PCT/US2022/019517 claims benefit to PRO 63/158,750 filed 3/9/2021.
Note(s): The earliest effective filing date is 3/9/2021 as the pending invention is fully supported in the provisional application.
Claim Interpretation
Independent claim 1 is directed to a composition comprising
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wherein the variables are as set forth therein.
Independent claim 7 is directed to a method of treating cancer as set forth therein wherein the compound
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is utilized.
Independent claim 18 is directed to a kit comprising
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.
Information Disclosure Statement
The information disclosure statement filed 12/18/2023 was considered.
Written Description Rejection
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 1-20 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.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection.
(1) The pending application does not sufficiently describe the invention as it relates to targeting units other than carbohydrates such as glucose, peptide, and peptoids (see independent claims 1, 7, and 18). (2) In addition, the pending application does not sufficiently describe the invention as it relates to “cancer treatment modalities other than the compound of Formula I” (see independent claim 15) other than immunotherapy, checkpoint inhibitor therapy, chemotherapy, surgical resection, oncolytic virus therapy, thermal therapy, and radiotherapy. Thus, what there reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms as set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
112 Second Paragraph Rejections
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 15 and 16 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.
Claim 15, lines 2-3: The claim is ambiguous because of the phrase “a cancer treatment modality other than the compound of Formula I”. In particular, it is unclear what specific treatments Applicant is referring to that are compatible with the pending invention.
Claim 16, line 3: The phrase “chemotherapy with a compound other than the compound of Formula I” is ambiguous. Specifically, it is unclear what other compound(s) Applicant is referencing that are compatible with chemotherapy itself as well as the pending invention.
Claim 16, line 4: The claim is ambiguous because of the phrase “and two or more thereof”. Specifically, it appears that the beginning portion of the claim allows for one of the listed treatment modalities to be present. The use of “two or more” is not consistent with the beginning of the claim. Did Applicant intend to write, “The method of claim 15 wherein the cancer treatment modality other than the compound of Formula I is selected from one or more of surgical resection, immunotherapy, chemotherapy, immunotherapy, checkpoint inhibitor therapy, oncolytic virus therapy, thermal therapy, and radiotherapy.”
Comments/Notes
It should be noted that no prior art is cited against the pending invention; however, Applicant must address and overcome the 112 first and second paragraph rejections above. In particular, the claims are distinguished over the prior art of record because the prior art neither anticipates nor renders obvious the structure and uses thereof as set forth in independent claims 1, 7, and 18.
The closest art is that of Fuks et al (J. Radioanal. Nucl. Chem., 2012, Vol. 292, pages 395-399). Fuks et al discloses a structurally similar structure (page 596, Scheme 1). In particular, the structure differs in the attachment of the vector. In the pending invention, the metal is attached to three of the nitrogens and three carboxyl groups in Formula I
(
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). However, for Fuks et al, the metal is attached to three carboxyl groups, two nitrogen groups, and a vector (
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).
Conclusion
Claims 1-20 are rejected.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. Hartley can be reached at (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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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
May 31, 2026
Prosecution Insights