DETAILED ACTION
This office action is in response to the communication received on 12/05/2025 concerning application no. 18/766,430 filed on 07/08/2024.
Claims 1-25 are pending (Claims 1-12 and 24-25 are withdrawn from consideration).
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 with traverse of Group II (Claims 13-23) in the reply filed on 12/05/2025 is acknowledged. The traversal is on the ground(s) that “Applicant respectfully notes that extracorporeal shockwave therapy (ESWT), to which the present claims are directed, is distinct from ultrasound therapy at least in that it uses high-energy acoustic pressure waves, which are audible to the human ear, whereas ultrasound uses high-frequency sound waves which are not audible. Moreover, the wave profile in ESWT is a single, powerful, rapid pressure pulse (a "shock" wave) whereas ultrasound typically uses continuous or pulsed vibrations (gentle waves).”
This is not found persuasive because nothing in the claims establishes “extracorporeal shockwave therapy (ESWT)”. Rather, it is acoustic based and it is well-known that ultrasound is acoustic based1. Assuming, arguendo, the Group I established ESWT, class A61N7/00 is relevant for the search. References such as Engles et al. (PGPUB No. US 2019/0290305; Titled “Acoustic Shockwave Apparatus And Method” (emphasis added)) are present in the class A61N7/00 and remain relevant to Group I. Additionally, it is noted that the original classifier placed the application in A61N7/00 and the classification has a presumption of being correct.
Furthermore, while Applicant argues regarding the classifications, Applicant has failed to address the other reasons for serious search and examination burden. As noted in the restriction, filed 10/07/2025, “there would be serious search and/or examination burden if restriction were note required because one or more of the following reasons apply:… b. The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries). Invention I requires the search of terms like "transducer" and "treatment adj area" and "characteristic near5 shockwave". Invention II requires the search of terms like "treatment adj zone" and "predetermined adj fixed adj geometry" and "majority near5 shockwave" and "body adj part". Invention III requires the search of terms like "non$lgaseous" and "opposite" and "terminat$3 with layer" and "secondary adj treatment adj zone". c. The inventions have different scopes and may require different considerations under 35 C. U.S.C. 101 and 35 U.S.C. 112.” (emphasis added).
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to because:
The drawings (Fig. 8) are objected to because, according to MPEP 608.02 and 67 CFR 1.84, "India ink, or its equivalent that secures solid black lines, must be used for drawings". Drawings should be presented as India ink drawings unless the illustration is not capable of being accurately or adequately depicted by India ink drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 13-23 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 13 is indefinite for the following reasons:
Recites “impedance-controlled”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what form of impedance is being referred to. Impedance can refer to electrical impedance, acoustic impedance, or thermal impedance.
Applicant is encouraged to provide consistent and clear language.
Claim 14 is indefinite for the following reasons:
Recites “impedance-controlled”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what form of impedance is being referred to. Impedance can refer to electrical impedance, acoustic impedance, or thermal impedance.
Applicant is encouraged to provide consistent and clear language.
Claim 15 is indefinite for the following reasons:
Recites “impedance-controlled”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what form of impedance is being referred to. Impedance can refer to electrical impedance, acoustic impedance, or thermal impedance.
Applicant is encouraged to provide consistent and clear language.
The term “high resistance” is a relative term which renders the claim indefinite. The term “high resistance” 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. It would be unclear to one with ordinary skill in the art what degree resistance is considered to be “high” and what would be insufficient to be considered “high”.
Claim 18 is indefinite for the following reasons:
Recites “impedance-controlled”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what form of impedance is being referred to. Impedance can refer to electrical impedance, acoustic impedance, or thermal impedance.
Applicant is encouraged to provide consistent and clear language.
Recites “the impedance of the user body part”. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 is indefinite for the following reasons:
Recites “impedance-controlled”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what form of impedance is being referred to. Impedance can refer to electrical impedance, acoustic impedance, or thermal impedance.
Applicant is encouraged to provide consistent and clear language.
Claim 20 is indefinite for the following reasons:
Recites “impedance-controlled”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what form of impedance is being referred to. Impedance can refer to electrical impedance, acoustic impedance, or thermal impedance.
Applicant is encouraged to provide consistent and clear language.
Claim 21 is indefinite for the following reasons:
Recites “wherein the acoustic shockwave is received from a shockwave transducer applied to the user body part opposite the terminal reflector”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the acoustic shockwave and the shockwave transducer are actively claimed as the preamble establishes that the claimed invention is an acoustic shockwave receiver device. It is further unclear if the claim is attempting to establishes a shockwave transducer as part of the acoustic shockwave receiver device.
Applicant is encouraged to provide consistent and clear language.
Recites “the terminal reflector”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “terminal reflector” is the same as the “terminating reflector” established claim 13 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the terminal reflector”. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 is indefinite for the following reasons:
Recites “impedance”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what form of impedance is being referred to. Impedance can refer to electrical impedance, acoustic impedance, or thermal impedance.
Applicant is encouraged to provide consistent and clear language.
Recites “impedance-controlled”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what form of impedance is being referred to. Impedance can refer to electrical impedance, acoustic impedance, or thermal impedance.
Applicant is encouraged to provide consistent and clear language.
Recites “the third shockwave receiver includes openings exposing the impedance-controlled layer to air, effectively providing an air reflector”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the claim is establishing an air reflector or not. If it is not an air reflector, it is further unclear what the scope of the element is such that it is “effectively providing an air reflector” and in what manner it is “effectively” an air reflector.
Applicant is encouraged to provide consistent and clear language.
Claim 23 is indefinite for the following reasons:
Recites “impedance-controlled”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what form of impedance is being referred to. Impedance can refer to electrical impedance, acoustic impedance, or thermal impedance.
Applicant is encouraged to provide consistent and clear language.
The term “fitting closely against the user body part” is a relative term which renders the claim indefinite. The term “closely” 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. It would be unclear to one with ordinary skill in the art what is considered to be sufficiently close to constitute as “fitting closely against the user body part”.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13-14, 17-21, and 23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Warlick et al. (PGPUB No. US 2024/0024704).
Regarding claim 13, Warlick teaches an acoustic shockwave receiver device for use in shockwave therapies, the receiver device comprising:
an impedance-controlled layer, at least partly conformable against a user body part (Paragraph 0049 teaches that the opposite side of the applicator contacting surface is preferably a gaseous filled membrane which is placed against the skin surface of the appendage. Preferably, the gas filled membrane has an exterior surface that has been treated with a coupling gel, like ultrasound gel to ensure the shock wave transmissions transmitted from the applicator through the appendage that exit the appendage impact the flexible gaseous filled membrane that conforms to and is coupled to the appendage that it is pressed against); and
a terminating reflector directly coupled to the impedance-controlled layer, the terminating reflector having a predetermined fixed geometry selected to receive and redirect to a treatment zone of the user body part at least a majority of an acoustic shockwave received through the user body part and the impedance-controlled layer (Paragraph 0049 that the membrane receives and reflects the shockwave transmissions from the applicator via the reflective interior. Paragraph 0050-51 teaches that the membrane can be shaped to work with the appendage of interest. Paragraph 0055 teaches that the shockwaves can be redirected and reflected back into the tissue for treatment).
Regarding claim 14, Warlick teaches the acoustic shockwave receiver device in claim 13, as discussed above.
Warlick further teaches an acoustic shockwave receiver device, wherein the impedance-controlled layer is non-gaseous (Paragraph 0049 teaches that the opposite side of the applicator contacting surface is preferably a gaseous filled membrane which is placed against the skin surface of the appendage. Preferably, the gas filled membrane has an exterior surface that has been treated with a coupling gel, like ultrasound gel to ensure the shock wave transmissions transmitted from the applicator through the appendage that exit the appendage impact the flexible gaseous filled membrane that conforms to and is coupled to the appendage that it is pressed against).
Regarding claim 17, Warlick teaches the acoustic shockwave receiver device in claim 13, as discussed above.
Warlick further teaches an acoustic shockwave receiver device, wherein the terminating reflector is formed of one or more materials configured to absorb and disperse the received acoustic shockwave to de-energize and/or limit effective return of the acoustic shockwave to the user body part (Paragraph 0055 teaches that the shockwaves can be redirected and reflected back into the tissue for treatment. Paragraph 0056 teaches that the membrane absorbs and reflects back the shockwaves. Paragraph 0057 teaches a reduction in the tensile component of the shock wave upon reflection).
Regarding claim 18, Warlick teaches the acoustic shockwave receiver device in claim 13, as discussed above.
Warlick further teaches an acoustic shockwave receiver device, wherein the impedance-controlled layer is selected or configured to substantially match the impedance of the user body part (Paragraph 0049 teaches that the opposite side of the applicator contacting surface is preferably a gaseous filled membrane which is placed against the skin surface of the appendage. Preferably, the gas filled membrane has an exterior surface that has been treated with a coupling gel, like ultrasound gel to ensure the shock wave transmissions transmitted from the applicator through the appendage that exit the appendage impact the flexible gaseous filled membrane that conforms to and is coupled to the appendage that it is pressed against).
Regarding claim 19, Warlick teaches the acoustic shockwave receiver device in claim 13, as discussed above.
Warlick further teaches an acoustic shockwave receiver device, wherein the impedance-controlled layer is acoustically transparent (Paragraph 0049 teaches that the opposite side of the applicator contacting surface is preferably a gaseous filled membrane which is placed against the skin surface of the appendage. Preferably, the gas filled membrane has an exterior surface that has been treated with a coupling gel, like ultrasound gel to ensure the shock wave transmissions transmitted from the applicator through the appendage that exit the appendage impact the flexible gaseous filled membrane that conforms to and is coupled to the appendage that it is pressed against. Paragraph 0049 that the membrane receives and reflects the shockwave transmissions from the applicator via the reflective interior).
Regarding claim 20, Warlick teaches the acoustic shockwave receiver device in claim 19, as discussed above.
Warlick further teaches an acoustic shockwave receiver device, wherein the impedance-controlled layer is a gel (Paragraph 0049 teaches that the opposite side of the applicator contacting surface is preferably a gaseous filled membrane which is placed against the skin surface of the appendage. Preferably, the gas filled membrane has an exterior surface that has been treated with a coupling gel, like ultrasound gel to ensure the shock wave transmissions transmitted from the applicator through the appendage that exit the appendage impact the flexible gaseous filled membrane that conforms to and is coupled to the appendage that it is pressed against).
Regarding claim 21, Warlick teaches the acoustic shockwave receiver device in claim 13, as discussed above.
Warlick further teaches an acoustic shockwave receiver device, wherein the acoustic shockwave is received from a shockwave transducer applied to the user body part opposite the terminal reflector (Paragraph 0049 that the membrane receives and reflects the shockwave transmissions from the applicator via the reflective interior. Paragraph 0050-51 teaches that the membrane can be shaped to work with the appendage of interest. Paragraph 0055 teaches that the shockwaves can be redirected and reflected back into the tissue for treatment. See Fig. 7).
Regarding claim 23, Warlick teaches the acoustic shockwave receiver device in claim 13, as discussed above.
Warlick further teaches an acoustic shockwave receiver device, wherein the impedance-controlled layer has at least one compliant surface configured to deform for fitting closely against the user body part (Paragraph 0049 teaches that the opposite side of the applicator contacting surface is preferably a gaseous filled membrane which is placed against the skin surface of the appendage. Preferably, the gas filled membrane has an exterior surface that has been treated with a coupling gel, like ultrasound gel to ensure the shock wave transmissions transmitted from the applicator through the appendage that exit the appendage impact the flexible gaseous filled membrane that conforms to and is coupled to the appendage that it is pressed against).
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 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 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Warlick et al. (PGPUB No. US 2024/0024704) in view of Papirov et al. (PGPUB No. US 2019/0380727).
Regarding claim 15, modified Warlick teaches the acoustic shockwave receiver device in claim 14, as discussed above.
However, Warlick is silent regarding an acoustic shockwave receiver device, wherein the impedance-controlled, non-gaseous layer includes an elastomeric shell containing a cohesive liquid filler selected for high resistance to cavitation.
In an analogous imaging field of endeavor, regarding shockwave treatment, Papirov teaches an acoustic shockwave receiver device, wherein the impedance-controlled, non-gaseous layer includes an elastomeric shell containing a cohesive liquid filler selected for high resistance to cavitation (Paragraph 0006 teaches the filling of a bladder with a gel. Paragraph 0053 teaches that the membrane is fluid filled. Paragraph 0058 teaches this facilitates the transfer over to the tissue of the shockwaves. Paragraph 0076 teaches that the fluid may be saline, water, medical gel, or a gel. See Fig. 1).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Warlick with Papirov’s teaching of the use of an elastomeric shell with a liquid filler. This modified apparatus would allow the user to treat heart muscle ischemia (Paragraph 0003 of Papirov). Furthermore, the modification will allow for the concentration and focus of shockwaves (Paragraph 0017-18 of Papirov).
Regarding claim 16, modified Warlick teaches the acoustic shockwave receiver device in claim 15, as discussed above.
However, Warlick is silent regarding an acoustic shockwave receiver device, wherein the cohesive liquid filler is a gel.
In an analogous imaging field of endeavor, regarding shockwave treatment, Papirov teaches an acoustic shockwave receiver device, wherein the cohesive liquid filler is a gel (Paragraph 0006 teaches the filling of a bladder with a gel. Paragraph 0053 teaches that the membrane is fluid filled. Paragraph 0058 teaches this facilitates the transfer over to the tissue of the shockwaves. Paragraph 0076 teaches that the fluid may be saline, water, medical gel, or a gel. See Fig. 1).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Warlick with Papirov’s teaching of the cohesive liquid filler being gel. This modified apparatus would allow the user to treat heart muscle ischemia (Paragraph 0003 of Papirov). Furthermore, the modification will allow for the concentration and focus of shockwaves (Paragraph 0017-18 of Papirov).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Warlick et al. (PGPUB No. US 2024/0024704) in view of Hassler et al. (US Patent No. 5,058,569).
Regarding claim 22, modified Warlick teaches the acoustic shockwave receiver device in claim 13, as discussed above.
However, Warlick is silent regarding an acoustic shockwave receiver device, wherein the terminating reflector is a first shockwave reflector, a second shockwave reflector, or a third shockwave reflector, wherein: the first shockwave reflector is configured to reflect the acoustic shockwave in a predetermined direction and has an impedance higher than the impedance-controlled layer, the higher impedance of the shockwave receiver facilitating in-phase maintenance of compression and tensile wave elements of the reflected acoustic shockwave; the second shockwave reflector is configured to reflect a portion of the shockwave in a predetermined manner and has an impedance lower than the impedance-controlled layer, the lower impedance facilitating an enhancement of a tensile wave element of the reflected acoustic shockwave; and the third shockwave receiver includes openings exposing the impedance-controlled layer to air, effectively providing an air reflector.
In an analogous imaging field of endeavor, regarding shockwave treatment, Hassler teaches an acoustic shockwave receiver device, wherein the terminating reflector is a first shockwave reflector, a second shockwave reflector, or a third shockwave reflector, wherein: the first shockwave reflector is configured to reflect the acoustic shockwave in a predetermined direction and has an impedance higher than the impedance-controlled layer, the higher impedance of the shockwave receiver facilitating in-phase maintenance of compression and tensile wave elements of the reflected acoustic shockwave; the second shockwave reflector is configured to reflect a portion of the shockwave in a predetermined manner and has an impedance lower than the impedance-controlled layer, the lower impedance facilitating an enhancement of a tensile wave element of the reflected acoustic shockwave; and the third shockwave receiver includes openings exposing the impedance-controlled layer to air, effectively providing an air reflector (Col. 5, lines 57-Col. 6, lines 19 teach that the reflector is of a material which is acoustically harder than the propagation medium, the shockwaves generated in this manner will be in the form of positive pressure pulses. The material having a larger acoustic harness is meaning that the impedance of the material is higher than the propagation medium. Fig. 2 shows the focus of the shockwaves).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Warlick with Hassler’s teaching of a shockwave reflector according to the impedance with respect to the impedance-controlled layer. This modified apparatus would allow the user to design a device with low manufacturing outlaw and cost and regain high efficiency (Col. 2, lines 18-24 of Hassler). Furthermore, the modification allows for generating focused shockwaves of the type suitable for use in extracorporeal lithotripsy, and in particular to such an apparatus wherein the shockwaves are electromagnetically generated (Col. 1, lines 9-12 of Hassler).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Spector et al. (PGPUB No. US 2012/0215142): Teaches ESWT and a gel-based impedance layer.
Maxwell et al. (PGPUB No. US 2016/0287909): Teaches ESWT and a gel-based impedance layer.
Bonutti (PGPUB No. US 2006/0064082): Teaches ESWT and a gel-based impedance layer.
Cioanta et al. (PGPUB No. US 2011/0034832): Teaches ESWT and a gel-based impedance layer.
Cioanta et al. (PGPUB No. US 2021/0308001): Teaches the focus and returning of received shockwaves.
Cioanta et al. (PGPUB No. US 2024/0188973): Teaches the focus and returning of received shockwaves.
Eisenhofer (PGPUB No. US 2003/0199857): Teaches the focus and returning of received shockwaves.
Rattner et al. (US Patent No. 5,207,215): Teaches the focus and returning of received shockwaves.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADIL PARTAP S VIRK whose telephone number is (571)272-8569. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
1 “A procedure that uses high-energy sound waves to look at tissues and organs inside the body.” (Link: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/ultrasound)