DETAILED ACTION
The following is a First Action, Non-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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 & 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 16/185215, 15/287084, 14/190873 provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Application No. 61/782034 fail to provide support for “a flexible sleeve”.
Application No. 61/833814 provides support for “a small silicone sleeve, or transition, may be used, as shown in FIG. 9A, to protect tissue from damage during dissection by smoothing the geometry between the dissection tip 120 and the outer sheath outer diameter.” Application No. 61/833814 fails to provide support for claim 25 a lubricious substance”.
Accordingly, claims 16-24 & 26-35 are given the priority date of 6/11/2013.
Specification
The disclosure is objected to because of the following informalities: updated the first paragraph with appropriate patent information.
Appropriate correction is required.
Claim Objections
Claim 16 is objected to because of the following informalities: amend “RF” to -radio frequency (RF)- in the first line of the last paragraph. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: amend “and the second” to -or the second- in ll. 2. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: amend “at least part of first” to -at least part of the first- in ll. 2. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 18, 20-24, 26-29, 31-32 & 34-35 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Chin (6,951,568).
Concerning claim 18, as illustrated in at least Figs. 1-3B, Chin ‘568 discloses a blood vessel harvesting system (endoscopic cannula 100; Col. 3, ll. 34-42), comprising:
a cannula with a dissection tip advanceable along an exterior surface of a blood vessel for separating the blood vessel from surrounding tissue (cannula 100 comprises an endoscopic dissection shaft 112 that extends out of a main body 128 of the cannula 100 for a length sufficient to allow the endoscopic dissection shaft 112 to be used for dissection and retraction without engaging tissue with the main body 128 of the cannula 100; Col. 3, ll. 34-42), wherein the cannula includes a first extendable-retractable cutting element and a second extendable-retractable cutting element that are movable back and forth in a longitudinal direction along the cannula between a retracted position and an extended position (flexible endoscopic scissors 156 are housed in the working lumen 120 and can be extended out of the working lumen 120; Col. 4, ll. 38-60);
a sleeve located proximally of the distal-most end of the dissection tip (flexible, preferably elastic, hood 116 extends from the distal end of the working lumen 120 to the proximal edge of the transparent tapered tip 104; Col. 5, ll. 28-53), wherein, in the extended position, the first extendable-retractable cutting element and the second extendable- retractable cutting element extend through a distal end of the sleeve (hood 116 expands or otherwise displaces to allow a surgical tool 156 to be extended from the working lumen 120, and collapses against the surface of the cannula 100 upon retraction of the surgical tool 156; Col. 5, ll. 28-64).
Concerning claim 20, Chin ‘568 discloses the distal end of the sleeve (116) is positioned over an outer surface of the dissection tip (104) (Fig. 2A-3B).
Concerning claim 21, Chin ‘568 discloses the distal end of the sleeve (116) conforms to an outer surface of the dissection tip (104) when the first and second extendable-retractable cutting elements (156) are in the retracted position (Col. 5, ll. 28-64; Fig. 2A & 3A).
Concerning claim 22, Chin ‘568 discloses the distal end of the sleeve (116) is not directly attached to the dissection tip (104) (Col. 5, ll. 28-64; Fig. 2A-3B).
Concerning claim 23, Chin ‘568 discloses wherein, in the extended position, the first and second extendable-retractable cutting elements (156) cause the distal end of the sleeve (116) to deflect (Col. 5, ll. 28-64; Fig. 2A-3B).
Concerning claim 24, Chin ‘568 discloses the distal end of the sleeve (116) is flexible (Col. 5, ll. 28-64; Fig. 2A-3B).
Concerning claim 26, Chin ‘568 discloses in the retracted position, respective distal ends of the first and second extendable-retractable cutting elements (156) are located proximally of a distal-most end of the dissection tip (104) (Col. 4, ll. 38-60; Fig. 2A & 3A).
Concerning claim 27, Chin ‘568 discloses the first and second extendable-retractable cutting elements (156) are movable from the retracted position to the extended position to bring the respective distal ends of the first and second extendable-retractable cutting elements (156) closer to the distal-most end of the dissection tip (104) (Col. 4, ll. 38-60; Fig. 2A-3B).
Concerning claim 28, Chin ‘568 discloses the first and second extendable-retractable cutting elements (156) are movable from the retracted position to the extended position to bring the respective distal ends of the first and second extendable-retractable cutting elements (156) out of the sleeve (116) through the distal end of the sleeve (116) (Col. 5, ll. 28-64; Fig. 2A-3B).
Concerning claim 29, as illustrated in at least Figs. 1-3B, Chin ‘568 discloses a blood vessel harvesting system (endoscopic cannula 100; Col. 3, ll. 34-42), comprising:
a cannula with a dissection tip advanceable along an exterior surface of a blood vessel for separating the blood vessel from surrounding tissue (cannula 100 comprises an endoscopic dissection shaft 112 that extends out of a main body 128 of the cannula 100 for a length sufficient to allow the endoscopic dissection shaft 112 to be used for dissection and retraction without engaging tissue with the main body 128 of the cannula 100; Col. 3, ll. 34-42), wherein the cannula includes a first extendable-retractable cutting element and a second extendable-retractable cutting element that are movable back and forth in a longitudinal direction along the cannula between a retracted position and an extended position (flexible endoscopic scissors 156 are housed in the working lumen 120 and can be extended out of the working lumen 120; Col. 4, ll. 38-60); and
a sleeve located proximally of the distal-most end of the dissection tip (flexible, preferably elastic, hood 116 extends from the distal end of the working lumen 120 to the proximal edge of the transparent tapered tip 104; Col. 5, ll. 28-53),
wherein, in the retracted position, the respective distal ends of the first extendable- retractable cutting element and the second extendable-retractable cutting element are positioned proximally of a distal end of the sleeve, wherein, in the extended position, the respective distal ends of the first extendable- retractable cutting element and the second extendable-retractable cutting element are positioned distally of the distal end of the sleeve, wherein the distal end of the sleeve is positioned over the dissection tip but not directly attached to the dissection tip to allow the respective distal ends of the first extendable-retractable cutting element and a second extendable-retractable cutting element to enter and exit the sleeve by passing between an outer surface of the dissection tip and an inner surface of the sleeve at the distal end of the sleeve (hood 116 expands or otherwise displaces to allow a surgical tool 156 to be extended from the working lumen 120, and collapses against the surface of the cannula 100 upon retraction of the surgical tool 156, where the tool 156 passes between an outer surface of the tip 104 and inner top surface of hood 116 when extended; Col. 5, ll. 28-64).
Concerning claim 31, Chin ‘568 discloses an endoscope (132) received in the endoscopic cannula (100), wherein the dissection tip (104) includes a transparent portion through which the blood vessel can be viewed with the endoscope (132) (Col. 3, ll. 34-42, Col. 4, ll. 8-37; Fig. 1).
Claim 32 is rejected upon the same rationale as applied to claim 21.
Claim 34 is rejected upon the same rationale as applied to claim 23.
Claim 35 is rejected upon the same rationale as applied to claim 24.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 19 & 30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chin (6,951,568), as applied to claims 18 & 29, in further view of Stewart et al. (2009/0023986).
Concerning claims 19 & 30¸Chin ‘568 discloses a source of bipolar energy activatable through the cannula to energize at least part of the first and second extendable-retractable cutting elements (156) so that, when a branch vessel that emanates from the blood vessel is positioned at least partly between the first and second extendable-retractable cutting elements (156), the source of bipolar energy can be used to seal off the branch vessel (Col. 5-6, ll. 65-39). Chin ‘568 fails to disclose the source of bipolar energy to be a RF source. However, Stewart et al. discloses a blood vessel harvesting system comprising first and second extendable-retractable cutting elements that apply bipolar RF energy. 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 ‘568 such that the source of bipolar energy is a RF source in order to provide the benefit of providing the predictable result of cauterizing tissue as taught by Stewart et al. ([0008]).
Claims 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chin (5,916,233) in view of Silverstein et al. (5,025,778) and Weadock et al. (6,527,771).
Concerning claim 16, as illustrated in at least Figs. 1-4B, Chin ‘233 discloses a blood vessel harvesting system (vessel harvesting apparatus; Col. 1, ll. 12-17), 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 (cannula 9 having a transparent tapered conical tip 13 is used to probe both anterior and posterior surfaces of the vessel and its side branches, and to separate the vessel from adjoining connective tissue; Col. 2-3, ll. 40-2, Col. 4-5, ll. 59-13), 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; and (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 distally in a longitudinal direction from the retracted position toward the distal-most end of the conical dissection tip (cauterizing shears, as an alternative to electrode 17, having first and second cutting elements may be used to cut and cauterize the side branch vessel 37 from the vessel of interest 33 and longitudinally extend out of access port 35; Col. 3-4, ll. 29-8); and
a source of 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 energy can be used to seal off the branch vessel (electrode 17/cauterizing shears is/are connected to a power supply 18 for selectively applying high-voltage signal to the electrode to electrocauterize side branch vessel 37; Col. 3-4, ll. 29-45);
a flexible seal located proximally of the distal-most end of the conical dissection tip (sliding seal may be incorporated in each lumen; Col. 4, ll. 9-45),
Chin ‘233 fails to disclose the flexible seal comprising a flexible sleeve, wherein, in the retracted position, the respective distal ends of the first and second extendable-retractable cutting elements are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the conical dissection tip by conforming to an outer surface of the conical dissection tip, and wherein, in the extended position, the respective distal ends of the first and second extendable-retractable cutting elements are positioned distally of the distal end of the flexible sleeve with the distal end of the flexible sleeve deflecting from said circumferential seal to permit passage of the respective distal ends of the first and second extendable-retractable cutting elements out of the flexible sleeve between the outer surface of the conical dissection tip and an inner surface of the flexible sleeve. However, Silverstein et al. disclose a system comprising a flexible sleeve (54) located circumferentially around a multi-lumen shaft (34) having an endoscope viewing window (46), wherein, in the retracted position, the respective distal ends of extendable-retractable elements (accessories are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the multi-lumen shaft (34) by conforming to an outer surface of the multi-lumen shaft (34), and wherein, in the extended position, the respective distal ends of the extendable-retractable elements (accessories) are positioned distally of the distal end of the flexible sleeve (54) with the flexible sleeve (54) deflecting from said circumferential seal to permit passage of the respective distal ends of the extendable-retractable elements (accessories) and out of the flexible sleeve (54) between the outer surface of the multi-lumen shaft (34) and an inner surface of the flexible sleeve (54). 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 ‘233 such that the flexible seal comprises a flexible sleeve, wherein, in the retracted position, the respective distal ends of the first and second extendable-retractable cutting elements are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the conical dissection tip by conforming to an outer surface of the conical dissection tip, and wherein, in the extended position, the respective distal ends of the first and second extendable-retractable cutting elements are positioned distally of the distal end of the flexible sleeve with the distal end of the flexible sleeve deflecting from said circumferential seal to permit passage of the respective distal ends of the first and second extendable-retractable cutting elements out of the flexible sleeve between the outer surface of the conical dissection tip and an inner surface of the flexible sleeve since Silverstein et al teaches the circumferential flexible seal to be an equivalent in the art for the purposes of preventing matter from passing from outside the lumen to inside the lumen. (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19)
Chin ‘233 in view of Silverstein et al. fail to specifically teach the sleeve located proximally of the distal-most end of the conical dissection tip. It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the invention of Chin’233 in view of Silverstein et al. such that the sleeve is located proximally of the distal-most end of the conical dissection tip in order to provide the benefit of visual access to the treatment site and, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Chin ‘233 in view of Silverstein et al. to disclose the source of energy to be a source of bipolar RF energy. However, Weadock et al. disclose a blood vessel harvesting system comprising first and second vessel harvesting elements (110, 122) connected to either a monopolar or a bipolar RF source of energy. 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 ‘233 in view of Silverstein et al. such that the source of energy is a source of bipolar RF energy since Weadock et al. teach bipolar and monopolar sources of energy to be equivalents in the art for the predictable result of vessel cauterization as taught by Weadock et al. (Col. 6, ll. 34-58; Fig. 1-3)
Claim 29 & 33 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chin (5,916,233) in view of Silverstein et al. (5,025,778)
Concerning claim 29, as illustrated in at least Figs. 1-4B, Chin ‘233 discloses a blood vessel harvesting system (vessel harvesting apparatus; Col. 1, ll. 12-17), comprising:
a cannula with a dissection tip advanceable along an exterior surface of a blood vessel for separating the blood vessel from surrounding tissue (cannula 9 having a transparent tapered conical tip 13 is used to probe both anterior and posterior surfaces of the vessel and its side branches, and to separate the vessel from adjoining connective tissue; Col. 2-3, ll. 40-2, Col. 4-5, ll. 59-13), wherein the cannula includes a first extendable-retractable cutting element and a second extendable-retractable cutting element that are movable back and forth in a longitudinal direction along the cannula between a retracted position and an extended position (cauterizing shears, as an alternative to electrode 17, having first and second cutting elements may be used to cut and cauterize the side branch vessel 37 from the vessel of interest 33 and longitudinally extend out of access port 35; Col. 3-4, ll. 29-8).
Chin ‘233 fails to disclose a sleeve, wherein, in the retracted position, the respective distal ends of the first extendable- retractable cutting element and the second extendable-retractable cutting element are positioned proximally of a distal end of the sleeve, wherein, in the extended position, the respective distal ends of the first extendable- retractable cutting element and the second extendable-retractable cutting element are positioned distally of the distal end of the sleeve, wherein the distal end of the sleeve is positioned over the dissection tip but not directly attached to the dissection tip to allow the respective distal ends of the first extendable-retractable cutting element and a second extendable-retractable cutting element to enter and exit the sleeve by passing between an outer surface of the dissection tip and an inner surface of the sleeve at the distal end of the sleeve. However, Silverstein et al. disclose a system comprising a flexible sleeve (54), wherein, in the retracted position, the respective distal ends of the extendable- retractable elements (accessories) are positioned proximally of a distal end of the sleeve (54), wherein, in the extended position, the respective distal ends of the extendable-retractable elements (accessories) are positioned distally of the distal end of the sleeve (54), wherein the distal end of the sleeve (54) is located circumferentially around a multi-lumen shaft (34) having an endoscope viewing window (46) but not directly attached to the multi-lumen shaft (34) to allow the respective distal ends of the extendable-retractable elements (accessories) to enter and exit the sleeve (54) by passing between an outer surface of the multi-lumen shaft (34) and an inner surface of the sleeve (54) at the distal end of the sleeve (54). 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 ‘233 to further comprise a flexible sleeve located proximally of the distal-most end of the conical dissection tip, wherein, in the retracted position, the respective distal ends of the first and second extendable-retractable cutting elements are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the conical dissection tip by conforming to an outer surface of the conical dissection tip, and wherein, in the extended position, the respective distal ends of the first and second extendable-retractable cutting elements are positioned distally of the distal end of the flexible sleeve with the distal end of the flexible sleeve deflecting from said circumferential seal to permit passage of the respective distal ends of the first and second extendable-retractable cutting elements out of the flexible sleeve between the outer surface of the conical dissection tip and an inner surface of the flexible sleeve since Silverstein et al teaches the circumferential flexible seal to be an equivalent in the art for the purposes of preventing matter from passing from outside the lumen to inside the lumen. (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19)
Chin ‘233 in view of Silverstein et al. fail to specifically teach the sleeve located proximally of the distal-most end of the dissection tip. It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the invention of Chin’233 in view of Silverstein et al. such that the sleeve is located proximally of the distal-most end of the dissection tip in order to provide the benefit of visual access to the treatment site and, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Concerning claim 33, Silverstein et al. further disclose the distal end of the sleeve (54) forms a seal with the outer surface of the multi-lumen shaft (34) when the first and second extendable-retractable elements are in the retracted position (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19).
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 16-24, 26-30 & 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,498,246 in view Silverstein et al. (5,025,778). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a blood harvesting system comprising an endoscopic cannula with a conical dissection tip and first and second extendable-retractable cutting elements and a source of bipolar RF energy to energize the cutting elements. The patent fails to disclose the limitations regarding the sleeve/flexible sleeve. However, Silverstein et al. disclose a system comprising a flexible sleeve (54) located circumferentially around a multi-lumen shaft (34) having an endoscope viewing window (46), wherein, in the retracted position, the respective distal ends of extendable-retractable elements (accessories are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the multi-lumen shaft (34) by conforming to an outer surface of the multi-lumen shaft (34), and wherein, in the extended position, the respective distal ends of the extendable-retractable elements (accessories) are positioned distally of the distal end of the flexible sleeve (54) with the flexible sleeve (54) deflecting from said circumferential seal to permit passage of the respective distal ends of the extendable-retractable elements (accessories) and out of the flexible sleeve (54) between the outer surface of the multi-lumen shaft (34) and an inner surface of the flexible sleeve (54). 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 patent to further comprise the limitations of the sleeve in order to provide the benefit of preventing matter from passing from outside the lumen to inside the lumen. (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19)
Claims 16-24, 26-30 & 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,814,481 in view Silverstein et al. (5,025,778). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a blood harvesting system comprising an endoscopic cannula with a conical dissection tip and first and second extendable-retractable cutting elements and a source of bipolar RF energy to energize the cutting elements.. The patent fails to disclose the limitations regarding the sleeve/flexible sleeve. However, Silverstein et al. disclose a system comprising a flexible sleeve (54) located circumferentially around a multi-lumen shaft (34) having an endoscope viewing window (46), wherein, in the retracted position, the respective distal ends of extendable-retractable elements (accessories are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the multi-lumen shaft (34) by conforming to an outer surface of the multi-lumen shaft (34), and wherein, in the extended position, the respective distal ends of the extendable-retractable elements (accessories) are positioned distally of the distal end of the flexible sleeve (54) with the flexible sleeve (54) deflecting from said circumferential seal to permit passage of the respective distal ends of the extendable-retractable elements (accessories) and out of the flexible sleeve (54) between the outer surface of the multi-lumen shaft (34) and an inner surface of the flexible sleeve (54). 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 patent to further comprise the limitations of the sleeve in order to provide the benefit of preventing matter from passing from outside the lumen to inside the lumen. (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19)
Claims 18-24, 26-30 & 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,943,328 in view Silverstein et al. (5,025,778). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a blood harvesting system comprising an endoscopic cannula with a conical dissection tip and first and second extendable-retractable cutting elements. The patent fails to disclose the limitations regarding the sleeve/flexible sleeve. However, Silverstein et al. disclose a system comprising a flexible sleeve (54) located circumferentially around a multi-lumen shaft (34) having an endoscope viewing window (46), wherein, in the retracted position, the respective distal ends of extendable-retractable elements (accessories are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the multi-lumen shaft (34) by conforming to an outer surface of the multi-lumen shaft (34), and wherein, in the extended position, the respective distal ends of the extendable-retractable elements (accessories) are positioned distally of the distal end of the flexible sleeve (54) with the flexible sleeve (54) deflecting from said circumferential seal to permit passage of the respective distal ends of the extendable-retractable elements (accessories) and out of the flexible sleeve (54) between the outer surface of the multi-lumen shaft (34) and an inner surface of the flexible sleeve (54). 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 patent to further comprise the limitations of the sleeve in order to provide the benefit of preventing matter from passing from outside the lumen to inside the lumen. (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19)
Claims 18-24, 26-30 & 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,363,056 in view Silverstein et al. (5,025,778). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a blood harvesting system comprising an endoscopic cannula with a conical dissection tip and first and second extendable-retractable cutting elements. The patent fails to disclose the limitations regarding the sleeve/flexible sleeve. However, Silverstein et al. disclose a system comprising a flexible sleeve (54) located circumferentially around a multi-lumen shaft (34) having an endoscope viewing window (46), wherein, in the retracted position, the respective distal ends of extendable-retractable elements (accessories are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the multi-lumen shaft (34) by conforming to an outer surface of the multi-lumen shaft (34), and wherein, in the extended position, the respective distal ends of the extendable-retractable elements (accessories) are positioned distally of the distal end of the flexible sleeve (54) with the flexible sleeve (54) deflecting from said circumferential seal to permit passage of the respective distal ends of the extendable-retractable elements (accessories) and out of the flexible sleeve (54) between the outer surface of the multi-lumen shaft (34) and an inner surface of the flexible sleeve (54). 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 patent to further comprise the limitations of the sleeve in order to provide the benefit of preventing matter from passing from outside the lumen to inside the lumen. (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19)
Claims 18-24, 26-30 & 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,537,353 in view Silverstein et al. (5,025,778). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a blood harvesting system comprising an endoscopic cannula with a conical dissection tip and first and second extendable-retractable cutting elements. The patent fails to disclose the limitations regarding the sleeve/flexible sleeve. However, Silverstein et al. disclose a system comprising a flexible sleeve (54) located circumferentially around a multi-lumen shaft (34) having an endoscope viewing window (46), wherein, in the retracted position, the respective distal ends of extendable-retractable elements (accessories are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the multi-lumen shaft (34) by conforming to an outer surface of the multi-lumen shaft (34), and wherein, in the extended position, the respective distal ends of the extendable-retractable elements (accessories) are positioned distally of the distal end of the flexible sleeve (54) with the flexible sleeve (54) deflecting from said circumferential seal to permit passage of the respective distal ends of the extendable-retractable elements (accessories) and out of the flexible sleeve (54) between the outer surface of the multi-lumen shaft (34) and an inner surface of the flexible sleeve (54). 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 patent to further comprise the limitations of the sleeve in order to provide the benefit of preventing matter from passing from outside the lumen to inside the lumen. (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19)
Claims 18-24, 26-30 & 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,874,415 in view Silverstein et al. (5,025,778). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a blood harvesting system comprising an endoscopic cannula with a conical dissection tip and first and second extendable-retractable cutting elements. The patent fails to disclose the limitations regarding the sleeve/flexible sleeve. However, Silverstein et al. disclose a system comprising a flexible sleeve (54) located circumferentially around a multi-lumen shaft (34) having an endoscope viewing window (46), wherein, in the retracted position, the respective distal ends of extendable-retractable elements (accessories are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the multi-lumen shaft (34) by conforming to an outer surface of the multi-lumen shaft (34), and wherein, in the extended position, the respective distal ends of the extendable-retractable elements (accessories) are positioned distally of the distal end of the flexible sleeve (54) with the flexible sleeve (54) deflecting from said circumferential seal to permit passage of the respective distal ends of the extendable-retractable elements (accessories) and out of the flexible sleeve (54) between the outer surface of the multi-lumen shaft (34) and an inner surface of the flexible sleeve (54). 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 patent to further comprise the limitations of the sleeve in order to provide the benefit of preventing matter from passing from outside the lumen to inside the lumen. (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19)
Claims 18-24, 26-30 & 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,751,896 in view Silverstein et al. (5,025,778). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a blood harvesting system comprising an endoscopic cannula with a conical dissection tip and first and second extendable-retractable cutting elements. The patent fails to disclose the limitations regarding the sleeve/flexible sleeve. However, Silverstein et al. disclose a system comprising a flexible sleeve (54) located circumferentially around a multi-lumen shaft (34) having an endoscope viewing window (46), wherein, in the retracted position, the respective distal ends of extendable-retractable elements (accessories are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the multi-lumen shaft (34) by conforming to an outer surface of the multi-lumen shaft (34), and wherein, in the extended position, the respective distal ends of the extendable-retractable elements (accessories) are positioned distally of the distal end of the flexible sleeve (54) with the flexible sleeve (54) deflecting from said circumferential seal to permit passage of the respective distal ends of the extendable-retractable elements (accessories) and out of the flexible sleeve (54) between the outer surface of the multi-lumen shaft (34) and an inner surface of the flexible sleeve (54). 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 patent to further comprise the limitations of the sleeve in order to provide the benefit of preventing matter from passing from outside the lumen to inside the lumen. (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19)
Claims 16-24, 26-30 & 32-35 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12,064,134 in view Silverstein et al. (5,025,778). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a blood harvesting system comprising an endoscopic cannula with a conical dissection tip and first and second extendable-retractable cutting elements and a source of bipolar RF energy to energize the cutting elements.. The patent fails to disclose the limitations regarding the sleeve/flexible sleeve. However, Silverstein et al. disclose a system comprising a flexible sleeve (54) located circumferentially around a multi-lumen shaft (34) having an endoscope viewing window (46), wherein, in the retracted position, the respective distal ends of extendable-retractable elements (accessories are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the multi-lumen shaft (34) by conforming to an outer surface of the multi-lumen shaft (34), and wherein, in the extended position, the respective distal ends of the extendable-retractable elements (accessories) are positioned distally of the distal end of the flexible sleeve (54) with the flexible sleeve (54) deflecting from said circumferential seal to permit passage of the respective distal ends of the extendable-retractable elements (accessories) and out of the flexible sleeve (54) between the outer surface of the multi-lumen shaft (34) and an inner surface of the flexible sleeve (54). 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 patent to further comprise the limitations of the sleeve in order to provide the benefit of preventing matter from passing from outside the lumen to inside the lumen. (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19)
Claims 18-24 & 26-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,539,163 in view Silverstein et al. (5,025,778). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a blood harvesting system comprising an endoscopic cannula with a conical dissection tip and first and second extendable-retractable cutting elements. The patent fails to disclose the limitations regarding the sleeve/flexible sleeve. However, Silverstein et al. disclose a system comprising a flexible sleeve (54) located circumferentially around a multi-lumen shaft (34) having an endoscope viewing window (46), wherein, in the retracted position, the respective distal ends of extendable-retractable elements (accessories are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the multi-lumen shaft (34) by conforming to an outer surface of the multi-lumen shaft (34), and wherein, in the extended position, the respective distal ends of the extendable-retractable elements (accessories) are positioned distally of the distal end of the flexible sleeve (54) with the flexible sleeve (54) deflecting from said circumferential seal to permit passage of the respective distal ends of the extendable-retractable elements (accessories) and out of the flexible sleeve (54) between the outer surface of the multi-lumen shaft (34) and an inner surface of the flexible sleeve (54). 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 patent to further comprise the limitations of the sleeve in order to provide the benefit of preventing matter from passing from outside the lumen to inside the lumen. (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19)
Claims 16-24 & 26-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55 & 68 of copending Application No. 18/448554 (reference application). 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 (a 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 by moving 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 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); a flexible sleeve located proximally of the distal-most end of the conical dissection tip (a flexible sleeve located proximally of the distal-most end of the dissection tip), wherein, in the retracted position, the respective distal ends of the first extendable-retractable cutting element and the second extendable-retractable cutting element are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the conical dissection tip by conforming to an outer surface of the conical dissection tip, and wherein, in the extended position, the respective distal ends of the first extendable-retractable cutting element and the second extendable-retractable cutting element are positioned distally of the distal end of the flexible sleeve with the distal end of the flexible sleeve deflecting from said circumferential seal to permit passage of the respective distal ends of the first extendable-retractable cutting element and the second extendable-retractable cutting element out of the flexible sleeve between the outer surface of the conical dissection tip and an inner surface of the flexible sleeve (wherein, in the retracted position, the respective distal ends of the first extendable-retractable cutting element and the second extendable-retractable cutting element are positioned proximally of the distal end of the flexible sleeve, and wherein, in the extended position, the respective distal ends of the first extendable-retractable cutting element and the second extendable-retractable cutting element are positioned distally of the distal end of the flexible sleeve // or // wherein, in the extended position, the first longitudinal cutting element and the second longitudinal cutting element extend through a distal end of the flexible sleeve, wherein, in the retracted position, respective distal ends of the first longitudinal cutting element and the second longitudinal cutting element are positioned proximally of the distal end of the flexible sleeve, wherein, in the extended position, the respective distal ends of the first longitudinal cutting element and the second longitudinal cutting element are positioned distally of the distal end of the flexible sleeve with the distal end of the flexible sleeve deflecting to permit passage of the respective distal ends of the first longitudinal cutting element and the second longitudinal cutting element out of the flexible sleeve between the outer surface of the conical dissection tip and an inner surface of the flexible sleeve); 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 vessels).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 16-24, 26-30 & 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-40 of copending Application No. 19/023097 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a blood harvesting system comprising an endoscopic cannula with a conical dissection tip and first and second extendable-retractable cutting elements and a source of bipolar RF energy to energize the cutting elements.. The patent fails to disclose the limitations regarding the sleeve/flexible sleeve. However, Silverstein et al. disclose a system comprising a flexible sleeve (54) located circumferentially around a multi-lumen shaft (34) having an endoscope viewing window (46), wherein, in the retracted position, the respective distal ends of extendable-retractable elements (accessories are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the multi-lumen shaft (34) by conforming to an outer surface of the multi-lumen shaft (34), and wherein, in the extended position, the respective distal ends of the extendable-retractable elements (accessories) are positioned distally of the distal end of the flexible sleeve (54) with the flexible sleeve (54) deflecting from said circumferential seal to permit passage of the respective distal ends of the extendable-retractable elements (accessories) and out of the flexible sleeve (54) between the outer surface of the multi-lumen shaft (34) and an inner surface of the flexible sleeve (54). 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 patent to further comprise the limitations of the sleeve in order to provide the benefit of preventing matter from passing from outside the lumen to inside the lumen. (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19)
Claims 18-24, 26-30 & 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-40 of copending Application No. 19/023168 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a blood harvesting system comprising an endoscopic cannula with a conical dissection tip and first and second extendable-retractable cutting elements. The patent fails to disclose the limitations regarding the sleeve/flexible sleeve. However, Silverstein et al. disclose a system comprising a flexible sleeve (54) located circumferentially around a multi-lumen shaft (34) having an endoscope viewing window (46), wherein, in the retracted position, the respective distal ends of extendable-retractable elements (accessories are positioned proximally of a distal end of the flexible sleeve to permit the distal end of the flexible sleeve to form a circumferential seal around the multi-lumen shaft (34) by conforming to an outer surface of the multi-lumen shaft (34), and wherein, in the extended position, the respective distal ends of the extendable-retractable elements (accessories) are positioned distally of the distal end of the flexible sleeve (54) with the flexible sleeve (54) deflecting from said circumferential seal to permit passage of the respective distal ends of the extendable-retractable elements (accessories) and out of the flexible sleeve (54) between the outer surface of the multi-lumen shaft (34) and an inner surface of the flexible sleeve (54). 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 patent to further comprise the limitations of the sleeve in order to provide the benefit of preventing matter from passing from outside the lumen to inside the lumen. (Col. 4-5, ll. 65-35,Col. 9, ll. 29-52; Figs. 1-9; Claim 19)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Odanaka et al. (5,830,126) disclose a conformable sleeve (23) for fluid supply.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
Prosecution Insights