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 .
Detailed Action
This is in response to the amendment filed 02/15/2022.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4, 5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 recites the cannula further comprises an elongated tube. It is the position of the Office that this does not further limit claim 1 because cannula, by its plain and ordinary meaning, is an elongated tube. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. See MPEP § 608.01(n).
This interpretation is consistent with the specification which describes the cannula as an elongated tube in paragraph [0022] of the specification: “The cannula tube is a hollow elongated tube”
Claim 5 is rejected because it is dependent on claim 4 which is also rejected.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6-18 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12-15, 17-22 of U.S. Patent No. 12,150,641 (Sauer)
Although the claims at issue are not identical, they are not patentably distinct from each other because the cannula with the longitudinal channels and circumferential channels of the surgical access system of claim 1 of the current application is not patentably distinct from Sauer’s, the cannula with the longitudinal channels and circumferential channels of the surgical access system recited in claims 1, 17, 22.
Regarding claim 2, the “an obturator coaxially insertable within the cannula comprising: a distal tip; and a retractable cutting element having an actuator; and an articulation interface” is not patentably distinct from the “an obturator coaxially insertable within the cannula comprising: a distal tip; and a retractable cutting element having an actuator; and an articulation interface” recited in Sauer’s claim 1.
Regarding claim 3, the “distal tip of the cannula further comprises one or more bridges distributed circumferentially along the one or more circumferential channels” is not patentably distinct from the “the distal tip of the cannula further comprises one or more bridges distributed circumferentially along the one or more circumferential channels” recited in Sauer’s claim 1.
Regarding claim 6, the “wherein the cannula and the articulation interface are continuous” is not patentably distinct from the “wherein the cannula and the articulation interface are continuous” recited in Sauer’s claim 2.
Regarding claim 7, the “wherein the obturator further comprises an elongated tube” is not patentably distinct from the “wherein the obturator further comprises an elongated tube” recited in Sauer’s claim 3.
Regarding claim 8, the “wherein the obturator further comprises an obturator knob having a passage in communication with an inside of the elongated tube of the obturator” is not patentably distinct from the “wherein the obturator further comprises an obturator knob having a passage in communication with an inside of the elongated tube of the obturator” recited in Sauer’s claim 4.
Regarding claim 9, the “wherein the distal tip of the obturator further comprises one or more passages in communication with an inside of the elongated tube of the obturator” is not patentably distinct from the “wherein the distal tip of the obturator further comprises one or more passages in communication with an inside of the elongated tube of the obturator” recited in Sauer’s claim 5.
Regarding claim 10, the “wherein the distal tip of the obturator further comprises two groups of one or more passages, the groups of one or more passages separated by a central passage” is not patentably distinct from the “wherein the distal tip of the obturator further comprises two groups of one or more passages, the groups of one or more passages separated by a central passage” recited in Sauer’s claim 6.
Regarding claim 11, the “wherein the obturator further comprises a slidable plunger element configured to control fluid flow inside the elongated tube of the obturator” is not patentably distinct from the “wherein the obturator further comprises a slidable plunger element configured to control fluid flow inside the elongated tube of the obturator” recited in Sauer’s claim 7.
Regarding claim 12, the “wherein the obturator further comprises a hollow actuator coupled to the slidable plunger element” corresponds the “wherein the obturator further comprises a hollow actuator coupled to the slidable plunger element” recited in Sauer’s claim 8.
Regarding claim 13, the “wherein the obturator further comprises an actuator rod coupled to the retractable cutting element” is not patentably distinct from the “wherein the obturator further comprises an actuator rod coupled to the retractable cutting element” recited in Sauer’s claim 9.
Regarding claim 14, the “wherein the actuator rod coupled to the retractable cutting element is slidably engaged inside the hollow actuator coupled to the slidable plunger element” is not patentably distinct from the “wherein the actuator rod coupled to the retractable cutting element is slidably engaged inside the hollow actuator coupled to the slidable plunger element” recited in Sauer’s claim 10.
Regarding claim 15, the “wherein the articulation interface is substantially spherical” is not patentably distinct from the “wherein the articulation interface is substantially spherical” recited in Sauer’s claims 12, 18.
Regarding claim 16, the “wherein the articulation interface is repositionable along the cannula” is not patentably distinct from the “wherein the articulation interface is repositionable along the cannula” recited in Sauer’s claim 13, 19.
Regarding claim 17, the “wherein the articulation interface is continuous with the cannula” is not patentably distinct from the “wherein the articulation interface is continuous with the cannula” recited in Sauer’s claim 14, 20.
Regarding claim 18, the “wherein the articulation interface comprises a universal joint” is not patentably distinct from the “, wherein the articulation interface comprises a universal joint” recited in Sauer’s claim 15, 21.
It is clear that all the elements of claims 1-3, 6-18 are to be found in claims 1-10, 12-15, 17-22 of the patent. The difference between claim 31 of the application and claim 18 of the patent lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claim 18 of the patent is in effect a “species” of the “generic” invention of claim 31. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). See MPEP § 2111.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Number 5,829,447 (Stevens et al.))
Regarding claim 20, Stevens et al. discloses a method of accessing a surgical site as shown in Figures 5-8, comprising: placing at least one pursestring suture in a wall of a heart; see col. 16, lines 1-17; securing the at least one pursestring suture to a cannula (access device 22); see col. 16, lines 41-46; placing an obturator tip of a surgical access system having a retractable blade (blade 62, see col. 16, lines 27-40) in contact with the wall of a heart; incising the wall with the retractable blade; see col. 16, lines 27-40; and securing the incised wall to the cannula of a surgical access system. See col. 16, lines 41-64.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim(s) 1, 4, 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2004/0087831 (Michels et al.) in view of U.S. Patent Publication Number 2002/0045908 (Nobles et al.)
Regarding claims 1, 4, 5, Michels et al. discloses as shown in Figures 2-4 a surgical access system, comprising: a cannula (sleeve 34, see paragraph [0045]) comprising: a distal tip (generally indicated as A) having: one or more longitudinal channels (suction lumens 46, see paragraph [0048]) distributed around a circumference of the distal tip; wherein the cannula further comprises an elongated tube, wherein the distal tip of the cannula is continuous with the elongated tube of the cannula.
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To be clear, the Office is interpreting manifold 48 as an articulation interface because it is an interface in which the sleeve can be articulated (i.e. grasped and manipulated by hand).
Michels et al. fails to disclose the cannula has one or more circumferential channels around the distal tip.
Hinchliffe, from the same filed of endeavor teaches a similar surgical access system as shown in Figures 10, 11 with a similar cannula which includes one or more circumferential channels (circumferential groove) for the purpose of receiving a suture. See col. 5, lines 39-59.
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 surgical access system disclosed by Michels to include the circumferential groove taught by Hinchliffe in order to configure the cannula to accommodate suture which can be used to repair tissue during a procedure, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claim 15, Michels et al. discloses wherein the retractable cutting element is selected from the group consisting of a blade, a scalpel, and scissors. See paragraph [0057].
Claim(s) 2, 6, 7, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2004/0087831 (Michels et al.) in view of U.S. Patent Publication Number 2002/0045908 (Nobles et al.) as applied to claim 1 above, and further in view of U.S. Patent Number 5,591,180 (Hinchliffe)
Regarding claim 2, Michels discloses an obturator (trocar 22, see paragraph [0045]) coaxially insertable within the cannula comprising: a distal tip; and a retractable cutting element (instrument 32, see paragraph [0057]); and an articulation interface (manifold 48, see paragraph [0048]),
Michels fails to disclose an actuator.
Nobles et al., from the same field of endeavor teaches a similar system as shown in figure 40 where a similar cutting element (needle) has an actuator (needle actuator 276, see paragraph [0194]).
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 surgical access system disclosed by Michels to include the needle actuator taught by Nobles et al. in order to actuate the instrument 32 more easily and remotely from the patiently, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claims 6, 7, 17 Michels discloses wherein the cannula and the articulation interface are continuous, wherein the obturator further (22) comprises an elongated tube, wherein the articulation interface is continuous with the cannula. See paragraph [0045] and Figures 2-4.
Claim(s) 8, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2004/0087831 (Michels et al.) in view of U.S. Patent Publication Number 2002/00459808 (Nobles et al.), U.S. Patent Number 5,591,180 (Hinchliffe) as applied to claim 7 above, and further in view of U.S. Patent Publication Number 2002/0038128 (Turovkivy).
Regarding claims 8, 9 Michels et al. fails to disclose wherein the obturator further comprises an obturator knob having a passage in communication with an inside of the elongated tube of the obturator.
Turovkivy, from the same field of endeavor teaches a similar system with an obturator (as shown in Figure 14, where the obturator an obturator knob (gripping element 414, see paragraph [0072]) having a passage in communication with an inside of the elongated tube of the obturator, wherein the distal tip of the obturator further comprises one or more passages in communication with an inside of the elongated tube of the obturator, for the purpose of accommodating a blade and actuating mechanism.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to incorporate the one or more passages in the obturator and the obturator knob in order to configure the obturator to allow a cutting element to be advanced through it, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2004/0087831 (Michels et al.) in view of U.S. Patent Publication Number 2002/00459808 (Nobles et al.), U.S. Patent Number 5,591,180 (Hinchliffe), U.S. Patent Publication Number 2002/0038128 (Turovkivy).as applied to claim 9 above, and further in view of U.S. Patent Publication Number 2013/0267938 (Greenberg et al.).
Regarding claim 10, Michels fails to disclose the distal tip of the obturator further comprises two groups of one or more passages, the groups of one or more passages separated by a central passage.
Greenberg et al. from the same field of endeavor teaches a similar system as shown in Figure 3 with an obturator, where the distal tip of the obturator further comprises two groups of one or more passages, for the purpose of accommodating multiple tools. See paragraph [0031].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to incorporate the two groups of one or more passages taught by Greenberg et al. in the tip of the obturator disclosed by Michels in order to accommodate two tools through tip of the obturator, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to incorporate a central passage separating the two groups, because it would only require the duplication of parts without changing how the system operates (allowing for accommodation of multiple tools). See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)
Claim(s) 11, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2004/0087831 (Michels et al.) in view of U.S. Patent Publication Number 2002/00459808 (Nobles et al.), U.S. Patent Number 5,591,180 (Hinchliffe) as applied to claim 7 above, and further in view of U.S. Patent Number 3,721,229 (Panzer).
Regarding claims 11, 12 Michels fails to disclose the obturator further comprises a slidable plunger element configured to control fluid flow inside the elongated tube of the obturator, hollow actuator coupled to the slidable plunger element.
Panzer, from the same field of endeavor teaches a similar system as shown in Figure 1, where the obturator further comprises a slidable plunger element (plunger of disclosed syringe) configured to control fluid flow inside the elongated tube of the obturator, hollow actuator (body of syringe) coupled to the slidable plunger element. See col. 3, lines 10-39.
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 surgical access system to include the syringe (which would include the plunger and hollow actuator) and the passage through the obturator disclosed by Michels in order to be able to draw fluid and expel fluid out of trocar 22, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2004/0087831 (Michels et al.) in view of U.S. Patent Publication Number 2002/00459808 (Nobles et al.), U.S. Patent Number 5,591,180 (Hinchliffe), U.S. Patent Number 3,721,229 (Panzer) as applied to claim 12 above, and further in view of U.S. Patent Publication Number 2002/0038128 (Turovkivy).
Regarding claims 13, Michels fails to disclose wherein the obturator further comprises an actuator rod coupled to the retractable cutting element, wherein the actuator rod coupled to the retractable cutting element is slidably engaged inside the hollow actuator coupled to the slidable plunger element.
Turovkivy, from the same field of endeavor teaches a similar system with an obturator as shown in Figure 14, where wherein the obturator further comprises an actuator rod (actuating mechanism 420) coupled to the retractable cutting element,
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 system disclosed by MIchels by substituting the cutting element disclosed by Michels for the cutting element and actuator rod taught by Turovkivy because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 2, 15, 16, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2004/0087831 (Michels et al.) in view of U.S. Patent Publication Number 2002/00459808 (Nobles et al.), U.S. Patent Number 5,591,180 (Hinchliffe) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2013/0085342 (Stefanchik et al.)
Regarding claims 2, 15, 16, 18 under an alternative interpretation, Michels discloses an obturator (trocar 22, see paragraph [0045]) coaxially insertable within the cannula comprising: a distal tip; and a retractable cutting element (instrument 32, see paragraph [0057]).
Michels fails to disclose an actuator and an articulation interface.
Nobles et al., from the same field of endeavor teaches a similar system as shown in figure 40 where a similar cutting element (needle) has an actuator (needle actuator 276, see paragraph [0194]).
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 surgical access system disclosed by Michels to include the needle actuator taught by Nobles et al. in order to actuate the instrument 32 more easily and remotely from the patiently, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Stefanchik et al., from the same field of endeavor teaches a similar system as shown in Figures 20, 21 where the system includes an articulation interface in the form of a ball 802 (substantially spherical) or universal joint 2108a, wherein the articulation interface is repositionable along the cannula (cannula can be inserted into at multiple positions), wherein the articulation interface is repositionable along the cannula. see paragraph [0081]
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify system disclosed by Michels to include the articulation interface taught by Stefanchik in order to articulate the system in multiple directions, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2004/0087831 (Michels et al.) in view of U.S. Patent Publication Number 2002/0045908 (Nobles et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2013/0144311 (Fung).
Regarding claim 19, Michels fails to disclose comprising at least one suture tube and at least one suture snare.
Fung, from the same field of endeavor teaches a similar system as shown in Figure 27, where the system includes a suture tube (2705) and at least one suture snare (2712), for the purpose of delivering a snare. See paragraph [0096].
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 system disclosed by Michels to include the at least one suture tube and at least one suture snare in order to configure the system to allow for snaring of an object within the body, , a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
It is worth noting, the applicant admits the claimed at least one suture tube and at least one suture snare as known before the effective filing date of the claimed invention in paragraph [0036] (“a suture snare, but other means of snaring, organizing and encapsulating sutures during a minimally invasive surgical procedure may be well known to those skilled in the art. Examples include, a simple snare in tube arrangement where the suture or snare may be held in position with common clamping methods such as butterfly clamps and the like”.
Alternatively, 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 system disclosed by Michels to include the at least one suture tube and at least one suture snare which the applicant admits is prior art, for the purpose of configuring the system to snare something in the body, or because it would only require combining prior art elements according to known methods to yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Conclusion
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/RICHARD G LOUIS/ Primary Examiner, Art Unit 3771