DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This application contains claims directed to the following patentably distinct species
Species A: figs. 1a-1b [medical device with four arms in a round shape, actuated by wires].
Species B: fig. 2 [medical device with two arms forming a central opening to expose distal end portion of insertion device, arms coupled by a hinge, actuated by wires].
Species C: fig. 3 [medical device with two arms enclosing the distal end portion of insertion device, arms coupled via hinge, actuated by wires].
Species D: fig. 4 [medical device with one or more spring arms, actuated by over-tube, coupling portion surrounding tubes and/or arms].
Species E: fig. 5 [medical device with one or more spring arms, actuated by over-tube, push rod, or strut, ring portion coupled to arms].
Species F: fig. 6 [medical device with one arm, ring portion including a slot coupled with arm, actuated by curved portion coupled to a slot in the arm(s)].
Species G: fig. 7 [medical device with one or more arms, ring portion coupled with arm(s), circumferential shrouds coupled to arm(s)].
Species H: fig. 8 [medical device with one or more arms, ring portion coupled with arm(s), actuated by a slat].
Species I: figs. 9a-9f [medical device with one or more arm elements, first wire forms a rail, second wire fixedly coupled to a portion of arm element].
The species are independent or distinct because the claims to the different species recite mutually exclusive structural characteristics of such species as shown in the drawings listed above and described in the written description for each figure. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, 1, 8, 11, and 17 generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
The inventions have acquired a different field of search (e.g., searching different classifications or electronic resources, or employing different search strategies or search queries).
For example, searching for the actuation mechanism alone, the search strategy would encompass wires, slats, over-tubes, push rods, and curved portions coupled to a slot. Example search query (actuation SAME (wire OR slat OR tube OR (push ADJ rod) OR slot)) yields 171,516 patent families.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Ethan Goldschen on 08/27/26 a provisional election was made without traverse to prosecute the invention of Species A, claims 1-2, 5-8, 10-15, and 17-18. Affirmation of this election must be made by applicant in replying to this Office action. Claims 3-4, 9, 16, and 19-20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Objections
Claim 5 and 13 objected to because of the following informalities:
In claim 5, line 3: “a distal end of the endoscope” should read “the distal end of the endoscope”.
In claim 13, line 1: “the distal opening of the arm” should read “the distal opening of the lumen”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations is: “one or more actuation mechanisms are movable to transition at least one arm” in claim 1.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1, 7-8, 10, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams et al. (US 6,761,685).
Regarding claim 1, an invention relating to endoscopic devices, Adams discloses (Figs. 7-15) a medical system (228) comprising: a plurality of discrete tubes (31/82) configured to be spaced around an exterior of an endoscope (30; Fig. 7; Col. 11, lines 1-7 & 15-24) [Note, the endoscope is not positively recited, so it is not considered part of the claimed invention and will be treated as functional language], wherein each tube includes a channel [i.e. interior space occupied by elements 72, 74, 76, 78, 80] (Col. 9, 66-67; Col. 10, line 1; Col. 11, lines 19-22; Col. 11, line 46); a distal portion (74, 76, 78) configured to be coupled to an outer surface of a distal end of the endoscope [i.e. elements 74, 76, 78 would be coupled to the endoscope via elements 31/82 and 29] (Col. 4, lines 62-65; Col. 9, lines 66-67; Col. 10, line 1), wherein the distal portion includes a plurality of arms [i.e. each arm is formed from elements 76 & 78] (Col. 10, lines 1-4), wherein each arm of the plurality of arms includes a lumen (89; Col. 10, lines 12-13), wherein each lumen is aligned with and connected to a respective channel of a respective tube of the plurality of discrete tubes [i.e. each lumen is within a respective channel and coaxially aligned] (Fig. 9; Col. 11, lines 20-21); and one or more actuation mechanisms [i.e. proximal end of inner sheath (80) which is considered structurally equivalent to corresponding structure described in the specification as performing the claimed function, and equivalents thereof and interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph], wherein the one or more actuation mechanisms are movable to transition at least one arm of the plurality of arms from a closed configuration to an open configuration, wherein in the closed configuration, the lumen of the at least one arm is unexposed [i.e. the elements 76 & 78 are completely inside of the slots and proximal of the distal end 40] (Fig. 9), and wherein, in the open configuration, the lumen of the at least one arm is exposed [i.e. the elements 76 & 78 are completely outside of the slots and distal of the distal end 40] (Fig. 11; Col. 5, lines 54-65; Col. 11, lines 24-33 & 38-45).
Regarding claim 7, Adams discloses the medical system of claim 1. Adams further discloses wherein, in the open configuration, a distal portion of the lumen of the at least one arm is angled radially inward toward a central longitudinal axis of the distal portion (see annotated figure below & Col. 12, lines 10-24).
PNG
media_image1.png
677
438
media_image1.png
Greyscale
Regarding claim 8, Adams discloses the medical system of claim 1. Adams further discloses wherein each arm of the plurality of arms is biased toward the open configuration or the closed configuration (Col. 5, lines 54-65; Col. 11, lines 24-33 & 38-45).
Regarding claim 10, Adams discloses the medical system of claim 1. Adams further discloses wherein each arm of the plurality of arms includes an arm tube that defines the lumen [i.e. elements 76 & 78 define lumens 89/154 and 89/153 for each respective arm] (Figs 10-13; Col. 11, lines 1-13).
Regarding claim 17, an invention relating to endoscopic devices, Adams discloses (Figs. 7-15) a medical system (228) comprising: a plurality of discrete tubes (31/82) configured to be spaced around an exterior of an endoscope (30; Fig. 7; Col. 11, lines 1-7 & 15-24) [Note, the endoscope is not positively recited, so it is not considered part of the claimed invention and will be treated as functional language]; and a distal portion (74, 76, 78) configured to be coupled to an outer surface of a distal end of the endoscope [i.e. elements 74, 76, 78 would be coupled to the endoscope via elements 31/82 and 29] (Col. 4, lines 62-65; Col. 9, lines 66-67; Col. 10, line 1), wherein the distal portion includes a plurality of arms [i.e. each arm is formed from elements 76 & 78] (Col. 10, lines 1-4), wherein each arm of the plurality of arms includes a lumen (89; Col. 10, lines 12-13), wherein each lumen is aligned with and connected to a respective tube of the plurality of discrete tubes [i.e. each lumen is within a respective channel and coaxially aligned] (Fig. 9; Col. 11, lines 20-21); wherein the plurality of arms are configured to transition from a first configuration to a second configuration, wherein in the first configuration, a distal opening of each lumen is covered [i.e. the elements 76 & 78 are completely inside of the slots and proximal of the distal end 40] (Fig. 9), and wherein, in the second configuration [i.e. the elements 76 & 78 are completely outside of the slots and distal of the distal end 40] (Figs. 11-12), the plurality of arms are arranged such that a medical instrument having an end effector is extendable through a tube of the plurality of discrete tubes, through the lumen of an arm of the plurality of arms, out of the distal opening of the lumen, and distally of a distal end of the arm to a target site (Abstract; Col. 10, lines 7-13; Col. 11, lines 13-16).
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.
Claims 2, 5, 6, 8, 10-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Adams et al. (US 6,761,685) in view of Marescaux et al. (US 2008/0269562).
Regarding claims 2, 5, 6, 8, and 10, Adams discloses (Figs. 7-15) a medical system (228) comprising: a plurality of discrete tubes (31/82) configured to be spaced around an exterior of an endoscope (30; Fig. 7; Col. 11, lines 1-7 & 15-24) [Note, the endoscope is not positively recited, so it is not considered part of the claimed invention and will be treated as functional language], wherein each tube includes a channel [i.e. interior space occupied by elements 72, 74, 76, 80] (Col. 9, 66-67; Col. 10, line 1; Col. 11, lines 19-22; Col. 11, line 46). Also, Adams discloses the plurality of discrete tubes permit the travel of the surgical instruments to the surgical site to perform a surgical operation (Col. 4, lines 33-35 & Col. 10, lines 7-14). However, Adams fails to disclose a distal portion configured to be coupled to an outer surface of a distal end of the endoscope, wherein the distal portion includes a plurality of arms, wherein each arm of the plurality of arms includes a lumen, wherein each lumen is aligned with and connected to a respective channel of a respective tube of the plurality of discrete tubes; and one or more actuation mechanisms, wherein the one or more actuation mechanisms are movable to transition at least one arm of the plurality of arms from a closed configuration to an open configuration, wherein in the closed configuration, the lumen of the at least one arm is unexposed, and wherein, in the open configuration, the lumen of the at least one arm is exposed; and wherein, in the closed configuration, the plurality of arms form a central opening [Claim 2]; wherein each arm of the plurality of arms is integrally formed with a coupling portion that is configured to be coupled to the outer surface of a distal end of the endoscope [Claim 5]; wherein, in the closed configuration, a distal portion of each arm is angled radially inward toward a central longitudinal axis of the distal portion [Claim 6]; wherein each arm of the plurality of arms is biased toward the open configuration or the closed configuration [Claim 8]; and wherein each arm of the plurality of arms includes an arm tube that defines the lumen [Claim 10].
In the same field of endeavor, which is endoscopic devices, Marescaux teaches (Figs. 1-5 & 9) a distal portion (14a-b) configured to be coupled to an outer surface of a distal end of the endoscope (Par. 0062) [Note, the endoscope is not positively recited, so it is not considered part of the claimed invention and will be treated as functional language], wherein the distal portion includes a plurality of arms (14a-b), wherein each arm of the plurality of arms includes a lumen (16a-b; Par. 0059), wherein each lumen is aligned with and connected to a respective channel of a respective tube of the plurality of discrete tubes [Note, given Marescaux teachings about the plurality of arms and respective lumens, each lumen would obviously align with and connect to a respective channel of a respective tube of the plurality of discrete tubes disclosed by Adams, in order for the surgical tools (25a-b) to be received and guided to the surgical site (Par. 0059), as intended by both prior art references]; and one or more actuation mechanisms (20), wherein the one or more actuation mechanisms are movable to transition at least one arm of the plurality of arms from a closed configuration (Fig. 5) to an open configuration (Fig. 4), wherein in the closed configuration, the lumen of the at least one arm is unexposed [i.e. the lumen is covered by elements 14a-b when closed], and wherein, in the open configuration, the lumen of the at least one arm is exposed (Fig. 4; Par. 0070 & 0073); wherein, in the closed configuration, the plurality of arms form a central opening (17; Par. 0064); wherein each arm of the plurality of arms is integrally formed with a coupling portion [i.e. the proximal end portion of elements 14a-b] that is configured to be coupled to the outer surface of a distal end of the endoscope [i.e. the proximal end portion of elements 14a-b which are pivotably coupled to the distal head portion (13) of the endoscope via hinge (24; Par. 0058 & 0062); wherein, in the closed configuration, a distal portion of each arm is angled radially inward toward a central longitudinal axis of the distal portion [i.e. the elements 14a-b are angled inward toward the longitudinal axis of element 11] (Figs. 3 & 5; Par. 0057-0058 & 0062); wherein each arm of the plurality of arms is biased toward the open configuration or the closed configuration [i.e. position controlled by sliding type control switch] (Par. 0070-0073); and wherein each arm of the plurality of arms includes an arm tube that defines the lumen (see annotated figure below & Par. 0059).
PNG
media_image2.png
275
462
media_image2.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Adams to have a distal portion configured to be coupled to an outer surface of a distal end of the endoscope, wherein the distal portion includes a plurality of arms, wherein each arm of the plurality of arms includes a lumen, wherein each lumen is aligned with and connected to a respective channel of a respective tube of the plurality of discrete tubes; and one or more actuation mechanisms, wherein the one or more actuation mechanisms are movable to transition at least one arm of the plurality of arms from a closed configuration to an open configuration, wherein in the closed configuration, the lumen of the at least one arm is unexposed, and wherein, in the open configuration, the lumen of the at least one arm is exposed; and wherein, in the closed configuration, the plurality of arms form a central opening [Claim 2]; wherein each arm of the plurality of arms is integrally formed with a coupling portion that is configured to be coupled to the outer surface of a distal end of the endoscope [Claim 5]; wherein, in the closed configuration, a distal portion of each arm is angled radially inward toward a central longitudinal axis of the distal portion [Claim 6]; wherein each arm of the plurality of arms is biased toward the open configuration or the closed configuration [Claim 8]; and wherein each arm of the plurality of arms includes an arm tube that defines the lumen [Claim 10]. Doing so would provide an obturator shape to temporarily displace tissue during insertion of the endoscopic surgery apparatus into a body (Par. 0023), as taught by Marescaux.
Regarding claim 11, an invention relating to endoscopic devices, Adams discloses (Figs. 2 & 7-15) a medical system (228) comprising: an endoscope (30) including one or more lumens [i.e. the space in endoscope 30 occupied by viewing device 27 (Col. 5, lines 35-40). Note, element 27 is shown in the embodiment of figure 2, and would be expected in the embodiment of figure 7 since both embodiments have an endoscope 30 which would have a viewing device]; and a tube (31/82) such that an instrument having an end effector is extendable through the tube (Col. 4, lines 33-35 & Col. 10, lines 7-14). However, Adams fails to disclose an arm disposed on an exterior of a distal end of the endoscope, wherein the arm includes a lumen; and the tube coupled to the arm, such that an instrument having an end effector is extendable through the tube and the lumen; wherein the arm is configured to transition from a first configuration to a second configuration, wherein, in the second configuration, a distal end of the arm extends farther radially away from a longitudinal axis of the endoscope than in the first configuration; and wherein, in the first configuration, a distal opening of the lumen is unexposed.
In the same field of endeavor, which is endoscopic devices, Marescaux teaches (Figs. 1-5 & 9) an arm (14a-b) disposed on an exterior of a distal end of a endoscope [i.e. the proximal end portion of elements 14a-b which are pivotably coupled to the distal head portion (13) of the endoscope via hinge (24); see Marescaux figure 3 and paragraphs 0058 & 0062], wherein the arm includes a lumen (16a-b; Par. 0059); and the tube coupled to the arm, such that an instrument having an end effector is extendable through the tube and the lumen [Note, given Marescaux teachings about the arm and it's lumen, the lumen of the arm would obviously couple to the tube disclosed by Adams, in order for the surgical tools (25a-b) to be received and guided to the surgical site (Par. 0059), as intended by both prior art references]; wherein the arm is configured to transition from a first configuration [i.e. closed position] to a second configuration [i.e. open position], wherein, in the second configuration, a distal end of the arm extends farther radially away from a longitudinal axis of the endoscope than in the first configuration; and wherein, in the first configuration, a distal opening (see annotated figure below) of the lumen is unexposed [i.e. distal opening is covered by elements 14a-b when closed] (Figs. 4-5; and 0059, 0063, 0073).
PNG
media_image3.png
274
198
media_image3.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Adams to have an arm disposed on an exterior of a distal end of the endoscope, wherein the arm includes a lumen; and the tube coupled to the arm, such that an instrument having an end effector is extendable through the tube and the lumen; wherein the arm is configured to transition from a first configuration to a second configuration, wherein, in the second configuration, a distal end of the arm extends farther radially away from a longitudinal axis of the endoscope than in the first configuration; and wherein, in the first configuration, a distal opening of the lumen is unexposed. Doing so would provide an obturator shape to temporarily displace tissue during insertion of the endoscopic surgery apparatus into a body (Par. 0023), as taught by Marescaux.
Regarding claim 12, Adams, as modified by Marescaux, discloses, wherein the distal opening of the lumen is distal of a distalmost face of the endoscope in the first configuration [Note, the top edge of the element with the lumen appears to align with the top edge of the arm which is distal to the distalmost face in the first configuration, hence the lumen would be distal to the distalmost face, see Marescaux annotated figures below].
PNG
media_image4.png
364
462
media_image4.png
Greyscale
PNG
media_image5.png
299
421
media_image5.png
Greyscale
Regarding claim 13, Adams, as modified by Marescaux, discloses wherein the distal opening of the arm is on an inside of arm [see Marescaux annotated figure below].
PNG
media_image6.png
314
505
media_image6.png
Greyscale
Regarding claim 14, Adams, as modified by Marescaux, discloses wherein the arm is one arm of a plurality of arms [i.e. elements 14a-b; see Marescaux Figure 4].
Regarding claim 15, Adams, as modified by Marescaux, discloses wherein, in the first configuration, the plurality of arms form a central opening [i.e. opening 17; see Marescaux paragraph 0064 and Figure 5].
Regarding claim 18, an invention relating to endoscopic devices, Adams discloses (Figs. 2 & 7-15) a medical system (228) comprising: a plurality of discrete tubes (31/82) configured to be spaced around an exterior of an endoscope (30; Fig. 7; Col. 11, lines 1-7 & 15-24) [Note, the endoscope is not positively recited, so it is not considered part of the claimed invention and will be treated as functional language]. Also, Adams discloses the plurality of discrete tubes permit the travel of the surgical instruments to the surgical site to perform a surgical operation (Col. 4, lines 33-35 & Col. 10, lines 7-14). Adams fails to disclose a distal portion configured to be coupled to an outer surface of a distal end of the endoscope, wherein the distal portion includes a plurality of arms, wherein each arm of the plurality of arms includes a lumen, wherein each lumen is aligned with and connected to a respective tube of the plurality of discrete tubes; wherein the plurality of arms are configured to transition from a first configuration to a second configuration, wherein in the first configuration, a distal opening of each lumen is covered, and wherein, in the second configuration, the plurality of arms are arranged such that a medical instrument having an end effector is extendable through a tube of the plurality of discrete tubes, through the lumen of an arm of the plurality of arms, out of the distal opening of the lumen, and distally of a distal end of the arm to a target site; and wherein, in the first configuration, the plurality of arms form a central opening [Claim 18].
In the same field of endeavor, which is endoscopic devices, Marescaux teaches (Figs. 1-5 & 9) a distal portion (14a-b) configured to be coupled to an outer surface of a distal end of the endoscope (Par. 0062) [Note, the endoscope is not positively recited, so it is not considered part of the claimed invention and will be treated as functional language], wherein the distal portion includes a plurality of arms (14a-b), wherein each arm of the plurality of arms includes a lumen (16a-b; Par. 0059), wherein each lumen is aligned with and connected to a respective tube of the plurality of discrete tubes [Note, given Marescaux teachings about the plurality of arms and respective lumens, each lumen would obviously align with and connect to a respective channel of a respective tube of the plurality of discrete tubes disclosed by Adams, in order for the surgical tools (25a-b) to be received and guided to the surgical site (Par. 0059), as intended by both prior art references]; wherein the plurality of arms are configured to transition from a first configuration [i.e. closed position] to a second configuration [i.e. open position], wherein in the first configuration, a distal opening (see annotated figure below) of each lumen is covered [i.e. distal opening is covered by elements 14a-b when closed] (Fig. 5), and wherein, in the second configuration (Fig. 4), the plurality of arms are arranged such that a medical instrument having an end effector is extendable through a tube of the plurality of discrete tubes, through the lumen of an arm of the plurality of arms, out of the distal opening of the lumen, and distally of a distal end of the arm to a target site [Note, given Marescaux teachings about the plurality of arms and respective lumens, each lumen would obviously align with and connect to a respective channel of a respective tube of the plurality of discrete tubes disclosed by Adams, in order for the surgical tools (25a-b) to be received and guided to the surgical site] (Par. 0059 & 0071); and wherein, in the first configuration, the plurality of arms form a central opening (17; Par. 0064).
PNG
media_image7.png
288
492
media_image7.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Adams to have a distal portion configured to be coupled to an outer surface of a distal end of the endoscope, wherein the distal portion includes a plurality of arms, wherein each arm of the plurality of arms includes a lumen, wherein each lumen is aligned with and connected to a respective tube of the plurality of discrete tubes; wherein the plurality of arms are configured to transition from a first configuration to a second configuration, wherein in the first configuration, a distal opening of each lumen is covered, and wherein, in the second configuration, the plurality of arms are arranged such that a medical instrument having an end effector is extendable through a tube of the plurality of discrete tubes, through the lumen of an arm of the plurality of arms, out of the distal opening of the lumen, and distally of a distal end of the arm to a target site; and wherein, in the first configuration, the plurality of arms form a central opening [Claim 18]. Doing so would provide an obturator shape to temporarily displace tissue during insertion of the endoscopic surgery apparatus into a body (Par. 0023), as taught by Marescaux.
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 1-2, 5-8, 10-15, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 9, 12, 14, and 17 of U.S. Patent No. 12,376,880. Concerning claims 1-2, 6-8, 10-14, and 17-18, although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims 1-2, 6-8, 10-14, and 17-18 are broader than the listed claims of Patent No. 12,376,880 and therefore are “anticipated” by the listed claims in Patent No. 12,376,880.
Claims
19/262,858
1
2
5
6
7
8
10
Claims
US Patent No
12,376,880
1
4
14
1
2
9
1
Claims
19/262,858
11
12
13
14
15
17
18
Claims
US Patent No
12,376,880
12
12
12
12
4
17
4
Regarding instant claim 5, Claim 14 of Patent No. 12,376,880 fails to claim wherein each arm of the plurality of arms is integrally formed with a coupling portion [in Claim 5 of application 19/262,858].
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Patent No. 12,376,880 to have wherein each arm of the plurality of arms is integrally formed with a coupling portion, instead of a plurality of parts, since it has been held that the use of a one piece construction instead of a plurality of separable parts would be merely a matter of obvious engineering choice. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Regarding instant claim 15, Claim 4 of Patent No. 12,376,880 fails to explicitly claim an endoscope including one or more lumens [in Claim 11 from which claim 15 depends in application 19/262,858]. However, Claim 1 from which claim 4 depends in Patent No. 12,376,880 recites “a longitudinal portion with a plurality of discrete tubes configured to be spaced around an exterior of an endoscope”, and endoscopes are well known to have lumens at least for a viewing device. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Patent No. 12,376,880 to have an endoscope including one or more lumens. Doing so would allow the view of a target surgical site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHIMA U IGBOKO/Examiner, Art Unit 3771
