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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15, in the reply filed on 05/23/2026 is acknowledged.
Claims 16-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/23/2026.
Status of the Claims
Claims 1-22 are currently pending.
Claims 16-22 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 23-27 are cancelled.
Claims 1-15 have been considered on the merits.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-7, 11, and 13-14 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Thomas et al (US20030092078 A1).
With regards to claim 1, Thomas teaches a method of isolating and removing a subset of target cells from a whole blood sample ([0017]). Thomas teaches adding a fusion protein comprising a first binding domain, a linker, and a second binding domain ([0017]/[0054]/[0055]/[0099]) wherein the first binding domain is specific for RBCs and the second binding domain is specific for a cell surface antigen expressed on a target blood cell (claim 66 of Thomas and [0044]). Thomas also teaches example 5 which demonstrates centrifuging the blood sample to produce a pellet comprising target cells bound to RBCs ([0102]-[0103]). Thomas teaches that the RBC and target cells have been removed from the blood cells remaining in the supernatant and that the target cells are isolated in the RBC pellet ([0102]-[0103]).
Regarding claims 2 and 3 Thomas teaches that the target cell is not an RBC and that the target cell is selected from T cells, B cells, NK cells, dendritic cells, monocytes, basophils, mast cells, progenitor cells, stem cells, and tumor cells ([0032]).
Regarding claims 4 and 5, Thomas teaches that the RBC antigen is glycophorin A (claim 66 of Thomas and [0044]).
Regarding claim 6, Thomas teaches that the target cell of a T cell can be targeted using anti-HLA-DR, which is one of the MHC-II peptides (see Table 1 and 2).
Regarding claim 7, Thomas teaches that target blood cells are removed from the whole blood ([0017]) and that the target blood cells can comprise antigen presenting cells (APCs) ([0034]).
Regarding claim 11, Thomas teaches wherein the linker is covalently bound, which is being interpreted to meet the limitation of stable ([0054]).
Regarding claim 13 and 14, Thomas teaches that the target cells are further separated from the RBCs from lysing the RBCs ([0104]).
Thus, Thomas anticipates the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al (US20030092078 A1), in view of Zhou et al (US20180078624 A1).
With regards to claims 8-9, Thomas teaches the limitations of the independent claim 1 and dependent claim 7 above and reproduced below.
Regarding claim 7, Thomas teaches that target blood cells are removed from the whole blood ([0017]) and that the target blood cells can comprise antigen presenting cells (APCs) ([0034]).
Thomas is silent as to whether the APCs are infected by a virus as required by claim 8. Thomas is silent as to whether the APCs comprise a cancer-inducing mutation as required by claim 9.
Regarding claims 8-9, Zhou teaches a method of using APCs loaded with various antigens including loading the APCs with a virus specific antigen known to induce cancer ([0222]). Additionally, Zhou teaches that these APCs are capable of being used to treat or prevent tumor progression, relapse, or metastasis in the form of APC culture, T cell culture, APC and T cell co-culture, PBMCs, or any combination thereof ([0122]).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the method of Thomas employing APCs with the genetically engineered APCs taught by Zhou to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Thomas teaches the separation of APCs in general employing the instant method and Zhou teaches genetically altered APCs which are taught to be isolated for the use of treating cancer ([0122]). Thus, the motivation to specifically apply the method of isolating the APCs of Thomas to the APCs of Zhou would be due to Zhou’s motivation to isolate and specifically use genetically altered APCs. One of ordinary skill in the art would have a reasonable expectation of success when combining Thomas and Zhou because Thomas teaches all necessary information to perform the method on APCs and Zhou provides the necessary information to obtain and use genetically modified APCs.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 1 and 10, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al (US20030092078 A1), in view of Zhou et al (US20120321626A1), referred to as Zhou 2 for clarity.
With regards to claims 10, 12, and 15, the limitations of the independent claim 1 and dependent claims 6 and 13 are taught above and reproduced below.
Regarding claim 6, Thomas teaches that the target cell of a T cell can be targeted using anti-HLA-DR, which is one of the MHC-II peptides (see Table 1 and 2).
Regarding claim 13, Thomas teaches that the target cells are further separated from the RBCs from lysing the RBCs ([0104]).
Thomas does not teach that the second binding domain comprises a single chain T cell receptor (scTCR) as required by claim 10. Thomas does not teach that the linker is cleavable as required by claim 12.
Regarding claim 15, Thomas does teach the steps of resuspending the pellet, and centrifuging the suspension containing RBC and target cells, whereby the RBCs are pelleted as described in the 102 rejection presented above however, the specific step of the linker having been cleaved which is required by claim 15 is not disclosed in Thomas.
However, Zhou 2 teaches about multi-specific fab fusion proteins and methods of use (abstract).
Regarding claim 10, Zhou 2 teaches that one of the binding domains for the fusion proteins can be a single chain T cell receptor ([0150]).
Regarding claim 12, Zhou 2 teaches that the fusion protein contains a cleavable linker and that a well known peptide sequence of PLGLAG in a substrate can be cleaved ([0184]).
Regarding claim 15, as described above, Thomas teaches all the steps of claim 15 besides cleaving the linker. Thomas teaches example 5 which demonstrates centrifuging the blood sample to produce a pellet comprising target cells bound to RBCs ([0102]-[0103]). Thomas teaches that the RBC and target cells have been removed from the blood cells remaining in the supernatant and that the target cells are isolated in the RBC pellet ([0102]-[0103]). Thomas also teaches an embodiment wherein the target cells are left remaining in the supernatant (Example 4, [0089]). Zhou 2 teaches a fusion protein which can be cleaved. Cleaving the fusion protein of Thomas would result in the desired/target cells be left behind in the supernatant during the re-centrifugation step which is a desirable outcome as described by Example 4 of Thomas.
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the method of Thomas employing APCs with the scTCR and cleavable linker taught by Zhou 2 to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Thomas teaches the separation of APCs in general employing the instant method and Zhou 2 teaches that the fusion proteins of the invention allow for selectivity and specificity in a controlled manner (abstract). One of ordinary skill in the art would have a reasonable expectation of success when combining Thomas and Zhou 2 because Thomas teaches all necessary information to perform the method and Zhou 2 provides the necessary information to use a scTCR and a cleavable linker.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
Prosecution Insights