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 .
Response to Amendment
This office action is responsive to the amendment filed on 05/11/2026. As directed by the amendment: claims 1, 20-23 & 26-27 have been amended. No claim has been cancelled.
Thus, claims 1-29 are still pending in this application.
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 1-8, 13-16 and 20-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krasnow (US 10413676 B1).
Regarding claim 1, Krasnow discloses an apparatus (10) comprising: a syringe (12) including a plunger (14) that communicates with a chamber configured to hold a liquid treatment substance ((20), fig 3, col 2, lines 48-55 ); and an ultrasound or shock wave pressure wave generator (22/24) coupled to the syringe (fig 3) and positioned to generate and propagate acoustic pressure waves ((25), an ultrasonic signal is a type of acoustic pressure wave) through the liquid treatment substance (20) in the chamber in a direction from the plunger (14) to and through a syringe funnel (18), whereby the acoustic pressure waves (25) propagate internally through the liquid treatment substance in the chamber (col 4, lines 38-48, fig 3).
Regarding claim 2, Krasnow discloses the apparatus of claim 1, further comprising a syringe needle (16) coupled to the syringe funnel (fig 1).
Regarding claim 3, Krasnow discloses apparatus of claim 1, wherein the pressure wave generator (24) is coupled to the plunger (fig 1).
Regarding claim 4, Krasnow discloses the apparatus of claim 3, further comprising a syringe needle (16) coupled to the syringe funnel (fig 1).
Regarding claim 5, Krasnow discloses the apparatus of claim 1, wherein the pressure wave generator is a shock wave or ultrasound generator (abstract and col 3, lines 6-35).
Regarding claim 6, Krasnow discloses the apparatus of claim 5, further comprising a syringe needle (16) coupled to the syringe funnel (fig 1).
Regarding claim 7, Krasnow discloses the apparatus of claim 1 wherein the pressure wave generator is selected from the group consisting of an electrohydraulic shock wave generator, electromagnetic shock wave generator and piezoelectric shock wave generator (col 3, lines 6-35 and col 4, lines 38-41).
Regarding claim 8, Krasnow discloses the apparatus of claim 7, further comprising a syringe needle (16) coupled to the syringe funnel (fig 1).
Regarding claim 13, Krasnow discloses the apparatus of claim 1, wherein the chamber includes a liquid treatment substance (20) comprising one or more of a vaccine, drug, antibiotic, medication, mixture of multiple active ingredients, gene medicine, stem cells, genetic material, RNA or mRNA genetic material, genetic modified material, immune cells cocktail, neutrophils, eosinophils, basophils, mast cells, monocytes, macrophages, dendritic cells, natural killer cells, lymphocyte B cells or T cells, base editor, liposomes, lipid nano-particles, lipid micro-particles, artificially or naturally enveloped active substance, nano-robot, nano-particle, protein, antibody and stem cell, and combinations thereof (fig 3, medication 20).
Regarding claim 14, Krasnow discloses the apparatus of claim 2, wherein the chamber includes a liquid treatment substance (20) comprising one or more of a vaccine, drug, antibiotic, medication, mixture of multipleactive ingredients, gene medicine, stem cells, genetic material, RNA or mRNA genetic material, genetic modified material, immune cells cocktail, neutrophils, eosinophils, basophils, mast cells, monocytes, macrophages, dendritic cells, natural killer cells, lymphocyte B cells or T cells, base editor, liposomes, lipid nano-particles, lipid micro-particles, artificially or naturally enveloped active substance, nano-robot, nano-particle, protein, antibody and stem cell, and combinations thereof (fig 3, medication 20).
Regarding claim 15, Krasnow discloses the apparatus of claim 1, wherein the pressure wave generator is battery- operated (col 3, lines 55-64).
Regarding claim 16, Krasnow discloses the apparatus of claim 15, further comprising a syringe needle (16) coupled to the syringe funnel (fig 1).
Regarding claim 20, Krasnow discloses a method of treating a human body or animal body with the apparatus of claim 1 comprising; placing a funnel (18) portion of the syringe in direct contact with the human body or animal body, generating acoustic pressure waves from the pressure wave generator through the liquid treatment substance in the chamber, and applying the liquid treatment substance from the chamber to the human body or animal body (fig 3, col 8, lines 60-67 and col 9, lines 1-32).
Regarding claim 21, Krasnow discloses a method of treating a human body or animal body with the apparatus of claim 1 comprising; placing a funnel portion of the syringe of the apparatus in direct contact with the human body or animal body, generating acoustic pressure waves from the pressure wave generator through the liquid treatment substance in the chamber, and injecting the liquid treatment substance from the chamber into the human body or animal body (fig 3, col 8, lines 60-67 and col 9, lines 1-32).
Regarding claim 22, Krasnow discloses the method of claim 21, wherein said acoustic pressure waves are simultaneously generated while the liquid treatment substance is being injected into the human body or animal body (col 9, lines 14-23- while plunger 14 is being depressed, plunger head 22 may send and receive ultrasonic signals 25 in the form of ultrasonic waves via ultrasonic transducer 24).
Regarding claim 23, Krasnow discloses the method of claim 20, wherein said acoustic pressure waves are simultaneously generated while the liquid treatment substance is being applied to the human body or animal body (col 9, lines 14-23).
Regarding claim 24, Krasnow discloses the method of claim 23, wherein the pressure wave generator is an ultrasound or shock wave generator (abstract and col 3, lines 6-35).
Regarding claim 25, Krasnow discloses the method of claim 22, wherein the pressure wave generator is an ultrasound or shock wave generator (abstract and col 3, lines 6-35).
Regarding claim 26, Krasnow discloses a method of treating a human body or animal body with the apparatus of claim 1 comprising dispensing the liquid treatment substance from the chamber with the plunger while simultaneously generating acoustic pressure waves with the pressure wave generator through the liquid treatment substance in the syringe(fig 3, col 8, lines 60-67 and col 9, lines 1-32).
Regarding claim 27, Krasnow discloses a method of treating a human body or animal body with the apparatus of claim 2 comprising dispensing the liquid treatment substance from the chamber with the plunger while simultaneously generating acoustic pressure waves with the pressure wave generator through the liquid treatment substance in the syringe (fig 3, col 8, lines 60-67 and col 9, lines 1-32).
Regarding claim 28, Krasnow discloses the method of claim 27, wherein the pressure wave generator is an ultrasound or shock wave generator (abstract and col 3, lines 6-35).
Regarding claim 29, Krasnow discloses the method of claim 26, wherein the pressure wave generator is an ultrasound or shock wave generator (abstract and col 3, lines 6-35).
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 9-12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Krasnow (US 10413676 B1) in view of Cioanta et al (US 20180221688 A1).
Regarding claim 9, Krasnow discloses the limitations of claim 1 but fails to teach said apparatus further comprising a reflector coupled to the syringe adjacent the shock wave generator.
Krasnow teaches that a porous membrane may be designed to allow medication to pass through while providing a surface with good reflective properties for the ultrasonic signals to reflect back towards ultrasonic transducer (col 5, lines 28-32).
However, However, Cioanta et al disclose an apparatus that use acoustic pressure shock waves (see para 0002, see fig 1A) comprising a shock wave generator (11) and a reflector (12) coupled to the shock wave generator (see fig 1A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the pressure wave generator of Krasnow and incorporate the teachings of Cioanta et al to have a reflector coupled to the syringe adjacent the shock wave generator. The modification would provide the benefit of precisely controlling the direction of the signal and increasing signal strength producing focused acoustic pressure shock waves (see para 0120-22).
Regarding claim 10, Krasnow in view of Cioanta et al disclose the apparatus of claim 9,
Cioanta et al further disclose the reflector is selected from the group consisting of a semi-ellipsoidal reflector, parabolic reflector, and combination semi-spherical and conical reflector (para 0119).
Regarding claim 11, Krasnow in view of Cioanta et al disclose the apparatus of claim 10,
Krasnow further discloses said apparatus comprising a syringe needle (16) coupled to the syringe funnel (fig 1).
Regarding claim 12, Krasnow in view of Cioanta et al disclose the apparatus of claim 9,
Krasnow further discloses said apparatus comprising a syringe needle (16) coupled to the syringe funnel (fig 1).
Regarding claim 19, Krasnow in view of Cioanta et al discloses the apparatus of claim 12,
Krasnow further discloses wherein the chamber includes a liquid treatment substance (20) comprising one or more of a vaccine, drug, antibiotic, medication, mixture of multipleactive ingredients, gene medicine, stem cells, genetic material, RNA or mRNA genetic material, genetic modified material, immune cells cocktail, neutrophils, eosinophils, basophils, mast cells, monocytes, macrophages, dendritic cells, natural killer cells, lymphocyte B cells or T cells, base editor, liposomes, lipid nano-particles, lipid micro-particles, artificially or naturally enveloped active substance, nano-robot, nano-particle, protein, antibody and stem cell, and combinations thereof (fig 3, medication 20).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Krasnow (US 10413676 B1) in view of Giustetto et al (US 20210069332 A1).
Regarding claim 17, Krasnow discloses the limitations of claim 1 and further discloses said apparatus further comprising a control console (50) operably coupled to the pressure wave generator (fig 5) but fails to teach wherein the control console automatically provides control parameters to the generator based on the type of liquid treatment substance provided in the chamber.
However, Giustetto et al disclose a system for inducing sonoporation of a drug (abstract) comprising a pressure wave generator (para 0027) and a control unit (input device and processor, para 0029 and 0030) to control parameters to the generator based on the type of treatment substance provided (para 0030-34, data entered include the type of drug).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Krasnow and incorporate the teachings of Giustetto et al to have said apparatus wherein the control console provides control parameters to the generator based on the type of liquid treatment substance provided in the chamber. This modification would provide the benefit of adjusting the timing and intensity of shockwaves based on the specific type of drugs administered (see para 0042).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Krasnow (US 10413676 B1) in view of Giustetto et al (US 20210069332 A1) and further in view of Roof (US 20080109260 A1).
Regarding claim 18, Krasnow in view of Giustetto et al discloses the limitations of claims 1 and 17, but fails to teach the control console is configured to receive a scanned code identifying the type of liquid treatment substance provided in the chamber.
However, Roof discloses a method and a system for capturing drug administration data (abstract and para 003) comprising a medical processing system that includes a handheld scanner configured to receive a scanned code identifying the type of treatment substance (para 0008 and 0009).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the control console of Krasnow and incorporate the teachings of Roof to have said control console configured to receive a scanned code identifying the type of liquid treatment substance provided in the chamber. This modification would provide the benefit of programming the treatment parameters automatically without the need of the user input (see para 0006-0007).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-29 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/FATIMATA SAHRA DIOP/ /BHISMA MEHTA/ Examiner, Art Unit 3783 Supervisory Patent Examiner, Art Unit 3783
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