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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/17/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The abstract of the disclosure is objected to because numerous typographical errors. The abstract comprises the language of claim 1, for more information see Claim Objections, In re claim 1. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1 and 20 are objected to because of the following informalities:
In re claim 1:
On line 4, “at least one optical fiber partially, configured to” should read “at least one optical fiber partially configured to”.
On line 5, “perpendicular to axis” should read “perpendicularly to an axis”.
On line 5, “the at least one optical fiber’s” should read “the at least one optical fiber”.
On line 10, “at least thermometer” should read “at least one thermometer”.
In re claim 20:
On line 3, “tissue at at least one location” should read “tissue at least one location”.
On line 9, “at least one optical fiber partially, configured to” should read “at least one optical fiber partially configured to”.
Appropriate correction is required.
Claim Interpretation
In re claim 2, the limitation “wherein the at least one optical fiber is a radial emission fiber” will be interpreted to mean that some modification, for example a cap or tube, is applied to the optical fiber to configure the optical fiber to be a radial emission fiber under broadest reasonable interpretation in line with the specification.
In re claim 3, the limitation “wherein the at least one optical fiber is a side-fire fiber” will be interpreted to mean that some modification, for example a cap or tube, is applied to the optical fiber to configure the optical fiber to be a side-fire fiber under broadest reasonable interpretation in line with the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 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.
The following limitations have insufficient antecedent basis in their respective claims:
In re claim 1, on line 2, “the anal sphincter area” lacks antecedent basis for this limitation in this claim.
In re claim 7, on line 2, “the delivery of the laser beam” lacks antecedent basis for this limitation in this claim.
In re claim 9, on line 2, “the delivery of the laser beam” lacks antecedent basis for this limitation in this claim.
In re claim 19, on line 2, “the external surface” lacks antecedent basis for this limitation in this claim.
In re claim 1, the limitation “received from the thermometer” is unclear as it is uncertain as to which of the at least one thermometers the limitation is referring. For purposes of examination, tis limitation will be interpreted as “received from the at least one thermometer”.
In re claim 3, the limitation “the fiber’s axis” is unclear. It is unclear is this is referring to the at least one optical fiber or one of the at least one optical fiber. For purposes of examination, the limitation will be interpreted as best understood as the at least one optical fiber.
In re claim 4, the limitation “the optical fiber’s axis” is unclear. See above claim 3 rejection. For purposes of examination, the limitation will be interpreted as best understood as the at least one optical fiber.
In re claim 6, the limitation “the optical fiber” is unclear. See above claim 3 rejection. For purposes of examination, the limitation will be interpreted as best understood as the at least one optical fiber.
Claims 11, 12, and 15 all recite “the thermometer” and are unclear, see above claim 1 rejection regarding the limitation “received from the thermometer”.
Claim Rejections - 35 USC § 102
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 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rajagopalan (US 20200060758).
In re claim 20, Rajagopalan discloses a method (Fig. 1) for treating a sphincter tissue of a patient [0259, 0283] comprising:
inserting a treatment device (Fig. 3: 100) into the patient’s anal sphincter area ([0259, 0283]: device can be “rectally inserted into a patient” and is “to deliver energy to tissue and treating tissue of the gastrointestinal tract”);
measuring a temperature of a sphincter tissue at at least one location [0246, 0324]: “ such as a temperature sensor configured to monitor the temperature of treatment provided by treatment assembly 140 and/or expandable assembly 130 and/or tissue proximate treatment assembly 140 “; and
radiating the patient’s anal sphincter area with a laser beam based on the temperature measurements ([0293]: “after the target tissue TT reaches the setpoint temperature, system 10 can deliver energy or otherwise treat the target tissue TT to maintain the setpoint temperature for an extended time period”; [0051, 0134, 0324]).,
wherein the treatment device comprises:
a cover (111a and 111b)
dimensioned for insertion into the anal sphincter area ([0259, 0283]: device can be “rectally inserted into a patient” and is “to deliver energy to tissue and treating tissue of the gastrointestinal tract”),
connected to a handpiece ([0126, 0283]: handle positioned on proximal end of 111a);
at least one optical fiber partially, configured to emit a laser beam [0279],
wherein the laser beam is directed perpendicularly to the optical axis of the at least one optical fiber [0112, 0245, 0365];
a laser source (330, [0275, 0365]) coupled to the at least one optical fiber ([0279, 0365]: “a laser energy delivery element such as an optical fiber”);
a thermometer ([0321]: “temperature sensors”) connected to the cover (149 is connected to 111a and 111b); and
a controller (310) configured to control the laser source based on temperature measurements received from the thermometer (311, [0282, 0321, 0324]).
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.
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.
Claims 1, 3-7, 9-11, and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan (US 20200060758) in view of Black (US 5163935).
In re claim 1, Rajagopalan discloses treatment device (Fig. 3: 10 and specifically 100), comprising:
a cover (111a and 111b)
dimensioned for insertion into the anal sphincter area ([0259, 0283]: device can be “rectally inserted into a patient” and is “to deliver energy to tissue and treating tissue of the gastrointestinal tract”),
connected to a handpiece ([0126, 0283]: handle positioned on proximal end of 111a);
at least one optical fiber partially, configured to emit a laser beam [0279],
wherein the laser beam is directed perpendicularly to axis of the at least one optical fiber’s [0112, 0245, 0365];
a laser source (330, [0275, 0365]) coupled to the at least one optical fiber ([0279, 0365]: “a laser energy delivery element such as an optical fiber”);
at least thermometer ([0321]: “temperature sensors”) connected to the cover (149 is connected to 111a and 111b); and
a controller (310) configured to control the laser source based on temperature measurements received from the thermometer (311, [0282, 0321, 0324]).
Rajagopalan lacks:
at least one holder for holding the at least one optical fiber at a fixed distance, of between 2 to 15 mm, from inner walls of the cover;
Black discloses a surgical laser endoscopic apparatus (Fig. 1) that, like the treatment device of Rajagopalan, treats tissue with the application of lasers (Col. 5, ln. 67-68 to col. 6, ln. 1-7). Black further discloses wherein an endoscopic tube (Fig. 1: 16) has a fiber holder (20) that hold an optical fiber (26, col. 4, ln. 48-53).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the treatment device as disclosed by Rajagopalan by providing holders to hold the optical fibers as taught by Black as the holder would provide support to the optical fiber in a predetermined position (Col. 3, ln. 53-56).
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide holding the at least one optical fiber at a fixed distance, of between 2 to 15 mm, from inner walls of the cover, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Black discusses the holders holding the optical fibers at a predetermined position (Col. 3, ln. 53-56) and the optical fiber being coaxial with the endoscopic tube (Black: Claim 1). While Black does not provide the dimensions recited in Claim 1, Black provides an outer diameter of the endoscopic tube, 2.5 mm, and a diameter of the optical fiber, 0.6 mm (Col. 4, ln. 54-59) which would set the optical fiber at a fixed distance of less than 1 mm from the inner walls of the cover. As the treatment device of Rajagopalan is dimensioned for insertion in the anal sphincter area, it would be obvious to one of ordinary skill in the art to optimize the distance of the at least one optical fiber to the inner walls of the cover to accommodate the size of the anal sphincter area. In re Aller, 105 USPQ 233.
In re claim 3, Rajagopalan discloses, wherein the at least one optical fiber is a side-fire fiber ([0357, 0358]: “fractional delivery can be achieved by treatment element 545 delivering one or more rays of light energy that each contact an energy delivery zone with a limited diameter (e.g. focused light light), such as a single ray of light delivered in a scanning (e.g. rotating and/or translating) fashion, or light delivered from an optical element that produces multiple rays of light in an appropriate pattern”) and the device further comprises an actuator configured to rotate the side-fire fiber around the fiber’s axis (320, [0284, 0287, 0358]).
In re claim 4, Rajagopalan discloses one or more optical elements configured to direct the laser beam to be perpendicular to the optical fiber’s axis ([0365-0367]: “Treatment element 545 can be constructed and arranged to deliver light energy in an array of light beams and/or to include an energy distribution element comprising a rotating element such as a rotating mirror; prism; diffractive optic; and combinations of these”).
In re claim 5, Rajagopalan discloses wherein the one or more optical elements are selected from, lenses, mirrors, prisms, and splitters ([0365]: “a rotating mirror; prism; diffractive optic; and combinations of these” and “an array of lenses”).
In re claim 6, the proposed combination yields a sleeve (Rajagopalan: Fig. 3: 141) inserted into the cover (Rajagopalan: 141 inserted into 111), at least partially encompassing the optical fiber (Rajagopalan: [0284]), and wherein the *holder (Black: Fig. 1: 20) is configured to hold the sleeve at the fixed distance of between 2 to 15 mm, from the inner walls of the cover (an endoscopic tube (Fig. 1: 16) has a fiber holder (20) that hold an optical fiber (10 and 26)).
*Regarding the limitation “holder is configured to hold the sleeve”, as the sleeve is encompassing the optical fiber, and the holder is holding the optical fiber, it would be apparent that the holder is also holding the sleeve in order to support the optical fiber in the predetermined position. See 35 U.S.C. 103, In re claim 1. Additionally, the limitation “configured to the hold the sleeve” comprises functional language. The prior art need only be able to perform this function in order to anticipate the claimed invention. It is clear that the system of the proposed combination could be operated in the claimed manner if desired. See MPEP 2114.
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the holder is configured to hold the sleeve at the fixed distance of between 2 to 15 mm, from the inner walls of the cover, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See 35 U.S.C. 103 rejection, In re claim 1.
In re claim 7, Rajagopalan discloses wherein the sleeve comprises an optically transparent portion configured to allow the delivery of the laser beam to the anal sphincter area during treatment (apparent; [0139, 0352-0353, 0357-358]: conduit 541 contains optical fibers and delivers light energy to treatment assembly 540, it is apparent that the conduit has an optically transparent portion to deliver light energy to the treatment assembly).
In re claim 9, Rajagopalan discloses wherein the cover comprises an optically transparent portion configured to allow the delivery of the laser beam to the anal sphincter area during treatment ([0359]: “balloon 543 selectively passes light energy delivered by treatment element 545”).
In re claim 10, Rajagopalan discloses wherein the optically transparent portion comprises at least one of: an optically transparent material and one or more windows allowing the delivery of the laser beam ([0359]: “configured to pass light energy through one or more apertures 542, such as a grid pattern of rows and/or columns of material transparent or at least partially transmissive to one or more wavelengths of light configured to treat target tissue, while the remaining portions of balloon 543 block (i.e. prevent transmission of) at least those wavelengths of light” ).
In re claim 11, Rajagopalan discloses wherein the thermometer is located at a distal end of the cover, away from the handpiece (Fig. 3: 149 on 140; [0321]: “sensor 149 positioned on treatment assembly 140, can comprise a sensor selected from the group consisting of: temperature sensors”; [0356]: “treatment assembly 540 is positioned on a distal portion but proximal to the distal end of shaft 511”).
In re claim 13, Rajagopalan discloses an axial movement element (320) for axially sliding the sleeve inside the cover [0284, 0287].
In re claim 14, Rajagopalan discloses a heating unit configured to provide heat to the anal sphincter area during treatment ([0188-0189]: “to deliver energy to tissue and treating tissue of the gastrointestinal tract”, [0052]).
In re claim 15, Rajagopalan discloses wherein the controller is further configured to control the heating unit based on the temperature measurements received from the thermometer [0051, 0134, 0324].
In re claim 16, Rajagopalan discloses wherein the controller is configured to:
a. receive the temperature measurements [0134];
b. control the heating unit to heat the anal sphincter area until the anal sphincter area reaches a desired temperature ([0293, 0338]: “system 10 is configured to maintain the temperature of target tissue TT at a setpoint temperature”); and
c. control the laser source to generate the laser beam only after the target temperature was reached ([0293]: “after the target tissue TT reaches the setpoint temperature, system 10 can deliver energy or otherwise treat the target tissue TT to maintain the setpoint temperature for an extended time period”).
In re claim 17, Rajagopalan discloses, wherein the controller is further configured to:
d. continuously receive temperature measurements ([0293, 0324, 0337-0338]: it is apparent temperature is received continuously as the temperature of the target tissue is maintained at its target temperature through monitoring the temperature);
e. terminate the laser generation if the temperature exceeds a predefined threshold temperature ([0321, 0324, 0332]: “Energy delivery from EDU 330 can be initiated, stopped and/or modified based on one or more sensor readings“, where the energy delivered can be laser energy and the sensor reading can be temperature readings).
In re claim 18, Rajagopalan discloses wherein the heating unit is selected from, radiofrequency (RF) electrodes attached to the cover, an ultrasound prob located in the cover, and a resistance wire located in the cover [0042, 0046]: “The target tissue segment inward facing surfaces can receive an energy type selected from the group consisting of: RF; ultrasound”.
In re claim 19, Rajagopalan discloses at least one pressure sensor located on the external surface of the sleeve (Fig. 3: 149 on 140; [0321]: “sensor 149 positioned on treatment assembly 140, can comprise a sensor selected from the group consisting of: temperature sensors”; [0356]: “treatment assembly 540 is positioned on a distal portion but proximal to the distal end of shaft 511”).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan (US 20200060758) in view of Black (US 5163935) in further view of Griffin (US 20210330383).
In re claim 2, the proposed system lacks:
wherein the at least one optical fiber is a radial emission fiber.
Griffin discloses an optical fiber with radial emission [0067] which can be used in light-based surgical procedures including laser therapies and laser ablation [0003].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the treatment device as disclosed by Rajagopalan by providing wherein the at least one optical fiber is a radial emission fiber as taught by Griffin because the radial emission has high efficiency (Griffin: [0067]) and would be able to target 360 degrees of the body cavity at once.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan (US 20200060758) in view of Black (US 5163935) in further view of Li (WO 2008137710).
In re claim 8, the proposed system lacks:
wherein the optically transparent portion comprises at least one of: an optically transparent material and one or more windows allowing the delivery of the laser beam.
Li discloses an imaging device that, similar to the treatment device of Rajagopalan, can provide laser therapy to body lumens [00117-00119]. Additionally, Li discloses a durable housing (i.e. sleeve; Fig. 4: 96; [0063]) surrounding an optical fiber (100, 102) which can be made of glass housing ([0063]; i.e. optically transparent material), comprises an opening or transparent window to enable light to reach an area [0063], and is within an optically transparent balloon(106, [0063]).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the treatment device as disclosed by Rajagopalan by providing wherein the optically transparent portion of the sleeve comprises at least one of an optically transparent material and one or more windows allowing the delivery of the laser beam as taught by Li as it would allow the light to pass through the device in order to treat a sample area (Li: [0063]) with the size limited by the window or optically transparent portion.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan (US 20200060758) in view of Black (US 5163935) in further view of Cosman (WO 9634571).
In re claim 12, the proposed system lacks:
wherein the thermometer is detachably connected to the cover.
Cosman discloses a thermosurgery system (title), that similar to the device disclosed by Rajagopalan is for heat ablating living tissue (Col. 19, ln. 1-2), Additionally, Cosman discloses wherein a temperature sensor (Fig. 2: 23; i.e. thermometer) is removable (Pg. 17, ln. 5-9) from a shaft (Fig. 2: 15; i.e. cover; pg. 10, ln. 1-17).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the treatment device as disclosed by Rajagopalan by providing wherein the thermometer is detachable connected to the cover as taught by Cosman as it would prevent a damaged thermometer from compromising the specific operation of the device, allowing other elements to be reusable (Cosman: pg. 17, ln. 5-9).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 8:30 am to 5:00 pm..
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/HALLE MARGARET WELCH/ Examiner, Art Unit 3796
/Benjamin J Klein/ Supervisory Patent Examiner, Art Unit 3792
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