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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/2025 has been entered.
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 1-6, 13, 14 and 20-29 are rejected under 35 U.S.C. 103 as being unpatentable over Parsons et al (US 4680027 A) in view of Babaev (US 20030229304 A1).
Regarding claim 1, Parsons et al disclose an apparatus (fig 1, abstract) comprising: a syringe (100) including a plunger (160) that communicates with a chamber (110/116) configured to hold a liquid treatment substance (col 7, lines 42-52) and a pressure wave generator (104 with cartridge 102, col 10, lines 56- 66, examiner notes: sudden release of gas generate pressure waves) coupled to the syringe (fig 2) and positioned to propagate pressure waves in a direction from the plunger to and through a syringe funnel (114), whereby the pressure waves propagate internally through the liquid treatment substance in the chamber (col 11, lines 11-24 and col 19, lines 50-58).
Parsons et al fail to teach said pressure wave generator is an-ultrasound or shock wave generator.
However, Babaev discloses an apparatus (2, fig 1) comprising a syringe (14) with a chamber (16) and pressure wave generator (4 and 8) wherein the pressure wave generator is a ultrasound wave generator (para 0027) and whereby the pressure waves propagate internally through the liquid treatment substance in the chamber (para 0029 and claim 1).
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 Parsons et al to have the pressure wave generator to be an-ultrasound as taught by Babaev. This would provide the benefit of inducing wave motion in fluid in said chamber and enhance the absorption of treatment substance delivered to certain body lumens (para 0014).
Regarding claim 2, Parsons et al in view of Babaev disclose the apparatus of claim 1,
Parsons et al further teach said apparatus comprising a syringe needle (122) coupled to the syringe funnel (fig 1).
Regarding claim 3, Parsons et al in view of Babaev disclose the apparatus of claim 1,
Parsons et al further teach wherein the pressure wave generator is coupled to the plunger (fig 4, mechanism 104 is coupled to plunger 160 via portion 234).
Regarding claim 4, Parsons et al in view of Babaev disclose the apparatus of claim 3,
Parsons et al further teach said apparatus comprising a syringe needle (122) coupled to the syringe funnel (fig 1).
Regarding claim 5, Parsons et al in view of Babaev disclose the apparatus of claim 1,
Babaev further teaches wherein the pressure wave generator (4/8) is a shock wave or ultrasound generator (para 0027).
Regarding claim 6, Parsons et al in view of Babaev disclose the apparatus of claim 5,
Parsons et al further teach said apparatus comprising a syringe needle (122) coupled to the syringe funnel (fig 1).
Regarding claim 13, Parsons et al in view of Babaev disclose the apparatus of claim 1,
Parsons et al further teach said apparatus wherein the chamber includes a liquid treatment substance 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 (abstract and col 1, lines 6-10).
Regarding claim 14, Parsons et al in view of Babaev disclose the apparatus of claim 2,
Parsons et al further teach said apparatus wherein the chamber includes a liquid treatment substance 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 (abstract and col 1, lines 6-10).
Regarding claim 20, Parsons et al in view of Babaev disclose a method of treating a human body or animal body (fig 1) with the apparatus of claim 1,
Parsons et al further teach said apparatus comprising placing a funnel portion (114) of the syringe in direct contact with the human body or animal body (see fig 13, skin 510), generating pressure waves from the pressure wave generator, and applying the liquid treatment substance from the chamber to the human body or animal body (col 11, lines 11-24 and col 19, lines 50-58).
Regarding claim 21, Parsons et al in view of Babaev disclose a method of treating a human body or animal body (fig 1) with the apparatus of claim 1,
Parsons et al further teach said apparatus comprising placing a funnel portion of the syringe of the apparatus in direct contact with the human body or animal body (see fig 13, skin 510), generating pressure waves from the pressure wave generator, and injecting the liquid treatment substance from the chamber into the human body or animal body (col 11, lines 11-24 and col 19, lines 50-58).
Regarding claim 22, Parsons et al in view of Babaev disclose the apparatus of claim 21,
Babaev further teaches the pressure waves are simultaneously generated while the liquid treatment substance is being injected into the human body or animal body (abstract and claim 4).
Regarding claim 23, Parsons et al in view of Babaev disclose the apparatus of claim 21,
Babaev further teaches the pressure waves are simultaneously generated while the liquid treatment substance is being applied to the human body or animal body (abstract and claim 4).
Regarding claim 24, Parsons et al in view of Babaev disclose the apparatus of claim 23,
Babaev further teaches wherein the pressure wave generator (4/8) is a shock wave or ultrasound generator (para 0027).
Regarding claim 25, Parsons et al in view of Babaev disclose the apparatus of claim 22,
Babaev further teaches wherein the pressure wave generator (4/8) is a shock wave or ultrasound generator (para 0027).
Regarding claim 26, Parsons et al in view of Babaev disclose a method of treating a human body or animal body (fig 1) with the apparatus of claim 1,
Parsons et al further comprising dispensing the liquid treatment substance from the chamber with the plunger while simultaneously generating pressure waves with the pressure wave generator through the liquid treatment substance in the syringe (col 11, lines 11-24 and col 19, lines 50-58).
Regarding claim 27, Parsons et al in view of Babaev a method of treating a human body or animal body (fig 1) with the apparatus of claim 2,
Parsons et al further comprising dispensing the liquid treatment substance from the chamber with the plunger while simultaneously generating pressure waves with the pressure wave generator through the liquid treatment substance in the syringe (col 11, lines 11-24 and col 19, lines 50-58).
Regarding claim 28, Parsons et al in view of Babaev disclose the apparatus of claim 27,
Babaev further teaches wherein the pressure wave generator (4/8) is a shock wave or ultrasound generator (para 0027).
Regarding claim 29, Parsons et al in view of Babaev disclose the apparatus of claim 26,
Babaev further teaches wherein the pressure wave generator (4/8) is a shock wave or ultrasound generator (para 0027).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Parsons et al (US 4680027 A) in view of Babaev (US 20030229304 A1) and further in view of Muller (US 5947928 A).
Regarding claim 7, Parsons et al in view of Babaev disclose the limitations of claim 1 but fail to teach 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.
However, Muller discloses an apparatus comprising a pressure wave generator (60) wherein the pressure waves propagate internally through the liquid treatment substance (col 6, lines 50-63) and wherein the pressure wave generator is selected from the group consisting of an piezoelectric shock wave generator (col 10, lines 13-17).
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 Parsons et al in view of Babaev to have said pressure wave generator selected from the group consisting of an piezoelectric shock wave generator as taught by Muller. This would provide the benefit of increasing the porosity of a biologic material so as to enhance medicament absorption (col 10, lines 13-17).
Regarding claim 8, Parsons et al in view of Babaev and Muller disclose the apparatus of claim 7,
Parsons et al further teach said apparatus comprising a syringe needle (122) coupled to the syringe funnel (fig 1).
Claims 9-12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Parsons et al (US 4680027 A) in view of Babaev (US 20030229304 A1) and further in view of Cioanta et al (US 20180221688 A1).
Regarding claim 9, Parsons et al in view of Babaev disclose the limitations of claim 1 but fail to teach the apparatus further comprising a reflector coupled to the syringe adjacent the shock wave generator.
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 Parsons et al in view of Babaev 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, Parsons et al in view of Babaev and 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, Parsons et al in view of Babaev and Cioanta et al disclose the apparatus of claim 10,
Parsons et al teach said apparatus further comprising a syringe needle (122) coupled to the syringe funnel (fig 1).
Regarding claim 12, Parsons et al in view of Babaev and Cioanta et al disclose the apparatus of claim 9,
Parsons et al further teach said apparatus comprising a syringe needle (122) coupled to the syringe funnel (fig 1).
Regarding claim 19, Parsons et al in view of Babaev and Cioanta et al disclose the apparatus of claim 12,
Parsons et al further disclose wherein the chamber includes a liquid treatment substance 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 (abstract and col 1, lines 6-10).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Parsons et al (US 4680027 A) in view of Babaev (US 20030229304 A1) and further in view of Millis et al (US 20170020598 A1).
Regarding claim 15, Parsons et al in view of Babaev disclose the limitations of claim 1 but fail to teach wherein the pressure wave generator is battery-operated.
However, Millis et al disclose a wave generator (102) wherein the pressure wave generator is battery-operated (para 0043-44).
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 Parsons et al in view of Babaev and incorporate the teachings of Millis et al to have pressure wave generator to be battery-operated. This would provide the benefit of having wave generator that includes a battery that powers its operation rather than requiring a continuous connection to an external power source to make it portable (para 0043-44).
Regarding claim 16, Parsons et al in view of Babaev and Millis et al disclose the apparatus of claim 15,
Parsons et al further teach said apparatus comprising a syringe needle (122) coupled to the syringe funnel (fig 1).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Parsons et al (US 4680027 A) in view of Babaev (US 20030229304 A1) and further in view of Giustetto et al (US 20210069332 A1).
Regarding claim 17, Parsons et al in view of Babaev disclose the limitations of claim 1 but fail to teach said apparatus further comprising a control console operably coupled to the pressure wave generator, wherein the control console 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 Parsons et al in view of Babaev and incorporate the teachings of Giustetto et al to have said apparatus comprising a control console operably coupled to the pressure wave generator, 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 Parsons et al (US 4680027 A) in view of Babaev (US 20030229304 A1) and further in view of Giustetto et al (US 20210069332 A1) and in view of Roof (US 20080109260 A1).
Regarding claim 18, Parsons et al in view of Babaev and Giustetto et al disclose the limitations of claims 1 and 17, but fail 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 disclose 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 Giustetto et al and incorporate the teachings of Roof to have 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, see Remarks, filed on 11/12/2025, with respect to the rejection(s) of claim(s) 1-29 have been fully considered and are not persuasive.
In regards to the argument that “Hansen does not disclose any structure or operation corresponding to an ultrasound or shock wave pressure wave generator that generates or propagates waves through liquid within a syringe”, examiner respectfully disagrees as Hansen teaches that pressure waves are generated during jet expelling (see para 0033 and fig 6).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the disclosure of Nieminen et al and incorporate the teachings of Hansen to have said pressure wave generator propagate shock waves in a direction from the plunger to and through a syringe funnel whereby the pressure waves propagate internally through the liquid treatment substance in the chamber.
However, upon further consideration, a new ground(s) of rejection is made in view of Parsons et al (US 4680027 A) and Babaev (US 20030229304 A1).
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /DUNG T ULSH/Examiner, Art Unit 3783