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 .
This Office Action is in response to the amendments dated March 26, 2026.
Claims 1, 3-5, 7-13, 15-16, and 18-23 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over independent Claim 1 combined with dependent Claims 5-8 of U.S. Patent No. 12,023,096. Although the claims at issue are not identical, they are not patentably distinct from each other because all elements in Claim 1 of the present patent application are claimed in Claims 1 and 5-8 of U.S. Patent No. 12,023,096, such that this is an anticipation-type nonstatutory double patenting rejection.
A comparison of present patent Application 18/634,485 and parent Patent 12,023,096 is shown (with bold highlights of common features) in the table shown below:
Current patent application 18/634,485
Parent Patent 12,023,096
Claim 1.
Claim 1.
A medical system for providing treatment to a target in a patient, the medical system comprising:
A medical laser apparatus, comprising:
an energy guide;
at least one laser apparatus comprising a first energy source configured to generate treatment energy to the target
a first energy source configured to generate energy for treating a target tissue through the energy guide;
a second energy source configured to provide an aiming beam to the target
a second energy source, different from the light source, configured to emit first and second aiming beams to a target tissue through the energy guide, the second aiming beam having at least one characteristic different from the first aiming beam; and
a light source, external to the at least one laser apparatus, configured to illuminate the target
a light source having at least two illumination modes for providing illumination to the target tissue;
a controller circuit configured to:
a controller comprising hardware, the controller being configured to:
receive a signal indicating one of the at least two illumination modes currently illuminating the target tissue;
select an aiming beam from the first and second aiming beams based on the illumination mode currently illuminating the target tissue; and
control the second energy source to emit the selected aiming beam to the target tissue.
Claim 5
receive an image of the illuminated target while the aiming beam is emitted toward the target; determine, based on the received image, whether a spot produced by the aiming beam is identifiable in the received image; and
wherein the controller is further configured to receive a signal indicating whether a spot caused by the first or second aiming beam can be identified in an image of the target tissue.
Claims 6-8
control operation of the at least one laser apparatus based at least in part on the determination, including preventing the first energy source from generating the treatment energy or directing the treatment energy to the target in response to determining that the spot is not identifiable in the received image.
6. The medical laser apparatus according to claim 5, wherein, when the spot cannot be identified in the image, the controller being further configured to switch one of the first or second aiming beams to another of the first or second aiming beams.
7. The medical laser apparatus according to claim 6, wherein the controller is further configured to receive a signal indicating whether a spot caused by the other of the first or second aiming beam can be identified in the image of the target tissue.
8. The medical laser apparatus according to claim 7, wherein, when the spot from the other of the first or second aiming beam cannot be identified in the image, the controller is configured to control the first energy source to prohibit the first energy source from generating energy for treating the target tissue.
Claim Objections
Claim 11 is objected to because of the following informalities: line 2 includes the amendment “the spot caused
Claim Rejections - 35 USC § 112(b)
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 11 and 22 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. It is unclear what is being claimed when claiming “wherein the controller circuit is configured to determine that the spot caused by the first or the second aiming beam cannot be identified from the received image when the disparity is below a threshold” (Claim 11) or “determining that the spot caused by the aiming beam cannot be identified from the received image when the disparity is below a threshold” (Claim 22). More specifically, it is unclear what the metes and bounds are of a “threshold” of the “disparity” in the image pixel data. Paragraph [0050] of the present patent application states “such determination may consider the spot to not be visible if a spot is detected but the disparity is below some predetermined threshold where a user would have trouble identifying the spot clearly from the image”. However, the specification and/or claims never define what the disparity is (different illumination levels?; different colors?; different flashing periods?). Furthermore the metes and bounds of the “threshold” is never defined in the specification. Rather, the threshold is described in paragraph [0050] of “some predetermined threshold” without a clear description of how that threshold has been predetermined. That is, it is unclear if a user would have trouble identifying the spot clearly from the image because a wavelength difference threshold has not been met, or an illumination level difference threshold has not been met, etc., and how that threshold is determined (subjectively?; mathematically?; etc.).
Appropriate correction by Applicant is required.
For purposes of examination, Examiner interprets a disparity being below a threshold as an aiming spot that is too dim to be seen in an image.
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.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1, 12-13, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Kohno (US PGPUB 2007/0027391 – “Kohno”) in view of Melsky et al. (US PGPUB 2011/0082449 – “Melsky”).
Regarding Claim 1, Kohno discloses:
A medical system (Kohno FIG. 1, optical diagnosis and treatment apparatus identified in Kohno paragraph [0042]) for providing treatment to a target in a patient (Kohno FIG. 1, internal region of living body 100), the medical system comprising:
at least one laser apparatus comprising a first energy source configured to generate treatment energy to the target(Kohno FIG. 1, laser 10) configured to generate treatment energy to the target (Kohno FRIG. 1, pulsed laser light 14; Kohno paragraph [0054], “When treatment is performed, the controller 25 changes the setting of the fs laser 10 to high output…sufficiently large to induce vaporization of the living body tissue due to multi-photon absorption at a convergence position (beam waist) of the pulsed laser light 14.”);
a light source (Kohno FIG. 1, light source 42), external to the at least one laser apparatus, configured to illuminate the targe (Kohno FIG. 1, illumination light 41, region 11 of living body 100; Kohno paragraph [0042], “light source 42 emits illumination light 41 for illuminating the region 11”); and
a controller circuit (Kohno FIG. 1, output control circuit 28) .
Kohno does not explicitly disclose a second energy source configured to provide an aiming beam to the target, or that the controller circuit is configured to receive an image of the illuminated target while the aiming beam is emitted toward the target; determine, based on the received image, whether a spot produced by the aiming beam is identifiable in the received image; and control operation of the at least one laser apparatus based at least in part on the determination, including preventing the first energy source from generating the treatment energy or directing the treatment energy to the target in response to determining that the spot is not identifiable in the received image.
Melsky teaches a second energy source configured to provide an aiming beam to the target (Melsky FIG. 9, aiming light source 31); and
the controller is configured to receive an image of the illuminated target while the aiming beam is emitted toward the target; determine, based on the received image, whether a spot produced by the aiming beam is identifiable in the received image; and control operation of the at least one laser apparatus based at least in part on the determination, including preventing the first energy source from generating the treatment energy or directing the treatment energy to the target in response to determining that the spot is not identifiable in the received image (Melsky FIG. 9, aiming light source, energy source 39, controller 37, detector 34; Melsky paragraph [0081], “FIG. 9 is a schematic block diagram shown the endoscope/ablator assembly 32 comprising endoscope 76 and ablation element 40 connected to an analyzer system. The analyzer system further includes a detector 34 for detecting reflected light (and preferable for generating an image)…The system can further include an energy source 39, a controller 37 and a user interface 38. In use, the endoscope 76 captures images which can be processed by the detector 34 and/or controller 37 to determine whether a suitable ablation path can be created. An aiming light source 31 can also be used to visualize the location where energy will be delivery to the tissue. If a suitable ablation path is seen by the surgeon, the controller 37 can transmit radiant energy from the ablation element 39 to a target tissue site to effect ablation. The controller can further provide simulated displays to the user, superimposing, for example, a predicted lesion pattern on the image acquired by the detector or superimposing dosimetry information based on the lesion location…The controller can further provide a safety shutoff to the system in the event that a clear transmission pathway between the radiant energy source and the target tissue is lost during energy delivery.” Examiner interprets this passage as teaching that the controller turns on radiant energy (“the controller 37 can transmit radiant energy…to a target tissue”) or turns it off (“The controller can further provide a safety shutoff to the system”) depending on whether the aiming beam is visible on the target (“controller 37 to determine whether a suitable ablation path can be created. An aiming light source 31 can also be used visualize the location where energy will be delivery to the tissue”). See also Melsky paragraph [0070], “If the "aiming beam" is projected onto a region of the atrium where a clear transmission pathway is seen (e.g., there is continuous contact (or the desired lesion path is otherwise cleared of blood), then the physician can begin the procedure. If, on the other hand, a clear transmission pathway is not seen at a particular location of the ablation element, then the ablation element can be moved until a clear lesion pathway is found.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Melsky’s laser pointer with the system disclosed by Kohno. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a treatment system that accurately directs treatment energy to a selected target.
Regarding Claim 12, Kohno in view of Melsky teaches the features of Claim 1, as described above.
Kohno further discloses an optical fiber (Kohno FIG. 1, optical fiber 21) operably coupled to at least one of (i) the first energy source (Kohno FIG. 1, laser 10) to direct the treatment energy to the target (Kohno FIG. 1, region 11), or (ii) the second energy source to direct the aiming beam to the target.
Regarding Claim 13, Kohno discloses:
A method of providing treatment to a target in a patient (Kohno FIG. 1, internal region of living body 100), the method comprising:
activating at least one laser apparatus (Kohno FIG. 1, laser 10) comprising a first energy source to direct treatment energy to the target (Kohno FRIG. 1, pulsed laser light 14; Kohno paragraph [0054], “When treatment is performed, the controller 25 changes the setting of the fs laser 10 to high output…sufficiently large to induce vaporization of the living body tissue due to multi-photon absorption at a convergence position (beam waist) of the pulsed laser light 14.”);
illuminating the target (Kohno FIG. 1, target 11) using a light source (Kohno FIG. 1, light source 42) that is external to the at least one laser apparatus (Kohno FIG. 1, showing light source 42 external to laser 10).
Kohno does not explicitly disclose:
a second energy source configured to provide an aiming beam to the target; or
receiving an image of the illuminated target while the aiming beam is emitted toward the target; determining, based on the received image, whether a spot produced by the aiming beam is identifiable in the received image; and controlling operation of the at least one laser apparatus based at least in part on the determination, including preventing the first energy source from generating the treatment energy or directing the treatment energy to the target in response to determining that the spot is not identifiable in the received image.
Melsky teaches: a second energy source configured to provide an aiming beam to the target (Melsky FIG. 9, aiming light source 31); and
receiving an image of the illuminated target while the aiming beam is emitted toward the target; determining, based on the received image, whether a spot produced by the aiming beam is identifiable in the received image; and controlling operation of the at least one laser apparatus based at least in part on the determination, including preventing the first energy source from generating the treatment energy or directing the treatment energy to the target in response to determining that the spot is not identifiable in the received image ((Melsky FIG. 9, aiming light source, energy source 39, controller 37, detector 34; Melsky paragraph [0081], “FIG. 9 is a schematic block diagram shown the endoscope/ablator assembly 32 comprising endoscope 76 and ablation element 40 connected to an analyzer system. The analyzer system further includes a detector 34 for detecting reflected light (and preferable for generating an image)…The system can further include an energy source 39, a controller 37 and a user interface 38. In use, the endoscope 76 captures images which can be processed by the detector 34 and/or controller 37 to determine whether a suitable ablation path can be created. An aiming light source 31 can also be used to visualize the location where energy will be delivery to the tissue. If a suitable ablation path is seen by the surgeon, the controller 37 can transmit radiant energy from the ablation element 39 to a target tissue site to effect ablation. The controller can further provide simulated displays to the user, superimposing, for example, a predicted lesion pattern on the image acquired by the detector or superimposing dosimetry information based on the lesion location…The controller can further provide a safety shutoff to the system in the event that a clear transmission pathway between the radiant energy source and the target tissue is lost during energy delivery.” Examiner interprets this passage as teaching that the controller turns on radiant energy (“the controller 37 can transmit radiant energy…to a target tissue”) or turns it off (“The controller can further provide a safety shutoff to the system”) depending on whether the aiming beam is visible on the target (“controller 37 to determine whether a suitable ablation path can be created. An aiming light source 31 can also be used visualize the location where energy will be delivery to the tissue”). See also Melsky paragraph [0070], “If the "aiming beam" is projected onto a region of the atrium where a clear transmission pathway is seen (e.g., there is continuous contact (or the desired lesion path is otherwise cleared of blood), then the physician can begin the procedure. If, on the other hand, a clear transmission pathway is not seen at a particular location of the ablation element, then the ablation element can be moved until a clear lesion pathway is found.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Melsky’s laser pointer with the method disclosed by Kohno. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that accurately directs treatment energy to a selected target.
Regarding Claim 21, Kohno in view of Melsky teaches the features of Claim 13, as indicated above.
Melsky further teaches determining whether the spot caused by the aiming beam can be identified from the received image is based on a disparity in image pixel data of at least a portion of the received image (Melsky paragraph [0073], “the aiming light has a pulsed operating mode in which the visible light from the aiming light unit is delivered in pulses to cause intermittent illumination of the tissue. This gives the aiming light an appearance of being a blinking light.” In other words, the pulsed aiming light causes pixel disruption to the received image. Examiner further notes that it is well known to a person having ordinary skill in the art to use a laser pointer to identify a region of interest during an endoscopic procedure. See Toida (US PGPUB 2002/0052547 – “Toida”) discussed in the conclusion section below.).
Regarding Claim 23, Kohno in view of Melsky teaches the features of Claim 13, as indicated above.
Kohno further discloses directing the treatment energy via at least an optical fiber (Kohno FIG. 1, therapeutic laser fiber 21).
Melsky further teaches directing the aiming beam to the target via at least an optical fiber (Melsky paragraph [0100], “the aiming beam is projected via the same optical fiber…as the treatment beam.”)
Claims 3-5, 7-9, 15-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kohno (US PGPUB 2007/0027391 – “Kohno”) in view of Melsky et al. (US PGPUB 2011/0082449 – “Melsky”), Rubinfeld et al. (US PGPUB 2014/0194957 – “Rubinfeld”), and Teramura (US PGPUB 2010/0076304 – “Teramura”).
Regarding Claim 3, Kohno in view of Melsky teaches the features of Claim 1, as described above.
Kohno further discloses:
an imaging sensor (Kohno FIG. 1 imaging means 45),
receive the image produced by the imaging sensor when the first or the second aiming beam is emitted to the target (Kohno paragraph [0042], “imaging means 45 captures an image of the surface of the region 11”).
Melsky further teaches:
control operation of the first energy source to provide treatment energy to the target based at least in part on the determination of whether the spot produced by the first or second aiming beam can be identified from the received image (Melsky paragraph [0070], “If the "aiming beam" is projected onto a region of the atrium where a clear transmission pathway is seen (e.g., there is continuous contact (or the desired lesion path is otherwise cleared of blood), then the physician can begin the procedure. If, on the other hand, a clear transmission pathway is not seen at a particular location of the ablation element, then the ablation element can be moved until a clear lesion pathway is found.”).
Kohno in view of Melsky does not explicitly teach:
wherein the light source has at least two selectable illumination modes for providing illumination to the target, and the controller circuit being further configured to: receive an indication of one of the at least two selectable illumination modes currently illuminating the target.
Rubinfeld teaches:
wherein the light source has at least two selectable illumination modes for providing illumination to the target (Rubinfeld FIG. 1, illumination intensity adjustment module 30 for controlling illumination source unit 10; Rubinfeld paragraph [0078], “The light guide 18 splits into separate light guide outputs 21 and 22 that are connected to illumination intensity adjustment module 30”), the controller circuit being further configured to:
receive an indication of one of the at least two selectable illumination modes currently illuminating the target (Rubinfeld FIG. 1, optical treatment devices 150,151; Rubinfeld paragraph [0078], “Outputs of module 30 are connected by light guides 50, 51 to respective left and right optical treatment devices or units 150, 151”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Rubinfeld’s illumination intensity adjustment module 30 and system for directing different illumination to different light ports with the medical system taught by Kohno in view of Melsky. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a medical device that is capable of providing different illumination to different therapeutic devices.
Kohno in view of Melsky and Rubinfeld does not explicitly teach:
control the second energy source to output one of a first or a second aiming beam to the target based at least in part on the indicated illumination mode, the second aiming beam having at least one characteristic different than the first aiming beam; and
determine whether the spot caused by the first or the second aiming beam can be identified from the received image.
Teramura teaches a controller circuit (Teramura FIG. 3, control portion 26) configured to:
control the second energy source (Teramura FIG. 3, aiming light source 70) to output one of a first (Teramura FIG. 3, green laser light source 80) or a second aiming beam (Teramura FIG. 3, red laser light source 78) to the target based at least in part on the indicated illumination mode (Teramura paragraph [0082], “red laser light source 78 and the green laser light source 80 which emit the aiming light Le are provided, and control is performed to switch the aiming light Le to red laser light or green laser light according to the observation mode, so that the visibility of the aiming light Le is improved according to the observation mode”), the second aiming beam (green) having at least one characteristic different than the first aiming beam (red);
determine whether the spot caused by the first or the second aiming beam can be identified from the received image (Teramura paragraph [0024], “the color of the guide light is the complementary color for the color of the illumination light, so that the visibility of the aiming light is improved”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Teramura’s selected aiming light with the medical system taught by Kohno in view of Melsky and Rubinfeld. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an aiming system that is visible when using different types of illumination light (see Teramura paragraph [0074]).
Regarding Claim 4, Kohno in view of Melsky, Rubinfeld, and Teramura teaches the features of Claim 3, as described above.
Kohno further discloses an endoscope including the imaging sensor and operably coupled to the light source and the controller circuit (Kohno paragraph [0034], “An optical diagnosis and treatment apparatus in an embodiment of the present invention is an apparatus, of which a part is incorporated into an endoscope”).
Regarding Claim 5, Kohno in view of Melsky, Rubinfeld, and Teramura teaches the features of Claim 3, as described above.
Teramura further teaches wherein the controller circuit is configured to: control the second energy source to output the first aiming beam to the target; and when a spot caused by the first aiming beam cannot be identified from an image produced when the first aiming beam is emitted to the target, control the second energy source to switch from the first aiming beam to the second aiming beam to direct to the target (Teramura paragraph [0070], “by switching the wavelength region of the aiming light Le between when an object to be measured is irradiated with illumination light in the normal light observation mode and when the object to be measured is irradiated with illumination light in the special light observation mode, the visibility of the position of measurement with the aiming light Le is improved in an observation portion image in the monitor 16”).
Regarding Claim 7, Kohno in view of Melsky, Rubinfeld, and Teramura teaches the features of Claim 3, as described above.
Teramura further teaches wherein the at least one characteristic includes at least one of a wavelength (Teramura FIG. 3, red laser light source 78; Teramura FIG. 3, green laser light source 80), a power level, or an emitting pattern.
Regarding Claim 8, Kohno in view of Melsky, Rubinfeld, and Teramura teaches the features of Claim 3, as described above.
Teramura further teaches wherein the controller circuit (Teramura FIG. 1, control portion 26) is configured to control the second energy source to output the first aiming beam when a white light illumination mode is indicated, and to output the second aiming beam when a special light illumination mode is indicated (Teramura paragraph [0070], “by switching the wavelength region of the aiming light Le between when an object to be measured is irradiated with illumination light in the normal light observation mode and when the object to be measured is irradiated with illumination light in the special light observation mode, the visibility of the position of measurement with the aiming light Le is improved in an observation portion image in the monitor 16”), the first aiming beam (Teramura FIG. 3, green laser light source 80) having a shorter wavelength than the second aiming beam (Teramura FIG. 3, red laser light source 78).
Regarding Claim 9, Kohno in view of Melsky, Rubinfeld, and Teramura teaches the features of Claim 8, as described above.
Teramura further teaches wherein the special light illumination mode includes at least one of a narrow band imaging mode (Teramura FIG. 2, white light source 42 and light guide 32; Teramura paragraph [0049], “while in the special light observation mode, only cyan light from white light from the white light source 42 is allowed to enter the light guide 32 “), an auto fluorescence imaging mode, or an infrared imaging mode.
Regarding Claim 15, Kohno in view of Melsky teaches the features of Claim 13, as indicated above.
Kohno further discloses receiving, via an imaging sensor (Kohno FIG. 1 imaging means 45), the image of the target when the first or the second aiming beam is emitted to the target (Kohno paragraph [0042], “imaging means 45 captures an image of the surface of the region 11”).
Melsky further teaches controlling operation of the first energy source via the controller circuit to provide treatment energy to the target based at least in part on the determination of whether the spot produced by the first or second aiming beam can be identified from the received image (Melsky paragraph [0070], “If the "aiming beam" is projected onto a region of the atrium where a clear transmission pathway is seen (e.g., there is continuous contact (or the desired lesion path is otherwise cleared of blood), then the physician can begin the procedure. If, on the other hand, a clear transmission pathway is not seen at a particular location of the ablation element, then the ablation element can be moved until a clear lesion pathway is found.”).
Kohno in view of Melsky does not explicitly teach receiving, via a controller circuit, an indication of an illumination mode currently used by the light source to illuminate the target.
Rubinfeld teaches receiving, via a controller circuit, an indication of an illumination mode currently used by the light source to illuminate the target (Rubinfeld FIG. 1, illumination intensity adjustment module 30 for controlling illumination source unit10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Rubinfeld’s positioning LED 434 with the medical system taught by Kohno in view of Melsky. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a medical device that is capable of aiming therapeutic treatment to a patient (Rubinfeld paragraph [0112], “UVA/blue light output port 426 is located, along with two adjustment or positioning light output ports 424A and 424B for adjustment or positioning light”).
Kohno in view of Melsky and Rubinfeld does not explicitly teach:
controlling the second energy source via the controller circuit to output one of a first aiming beam or a second aiming beam to the target based at least in part on the indicated illumination mode, the second aiming beam having at least one characteristic different than the first aiming beam;
determining, via the controller circuit, whether the spot caused by the first or the second aiming beam can be identified from the received image.
Teramura teaches:
controlling the second energy source (Teramura FIG. 3, aiming light source 70) via the controller circuit (Teramura FIG. 3, control portion 26) to output one of a first aiming beam (Teramura FIG. 3, green laser light source 80) or a second aiming beam (Teramura FIG. 3, red laser light source 78) to the target based at least in part on the indicated illumination mode (Teramura paragraph [0082], “red laser light source 78 and the green laser light source 80 which emit the aiming light Le are provided, and control is performed to switch the aiming light Le to red laser light or green laser light according to the observation mode, so that the visibility of the aiming light Le is improved according to the observation mode”), the second aiming beam (green) having at least one characteristic different than the first aiming beam (red);
determining, via the controller circuit, whether the spot caused by the first or the second aiming beam can be identified from the received image (Teramura paragraph [0024], “the color of the guide light is the complementary color for the color of the illumination light, so that the visibility of the aiming light is improved”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the use of Teramura’s selected aiming light with the method taught by Kohno in view of Melsky and Rubinfeld. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of method that utilizes different types of illumination light for specific purposes (see Teramura paragraph [0074]).
Regarding Claim 16, Kohno in view of Melsky, Rubinfeld, and Teramura teaches the features of Claim 15, as described above.
Teramura further teaches wherein controlling the second energy source to output one of the first or the second aiming beam to the target includes: controlling the second energy source to output the first aiming beam to the target; and when a spot caused by the first aiming beam cannot be identified from an image produced when the first aiming beam is emitted to the target, controlling the second energy source to switch from the first aiming beam to the second aiming beam to direct to the target (Teramura paragraph [0070], “by switching the wavelength region of the aiming light Le between when an object to be measured is irradiated with illumination light in the normal light observation mode and when the object to be measured is irradiated with illumination light in the special light observation mode, the visibility of the position of measurement with the aiming light Le is improved in an observation portion image in the monitor 16”).
Regarding Claim 18, Kohno in view of Melsky, Rubinfeld, and Teramura teaches the features of Claim 15, as described above.
Teramura further teaches wherein the at least one characteristic includes at least one of a wavelength (Teramura FIG. 3, red laser light source 78; Teramura FIG. 3, green laser light source 80), a power level, or an emitting pattern.
Regarding Claim 19, Kohno in view of Melsky, Rubinfeld, and Teramura teaches the features of Claim 15, as described above.
Teramura further teaches controlling the second energy source via the controller circuit to output the first aiming beam when a white light illumination mode is indicated, and to output the second aiming beam when a special light illumination mode, including at least one of a narrow band imaging mode, an auto fluorescence imaging mode, or an infrared imaging mode, is indicated (Teramura paragraph [0070], “by switching the wavelength region of the aiming light Le between when an object to be measured is irradiated with illumination light in the normal light observation mode and when the object to be measured is irradiated with illumination light in the special light observation mode, the visibility of the position of measurement with the aiming light Le is improved in an observation portion image in the monitor 16”), the first aiming beam (green) having a shorter wavelength than the second aiming beam (red).
Regarding Claim 20, Kohno in view of Melsky, Rubinfeld, and Teramura teaches the features of Claim 15, as described above.
Teramura further teaches wherein determining whether the spot caused by the first or the second aiming beam can be identified from the received image is based on a disparity in image pixel data of at least a portion of the received image (Teramura paragraph [0089], “the position of irradiation of the aiming light Le can be visually recognized in an observation portion image displayed on the monitor for an observed image 16”; Examiner interprets Teramura’s aiming light displayed on an image as being visible due to a disparity in image pixel data where the aiming light hits the target/image).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kohno (US PGPUB 2007/0027391 – “Kohno”) in view of Melsky et al. (US PGPUB 2011/0082449 – “Melsky”) and Teramura (US PGPUB 2010/0076304 – “Teramura”).
Regarding Claim 10, Kohno in view of Melsky teaches the features of Claim 1, as described above.
Kohno in view of Melsky does not explicitly teach wherein the controller circuit is configured to determine whether the spot caused by the aiming beam can be identified from the received image based on a disparity in image pixel data of at least a portion of the received image.
Teramura teaches wherein the controller circuit is configured to determine whether the spot caused by the first or the second aiming beam can be identified from the received image based on a disparity in image pixel data of at least a portion of the received image (Teramura paragraph [0089], “the position of irradiation of the aiming light Le can be visually recognized in an observation portion image displayed on the monitor for an observed image 16”; Examiner interprets Teramura’s aiming light displayed on an image as being visible due to a disparity in image pixel data where the aiming light hits the target/image).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Teramura’s selected aiming light with the medical system taught by Kohno in view of Melsky. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an aiming system that is visible when using different types of illumination light (see Teramura paragraph [0074]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kohno (US PGPUB 2007/0027391 – “Kohno”) in view of Melsky et al. (US PGPUB 2011/0082449 – “Melsky”), Teramura (US PGPUB 2010/0076304 – “Teramura”), and Huang et al. (US PGPUB 2011/0181791 – “Huang”).
Regarding Claim 11, Kohno in view of Melsky and Teramura teaches the features of Claim 10, as described above.
Kohno in view of Melsky and Teramura does not explicitly teach wherein the controller circuit is configured to determine that the spot caused by the aiming beam cannot be identified from the received image when the disparity is below a threshold.
Huang teaches wherein the controller circuit (Huang FIG. 10, processor 1020) is configured to determine that the spot caused by the aiming beam cannot be identified from the received image when the disparity is below a threshold (Huang paragraph [0040], “various embodiments of the present invention can, with a single calibration pulse, measure the difference between the laser diode's nominal operating characteristic and an existing operating characteristic. Further, the calibration pulse can be…dim enough so as to be virtually invisible to an observer”; Examiner interprets a laser pulse that is so dim that it is virtually invisible to an observer as reading on an aiming beam that creates an image disparity that is below a threshold).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Huang’s nearly invisible dim laser with the medical system taught by Kohno in view of Melsky and Rubinfeld. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a test/calibration laser that is too dim to be of use when identifying a target, such that corrective modifications to the laser can be applied (e.g., increasing the intensity level of the laser).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Kohno (US PGPUB 2007/0027391 – “Kohno”) in view of Melsky et al. (US PGPUB 2011/0082449 – “Melsky”) and Griffin et al. (US PGPUB 2004/0207625 – “Griffin”).
Regarding Claim 22, Kohno in view of Melsky teaches the features of Claim 21, as indicated above.
Kohno in view of Melsky does not explicitly teach determining that the spot caused by the aiming beam cannot be identified from the received image when the disparity is below a threshold.
Griffin teaches determining that the spot caused by the aiming beam cannot be identified from the received image when the disparity is below a threshold (Griffin paragraph [0364], “an operator performs a laser "spot" focusing procedure in step 728 of FIG. 27A where the operator adjusts the probe 142 to align laser spots projected onto the tissue sample. The user adjusts the probe while looking at a viewfinder with an overlay indicating the proper position of the laser spots.”; Griffin paragraph [0368]. “In some instances, a laser spot projected onto tissue is unclear, indistinct, or invisible.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Griffin’s invisible dim laser with the medical system taught by Kohno in view of Melsky. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an aiming laser spot that is too dim to be of use when identifying a target, such that corrective modifications to the laser can be applied (e.g., increasing the intensity level of the laser).
Response to Arguments
Applicant's arguments, see pages 7-8, filed March 26, 2026, with respect to the obviousness-type nonstatutory double patent rejection of Claim 1 over Claim 1 of parent U.S. Patent 12,023,096 have been fully considered but they are moot and/or not persuasive. Specifically, all features in currently-amended Claim 1 are claimed in Claim 1 and its dependent Claims 5-8 of parent U.S. Patent 12,023,096. As such, current Claim 1 is now rejected under anticipation-type double patenting over Claim 1 and its dependent Claims 5-8 of parent U.S. Patent 12,023,096.
Applicant’s arguments, see pages 8-10, filed March 26, 2026, with respect to the rejection(s) of Claims 1 and 13 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive in view of the present amendments. Therefore, the rejection of Claims 1 and 13 under 35 U.S.C. 102(a)(1) has been withdrawn. However, upon further consideration, a new ground(s) of rejection under 35 U.S.C. 103 is made in view of Melsky et al. (US PGPUB 2011/0082449 – “Melsky”), as described above. As such, Claims 1 and 13 stand finally rejection.
Applicant’s arguments, see pages 10-11, regarding the rejection of Claims 3-5, 7-12, 15-16, and 18-20 under 35 U.S.C. 103, are moot, since the arguments merely assert that the art cited in the rejection of Claims 3-5, 7-12, 15-16, and 18-20 does not overcome the rejection of their respective base/independent Claims 1 and 13. As described above, Claims 1 and 13 are now rejected in view of Melsky et al. (US PGPUB 2011/0082449 – “Melsky”).
As such, Claims 1, 3-5,7-13, 15-16, and 18-20, as well as new Claims 21 and 23, stand finally rejected under 35 U.S.C. 103.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure includes:
Toida (US PGPUB 2002/0052547 – “Toida”), which teaches in Toida paragraph [0058] “a green aiming-light L2 is…projected onto the interior of the body cavity 1 as a green spot light. The reflected-light of this aiming-light L2 is also displayed on the monitor 182 as a bright point within the target-subject image 2 displayed thereon”).
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 JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
05/19/2026
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