DETAILED ACTION
1. This office action is in response to the communicated dated 14 July 2025 concerning application number 17/261,091 effectively filed on 29 June 2022.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Election/Restrictions
3. Applicant’s election without traverse of group II (claims 41-50) in the reply filed on 14 July 2025 is acknowledged.
Information Disclosure Statement
4. The Information Disclosure Statement submitted on 26 February 2025 has been considered by the Examiner.
Status of Claims
5. Claims 1-40 have been canceled; claims 41-50 have been added; and claims 41-50 are under consideration for patentability.
Response to Arguments
6. Applicant’s arguments dated 14 July 2025, referred to herein as “the Arguments”, have been fully considered, but they are not persuasive in view of the new grounds of rejection necessitated by Applicant’s amendments to the claims.
Claim Objections
7. Claims 44 and 49 are objected to because of the following informalities.
Claims 44 and 49 contain minor grammatical and typographical errors.
Claim 44, line 2: The Examiner suggests changing “four times greater the energy” to “four times greater than the energy”.
Claim 49, line 1: The Examiner suggests changing “The laser system of any one of claims 41, 43, or 46” to “The laser system of claim 41”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
8. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
9. Claim 41-50 are rejected under 35 U.S.C. 103 as being unpatentable over Falkenstein et al. (US 2018/0092693 A1) in view of Deladurantaye et al. (US 2015/0342678 A1).
Regarding claim 41, Falkenstein teaches a laser system for treating calculi in a living body (the laser system 100 is configured to treat calculi (e.g., stones) in the subject’s body [abstract, 0023]), comprising:
a diode-pumped thulium fiber laser configured to emit pulsed laser energy within a wavelength (the laser system 100 comprises a lasing medium 22 which includes a Thulium (Tm) fiber laser [0007, 0023-0024]. Specifically, the optical pump 24 is configured to optically excite the lasing medium 22 (e.g., Thulium fiber laser) to produce a laser pulse at various wavelengths [0007, 0023-0025]); and
a controller configured to control the laser such that the pulsed laser energy is emitted as a sequence of pulses separated in time by a rest period (the controller 50 is configured to control the laser system 100 to deliver multiple pulses that are spaced apart [abstract, 0006-0007, 0027]).
Falkenstein does not explicitly teach the wavelength range to be between 1.908 to 1.96 microns.
However, Falkenstein teaches that the laser system may be controlled to emit the laser pulses at various wavelengths ([0025, 0027]). Thus, a person having ordinary skill in the art would have found it obvious to modify the pulsed energy to be within a wavelength range of 1.908 to 1.96 microns. The advantage of such modification may improve the treatment of a calculi (e.g., stone) within the subject’s body ([0023, 0025, 0027]). The Examiner further submits that the skilled artisan could arrive at the claimed wavelength range via routine experimentation (MPEP 2144.05).
Falkenstein does not explicitly teach wherein the pulsed laser energy is emitted as a sequence of sub-pulse groups separated in time by the rest period, each sub-pulse group includes at least three sub-pulses separated in time by a variable sub-pulse interval, and the third sub-pulse has a power that is lower than a power of the first sub-pulse.
The prior art by Deladurantaye is analogous to Falkenstein, as they both teach a laser system that is configured to treat calculi (e.g., stone) within a living body ([0051-0052]).
Deladurantaye teaches wherein the pulsed laser energy is emitted as a sequence of sub-pulse groups separated in time by the rest period (the sequence of sub-pulses may be separated by time delays [0051, 0081]), wherein each sub-pulse group includes at least three sub-pulses ([0051, 0080-0081]).
Deladurantaye does not explicitly teach wherein the three sub-pulses of each sub-pulse group are separated in time by a variable sub-pulse interval, and the third sub-pulse has a power that is lower than a power of the first sub-pulse.
However, the Examiner respectfully submits that Deladurantaye teaches time dependent pulse parameters (e.g., delays or intervals between sub-pulses) and pulse power parameters which may be controlled or adjusted by the laser system ([0081, 0085-0086]). Thus, a person having ordinary skill in the art would have found it obvious to try to configure the three sub-pulses to be separated in time by a variable sub-pulse interval and the third sub-pulse to have a power that is lower than a power of the first sub-pulse (MPEP 2143). The advantage of such modification may improve the treatment of calculi (e.g., stones) in a patient’s body (see paragraphs [0051-0052, 0081, 0085-0086] by Deladurantaye).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Falkenstein’s pulsed laser energy to be emitted as a sequence of sub-pulse groups having three sub-pulses that are separated in time by a variable sub-pulse interval and the third sub-pulse having a power that is lower than the power of the first sub-pulse, as suggested by Deladurantaye. The advantage of such modification may improve the treatment of calculi (e.g., stones) in a patient’s body (see paragraphs [0051-0052, 0081, 0085-0086] by Deladurantaye).
Regarding claim 42, Falkenstein in view of Deladurantaye suggests the laser system of claim 41. Falkenstein and Deladurantaye do not explicitly teach wherein the power of the second sub-pulse is greater than a power of the first sub-pulse.
However, the Examiner respectfully submits that Deladurantaye teaches pulse power parameters which may be controlled or adjusted by the laser system ([0081, 0085-0086]). Thus, a person having ordinary skill in the art would have found it obvious to try to configure the second sub-pulse to have a power that is greater than a power of the first sub-pulse (MPEP 2143). The advantage of such modification may improve the treatment of calculi (e.g., stones) in a patient’s body (see paragraphs [0051-0052, 0081, 0085-0086] by Deladurantaye).
Regarding claim 43, Falkenstein teaches a laser system for treating calculi in a living body (the laser system 100 is configured to treat calculi (e.g., stones) in the subject’s body [abstract, 0023]), comprising:
a diode-pumped thulium fiber laser configured to emit pulsed laser energy within a wavelength (the laser system 100 comprises a lasing medium 22 which includes a Thulium (Tm) fiber laser [0007, 0023-0024]. Specifically, the optical pump 24 is configured to optically excite the lasing medium 22 (e.g., Thulium fiber laser) to produce a laser pulse at various wavelengths [0007, 0023-0025]);
a controller configured to control the laser such that the pulsed laser energy is emitted as a sequence of pulses separated in time by a rest period (the controller 50 is configured to control the laser system 100 to deliver multiple pulses that are spaced apart [abstract, 0006-0007, 0027]).
Falkenstein does not explicitly teach the wavelength range to be between 1.908 to 1.96 microns.
However, Falkenstein teaches that the laser system may be controlled to emit the laser pulses at various wavelengths ([0025, 0027]). Thus, a person having ordinary skill in the art would have found it obvious to modify the pulsed energy to be within a wavelength range of 1.908 to 1.96 microns. The advantage of such modification may improve the treatment of a calculi (e.g., stone) within the subject’s body ([0023, 0025, 0027]). The Examiner further submits that the skilled artisan could arrive at the claimed wavelength range via routine experimentation (MPEP 2144.05).
Falkenstein does not explicitly teach wherein the pulsed laser energy is emitted as a sequence of sub-pulse groups separated in time by the rest period, each sub-pulse group includes at least three sub-pulses separated in time by a variable sub-pulse interval, and the third sub-pulse has an energy that is greater than an energy of the first sub-pulse.
The prior art by Deladurantaye is analogous to Falkenstein, as they both teach a laser system that is configured to treat calculi (e.g., stone) within a living body ([0051-0052]).
Deladurantaye teaches wherein the pulsed laser energy is emitted as a sequence of sub-pulse groups separated in time by the rest period (the sequence of sub-pulses may be separated by time delays [0051, 0081]), wherein each sub-pulse group includes at least three sub-pulses ([0051, 0080-0081]).
Deladurantaye does not explicitly teach wherein the three sub-pulses of each sub-pulse group are separated in time by a variable sub-pulse interval, and the third sub-pulse has an energy that is greater than an energy of the first sub-pulse.
However, the Examiner respectfully submits that Deladurantaye teaches time dependent pulse parameters (e.g., delays or intervals between sub-pulses) and pulse power parameters (e.g., energy) which may be controlled or adjusted by the laser system ([0081, 0085-0086]). Thus, a person having ordinary skill in the art would have found it obvious to try to configure the three sub-pulses to be separated in time by a variable sub-pulse interval and the third sub-pulse to have an energy that is greater than an energy of the first sub-pulse (MPEP 2143). The advantage of such modification may improve the treatment of calculi (e.g., stones) in a patient’s body (see paragraphs [0051-0052, 0081, 0085-0086] by Deladurantaye).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Falkenstein’s pulsed laser energy to be emitted as a sequence of sub-pulse groups having three sub-pulses that are separated in time by a variable sub-pulse interval and the third sub-pulse having an energy that is greater than the energy of the first sub-pulse, as suggested by Deladurantaye. The advantage of such modification may improve the treatment of calculi (e.g., stones) in a patient’s body (see paragraphs [0051-0052, 0081, 0085-0086] by Deladurantaye).
Regarding claim 44, Falkenstein in view of Deladurantaye suggests the laser system of claim 43. Falkenstein and Deladurantaye do not explicitly teach wherein the energy of the third sub-pulse is at least four times greater than the energy of the first sub-pulse.
However, the Examiner respectfully submits that Deladurantaye teaches pulse power parameters (e.g., energy) which may be controlled or adjusted by the laser system ([0081, 0085-0086]). Thus, a person having ordinary skill in the art would have found it obvious to try to configure the energy of the third sub-pulse to be at least four times greater than the energy of the first sub-pulse (MPEP 2143). The advantage of such modification may improve the treatment of calculi (e.g., stones) in a patient’s body (see paragraphs [0051-0052, 0081, 0085-0086] by Deladurantaye).
Regarding claim 45, Falkenstein in view of Deladurantaye suggests the laser system of claim 43. Falkenstein and Deladurantaye do not explicitly teach wherein the energy of the second sub-pulse is at least two times greater than the energy of the first sub-pulse.
However, the Examiner respectfully submits that Deladurantaye teaches pulse power parameters (e.g., energy) which may be controlled or adjusted by the laser system ([0081, 0085-0086]). Thus, a person having ordinary skill in the art would have found it obvious to try to configure the energy of the second sub-pulse to be at least two times greater than the energy of the first sub-pulse (MPEP 2143). The advantage of such modification may improve the treatment of calculi (e.g., stones) in a patient’s body (see paragraphs [0051-0052, 0081, 0085-0086] by Deladurantaye).
Regarding claim 46, Falkenstein teaches a laser system for treating calculi in a living body (the laser system 100 is configured to treat calculi (e.g., stones) in the subject’s body [abstract, 0023]), comprising:
a diode-pumped thulium fiber laser configured to emit pulsed laser energy within a wavelength (the laser system 100 comprises a lasing medium 22 which includes a Thulium (Tm) fiber laser [0007, 0023-0024]. Specifically, the optical pump 24 is configured to optically excite the lasing medium 22 (e.g., Thulium fiber laser) to produce a laser pulse at various wavelengths [0007, 0023-0025]);
a controller configured to control the laser such that the pulsed laser energy is emitted as a sequence of pulses separated in time by a rest period (the controller 50 is configured to control the laser system 100 to deliver multiple pulses that are spaced apart [abstract, 0006-0007, 0027]).
Falkenstein does not explicitly teach the wavelength range to be between 1.908 to 1.96 microns.
However, Falkenstein teaches that the laser system may be controlled to emit the laser pulses at various wavelengths ([0025, 0027]). Thus, a person having ordinary skill in the art would have found it obvious to modify the pulsed energy to be within a wavelength range of 1.908 to 1.96 microns. The advantage of such modification may improve the treatment of a calculi (e.g., stone) within the subject’s body ([0023, 0025, 0027]). The Examiner further submits that the skilled artisan could arrive at the claimed wavelength range via routine experimentation (MPEP 2144.05).
Falkenstein does not explicitly teach wherein the pulsed laser energy is emitted as a sequence of sub-pulse groups separated in time by the rest period, each sub-pulse group includes at least three sub-pulses separated in time by a variable sub-pulse interval, and the third sub-pulse has a power that is greater than a power of the first sub-pulse.
The prior art by Deladurantaye is analogous to Falkenstein, as they both teach a laser system that is configured to treat calculi (e.g., stone) within a living body ([0051-0052]).
Deladurantaye teaches wherein the pulsed laser energy is emitted as a sequence of sub-pulse groups separated in time by the rest period (the sequence of sub-pulses may be separated by time delays [0051, 0081]), wherein each sub-pulse group includes at least three sub-pulses ([0051, 0080-0081]).
Deladurantaye does not explicitly teach wherein the three sub-pulses of each sub-pulse group are separated in time by a variable sub-pulse interval, and the third sub-pulse has a power that is greater than a power of the first sub-pulse.
However, the Examiner respectfully submits that Deladurantaye teaches time dependent pulse parameters (e.g., delays or intervals between sub-pulses) and pulse power parameters (e.g., energy) which may be controlled or adjusted by the laser system ([0081, 0085-0086]). Thus, a person having ordinary skill in the art would have found it obvious to try to configure the three sub-pulses to be separated in time by a variable sub-pulse interval and the third sub-pulse to have a power that is greater than a power of the first sub-pulse (MPEP 2143). The advantage of such modification may improve the treatment of calculi (e.g., stones) in a patient’s body (see paragraphs [0051-0052, 0081, 0085-0086] by Deladurantaye).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Falkenstein’s pulsed laser energy to be emitted as a sequence of sub-pulse groups having three-sub pulses that are separated in time by a variable sub-pulse interval and the third sub-pulse having a power that is greater than the power of the first sub-pulse, as suggested by Deladurantaye. The advantage of such modification may improve the treatment of calculi (e.g., stones) in a patient’s body (see paragraphs [0051-0052, 0081, 0085-0086] by Deladurantaye).
Regarding claim 47, Falkenstein in view of Deladurantaye suggests the laser system of claim 46. Falkenstein and Deladurantaye do not explicitly teach wherein the power of the third sub-pulse is at least four times greater than the power of the first sub-pulse.
However, the Examiner respectfully submits that Deladurantaye teaches pulse power parameters which may be controlled or adjusted by the laser system ([0081, 0085-0086]). Thus, a person having ordinary skill in the art would have found it obvious to try to configure the power of the third sub-pulse to be at least four times greater than the power of the first sub-pulse (MPEP 2143). The advantage of such modification may improve the treatment of calculi (e.g., stones) in a patient’s body (see paragraphs [0051-0052, 0081, 0085-0086] by Deladurantaye).
Regarding claim 48, Falkenstein in view of Deladurantaye suggests the laser system of claim 46. Falkenstein and Deladurantaye do not explicitly teach wherein the power of the second sub-pulse is at least two times greater than the power of the first sub-pulse.
However, the Examiner respectfully submits that Deladurantaye teaches pulse power parameters which may be controlled or adjusted by the laser system ([0081, 0085-0086]). Thus, a person having ordinary skill in the art would have found it obvious to try to configure the power of the second sub-pulse to be at least two times greater than the power of the first sub-pulse (MPEP 2143). The advantage of such modification may improve the treatment of calculi (e.g., stones) in a patient’s body (see paragraphs [0051-0052, 0081, 0085-0086] by Deladurantaye).
Regarding claim 49, Falkenstein in view of Deladurantaye suggests the laser system of claim 41. Falkenstein teaches the laser system further comprising a power source connected to the TFL (the power supply 30 is coupled to the optical pump 24 which optically excites the lasing medium 22 (e.g., Thulium fiber laser) to produce a laser pulse at various wavelengths [0007, 0023-0025]) and to provide a variable power delivery in response to the receipt of a control signal from the controller (the power supply 30 may adjust the delivery parameters of the pulses in response to the receipt of a control signal from the controller 50 [0027]).
Regarding claim 50, Falkenstein teaches a fiber guiding the laser pulses to the calculi (the laser system 100 comprises a flexible optical fiber 12 which delivers the laser pulses to the calculi (e.g., stone) [0023]).
Statement on Communication via Internet
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Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
10. 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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/J.B.S./Examiner, Art Unit 3792
/ANKIT D TEJANI/Primary Examiner, Art Unit 3796