DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because of the following informalities: the mechanism 400 (see fig. 6 and 7) is being referred to “movement mechanism’ (see par. [0067] of the PG Pub. version of the specification) and “motion mechanism” (see par. [0070] of the Pg. Pub. version of the specification). Throughout the specification, the mechanism 400 for directing ultrasonic treatment being referred to as “movement mechanism” and “motion mechanism”. The examiner suggests to amend the specification to recite “movement mechanism” from “motion mechanism” to be consistent with the specification and figure 6. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,723,622. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and U.S. Patent No. 11,723,622 are directed to ultrasound system with a seal housing; ultrasound element configured to focus ultrasound below a skin; and a movement mechanism. Furthermore, the claims of U.S. Patent No. 11,723,622 are narrower than claim 1 of current application.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,102,473. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and U.S. Patent No. 12,102,473 are directed to ultrasound system with a seal housing; ultrasound element configured to focus ultrasound below a skin; and a movement mechanism. Furthermore, the claims of U.S. Patent No. 12,102,473 are narrower than claim 1 of current application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6 and 19 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 6 and 19, the claim limitation that the module comprises a latch mechanism was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification and figures do disclose a latch mechanism (see par. [0068] and 140 in fig. 1), however, independent claims 1 and 13 are directed to the detachable module and the latch is part of the hand wand 100 and not the module 200. Therefore, the module comprising the latch mechanism is new matter.
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 8-9 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.
Regarding claim 8, the claim limitation “a depth” is indefinite because it is unclear if this depth is the same depth that is already recited in claim 1 or different depth.
Regarding claim 9, the claim limitation “a treatment frequency” is indefinite because it is unclear if this treatment frequency is the same treatment frequency that is already recited in claim 1 or different treatment frequency.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Regarding claims 3-5, the claims are directed to the integrated receptable and further narrows the claim element integrated receptable which is part of the hand wand, however, the independent claim 1 is directed to the ultrasound detachable transducer module and not the hand wand. Therefore, claims improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-3, 5-7 are 10-12 are rejected under pre-AIA 35 U.S.C. 102 (a) as being anticipated by Bockenstedt et al. (US 2009/0240146; hereinafter Bockenstedt).
Regarding claim 1, Bockenstedt discloses a mechanical arm. Bockenstedt shows a module for ultrasound treatment (see fig. 1 and 3; par. [0050]), comprising: a sealed housing comprising an acoustically transparent window (see fig. 1 and 6A), a circuit board comprising a storage device (see par. [0050]) and a circuit board interface (see par. [0041], [0048], [0049], [0074]), an ultrasonic treatment piezoelectric element configured to focus ultrasound at a depth below a skin surface with a treatment frequency (see par. [0013], [0050], [0051]), wherein the ultrasonic treatment piezoelectric element is acoustically coupled to the acoustically transparent window via an acoustic fluid in the sealed housing (see fig. 6A and par. [0046]) ,and wherein the ultrasonic treatment piezoelectric element is configured to direct the ultrasonic treatment in with thermal lesions in a tissue (see par. [0013]), wherein the circuit board interface is configured for electrical connection to a pin connector (see par. [0041], [0048], [0049], [0074]), the pin connector comprising one or more pins (see par. [0041], [0048], [0049], [0074]; fig. 5A), wherein the storage device is configured for containing calibration data or storage data (see par. [0050]), wherein the circuit board interface is configured for placement on the sealed housing (see fig. 5A and 6A), and wherein the circuit board interface is configured to be operably coupled to a detachable hand wand (see abstract; par. [0050]).
Regarding claim 2, Bockenstedt shows wherein the circuit board interface is configured for removable insertion and detachment with an integrated receptacle of the detachable hand wand (see fig. 3 and par. [0050]).
Regarding claim 3, Bockenstedt shows wherein the integrated receptacle is configured for interchangeable attachment to a second transducer module (see par. [0050] and abstract), wherein the second transducer module comprises a second circuit board (see par. [0041], [0048], [0049], [0050], [0074]; fig. 5A).
Regarding claim 5, Bockenstedt shows wherein the integrated receptacle comprises a magnetic coupling configured to move the ultrasonic treatment piezoelectric element within the sealed housing (see par. [0037], [0067]).
Regarding claim 6, Bockenstedt shows further comprising a latch mechanism configured for removable attachment between the module and the detachable hand wand (see fig. 6A).
Regarding claim 7, Bockenstedt shows wherein the circuit board interface is connected to a microprocessor for controlling the ultrasound treatment (see par. [0050]).
Regarding claim 10, Bockenstedt shows wherein the circuit board interface is configured to electronically connect an ultrasound imaging piezoelectric element through the detachable hand wand to a display for providing an ultrasonic image (see par. [0042]).
Regarding claim 11, Bockenstedt shows wherein the ultrasonic treatment piezoelectric element is configured for connection to a graphical user interface configured for control of the ultrasound treatment (see par. [0056]).
Regarding claim 12, Bockenstedt shows wherein the circuit board interface is configured for operation via electrical communication with an electronic key (see par. [0050], [0056] and fig. 3).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bockenstedt et al. (US 2009/0240146; hereinafter Bockenstedt), in view of Zanelli et al. (US 2005/0154332; hereinafter Zanelli).
Regarding claim 4, Bockenstedt shows wherein the integrated receptacle is configured for operable attachment to a motor in the detachable hand wand (see par. [0037], [0051], [0061]), but fails to explicitly state wherein the motor is configured to linearly move the ultrasonic treatment piezoelectric element within the sealed housing.
Zanelli discloses a ultrasound treatment device and teaches wherein the motor is configured to linearly move the ultrasonic treatment piezoelectric element within the sealed housing (see fig. 5). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the motor is configured to linearly move the ultrasonic treatment piezoelectric element within the sealed housing in the invention of Bockenstedt, as taught by Zanelli, to be able to treat adjacent tissue without moving the ultrasound treatment device.
Claims 8-9, 13-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bockenstedt et al. (US 2009/0240146; hereinafter Bockenstedt), in view of Gliklich et al. (US 2007/0032784; hereinafter Gliklich).
Regarding claims 8-9, Bockenstedt discloses the invention substantially as described in the 102 rejection above, but fails to explicitly state wherein the ultrasonic treatment piezoelectric element is configured to deliver ultrasound energy with a treatment frequency in a range of 1 MHz to 10 MHz, and focus ultrasound at depth in a range between 3 mm and 9 mm below the skin surface.
Gliklich discloses a targeted muscle ablation for reducing signs of aging and teaches treatment frequency in a range of 1 MHz to 10 MHz (see par. [0016], [0032]) and focus ultrasound at depth in a range between 3 mm and 9 mm below the skin surface (see par. [0031]), and an acoustic power in a range of 1 watt to 100 watts (see par. [0016], [0034]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of treatment frequency in a range of 1 MHz to 10 MHz, and focus ultrasound at depth in a range between 3 mm and 9 mm below the skin surface in the invention of Bockenstedt, as taught by Gliklich, to be able to safely treat layers beneath the dermal layer for reducing signs of aging.
Regarding claim 13, Bockenstedt discloses a mechanical arm. Bockenstedt shows a module for ultrasound treatment (see fig. 1 and 3; par. [0050]), comprising: a sealed housing (see fig. 1 and 6A), an ultrasonic piezoelectric element (see par. [0013], [0050], [0051]), and a circuit board (see par. [0041], [0048], [0049], [0074]), wherein the circuit board comprises a storage device and a circuit board interface (see par. [0050]), wherein the storage device is configured for containing calibration data or storage data (see par. [0050]), and wherein the circuit board interface is configured for electrical connection to a pin connector comprising one or more pins (see par. [0041], [0048], [0049], [0074]), wherein the circuit board interface is configured to be operably coupled to a detachable hand wand (see abstract; par. [0050]), wherein the ultrasonic piezoelectric element is configured to focus ultrasound at a treatment frequency (see par. [0030]), wherein the module is configured to detach from the detachable hand wand at the circuit board interface (see abstract; par. [0050]), which thereby permits a second transducer module to interchangeably attach to the detachable hand wand (see abstract; par. [0050]).
But, Bockenstedt fails to explicitly state that the treatment frequency in a range of 1 MHz to 10 MHz, wherein the ultrasonic piezoelectric element is configured to focus ultrasound at a depth in a range between 3 mm and 9 mm below a skin surface.
Gliklich discloses a targeted muscle ablation for reducing signs of aging and teaches treatment frequency in a range of 1 MHz to 10 MHz (see par. [0016], [0032]) and focus ultrasound at depth in a range between 3 mm and 9 mm below the skin surface (see par. [0031]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of treatment frequency in a range of 1 MHz to 10 MHz, and focus ultrasound at depth in a range between 3 mm and 9 mm below the skin surface in the invention of Bockenstedt, as taught by Gliklich, to be able to safely treat layers beneath the dermal layer for reducing signs of aging.
Regarding claim 14, Bockenstedt and Gliklich disclose the invention substantially as described in the 103 rejection above, furthermore, Bockenstedt shows wherein the circuit board interface is connected to a microprocessor for controlling the ultrasound treatment (see par. [0050]).
Regarding claim 15, Bockenstedt and Gliklich disclose the invention substantially as described in the 103 rejection above, furthermore, Bockenstedt shows wherein the ultrasonic piezoelectric element is electronically coupled to a treatment button of the detachable hand wand (see fig. 3), the treatment button configured for operably controlling the ultrasonic piezoelectric element when the sealed housing is coupled to an integrated receptacle at the circuit board interface (see fig. 3, 5A and 6A; par. [0041], [0048], [0049], [0074]).
Regarding claim 16, Bockenstedt and Gliklich disclose the invention substantially as described in the 103 rejection above, furthermore, Bockenstedt shows wherein the circuit board interface is configured for interchangeable coupling to the detachable hand wand at the circuit board interface via at least one pin at the pin connector (see fig. 3, 5A and 6A; par. [0041], [0048], [0049], [0074]).
Regarding claim 17, Bockenstedt and Gliklich disclose the invention substantially as described in the 103 rejection above, furthermore, Gliklich teaches wherein the ultrasonic piezoelectric element is configured to provide ultrasound treatment at the depth for treatment in a fat tissue (see par. [0040]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of treating fat tissue in the invention of Bockenstedt, as taught by Gliklich, to be able to reduce signs of aging.
Regarding claim 18, Bockenstedt and Gliklich disclose the invention substantially as described in the 103 rejection above, furthermore, Gliklich teaches wherein the ultrasound treatment is a skin tightening (see par. [0041]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of skin tightening in the invention of Bockenstedt, as taught by Gliklich, to be able to reduce signs of aging.
Regarding claim 19, Bockenstedt and Gliklich disclose the invention substantially as described in the 103 rejection above, furthermore, Bockenstedt shows a latch mechanism configured for removably attachment of the module with the detachable hand wand (see fig. 6A).
Regarding claim 20, Bockenstedt and Gliklich disclose the invention substantially as described in the 103 rejection above, furthermore, Bockenstedt shows wherein the ultrasonic piezoelectric element is configured for connection to a graphical user interface configured for control of the ultrasound treatment (see par. [0056]).
Response to Arguments
The previous double patent rejections over U.S. Patent No. 10,537,304, U.S. Patent No. 11,123,039, U.S. Patent No. 12,102,473, copending Application No. 18/805,211, copending Application No. 19/025,430, copending Application No. 19/025,676, and copending Application No. 19/025,353 have been withdrawn in view of Applicant's amendments to the clams.
The previous objection to claim 1 has been withdrawn in view of Applicant’s amendment to claim 1.
The previous claim interpretation under 35 USC 112 (f) for claim element "movement mechanism" has been withdrawn in view of Applicant's amendment to claim 1.
The examiner has maintained the previous object to specification the mechanism 400 (see fig. 6 and 7) is being referred to "movement mechanism' (see par. [0067] of the PG Pub. version of the specification) and "motion mechanism" (see par. [0070] of the Pg. Pub. version of the specification). Throughout the specification, the mechanism 400 for directing ultrasonic treatment being referred to as "movement mechanism" and "motion mechanism". The Applicant states on page 5 (see response filed on 04/17/2026) that claim 1 has been amended to remove the claim element "movement mechanism" which invoke 35 USC 112 (f) and therefore the specification objection should be withdrawn, however, the objection to specification was not related to claim interpretation under 35 USC 112 (f) or claim objection. The objection to specification because the specification refers mechanism 400 (see fig. 6 and 7) as "movement mechanism' and "motion mechanism", and is not consistent through out the specification.
Applicant's arguments filed on 04/17/2026, with respect to prior art rejection of independent claim 1 have been considered but are moot because the new ground of rejection does not rely on any rejection applied in the prior Office action of record for any teaching or matter specifically challenged in the argument. The examiner has provided new prior art Bockenstedt to address independent claims 1 and 13.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
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