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 .
Claims 5 and 13 are cancelled. A complete action on the merits of pending claims 1-4, 6-12, and 14-22 appears herein.
Response to Arguments
Applicant's arguments filed 01/13/2026 have been fully considered but they are not persuasive.
Applicant argues “In rejecting independent claim 1, the OA asserted that Truckai teaches, inter alia, an upper end of a first movable grip 37 is coupled to the elongate extension member 10 via spring 39 and is moveable therewith (see OA page 7, first paragraph). Applicant respectfully disagrees. First, Truckai teaches that the spring 39 "rests against" the collar 13 and the handle rail adjacent the asserted first moveable grip 37. The spring 39 performs no coupling function whatsoever. Additionally, Truckai teaches that the asserted second moveable grip 34 moves the asserted elongate extension member 10 relative to the first moveable grip 37 when the second moveable grip 34 contacts the collar 13, to which the asserted elongate extension member 10 is attached. See paragraph [0078] and cited FIGS. 6-7. As such, Truckai fails to teach all that is relied upon in the rejection.”
Examiner respectfully disagrees and contends that, as seen in Fig. 6 of Truckai, spring (39) connects (couples) grip (37) with extension member (10), even in indirectly, through collar (13). Furthermore, in the event that grip (34) is held steady, and grip (37) is translated relative to grip (34), extension member (10) would undergo corresponding movement.
Applicant further argues “The OA introduced Hasson as allegedly teaching a handle/grip assembly 38 having a first moveable grip 60 coupled to an elongate extension member 56 and moveable therewith, and a second moveable grip 58 coupled to an elongate shaft 36 and moveable therewith. The OA asserted it would have been obvious to have modified Truckai to use the grip assembly 38 of Hasson in place of the handle 6 of Truckai, wherein the handle 58 of Hasson is coupled to the introducer sheath 32 of Truckai and the handle 60 of Hasson is coupled to the shaft 10 of Truckai. Applicant respectfully disagrees that a person having ordinary skill in the art, hereinafter "PHOSITA", would substitute the pistol-grip style pivoting mechanism of Hasson for the in-line sliding mechanism of Truckai. In spite of the OA's assertion that the modification would be a simple substitution of one handle assembly for another, Applicant respectfully points out that the operation of the modified device would differ from that of the original device of Truckai. In one example difference, the handle 60 of Hasson appears to have a direct connection to the asserted elongate extension member 56. No such direct connection between the asserted first moveable grip 37 of Truckai and the asserted elongate extension member (shaft 10) of Truckai appears to exist. Additionally, with the handle 58 of Hasson coupled to the introducer sheath 32 of Truckai, and the handle 60 of Hasson coupled to the shaft 10 of Truckai as proposed, when moving the handle 60 closer to the handle 58 of Hasson (e.g., squeezing the grips together), the handle 58 would be incapable of moving the shaft 10 relative to the handle 60 after the introducer sheath 32 has been retracted to permit the spring member 15/19 to open the RF applicator, as taught by Truckai at paragraph [0078]. Accordingly, the PHOSITA would not be motivated to substitute the grip assembly of Hasson for the grip assembly of Truckai because doing so would change the principle of operation of the original device (MPEP 2143.01 Section VI).”
Examiner respectfully contends, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, Truckai teaches a syringe-like grip comprising a sliding actuation motion configured to move a distal end effector between a first and second configuration. Hasson teaches a pistol-like grip comprising a pivoting actuation motion configured to move a distal end effector between a first and second configuration. Lopez Zepeda teaches a pistol-like grip comprising a sliding actuation motion configured to move a distal end effector between a first and second configuration. Additionally, even though the pistol-like grip of Hasson has a pivoting actuation motion, the portions of the device of Hasson configured to be actuated by said pistol-like grip are configured to move in a linear translating/sliding motion. Replacing one actuating grip configured to cause sliding motion for another is well within the ability of one of ordinary skill in the art. Furthermore, Examiner respectfully contends the handle 58 of Hasson would be capable of moving the shaft 10 of Truckai relative to the handle 60 of Hasson after the introducer sheath 32 of Truckai has been retracted to permit the spring member 15/19 of Truckai to open the RF applicator simply by moving handles 58 and 60 away from each other.
Applicant further argues “At OA page 9, the Examiner acknowledged that the combination of Truckai and Hasson fails to teach the lower end of the first moveable grip 60 of Hasson is spaced apart proximally from a lower end of the second moveable grip 58 of Hasson when disposed in the delivery configuration. Applicant agrees. Lopez Zepeda was introduced as teaching a sliding grip arrangement that satisfies the missing claim limitation. The OA asserted that it would have been obvious to modify the pivoting grip assembly of Hasson to operate in a sliding configuration, as in Lopez Zepeda because doing so would be a simple substitution of one mode of grip actuation for another. Applicant respectfully disagrees, noting that the proposed modifications substitute the sliding arrangement of Truckai for the pivoting arrangement of Hasson, and then modifies the pivoting arrangement of Hasson back to a sliding arrangement. It is unclear why the PHOSITA would further modify the modified device of Truckai full-circle back to a sliding arrangement (as in the original device of Truckai). Why not just use the original device of Truckai? It appears clear that the only reason to make the proposed modifications is through the use of impermissible hindsight to add elements recited in the claim that are missing from Truckai based on the instant disclosure. This is clearly improper.”
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Examiner respectfully contends that Truckai, as further discussed in the rejection to claim 1 below, was modified to replace the syringe-like grip of Truckai for the pistol-like grip of Hasson. The sliding actuation motion of Truckai becoming a pivoting actuation motion of Hasson was merely a result of the grip change, and not the focus of the modification. The Truckai/Hasson combination, as further discussed in the rejection to claim 1 below, was modified to change the pivoting actuation motion of the handle of Hasson to a sliding actuation motion taught by the sliding pistol-like grip of Lopez Zepeda.
Applicant further argues “Furthermore, the actual proposed modification of the pivoting grip arrangement of Hasson to the sliding arrangement of Lopez Zepeda appears to be improper for several reasons. First, Hasson teaches that the disclosed pivoting arrangement facilitates a releasable locking structure that may be operated with one hand (the same hand operating the grip assembly). See column 3, lines 19-24, for example. The sliding arrangement of Lopez Zepeda fails to accommodate the same one-handed locking operation as Hasson. Instead, Lopez Zepeda appears to teach the use of a locking mechanism shown in FIGS. 12-12A, which is positioned at the upper end of the handle 12 in FIGS. 3A-3B, and which requires rotation by the user to lock the "arrow" 14 relative to the handle 12. Since Lopez Zepeda teaches that the springs 17a/17b cause the device to revert to its original position, it is clear that the grip 15 and the handle 12 must be held in position while the lock is actuated. There is no evidence that this locking actuation may be done with the same hand holding the grip 15 and the handle 12, which would lead the PHOSITA to conclude that a second hand is required to lock the device of Lopez Zepeda. The PHOSITA would consider this requirement to be undesirable since the device of Hasson being modified considers single-handed operation to be advantageous/convenient. Accordingly, the PHOSITA would recognize that the modification of the grip assembly of Hasson to use the sliding arrangement of Lopez Zepeda would render the original device of Hasson being modified unsuitable for its intended purpose of one- handed operation (MPEP 2143.01 Section V), and the proposed modification is improper.”
Examiner respectfully disagrees contends that, as further discussed in the rejection to claim 1 below, the grips of Lopez Zepeda were not incorporated into the Truckai/Hasson combination. Instead, Lopez Zepeda was merely used to teach a sliding actuation motion. Hasson also teaches a spring configured to bias the handles away from each other, (Col. 7, Lines 5-20) meaning that Hasson’s grips (58 and 60) must also be held in position by the user while the lock is actuated. Even if Hasson didn’t teach that the grips (58 and 60) are biased apart from each other, one of ordinary skill in the art could maintain the grips (60 and 58) of Hasson in position using their fingers and palm while the thumb actuates the locking mechanism. Furthermore, as best understood by examiner, the grips (58 and 60) of Hasson moving closer to and away from each other via a sliding motion as opposed to a pivoting motion would have no bearing on a user’s ability to keep them in a close configuration while the locking mechanism is engaged.
Applicant further argues “Secondly, Hasson teaches that the disclosed grip assembly permits operation of the working tip without changing the location of the working tip relative to the rear handle. See column 3, lines 9-15. Lopez Zepeda on the other hand does not appear to teach such a configuration. Instead, the securing cylinder or drum 50 disposed at the distal end of the device of Lopez Zepeda clearly changes position relative to the rear handle (ref. 12) when the grip 15 is moved toward the handle 12, as seen in FIGS. 3A-3B. Since Lopez Zepeda further teaches end effectors are attached to the securing cylinder or drum 50 (see FIGS. 4-5), Lopez Zepeda cannot be said to actuate/operate the working tip without changing the position of the working tip. Indeed, Lopez Zepeda appears to expressly disclose that the device is used to move the uterus away from other tissues during a hysterectomy procedure. See Abstract, for example. Since the sliding arrangement of Lopez Zepeda would not permit operation of the working tip without changing the location of the working tip relative to the rear handle 12, the PHOSITA would not be motivated to modify the grip assembly of Hasson to use the sliding arrangement of Lopez Zepeda, and the proposed modification is improper.”
Examiner respectfully contends that, as further discussed in the rejection to claim 1 below, the grips of Lopez Zepeda were not incorporated into the Truckai/Hasson combination. Instead, Lopez Zepeda was merely used to teach a sliding actuation motion. Therefore, the ability of Lopez Zepeda to actuate the working tip without changing the position of the working tip is irrelevant.
Applicant further argues “Furthermore, the spring assembly of Truckai relies upon slidable downward movement of the spring assembly within the proximal grip 144. The entire spring mechanism of Truckai is contained within the proximal grip 144, as shown in FIG. 34, and interference with the user's hand is avoided. This is noticeably different than the horizontal movement of the spring assembly 98 of Hasson which is disposed entirely outside of the proximal grip 58, where the mechanism may be interfered with by the user's hand. As such, adapting the spring assembly 98 of Hasson to the embodiment of FIG. 21 of Truckai appears to require more than mere substitution, and would not be undertaken by the PHOSITA.”
Examiner respectfully contends that the spring assembly 98 of Hasson comprises a cover that would prevent interference by or pinching of a user’s hand.
Applicant further argues “Applicant respectfully traverses the characterization of Truckai set forth in the rejection. The PHOSITA would not characterize the "lower half' of the grips "up until the portions connected together via pivot pin" to properly correspond to the claimed lower ends of the first and second moveable grips, in accordance with MPEP 2111 as discussed above with respect to claim 11. The rejection appears to apply an interpretation tailored to fit the parameters of the claim solely in an effort to reject the claim. The PHOSITA would clearly, easily, and unambiguously understand the portions (e.g., "lower half') of the moveable grips characterized by the Examiner as "lower ends" as actually being medial portions of the moveable grips. The PHOSITA would clearly, easily, and unambiguously understand that the lower ends of the grips 142/144 are pivotably coupled together by the pivot pin 166, and thus cannot be spaced apart from each other in the delivery configuration, nor can they be moved closer to each other, as required by claim 19. For at least these reasons, Truckai fails to teach all that is relied upon in rejecting the claim.”
Examiner respectfully contends that, as further discussed in the rejection to claim 19 below, the grips (142 and 144) of Truckai were modified to operate in a translating/sliding configuration similar to that taught by Lopez Zepeda, and would therefore no longer be pivotably coupled to each other. In said sliding configuration, the upper and lower portions of the grips (142 and 144) would be able to be spaced apart from and moved closer to each other.
Applicant further argues “At OA page 20, the Examiner acknowledged that Truckai fails to teach the claimed upper and lower springs. Lopez Zepeda was introduced as allegedly teaching a sliding grip arrangement and asserted that it would have been obvious to modify Truckai to use the sliding grip arrangement in place of the pivoting grip arrangement of Truckai such that the combined references teach upper and lower ends of the grips being spaced apart in the delivery configuration. Polo was introduced as allegedly teaching a handle having first and second moveable grips, wherein upper ends of the grips are urged apart by an upper spring and lower ends of the grips are urged apart by a lower spring, and when the grips are approximated toward each other, the springs are compressed. The OA asserted that it would have been obvious to modify the Truckai/Lopez Zepeda combination to include the upper and lower springs of Polo in place of the spring assembly of Truckai because doing so would be a simple substitution of one spring assembly for another. Applicant respectfully disagrees. The spring assembly of Truckai relies upon slidable downward movement of the spring assembly within the proximal grip 144. The entire spring mechanism of Truckai is contained within the proximal grip 144, as shown in FIG. 34, and interference with the user's hand is avoided. This is noticeably different than the horizontal movement of the springs of Polo. Additionally, the lower spring of Polo is disposed entirely outside of the grips, where the spring may be interfered with by the user's hand and/or the user's hand may be pinched between the coils of the spring. As such, adapting the springs of Polo to the embodiment of FIG. 21 of Truckai appears to require more than mere substitution, and would not be undertaken by the PHOSITA in view of the additional risks created when compared to the original spring assembly of Truckai.”
Examiner respectfully contends that a person of ordinary skill in the art would recognize that any risks posed by having the spring located outside of the grips and/or possibly interfacing with a user’s hand can be mitigated by disposing a cover over said spring, similar to the lower spring assembly shown in Fig. 7A-B of Hasson.
Applicant’s arguments, see Remarks, filed 01/13/2026, with respect to the rejection(s) of claim(s) 11 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Truckai (US 2005/0085880 A1) in view of Polo (US 9,055,967 B1).
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 1-4, 6-12, and 14-22 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 3-5 and 10 of U.S. Patent No. 11,969,205. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 11,969,205 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.
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.
Claim(s) 1-4, 6-10, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US 2005/0085880 A1) in view of Hasson (US 5,211,655) in view of Lopez Zepeda (US 2010/0280524 A1).
Regarding claim 1, Truckai teaches
an elongated shaft having a proximal end and a distal end; (Fig. 6-7, Char. 32: introducer sheath)
an elongate extension member having a proximal end and a distal end, (Fig. 6-7, Char. 10: shaft) the elongate extension member extending through a lumen of the elongate shaft (Fig. 6-7) and axially slidable relative thereto; (Par. [0079])
an energy applicator coupled to the distal ends of the elongated shaft and the elongate extension member, (Fig. 1-2, Char. 2: RF applicator head) wherein axial translation of the elongate extension member relative to the elongate shaft actuates the energy applicator between a delivery configuration and deployed configuration; (Fig. 6-7 and Par. [0078]) and
a handle coupled to the proximal ends of the elongated shaft and the elongate extension member, (Fig. 1-2 and 6-7, Char. 6: handle) the handle including a first moveable grip (Fig. 6-7, Char. 37: finger cutout) and a second moveable grip (Fig. 6-7, Char. 34: handle) configured to be actuated to move the energy applicator between the delivery configuration and the deployed configuration, (Fig. 6-7) an upper end of the first moveable grip coupled to the elongate extension member and moveable therewith, (Fig. 1-2 and 6-7: an upper portion of finger cutout (37) is coupled to shaft (10) via spring (39)) and an upper end of the second moveable grip coupled to the elongate shaft (Fig. 1-2 and 6-7: an upper portion of handle (34) is coupled to introducer sheath (32));
wherein in the delivery configuration the first and second moveable grips are in an initial position in which the upper end of the first moveable grip is spaced apart proximally from the upper end of the second moveable grip and a lower end of the first moveable grip is spaced apart proximally from a lower end of the second moveable grip; (Fig. 6)
wherein in the deployed configuration the first and second moveable grips are approximated toward one another such that the upper end of the first moveable grip is moved closer to the upper end of the second moveable grip and the lower end of the first moveable grip is moved closer to the lower end of the second moveable grip; (Fig. 7)
wherein a lower spring is positioned between the lower end of the first moveable grip and the lower end of the second moveable grip. (Fig. 6)
Truckai, as applied to claim 1 above, is silent regarding the upper end of the first moveable grip being moveable with the elongate extension member.
Hasson, in a similar field of endeavor, teaches a handle (Fig. 2, Char. 38: grip assembly) coupled to the proximal ends of the elongated shaft (Fig. 1a and 2, Char. 36: body) and the elongate extension member, (Fig. 2, Char. 56: operating rod) the handle including a first moveable grip (Fig. 2, Char. 60: handle) and a second moveable grip (Fig. 2, Char. 58: handle) configured to be actuated to move an end effector (Fig. 1a-b, Char. 40: jawed working tip) between a first configuration (Fig. 1a) and a second configuration, (Fig. 1b) an upper end of the first moveable grip coupled to the elongate extension member (Fig. 2) and moveable therewith, (Col. 6, Lines 18-37) and an upper end of the second moveable grip coupled to the elongate shaft and moveable therewith; (Fig. 2); (Col. 6, Lines 18-37; In an event in which handle (60) is held still and handle (58) is actuated relative to handle (60), mounting element (64) would actuate body (36) relative to operating rod (56))
wherein in the delivery configuration the first and second moveable grips are in an initial position in which the upper end of the first moveable grip is spaced apart proximally from the upper end of the second moveable grip and a lower end of the first moveable grip is spaced apart from a lower end of the second moveable grip; (Fig. 1a)
wherein in the deployed configuration the first and second moveable grips are approximated toward one another such that the upper end of the first moveable grip is moved closer to the upper end of the second moveable grip and the lower end of the first moveable grip is moved closer to the lower end of the second moveable grip; (Fig. 1b)
wherein a lower spring is positioned between the lower end of the first moveable grip and the lower end of the second moveable grip. (Fig. 2 and 4, Char. 100: compression coil spring)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Truckai, as applied to claim 1 above, to incorporate the teachings of Hasson, and include the grip assembly (38) of Hasson in place of handle (6) of Truckai, such that handle (58) of Hasson is coupled to introducer sheath (32) of Truckai, and handle (60) of Hasson is coupled to shaft (10) of Truckai. Doing so would be a simple substitution of one handle assembly for another for the predictable result of allowing a user to easily hold the device and actuate the distal end effector of Truckai.
The combination of Truckai/Hasson, as applied to claim 1 above, is silent regarding the lower end of the first moveable grip (60) of Hasson is spaced apart proximally from a lower end of the second moveable grip (58) of Hassan when disposed in the delivery configuration.
Lopez Zepeda, in a similar field of endeavor, teaches a surgical device comprising a grip arrangement in which a first and second movable grips are configured to slide relative to each other such that a distal assembly changes between a first and second configuration. (Fig. 3A-B)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Truckai/Hasson, as applied to claim 1 above, to incorporate the teachings of Lopez Zepeda, and configure the grip (58) and handle (60) of Hasson to operate in a sliding configuration relative to each other instead of a pivoting configuration. Doing so would be a simple substitution of one mode of grip actuation for another for the predictable result of transitioning the RF applicator head of Truckai between a deployed configuration and a delivery configuration.
Regarding claim 2, the combination of Truckai/Hasson/Lopez Zepeda, as applied to claim 1 above, teaches the upper end of the first moveable grip is coupled to the proximal end of the elongate extension member. (Hasson: Fig. 2 – it is implicit that this feature be present in the Truckai/Hasson/Lopez Zepeda combination based on the rejection to claim 1 above.)
Regarding claim 3, the combination of Truckai/Hasson/Lopez Zepeda, as applied to claim 2 above, teaches the upper end of the second moveable grip is coupled to the proximal end of the elongate shaft. (Hasson: Fig. 2 – it is implicit that this feature be present in the Truckai/Hasson/Lopez Zepeda combination based on the rejection to claim 1 above.)
Regarding claim 4, the combination of Truckai/Hasson/Lopez Zepeda, as applied to claim 3 above, is silent regarding the upper end of the second moveable grip is pivotably coupled to the proximal end of the elongate shaft.
Truckai, in the Fig. 21 embodiment, teaches a handle (Fig. 21, Char. 106: handle) coupled to proximal ends of an elongated shaft (Fig. 21, Char. 104: sheath) and an elongate extension member, (Fig. 23, Char. 108: tubing) the handle including a first moveable grip (Fig. 21, Char. 144: proximal grip) and a second moveable grip (Fig. 21, Char. 142: distal grip) configured to be actuated to move an energy applicator (Fig. 21-23, Char. 102: applicator head) between a first configuration and a second configuration, (Par. [0108]: Applicator head (102) is slidably disposed within the sheath (104) during insertion of the device into the uterine cavity, and applicator head (102) extends from the distal end of the sheath (104) to expand into contact with body tissue; Page 10, Par. [0158]: motion between the grips causes a relative rearward motion in hypotube (120) and forward motion in hypotube (122). The relative motion in hypotubes (120) and (122) casues deflection in flexures (124), and (136) which deploys and tensions the electrode array.) an upper end of the first moveable grip coupled to the elongate extension member and moveable therewith, (Fig. 21-22) and an upper end of the second moveable grip coupled to the elongate shaft and moveable therewith; (Fig. 21-22)
wherein in the first configuration the first and second moveable grips are in an initial position in which the upper end of the first moveable grip is spaced apart from the upper end of the second moveable grip and a lower end of the first moveable grip is spaced apart from a lower end of the second moveable grip; (Fig. 21: The lower ends of distal and proximal grips (142 and 144) would be considered spaced apart at least in that the lower half of distal and proximal grips are spaced apart from each other up until the portions connected together via pivot pin (166))
wherein in the second configuration the first and second moveable grips are approximated toward one another such that the upper end of the first moveable grip is moved closer to the upper end of the second moveable grip and the lower end of the first moveable grip is moved closer to the lower end of the second moveable grip; (Fig. 22)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Truckai/Hasson/Lopez Zepeda, as applied to claim 3 above, to incorporate the teachings of the Fig. 21 embodiment of Truckai, and include the grips (142 and 144) of Truckai in place of the handles (58 and 60) of Hasson. Doing so would be a simple substitution of one set of grips for another for the predictable result of allowing a user to easily grasp the device and actuate the energy applicator between configurations by actuating the handle assembly.
Regarding claim 6, the combination of Truckai/Hasson/Lopez Zepeda, as applied to claim 1 above, teaches the lower spring urges the lower ends of the first and second moveable grips apart. (Hasson: Col. 7, Lines 6-10 – it is implicit that this feature be present in the Truckai/Hasson/Lopez Zepeda combination based on the rejection to claim 1 above.)
Regarding claim 7, the combination of Truckai/Hasson/Lopez Zepeda, as applied to claim 1 above, further teaches the lower spring is compressed when the lower ends of the first and second moveable grips are moved closer together. (Hasson: Fig. 1b – it is implicit that this feature be present in the Truckai/Hasson/Lopez Zepeda combination based on the rejection to claim 1 above.)
Regarding claim 8, the combination of Truckai/Hasson/Lopez Zepeda, as applied to claim 1 above, teaches an upper spring positioned between the upper end of the first moveable grip and the upper end of the second moveable grip. (Lopez Zepeda: Fig. 3A-B, Char. 17b: Spring – it is implicit that this feature be present in the Truckai/Hasson/Lopez Zepeda combination based on the rejection to claim 1 above.)
Regarding claims 9 and 10, the combination of Truckai/Hasson, as applied to claim 8 above, teaches the upper spring urges the upper ends of the first and second moveable grips apart; (Lopez Zepeda: Par. [0036] – it is implicit that this feature be present in the Truckai/Hasson/Lopez Zepeda combination based on the rejection to claim 1 above.) and the upper spring being coaxially mounted over the elongate extension member to compress as the upper ends of the first and second moveable grips are moved closer together. (Lopez Zepeda: Fig. 3A-B – it is implicit that this feature be present in the Truckai/Hasson/Lopez Zepeda combination based on the rejection to claim 1 above.)
Regarding claim 21, the combination of Truckai/Hasson/Lopez Zepeda, as applied to claim 1 above, teaches a sliding member positioned between the lower end of the proximal moveable grip and the lower end of the distal moveable grip. (Hasson: Fig. 2, Col. 7, Lines 15-20: Cup shaped element (102) of spring assembly (98) slides relative to cup shaped element (106) – it is implicit that this feature be present in the Truckai/Hasson/Lopez Zepeda combination based on the rejection to claim 1 above.)
Claim(s) 11, 12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US 2005/0085880 A1) in view of Polo (US 9,055,967 B1).
Regarding claim 11, Truckai teaches
an elongated shaft having a proximal end and a distal end; (Fig. 21, Char. 104: sheath)
an elongate extension member having a proximal end and a distal end, (Fig. 23, Char. 122: hypotube) the elongate extension member extending through a lumen of the elongate shaft and axially slidable relative thereto; (Page 10, Par. [0158]: Hypotube (122) is slidably disposed within sheath (104))
an energy applicator coupled to the distal ends of the elongated shaft and the elongate extension member, (Fig. 21-23, Char. 102: applicator head) wherein axial translation of the elongate extension member relative to the elongate shaft actuates the energy applicator between a delivery configuration and deployed configuration; (Par. [0108]: Applicator head (102) is slidably disposed within the sheath (104) during insertion of the device into the uterine cavity, and applicator head (102) extends from the distal end of the sheath (104) to expand into contact with body tissue; Par. [0158]: motion between the grips causes a relative rearward motion in hypotube (120) and forward motion in hypotube (122). The relative motion in hypotubes (120) and (122) causes deflection in flexures (124), and (136) which deploys and tensions the electrode array.) and
a handle coupled to the proximal ends of the elongated shaft and the elongate extension member, (Fig. 21, Char. 106: handle) the handle including a proximal moveable grip (Fig. 21, Char. 144: proximal grip) and a distal moveable grip configured to be actuated to move the energy applicator between the delivery configuration and the deployed configuration; (Par. [0154]-[0156])
wherein an upper end of the proximal moveable grip is coupled to the proximal end of the elongate extension member; (Par. [0156]: Hypotube (120) terminates within frame (178); Fig. 32: Proximal grip (144) would be at least indirectly coupled to the proximal end of hypotube (120) via at least coupler (174), sliding collar (184), tubing (108), and frame (174))
wherein an upper end of the distal moveable grip is coupled to the proximal end of the elongate shaft; (Fig. 22)
wherein in the delivery configuration the proximal and distal moveable grips are in an initial position in which the upper end of the proximal moveable grip is spaced apart proximally from the upper end of the distal moveable grip and a lower end of the proximal moveable grip is spaced apart proximally from a lower end of the distal moveable grip; (Fig. 21: The lower ends of distal and proximal grips (142 and 144) would be considered spaced apart proximally at least in that the lower half of distal and proximal grips are spaced apart from each other up until the portions connected together via pivot pin (166))
wherein in the deployed configuration both the upper and lower ends of the proximal moveable grip are moved distally an axial distance relative to the elongate shaft such that the upper end of the proximal moveable grip is moved closer to the upper end of the distal moveable grip and the lower end of the first moveable grip is moved closer to the lower end of the second moveable grip, (Fig. 22)
The Fig. 21 embodiment of Truckai, as applied to claim 11 above, further teaches using a spring assembly to bias the first and second moveable grips apart. (Par. [0155])
The Fig. 21 embodiment of Truckai, as applied to claim 11 above, is silent regarding a lower spring is positioned between the lower end of the first moveable grip and the lower end of the second moveable grip.
Polo, in a similar field of endeavor, teaches a handle assembly (Fig. 1, at least Char. 18, 19, and 20) comprising a first grip (Attached “Annotated Polo Fig 1” below: The grip component labeled “1st movable grip”) and a second grip (Attached “Annotated Polo Fig 1” below: The grip component labeled “2nd movable grip”) movable relative to each other, (Fig. 1-3) and an upper spring (Fig. 1, Char. 19: tube spring) and a lower spring (Fig. 1, Char. 20: handle spring) positioned between the upper and lower ends respectively of the first moveable grip and the second moveable grip; (Fig. 1-3) wherein the upper and lower springs urge the upper and lower ends of the first and second moveable grips apart. (Fig. 1-3 and Col. 10, Lines 21-28)
Annotated Polo Fig. 1
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It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Truckai, as applied to claim 11 above, to incorporate the teachings of Polo, and include the handle (18) and springs (19 and 20) of Polo in place of the handles (142 and 144) and spring (198) of Truckai, such that the tube spring (19) of Polo is disposed coaxially over the tubing (108) of Truckai. Doing so would be a simple substitution of one handle and spring arrangement for another for the predictable result of actuating the energy applicator between a delivery deployed configuration and biasing the grips of the handle assembly apart from each other.
Regarding claim 12, the Truckai/Polo combination, as applied to claim 11 above, teaches the upper end of the distal moveable grip is pivotably coupled to the proximal end of the elongate shaft. (Truckai: Fig. 21-22; Polo: Fig. 1-3: Handle (18) would have to be pivotably coupled to external tube (3) in order for full translation/movement – it is implicit that this feature be present in the Truckai/Polo combination based on the rejection to claim 11 above.)
Regarding claim 14, the Truckai/Polo combination, as applied to claim 11 above, teaches the lower spring urges the lower ends of the proximal and distal moveable grips apart. (Polo: Fig. 1-3 and Col. 10, Lines 21-28 – it is implicit that this feature be present in the Truckai/Polo combination based on the rejection to claim 11 above.)
Regarding claim 15, the Truckai/Polo combination, as applied to claim 14 above, teaches the lower spring is compressed when the lower ends of the proximal and distal moveable grips are moved closer together. (Polo: Fig. 1-3 and Col. 10, Lines 21-28 – it is implicit that this feature be present in the Truckai/Polo combination based on the rejection to claim 11 above.)
Regarding claim 16, the Truckai/Polo combination, as applied to claim 11 above, teaches an upper spring positioned between the upper end of the proximal moveable grip and the upper end of the distal moveable grip. (Polo: Fig. 1-3 – it is implicit that this feature be present in the Truckai/Polo combination based on the rejection to claim 11 above.)
Regarding claim 17, the combination of Truckai/Polo, as applied to claim 16 above, teaches the upper spring urges the upper ends of the proximal and distal moveable grips apart. (Polo: Col. 8, Lines 55-62 – it is implicit that this feature be present in the Truckai/Polo combination based on the rejection to claim 11 above.)
Regarding claim 18, the combination of Truckai/Hasson/Polo, as applied to claim 16 above, teaches the upper spring is coaxially mounted over the elongate extension member to compress as the upper ends of the proximal and distal moveable grips are moved closer together. (Polo: Fig. 1-3 – it is implicit that this feature be present in the Truckai/Polo combination based on the rejection to claim 11 above.)
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US 2005/0085880 A1) in view of Polo (US 9,055,967 B1), as applied to claim 11 above, and further in view of Hasson (US 5,211,655).
Regarding claim 22, the combination of Truckai/Polo, as applied to claim 11 above, is silent regarding a sliding member positioned between the lower end of the proximal moveable grip and the lower end of the distal moveable grip.
Hasson, in a similar field of endeavor, teaches a sliding member positioned between the lower end of a proximal moveable grip and the lower end of a distal moveable grip. Fig. 2, Col. 7, Lines 15-20: Cup shaped element (102) of spring assembly (98) slides relative to cup shaped element (106))
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Truckai/Polo, as applied to claim 11 above, to incorporate the teachings of Hasson, and include the cup shaped element (102) of Hasson disposed over the lower spring (20) of Polo. Doing so would protect the spring (20) of Polo from becoming accidentally damaged, as well as minimize the risk of a user’s hand from interfering or becoming pinched by said spring accidentally during use.
Claim(s) 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US 2005/0085880 A1) in view of Lopez Zepeda (US 2010/0280524 A1) in view of Polo (US 9,055,967 B1).
Regarding claim 19, Truckai teaches
an elongated shaft having a proximal end and a distal end; (Fig. 21, Char. 104: sheath)
an elongate extension member having a proximal end and a distal end, (Fig. 23, Char. 108: tubing) the elongate extension member extending through a lumen of the elongate shaft and axially slidable relative thereto; (Par. [0110]: Tubing (108) is slidably disposed within sheath (104))
an energy applicator coupled to the distal ends of the elongated shaft and the elongate extension member, (Fig. 21-23, Char. 102: applicator head) wherein axial translation of the elongate extension member relative to the elongate shaft actuates the energy applicator between a delivery configuration and deployed configuration; (Par. [0108]: Applicator head (102) is slidably disposed within the sheath (104) during insertion of the device into the uterine cavity, and applicator head (102) extends from the distal end of the sheath (104) to expand into contact with body tissue; Page 10, Par. [0158]: motion between the grips causes a relative rearward motion in hypotube (120) and forward motion in hypotube (122). The relative motion in hypotubes (120) and (122) casues deflection in flexures (124), and (136) which deploys and tensions the electrode array.) and
a handle coupled to the proximal ends of the elongated shaft and the elongate extension member, (Fig. 21, Char. 106: handle) the handle including a first moveable grip (Fig. 21, Char. 144: proximal grip) and a second moveable grip (Fig. 21, Char. 142: distal grip) configured to be actuated to move the energy applicator between the delivery configuration and the deployed configuration; (Par. [0154]-[0156])
wherein in the delivery configuration the first and second moveable grips are in an initial position in which the upper end of the first moveable grip is spaced apart proximally from the upper end of the second moveable grip and the lower end of the first moveable grip is spaced apart from the lower end of the second moveable grip; (Fig. 21: The lower ends of distal and proximal grips (142 and 144) would be considered spaced apart at least in that the lower half of distal and proximal grips are spaced apart from each other up until the portions connected together via pivot pin (166))
wherein in the deployed configuration the first and second moveable grips are approximated toward one another to move the upper end of the first moveable grip closer to the upper end of the second moveable grip and to move the lower end of the first moveable grip closer to the lower end of the second moveable grip. (Fig. 22)
Truckai, as applied to claim 19 above, is silent regarding an upper end of the first moveable grip is urged apart from an upper end of the second moveable grip by an upper spring; wherein the lower end of the first moveable grip is spaced apart proximally from the lower end of the second moveable grip in the delivery configuration; and wherein a lower end of the first moveable grip is urged apart from a lower end of the second moveable grip by a lower spring; and when the first and second moveable grips are approximated toward one another, the upper and lower springs are compressed.
Lopez Zepeda, in a similar field of endeavor, teaches a surgical device comprising a grip arrangement in which a first and second movable grips are configured to slide relative to each other such that a distal assembly changes between a first and second configuration. (Fig. 3A-B)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Truckai, as applied to claim 19 above, to incorporate the teachings of Lopez Zepeda, and configure the distal and proximal grips (142 and 144) of Truckai to operate in a sliding configuration relative to each other instead of a pivoting configuration. Doing so would be a simple substitution of one mode of grip actuation for another for the predictable result of transitioning the RF applicator head of Truckai between a deployed configuration and a delivery configuration.
In this combination, both the upper and lower ends of the proximal grip (144) of Truckai would be spaced apart proximally from the upper and lower ends of distal grip (142) in the delivery configuration.
The combination of Truckai/Lopez Zepeda, as applied to claim 19 above, is silent regarding an upper end of the first moveable grip is urged apart from an upper end of the second moveable grip by an upper spring; wherein a lower end of the first moveable grip is urged apart from a lower end of the second moveable grip by a lower spring; and when the first and second moveable grips are approximated toward one another, the upper and lower springs are compressed.
Polo, in a similar field of endeavor, teaches a handle (Fig. 1-2, Char. 18: handle) coupled to the proximal ends of an elongated shaft (Fig. 1-2, Char. 3: external tube) and an elongate extension member, (Fig. 1-2, Char. 2: internal tube) the handle including a first moveable grip (Fig. 1-2: The grip of handle (18) contacting external tube (3)) and a second moveable grip (Fig. 1-2: The grip of handle (18) containing electric motor (21) and switch (22) in the grip’s upper portion) configured to be actuated to move the energy applicator between a first configuration (Fig. 1) and a second configuration; (Fig. 3) wherein an upper end of the first moveable grip is urged apart from an upper end of the second moveable grip by an upper spring; (Fig. 1, Char. 19: tube spring) wherein a lower end of the first moveable grip is urged apart from a lower end of the second moveable grip by a lower spring; (Fig. 1, Char. 20: handle spring) and when the first and second moveable grips are approximated toward one another, the upper and lower springs are compressed. (Fig. 3)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Truckai/Lopez Zepeda, as applied to claim 19 above, to incorporate the teachings of Polo, and include the upper and lower springs of Polo in place of the spring assembly of Truckai. Doing so would be a simple substitution of one spring assembly for another for the predictable result of biasing the distal and proximal grips of Truckai apart from each other.
Regarding claim 20, the combination of Truckai/Lopez Zepeda/Polo, as applied to claim 19 above, teaches the upper spring is coaxially mounted over the elongate extension member to compress as the upper ends of the first and second moveable grips are moved closer together. (Polo: Fig. 3 – it is implicit that this feature be present in the Truckai/Lopez Zepeda/Polo combination based on the rejection to claim 19 above.)
Conclusion
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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