DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant's submission filed on 11/04/2025 has been entered. Accordingly, claims 1-20 remain pending, claims 1-6, 8-15, and 17-19 have been amended.
Response to Arguments
Priority
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
In response, while applicant did file an original copy of Application No. PCTJP2021009531, no certified English translation was filed. Regarding, Application No. PCT/JP2022/008752, neither an original copy nor a certified English language copy has been filed. If applicant wishes to perfect the earliest priority date relating to either of these two above documents, applicant should filed certified English language translations of each document.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Claim interpretations under 35 USC 112(f)
In light of applicant's claim amendments filed 11/04/2025 have rendered the previous claim interpretations moot and they have been withdrawn.
Rejections under 35 USC 112
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
On pages 10-11 of the response, applicant cites in paragraphs [0017], [0023] for support of the limitations of claims 7, 16, and 20 rejected under 112(a), applicant argues
of the “English specification” stating that
“[P]aragraph [0017] of the original English specification expressly discloses that ‘the bubble B repeatedly forms and contracts, which vibrates the distal end 2a in the radial direction" and paragraph [0023] adds that ‘The aforementioned pulse group is repeatedly emitted at the repetition frequency fl, so that the distal end 2a vibrates in the radial direction at the repetition frequency fl, as shown in Fig. 5A, whereby the laser beam L emitted from the distal end 2a is scanned in the radial direction.’ Such disclosure, in combination with the portions of the present disclosure cited by the Examiner at least inherently support that ‘the first period and the second period are alternately repeated.’. A ‘vibration,’ as disclosed in the original disclosure clearly refers to alternately repeating the first and second periods and those skilled in the art would understand the disclosure as supporting the same”.
In response, it is noted that [0017] (which corresponds to [0037] of the PG Pub) discloses:
“As shown in FIG. 3 , when the pulsed laser beam L is emitted from the distal end 2 a in the liquid medium M, the bubble B is generated at the distal end 2 a. The bubble B coming into contact with or close to the operation member 4 contracts, which induces movement of the vibration region 2 b toward the operation member 4. Consequently, the bubble B repeatedly forms and contracts, which vibrates the distal end 2 a in the radial direction”.
And [0023] (which corresponds to [0046] of the PG Pub) discloses:
“The aforementioned pulse group is repeatedly emitted at the repetition frequency f1, so that the distal end 2 a vibrates in the radial direction at the repetition frequency f1, as shown in FIG. 5A, whereby the laser beam L emitted from the distal end 2 a is scanned in the radial direction. The repetition frequency f1 is set to a resonance frequency of the vibration region 2 b of the optical fiber 2 in accordance with calibration, to be described later”.
Accordingly, neither [0017] ([0037) nor [0023] ([0046]) describe the alternation of “the first period and the second period”. Additionally, a review of the specification could not find reference to support applicant’s argument that “A ‘vibration,’ as disclosed in the original disclosure clearly refers to alternately repeating the first and second periods and those skilled in the art would understand the disclosure as supporting the same” and it is unclear how a physical force/oscillatory movements of objects – such as vibration, having both a magnitude and direction – as so aforementioned is defined to be, as known in the physical arts “clearly refers to alternately repeating” set separate units of time (e.g., the first period and the second period), which is separately defined in the physical arts as a scalar fundamental quantity, having a magnitude, but no direction. In [0072] of [0071] of the PG Pub, the disclosure was found which states
“During the third period III corresponding to the first half of the subsequent repetition cycle T1, the pulse group is emitted again from the distal end 2 a, and the bubble B coming into contact with or close to the operation member 4 forms and contracts, which causes the distal end 2 a to move closer toward the operation member 4. During the subsequent second period II, the distal end 2 a moves away from the operation member 4, and the emission of the pulse group stops during that time” and
“Subsequently, the emission of the pulse group in the third period III and the stoppage of the pulse group in the second period II are alternately repeated”.
It is not clear if applicant meant to refer to the above discussion and movement and stoppage of movement of the distal end of the optical fiber. However, the limitation under investigation does not recite “the third period II” nor a “stoppage of the pulse group” of “the second period II”. Parent claim 1 recites “emitting a pulsed laser beam from a distal end of an optical fiber in a liquid medium during a first period…wherein the first period is a period for moving the optical fiber closer toward an operation member disposed parallel to the optical fiber by utilizing contraction of the bubble that comes into contact with or close to the operation member” and “stopping emission of the pulsed laser beam from the distal end during a second period…wherein the second period is a period for moving the optical fiber away from the operation member”, as defined in parent claim 1, movement occurs in both periods, unlike the disclosure in [0070]-[0071]. It is unclear if applicant meant that for each of the oppositional movements recited in claim 7, as earlier defined in parent claim 1 to occur un discrete time periods, are meant when the motion of the distal end of the optical fiber moves without restraint (e.g., free vibrations) during one period, and when the motion of the distal end of the optical fiber is countered by a restoring force (e.g., forced vibrations) in another separate period; as vibrations are defined in the physical arts as being occurring when an object that is disturbed from its equilibrium position and responds with periodic back-and-forth motion (both the free vibrations and the forced vibrations).
Therefore, the claims remain rejected under 112(a).
Regarding the previous rejections under 112(b), applicant indicates that “the claims have been amended, where necessary, in a manner believed to overcome the Examiner's rejection as to indefiniteness”. Accordingly, in response to the amendments filed 11/04/2025, the previous rejections of claims 3-4 and 11-13 have been rendered moot and have been withdrawn.
However, the remaining previous rejections of the claims under 112(b) were not remedied nor addressed by the recent amendments to the claims and have added additional issues regarding clarity and new matter in the claims. Please see the new 112(a) new matter and updated rejections 112(b) outlined below.
Therefore, the claims remain rejected under 112(b).
Rejections under 35 USC 102/103
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
Applicant argues in the first-second paragraphs of page 13
“Firstly, the Applicant submits that there is no suggestion to combine Visuri and Anderson with Fujinuma. That is, Visuri and Anderson do not disclose or suggest vibrating the optical fiber (or even moving the distal end of the optical fiber closer to a fixed operation member). Therefore, there is no suggestion to use the methodology of Fujinuma to detect movement or determine the frequency of such movement. Those having ordinary skill in the art would have no occasion to modify Visuri and/or Anderson with the methodology of Fujinuma to detect movement or determine the frequency of such movement since Visuri and Anderson do not disclose or suggest such movement of the distal end of an optical fiber or disclose or suggest the need for the same. Therefore, the methodology of Fujinuma to detect movement or determine the frequency of a distal end of an optical fiber could only have been gleaned from the present disclosure using impermissible hindsight.
Secondly, even if such combination is proper, the Applicant submits that such combination fails to disclose or suggest all of the features of claim 1. That is, although Visuri and Anderson disclose generating bubbles, the bubbles are not disclosed as (i) enveloping the distal end of the optical fiber or (ii) moving the distal end of the optical fiber towards a fixed operation member in a first period (e.g., due to a contraction force of the bubble) and away from the fixed operation member in a second period (e.g., due to a restoring force of the optical fiber). Such features have been clarified in claim 1…”.
As a preliminary matter, applicant is reminded that “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). (See MPEP 2145(X)(D)(1)).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “vibrating the optical fiber”, “moving the distal end of the optical fiber closer to a fixed operation member”, “detect movement or determine the frequency of such movement”, “moving the distal end of the optical fiber towards a fixed operation member in a first period”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation to combine primary reference Visuri with the cited disclosure of secondary reference Anderson is so that order to use the first pulse to cause the bubble to form so that the timing between pulses can regulate the depth of the tissue ablation (see column 3, lines 56-59 of Anderson). The motivation to combine modified primary reference Visuri with the cited disclosure of tertiary reference Fujinuma is for in order to change the driving frequency and the modulation frequency at the same rate as a rate of change of the resonance frequency when the detected resonance frequency changes (see [0007] of Fujinuma).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant’s remarks on pages 13-14, characterize the field of endeavor more narrowly than is appropriate. As noted in In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009), “This court cannot, in the face of KSR, cling to formalistic rules for obviousness, customize its legal tests in specific scientific fields in a way that deem entire classes of prior art teachings irrelevant, or discount significant abilities of artisans of ordinary skill in an advanced area of art”.
Further, in response to applicant's argument that the prior art references fail to teach or disclose the limitations of claims 9 and 18, and their corresponding dependent claims, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Additionally, as remarked in the rejections under 112(a) and 112(b), both new and outstanding, questions regarding new matter, written description, and indefiniteness issues exist in the claims which impact determining the scope of protection that applicant is seeking for applicant’ invention.
Therefore, the claims remain rejected and the rejection has been made final.
Priority
Applicant is reminded that in order for a patent issuing on the instant application to obtain priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) or (b), based on priority papers filed in a parent or related Application No. PCT/JP2022/008752 (which the present application claims the benefit under 35 U.S.C. 120, 121, 365(c), or 386(c) or is a reissue application of a patent issued on the related application), a claim for such foreign priority must be timely made in this application. To satisfy the requirement of 37 CFR 1.55 for a certified copy of the foreign application, applicant may simply identify the parent nonprovisional application or patent for which reissue is sought containing the certified copy.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application(s) for parent or related Application No. PCTJP2021009531 and for parent or related Application No. PCT/JP2022/008752 (both to which the present application claims the benefit under 35 U.S.C. 120, 121, 365(c), or 386(c) or is a reissue application of a patent issued on the related application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the bubble that envelops the distal end of the optical fiber and the bubble which has an outer periphery that comes into contact with or close to the operation member, the operation member being fixed relative to the distal end of the optical fiber must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "first period" and "T1" have both been used to designate when the bubble is generated (see [0008], [0038], [0044]-[0045]). 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: f1, f3, first period I, second period II, third period III, the second period II being the second half of one repetition cycle T1 (see FIG. 4, [0044]-[0045], [0052], [0056]), T2 (see [0065], FIGS. 6, 7, 8B), T4. 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. 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 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 1-20 are 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.
Claim 1 has been amended to recite “…generating a bubble enveloping the distal end”, “…contraction of the bubble that envelops the distal end of the optical fiber and has an outer periphery that comes into contact with or close to the operation member”, and “the operation member being fixed relative to the distal end of the optical fiber” in lines 3-4 and 9-11, while support could be found for the contracting of the bubble B coming into contact with or close to the operation member (see [0037], FIG. 3); and the during the first period I corresponding to the first half of the first repetition cycle T1, the pulse group is emitted from the distal end, and the bubble coming into contact with or close to the operation member forms and contracts, which causes the distal end to move closer toward the operation member (see [0069], FIG. 6), and the pulse group is emitted from the distal end during the first period I corresponding to the first half of the first repetition cycle T1, causing the bubble to form during time to come into contact with or close to the operation member during time t2 and to then contract during time t3, which causes the distal end to move closer toward the operation member, when the emission of the pulse group stops during the subsequent second period II, the distal end moves away from the operation member (see [0065], [0069]-[0070], FIGS. 7), also corresponding the first half of the subsequent repetition cycle T1 during a third period III, the pulse group is emitted again from the distal end, again the bubble will form and contract which will come into contact with or close to the operation member (see [0065], [0070], FIGS. 8A-8B); the distal end of the optical fiber being located in the liquid medium which is disposed outside of the sheath (see [0006], [0036], [0053], FIGS. 1-3, 5, 8A-8B, 9A-9D); the vibration region of the optical fiber being included in/part of the distal end and located to one side of the distal end (see [0031]).
Cambridge dictionary defines the term “enveloping” to mean “to cover or surround something completely”.
And support could be found for in one embodiment where located at the distal end of the sheath, is a support section which supports the optical fiber at a position located at a base end side relative to a distal end of the optical fiber with a distance so that at the support section, the position of the optical fiber is fixed in the radial direction (see [0031], FIG. 2) so that a vibration region 2 b of the optical fiber 2 which is disposed at a distal end side relative to the support section and which includes the distal end is supported in a cantilever manner by the sheath, and the vibration region can be vibrated in the radial direction of the optical fiber about a part, acting as a fulcrum, of the optical fiber in the support section (see [0032], FIG. 2), a plate-shaped member is disposed parallel to and protrudes relative to the distal end [including the vibration region relative to the support section/distal end of the sheath] of the optical fiber by being fixed to the distal end of sheath and the length of the plate-shaped member protrudes or extends in a longitudinal direction, beyond the distal end of the optical fiber, the plate-shaped member is the operation member (see [0032], FIG. 2), the operation member is provided for applying, to the distal end of the optical fiber, a contraction force which acting toward the operation member during contraction of a bubble B which has been generated at the distal end of the optical fiber (see [0033], FIG. 2); and in separate embodiment where the operation member being directly fixed to the optical fiber and is, therefore, combined with the optical fiber (see [0084], FIG. 9D).
However, this does not provide support for what is claimed (i.e., that the bubble completely surrounds the entirety/whole of the distal end of the optical fiber inclusive of the vibration region is entirely surrounded by the bubble and that the combination of the two structurally and functionally separate embodiments outlined above), and no basis has been pointed to for these new limitations in applicant' s remarks. In the absence of support for the newly recited limitations, these claims and claims dependent thereon are deemed to constitute new matter. This is a NEW MATTER rejection.
Claims 9 and 18 are also rejected for reciting the same and/or limitations outlined above.
All dependent claims are also rejected by the nature of their dependency.
Claim 7 recites “wherein the first period and the second period are alternately repeated” in lines 1-2, while support could be found for the processor to control the laser oscillator to repeatedly emit a pulse group, including one or more pulsed laser beams L arranged in a time direction, from the distal end a at a repetition frequency f1=1/T1, and the processor sets the timing for emitting the pulse group from the distal end based on the repetition frequency f1, the pulse group is emitted from the distal end a during a first period I and a third period III, and stops the emission of the laser beam L from the distal end a during a second period II (see [0044], FIG. 4), the pulse group from the first period I is repeatedly emitted at the repetition frequency f1 (see [0046]), the pulse group from the third period III is repeatedly emitted at the repetition frequency f1 (see [0046]); the processor causes the laser oscillator to repeatedly generate the pulsed laser beam L, so that the pulsed laser beam L is repeatedly emitted from the distal end of the optical fiber (see [0057]); the emission of the pulse group in the third period III and the stoppage of the pulse group in the second period II are alternately repeated (see [0071]).
However, this does not provide support for what is claimed, and no basis has been pointed to for these limitations in applicant' s remarks. The absence of support for the recited limitations as rejected raises doubt to regarding at the time the application was filed, if the applicant had possession of the claimed invention. These claims and claims dependent thereon are deemed to failing to comply with the written description requirement. This is a WRITTEN DESCRIPTION rejection.
Claims 16 and 20 are also rejected for reciting the same and/or limitations outlined above.
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 1-20 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 1 has been amended to recite “emitting a laser beam from a distal end of an optical fiber in a liquid medium during a first period, the laser beam being emitted for generating a bubble enveloping the distal end”, “wherein the first period is a period for moving the distal end of the optical fiber closer toward an operation member disposed parallel to the optical fiber by due to contraction of the bubble that envelops the distal end of the optical fiber and has an outer periphery that comes into contact with or close to the operation member” in lines 2-4 and 5-8, which renders the claim indefinite because it is unclear what functional meaning applicant meant to impart when reciting that the first period as being able to “due to” contraction of the bubble that comes into contact with or close to the operation member in order to or moving the optical fiber closer toward an operation member disposed parallel to the optical fiber.
Claims 9 and 18 are also rejected for reciting the same and/or limitations outlined above.
All dependent claims are also rejected by the nature of their dependency.
Claim 2 recites “wherein the optical fiber moves away from the operation member by a restoring force of the optical fiber during the second period” in lines 2-4, which renders the claim indefinite because it is unclear what structural and functional meaning applicant meant to impart on the optical fiber physically moving away from the operation member as it is unclear what structure serves as a source which exerts or generates a “restoring force” of the optical fiber. Is also unclear if the restoring force is a property possessed by the optical fiber itself or exerted upon/on the optical fiber, and that applicant meant to recite “…a restoring force on the optical fiber during the second period”. It is further unclear how the force is “restoring” as it is unclear what property or function is being “restored” by the exertion or application of the force. It appears, although it is unclear, that applicant may be attempting to claim software for performing these functions, and not a physical processor and/or other device which has been specifically configured to perform these functions. Accordingly, it is not clear if the claim is patent eligible under 35 USC 101. Applicant is advised in their next response to amend the claim to clearly recite the physical structures that perform each of the claimed limitations.
Claim 10 is also rejected for reciting the same and/or limitations outlined above.
Claim 8 recites “wherein the method comprises increasing a vibration amplitude of the distal end of the optical fiber resulting in a contraction force of the bubble acting on the distal end of the optical fiber multiple times by repeating, multiple times, the emission of the laser beam in the first period to repeat generation and contraction of the bubble” in lines 1-6, which renders the claim indefinite because it is unclear by what structure performs the function of “resulting in” a contraction force of the bubble acting on the distal end of the optical fiber multiple times”, as it is unclear what applicant meant as to refer which “resulting in a contraction force of the bubble acting on the distal end of the optical fiber. It is unclear if the contraction force is a component of the bubble itself or acted upon the bubble, in response to an action by a physical device. It is also under if the contraction force is required by the claim, as the claim only recites the “resulting” in a contraction force, and does not actively recite a generation or generating, by a specific physical device, a contraction force at the bubble. It appears, although it is unclear, that applicant may be attempting to claim software for performing these functions, and not a physical processor and/or other device which has been specifically configured to perform these functions. Accordingly, it is not clear if the claim is patent eligible under 35 USC 101. Applicant is advised in their next response to amend the claim to clearly recite the physical structures that perform each of the claimed limitations.
Claim 17 is also rejected for reciting the same and/or limitations outlined above.
Claim 9 recites “for generating a bubble enveloping the distal end”, “for moving the optical fiber closer toward an operation member”, “utilizing contraction of the bubble that comes into contact with or close to the operation member”, “for moving the distal end of the optical fiber away from the operation member”, “…at each frequency based on information from the movement sensor”, and “…for emitting the laser beam from the distal end based on the resonance frequency” in lines 9-25, which renders the claim indefinite because it is unclear the limitations in question are required by the claim as there is no step recited in the claim which actively recites each of these steps/functions as being positively performed. Therefore, these limitations have been interpreted as intended use. it is also unclear what applicant meant to recite when reciting “at each frequency based on information from the movement sensor”, as the claim previously recites only a singular frequency, therefore, it is unclear to what each frequency refers, as it is unclear to what “information from the movement sensor” is meant to refer, as there is no structure recited as being associated with receiving and processing the information from the movement detector and to what type of data the information pertains.
Claims 12 and 18 are also rejected for reciting the same and/or limitations outlined above.
All dependent claims are also rejected by the nature of their dependency.
Claim Objections
Claim5 is objected to because of the following informalities: the limitation “wherein the processor is configured to change a pulse-group frequency of the plurality of laser beams” should be amended to recite “wherein the processor is configured to change a pulse-group frequency of the plurality of the laser beams”. Appropriate correction is required.
Claim 14 is also rejected for reciting the same and/or limitations outlined above.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Visuri et al. (US6538739, hereafter “Visuri”), in view of Anderson et al. (US5776127, hereafter “Anderson”), in further view of Fujinuma (US20180064323).
Regarding claims 1, 9, and 18, Visuri discloses a laser irradiation device and method (column 2, lines 43-45, FIG. 1) comprising and a storage medium (claim 5, means for storing), a laser scanning program causing a laser irradiation device (FIG. 3) to execute:
an optical fiber that emits a laser beam from a distal end thereof in a liquid medium (18 in FIG. 1, abstract pulsed laser emitted in fluid surrounding distal end of the device);
a processor comprising a hardware, the processor controlling the laser beam emitted from the optical fiber (72 in FIG. 3, column 5, lines 48-50, the computer is used to control the laser); and
a detector that detects of the optical fiber (FIGS. 1-2A, claim 2, detector 30 detects the reflected portion of said beam),
wherein the processor is configured to emit the laser beam from the distal end during a first period (72 in FIG. 3, column 5, lines 48-50, the computer is used to control the laser, column 7, lines 19-24, the laser pulse duration [first period] is ideally short enough to induce an isochoric (constant volume) heating process), the laser beam being emitted for generating a bubble enveloping the distal end (column 3, lines 43-46, the laser beam is directed to a site for bubble formation), and
wherein the processor is configured to stop emission of the laser beam from the distal end during a second period (column 11, lines 25-27, discontinuing/stopping firing/emission of the first beam of laser light from the high repetition laser system for at least a second period of time), and
wherein the processor is configured to:
determine a resonance frequency of the optical fiber (column 7, lines 64-66, a resonant operation [therefore, including a frequency thereof] is determined by synchronizing the laser pulse repetition rate with the cavity lifetime), and
determine a timing for emitting the laser beam from the distal end based on the resonance frequency (column 8, lines 43-45, a resonant operation [therefore, including a frequency thereof] is determined by matching the laser pulse period to the lifetime of the vapor bubble).
but does not explicitly disclose wherein the first period is a period for moving the distal end of the optical fiber closer toward an operation member* disposed parallel to the optical fiber due to contraction of the bubble that envelops the distal end of the optical fiber and has an outer periphery that comes into contact with or close to the operation member, the operation member being fixed relative to the distal end of the optical fiber, nor wherein the second period is a period for moving distal end the optical fiber away from the operation member, nor wherein the processor is configured to change a frequency of the pulsed laser beam.
However, in the same field of endeavor, Anderson teaches wherein the first period is a period for moving the distal end of the optical fiber closer toward an operation member* disposed parallel to the optical fiber (see optical waveguides 16, 21 as are parallel to operation member/plate 22 in FIG. 1) due to contraction of the bubble that envelops the distal end of the optical fiber (see FIGS. 2A-2C, enveloping end of optical fiber) and has an outer periphery that comes into contact comes close** to the operation member (column 6, lines 51-54, the first pulse is adjusted to vary/control the contraction/collapse of vapor bubble as seen in FIG.4, see FIGS. 3C-3D, as the vapor bubble collapses, more of the surface area of the optical fiber(s) are in contact [moved closer] to the operation member), the operation member being fixed relative to the distal end of the optical fiber (see FIG. 1, column 3, lines 14-15, column 5, lines 59-61, the optical fibers are fixed to the operation member/plate 22 positioned above the distal end of the operation member 24, therefore, as the optical fiber is fixed to the operation member, the position of the operation member is known/fixed relative to the position of the optical fiber),and
wherein the second period is a period for moving the distal end of the optical fiber away from the operation member (column 1, lines 49-55, once the bubble reaches a desirable size during a predetermined time period, a second laser pulse is delivered from the fiber and propagates through the bubble before reaching the tissue, thereby, as the second laser pulse propagates through the bubble, it generates a force in the direction of the tissue which would move the optical fiber away from the operation member, as the absorption of the pulse leads to rapid heating of the fluid that expands outwardly in all directions);
wherein the processor is configured to:
change a frequency of the laser beam (column 5, lines 21-23, FIG. 1, column 7, lines 40-47, processor/laser control source 27 controls the laser shots be between/change/vary from about 10 and 1 kHz and repetition rate to be between/change/vary from 6 and 50 Hz).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the laser irradiation device and method, and storage device disclosed by Visuri with the first period being a period for moving the distal end of the optical fiber closer toward an operation member disposed parallel to the optical fiber due to contraction of the bubble that envelops the distal end of the optical fiber (see FIGS. 2A-2C, enveloping end of optical fiber) and has an outer periphery that comes into contact comes close** to the operation member and the second period being a period for moving the distal end of the optical fiber away from the operation member, the processor is configured to change a frequency of the pulsed laser beam, and the operation member being fixed relative to the distal end of the optical fiber as taught by Anderson in order to use the first pulse to cause the bubble to form so that the timing between pulses can regulate the depth of the tissue ablation (column 3, lines 56-59 of Anderson).
Modified Visuri does not explicitly disclose the sensor is a movement sensor that detects movement of the optical fiber, the determination of the resonance frequency of the optical fiber as being based on the detected movement.
And, specifically, with respect to claim 19, modified Visuri does not explicitly disclose the storage medium as storing a laser scanning program.
However, in the same field of endeavor, Fujinuma teaches a movement sensor that detects movement of the optical fiber (13 in FIG. 1),
detect movement of the optical fiber at each frequency based on information from the movement sensor ([0006], [0021] resonance-frequency detector of the optical fiber, the optical fiber vibrates in two directions [movements]);
determine a resonance frequency of the optical fiber (abstract, [0006], [0035] the driving of the optical fiber is based on the determined resonance frequency detected) based on the detected movement ([0035]-[0036] based on the movement of the distal end of the optical fiber as it is movement along a spiral locus).
And with regard to claim 19, Fujinuma teaches the storage medium as storing a laser scanning program ([0035] the method for controlling a certain driving frequency, modulation frequency, sampling rate, etc., are set by a user based on the resonance frequency of the optical fiber are input to the controller).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the laser irradiation device and method, and storage device disclosed by Visuri with the detector is a movement sensor that detects movement of the optical fiber, the determination of the resonance frequency of the optical fiber as being based on the detected movement, the storage medium as storing a laser scanning program, as taught by Fujinuma in order to change the driving frequency and the modulation frequency at the same rate as a rate of change of the resonance frequency when the detected resonance frequency changes ([0007] of Fujinuma).
*For the purposes of examination, the limitation has been interpreted under the broadest reasonable interpretation to mean any structure as known in the art capable of performing the claimed function and/or structural arrangement in relation to the distal end of the optical fiber as outlined in the claim(s).
**For the purposes of examination, the limitation has been interpreted in the alternative, requiring the bubble that envelops the distal end of the optical fiber and has an outer periphery that comes into contact comes into contact with the operation member; or requiring the bubble that envelops the distal end of the optical fiber and has an outer periphery that comes into contact comes close to the operation member.
Regarding claims 2 and 10, Visuri, in view of Anderson and Fujinuma, substantially discloses all the limitations of the claimed invention, specifically, Fujinuma discloses wherein the optical fiber moves away by a restoring force of the optical fiber during the second period (FIGS. 5A-6, [0025], [0043]-[0049] the optical fiber is periodically [second period] vibrated which cause the optical fiber to move/vibrate in an outward direction) and Anderson discloses from the operation member (see as cited above, therefore, under the broadest reasonable interpretation, one of ordinary skill in the art would understand that the vibrational force of Fujinuma could cause the optical fiber to move away from the operation member of Anderson).
Regarding claims 3 and 11, Visuri, in view of Anderson and Fujinuma, substantially discloses all the limitations of the claimed invention, specifically, Fujinuma discloses wherein the processor is configured to emit the laser beam from the distal end during a third period subsequent to the second period (see the multiple periods, including a second a third period, as outlined in FIG. 2), and
wherein the third period is a period for moving the optical fiber closer toward (FIGS. 5A-6, [0025], [0043]-[0049] the optical fiber is periodically [second period] vibrated which cause the optical fiber to move/vibrate in an inward direction) and Anderson discloses the operation member (see as cited above, therefore, under the broadest reasonable interpretation, one of ordinary skill in the art would understand that the vibrational force of Fujinuma could cause the optical fiber to move closer toward from the operation member of Anderson).
Regarding claims 4 and 13, Visuri, in view of Anderson, substantially discloses all the limitations of the claimed invention, specifically, Anderson discloses wherein the processor is configured to emit a plurality of the plurality of the laser beams during the first period (FIG. 4, see pulse group 50 emits a plurality of 46 pulsed laser beams).
Regarding claims 5 and 14, Visuri, in view of Anderson and Fujinuma, substantially discloses all the limitations of the claimed invention, specifically, Anderson discloses wherein the processor is configured to change a pulse-group frequency of the plurality of laser beams and a number of pulses therein (FIG. 4, see pulse group 50 emits a plurality of 46 pulsed laser beams can be changed to be 48 pulsed laser beams in pulse group 52), the pulse-group frequency being a repetition frequency of the plurality of laser beams (column 7, lines 33-38, the time periods for separating the pulse groups [pulse-group frequency] is determined by the repetition rate of the laser), the number of pulses being the number of the plurality of laser beams (see as illustrated in FIG. 4), and
wherein the processor is configured to determine the pulse-group frequency of the plurality of laser beams and the number of pulses therein in the first period (column 7, lines 5-19, the vapor bubble size creation is time-dependent and the duration/first period is used to determine the timing of the pulses in the pulse group [pulse frequency] and the number of pulses in the pulse group that should be emitted based on the desired vapor bubble size) and Fujinuma discloses based on movement of the optical fiber at each pulse-group frequency and at each number of pulses ([0026]-[0027] the movement detector detects movement of the optical fiber via detection of the resonance frequency, which is then transmitted to the controller which then uses the information from the movement detector to set the driving frequency of the optical fiber [which then determines the number and frequency of the pulses from the pulse group emitted]).
Regarding claims 6, 15, and 19, Visuri, in view of Anderson, substantially discloses all the limitations of the claimed invention, specifically, Anderson discloses wherein a number of pulses is (T2/T3)+1 (see FIGS. 3C-3D, 4),
wherein the T3 indicates a time from start of the emission of the laser beam to vanishing of the bubble (time from start of laser beam 14 emission in 3C to start of bubble vanishing after laser beam 20 in FIG. 3D), and wherein the T2 indicates a time from a start of emission of a first laser beam in one pulse group to start of emission of a last laser beam in the one pulse group (time from start of laser beam 14 emission in 3C to start of laser beam 20 emission in FIG. 3D), wherein T2 indicates the time as a time from the start of the emission of the first laser beam in the one pulse group to a first contact between the bubble and the operation member (time from start of laser beam 14 emission in 3C to start of bubble contacting 22 in FIG. 3C).
Regarding claims 7, 16, and 20, Visuri, in view of Anderson, substantially discloses all the limitations of the claimed invention, specifically, Anderson discloses wherein the first period and the second period are alternately repeated (column 7, lines 33-38, a first period for firing a pulse and time periods separating the next pulse are determined by the repetition rate of the laser, meaning that the first period when a pulse is fired followed by a second period a pulse is not fired is repeated at the rate set by the laser).
Regarding claims 8 and 17, Visuri, in view of Anderson and Fujinuma, substantially discloses all the limitations of the claimed invention, specifically, Fujinuma discloses wherein the method comprises increasing a vibration amplitude of the distal end of the optical fiber (abstract, controlling the amplitude of vibrations of the optical fiber) and specifically, Anderson discloses resulting in a contraction force of the bubble acting on the distal end of the optical fiber (column 6, lines 51-54, the duration (i.e., power) of the first pulse can be adjusted to vary the size, and lifetime before collapse/contraction force of the bubble on the distal end) multiple times by means of repeating, multiple times, the emission of the laser beam in the first period to repeat generation and contraction of the bubble (column 7, lines 29-47, this process is repeated multiple times, by repetitive illumination of the tissue using multiple two-pulse sequences, the repetition rate is set by the laser and the rate is long enough so that each vapor bubble completely collapses between laser shots, before generation of the next vapor bubble).
Regarding claim 12, Visuri, in view of Fujinuma, substantially discloses all the limitations of the claimed invention, specifically, Visuri discloses further comprising:
a laser oscillator that supplies the laser beam to the optical fiber (column 10, lines 35-36 the laser an optical parametric oscillator (OPO) pumped laser); and specifically, Fujinuma discloses
a support member that supports the optical fiber in a cantilever manner (abstract, see 17 in FIG. 1, the optical fiber is free at the distal end 17a, and is configured to vibrate, via the actuators 19 [support member], therefore, as the optical fiber is free on one end and is configured to vibrate, it would be understood by one of ordinary skill in the optical fiber arts that the optical fiber is supported in a cantilever manner).
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 AMY SHAFQAT whose telephone number is (571)272-4054. The examiner can normally be reached Monday-Friday 9:30AM-5:30PM MST.
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, Keith Raymond can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.S./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798