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 10/28/2025 wherein claims 11, 20, 23, and 26-28 were canceled; claims 1-3, 13, and 22 were amended; and claims 29 and 30 were added.
Note(s): Claims 1-10, 12-19, 21, 22, 24, 25, 29, and 30 are pending.
Priority
This application is a 371 of PCT/US2020/029790 filed 4/24/2020 and PCT/US2020/029790 claims benefit to PRO 62838589 filed 4/25/2019.
Note(s): The earliest effective filing date is 4/25/2019 as the invention was fully disclosed in the provisional application.
Claim Interpretation
Independent claim 1 is directed to a method for targeted depletion of a subject's hematopoietic stem cells, the method comprising: administering to the subject an effective amount of a composition comprising a radiolabeled antibody against CD135 conjugated to p-SCN-Bn-DOTA wherein the radiolabel is selected from 1311, 1251, 123I, 90Y, 177Lu, 186Re, 188Re, 89Sr, 153Sm, 32P, 225Ac, 213Bi, 213Po, 211At, 212Bi, 213Bi, 223Ra, 227Th, 149Tb, 137Cs, 212Pb, and 103Pd.
Independent claim 13 is directed to a method of treating a subject afflicted with a cancerous disorder treatable via bone marrow transplant, the method comprising:
(i) administering to the subject an amount of a radiolabeled antibody effective to deplete or ablate the subject's hematopoietic stem cells; and
(ii) after a suitable time period, performing the bone marrow transplant on the subject to treat the subject's disorder, wherein the cancerous disorder is a leukemia or a lymphoma and the antibody comprises a conjugate of anti-CD135 and p-SCN-Bn-DOTA wherein the radiolabeled is selected from 1311, 1251, 123I, 90Y, 177Lu, 186Re, 188Re, 89Sr, 153Sm, 32P, 225Ac, 213Bi, 213Po, 211At, 212Bi, 213Bi, 223Ra, 227Th, 149Tb, 137Cs, 212Pb, and 103Pd.
Independent claim 18 is directed to a method for treating a subject afflicted with a non-cancerous disorder treatable via genetically edited cell therapy comprising:
(i) administering to the subject an amount of a radiolabeled antibody effective to deplete the subject's hematopoietic stem cells, and
(ii) after a suitable time period, performing the therapy on the subject to treat the subject's disorder, wherein the non-cancerous disorder is selected from the group consisting of a hemoglobinopathy, a congenital immunodeficiency, and a viral infection, and the antibody comprises anti-CD34, anti-CD117, anti-CD135, or a combination thereof, and wherein the radiolabeled antibody is labeled with 1311, 1251, 123I, 90Y, 177Lu, 186Re, 188Re, 89Sr, 153Sm, 32P, 225Ac, 213Bi, 213Po, 211At, 212Bi, 213Bi, 223Ra, 227Th, 149Tb, 137Cs, 212Pb, and 103Pd.
Independent claim 30 is directed to a method of targeting depletion of a subject’s hematopoietic stems cells comprising administering and effective amount of a radiolabeled antibody comprising a conjugate of an anti-CD135 monoclonal antibody and p-SCN-bn-DOTA wherein the radiolabel is selected from 1311, 1251, 123I, 90Y, 177Lu, 186Re, 188Re, 89Sr, 153Sm, 32P, 225Ac, 213Bi, 213Po, 211At, 212Bi, 213Bi, 223Ra, 227Th, 149Tb, 137Cs, 212Pb, and 103Pd.
Applicant’s Election
Once again, Applicant’s election without traverse of Group I (pending claims 1-10, 12, and newly added claim 29) was acknowledged in the reply filed on 3/21/2025.
Note(s): Due to the amending of independent claim 13 and the addition of newly added claim 30 to be of the same scope as independent claim 1, those claims have been added to Group I. Thus, modified Group I includes pending claims 1-10, 12-17, 29, and 30. The full scope of modified Group I was examined.
Withdrawn Claims
Claims 18, 19, 21, 22, 24, and 25 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 10/28/2025 to the rejection of claims 1, 3, 9, and 10 made by the Examiner under 35 USC 103 have been fully considered and deemed persuasive because Applicant amended the claims to overcome the rejection. Therefore, the said rejection is hereby WITHDRAWN.
NEW GROUNDS OF REJECTIONS
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 4 and 5 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 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. The pending application does not sufficiently describe the invention as it relates to non-cancerous disorders that are treatable via genetically edited cell therapy other than sickle cell disease, severe combined immunodeficiency disease, and beta thalassemia. Thus, what the 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.
Allowable Claims
Claims 1-3, 9, 10, 12-17, 29, and 30 are allowable over the prior art of record.
Claim Objections
Claims 6-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Comments/Notes
It should be noted that no prior art is cited against modified Group I (pending claims 1-10, 12-17, 29, and 30). In particular, the claims are distinguished over the prior art of record because the prior art neither anticipates nor renders obvious targeted methods of hematopoietic stem cell depletion as set forth in independent claims 1 and 30 and a method of treating leukemia or a lymphoma as set forth in independent claim 13. The closest art is that of Navarro et al (Bioconjugate Chem., August 2019, Vol. 30, pages 2393-2403) which was made available to the public after Applicant’s earliest effective filing date.
Conclusion
Claims 1-3, 9, 10, 12-17, 29, and 30 are allowable over the prior art of record. Claims 4 and 5 are rejected. Claims 6-8 are objected. Claims 18, 19, 21, 22, 24, and 25 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
February 10, 2026