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
This office action is in response to the reply filed on 12/15/25. In the reply, the applicant elected Group I without traverse and amended claims 1, 16. Claims 1-19 are pending with claims 10-15 being withdrawn.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/5/25;10/24/25;12/26/24;2/14/24;9/14/23;8/23/23;5/31/23 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
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.
Claims 1-4, 6-9, 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flores et al. (US 2017/0232229) (“Flores”).
(claim 1) Flores discloses: (Fig. 3A) A surgical plunger assembly in combination with a cannula assembly, comprising: a stylet 30 configured to cooperate with the cannula assembly, the stylet comprising opposing proximal and distal ends; a connector 60 comprising an internal seal 65 coupled to the stylet; and a support body 20 coupled to the connector and extending above the distal end of the stylet, wherein the support body encloses a sub-length of the stylet, wherein the stylet is longitudinally moveable relative to the support body between first and second positions, wherein, in the first position, the proximal end of the stylet is closer to the connector than in the second position. [0117] Fig. 2A,3A
Claim 2: a plunger comprising a first segment coupled to or defined by the stylet and a second segment having a greater cross-sectional size that the first segment, wherein the second segment merges into an external plunger flange, wherein the support body encloses the first segment and at least a portion of the second segment and the first segment and the second segment are longitudinally movable relative to the support body, and wherein with the plunger in a first position, the stylet is in the first position and the second segment of the stylet resides closer to the connector than when the stylet is in the second position. See Figs. 2a,3a
Claim 3: the stylet has a length outside the support body that is in a range of 6 inches and 10 feet. [0105]
Claim 4: the stylet comprises an MRI compatible material [0018] and has a maximal outer diameter in a range of about 0.005 inches and about 0.020 inches. [0099]
Claim 6: the stylet comprises fused silica. [0010,0104]
Claim 7: a drive screw 50s that resides at least partially in the support body 20 and that is coupled to the proximal end of the stylet.
Claim 8: a collar 40w that is coupled to the support body and the drive screw, wherein the collar is rotatable in clockwise and counterclockwise directions to translate the stylet. [0111,0117] Fig. 3a
Claim 9: a support tube 70 residing inside the support body and coupled to the connector above the seal, wherein the stylet is slidably coupled to the support tube to retract and extend inside the support tube while the support body slidably retracts and extends in concert with the stylet about an outer wall of the support tube. [0117]
Claim 16: the stylet is sized and configured to have a length that is at least as long as a length of the cannula assembly with an open channel formed by an inner tube thereof, and wherein the stylet retracts and cooperates with a distal end 20d of the cannula assembly to create a vacuum to intake and front-load a therapeutic substance into the inner tube and hold the front-loaded therapeutic substance entirely between a distal end and proximal portion of the cannula assembly in a ready to dispense configuration to thereby provide a front-loadable delivery system. [0168,0147]
Claim 17: the therapeutic substance comprises target cells. [0147,0083]
Claim 18: the cannula assembly and stylet are configured to cooperate to deliver the therapeutic substance to an intrabrain target site. [0168,0147]
Claim 19: the stylet is configured to move distally toward the distal end of the cannula assembly to deliver the front-loaded therapeutic substance to a target intrabrain site. [0168,0147]
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Flores.
Flores discloses the invention as substantially claimed but does not directly disclose the stylet comprises Nitinol. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the stylet comprise Nitinol since it has been held within the general skill of one skilled in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783