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 .
Claim Status
Claims 8-11, 13-14, 20, 28-30 are cancelled.
Claims 1-7, 12, 15-19, 21-27 are pending.
Claims 1-7, 12, 15 are examine on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-7, 12 and 15) in the reply filed on 05/14/2025 is acknowledged.
Claims 16-19 and 21-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/14/2025.
Priority
This application claims priority to co-pending U.S. provisional No.: 62/940,553 filed on November 26, 2019 is acknowledged.
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.
Claims 1-7, 12, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Uhland et al. (“Uhland”, EP 2 514 411 B1, cited as reference 1 on IDS filed 05/17/2022) in view of Adamo et al. (“Adamo”, J. Micromech. Microeng. 2013).
Regarding claims 1-2, 6, Uhland teaches devices, systems, and methods described herein may be used for targeted delivery of therapeutic, diagnostic, or other substances into or through a variety of types of tissues or biological barriers, including suitable cells, tissues, or organs (e.g., paragraph 0020). Uhland teaches the drug delivery device includes a gas source which contains or produces a pressurized gas. The drug delivery device also includes one or more collimators that are fluidly connected with the gas source. Each of the collimators may be adapted to form a plurality of collimated gas streams comprising the gas (e.g., paragraph 0021). Uhland teaches the method includes delivering a pressurized gas into a collimator to produce a plurality of collimated streams of gas; penetrating the tissue with the plurality of collimated streams of gas to produce a plurality of pores in the tissue (it reads on displacing the fluid adjacent to the cell); and delivering the substance into the tissue via the plurality of pores (e.g., paragraph 0052). Uhland teaches transdermal drug delivery approach utilizes high velocity jets to impart sufficient momentum to a drug form to cause the drug form to breach the stratum corneum. Most commonly high velocity jet injectors are5liquid-based. Liquid-based high velocity jet injectors produce liquid jets composed of liquid solutions or colloidal suspensions of drug macromolecules to deliver the drug to the patient. The liquid jet velocity may be in the range of 100 m/s to 150 m/s (e.g., paragraph 0005).
Regarding claim 5, Uhland teaches administration of substances, such as drugs, into a biological tissue, and in certain embodiments more particularly relates to devices and methods for the transdermal delivery of a drug to a patient (e.g., paragraph 0001).
Uhland does not teach the mechanically generated liquid beam as required by claims 3. Uhland does not teach the electroporation as required by instant claim 12. Uhland does not teach the poration of the membrane is caused by the liquid beam, as required by instant claim 15. However, this is cured by Adamo.
Regarding claims 3-4, 15, Adamo teaches microfluidic-based injection system designed to achieve intracellular delivery of macromolecules by directing a picoliter jet of a solution toward the individual cells (it reads into mechanically generated liquid beam) (e.g., abstract). Adamo teaches a device concept in which suspended cells flow
into a microfluidic chip and are lined up using a channel with a width comparable to that of the cells of interest; in the top wall of the channel, there is a miniaturized nozzle through which a high-speed liquid jet can be fired onto the cells upon their passage. The jet has a small volume in comparison to the cell volume and contains the compound to be injected. If the jet has sufficient energy to penetrate the cell, it will deliver a portion of its payload inside the cell. The jet is created using a miniaturized nozzle in communication with a chamber, where sudden compression of a piezoelectric membrane generates pressure pulses whenever a jet is needed (e.g., page 3; Fig 1; Fig. 3; Fig. 4). The order of magnitude of jet speeds that can penetrate a cell membrane can be estimated with a simple model equating the force a jet exerts onto a surface (∼ρV2A, with ρ being the density of the liquid, V the speed of the jet and A the cross-sectional area of the jet) with the force needed to rupture the cell membrane; assuming the cell membrane to have a thickness of ∼10 nm, we estimated a required penetration speed of 1–5 m s–1 for a jet that is 1–4 μm in diameter (e.g., page3). Adamo teaches that once a cell is penetrated, the injection volume can be controlled by varying the duration of the jet and its speed; microinjection volumes are typically of the order of 1/10 of the cell volume; 19]; therefore, a cell with a diameter of 12 μm should require a 0.1 pL injection volume (e.g., page 3) (The device of Adamo is a micro-scale “needle-less-injector; the “jet” implies a high-velocity, focused stream of liquid; the force of the mechanically disrupts the cell membrane and these transient pores allow the macromolecules from the jet to enter the cell’s cytoplasm).
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Regarding claim 12, Adamo teaches that in electroporation the cells are exposed for a short period of time to an electric field that forms pores in the cell membrane (e.g., page 1).
It would have obvious to one of ordinary skill in the art before the effective filing day of the claimed invention to combine the teaching of Uhland -method includes delivering a pressurized gas into a collimator to produce a plurality of collimated streams of gas; penetrating the tissue with the plurality of collimated streams of gas to produce a plurality of pores in the tissue; and delivering the substance into the tissue via the plurality of pores; with a microfluid system designed to direct liquid jet toward cells enabling the introduction of macromolecules as taught by Hardee to obtain a method using a gas jet to displace fluid around the cell and a mechanically generated liquid beam to deliver DNA, RNA, proteins or nanoparticles to host cells.
One would have been motivated to develop a method using a mechanically generated liquid beam that creates temporary pores in the cells to facilitate the delivering exogenous material into host cells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIO GOMEZ RODRIGUEZ whose telephone number is (571)270-0991. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/JULIO WASHINGTON GOMEZ RODRIGUEZ/ Examiner, Art Unit 1637
/J. E. ANGELL, Ph.D./ Primary Examiner, Art Unit 1637