DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I and species “HER2”, “small molecule”, and “cancer” in the reply filed on 7/7/2026 is acknowledged. The traversal is on the ground(s) that Group I and II have unity of invention. This is not found persuasive because as stated in the restriction, even though the inventions of these groups require the same technical feature that feature is not novel over the prior art Yaman et al. The requirement is still deemed proper and is therefore made FINAL.
Claims 12-16, 18, 19, 21, 22, 24, and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/7/2026.
Claims 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/7/2026.
Claims 1-9 are pending and will be examined on the merits.
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 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.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: it is unclear the relationship of recited elements in Claim 4 and how they relate to the elements recited in claim 3, furthermore the claim recites 2 independent sentences. Appropriate correction is required. Claim 4 will not be further examined on the merits.
Claim 5 recites the limitation "the first and second specificity" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-3, 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yaman et al. (August 2019, cited on IDS filed 11/03/2019).
The claims are drawn to a chimeric antigen receptor (CAR) T cell membrane coated particle (CAR-T-MNP) comprising a T cell membrane comprising a CAR on its cell membrane and an engineered particle comprising a small molecule anticancer drug.
Yaman et al. discloses a chimeric antigen receptor (CAR) T cell membrane coated particle (CAR-T-MNP) (Pg. ii, first paragraph, Anti-her2 CAR-T cell membrane coated PLGA nanoparticles (CAR-T-MNPs)) comprising (i) a T cell membrane comprising a CAR on its cell membrane (Pg. ii, first paragraph, Anti-HER2 based chimeric antigen receptor (CAR) engineered Jurkat T cell membranes), and (ii) an engineered particle; wherein the engineered particle comprises a therapeutic agent (Pg. ii, first paragraph, anti-cancer drug afatinib loaded poly(D,L-lactide-co-glycolide} (PLGA) nanoparticles (NPs)). Yaman et al. further discloses the CAR-T-MINP of claim 1, wherein the CAR comprises a first specificity specific for a cancer cell specific marker such as HER2. Yaman et al. discloses the CAR-T-MNPs of claim 1, wherein the CAR-T-MNP comprises (i) bi-specific CAR comprising a CAR-T plasma membrane with an intracellular facing binding moiety and an extracellular facing binding moiety (see Pg. 97, last paragraph-Pg. 98, first paragraph), double sided CARs (intracellular and extracellular facing ScFv modified CARs); isolated membranes are going to have targeting ScFv's on both sides of their lipid bilayer and when it is extruded along with NPs, the out layer of the membrane is always going to have outfacing ScFv's, and/or (ii) two or more differently targeting CARs. Yaman et al. disclose modifying the nanoparticle surface with targeting moieties is significantly enhancing its targeting ability to specifically bind to certain cancer cells. Furthermore, this specific ligand-receptor interaction facilitates the uptake of NPs inside cytoplasm via receptor-mediated endocytosis. The efficiency is defined as capability of delivering nanocarriers selectively to the targeted tissue. Aptamers, antibodies, peptides, nucleic acids, growth factors and various small molecules can be given as examples for targeting moieties utilized in active drug delivery
applications (see section 1.5.1 pgs 12-13). Yaman et al. disclose combining afatinib loaded PLGA NPs with CAR-T cell membranes from genetically engineered human Jurkat lymphocytes to target Her-2 positive lung cancer for therapy and therefore teach each and every limitation of Claims 1-3 and 5-9.
Conclusion
Claims 1-9 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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