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 13-22 and 41-53 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 application does not describe how to use the method for treating cancer or precancerous disorders in a mammalian subject across the scope of cancer or precancerous disorders in a mammalian subject.
A GRP78 targeting agent is a specialized molecule designed to bind specifically to Glucose-Regulated Protein 78 (GRP78) known to be used to treat certain cancers. However, Glucose-regulated protein 78 (GRP78) treats specific cancers because it is only effective when tumor cells heavily rely on endoplasmic reticulum (ER) stress and cell-surface signaling for survival. The application does not describe methods and protocols for how cancers and precancers can be treated across the scope of cancers and precancers, except for when the cancer is breast cancer or acute myeloid leukemia. Such cancers are demonstrated in applicant’s specification (Examples 1-7). Further regarding the recitation of "a precancerous disorder," this is not a standard, formally defined medical term of art. While it is descriptive and frequently used in casual clinical conversation, medical literature, and patient education, the formal medical community relies on more precise pathological classifications. There is no description in the application of what disorders fall under the scope of “precancerous disorder” within the scope of he claim and what disorders do not fall under the scope of the claim. It is therefore unclear what disorders are under the scope of this term and which disorders are not within the scope of the claims.
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 13-22 and 41-53 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. In claim 1, “disorder in mammalian subject” renders the claim indefinite because the language does not use proper English grammar and “disorder in mammalian subject” does not make grammatical sense. Proper grammar would be “disorder in a mammalian subject.”
Further regarding the recitation of "a precancerous disorder," this is not a standard, formally defined medical term of art. While it is descriptive and frequently used in casual clinical conversation, medical literature, and patient education, the formal medical community relies on more precise pathological classifications. It is therefore unclear what disorders are under the scope of this term and which disorders are not within the scope of the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13-22 and 41-53 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 10851161 to the University of Southern California (hereinafter 'California'; IDS filed 3/28/2024). California discloses a method for treating a cancer or precancerous disorder in a mammalian subject such as a human patient (methods of treating acute myeloid leukemia in a human patient; column 4; line 67; column 37, lines 40-41, 44-46; column 38, lines 35-36), comprising: administering to a mammalian subject in need of treatment for a cancer or' precancerous disorder, a therapeutically effective amount of a radiolabeled GRP78 targeting agent (The method includes administering to the subject a therapeutically effective amount of an antibody or antigen-binding fragment which binds to human cell surface GRP78 linked to a radioactive label; column 4, line 63-66; column 5, lines 23-26, 31-33), wherein the radiolabeled GRP78 targeting agent preferably comprises at least one radiolabel selected from 1311, 1251, 1231, 90Y, 177Lu, 186Re, 188Re, 89Sr, 153Sm, 32P, 225Ac, 213PO, 211At, 212Bi, 213Bi, 223Ra, 227Th, 149Tb, 161Tb, 47Sc, 67Cu, 134Ce, 137Cs, 212Pb, and 103Pd (Examples of labels for polypeptides include, but are not limited to, the following: radioisotopes or radionuclides "e.g. 1311, 1251 , 90Y"; column 21, lines 54~56). As per claim 14, California discloses the method of claim 13. California further discloses wherein the radiolabeled GRP78 targeting agent comprises at least one radiolabel selected from 90Y, 177Lu, 186Re, 225Ac, 211At, 212Bi, 213Bi, 227Th, 149Tb, 161Tb, 47Sc, 67Cu, 134Ce, 137Cs, and 212Pb (administering to the subject an antibody or antigen-binding fragment which binds to cell surface GRP78 covalently linked to an additional functional moiety, such as a label. Examples of labels for polypeptides include, but are not limited to, the following: radioisotopes or radionuclides "e.g. 90Y"; column 5, lines 7-9, 23-26; column 21, lines 54-56). As per claim 15, California discloses the method of claim 13 or 14. California further discloses wherein the cancer or precancerous disorder is a hematological cancer or precancerous disorder (methods of treating acute myeloid leukemia in a human patient; column 4, line 67; column 37, lines 40-41, 44-46; column 38, lines 35-36). As per claim 35, California discloses use of a radiolabeled cell surface GRP78 targeting agent for the treatment of a hematological or solid tumor cancer in a human patient (methods of treating acute myeloid leukemia in a human patient. The method includes administering to the subject a therapeutically effective amount of an antibody or antigen-binding fragment which binds to a human cell surface GRP78 linked to a radioactive label; column 4, line 63-67; column 5, lines 23-26, 31-33; column 37, lines 40-41, 44-46; column 38, lines 35-36). California further teaches a method for treating acute myeloid leukemia in a mammalian subject such as a human patient (methods of treating acute myeloid leukemia in a human patient; column 4, line 67; column 37, lines 40-41, 44-46; column 38, lines 35-36), comprising: administering to the mammalian subject a therapeutically effective amount of a radiolabeled GRP78 targeting agent (the method includes administering to the subject a therapeutically effective amount of an antibody or antigen-binding fragment which binds to human cell surface GRP78 linked to a radioactive label; column 4, lines 63-66; column 5, lines 23-26, 31-33), wherein the radiolabeled GRP78 targeting agent preferably comprises at least one radiolabel selected from 1311, 1251, 1231, 90Y, 177Lu, 186Re, 188Re, 89Sr, 153Sm, 32P, 225Ac, 213PO, 211At, 212Bi, 213Bi, 223Ra, 227Th, 149Tb, 161Tb, 47Sc, 67Cu, 134Ce, 137Cs, 212Pb, and 103Pd (monoclonal antibodies against the GRP78 marker labeled with 125Iodine (1251) may be effectively used for such imaging; column 37, lines 20-25).
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
September 3, 2026
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