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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7-10 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 7 recite “the first optical sensor module” and “dependence of the sensed distance and/or of the detected properties.”, however these have an antecedent basis issue. It is unclear what “the first optical sensor module” being referenced is as it is not recited earlier in claim 7 nor in the claims from which 7 depends (likewise for “the sensed distance” and “the detected properties”). The claim tree for claim 7 recites a “sensor module” and a “second optical sensor module” but no “first optical sensor module” (likewise for “the sensed distance” and “the detected properties”) thus is the first one of those others or something else. For the above reasons the claim does not clearly define the metes and bounds of the claim and is indefinite. The claims which depend from this claim share this issue and are likewise rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 11, 13-14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20220110525 to Seifert et al. (hereinafter Seifert).
Regarding Claim 1, an interpretation of Seifert discloses a fiber-optic medical treatment apparatus comprising a medical treatment device and a disposable fiber-optic device (abstract, [0003], see also [0099]), wherein the disposable fiber-optic device comprises an at least double-clad optical fiber having a proximal end and a distal end ([0047], [0078]-[0079] see also [0099]; Optical fibers have two ends), the distal end being configured to be advanced through a working channel of an endoscope ([0047], [0080], [0084] see also [0099]; to the extent “to be advanced . . .” is an intended use of the device the device recited is structurally capable of performing the intended use), wherein the at least double- clad optical fiber has at least one core and two or more claddings ([0047], [0078]-[0079] see also [0099]);
wherein the medical treatment device comprises:
- a control unit configured to control operation of the medical treatment device ([0049] see also [0046], [0055], [0099]; elements are programmed to perform the recited elements);
- a treatment laser source configured to output treatment laser radiation for treatment of a medical condition ([0074]-[0076]] see also [0099]; to the extent “for treatment . . .” is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use); wherein the medical treatment apparatus is configured to output the treatment laser radiation through at least one of the two or more claddings of the at least doubled-clad optical fiber towards tissue to be treated ([0074]-[0076]], [0078]-[0079], [0092] see also [0099]);
- a sensor module configured to output and receive sensor laser radiation through the at least doubled-clad optical fiber ([0005], [0012], [0058] see also [0099]) and to optically measure one or more parameters of the treatment based on the received sensor laser radiation ([0005], [0012], [0055]-[0056], [0058], [0067] see also [0099]);
wherein the at least one core of the at least double- clad fiber has a V number of less than 10 at a wavelength of the sensor laser radiation ([0047], [0078]-[0079] see also [0099]; Examiner notes that a V mode of 10, M = V2/2, is approximately 50 modes for further discussion see V modes from RP Photonics encyclopedia in the pertinent art section below), wherein the medical treatment apparatus is configured to output the sensor laser radiation through the at least one core of the at least doubled-clad optical fiber ([0047], [0078]-[0079] see also [0099], and wherein the medical treatment apparatus is configured to time division multiplex the output of the treatment laser radiation and at least the optical measurement of the one or more parameters ([0004], [0067]-[0069], [0074]-[0076], [0078]-[0079], [0096] see also [0092], [0099]; it is dividing the time between the sources).
Regarding Claim 3, an interpretation of Seifert further discloses fiber-optic medical treatment apparatus according to claim 1, wherein the sensor module comprises a first optical sensor module configured to perform interferometric distance sensing of a distance between the distal end of the at least double-clad optical fiber and the tissue to be treated ([0005], [0012], [0017], [0056] see also [0046], [0099]; OCT infererometer).
Regarding Claim 11, an interpretation of Seifert further discloses wherein the medical treatment device comprises at least one of an audible power indicator and a visible power indicator configured to output at least one of an audible indication and a visual indication ([0081], [0094], [0186] see also [0191]), respectively, that is indicative of a current laser power of the treatment laser radiation ([0081], [0094], [0186] see also [0191]).
Regarding Claim 13, an interpretation of Seifert wherein the at least one core is a few-mode core or a single-mode core at least at a wavelength of the sensor laser radiation ([0047] including “any one or combination of one or more single mode fibers and one or more multi-mode fibers”, [0052], [0078]-[0079]).
Regarding Claim 14, an interpretation of Seifert further discloses wherein the at least two claddings include a multi-mode inner cladding surrounding the at least one core, the inner cladding being surrounded by at least one outer cladding ([0060], [0078] including “a waveguide cladding”, [0079] including “a second light source is provided through a cladding of the fiber” see also [0099]).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seifert in view of US 20090028495 of Anrig et al. (hereinafter Anrig).
Regarding Claim 2, an interpretation of Seifert further discloses:
- a connector module ([0083]-[0084], Fig. 1C see also [0099]) for optically connecting the proximal end of the at least double-clad optical fiber to the medical treatment device ([0078], [0084], Fig. 1C), wherein the connector module comprises:
- a first optical fiber ([0083]-[0084], Fig. 1C see also [0099]),
- a second optical fiber ([0083]-[0084], Fig. 1C see also [0099]),
- a first optical connector for optically connecting the first optical fiber to the medical treatment device ([0083]-[0084], Fig. 1C see also [0099]),
- a second optical connector for optically connecting the second optical fiber to the medical treatment device ([0083]-[0084], Fig. 1C see also [0099]), and
- an optical combiner module configured to couple radiation between the first optical fiber and the at least one core of the at least double-clad optical fiber and to couple radiation between the second optical fiber and the at least one cladding of the at least double-clad optical fiber ([0083]-[0084], Fig. 1C see also [0099]).
An interpretation of Seifert may not explicitly disclose the first and second optical connectors detachably connecting the first and second optical fibers, respectively, to the medical treatment device.
However, in the same field of endeavor (optical connectors), Anrig teaches an electro-optical hybrid connection assembly that includes (Figs. 1-4): an optical connector for detachably connecting two optical fibers. Abstract: "An electro-optical hybrid connection assembly provides an optical connection of at least a first optical fiber and a second optical fiber that define a fiber axis and … ."
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to use an optical connector along the lines of Anrig in a system according to Seifert as set forth above in order to provide detachable attachment for fiber optic cables and/or optical fibers. This provides one rationale to combine the references. Another completely independent and separately sufficient rationale arises as follows. In making the combination (above), the combining of prior art elements (listed above) according to known methods (per the references) to yield predictable results (an optical fiber cable system) would occur as each element merely performs the same function in combination as it does separately. MPEP § 2141(III). This additional rationale is a sufficient, a complete, and an explicitly-recognized rationale to combine the references and conclude that the claim is obvious both under the controlling KSR Supreme Court case and MPEP § 2141(III)(A). Current Office policy regarding the determination of obviousness is set forth in the Federal Register notice at 89 Fed. Reg. 14449 (Feb. 27, 2024).
Claim Rejections - 35 USC § 103
Claim(s) 4-8, 10, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seifert in view of US 20210038311 to Shelton et al. (hereinafter Shelton – Cited in IDS dated 5/13/26).
Regarding Claim 4, an interpretation of Seifert may not explicitly disclose wherein the control unit is configured to control at least one of a laser power and a further operational parameter of the treatment laser radiation responsive to the sensed distance.
However, in the same field of endeavor (light therapy devices), Shelton teaches wherein the control unit is configured to control at least one of a laser power and a further operational parameter of the treatment laser radiation responsive to sensed distance ([0109], [0130]-[0131] see also [0191]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the light treatment device with sensing and treatment as recited by Seifert to include the analysis of the sensor data and adjustments to the therapy system as recited by Shelton in order to reduce surgery time, complexity and improve efficacy ([0055], [0058]).
Regarding Claim 5, an interpretation of Seifert further discloses senses elements located in front of the distal end of the at least double-clad optical fiber ([0005], [0012], [0055]-[0056], [0058], [0067] see also [0099]).
an interpretation of Seifert may not explicitly disclose wherein the first optical sensor module is further configured to detect and distinguish a plurality of different types of material from sensed signals, and wherein the control unit is configured to control at least one of a laser power and a further operational parameter of the treatment laser radiation responsive to the detected type of material.
However, in the same field of endeavor (light therapy devices), Shelton teaches wherein the first optical sensor module is further configured to detect and distinguish a plurality of different types of material from sensed signals ([0073]-[0074], [0117]-[0118] see also [0191]), and wherein the control unit is configured to control at least one of a laser power and a further operational parameter of the treatment laser radiation responsive to the detected type of material ([0073], [0109], [0130]-[0131] see also [0191]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the light treatment device with sensing and treatment as recited by Seifert to include the analysis of the sensor data and adjustments to the therapy system as recited by Shelton in order to reduce surgery time, complexity and improve efficacy ([0055], [0058]).
Regarding Claim 6, an interpretation of Seifert wherein the sensor module comprises a second optical sensor module configured for spectroscopic analysis of the tissue to be treated ([0005], [0012], [0017], [0056] see also [0046], [0099]; spectroscopy, NIRS or other etc.)
An interpretation of Seifert may not explicitly disclose to compute an indicator of a progress of the treatment.
However, in the same field of endeavor (light therapy devices), Shelton teaches and to compute an indicator of a progress of the treatment ([0073]-[0074] including “the laser feedback control system 100 may monitor properties of the target tissue 122 during a therapeutic procedure (e.g., ablation) to determine if the tissue was suitably ablated prior to another therapeutic procedure”).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the light treatment device with sensing and treatment as recited by Seifert to include the analysis of the sensor data and adjustments to the therapy system as recited by Shelton in order to reduce surgery time, complexity and improve efficacy ([0055], [0058]).
Regarding Claim 7, an interpretation of Seifert is further disclosed to a) activate the first optical sensor module to sense ([0005], [0012], [0055]-[0056], [0058], [0067] see also [0099]); b) activate the second optical sensor module to detect one or more spectroscopic properties of the tissue to be treated ([0005], [0012], [0055]-[0056], [0058], [0067] see also [0099]); and c) control the treatment laser source ([0074]-[0076]], [0078]-[0079], [0092] see also [0099.
An interpretation of Seifert may not explicitly disclose wherein the control unit is configured, responsive to a received user input; first sensor to sense the distance between the distal end of the at least double-clad optical fiber and the tissue to be treated; control treatment laser source at least in part in dependence of the sensed distance and/or of the detected properties.
However, in the same field of endeavor (light therapy device), Shelton teaches wherein the control unit is configured, responsive to a received user input ([0182] see also [0191])); to sense the distance between the distal end of the at least double-clad optical fiber and the tissue to be treated ([0073]-[0074], [0117]-[0118] see also [0191]); control treatment laser source at least in part in dependence of the sensed distance and/or of the detected properties ([0057], [0062], [0073], [0109] see also [0191]) .
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the light treatment device with sensing and treatment as recited by Seifert to include the analysis of the sensor data and adjustments to the therapy system as recited by Shelton in order to reduce surgery time, complexity and improve efficacy ([0055], [0058]).
Regarding Claim 8, an interpretation of Seifert further discloses repeating the sensing and treatment steps ([0074], [0076], [0096]).
an interpretation of Seifert may not explicitly disclose wherein the control unit is configured to repeat steps while said user input is received or until a termination input is received.
However, in the same field of endeavor (light therapy device), Shelton teaches herein the control unit is configured to repeat steps while said user input is received ([0182] see also [0191])).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the light treatment device with sensing and treatment as recited by Seifert to include the repeated steps of treatment, analysis of the sensor data and adjustments to the therapy system as recited by Shelton in order to reduce surgery time, complexity and improve efficacy ([0055], [0058]).
Regarding Claim 10, an interpretation of Seifert discloses
wherein the control unit is configured to synchronize operation of the visualization elements with the operation of the treatment laser source such that image data is recorded by the camera only when the medical treatment apparatus does not emit treatment laser radiation ([0075], [0077], [0096], Fig. 6).
An interpretation of Seifert may not explicitly disclose wherein the control unit is configured to output a camera control signal operable to control operation of a camera of the endoscope.
However, in the same field of endeavor (light therapy device), Shelton teaches wherein the control unit is configured to output a camera control signal operable to control operation of a camera of the endoscope ([0062]-[0063], [0101]-[0102]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the light treatment device with sensing and treatment as recited by Seifert to include specifically a camera from the endoscope as recited by Shelton as this is merely combining the recited prior art elements of Seifert and Shelton according to known methods to yield predictable results.
Regarding Claim 12, an interpretation of Seifert may not explicitly disclose a handheld communication device communicatively coupled to the medical treatment device, the handheld communication device comprising a user input device configured to receive user input from a patient during treatment with the medical treatment apparatus, the user input being indicative of discomfort experienced by the patient during treatment; and wherein the control unit is configured to select at least one of a laser power and a further operational parameter of the treatment laser radiation at least in part responsive to the received user input.
However, in the same field of endeavor (light therapy device), Shelton teaches a handheld communication device communicatively coupled to the medical treatment device ([0184]), the handheld communication device comprising a user input device configured to receive user input from a patient during treatment with the medical treatment apparatus ([0184]; to the extent “from a patient . . .” is an intended use of the device is structurally capable of performing the intended use).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the light treatment device with sensing and treatment as recited by Seifert to include a user device for controlling the treatment device as recited by Shelton as this is merely combining the recited prior art elements of Seifert and Shelton according to known methods to yield predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seifert in view of US 20130338510 to Tearney et al. (hereinafter Tearney; cited in IDS dated 7/12/24).
Regarding Claim 15, an interpretation of Seifert may not explicitly disclose wherein the treatment laser radiation is multi-mode radiation and the sensor laser radiation includes at least one of single-mode laser radiation and few-mode laser radiation.
However, in the same field of endeavor (light therapy devices), Tearney teaches wherein the treatment laser radiation is multi-mode radiation and the sensor laser radiation includes at least one of single-mode laser radiation ([0143]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the light treatment device with sensing and treatment as recited by Seifert to include the specific multimode treatment laser and single mode sensor as recited by Tearney as this is merely combining the recited prior art elements of Seifert and Tearney (particular mode set up) according to known methods to yield predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130338510 to Tearney et al. (hereinafter Tearney) in view of US 20110279821 to Brennan et al. (hereinafter Brennan; cited in IDS dated 7/12/24)
Regarding Claim 1, an interpretation of Tearney discloses a fiber-optic medical treatment apparatus comprising a medical treatment device and a disposable fiber-optic device (abstract, Figs. 1, 16-18 see also [0222]), wherein the disposable fiber-optic device comprises an at least double-clad optical fiber having a proximal end and a distal end ([0018] including “The optical fiber may be double-cladded and/or dual-cored.” see also [0222]; Optical fibers have two ends), the distal end being configured to be advanced through a working channel of an endoscope ([0066], [0127]-[0128] see also [0222]), wherein the at least double- clad optical fiber has at least one core and two or more claddings ([0018 see also [0222]]);
wherein the medical treatment device comprises:
- a control unit configured to control operation of the medical treatment device ([0134]-[0135] see also [0222]);
- a treatment laser source configured to output treatment laser radiation for treatment of a medical condition ([0060], [0140]-[0143] see also [0222]; to the extent “for treatment . . .” is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use); wherein the medical treatment apparatus is configured to output the treatment laser radiation through at least one of the two or more claddings of the at least doubled-clad optical fiber towards tissue to be treated ([0060], [0143] see also [0222]);
- a sensor module configured to output and receive sensor laser radiation through the at least doubled-clad optical fiber ([0018], [0063], [0143]) and to optically measure one or more parameters of the treatment based on the received sensor laser radiation ([0063], [0080]-[0081] see also [0222]);
wherein the at least one core of the at least double- clad fiber has a V number of less than 10 at a wavelength of the sensor laser radiation ([0018], [0143] see also [0222]), wherein the medical treatment apparatus is configured to output the sensor laser radiation through the at least one core of the at least doubled-clad optical fiber ([0060], [0143] see also [0222]), and wherein the medical treatment apparatus is configured to multiplex the output of the treatment laser radiation and at least the optical measurement of the one or more parameters ([0142]-[0143], [0150] see also [0222]).
An interpretation of Tearney discloses multiplexing using wavelength division but it does not explicitly disclose wherein the medical treatment apparatus is configured to use time-division.
However, in the same field of endeavor (light therapy devices), Brennan teaches that wavelength division multiplexing and time division multiplexing are alternatives ([0011] including “optical controller, for example, may be an optical switch, a time-division multiplexer, or a wavelength-division multiplexer”, [0050]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the treatment device of Tearney using wavelength modulation and substitute time division multiplexing as recited by Brennan because it is merely the simple substitution of one known element for another to obtain predictable results of transmitting through the one or more fiber(s) in timesplices ([0050]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Rüdiger Paschotta, article on "V-number" in the RP Photonics Encyclopedia, retrieved 2026-07-26, https://doi.org/10.61835/8ty.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R MOSS whose telephone number is (571)272-3506. The examiner can normally be reached Monday - Friday (9:30 am - 5:30 pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571)272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James Moss/Examiner, Art Unit 3792
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