DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 11/13/2025 with regards to the rejection of claim(s) 29 over Hallen (US 2022/0117779 A1) have been fully considered but they are not persuasive.
Regarding claim 29, rejected under Hallen, Applicant contends that Hallen does not expressly or adequately disclose the amended limitations of “a first portion of the hollow tube is embedded in the first member” and “a second portion of the hollow tube is disposed outside of the first member and at least partially within the outer sheath, the second portion of the hollow tube and the first member extending through the outer sheath radially adjacent to one another” on the grounds that no portion of the vacuum line (116/216) of Hallen is “radially adjacent” to the forceps, but rather the vacuum lines within the shaft (524) extend “axially adjacent” to said forceps jaws. The examiner respectfully disagrees. With reference to Examiner’s Diagram of Fig. 6 below, the “second portion” of the vacuum line of Hallen that is immediately adjacent to the jaw body is disposed within the radial confines of the outer tube, together with the proximal portion of the jaw bodies when the outer tube is translated distally over the proximal regions of the jaws during a closing actuation (see Para. [0026]). During this initial closing arrangement, the distal-most portion of the “second portion” of the vacuum lines is extending through the outer tube radially adjacent with the jaw since the jaw is extending radially-outward from the shaft (524) within which the “second portion” of the vacuum line is disposed. While the jaw remains axially adjacent to the second portion of the vacuum line, the partial opening of the jaws also leaves the jaws radially adjacent (i.e., in a different radial plane from) the distal-most region of the second portion of the vacuum line.
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Examiner’s Diagram of Fig. 6
Additionally regarding the rejection of claim 29 under Hallen, Applicant contends that Hallen does not expressly or adequately disclose the limitations of “the hollow tube includes i.) a main portion at least partially embedded in the first member and ii.) a plurality of branch portions that are each embedded in the first member” and “the plurality of branch portions each extend between and connect the main portion and a respective aperture of the plurality of apertures” on the grounds that the Examiner’s interpretation to view the length of the aperture holes (534) extending through a thickness of the jaw body to connect an aperture opening within the jaw face to the main vacuum line is improper. Applicant contends that all portions of the aperture openings (534) are just “holes” that neither comprise not constitute “branch portions” as required by the claim. The Examiner respectfully maintains that the length the “apertures 534” travel through a thickness of the jaw body to connect the opening in the jaw face to the internal lumen of said jaw constitutes a “branch portion” in light of the currently-applied claim language. The Examiner notes that there is no mention of “branch portions” within the specification of the claimed invention. In addressing the “plurality of branch portions”, Applicant appears to be making a reference to “apertures 402” shown in the jaw embodiment of Figs. 4-6 in which a plurality of “branches” (referred to within the specification as “apertures 402”) extend through a thickness of the jaw body to connect an opening within the jaw face to the vacuum line within the jaw body. Since an “aperture” is defined to be an “opening”, the Examiner respectfully maintains that the “aperture” of the jaws of Hallen is merely the cut-out opening within the jaw face, whereas the length the cut-out travels through the thickness of the jaw body constitutes a “branch portion” that connects the cut-out opening within the jaw face to the vacuum line disposed within the lumen of said jaw body. Without further structural limitations within the claims or specification of the claimed invention, the Examiner respectfully maintains the position that the length the “aperture 534” travels through the jaw thickness constitutes a “branch portion”.
Applicant's arguments filed 11/13/2025 with regards to the rejection of claim(s) 1 over Batchelor (US 2019/0192178 A1) have been fully considered but they are not persuasive.
Regarding the rejection of claim 1 over Batchelor, Applicant contends that Batchelor does not expressly disclose the amended limitations of “the fluid passage is fluidically connectable with a source or suction having a suction pressure sufficient to draw the body toward the first jaw surface and to provide additional holding power when the body is grasped between the first jaw surface and the second jaw surface” on the grounds that when the jaws of Batchelor are in the closed position, the fluid line is pinched by the flanges of the jaws to cut-off suction to tissue. The Examiner respectfully disagrees with the interpretation of Batchelor in light of the currently-presented claim language. Para. [0048]-[0049] of Batchelor specifically mention that the suction applied through the fluid lines within the jaws helps to secure a feature of interest against the jaws during closing of said jaws. While the suction may be cut-off during a fully closure of the jaws, during the initial states of closure, and even during a grasping of an object when the jaws cannot completely close, the suction applied through said fluid lines serves to hold features of interest on the jaws and prevent slippage. Since the claims merely require “providing additional holding power” for the jaws without expressly requiring any jaw configuration/position, Batchelor is understood to disclose these cited limitations.
Applicant's arguments filed 11/13/2025 with regards to the rejection of claim(s) 29 over Batchelor in view of Hallen have been fully considered but they are not persuasive.
Regarding the rejection of claim 29 under Batchelor, in view of Hallen, Applicant contends that the combination does not expressly or adequately disclose the limitations of “the hollow tube includes i.) a main portion at least partially embedded in the first member and ii.) a plurality of branch portions that are each embedded in the first member” and “the plurality of branch portions each extend between and connect the main portion and a respective aperture of the plurality of apertures” on the grounds that Batchelor does not expressly disclose additional branch lines that connect to a respective fluid opening, only showing a single fluid opening (40) in Fig. 2A. As discussed in the rejection (modified in the rejection below for clarity), Hallen provides a teaching of wherein a suction forceps may comprise any number of suction apertures of any shape/size as a matter of obviousness within the art without affecting the scope of functionality of the device (see Para. [0040] and Figs. 5-7). Since Batchelor does not provide any specific functional quality to the number of fluid openings (40), this is understood to not be a critical functional aspect of the invention and it would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have modified the number of distal fluid openings disposed within the upper first jaw of Batchelor to comprise a plurality of apertures (i.e., more than one) as disclosed by Hallen, since Hallen discloses that it is a matter of obviousness to include any number of distal fluid/vacuum apertures without departing from the scope of or altering the functionality of the disclosed vacuum forceps (see Para. [0040]). Therefore, one of ordinary skill in the art would have expected the device of Batchelor to functional equally well with more than one distal fluid line opening. Additional angular “branch passages” would be included the connect the additional aperture openings to the main passage of the fluid line to remain consistent with the disclosure of Batchelor without departing from the scope of or changing the functionality of the device of Batchelor.
Applicant's arguments filed 11/13/2025 with regards to the rejection of claim(s) 34 over Hallen have been fully considered but they are not persuasive.
Regarding the rejection of claim 34 under Hallen, Applicant contends that Hallen does not expressly or adequately disclose the limitations of “a diameter of at least one of the plurality of first branch portions is equal to i.) a diameter of the respective first aperture and ii.) a diameter of at least a portion of the first main portion” and “ a diameter of the at least one of the plurality of second branch portions is equal to i.) a diameter of the respective second aperture and ii.) a diameter of at least a portion of the second main portion” on the grounds that it would not have been obvious to have modified the sizes of the first and second branches as claimed due to inherent fluid dynamics within the suction system impacting the overall functionality of the device of Hallen, resulting in a fundamental and substantial change in the operation of the vacuum system of Hallen. The Examiner respectfully disagrees. Hallen does not provide any express disclosure pertaining to a critical or important functionality associated with the size of the vacuum apertures. In Applicant’s arguments, there does not appear to be any reference to the disclosure of Hallen in providing an express reference pertaining to the sizes of the apertures in relation to fluid dynamics. Rather, Hallen provides a disclosure in Para. [0040] reciting that the through-holes may have any arrangement, size and number without departing from the scope of the claimed invention. While this paragraph pertains to a different embodiment, this is the only portion within the disclosure of Hallen referencing any criticality of the vacuum through-holes. Further, Applicant does not provide any criticality or special function to the relative sizes of the vacuum apertures, leading one of ordinary skill in the art to conclude that the claimed relative sizes of the vacuum apertures is not critical to the functioning of the device and would be confident in altering the sizes of the vacuum apertures without impacting the overall function of prior art references to arrive at the claimed invention.
Claim Objections
5. Applicant’s arguments, see “Remarks”, filed 11/13/2025, with respect to the objection to claim 34 for containing an errant “)” have been fully considered and are persuasive in light of Applicant’s amendment to remove the cited typographical error. The objection of claim 34 has been withdrawn.
Claim Rejections - 35 USC § 112
6. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
7. Claims 1, 6-7, 11-12, 20-31 and 33-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “wherein the fluid passage is in fluid communication with the source of suction via a hollow tube, at least a port of the hollow tube disposed outside of the first member and contacting an exterior surface of the angular portion of the first member” which has no written support within the specification of the claimed invention. Para. [0007] recites merely wherein the hollow tube extends into the jaw members to connect apertures within the jaw face to a proximal vacuum source, without providing any support for the claimed phrase “at least a port of the hollow tube disposed outside of the first member and contacting an exterior surface of the angular portion of the first member”. Applicant appears to be relying on Fig. 9 wherein hollow tubes (910/912) extend within the angular portion (704) of the jaws, but this figure does not clearly or adequately show that a portion of the hollow tube contacts an exterior surface of the angular portion of the first member. Without a cross-section reference image showing the claimed “contact”, there is no clear written or illustrated support for the claimed language, rendering the amended limitation as new matter.
Claims 6-7, 11-12 and 20-28 are also rejected under 112(a) as failing to comply with the written description requirement due to their dependency from and further modification of claim 1.
Claim 20 recites the limitations “the at least one aperture including a plurality of apertures; the fluid passage includes i.) a main passage at least partially embedded in the first member and ii.) a plurality of branch passages that are each embedded in the first member; and the plurality of branch passages each extend between and connect the main passage and a respective aperture of the plurality of aperture” which, when modifying the invention of claim 1, has no written support in the specification of the claimed invention. Claim 1’s recitation of “wherein the fluid passage is in fluid communication with the source of suction via a hollow tube, at least a port of the hollow tube disposed outside of the first member and contacting an exterior surface of the angular portion of the first member” is, from what the Examiner can determine, drawn to the jaw embodiment in Figs. 7-10 in which the fluid passage extends outside of the first member, contacting an exterior surface thereof. The cited limitations of claim 20 appear to be directed to the jaw embodiment of Figs. 4-6 in which a plurality of branch passages (402) extend between apertures within the jaw surface and a main passage of the fluid line extending within the jaw bodies. The specification does not provide any written support that the different jaw embodiments (Figs. 1-3, 4-6 and 7-10) are combinable with one-another. Due to the lack of written details pertaining to the location and orientation of the fluid passage/hollow tube, the Examiner relies solely on the included drawings to show and illustrate these claimed features which are disclosed as distinct, independent embodiments (see Spec. Para. [0014]-[0016]) that cannot be combined without an express recitation from the specification. Since no such disclosure appears within the specification, claim 20 is rejected under 112(a) as failing to comply with the written description requirement/new matter since the limitations provided therein are drawn to a different jaw embodiment than that of claim 1 without written support that the embodiments are combinable.
Claims 21-26 are also rejected under 112(a) as failing to comply with the written description requirement due to their dependency from and further modification of claim 20.
Claim 29 recites “wherein a first portion of the hollow tube is embedded in the first member; wherein a second portion of the hollow tube is disposed outside of the first member and at least partially within the outer sheath; the second portion of the hollow tube and the first member extending through the outer sheath radially adjacent to one-another” which, while lacking any written support within the specification, appears to be shown in the jaw embodiment of Figs. 7-10. However, claim 29 later recites, “wherein the hollow tube includes i.) a main portion at least partially embedded in the first member and ii.) a plurality of branch portions that are each embedded in the first member; and wherein the plurality of branch portions each extend between and connect the main portion and a respective aperture of the plurality of apertures” which, while lacking any written description within the specification, appears to be shown in the jaw embodiment of Figs. 4-6 in which a plurality of branch channels (“apertures 402”) connect an aperture within the jaw face and a main portion of the hollow tube embedded within body of the first member. The specification does not mention “branch passages” but the Examiner interprets that portions of the “apertures 402” extending between the opening apertures in the jaw face and the main portion of the hollow tube are the intended “branch portions” referred to in the claims. Since these “branch portions” are not discussed in the specification, the Examiner is relying solely on the disclosed figures to show and provide support for this limitation. As the only embodiment showing these “branch portions” is the jaw embodiment of Figs. 4-6, the two above-cited limitations are attempting to combine the jaw embodiments of Figs. 4-6 and 7-10 which are not disclosed to be combinable are therefore render the claim as failing to comply with the written description requirement/new matter.
Claims 30-31 and 33 are also rejected under 112(a) as failing to comply with the written description requirement due to their dependency from and further modification of claim 29.
Claim 30 recites “wherein the first member includes…an angular portion extending obliquely between and connecting the first portion and the second portion; and the hollow tube projects out of the first member through the angular portion of the first member and into an interior space of the outer sheath that surrounds the two elongated members” which does not have any written support within the specification of the claimed invention. Para. [0007] recites merely wherein the hollow tube extends into the jaw members to connect apertures within the jaw face to a proximal vacuum source, without providing any support for the claimed phrase “the hollow tube projects out of the first member through the angular portion of the first member and into an interior space of the outer sheath that surrounds the two elongated members”. Applicant appears to be relying on Fig. 9 wherein hollow tubes (910/912) extend proximally out from the angular portion (704) of the jaws. However, this jaw embodiment (Figs. 7-10) attempts to combine the jaw embodiment of Figs. 7-10 with the jaw embodiment of Figs. 4-6, as recited in claim 29 (pending resolution to the 112(a) rejection above) without express recitation or support within the specification that the jaw embodiments are combinable.
Claim 35 recites, “wherein: the first main portion of the first hollow tube includes i) an embedded region that is embedded in the first member and ii) a free region that is disposed outside of the first member and at least partially within a space defined radially between the first member and the outer sheath; the second main portion of the second hollow tube includes i) an embedded region that is embedded in the second member and ii) a free region that is disposed outside of the second member and at least partially within a space defined radially between the second member and the outer sheath; and the free region of the first main portion of the first hollow tube, the free region of the second main portion of the second hollow tube, the first member, and the second member extend through the outer sheath radially adjacent to one another which does not have written support within the specification of the claimed invention. Para. [0007] recites merely wherein the hollow tube extends into the jaw members to connect apertures within the jaw face to a proximal vacuum source, without providing any support for the claimed phrase “the first main portion of the first hollow tube includes… a free region that is disposed outside of the first member and at least partially within a space defined radially between the first member and the outer sheath” and “the second main portion of the second hollow tube includes…a free region that is disposed outside of the second member and at least partially within a space defined radially between the second member and the outer sheath” and the free region of the first main portion of the first hollow tube, the free region of the second main portion of the second hollow tube, the first member, and the second member extend through the outer sheath radially adjacent to one another. Applicant appears to be referencing the jaw embodiment of Figs. 7-10 in which the hollow tube extends proximally out from the jaw angular portion (704) distally of the proximal-most region of the jaws, allowing a portion of the hollow tube to extend radially adjacent to a portion of the corresponding jaw within the outer sheath. However, these claimed limitations, drawn to the jaw embodiment of Figs. 7-10, are not combinable with the jaw embodiment of Figs. 4-6 to which claim 34 is in reference to with the limitations “a first/second hollow tube disposed at least partially in a corresponding first/second jaw member, the hollow tubes including i.) a main portion disposed at least partially in the corresponding jaw and ii.) a plurality of branch portions disposed in the corresponding jaw, the plurality of branch portions each projecting radially outward from the main portion(s) and opening into a space defined between the corresponding jaw surface via a respective aperture of the plurality of apertures” which, while lacking detailed written support, appears to be shown in the jaw embodiment of Figs. 4-6 in which a plurality of “branch portions 402” extend from an aperture within the jaw face to a main portion of the hollow tube within the jaw body. Since the specification does not provide a recitation that the different jaw embodiments are combinable, claim 35’s reference to a jaw embodiment different than that of claim 34 renders claim 35 are failing to comply with the written description requirement/new matter requirements.
Claim Rejections - 35 USC § 102
8. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
9. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10. Claim(s) 29 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hallen (US 2022/0117779 A1), considered prior art because of the provisional patent application filed 10/15/2020 providing full 112 written support for the published pre-grant document (previously of record).
Regarding claim 29, Hallen discloses:
A surgical forceps (surgical instruments 100, see Fig. 1), comprising:
two elongated members including a first member and a second member (arms 526, see Fig. 5), the first member having a distal end with a first jaw surface (jaw 522a, see Fig. 5), the second member having a distal end with a second jaw surface (jaw 522b, see Fig. 5) disposed in opposing relation to the first jaw surface (see Figs. 5-6);
an outer sheath in which the two elongated members are disposed (sleeve 106, see Fig. 1; the outer sleeve (106) is present in all embodiments to house and cause actuation of the jaws, as shown in Fig. 1; see Para. [0025]-[0026] and [0031]), the two elongated members protruding from a distal end opening of the outer sheath (see Fig. 1 showing jaws 122, akin to jaws 522, extending from a distal end of the sleeve 106; see Para. [0031] mentioning wherein the jaws shown in Figs. 5-6 are interchangeable with the jaws shown in Fig. 1) such that
i) the first jaw surface and the second jaw surface are disposed outside of the outer sheath (see Fig. 1) and
ii) when a distance between the distal end opening and the first jaw surface and the second jaw surface is reduced, the first jaw surface and the second jaw surface are brought toward one another for grasping a body therebetween (see Para. [0026] mentioning wherein distal translation of the outer sheath causes closing of the jaws);
a hollow tube (vacuum lines 116/216, see Figs. 1-3, which extend from the proximal end of the handle (shown in Figs. 1-3), through the shaft (524) and into the jaws to connect to the vacuum apertures (534) as recited in Para. [0035]) partially embedded in the first member (see Para. [0035] mentioning wherein the vacuum lines extend through the shaft and into the jaws to couple the vacuum apertures (534) to the vacuum source; the distal portion of the vacuum lines extend into the jaws while the proximal portion does not, resulting in a “partial embedding” of the vacuum lines within the jaw(s)) and projecting out of the first member (see Para. [0035] mentioning where the vacuum lines extend from the proximal end of the handle, through the shaft (524), and into each jaw to connect the apertures to the vacuum source; the portion of the vacuum lines extending proximally from the jaw into the lumen of shaft (524) “projects” out of from jaws; see Examiner’s Diagram of Fig. 6 below for reference), the hollow tube connected to a plurality of apertures (see Fig. 5 showing a plurality of apertures (534) and Para. [0040] mentioning wherein the device can comprise any number of apertures in any shape or size as desired by a user) disposed in the first jaw surface (see Fig. 5) such that the hollow tube is in fluid communication with a space defined between the first jaw surface and the second jaw surface (see Para. [0035] and Figs. 6-7);
wherein a first portion of the hollow tube is embedded in the first member (see Para. [0035] mentioning wherein the vacuum lines extend distally from a proximal vacuum source, through the shaft (524) and into both jaws to connected to the apertures (534); the portion of the vacuum lines disposed/embedded within the jaws are designated as the “first portions” thereof; see Examiner’s Diagram of Fig. 6 below for reference);
wherein a second portion of the hollow tube is disposed outside of the first member (see Para. [0035] mentioning wherein a more proximal portion of vacuum lines extend through shaft (524) proximal to the jaws to connect to a proximal vacuum source; the portion of the vacuum lines extending through the shaft, proximal to the jaws (526), are designated as the “second portions” thereof; see Examiner’s Diagram of Fig. 6 below for reference), and at least partially within the outer sheath (the proximal, “second portion” of the vacuum lines are disposed within shaft (524) which itself is disposed within sleeve (106) as recited in Para. [0025]-[0026] and [0031]), the second portion of the hollow tube and the first member extending through the outer sheath (the “second portion” of the vacuum lines are disposed through the shaft (524) which itself is disposed within the sleeve; see also Para. [0026] mentioning wherein the outer sleeve axially translates over the jaws to cause a closing actuation thereof; as the sleeve is translated distally over at least a proximal portion of the jaws, both of the jaws and the “second portion” of the vacuum lines are disposed radially within said sleeve) radially adjacent to one another (see Examiner’s Diagram of Fig. 6 below showing wherein the illustrated jaw (i.e., the first member) extends both longitudinally and radially outward from the “second portion” of the vacuum line while remaining adjacent thereto);
wherein the hollow tube is fluidically connectable with a source of suction (see Para. [0036]) having a suction pressure sufficient to draw the body toward the first jaw surface (see Para. [0024], [0040] and [0044]);
wherein the hollow tube includes:
a main portion at least partially embedded in the first member (distal-most portion of the vacuum lines that extend through the each jaw to connect to each of the plurality of apertures; see Para. [0035] and Examiner’s Diagram of Fig. 6 below); and
a plurality of branch portions that are each embedded in the first member (see Examiner’s Diagram of Fig. 7 below; the thickness/width of each of the vacuum through-holes (534) traveling through a length of the jaw body and connecting the aperture opening to the interior space of the jaw (i.e., to the vacuum lines) are designated as the “plurality of branch portions” which connect the aperture opening in the jaw face to the vacuum line(s) disposed within the jaw body; this is consistent with the disclosed invention as shown in Fig. 5 wherein each elongated portion of “aperture 402” is interpreted to be the “branch portion” connecting the aperture within the jaw face to the hollow vacuum tube within the jaw body. No other mention of “branch passages” or details pertaining to the “aperture 402” is found within the disclosed Specification to provide further limiting structure and/or function of the claimed “branch portions”); and
wherein the plurality of branch portions each extend between and connect the main portion and a respective aperture of the plurality of apertures (the thickness/length of the vacuum channels within the jaw walls connect of each vacuum aperture/opening of the jaw face with the vacuum lines within the lumen of the jaw bodies as shown in Fig. 5 and Examiner’s Diagram of Fig. 7 below).
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Examiner’s Diagram of Fig. 6
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Examiner’s Diagram of Fig. 7
Claim Rejections - 35 USC § 103
11. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
12. 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.
13. Claim(s) 1, 6-7, 11-12 and 20-31 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Batchelor (US 2019/0192178 A1)(previously of record) in view of Hallen (US 2022/0117779 A1)(previously of record).
Regarding claim 1, Batchelor discloses:
A surgical forceps (see Fig. 1), comprising:
two elongated members including a first member and a second member (jaws 10, see Fig. 1), the first member having a distal end with a first jaw surface (see Fig. 2A showing a first jaw surface as the upper jaw 10), the second member having a distal end with a second jaw surface (see Fig. 2A showing a second jaw surface as the lower jaw 10) disposed in opposing relation to the first jaw surface (see Fig. 2A);
an outer sheath (tube 9, see Fig. 1) in which the two elongated members are disposed (see Fig. 1 showing wherein the proximal portions of the jaws are disposed within tube 9; see also Para. [0031] mentioning wherein the outer tube may function to actuate and house the jaw members), the two elongated members protruding from a distal end opening of the outer sheath (see Fig. 1 showing wherein the distal portions of the jaws are exposed from tube 9) such that:
the first jaw surface and the second jaw surface are disposed outside of the outer sheath (see Fig. 1);
a fluid passage is disposed in the first member (a distal portion of fluid line 20 is disposed within the upper jaw, see Fig. 2A), the fluid passage opening into a space defined between the first jaw surface and the second jaw surface (see Fig. 2A) via at least one aperture disposed in the first jaw surface (opening 40, see Fig. 2A);
wherein the fluid passage is fluidically connectable with a source of suction having a suction pressure sufficient to draw the body toward the first jaw surface (see Para. [0055] and [0057]) and to provide additional holding power when the body is grasped between the first jaw surface and the second jaw surface (see Para. [0055] and [0057] mentioning wherein the fluid line connects to a fluid opening (40) within the jaw surface and is configured to apply a vacuum therethrough; the vacuum applied through the jaws is disclosed to “assist in the holding of a feature of interest on the jaws”);
wherein the first member includes:
a first portion (proximal portion of the upper jaw member, see Examiner’s Diagram of Fig. 2A below);
a second portion disposed outside of the outer sheath (see Fig. 1 showing wherein a distal portion of the jaws are extending distally from tube 9); and
an angular portion extending obliquely between and connecting the first portion and the second portion (see Examiner’s Diagram of Fig. 2A below illustrating an angular portion extending obliquely between a proximal first portion and distal second portion of the upper first jaw member);
wherein the fluid passage is in fluid communication with the source of suction via a hollow tube (see Para. [0055] and [0057] mentioning wherein a vacuum can be applied through the fluid line (20) into the passage disposed within the upper first jaw, the proximal portion of the fluid line extending proximally from the jaws and through the tube 9 constituting the “hollow tube”), at least a portion of the hollow tube disposed outside of the first member and contacting an exterior surface of the angular portion of the first member (see Examiner’s Diagram of Fig. 2A below showing wherein a proximal portion of the fluid line extends proximally out from and contacts a surface of the angular portion of the upper jaw).
However, while Batchelor discloses wherein the outer tube may be used to open and close the end effector jaws (see Para. 0031]), Batchelor does not expressly disclose an actuation mechanism for this feature and thus does not expressly disclose:
when a distance between the distal end opening and the first jaw surface and the second jaw surface is reduced, the first jaw surface and the second jaw surface are brought toward one another for grasping a body therebetween;
wherein a diameter of the at least one aperture is equal to a diameter of at least a portion of the fluid passage; and
wherein the first portion of the first member is disposed at least partially in the outer sheath.
In the same field of endeavor, namely surgical forceps devices comprising a vacuum tube, Hallen teaches:
A surgical forceps (surgical instruments 100, see Fig. 1), comprising:
two elongated jaw members (arms 526, see Fig. 5);
an outer sheath in which the two elongated members are disposed (sleeve 106, see Fig. 1; the outer sleeve is noted to be present in all embodiments to house the jaws per Para. [0025]-[0026] and [0031]), the two elongated members protruding from a distal end opening of the outer sheath (see Fig. 1 showing jaws 122, akin to jaws 522, extending from a distal end of the sleeve 106) such that
i) the first jaw surface and the second jaw surface are disposed outside of the outer sheath (see Fig. 1) and
ii) when a distance between the distal end opening and the first jaw surface and the second jaw surface is reduced, the first jaw surface and the second jaw surface are brought toward one another for grasping a body therebetween (see Para. [0026] mentioning wherein during actuation, the outer sleeve is advanced and retracted over the jaw members to cause opening and closing thereof).
Since Batchelor discloses wherein the outer tube (9) may house and actuate the jaws but is silent as to a specific mechanism of performing this function, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to the available analogous prior art and to have modified the actuation mechanism of the outer tube of Batchelor to comprise the function of, wherein upon actuation of a proximal trigger, the outer tube 9 is axially translated over the distal jaws to cause opening and closing thereof as taught and suggested by Hallen. Upon initial actuation of the outer tube of Batchelor, the proximal portion of the jaw members would be disposed within the outer tube 9 while the distal portion is still exposed therefrom until complete jaw closure wherein the jaws are entirely within the outer tube (see Hallen Para. [0026]).
Regarding the limitations of “wherein a diameter of the at least one aperture is equal to a diameter of at least a portion of the fluid passage”, there is no evidence of record that establishes that changing the size of the fluid lines would result in a difference in function of the device of Batchelor. A person having ordinary skill in the art, being faced with modifying the size of the fluid lines of Batchelor would have a reasonable expectation of success in making such a modification and it appears the device of Batchelor would function as intended being given the claimed fluid line sizes. Lastly, applicant has not disclosed that the claimed size of the apertures and/or the fluid line solves any stated problem and provides no description in regards to the size of the fluid line and indicates that the sizes of the apertures are typically within a range of 1 micron to 1 millimeter, providing no description that the size of the apertures are equal to the diameter of the fluid passage, in addition to providing no preferred or exemplary diameter of the main passage. Therefore, it appears to the examiner that the limitations for this claim does not have written support within the specification and instead rely on the disclosed drawings to show these features. The examiner therefore contends that the relative sizes and dimensions claimed contain no criticality and thus one of ordinary skill in the art would have had a reasonable expectation of success in modifying the size of the fluid lines to have diameters equal the diameter of their respective apertures, since it has been held that matters of shape and size are within the capabilities of one of skill in the art to modify as a matter of design choice, absent a disclosure of criticality.
Therefore, it would have been obvious to one of having ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the diameters of the fluid lines of Batchelor to comprise a diameter that is equal a diameter of the respective aperture.
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Examiner’s Diagram of Fig. 2A
Regarding claim 6, the combination of Batchelor and Hallen disclose the invention of claim 1, Batchelor further discloses wherein the first jaw surface and the second jaw surface are each elongated, having a width and a length that exceeds the width (see Fig. 2A and 3-4 showing clearly that the jaws of Batchelor are longer than they are wide).
Regarding claim 7, the combination of Batchelor and Hallen disclose all of the limitations of the invention of claim 1.
Hallen further discloses wherein the two elongated members are each bent outwardly then toward one another forming a pincer configuration (see Fig. 5-6) as an alternative to a configuration in which the grip faces extend in a direction parallel to the longitudinal axis (see Figs. 8-9 and Para. [0039], both of which are configured to be used interchangeably with same surgical instrument to which the jaws are attached (see Para. [0031] and [0037]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the jaws of the device of Batchelor be shaped such that they are bent outwardly then toward one another forming a pincer configuration as disclosed by Hallen since Hallen discloses wherein this configuration is interchangeable with a configuration in which the jaws extend in a direction parallel to the longitudinal axis without departing from the scope of functionality of the disclosed suction forceps. Therefore, without any expressly disclosed benefit to utilizing one configuration over the other, one of ordinary skill in the art would have expected the device of Batchelor to functionally equally well with either a pincer or planar distal jaw tip configuration.
Regarding claim 11, the combination of Batchelor and Hallen disclose the invention of claim 1, Batchelor further discloses:
A method of performing a surgical procedure, comprising:
providing the surgical forceps of claim 1 (see Fig. 1);
inserting the distal end of each of the two elongated members into an anatomical space (see Para. [0027] wherein the jaws are configured to grip tissue, veins and arteries that are disposed within an anatomical space);
grasping a body with the first jaw surface and the second jaw surface (see Para. [0005], [0027] and [0056]);
drawing the body toward the first jaw surface via the suction pressure (see Para. [0005] and [0040]); and
at least one of i) manipulating the body in the anatomical space with the surgical forceps and ii) removing the body from the anatomical space with the surgical forceps (see Para. [0005] and [0040] wherein tissue is gripped between the pair of jaws while a suction is applied thereto, thereby manipulating the gripped tissue; see also Para. [0045]-[0046] wherein a blade disposed between the jaws may be used to cut tissue, thereby further manipulating said tissue).
Regarding claim 12, the combination of Batchelor and Hallen disclose the method of claim 11, Batchelor further discloses wherein the body is at least one of: a tissue; a retinal tissue; an extramacular preretinal tissue; an internal limiting membrane (ILM) in a macula of an eye; a foreign body disposed in the anatomical space; inflammatory debris; and an inflammatory membrane (see Para. [0056] wherein the jaws are configured to grip tissue).
Regarding claim 20, the combination of Batchelor and Hallen disclose all of the limitations of the invention of claim 1, Batchelor further discloses wherein the fluid passage includes a main passage at least partially embedded in the first member (see Examiner’s Diagram of Fig. 2A_Jaws below showing wherein the fluid line comprises a “main passage” embedded within the upper jaw identified as the linearly-extending proximal portion of the fluid line disposed within the upper first jaw) and a branch passage that is embedded in the first member (see Examiner’s Diagram of Fig. 2A_Jaws below showing wherein the fluid line comprises an angled “branch passage” extending distally from the “main passage” and embedded within the upper jaw member defined as the angular distal portion of the fluid line disposed within the upper first jaw and connecting to the fluid opening (40)) and the branch passage extends between and connects the main passage and the distal aperture (see Examiner’s Diagram of Fig. 2A_Jaws below showing wherein the identified “branch passage” extends between the distal aperture (40) and the “main passage” of the fluid line).
However, the combination as currently presented does not expressly disclose wherein: the at least one aperture includes a plurality of apertures; and the fluid passage includes a plurality of branch passages that are each embedded in the first member.
Hallen further teaches wherein a surgical suction forceps may comprise any number of distal suction apertures in any arrangement and size as a matter of obviousness within the art without affecting the scope of functionality of the device (see Para. [0040] and Figs. 5-7), wherein the vacuum lines of Hallen fluidly connect to the through-holes disposed within the forceps jaws (see Para. [0036]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have modified the number of distal fluid line openings disposed within the upper first jaw of Batchelor to comprise a plurality of apertures (i.e., more than one) as disclosed by Hallen, since Hallen discloses that it is a matter of obviousness to include any number of distal fluid/vacuum apertures without departing from the scope of or altering the functionality of the disclosed vacuum forceps (see Para. [0040]). Therefore, one of ordinary skill in the art would have expected the device of Batchelor to functional equally well with more than one distal fluid line opening. Additional angular “branch passages” would be included the connect the additional aperture openings to the main passage of the fluid line to remain consistent with the disclosure of Batchelor.
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Examiner’s Diagram of Fig. 2A_Jaws
Regarding claim 21, the combination of Batchelor and Hallen disclose all of the limitations of the invention of claim 20.
However, while Hallen, as incorporated into the device of Batchelor, discloses wherein the vacuum/fluid through-holes within the jaws could have any size, shape and number (see Para. [0040]) as a matter of obviousness, none of either Batchelor or Hallen expressly disclose wherein a diameter of at least a portion of the main passage is equal to a diameter of at least one of the plurality of apertures.
There is no evidence of record that establishes that changing the size of fluid/vacuum openings within each jaw member would result in a difference in function of the device of Batchelor. Rather, Hallen, as incorporated into the device of Batchelor, expressly discloses that it is within the scope of the invention for a user to configure the vacuum/fluid openings to be any size, shape or number desired to best fit the function of the device (see Hallen Para. [0040]). Further, a person having ordinary skill in the art, being faced with modifying the openings of Batchelor would have a reasonable expectation of success in making such a modification and it appears the device of Batchelor would function as intended being given the claimed opening and/or main passage sizes. Lastly, applicant has not disclosed that the claimed size of the apertures solves any stated problem, indicating that the sizes of the apertures are typically within a range of 1 micron to 1 millimeter, and provides no description that the size of the apertures are equal to the diameter of the main fluid passage, in addition to providing no preferred or exemplary diameter of the main passage. It appears to the examiner that the limitations for this claim does not have written support within the specification and instead rely on the disclosed drawings to show these features. The examiner therefore contends that the relative sizes and dimensions claimed contain no criticality and thus one of ordinary skill in the art would have had a reasonable expectation of success in modifying the size of the apertures to have diameters equal to at least a portion of the main passage, since it has been held that matters of shape and size are within the capabilities of one of skill in the art to modify as a matter of design choice, absent a disclosure of criticality.
Therefore, it would have been obvious to one of having ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the diameters of the fluid/vacuum openings of Batchelor to comprise a diameter that is equal to the diameter of at least a portion of the main passage as a matter of design choice within the skill of the art.
Regarding claim 22, the combination of Batchelor and Hallen discloses all of the limitations of the invention of claim 20.
However while Hallen, as incorporated into the device of Batchelor, discloses wherein the through-holes within the jaws could have any size, shape and number (see Para. [0040]) as a matter of obviousness, none of either Batchelor or Hallen expressly disclose wherein a diameter of at least one of the plurality of branch passages is equal to a diameter of the respective aperture.
There is no evidence of record that establishes that changing the size of vacuum/fluid openings of each jaw member would result in a difference in function of the device of Batchelor. Rather, Hallen, as incorporated into the device of Batchelor, expressly discloses that it is within the scope of the invention for a user to configure the vacuum/fluid apertures to be any size, shape or number desired to best fit the function of the device (see Hallen Para. [0040]). Further, a person having ordinary skill in the art, being faced with modifying the vacuum/fluid openings of Batchelor would have a reasonable expectation of success in making such a modification and it appears the device of Batchelor would function as intended being given the claimed vacuum/fluid opening sizes. Lastly, applicant has not disclosed that the claimed size of the apertures solves any stated problem, indicating that the sizes of the apertures are typically within a range of 1 micron to 1 millimeter, and provides no description that the size of the apertures are equal to the diameter of the fluid passage, in addition to providing no preferred or exemplary diameter of the main passage. It appears to the examiner that the limitations for this claim does not have written support within the specification and instead rely on the disclosed drawings to show these features. The examiner therefore contends that the relative sizes and dimensions claimed contain no criticality and thus one of ordinary skill in the art would have had a reasonable expectation of success in modifying the size of the vacuum/fluid openings to have diameters equal to at least a portion of the corresponding branch passages passage, since it has been held that matters of shape and size are within the capabilities of one of skill in the art to modify as a matter of design choice, absent a disclosure of criticality.
Therefore, it would have been obvious to one of having ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the diameters of the vacuum/fluid openings of Batchelor to comprise a diameter that is equal to the diameter of the branch passages as a matter of design choice within the skill of the art.
Regarding claim 23, the combination of Batchelor and Hallen discloses all of the limitations of the invention of claim 20.
However, while Hallen, as incorporated into the device of Batchelor, discloses wherein the through-holes within the jaws could have any size, shape and number (see Para. [0040]), none of either Batchelor or Hallen expressly disclose wherein a diameter of at least one of the plurality of branch passages is equal to a diameter of at least a portion of the main passage.
There is no evidence of record that establishes that changing the size of fluid lines of each jaw member would result in a difference in function of the device of Batchelor. Rather, Hallen, as incorporated into the device of Batchelor, expressly discloses that it is within the scope of the invention for a user to configure the apertures of the vacuum lines to be any size, shape or number desired to best fit the function of the device (see Hallen Para. [0040]). Further, a person having ordinary skill in the art, being faced with modifying the fluid lines of Batchelor would have a reasonable expectation of success in making such a modification and it appears the device of Batchelor would function as intended being given the claimed fluid line sizes. Lastly, applicant has not disclosed that the claimed size of the fluid lines solves any stated problem providing no description that the diameter of the branch passages are equal to the diameter of the main passage, in addition to providing no preferred or exemplary diameter of the main passage. It appears to the examiner that the limitations for this claim does not have written support within the specification and instead rely on the disclosed drawings to show these features. The examiner therefore contends that the relative sizes and dimensions claimed contain no criticality and thus one of ordinary skill in the art would have had a reasonable expectation of success in modifying the size of the branch passages to have diameters equal to at least a portion of the main passage, since it has been held that matters of shape and size are within the capabilities of one of skill in the art to modify as a matter of design choice, absent a disclosure of criticality.
Therefore, it would have been obvious to one of having ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the diameters of the branch passages of Batchelor to comprise a diameter that is equal to the diameter of main passage connecting thereto as a matter of design choice within the skill of the art.
Regarding claim 24, the combination of Batchelor and Hallen disclose all of the limitations of the invention of claim 20.
However, while Hallen, as incorporated into the device of Batchelor, discloses wherein the through-holes within the jaws could have any size, shape and number (see Para. [0040]) as a matter of obviousness, none of either Batchelor or Hallen expressly disclose wherein a diameter of at least one of the plurality of branch passages is equal to i) a diameter of the respective aperture and ii) a diameter of at least a portion of the main passage.
There is no evidence of record that establishes that changing the size of fluid lines and/or apertures of each jaw member would result in a difference in function of the device of Batchelor. Rather, Hallen, as incorporated into the device of Batchelor, expressly discloses that it is within the scope of the invention for a user to configure the apertures of the vacuum lines to be any size, shape or number desired to best fit the function of the device (see Hallen Para. [0040]). Further, a person having ordinary skill in the art, being faced with modifying the fluid lines and/or apertures of Batchelor would have a reasonable expectation of success in making such a modification and it appears the device of Batchelor would function as intended being given the claimed fluid line and apertures sizes. Lastly, applicant has not disclosed that the claimed size of the fluid lines or apertures solves any stated problem providing no description that the diameter of the branch passages are equal to the diameter of the main passage, in addition to providing no preferred or exemplary diameter of the main passage. It appears to the examiner that the limitations for this claim does not have written support within the specification and instead rely on the disclosed drawings to show these features. The examiner therefore contends that the relative sizes and dimensions claimed contain no criticality and thus one of ordinary skill in the art would have had a reasonable expectation of success in modifying the size of the branch passages to have diameters equal to at least a portion of the main passage and a diameter of a respective aperture, since it has been held that matters of shape and size are within the capabilities of one of skill in the art to modify as a matter of design choice, absent a disclosure of criticality.
Therefore, it would have been obvious to one of having ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the diameters of the branch passages of Batchelor to comprise a diameter that is equal to the diameter of main passage connecting thereto in addition to the distal aperture as a matter of design choice within the skill of the art.
Regarding claim 25, the combination of Batchelor and Hallen disclose the invention of claim 20, Batchelor, as modified by Hallen, further discloses wherein the plurality of branch passages each project radially outward from the main passage (see Examiner’s Diagram of Fig. 2A above showing wherein the branch passages of Batchelor are projecting radially outward from the main passage to connect to the opening apertures within the jaw face).
Regarding claim 26, the combination of Batchelor and Hallen disclose the invention of claim 20, Batchelor, as modified by Hallen, further discloses wherein the plurality of branch passages each extend obliquely relative to the first jaw surface and at least a portion of the main passage (see Examiner’s Diagram of Fig. 2A _Jaws above showing wherein the branch passages of Batchelor extend at a varying oblique angle between the main passage and distal opening in a gradual bend).
Regarding claim 27, the combination of Batchelor and Hallen disclose all of the limitations of the invention of claim 1.
Hallen further teaches wherein the fluid passage is defined directly by the first member (see Figs. 6-7 and Para. [0035] mentioning wherein the jaws may be hollow to connect to the vacuum source; see also Para. [0035] mentioning wherein a physical vacuum line may extend through the jaws as an alternative to the hollow opening configuration).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have achieved the predictable result of having the fluid passage be defined by a hollow space within the upper jaw of Batchelor since Hallen discloses wherein a physical vacuum line or a hollow chamber acting as a vacuum line may be used interchangeably with one-another as a matter of obviousness without affecting the scope or functional of the disclosed suction forceps. Therefore, one of ordinary skill in the art would have expected the forceps of Batchelor to function equally well with either a hollow chamber or physical fluid line acting as a lumen for transmitting a vacuum source to the distal openings within the first jaw without affecting the overall functionality of the disclosed device.
Regarding claim 28, the combination of Batchelor and Hallen disclose the invention of claim 1, Batchelor further discloses wherein the fluid passage is defined by a portion of the hollow tube that is embedded in the first member (see Batchelor Fig. 2A and Para. [0057] mentioning wherein the fluid line is a physical line that can be opened and closed).
Regarding claim 29, Batchelor discloses:
A surgical forceps (see Fig. 1), comprising:
two elongated members including a first member and a second member (jaws 10, see Fig. 1), the first member having a distal end with a first jaw surface (see Fig. 2A showing a first jaw surface as the upper jaw 10), the second member having a distal end with a second jaw surface (see Fig. 2A showing a second jaw surface as the lower jaw 10) disposed in opposing relation to the first jaw surface (see Fig. 2A);
an outer sheath (tube 9, see Fig. 1) in which the two elongated members are disposed (see Fig. 1 showing wherein the proximal portions of the jaws are disposed within tube 9 and Para. [0031] mentioning wherein the outer tube may function to actuate the jaw members), the two elongated members protruding from a distal end opening of the outer sheath (see Fig. 1 showing wherein the distal portions of the jaws are exposed from tube 9) such that:
the first jaw surface and the second jaw surface are disposed outside of the outer sheath;
a hollow tube (fluid line 20, see Fig. 2A) partially embedded in the first member (see Fig. 2A) and projecting out of the first member (see Fig. 2A showing wherein a proximal portion of the fluid line projects proximally out from the upper first jaw member), the hollow tube connected at least one aperture (opening 40, see Fig. 2A) disposed in the first jaw surface (see Fig. 2A) such that the hollow tube is in fluid communication with a space defined between the first jaw surface and the second jaw surface (see Para. [0055] and [0057]);
wherein a first portion of the hollow tube is embedded in the first member (see Fig. 2A showing a distal portion of the fluid tube is embedded within the upper first jaw; this portion of the fluid line is designated as the “first portion” of said fluid line);
wherein a second portion of the hollow tube is disposed outside of the first member (see Fig. 2A showing wherein a proximal portion of the fluid line projects proximally out from the upper first jaw; this portion of the fluid line proximal to the jaws is designated as the “second portion” of said fluid line), and at least partially within the outer sheath (as the proximal portions of each jaw are disposed within the tube 9, the “second portion” of the fluid line projects proximally from the upper first jaw into the tube 9), the second portion of the hollow tube and the first member extending through the outer sheath radially adjacent to one-another (see Para. [0031] mentioning wherein the outer tube may function to bias the jaws and house at least a portion of said jaws therein; see Fig. 2A showing wherein the jaw is along a different radial plane to that of the “second portion” of the fluid line when in the open configuration which places the first jaw and “second portion” of the fluid line radially-adjacent to one-another);
wherein the hollow tube is fluidically connectable with a source of suction (see Para. [0055] and [0057]) having a suction pressure sufficient to draw the body toward the first jaw surface (see Para. [0055] and [0057]); and
wherein the hollow tube includes:
a main portion at least partially embedded in the first member (see Fig. 2A_Jaws below illustrating a “main portion” of the fluid line disposed within the first member); and
at least one branch portion that is embedded in the first member (see Fig. 2A_Jaws below illustrating a “branch portion” of the fluid line angularly extending distally from the “main portion”);
wherein the branch portion extends between and connect the main portion and a respective aperture (see Fig. 2A_Jaws below showing wherein the “branch portion” extends between the “main portion” and the fluid opening).
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Examiner’s Diagram of Fig. 2A_Jaws
However, while Batchelor discloses wherein the outer tube may be used to open and close the end effector jaws (see Para. 0031]), in addition to wherein one or more fluid lines may be present within a single jaw member (see Para. [0049]), Batchelor does not expressly disclose:
when a distance between the distal end opening and the first jaw surface and the second jaw surface is reduced, the first jaw surface and the second jaw surface are brought toward one another for grasping a body therebetween;
a plurality of apertures disposed in the first member;
a plurality of branch portions embedded in the first member such that the plurality of branch portions extend between and connect the main portion and a respective aperture of the plurality of apertures.
In the same field of endeavor, namely surgical forceps devices comprising a vacuum tube, Hallen teaches:
A surgical forceps (surgical instruments 100, see Fig. 1), comprising:
two elongated jaw members (arms 526, see Fig. 5);
an outer sheath in which the two elongated members are disposed (sleeve 106, see Fig. 1, noting that the outer sleeve is present in all embodiments to house the jaws unless otherwise stated, see Para. [0025]-[0026]), the two elongated members protruding from a distal end opening of the outer sheath (see Fig. 1 showing jaws 122, akin to jaws 522, extending from a distal end of the sleeve 106) such that
i) the first jaw surface and the second jaw surface are disposed outside of the outer sheath (see Fig. 1) and
ii) when a distance between the distal end opening and the first jaw surface and the second jaw surface is reduced, the first jaw surface and the second jaw surface are brought toward one another for grasping a body therebetween (see Para. [0026] mentioning wherein during actuation, the outer sleeve is advanced and retracted over the jaw members to cause opening and closing thereof).
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 the actuation mechanism of the outer tube of Batchelor to comprise wherein upon actuation of a proximal trigger, the outer tube 9 is slid over the distal jaws to cause opening and closing as taught and suggested by Hallen to, in this case, provide a known actuation method of allowing the outer tube to actuate the distal end effector jaws. Since Batchelor was silent as to a method of how this disclosed mechanism occurs, one of ordinary skill in the art would have looked to available prior art to provide a known means of initiating this actuation method. Therefore, upon initial actuation of the outer tube of Batchelor, the proximal portion of the jaw members would be disposed within the outer tube 9 while the distal portion is still exposed therefrom until complete jaw closure wherein the jaws are entirely within the outer tube (see Hallen Para. [0026]).
Hallen further teaches wherein a surgical suction forceps may comprise any number of distal suction apertures in any arrangement and size as a matter of obviousness within the art without affecting the scope of functionality of the device (see Para. [0040] and Figs. 5-7), wherein the vacuum lines of Hallen connect directly to the through-holes disposed within the forceps jaws (see Para. [0036]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have modified the number of distal fluid line openings disposed within the upper first jaw of Batchelor to comprise a plurality of apertures (i.e., more than one) as disclosed by Hallen, since Hallen discloses that it is a matter of obviousness to include any number of distal fluid/vacuum apertures without departing from the scope of or altering the functionality of the disclosed vacuum forceps (see Para. [0040]). Therefore, one of ordinary skill in the art would have expected the device of Batchelor to functional equally well with more than one distal fluid line opening. Additional angular “branch passages” would be included the connect the additional aperture openings to the main passage of the fluid line to remain consistent with the disclosure of Batchelor.
Regarding claim 30, the combination of Batchelor and Hallen disclose the invention of claim 29, Batchelor, as modified by Hallen, further discloses wherein: the first member includes: a first portion (proximal portion of the upper jaw member, see Examiner’s Diagram of Batchelor Fig. 2A below) disposed at least partially in the outer sheath (during initial actuation of the tube of Batchelor over the distal jaws to cause a closing force to be imparted thereto, as incorporated from the teachings of Hallen, the proximal “first portion” of the jaws of Batchelor would be disposed within the tube 9); a second portion disposed outside of the outer sheath (see Examiner’s Diagram of Batchelor Fig. 2A below showing a “second portion” that would protrude from the tube 9 during initial actuation of the tube over the distal jaws before the jaws become completely closed); and an angular portion extending obliquely between and connecting the first portion and the second portion (see Examiner’s Diagram of Batchelor Fig. 2A below illustrating this “angular portion” of the jaws of Batchelor); and the hollow tube projects out of the first member through the angular portion of the first member (see Examiner’s Diagram of Batchelor Fig. 2A below) and into an interior space of the outer sheath that surrounds the two elongated members (as the jaws are contained within the tube 9 of Batchelor, the proximal portion of the fluid line shown in Fig. 2A projects proximally out from the angular portion of the upper first jaw and into the outer tube 9 surrounding the proximal portion of the jaws).
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Batchelor Examiner’s Diagram of Fig. 2A
Regarding claim 31, the combination of Batchelor and Hallen disclose the invention of claim 1, Batchelor further discloses wherein the hollow tube projects out of the first member at a location that is offset from the outer sheath in a radially inward direction (see Figs. 2A-2B showing wherein the proximal portion of the fluid line can become “pinched’ (see Para. [0050]) causing the fluid line to deflect at an angle which would be radially offset from a central axis of the outer tube within which the fluid line extends).
Regarding claim 33, the combination of Batchelor and Hallen disclose all of the limitations of the invention of claim 29.
While Hallen discloses wherein the through-holes within the jaws could have any size, shape and number (see Para. [0040]) as a matter of obviousness, none of either Batchelor or Hallen expressly disclose wherein a diameter of at least one of the plurality of branch portions of the hollow tube is equal to at least one of i) a diameter of the respective aperture and ii) a diameter of at least a portion of the main portion of the hollow tube.
There is no evidence of record that establishes that changing the size of fluid lines and/or apertures of each jaw member would result in a difference in function of the device of Batchelor. Rather, Hallen expressly discloses that it is within the scope of the invention for a user to configure an aperture at the distal end of at least one vacuum line to be any size, shape or number desired to best fit the function of the device (see Hallen Para. [0040]). Further, a person having ordinary skill in the art, being faced with modifying the fluid lines and/or apertures of Batchelor would have a reasonable expectation of success in making such a modification and it appears the device of Batchelor would function as intended being given the claimed fluid line and apertures sizes. Lastly, applicant has not disclosed that the claimed size of the fluid lines or apertures solves any stated problem providing no description that the diameter of the branch passages are equal to the diameter of the main passage, in addition to providing no preferred or exemplary diameter of the main passage. It appears to the examiner that the limitations for this claim does not have written support within the specification and instead rely on the disclosed drawings to show these features. The examiner therefore contends that the relative sizes and dimensions claimed contain no criticality and thus one of ordinary skill in the art would have had a reasonable expectation of success in modifying the size of the branch passages to have diameters equal to at least a portion of the main passage and a diameter of a respective aperture, since it has been held that matters of shape and size are within the capabilities of one of skill in the art to modify as a matter of design choice, absent a disclosure of criticality.
Therefore, it would have been obvious to one of having ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the diameters of the branch passages of Batchelor to comprise a diameter that is equal to the diameter of main passage connecting thereto in addition to the distal aperture as a matter of design choice within the skill of the art.
14. Claim(s) 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hallen (US 2022/0117779 A1), considered prior art because of the provisional patent application filed 10/15/2020 providing full 112 written support for the published pre-grant document (previously of record).
Regarding claim 33, Hallen discloses all of the limitations of the invention of claim 32.
However, Halen does not expressly disclose wherein a diameter of at least one of the plurality of branch portions of the hollow tube is equal to at least one of i) a diameter of the respective aperture and ii) a diameter of at least a portion of the main portion of the hollow tube.
There is no evidence of record that establishes that changing the size of the branch portions of the vacuum lines would result in a difference in function of the device of Hallen. A person having ordinary skill in the art, being faced with modifying the size of the vacuum lines and/or vacuum apertures of Hallen would have a reasonable expectation of success in making such a modification and it appears the device of Hallen would function as intended being given the claimed vacuum line and aperture sizes. Lastly, applicant has not disclosed that the claimed size of the apertures and/or the branch portions solves any stated problem and provides no description of the size of the branch portion and indicates that the size of the apertures is typically between 1 micron and 1 millimeter (see Specification Para. [0013]), it appears to the examiner that the limitations for this claim does not have written support within the specification and instead rely on the disclosed drawings to show these features. The examiner therefore contends that the relative sizes and dimensions claimed contain no criticality and thus one of ordinary skill in the art would have had a reasonable expectation of success in modifying the size of the branch portions (i.e., the diameter of the portions of the apertures extending through the distal wall of the jaws to the distal opening) to have diameters equal the diameter of their respective distal apertures and a portion of the main portion of the proximal portion of the vacuum lines, since it has been held that matters of shape and size are within the capabilities of one of skill in the art to modify as a matter of design choice, absent a disclosure of criticality.
Therefore, it would have been obvious to one of having ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the diameters of the portions of the apertures extending through the thickness of the jaws to the distal opening of Hallen to comprise a diameter that is equal to at least one of i) a diameter of the respective aperture and ii) a diameter of at least a portion of the main portion of the hollow tube as a matter of design choice within the skill of the art.
Regarding claim 34, Hallen discloses:
A surgical forceps (surgical instruments 100, see Fig. 1), comprising:
two elongated members including a first member and a second member (arms 526, see Fig. 5);
the first member having a distal end with a first jaw surface (jaw 522a, see Fig. 5) and a plurality of first apertures disposed in the first jaw surface (see Fig. 5 showing a plurality of apertures 534 and Para. [0040] mentioning wherein the device can comprise any number of apertures in any shape or size as desired by a user);
the second member having a distal end with a second jaw surface (jaw 522b, see Fig. 5) disposed in opposing relation to the first jaw surface (see Figs. 5-6) and a plurality of second apertures disposed in the second jaw surface (see Fig. 5 showing a plurality of apertures 534 and Para. [0040] mentioning wherein the device can comprise any number of apertures in any shape or size as desired by a user);
an outer sheath in which the two elongated members are disposed (sleeve 106, see Fig. 1; the outer sleeve (106) is present in all embodiments to house and cause actuation of the jaws, as shown in Fig. 1; see Para. [0025]-[0026] and [0031]), the two elongated members protruding from a distal end opening of the outer sheath (see Fig. 1 showing jaws 122, akin to jaws 522, extending from a distal end of the sleeve 106; see Para. [0031] mentioning wherein the jaws shown in Figs. 5-6 are interchangeable with the jaws shown in Fig. 1) such that:
i) the first jaw surface and the second jaw surface are disposed outside of the outer sheath (see Fig. 1) and
ii) when a distance between the distal end opening and the first jaw surface and the second jaw surface is reduced, the first jaw surface and the second jaw surface are brought toward one another for grasping a body therebetween (see Para. [0026] mentioning wherein distal translation of the outer sheath causes closing of the jaws);
a first hollow tube disposed at least partially in the first member (vacuum line(s) 116/216 extending from the handle, through the shaft (524) and into jaw 522a, see Figs. 1-2 and Para. [0035]), the first hollow tube including:
i.) a first main portion disposed at least partially in the first member (see Para. [0035] wherein the vacuum lines extend distally from a proximal vacuum source, through the shaft (524) and into both jaws; the portion of the vacuum lines disposed/embedded within jaw 522a is designated as the “first main portion” thereof; see Examiner’s Diagram of Fig. 6 below for reference) and
ii.) a plurality of first branch portions disposed in the first member (see Examiner’s Diagram of Fig. 7 below showing a plurality of “first branch portions” within jaw 522a; the thickness/width of each of the vacuum through-holes (534) traveling through a length of the jaw body and connecting the aperture opening to the interior space of the jaw (i.e., to the vacuum lines) are designated as the “plurality of first branch portions” which connect the aperture opening in the jaw face to the vacuum line(s) disposed within the jaw body; this is consistent with the disclosed invention as shown in Fig. 5 wherein each elongated portion of “aperture 402” is interpreted to be the “branch portion” connecting the aperture within the jaw face to the hollow vacuum tube within the jaw body. No other mention of “branch passages” or details pertaining to the “aperture 402” is found within the disclosed Specification to provide further limiting structure and/or function of the claimed “branch portions”), the plurality of first branch portions each projecting radially outward from the first main portion (see Fig. 5 showing wherein each opening extends radially outward from the main body of the jaws within which the vacuum lines are disposed) and opening into a space defined between the first jaw surface and the second jaw surface via a respective first aperture of the plurality of first apertures (see Figs. 5-7 showing wherein each thickness portion of the apertures open up to a distal opening (524) that opens into a space defined between each jaw); and
a second hollow tube disposed at least partially in the second member (vacuum line(s) 116/216 extending from the handle, through the shaft (524) and into jaw 522b, see Figs. 1-2 and Para. [0035), the second hollow tube including:
i.) a second main portion disposed at least partially in the second member (see Para. [0035] wherein the vacuum lines extend distally from a proximal vacuum source, through the shaft (524) and into both jaws; the portion of the vacuum lines disposed/embedded within jaw 522b is designated as the “second main portion” thereof; see Examiner’s Diagram of Fig. 6 below for reference) and
ii.) a plurality of second branch portions disposed in the second member (see Examiner’s Diagram of Fig. 7 below showing a plurality of “second branch portions” within jaw 522b; the thickness/width of each of the vacuum through-holes (534) traveling through a length of the jaw body and connecting the aperture opening to the interior space of the jaw (i.e., to the vacuum lines) are designated as the “plurality of second branch portions” which connect the aperture opening in the jaw face to the vacuum line(s) disposed within the jaw body; this is consistent with the disclosed invention as shown in Fig. 5 wherein each elongated portion of “aperture 402” is interpreted to be the “branch portion” connecting the aperture within the jaw face to the hollow vacuum tube within the jaw body. No other mention of “branch passages” or details pertaining to the “aperture 402” is found within the disclosed Specification to provide further limiting structure and/or function of the claimed “branch portions”), the plurality of second branch portions each projecting radially outward from the second main portion (see Fig. 5 showing wherein each opening extends radially outward from the main body of the jaws within which the vacuum lines are disposed) and opening into the space defined between the first jaw surface and the second jaw surface via a respective second aperture of the plurality of second apertures (see Figs. 5-7 showing wherein each thickness portion of the apertures open up to a distal opening (524) that opens into a space defined between each jaw);
wherein the first hollow tube and the second hollow tube are each fluidically connectable with a source of suction (see Para. [0036]) having a suction pressure sufficient to draw the body toward at least one of the first jaw surface and the second jaw surface (see Para. [0024], [0040] and [0044]).
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Examiner’s Diagram of Fig. 6
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Examiner’s Diagram of Fig. 7
However, Hallen does not expressly disclose:
wherein a diameter of at least one of the plurality of first branch portions is equal to
i) a diameter of the respective first aperture and
ii) a diameter of at least a portion of the first main portion;
wherein a diameter of at least one of the plurality of second branch portions is equal to
i) a diameter of the respective second aperture and
ii) a diameter of at least a portion of the second main portion; and
There is no evidence of record that establishes that changing the size of the branch portions of the vacuum lines would result in a difference in function of the device of Hallen. A person having ordinary skill in the art, being faced with modifying the size of the vacuum lines and/or vacuum apertures of Hallen would have a reasonable expectation of success in making such a modification and it appears the device of Hallen would function as intended being given the claimed vacuum line and aperture sizes. Lastly, applicant has not disclosed that the claimed size of the apertures and/or the branch portions solves any stated problem and provides no description of the size of the branch portion and indicates that the size of the apertures is typically between 1 micron and 1 millimeter (see Specification Para. [0013]), it appears to the examiner that the limitations for this claim does not have written support within the specification and instead rely on the disclosed drawings to show these features. The examiner therefore contends that the relative sizes and dimensions claimed contain no criticality and thus one of ordinary skill in the art would have had a reasonable expectation of success in modifying the size of the branch portions (i.e., the diameter of the portions of the apertures extending through the distal wall of the jaws to the distal opening) to have diameters equal the diameter of their respective distal apertures and a portion of the main portion of the proximal portion of the vacuum lines, since it has been held that matters of shape and size are within the capabilities of one of skill in the art to modify as a matter of design choice, absent a disclosure of criticality.
Therefore, it would have been obvious to one of having ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the diameters of the portions of the apertures extending through the thickness of each jaw to their respective distal opening of Hallen to comprise a diameter that is equal to at least one of i) a diameter of their respective aperture and ii) a diameter of at least a portion of their respective main portion of the hollow tube as a matter of design choice within the skill of the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 20190328451 A1 to Smith, US 12558143 B2 to Gander, US 12150892 B2 to Tazawa and US 12178747 B2 to Tazawa all disclose surgical suction forceps devices comprising a plurality of vacuum branches within the end effector jaws and/or at least one main portion and branched portion of a vacuum or fluid line.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771