DETAILED ACTION
The following is a Non-Final Office Action on the merits.
The Examiner notes the status as non-final as the rejections of claims 19-20 were omitted in the previous office action, but follow the rejections of claims 9-10 and the interpretation of claim 4 to be dependent on claim 2 to provide proper antecedent basis for “the guiding tube”.
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 .
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 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.
Response to Amendment
Acknowledgment is made to the amendment received 1/6/2016.
Applicant’s amendments to the drawings and specification are sufficient to overcome the drawings objection to Fig. 3 containing two figures.
Applicant’s amendments to the specification are sufficient to overcome the specification objections.
Applicant’s amendments to the claims are sufficient to overcome the are objections.
The Examiner notes that while claim 5 is now withdrawn in respect to the 35 USC 112(a)/first paragraph rejection and drawings objection set forth in the previous office action, claim 5 must be cancelled since there is no support in the originally filed disclosure.
Priority
The Examiner notes that claim 5 is now withdrawn. Thus, the priority applications provide support and/or enablement.
Drawings
The drawings are objected to because Figs. 1 & 2 contain boxes with no word labels.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the cleaning element that is configured to clean both the tip of the optical fiber when it is moving inside the guiding tube and to also clean the blade of the knife (withdrawn claim 5) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 4 is objected to because of the following informalities: amend “claim 1” to -claim 2- to provide proper antecedent basis for “the guiding tube”. Appropriate correction is required. The claim will be interpreted in this manner.
Claim 19 is objected to because of the following informalities: amend “the tissue properties” to -properties of the tissue- in ll. 7 to provide proper antecedent basis for “properties”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 7 & 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roschak et al. (2009/0275840, previously cited) in view of Lin et al. (2006/0173359, previously cited).
Concerning claim 1, as illustrated in at least Fig. 3A-4D, Roschak et al. disclose a tissue sensing device configured to attach to an electrosurgical knife (device 200 is capable of attachment to a medical appliance 300, which can be an electrosurgical knife for a cutting procedure; [0044]), the tissue sensing device comprising:
a body (handle portion 196; [0026]) having:
a proximal end portion configured to receive a portion of a housing of the electrosurgical knife (proximal end of handle portion 196 can engage proximal end fitting 302 of medical appliance 300; [0026], [0044]),
a distal end portion configured to movably support a blade of the electrosurgical knife (lumen 215 of catheter 202 supports a movable device/appliance 300; [0038]), and
a grip portion positioned between the distal end portion and the proximal end portion (distal end of handle portion 196; [0026]); and
an optical system (sensing assembly 206 includes sensing element 208 on the distal end of catheter 202 and can be a fiber-optic system connected to control system 190 of catheter 202 that measures reflected light or energy; [0028-0029]) having:
a distal end arranged at the distal end portion of the body (sensing tip 208 has a distal end located at the distal end portion of catheter 202; [0023]), such that when the blade of the electrosurgical knife is supported by the distal end portion of the body, the distal end of the optical fiber is configured to be positioned separately from the blade, (when device 300 is supported by catheter 202 in lumen 215, coupling element 198 that engages device 300 can be held while handle portion 196 is moved distally and proximally to separately position sensing tip 208 with respect to device 300; [0023], [0028-0029], [0045-0046]) the distal end portion of the body is configured to be moved relative to the blade (catheter 202 can be moved with respect to device 300 by moving distal end of handle portion 196 with respect to sliding mechanism/actuator 194 and holding coupling element 198; [0023], [0027-0029], [0045-0046]), and
a proximal end connectable to a console system (sensing assembly 206 can be a fiber-optic system connected at its proximal end to control system 190 of catheter 202 that measures reflected light or energy; [0028-0029]).
Roschak et al. fail to specifically disclose the fiber-optic system to comprise an optical fiber having a distal end arranged at the distal end portion and a proximal end configured to be connected to the optical console. However, Lin et al. disclose a tissue sensing device (10) comprising a body (40) having a proximal end portion and a distal end portion (42), an optical sensor that is an optical fiber (44 or 45 or 46 or 47 or 48) having a distal end arranged at the distal end portion (42) and a proximal end configured to be connected to an optical console (20, 50, 60). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the fiber optic sensing system of Roschak et al. to comprise an optical fiber having a distal end arranged at the distal end portion and a proximal end configured to be connected to the optical console in order to provide the benefit of collecting reflectance light at one or more locations directly opposite or about the working tip as taught by Lin et al. ([0047-0050]; Fig. 1)
Concerning claim 7, Roschak et al. disclose the distal end of the optical fiber (208) is configured to protrude beyond an end of the blade of the electrosurgical knife (300) ([0023], [0027-0029], [0045-0046]; Fig. 3A).
Concerning claim 9, while Roschak et al. disclose the sensing assembly (206) can be a fiber-optic system connected at its proximal end to control system (190), Roschak et al. fail to specifically disclose the optical console connected to the proximal end of the optical fiber, wherein the optical console comprises: a light source configured to provide light to illuminate tissue, a light detector configured to detect light reflected from the tissue, and a processor configured to spectrally analyze the reflected light to measure diffuse reflectance and determine tissue properties based on the measured diffuse reflectance. However, Lin et al. further disclose the optical console (20, 50, 60) connected to the proximal end of the optical fiber (44 or 45 or 46 or 47 or 48), wherein the optical console (20, 50, 60) comprises: a light source (22 or 24) configured to provide light to illuminate tissue, a light detector (50) configured to detect light reflected from the tissue, and a processor (60) configured to spectrally analyze the reflected light to measure diffuse reflectance and determine tissue properties based on the measured diffuse reflectance. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the fiber optic sensing system of Roschak et al. such that the optical console comprises: a light source configured to provide light to illuminate tissue, a light detector configured to detect light reflected from the tissue, and a processor configured to spectrally analyze the reflected light to measure diffuse reflectance and determine tissue properties based on the measured diffuse reflectance in order to provide the benefit of identifying the tissue as taught by Lin et al. ([0007], [0047-0048], [0052]; Fig. 1)
Claims 2 & 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roschak et al. (2009/0275840, previously cited) in view of Lin et al. (2006/0173359, previously cited), as applied to claim 1, in further view of Fogarty et al. (6,405,733, previously cited).
Concerning claim 2, Roschak et al. in view of Lin et al. fail to disclose a guiding tube configured to movably accommodate the optical fiber within the guiding tube. However, Fogarty et al. disclose a medical device (Fig. 5A-C) comprising a sensing optical fiber movably accommodated with respect to a blade (600) within a guiding tube (660) such that the distal end of the optical fiber can protrude beyond the distal end portion. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Roschak et al. in view of Lin et al. such that the optical fiber is movably accommodated within the guiding tube in order to provide the benefit of deploying fiber optics as the operator sees fit as taught by Fogarty et al. (Col. 19, ll. 31-37, Col. 19-20, ll. 62-7, Col. 20, ll. 41-49, Col. 25, ll. 57-60; Fig. 5A-C)
Concerning claim 6, Roschak et al. in view of Lin et al. fail to disclose the optical fiber is configured to be moved relative to the distal end portion of the body, such that the distal end of the optical fiber is configured to protrude beyond the distal end portion of the body. However, Fogarty et al. disclose a medical device (Fig. 5A-C) comprising a sensing optical fiber (14) adapted to move relative to a distal end portion of a body (400) so that the distal end of the optical fiber protrudes beyond the distal end portion. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Roschak et al. in view of Lin et al. such that the optical fiber is configured to be moved relative to the distal end portion of the body, such that the distal end of the optical fiber is configured to protrude beyond the distal end portion of the body in order to provide the benefit of deploying fiber optics as the operator sees fit as taught by Fogarty et al. (Col. 19, ll. 31-37, Col. 19-20, ll. 62-7, Col. 20, ll. 41-49; Fig. 5A-C)
Claim 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roschak et al. (2009/0275840, previously cited) in view of Lin et al. (2006/0173359, previously cited), as applied to claim 1, in further view of Haijar (5,456,681, previously cited).
Concerning claim 3, Roschak et al. in view of Lin et al. fail to disclose a protection plug arranged at the distal end of the optical fiber, the protection plug configured to protect the optical fiber and transmit light therethrough. However, Haijar further disclose a protection plug (15) arranged at the distal end of the optical fiber, the protection plug configured to protect the optical fiber and transmit light therethrough. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Roschak et al. in view of Lin et al. to further comprise a protection plug arranged at the distal end of the optical fiber the protection plug configured to protect the optical fiber and transmit light therethrough in order to provide the benefit of isolating the fiber from the surroundings as taught by Haijar. (Col. 3-4, ll. 58-32; Fig. 4a-e)
Claims 4 & 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roschak et al. (2009/0275840, previously cited) in view of Lin et al. (2006/0173359, previously cited) and Fogarty et al. (6,405,733, previously cited), as applied to claim 2, in further view of Haijar (5,456,681, previously cited).
Concerning claims 4 & 21¸ Roschak et al. in view of Lin et al. and Fogarty fail to disclose a cleaning element, or specifically a brush, configured to clean a tip of the optical fiber when the optical fiber is moving inside the guiding tube. However, Haijar disclose a medical device (10) comprising an optical fiber (14) movably accommodated within a guiding tube (20) and a cleaning element (22), specifically a brush, configured to clean a tip of the optical fiber when the optical fiber (14) is moving inside the guiding tube (20). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Roschak et al. in view of Lin et al. and Fogarty et al. to further comprise a cleaning element, specifically a brush, configured to clean a tip of the optical fiber when the optical fiber is moving inside a guiding tube in order to provide the benefit of having a means for removing attached tissue fragments while the fiber remains at the treatment site as taught by Haijar. (Col. 3, ll. 9-24, Col. 4, ll. 58-32; Fig. 4a-e)
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roschak et al. (2009/0275840, previously cited) in view of Lin et al. (2006/0173359, previously cited), as applied to claim 1, in further view of Tearney et al. (2007/0239033, previously cited).
Concerning claim 8, Roschak et al. in view of Lin et al. fail to disclose a fiber connector configured to optically connect the optical fiber to an optical cable that is configured to connect to the optical console. However, Tearney et al. disclose a device (2) comprising a fiber connector (58) for optically connecting an optical fiber (25) to an optical cable (24) for connecting the optical fiber (25) to an optical console (5). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Roschak et al. in view of Lin et al. to further comprise a fiber connector configured to optically connect the optical fiber to an optical cable that is configured to connect to the optical console in order to provide the benefit of providing the light source and light detector as taught by Tearney et al. ([0050], [0063]; Fig. 1 & 15)
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roschak et al. (2009/0275840, previously cited) in view of Lin et al. (2006/0173359, previously cited), as applied to claim 1, in further view of Mische et al. (2007/0112343, previously cited).
Concerning claim 10, Roschak et al. in view of Lin et al. fail to disclose the grip portion of the body is configured to be elastically deformed to move the distal end portion of the body relative to the blade of the electrosurgical knife. However, Mische et al. disclose an electrosurgical knife (10) comprising a grip portion (12, 16, 22) that is configured to be elastically deformed (spring 22 is elastically deformed) to move a distal end portion of a device (16) relative to a blade (20) of the electrosurgical knife (18). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Roschak et al. in view of Lin et al. such that the grip portion of the body is configured to be elastically deformed to move the distal end portion of the body relative to the blade of the electrosurgical knife in order to provide the benefit of maintaining the distal end portion in a non-retracted position when not actively pulled backwards as taught by Mische et al. ([0034]; Fig. 1A-B)
Claims 11-12, 15 & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roschak et al. (2009/0275840, previously cited) in view of Maahs et al. (2006/0184161, previously cited) and Lin et al. (2006/0173359, previously cited).
Concerning claims 11 & 15, as illustrated in at least Fig. 3A-4D, Roschak et al. disclose a system (Fig. 3A), the system comprising:
a surgical tool comprising housing and a blade (device/appliance 300 comprises fitting 302 and a distal tip; [0038], [0044]); and
a tissue sensing device (device 200 is capable of attachment to a medical appliance 300, which can be an electrosurgical knife for a cutting procedure; [0044]) comprising: a body (handle portion 196; [0026]) having:
a proximal end portion configured to receive a portion of a housing of the surgical tool (proximal end of handle portion 196 can engage proximal end fitting 302 of medical appliance 300; [0026], [0044]),
a distal end portion configured to movably support a distal end of the surgical tool (lumen 215 of catheter 202 supports a movable device/appliance 300; [0038]), and
a grip portion positioned between the distal end portion and the proximal end portion (distal end of handle portion 196; [0026]), and
an optical system (sensing assembly 206 includes sensing element 208 on the distal end of catheter 202 and can be a fiber-optic system connected to control system 190 of catheter 202 that measures reflected light or energy; [0028-0029]) having:
a distal end arranged at the distal end portion of the body (sensing tip 208 has a distal end located at the distal end portion of catheter 202; [0023]), such that when the distal end of the surgical tool is supported by the distal end portion of the body, the distal end of the optical fiber is configured to be positioned separately from the blade, (when device 300 is supported by catheter 202 in lumen 215, coupling element 198 that engages device 300 can be held while handle portion 196 is moved distally and proximally to separately position sensing tip 208 with respect to device 300; [0023], [0028-0029], [0045-0046]) the distal end portion of the body configured to be moved relative to the tool distal end (catheter 202 can be moved with respect to device 300 by moving distal end of handle portion 196 with respect to sliding mechanism/actuator 194 and holding coupling element 198; [0023], [0027-0029], [0045-0046]), and
a proximal end connectable to a console system (sensing assembly 206 can be a fiber-optic system connected at its proximal end to control system 190 of catheter 202 that measures reflected light or energy; [0028-0029]).
While Roschak et al. disclose various tool tips ([0047]; Fig. 4A-D), Roschak et al. fail to disclose the system to be for cutting tissue and the tool to be an electrosurgical knife comprising a blade. However, Maahs et al. disclose an electrosurgical device comprising interchangeable tips (60-78), including an electrosurgical needle knife (78) that inherently comprises an electrical console for providing electrical current to the blade of the electrosurgical knife for a cutting procedure. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Roschak et al. such the system is for cutting tissue and the tool is an electrosurgical knife comprising a blade to provide the benefit of performing simultaneous tissue cutting and ablation procedures as taught by Maahs et al. ([0041]; Fig. 3A-J)
Roschak et al. in view of Maahs et al. fail to specifically disclose the fiber-optic system to comprise an optical fiber having a distal end arranged at the distal end portion and a proximal end configured to be connected to the optical console. However, Lin et al. disclose a tissue sensing device (10) comprising a body (40) having a proximal end portion and a distal end portion (42), an optical sensor that is an optical fiber (44 or 45 or 46 or 47 or 48) having a distal end arranged at the distal end portion (42) and a proximal end configured to be connected to an optical console (20, 50, 60). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the fiber optic sensing system of Roschak et al. in view of Maahs et al. to comprise an optical fiber having a distal end arranged at the distal end portion and a proximal end configured to be connected to the optical console in order to provide the benefit of collecting reflectance light at one or more locations directly opposite or about the working tip as taught by Lin et al. ([0047-0050]; Fig. 1)
Concerning claim 12, Roschak et al. disclose the medical appliance (300) comprises a lever (194) configured to move the distal end portion of the body (202) between a first position in which the distal end portion is located at a tip portion of the medical appliance (300), and a second position in which the distal end portion is located near the housing (302) of the medical appliance (300) ([0026], [0045]; Fig. 3A).
Claim 19 is rejected upon the same rationale as presented for claim 9.
Claims 13 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roschak et al. (2009/0275840, previously cited) in view of Maahs et al. (2006/0184161, previously cited) and Lin et al. (2006/0173359, previously cited), as applied to claim 11, in further view of Mische et al. (2007/0112343, previously cited).
Concerning claim 13, Roschak et al. in view of Maahs et al. and Lin et al. fail to disclose an elastic element configured to bias the distal end portion of the body in a direction relative to the tip portion of the blade. However, Mische et al. disclose an electrosurgical knife (10) comprising an elastic element (22) for biasing a distal end portion of a device (16) in a direction to a tip portion (20) of a blade (18). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Roschak et al. in view of Maahs et al. and Lin et al. to further comprise an elastic element configured to bias the distal end portion of the body in a direction relative to the tip portion of the blade in order to provide the benefit of maintaining the distal end portion in a non-retracted position when not actively pulled backwards as taught by Mische et al. ([0034]; Fig. 1A-B)
Claim 20 is rejected upon the same rationale as presented for claim 10.
Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roschak et al. (2009/0275840, previously cited) in view of Maahs et al. (2006/0184161, previously cited) and Lin et al. (2006/0173359, previously cited), as applied to claim 11, in further view of Allen (4,314,559, previously cited).
Concerning claim 14, Roschak et al. in view of Maahs et al. and Lin et al. fail to disclose the electrosurgical knife is coated with an anti-sticking layer. However, Allan discloses an electrosurgical knife (10) that is coated with an anti-sticking layer (26). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Roschak et al. in view of Maahs et al. and Lin et al. such that the electrosurgical knife is coated with an anti-sticking layer in order to provide the benefit of avoiding the blade sticking to the tissue and causing blade dullness as taught by Allen. (Col. 1, ll. 34-47, Col. 3, ll. 25-37; Fig. 2)
Claims 16 & 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roschak et al. (2009/0275840, previously cited) in view of Maahs et al. (2006/0184161, previously cited) and Lin et al. (2006/0173359, previously cited), as applied to claim 11, in further view of Fogarty et al. (6,405,733, previously cited).
Claim 16 is rejected upon the same rationale as provided for claim 2.
Claim 18 is rejected upon the same rationale as provided for claims 6-7.
Claims 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roschak et al. (2009/0275840, previously cited) in view of Maahs et al. (2006/0184161, previously cited) and Lin et al. (2006/0173359, previously cited), as applied to claim 11, in further view of Haijar (5,456,681, previously cited).
Claim 17 is rejected upon the same rationale as provided for claim 3.
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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,576,717. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a system comprising an electrosurgical knife blade and a tissue sensing device (electrosurgical knife and blade) comprising a body having: a proximal end portion configured to receive a portion of a housing of the electrosurgical knife, a distal end portion configured to movably support a blade of the electrosurgical knife, and a grip portion positioned between the distal end portion and the proximal end portion (a first body having a first body proximal end portion configured to receive a portion of a housing of the electrosurgical knife, a first body distal end portion configured for movably supporting the blade, and a grip portion between the first body distal end portion and the first body proximal end portion); and an optical fiber having: a distal end arranged at the distal end portion of the body, such that when the blade of the electrosurgical knife is supported by the distal end portion of the body, the distal end of the optical fiber is configured to be positioned separately from the blade, the distal end portion of the body configured to be moved relative to the blade, and a proximal end connectable to an optical console (an optical fiber having a distal end and a proximal end configured to be connected to an optical console, wherein: the distal end of the optical fiber is further arranged at the first body distal end portion such that when the blade is supported by the first body distal end portion, the distal end of the optical fiber is configured to be positioned separately to the blade, and wherein the second body distal end portion is configured to be moved at least partially independently from the first body distal end potion relative to the blade). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Response to Arguments
Applicant's arguments filed 1/6/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments regarding no labels in the text box, the Examiner respectfully notes MPEP 6.08.02(d) states:
(a) The drawing in a nonprovisional application must show every feature of the invention specified in the claims. However, conventional features disclosed in the description and claims, where their detailed illustration is not essential for a proper understanding of the invention, should be illustrated in the drawing in the form of a graphical drawing symbol or a labeled representation (e.g., a labeled rectangular box). In addition, tables that are included in the specification and sequences that are included in sequence listings should not be duplicated in the drawings.
In response to Applicant’s arguments that Roschak fails to disclose that the lumen is “movable”, the Examiner respectfully disagrees. Under broadest reasonable interpretation, the lumen 215 is “movable” in at least two ways: (1) in space; and (2) with respect to device 300, actuator 194, and coupling element 198.
In response to Applicant's argument that Roschak fails to disclose “a distal end portion configured to movably support a blade”, the Examiner respectfully disagrees and maintains the distal end portion of lumen 215 is capable of movably supporting an electrosurgical knife blade. Further, Roschak teaches that medical device 300 can advance or retract within lumen 215 ([0027]). Since lumen 215 surrounds medical device 300 and the distal end portion of lumen 215 moves to the target tissue site, and thus also moves medical device 300 to the target tissue site and supports the function of medical device by moving to the target tissue site, medical device 300 is “movably supported” by the distal end portion.
In response to Applicant’s arguments that manipulation of the coupling element and actuator, to in turn manipulate the medical device 300, “is different from the distal end portion of the body itself…being moved relative to the blade accommodated by the distal end”, the Examiner respectfully disagrees. As stated above, Roschak teaches that medical device 300 can advance or retract within lumen 215 ([0027]). Movement of the elements in at least Fig. 3A can be considered from two perspectives: (1) actuator 194 coupled to coupling element 198 and medical device 300 move with respect to catheter 202/lumen 215; or (2) catheter 202/lumen 215 move with respect to actuator 194 coupled to coupling element 198 and medical device 300.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794