DETAILED ACTION
The following is a Final Office Action on the merits.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 4/6/2026.
Applicant’s amendments to the specification are sufficient to overcome the specification objections set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC 112(b)/second paragraph & 112(d)/fourth paragraph rejections set forth in the previous office action.
Terminal Disclaimer
The terminal disclaimer filed on 4/6/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent Nos. 9,498,246 & 9,814,481 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 45 is objected to because of the following informalities: amend “RF” to -radiofrequency (RF)- in ll. 14. Appropriate correction is required.
Claims 45, 46, 56 (twice) are objected to because of the following informalities: amend “at least one cutting element selected from the group consisting of the first extendable- retractable cutting element and the second extendable-retractable cutting element” to -at least one cutting element selected from the group of the first extendable- retractable cutting element and the second extendable-retractable cutting element- for proper Markush wording. Appropriate correction is required.
Claim 50 is objected to because of the following informalities: amend “at least one cutting element selected from the group consisting of the first energizable cutting element and the second energizable cutting element” to -at least one cutting element selected from the group of the first energizable cutting element and the second energizable cutting element- for proper Markush wording. Appropriate correction is required.
Claim 50 is objected to because of the following informalities: amend “extend” to -extends- in ll. 5. 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 45 & 48-52 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kadykowski et al. (2008/0208192, previously cited) in view of Chin (5,916,233, previously cited) and Rydell (5,891,141, previously cited).
Concerning claim 45, as illustrated in at least Figs. 1-4, Kadykowski et al. disclose a blood vessel harvesting system (endoscopic dissecting/harvesting device 2; [0020]), comprising:
an endoscopic cannula with a conical shape tip advanceable along an exterior surface of a blood vessel for separating the blood vessel from surrounding tissue (sheath 4 has a conical shaped tip; [0039]), wherein the endoscopic cannula includes a first extendable-retractable cutting element and a second extendable-retractable cutting element (capture tool 20 and sealing tool 30 are stored in a position that is in alignment within an annular space 6 defined by the sheath 4 and can be extended and retracted; [0035-0037], [0039]) that are:
(a) selectively maintainable in a retracted position in which respective distal ends of the first extendable-retractable cutting element and the second extendable-retractable cutting element are located proximally of a distal-most end of the conical tip (in the stored position, capture tool 20, comprising capture ring 24 and capture tube 22, and sealing tool 30, comprising sealing ring 34 and sealing tube 32, are in alignment within an annular space 6 defined by sheath 4 and located proximally of the tip; [0021]); and
(b) movable from the retracted position to an extended position which includes the respective distal ends of the first extendable-retractable cutting element and the second extendable-retractable cutting element being movable distally in a longitudinal direction toward the distal-most end of the conical tip (sealing tube 32 is manipulated distally and rotationally to extend the sealing ring 34 onto a far side of a vessel branch B that extends from the vessel and capture ring 24 and sealing ring 34, the sealing tube 32 is retracted in an axial direction, and then to continue, sealing ring 24 is moved to a further extended position toward the distal-most end of the conical tip; [0035-0037], [0039]);
an endoscope received in the endoscopic cannula, (endoscope 8 is located in sheath 4; [0020]); and
a source of bipolar energy activatable through the endoscopic cannula to energize at least part of first extendable-retractable cutting element and at least part of the second extendable-retractable cutting element so that, when a branch vessel that emanates from the blood vessel is positioned at least partly between the first extendable-retractable cutting element and the second extendable-retractable cutting element, the source of bipolar energy can be used to seal off the branch vessel (capture ring 24 can be a ground for the sealing ring 34 that uses a high frequency alternating voltage to cauterize the vessel; [0038]),
wherein at least one cutting element selected from the group of the first extendable-retractable cutting element and the second extendable-retractable cutting element is rotatable about a central longitudinal axis of the endoscopic cannula so that the first extendable-retractable cutting element and the second extendable-retractable cutting element can be moved relatively closer to one another in a circumferential manner about the central longitudinal axis (sealing tube 32 has a desired cross-sectional shape, such as, for example, round shown in FIG. 1, that allows the sealing tube 32 to be circumferentially rotated on-axis about a longitudinal axis A and off-axis about a central longitudinal axis of sheath 4 in a 360 degree manner with respect to capture tube 22 such that vessel V is substantially encircled or retained in inner open space 28 and inner open space 38 where capture ring 24 and sealing ring 34 are moved relatively closer to one another in a circumferential manner; [0027], [0030], [0032]).
Kadykowski et al. fail to disclose the conical tip to be a conical dissection tip and that includes a transparent portion through which the blood vessel can be viewed with the endoscope. However, Chin discloses a blood vessel harvesting system comprising an endoscopic cannula (9) with a conical dissection tip (13) that includes a transparent portion through which the blood vessel can be viewed with an endoscope (27) such that tissue may be dissected along the vessel of interest while being visualized through the transparent tapered tip. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Kadykowski et al. such that the conical tip is a conical dissection tip and that includes a transparent portion through which the blood vessel can be viewed with the endoscope in order to provide the benefit of dissecting tissue along the vessel of interest while being visualized through the transparent tapered tip as taught by Chin. (Col. 1-2, ll. 53-12 & Col. 2-3, ll. 40-28; Fig. 1)
Kadykowski et al. fail to disclose the bipolar energy to be RF bipolar energy. However, Rydell discloses a blood vessel harvesting system that uses RF energy to seal and cut a vessel. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Kadykowski et al. such that the bipolar energy is RF bipolar energy in order to provide the benefit of an energy sufficient to effect coagulation and sealing to the vessel as taught by Rydell. (Col. 4, ll. 37-53)
Concerning claim 48, Kadykowski et al. disclose in the extended position, the first extendable-retractable cutting element (20) and the second extendable-retractable cutting element (30) extend through an opening (6) in an exterior surface of the endoscopic cannula (4) ([0021]; Fig. 4).
Concerning claim 49, Kadykowski et al. disclose the first extendable-retractable cutting element (20) and the second extendable-retractable cutting element (30) are movable from the retracted position to the extended position to bring the respective distal ends (24, 34) of the first extendable-retractable cutting element (20) and the second extendable-retractable cutting element (30) out of the endoscopic cannula (4) by moving the respective distal ends through said opening (6) in the longitudinal direction (capture ring 24 and/or sealing ring 34 can be moved both longitudinally and rotationally between a retracted position (located within cannula 4 in a proximal position) and an extended position (located exterior to cannula 5 and in a more distal position) ([0021]; Fig. 3-4).
Concerning claim 50, as illustrated in at least Figs. 1-4, Kadykowski et al. disclose a blood vessel harvesting system (endoscopic dissecting/harvesting device 2; [0020]), comprising:
an endoscopic cannula with a conical shape tip advanceable along an exterior surface of a blood vessel for separating the blood vessel from surrounding tissue (sheath 4 has a conical shaped tip; [0039]), wherein the endoscopic cannula includes a first energizable cutting element and a second energizable cutting element (capture tool 20 and sealing tool 30 are stored in a position that is in alignment within an annular space 6 defined by the sheath 4 and can be extended and retracted and used in a bipolar manner; [0035-0039]),
an endoscope received in the endoscopic cannula, (endoscope 8 is located in sheath 4; [0020]); and
a source of bipolar RF energy activatable through the endoscopic cannula to energize the first energizable cutting element and the second energizable cutting element so that, when a branch vessel that emanates from the blood vessel is positioned at least partly between the first energizable cutting element and the second energizable cutting element, the source of bipolar RF energy can be used to seal off the branch vessel (capture tool 20 and the sealing tool 30 are operatively connected to a power supply 40 where at least one of the capture ring 24 and the sealing ring 24 acts as an electrode and is configured for being electrically energized to cauterize the branch B and/or the capture ring 24 can be a ground for the sealing ring 34 that uses a high frequency alternating voltage to cauterize the vessel. In yet other embodiments, the sealing tool 30 can be an ultrasonic cauterizing tool or a bipolar electrocautery tool; [0038]), wherein the first energizable cutting element and the second energizable cutting element are:
(a) selectively maintainable in a retracted position in which respective distal ends of the first energizable cutting element and the second energizable cutting element are located inside the endoscopic cannula proximally of a distal-most end of the conical dissection tip (in the stored position, capture tool 20, comprising capture ring 24 and capture tube 22, and sealing tool 30, comprising sealing ring 34 and sealing tube 32, are in alignment within an annular space 6 defined by sheath 4 and located proximally of the tip; [0021]); and
(b) movable from the retracted position to an extended position which includes the respective distal ends of the first energizable cutting element and the second energizable cutting element being movable to outside the endoscopic cannula by moving distally in the longitudinal direction toward the distal- most end of the conical dissection tip (sealing tube 32 is manipulated distally and rotationally to extend the sealing ring 34 onto a far side of a vessel branch B that extends from the vessel and capture ring 24 and sealing ring 34, the sealing tube 32 is retracted in an axial direction, and then to continue, capture ring 24 is moved to a further extended position toward the distal-most end of the conical tip and both sealing ring 34 and capture ring 24 are rotationally and longitudinally moved to outside the sheath 4 toward the distal-most end of the conical tip ; [0035-0037], [0039]);
wherein at least one cutting element selected from the group of the first energizable cutting element and the second energizable cutting element is rotatable about the central longitudinal axis of the endoscopic cannula so that the first energizable cutting element and the energizable cutting element can be moved relatively closer to one another in a circumferential manner about the central longitudinal axis (sealing tube 32 has a desired cross-sectional shape, such as, for example, round shown in FIG. 1, that allows the sealing tube 32 to be circumferentially rotated on-axis about a longitudinal axis A and off-axis about a central longitudinal axis of sheath 4 in a 360 degree manner with respect to capture tube 22 such that vessel V is substantially encircled or retained in inner open space 28 and inner open space 38 where capture ring 24 and sealing ring 34 are moved relatively closer to one another in a circumferential manner; [0027], [0030], [0032]).
Kadykowski et al. fail to disclose the conical tip to be a conical dissection tip and that includes a transparent portion through which the blood vessel can be viewed with the endoscope. However, Chin discloses a blood vessel harvesting system comprising an endoscopic cannula (9) with a conical dissection tip (13) that includes a transparent portion through which the blood vessel can be viewed with an endoscope (27) such that tissue may be dissected along the vessel of interest while being visualized through the transparent tapered tip. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Kadykowski et al. such that the conical tip is a conical dissection tip and that includes a transparent portion through which the blood vessel can be viewed with the endoscope in order to provide the benefit of dissecting tissue along the vessel of interest while being visualized through the transparent tapered tip as taught by Chin. (Col. 1-2, ll. 53-12 & Col. 2-3, ll. 40-28; Fig. 1)
Kadykowski et al. fail to disclose the bipolar energy to be RF bipolar energy. However, Rydell discloses a blood vessel harvesting system that uses RF energy to seal and cut a vessel. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Kadykowski et al. such that the bipolar energy is RF bipolar energy in order to provide the benefit of an energy sufficient to effect coagulation and sealing to the vessel as taught by Rydell. (Col. 4, ll. 37-53)
Concerning claim 51, Kadykowski et al. disclose one of the first extendable-retractable cutting element (20) or the second extendable-retractable cutting element (30) is rotatable off-axis about the central longitudinal axis of the endoscopic cannula (4) while another of the first extendable-retractable cutting element (20) or the second extendable-retractable cutting element (30) is able to remain in a rotationally stationary position about the central longitudinal axis so that the first extendable-retractable cutting element (20) and the second extendable-retractable cutting element (30) can be moved relatively closer to one another in a circumferential manner about the central longitudinal axis ([0021], [0023], [0026-0027], [0030], [0034]; Fig. 1-4).
Concerning claim 52, Kadykowski et al. disclose wherein, in the extended position, the first extendable-retractable cutting element (20) and the second extendable-retractable cutting element (30) extend parallel to one another along the conical dissection tip and remain extending parallel to one another in planes extending perpendicular to and along the conical dissection tip when moved relatively closer to one another in the circumferential manner about the central longitudinal axis of the endoscopic cannula (6) ([0021], [0023], [0026-0027], [0030], [0034]; Fig. 1-4).
Claim 46 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kadykowski et al. (2008/0208192, previously cited) in view of Chin (5,916,233, previously cited) and Rydell (5,891,141, previously cited), as applied to claim 45, in further view of Bennett et al. (6,019,771, previously cited).
Concerning claim 46, Kadykowski et al. in view of Chin and Rydell disclose at least one of the first extendable-retractable cutting element and the second extendable-retractable cutting element is usable to mechanically cut through a sealed-off portion of the branch vessel. However, Bennet discloses system comprising first and second energized cutting elements (4, 5) that are used to also mechanically cut through tissue. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Kadykowski et al. in view of Chin and Rydell such that at least one of the first extendable-retractable cutting element and the second extendable-retractable cutting element is usable to mechanically cut through a sealed-off portion of the branch vessel in order to provide the benefit of forming functional scissors and enhancing the vessel severing function taught by Bennett et al. (Col. 4-5, ll. 65-51; Fig. 1)
Claim 53 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kadykowski et al. (2008/0208192, previously cited) in view of Chin (5,916,233, previously cited) and Rydell (5,891,141, previously cited), as applied to claim 45, in further view of Puskas (6,042,538, previously cited).
Concerning claim 53, Chin further disclose the conical dissection tip (31) includes an internal apex and an external apex, the external apex proximate the distal-most end of the conical dissection tip (31), the internal apex and the external apex being co-linear with a central longitudinal axis of the conical dissection tip (31) (Col. 3, ll. 3-28; Fig. 2A). Kadykowski et al. in view of Chin and Rydell fail to disclose the external apex to be indented. However, Puskas discloses a method for vessel harvesting comprising using a surgical device comprising a dissection tip (5) having an indented external apex (20). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Chin such that the external apex is indented in order to provide the benefit of accommodating curvature of the tissue as taught by Puskas (Col. 4, II. 49-55; Fig. 7).
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.
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Claims 45 & 54-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of copending Application No. 18/631669 (reference application) in view of Chin (5,916,233). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a blood vessel harvesting system (blood vessel harvesting system), comprising: an endoscopic cannula with a conical dissection tip advanceable along an exterior surface of a blood vessel for separating the blood vessel from surrounding tissue, wherein the endoscopic cannula includes a first extendable-retractable cutting element and a second extendable- retractable cutting element (an endoscopic cannula with a conical dissection tip advanceable along an exterior surface of a blood vessel for separating the blood vessel from surrounding tissue, wherein the endoscopic cannula includes a first extendable-retractable cutting element and a second extendable- retractable cutting element) that are: (a) selectively maintainable in a retracted position in which respective distal ends of the first extendable-retractable cutting element and the second extendable-retractable cutting element are located proximally of a distal-most end of the conical dissection tip ((a) selectively maintainable in a retracted position in which respective distal ends of the first extendable-retractable cutting element and the second extendable-retractable cutting element are located proximally of a distal-most end of the conical dissection tip); and (b) movable from the retracted position to an extended position which includes the respective distal ends of the first extendable-retractable cutting element and the second extendable-retractable cutting element distally in a longitudinal direction from the retracted position toward the distal-most end of the conical dissection tip ((b) movable from the retracted position to an extended position by moving the respective distal ends of the first extendable-retractable cutting element and the second extendable-retractable cutting element being movable distally in a longitudinal direction toward the distal-most end of the conical dissection tip); and a source of bipolar RF energy activatable through the endoscopic cannula to energize at least part of first extendable-retractable cutting element and at least part of the second extendable-retractable cutting element so that, when a branch vessel that emanates from the blood vessel is positioned at least partly between the first extendable-retractable cutting element and the second extendable-retractable cutting element, the source of bipolar RF energy can be used to seal off the branch vessel (a source of bipolar RF energy activatable through the endoscopic cannula to energize at least part of first extendable-retractable cutting element and at least part of the second extendable-retractable cutting element so that, when a branch vessel that emanates from the blood vessel is positioned at least partly between the first extendable-retractable cutting element and the second extendable-retractable cutting element, the source of bipolar RF energy can be used to seal off the branch vessel), wherein at least one cutting element selected from the group of the first extendable-retractable cutting element and the second extendable-retractable cutting element is rotatable about a central longitudinal axis of the endoscopic cannula so that the first extendable-retractable cutting element and the second extendable-retractable cutting element can be moved relatively closer to one another in a circumferential manner about the central longitudinal axis (wherein at least one of the first extendable-retractable cutting element and the second extendable-retractable cutting element is rotatable about a longitudinal axis of the endoscopic cannula so that the first extendable- retractable cutting element and the second extendable-retractable cutting element can be moved relatively closer to one another in a circumferential manner about the longitudinal axis). The co-pending application fails to disclose an endoscope received in the endoscopic cannula, wherein the conical dissection tip includes a transparent portion through which the blood vessel can be viewed with the endoscope. However, Chin discloses a blood vessel harvesting system comprising an endoscopic cannula (9) with a conical dissection tip (13) that includes a transparent portion through which the blood vessel can be viewed with an endoscope (27) such that tissue may be dissected along the vessel of interest while being visualized through the transparent tapered tip. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of the co-pending application such that the conical tip is a conical dissection tip and that includes a transparent portion through which the blood vessel can be viewed with the endoscope in order to provide the benefit of dissecting tissue along the vessel of interest while being visualized through the transparent tapered tip as taught by Chin. (Col. 1-2, ll. 53-12 & Col. 2-3, ll. 40-28; Fig. 1)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 56-69 are allowed.
Claim 47 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination teach: “wherein the respective distal ends of the first extendable-retractable cutting element and the second extendable-retractable cutting element are movable distally beyond the distal-most end of the conical dissection tip “ (claim 47) and “wherein the first longitudinal cutting element and the second longitudinal cutting element are movable distally in a longitudinal direction along the cannula from a retracted position to an extended position, wherein, in the extended position, respective distal ends of the first longitudinal cutting element and the second longitudinal cutting element are positioned distally beyond a distal-most end of the conical dissection tip” (claim 56) in combination with the other limitations.
Response to Arguments
Applicant's arguments filed 4/6/2026 have been fully considered but they are not persuasive.
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the tools rotate on-axis with respect to the central longitudinal axis of the sheath) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner notes that the rings of Kadykowski rotate with respect to longitudinal axis A which is parallel to the central longitudinal axis of the sheath, and thus the rings also rotate off-axis about the central longitudinal axis of the sheath.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794