DETAILED ACTION
This action is in response to applicant's preliminary amendments filed 12/23/24.
The examiner acknowledges the amendments to the claims.
Claims 7-8, 11-12, 16, 18, 20, 23, 30-42 are pending in this application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “coupling mechanism” in claims 7, 32.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 42 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 42 recites the limitations "the first gear assembly", “the elongate grasper member” and “the second gear assembly” in lines 1-3. There is insufficient antecedent basis for these limitations in the claim. For examination purposes, Claim 42 will be read as being dependent on Claim 41, which recites these limitations, and therefore will be read as --The system of claim 41--.
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.
Claims 7-8, 23, 30-33, 38, 40 are rejected under 35 U.S.C. 103 as being unpatentable over Chao (U.S. Pub. No. 2015/0257908) in view of Clerc et al., hereinafter “Clerc” (U.S. Pub. No. 2012/0041534).
Regarding claims 7 and 30-33, Chao discloses a system for delivering an implant, the system comprising a delivery device comprising:
an outer tubular member (deployment instrument 210; Figure 16) comprising an imaging device 216 located in a distal end region of the outer tubular member ([0030], [0085]);
an inner tubular member (sheath 214) being within the outer tubular member (within lumen 212), wherein the inner tubular member is adapted to house at least a portion of an implant (receiving implant 150A/152/150B);
one or more structures ([0083]; pusher or release mechanism) slidably advanceable within the inner tubular member to cause deployment of the implant from within the inner tubular member.
However, Chao does not disclose a proximal control device coupled with the inner tubular member and the one or more structures, and releasably coupled with the outer tubular member with a coupling mechanism, wherein the proximal control device is configured to longitudinally move the inner tubular member and the outer tubular member concurrently, wherein the proximal control device comprises a first portion comprising a first housing comprising a handle, and a second portion comprising a second housing, the second portion being slidable with respect to the first portion, wherein the inner tubular member is secured to the first housing, and the outer tubular member is secured to the second housing, wherein release of the coupling mechanism permits the first portion to be decoupled from the second portion, wherein the coupling mechanism comprises a deflectable member receivable within a groove of a shaft portion of the first portion of the proximal control device.
In the same field of art, namely devices for delivering implants, Clerc teaches
in Figure 3, a proximal control device (including handle 88) coupled with an inner tubular member 56, and releasably coupled with an outer tubular member 52 with a coupling mechanism (latch slidable within track, such as pin 74 that slides into track to fix the relative positions between handle portions 72, 88; [0030]), wherein the proximal control device is configured to longitudinally move the inner tubular member and the outer tubular member concurrently (when the inner tubular member and the outer tubular member are locked together with pin 74, moving proximal control device 88 moves both the inner and outer tubular members together as they all move as a unit; it is noted that the claim does not require that the inner tubular member and the outer tubular are longitudinally moved with respect to the proximal control device, and so moving the whole delivery device would move the inner and outer tubular member concurrently), wherein the proximal control device comprises a first portion (88/proximal segment of 56) comprising a first housing 88 comprising a handle, and a second portion comprising a second housing 72, the second portion being slidable with respect to the first portion (handles and the respective sheaths 56, 52 are slidable relative to one another; [0007], [0028], [0030]), wherein the inner tubular member 56 is secured to the first housing 88, and the outer tubular member 52 is secured to the second housing 72, wherein release of the coupling mechanism 74 permits the first portion to be decoupled from the second portion, wherein the coupling mechanism comprises a deflectable member (removable pin 74; Figure 3, [0030]) receivable within a groove 76 of a shaft portion (segment of 56) of the first portion of the proximal control device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chao with a proximal control device and coupling mechanism as claimed, as taught by Clerc, in order to facilitate selective handling and adjustable actuation of the first and second tubular members, respectively, by a user, and in order to prevent inadvertent or undesirable movement between the first and second tubular members, and to maintain position of an imaging device for visualization (Clerc, [0030]). It is noted that once the combination is made, the proximal control device will also be coupled to the one or more structures, since the elements are all coupled together within the same delivery device.
Regarding claim 8, Chao as modified teaches further comprising the implant 150A/152/150B (Chao; Figure 16), wherein the implant is configured to maintain a prostatic urethra in an at least partially open state (abstract of Chao).
Regarding claim 23, Chao as modified teaches an anchor member (Chao, [0085]; a balloon may be placed within the bladder to ensure proper anatomic positioning of the implant), wherein the anchor member comprises an anchor configured to contact a bladder wall, wherein the anchor is an inflatable balloon (Id.). However, Chao does not expressly teach the anchor member being elongate, although it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon anchor to be elongate, in order to conform to the bladder wall as well as to increase the surface area and enhance contact and stability with the bladder wall.
Regarding claim 38, Chao as modified teaches the claimed invention, as discussed above, except for wherein the distal end region of the outer tubular member further comprises an illumination device.
Clerc further teaches in Figure 3 and [0029] that an imaging device 60 on a distal end region of outer tubular member 52 can include illumination device 66 to illuminate and facilitate visualization of the body lumen.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chao as modified with an illumination device, as taught by Clerc, in order to illuminate and facilitate visualization of the body lumen.
Regarding claim 40, Chao as modified teaches a distal end region of the inner tubular member 214 is distal to the distal end region of the outer tubular member 210 by a separation distance (Figure 16), and wherein the proximal control device is configured to longitudinally move the outer tubular member and inner tubular member concurrently without changing the separation distance (Clerc, [0030]; when the inner tubular member and the outer tubular member are axially locked with pin 74, moving proximal control device 88 moves both the inner and outer tubular members together as they all move as a unit without changing a separation distance; it is noted that the claim does not require that the inner tubular member and the outer tubular are longitudinally moved with respect to the proximal control device, and so moving the whole delivery device would move the inner and outer tubular member concurrently).
Claims 11, 12, 16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chao (U.S. Pub. No. 2015/0257908) in view of Clerc (U.S. Pub. No. 2012/0041534), as applied to claim 8 above, and further in view of Brenneman (U.S. Pat. No. 5,160,341).
Regarding claims 11, 12, 16, 18 and 20, Chao as modified teaches the claimed invention, as discussed above, except for the one or more structures comprise: an elongate grasper member configured to releasably couple with a proximal portion of the implant; and a distal control member configured to releasably couple with a distal portion of the implant, wherein the distal control member comprises a retainer configured to releasably couple with the distal portion of the implant, wherein the implant comprises a distal engagement member configured to releasably couple with the retainer, an elongate member coupled with the retainer and having a proximal end that is manipulatable by a user to permit release of the distal portion of the implant from the retainer, wherein the distal control member comprises a recess adapted to receive the distal portion of the implant.
In the same field of art, namely delivery devices for implants, Brenneman teaches in Figures 1, 7-10, col. 6, lines 28-35, one or more structures comprise: an elongate grasper member 28 configured to releasably couple with a proximal portion of implant 70; and a distal control member 26 configured to releasably couple with a distal portion of the implant, the distal control member comprises a retainer (slot 26) configured to releasably couple with the distal portion of the implant, wherein the implant comprises a distal engagement member (distal tip of implant 70) configured to releasably couple with the retainer (Id.), further comprising an elongate member 20 coupled with the retainer and having a proximal end (at 50) that is manipulatable by a user (via actuation lever 50) to permit release of the distal portion of the implant from the retainer (col. 6, line 61 to col. 7, line 19). A proximal control device (including pin 56 and slot 58; Figures 4 and 6; col. 5, lines 52-63) is configured to rotate and longitudinally move an inner tubular member 16 with respect to the distal control member 26 while the distal control member is releasably coupled with the distal portion of the implant 70. The distal control member comprises a recess (slot 26) adapted to receive the distal portion of the implant (Id.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chao as modified with the elongate grasper member, distal control member, and proximal control device as claimed, as taught by Brenneman, in order to securely attach the proximal and distal ends of the implant to the delivery device and to facilitate deployment of the implant.
Claims 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Chao (U.S. Pub. No. 2015/0257908) in view of Clerc (U.S. Pub. No. 2012/0041534), as applied to claim 33 above, and further in view of Ferrera (U.S. Pub. No. 2004/0193246).
Regarding claims 34-36, Chao as modified teaches the claimed invention, as discussed above, except for the groove is annular and extends about the periphery of the shaft portion, wherein the shaft portion is secured to the inner tubular member, wherein the deflectable member is slidable within the groove, such that the shaft portion is rotatable while the deflectable member is received within the groove, wherein the shaft portion comprises multiple grooves, each adapted to receive the deflectable member.
In Figure 5C and [0072]-[0074] Ferrera teaches multiple annular grooves (plurality of locking detents 44 can be “circumferential grooves” that receive a locking pin) that extend about a periphery of a shaft portion 46, the shaft portion is secured to an inner tubular member (hub 36 having a lock housing 43 that holds a locking pin 42), wherein a deflectable member (locking pin 42) is slidable within the groove (the pin can be withdrawn from or engage with the locking detents 44), such that the shaft portion is rotatable while the deflectable member is received within the groove (since the grooves are annular/circumferential, shaft portion 46 would be capable of rotating).
It would have been obvious to one of ordinary skill before the effective filing date to modify the groove as claimed, as taught by Ferrera, in order to facilitate adjusting a proper orientation for deploying an implant (Id.).
Claims 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Chao (U.S. Pub. No. 2015/0257908) in view of Clerc (U.S. Pub. No. 2012/0041534), as applied to claim 30 above, and further in view of Haggerty et al., hereinafter “Haggerty” (U.S. Pub. No. 2017/0078583).
Regarding claims 37 and 39, although Clerc teaches in Figure 3, [0031], [0033] a second portion having a circuit board 80 (although shown in Figure 3 as being in handle 88¸ it may be located in different handles such as second portion 72 Id.), a passage of wires to supply power and video signals to and from an imaging device (cameras; Id., [0019]), Chao as modified does not teach the second portion comprises a flexible bus having a first end electrically connected to a printed circuit board within the second portion and a second end electrically connected to the imaging device, and a second flexible bus having a first end electrically connected to the printed circuit board within the second portion and a second end electrically connected to the illumination device. Clerc further teaches in Figure 3 and [0029] that an imaging device 60 on a distal end region of outer tubular member 52 can include illumination device 66 to illuminate and facilitate visualization of the body lumen.
In Figure 15 and [0194], [0307] Haggerty teaches a printed circuit board may communicate with components (imaging/camera and illumination/LEDs) at a distal end of a shaft through first and second flexible buses (one or more ribbon cables).
It would have been obvious to one of ordinary skill before the effective filing date to modify Chao as modified with a printed circuit board and first and second flexible buses as claimed, as taught by Haggerty, in order to control or process image data and providing power to the illumination device (Haggerty; [0111]).
Claims 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Chao (U.S. Pub. No. 2015/0257908) in view of Clerc (U.S. Pub. No. 2012/0041534) and Brenneman (U.S. Pat. No. 5,160,341), as applied to claim 11 above, and further in view of Gunderson (U.S. Patent No. 5,776,142).
Regarding claims 41-42, Chao as modified teaches the claimed invention, as discussed above, including the proximal control device comprising a user actuator (handle in Brenneman; Figure 1), a first gear assembly coupled with the user actuator and configured to control longitudinal movement of the elongate grasper member (gear 46 is coupled with handle/actuation lever 50 to control elongate grasper member 28; col. 6, line 61 to col. 7, line 19), and a cam assembly configured to control longitudinal and rotational movement of inner tubular member 16 (including pin 56 and slot 58; Brenneman, Figures 4 and 6; col. 5, lines 52-63). However, Chao as modified
does not teach a second gear assembly coupled with the cam assembly, wherein the second gear assembly is configured to control rotation of the inner tubular member.
In col. 9, lines 11-17, Gunderson teaches controlling rotation and longitudinal movement can be achieved by a second gear assembly (devices incorporating a variety of elements including gears, rack and pinion, combinations of the above).
It would have been obvious to one of ordinary skill before the effective filing date to modify Chao as modified with a second gear assembly to control rotation of the inner tubular member, as taught by Gunderson, since user actuators including multiple gear assemblies are old and well known in the art for transmission of forces to longitudinal and/or rotational movement and provide a mechanical advantage to a user. Once the combination is made, the second gear assembly would be coupled with the cam assembly as they are connected within the proximal control device.
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 7-8, 23, 30-33, 38, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-14 of U.S. Patent No. 11,771,575 in view of Clerc (U.S. Pub. No. 2012/0041534). The claims at issue are not patentably distinct from another because it’s clear they both recite a delivery system including first/outer tubular member having an imaging device and a second/inner tubular member capable of housing a prostatic urethra implant, and releasing the implant from the delivery system, and concurrently moving the first/outer and second/inner tubular members. The difference lies in the fact that the application claims have features that are merely obvious, such as a proximal control device coupled with the inner tubular member and the one or more structures, and releasably coupled with the outer tubular member with a coupling mechanism, wherein the proximal control device is configured to longitudinally move the inner tubular member and the outer tubular member concurrently, wherein the proximal control device comprises a first portion comprising a first housing comprising a handle, and a second portion comprising a second housing, the second portion being slidable with respect to the first portion, wherein the inner tubular member is secured to the first housing, and the outer tubular member is secured to the second housing, wherein release of the coupling mechanism permits the first portion to be decoupled from the second portion, wherein the coupling mechanism comprises a deflectable member receivable within a groove of a shaft portion of the first portion of the proximal control device.
In the same field of art, namely devices for delivering implants, Clerc teaches
in Figure 3, a proximal control device (including handle 88) coupled with an inner tubular member 56, and releasably coupled with an outer tubular member 52 with a coupling mechanism (latch slidable within track, such as pin 74 that slides into track to fix the relative positions between handle portions 72, 88; [0030]), wherein the proximal control device is configured to longitudinally move the inner tubular member and the outer tubular member concurrently (when the inner tubular member and the outer tubular member are locked together with pin 74, moving proximal control device 88 moves both the inner and outer tubular members together as they all move as a unit; it is noted that the claim does not require that the inner tubular member and the outer tubular are longitudinally moved with respect to the proximal control device, and so moving the whole delivery device would move the inner and outer tubular member concurrently), wherein the proximal control device comprises a first portion (88/proximal segment of 56) comprising a first housing 88 comprising a handle, and a second portion comprising a second housing 72, the second portion being slidable with respect to the first portion (handles and the respective sheaths 56, 52 are slidable relative to one another; [0007], [0028], [0030]), wherein the inner tubular member 56 is secured to the first housing 88, and the outer tubular member 52 is secured to the second housing 72, wherein release of the coupling mechanism 74 permits the first portion to be decoupled from the second portion, wherein the coupling mechanism comprises a deflectable member (removable pin 74; Figure 3, [0030]) receivable within a groove 76 of a shaft portion (segment of 56) of the first portion of the proximal control device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patent claims with a proximal control device and coupling mechanism as claimed, as taught by Clerc, in order to facilitate selective handling and adjustable actuation of the first and second tubular members, respectively, by a user, and in order to prevent inadvertent or undesirable movement between the first and second tubular members, and to maintain position of an imaging device for visualization (Clerc, [0030]). It is noted that once the combination is made, the proximal control device will also be coupled to the one or more structures, since the elements are all coupled together within the same delivery device.
Claims 11, 12, 16, 18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-14 of U.S. Patent No. 11,771,575 in view of Clerc (U.S. Pub. No. 2012/0041534), as applied to claim 8 above, and further in view of Brenneman (U.S. Pat. No. 5,160,341).
Regarding claims 11, 12, 16, 18 and 20, the patent claims as modified teaches the claimed invention, as discussed above, except for features that are merely obvious.
In the same field of art, namely delivery devices for implants, Brenneman teaches in Figures 1, 7-10, col. 6, lines 28-35, one or more structures comprise: an elongate grasper member 28 configured to releasably couple with a proximal portion of implant 70; and a distal control member 26 configured to releasably couple with a distal portion of the implant, the distal control member comprises a retainer (slot 26) configured to releasably couple with the distal portion of the implant, wherein the implant comprises a distal engagement member (distal tip of implant 70) configured to releasably couple with the retainer (Id.), further comprising an elongate member 20 coupled with the retainer and having a proximal end (at 50) that is manipulatable by a user (via actuation lever 50) to permit release of the distal portion of the implant from the retainer (col. 6, line 61 to col. 7, line 19). A proximal control device (including pin 56 and slot 58; Figures 4 and 6; col. 5, lines 52-63) is configured to rotate and longitudinally move an inner tubular member 16 with respect to the distal control member 26 while the distal control member is releasably coupled with the distal portion of the implant 70. The distal control member comprises a recess (slot 26) adapted to receive the distal portion of the implant (Id.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patent claims as modified with the elongate grasper member, distal control member, and proximal control device as claimed, as taught by Brenneman, in order to securely attach the proximal and distal ends of the implant to the delivery device and to facilitate deployment of the implant.
Claims 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-14 of U.S. Patent No. 11,771,575 in view of Clerc (U.S. Pub. No. 2012/0041534), as applied to claim 33 above, and further in view of Ferrera (U.S. Pub. No. 2004/0193246).
Regarding claims 34-36, the patent claims as modified teaches the claimed invention, as discussed above, except for features that are merely obvious.
In Figure 5C and [0072]-[0074] Ferrera teaches multiple annular grooves (plurality of locking detents 44 can be “circumferential grooves”) that extend about a periphery of a shaft portion 46, the shaft portion is secured to an inner tubular member (hub 36 having a lock housing 43 that holds a locking pin 42), wherein a deflectable member (locking pin 42) is slidable within the groove (the pin can be withdrawn from or engage with the locking detents 44), such that the shaft portion is rotatable while the deflectable member is received within the groove (since the grooves are annular/circumferential shaft portion 46 would be capable of rotating).
It would have been obvious to one of ordinary skill before the effective filing date to modify the groove as claimed, as taught by Ferrera, in order to facilitate adjusting a proper orientation for deploying an implant (Id.).
Claims 37 and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-14 of U.S. Patent No. 11,771,575 in view of Clerc (U.S. Pub. No. 2012/0041534) in view of Clerc (U.S. Pub. No. 2012/0041534), as applied to claim 30 above, and further in view of Haggerty (U.S. Pub. No. 2017/0078583).
Regarding claims 37 and 39, although Clerc teaches in Figure 3, [0031], [0033] a second portion having a circuit board 80 (although shown in Figure 3 as being in handle 88¸ it may be located in different handles such as second portion 72 Id.), a passage of wires to supply power and video signals to and from an imaging device (cameras; Id., [0019]), the patent claims as modified does not teach the second portion comprises a flexible bus having a first end electrically connected to a printed circuit board within the second portion and a second end electrically connected to the imaging device, and a second flexible bus having a first end electrically connected to the printed circuit board within the second portion and a second end electrically connected to the illumination device. Clerc further teaches in Figure 3 and [0029] that an imaging device 60 on a distal end region of outer tubular member 52 can include illumination device 66 to illuminate and facilitate visualization of the body lumen.
In Figure 15 and [0194], [0307] Haggerty teaches a printed circuit board may communicate with components (imaging/camera and illumination/LEDs) at a distal end of a shaft through first and second flexible buses (one or more ribbon cables).
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims as modified with a printed circuit board and first and second flexible buses as claimed, as taught by Haggerty, in order to control or process image data and providing power to the illumination device (Haggerty; [0111]).
Claims 41-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-14 of U.S. Patent No. 11,771,575 in view of Clerc (U.S. Pub. No. 2012/0041534) and Brenneman (U.S. Pat. No. 5,160,341), as applied to claim 11 above, and further in view of Gunderson (U.S. Patent No. 5,776,142).
Regarding claims 41-42, the patent claims as modified teaches the claimed invention, as discussed above, including the proximal control device comprising a user actuator (handle in Brenneman; Figure 1), a first gear assembly coupled with the user actuator and configured to control longitudinal movement of the elongate grasper member (gear 46 is coupled with handle/actuation lever 50 to control elongate grasper member 28; col. 6, line 61 to col. 7, line 19), and a cam assembly configured to control longitudinal and rotational movement of inner tubular member 16 (including pin 56 and slot 58; Brenneman, Figures 4 and 6; col. 5, lines 52-63). However, Chao as modified
does not teach a second gear assembly coupled with the cam assembly, wherein the second gear assembly is configured to control rotation of the inner tubular member.
In col. 9, lines 11-17, Gunderson teaches controlling rotation and longitudinal movement can be achieved by first and second gear assemblies (devices incorporating a variety of elements including gears, rack and pinion, combinations of the above).
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims as modified with a second gear assembly to control rotation of the inner tubular member, as taught by Gunderson, since user actuators including multiple gear assemblies are old and well known in the art for transmission of forces to longitudinal and/or rotational movement with a mechanical advantage to a user. Once the combination is made, the second gear assembly would be coupled with the cam assembly as they are connected within the proximal control device.
Conclusion
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/DIANE D YABUT/Primary Examiner, Art Unit 3771