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 II in the reply filed on 01/26/2026 is acknowledged.
Applicant’s claim amendments dated 01/26/2026 have canceled the non-elected claims.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 46 is objected to because of the following informalities: change “about1” to “about 1” (line 3). Appropriate correction is required.
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.
Claims 20, 37-38, 44, 46, and 54 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation "the microchannel(s)" in line 8 and in line 16. There is insufficient antecedent basis for this limitation in the claim. The prior lines of the claim recite “one or a plurality of microchannels” rather than “microchannel(s)”.
Claim 20 recites the limitation "the metal region(s)" in lines 13-14. There is insufficient antecedent basis for this limitation in the claim. The prior lines of the claim recite “a metal region” rather than “metal region(s)”.
Claim 20 recites the limitation "the illuminated chamber(s)" in line 14, in line 15, and in line 16. There is insufficient antecedent basis for this limitation in the claim. The prior lines of the claim recite wherein the pulse laser is configured to illuminate one or more chambers rather than “illuminated chamber(s)”.
Claim 20 recites the limitation "the surface of said substrate” in lines 15-16. There is insufficient antecedent basis for this limitation in the claim. The prior lines of the claim recite “an outer surface” of the substrate.
The term “substantially” in claim 44 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification appears to merely restate the claim language and does not provide a standard for ascertaining the requisite degree of the term “substantially”.
Dependent claims are rejected for the same reason(s) as the base claim(s) upon which they depend.
Claim Rejections - 35 USC § 103
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 20, 37-38, 44, 46 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner et al. (US Patent Application Publication 2019/0071695) in view of Madrid (Pulsed laser-activated thermoplasmonic substrates for intracellular delivery) (already of record).
Regarding claim 20, Wagner et al. discloses a laser-actuated injector for delivery of a cargo into a cell (Abstract), the injector comprising:
a substrate (701) comprising a first layer (para. 62) (Fig. 8, sheet 4 of 12), wherein the substrate defines an outer surface (Fig. 8, sheet 4 of 12) and where the substrate comprises a chamber (called cargo reservoir, element 705) disposed within the substrate (para. 62) (Fig. 8, sheet 4 of 12) wherein the chamber is in fluid communication with a plurality of microchannels (703) leading from the chamber to the outer surface of the substrate where the microchannels open to the outer surface of the substrate (para. 62) (Fig. 8, sheet 4 of 12), and where a metal region that can survive heating sufficient to transform a fluid within the chamber into bubbles when irradiated by a pulse laser is provided (para. 4-5, 13, 55); and
a pulse laser configured to illuminate the metal region where the laser is configured to heat the metal region and a fluid to create liquid jetting that ejects out to the surface of the substrate through the microchannels opening into the chamber.
Wagner et al. is silent as to a plurality of the chambers, wherein the metal region is provided within each chamber such that the pulse laser is configured to illuminate one or more of the chambers to heat the metal region and a fluid contained within the one or more illuminated chambers, and wherein the fluid is transformed into a supercritical fluid.
As to the limitation regarding the plurality of chambers, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the substrate disclosed by Wagner et al. to comprise a plurality of the chambers disposed therein, as such a modification would require mere duplication of the chamber already disclosed by Wagner et al., and would yield the predictable outcome of allowing multiple experiments to be run in parallel as is notoriously well known in the art.
As to the limitation regarding the metal region being provided within each chamber such that the chambers are illuminated to heat the metal region, Wagner et al. discloses that the chamber (705) is provided separately from cells (704) (para. 62) (Fig. 8, sheet 4 of 12) and that the pulse laser is operated to deliver cargo into the cells (Abstract). Furthermore, Wagner et al. discloses another embodiment that “uses a separate cavity 402 where the laser is focused 401 in order to cause bubble formation and a shockwave that projects a shockwave 403 into a chamber with cells 404” (para. 50) (Fig. 5, sheet 3 of 12). This embodiment involves illuminating the separate cavity such a fluid contained therein is ejected out through a microchannel into a chamber containing cells (see p. 1379 col. 1 and Fig. 1 of “Pulsed laser triggered high speed microfluidic fluorescence activated cell sorter”, Wu et al., which is incorporated by reference by Wagner et al. when discussing this embodiment). Wagner et al. discloses that this configuration is beneficial in “reducing the possibility of direct laser damage to the cells” (para. 50).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the metal region disclosed by Wagner et al. such that each chamber comprises a metal region, wherein the pulse laser is configured to illuminate one or more of the chambers to heat a metal region and cause a fluid contained within a chamber to eject out, as Wagner et al. discloses such a configuration in another embodiment, and the skilled artisan would have been motivated to adopt this configuration to reduce the possibility of direct laser damage to cells as disclosed by Wagner et al.
As to the limitation regarding the fluid being transformed into a supercritical fluid, Madrid discloses a device for delivery of a cargo into a cell by means of illuminating a metal region with a pulse laser such that the metal region heats a surrounding fluid to generate bubbles therein which thereby porate cells for the delivery of the cargo (p. 1 para. 1-p. 2 para. 1) (thus, the working principle is the same as that of the disclosed invention of Wagner et al.). Specifically, Madrid discloses wherein the pulse laser is configured to heat the metal region to a temperature sufficient to transform the fluid to a supercritical fluid wherein the metal region survives this heating (p. 23 para. 3, p. 47 para. 1).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the pulse laser and metal region disclosed by Wagner et al. such that the pulse laser is configured to heat the metal region so as to transform the fluid into a supercritical fluid wherein the metal region survives heating to this temperature (thus rendering the laser-actuated injector a laser-actuated supercritical injector as claimed), based on the teachings of Madrid, as the skilled artisan would have been motivated to select a configuration recognized in the art to be suitable for achieving laser-actuated delivery of cargo into the cells.
Regarding claim 37, Wagner et al. teaches wherein each chamber comprising the plurality of chambers comprises a metal region, as discussed in the rejection of claim 20, above.
Regarding claim 38, Wagner et al. discloses wherein the metal region comprises gold or titanium (para. 90).
Regarding claim 44, Wagner et al. teaches the chambers, as set forth in the rejection of claim 20 above.
Wagner et al. does not disclose any particular shape for the chambers; however, Wagner et al. discloses elsewhere that substantially cylindrical containers (such as a petri dish) may be used during operation (para. 103).
Nonetheless, it has been held that changes in shape are considered a matter of choice which a person of ordinary skill in the art would find prima facie obvious absent persuasive evidence that the particular shape configuration is significant (MPEP §2144.04).
It would have been obvious to one of ordinary skill in the art to form the chambers taught by Wagner et al. to have a substantially cylindrical shape, as is known in the art, absent persuasive evidence that the particular shape configuration is significant.
Regarding claim 46, Wagner et al. discloses wherein the device is a microfluidic device (title) and therefore it is understood that the chambers and microchannels have dimensions on the order of micrometers.
However, Wagner et al. does not expressly teach dimensions as claimed in claim 46.
Nonetheless, Wagner et al. incorporates by reference “Pulsed laser triggered high speed microfluidic fluorescence activated cell sorter”, Wu et al., as discussed in the rejection of claim 20, above. Wu et al. discloses wherein a microchannel (called nozzle) through which fluid is ejected by laser activation has a channel width of 20 µm (p. 1379 col. 1 para. 3-p. 1380 col. 2 para. 2, Fig. 1).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the microchannels disclosed by Wagner et al. to have an average diameter of 20 µm (falls within the claim range of about 0.1 µm up to about 30 µm), as the skilled artisan would have been motivated to use a particular channel dimension recognized in the art to be suitable for ejecting fluid actuated by laser operation.
Regarding claim 54, Wagner et al. discloses wherein the substrate comprises at least about 8 microchannels (703) associated with a respective chamber (705) (Fig. 8, sheet 4 of 12).
Wagner et al. is silent as to wherein the substrate comprises a number of microchannels and/or a density of microchannels as claimed in claim 54.
Nonetheless, increasing the number of microchannels would amount to mere duplication of the microchannels and/or chambers (as each chamber has a plurality of microchannels associated therewith, see Fig. 8) disclosed by Wagner et al., and it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the substrate disclosed by Wagner et al. to comprise at least about 50 microchannels (falls within the claim range), e.g., by duplicating the microchannels and/or disclosed taught by Wagner et al., as such a modification would yield the predictable result of allowing multiple intracellular delivery operations to be performed in parallel.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Shinde et al. (US Patent Application Publication 2023/0279327) is directed to a platform for laser-actuated injection of cargo into single cells.
Conclusion
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799