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 .
Response to Amendment
The amendment filed 09/05/2025 has been entered. Claims 1-13, 18-22, 25, and 27-34 remain pending in the application, claims 14-17, 23-24 and 26 have been cancelled, and claims 18-24 have been withdrawn. Applicant’s amendments to the claims have not overcome the prior art rejections previously set forth in the Non-Final Office Action mailed 05/05/2025.
Response to Arguments
Applicant’s arguments on pages 16-17 with respect to claims have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference (103 rejection of Wan) applied in the prior rejection of record for any teaching or matter specifically challenged in the argument with regards to claims 1 and 4-9, an interpretation of Heisler in view of Wan is now applied to claims 4-9. Arguments directed to the claims as amended are addressed in the body of the rejection below.
Applicant's arguments filed 09/05/2025 have been fully considered but they are not persuasive with regards to independent claim 1 on pages 11-15.
Applicant explains on pages 11-14 that the preamble of claim 1 is a claim limitation that must be considered during examination, and then argues on pages 14-15 that Richards, Heisler, and Nobles each fail to describe or suggest a suturing guidance device.
With respect to Richards, although the specification mainly discloses a gynecological speculum, paragraph 79 discloses “Specula arranged in accordance with aspects of the invention may be used in a variety of different ways, with a variety of different tools and a variety of different body openings. For example, the speculum may be used in procedures involving the use of… a scalpel or suturing instrument.” Therefore, it is clear that the device of Richards can be a suturing guidance device, as it also reads on the elements and structures claimed in claim 1 that are associated with being a suturing guidance device. Therefore, the rejection in view of Richards in maintained.
With respect to Heisler and Nobles, although the specification mainly discloses an end-cutting shaver blade and an optical valvulotome, respectively, the claim limitation is functional. That is, both devices comprise of the structure and elements as claimed in claim 1 that are associated with being a suturing guidance device, and therefore reads on being a suturing guidance device capable for wound closure procedures. In order for the preamble to give “life, meaning, and vitality” to claim 1, the claim must detail how the suturing guidance is done in a positive manner (for example, positively reciting the suture). This would seemingly eliminate the interpretation of the prior art rejections in view of Heisler and Nobles. However, for the purposes of the claims as written, the rejections in view of Heisler and Nobles are maintained.
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(s) 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 limitation(s) is/are: “guide structure” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are 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/these limitation(s) 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(s) to avoid it/them 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(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-9, 25, 27-28, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Heisler et al. (US Patent 6,419,684) in view of Wan et al. (US Patent 5,480,407), hereinafter known as “Heisler” and “Wan,” respectively.
With regards to claim 1, Heisler discloses (Figures 8-11) a suturing guidance device 304 for wound closure procedures (functional limitation – although Heisler’s device is an end-cutting arthroscopic shaver blade, the device comprises of the structure/elements claimed below and therefore reads on being a suturing guidance device for wound closure procedures), comprising:
an elongated annular body 304 having a proximal portion terminating in a proximal end (opposite end of 330), a distal portion 330 terminating in a distal end, and a proximal-to-distal passage extending completely through the annular body 304 from the proximal end to the distal end (see element 300 passing through the passage of 304 in figures 8 and 10);
wherein the annular body 304 is monolithic (see full length of the annular body 304 in figure 8 – no breaks or disruptions along the length of annular body 304 thus being monolithic);
wherein the distal portion 330 of the annular body 304 is adapted for temporary placement within or through an opening in a tissue layer (Col 5 lines 21-32 – functional limitation – annular body 304 is capable of being temporary placed, as it can be removed after use);
wherein the passage extending through the annular body 304 is hollow (figures 8 and 10), thereby enabling a user to access and introduce instrumentation 302 into an anatomical space through the passage in the annular body 304 until the annular body 304 is removed from the opening (functional limitation – Col 4 lines 54-63 - the instrumentation is functionally recited and therefore not structurally required by the claims, thus element 302 is served as an example as instrumentation however any other instrumentation is capable of traversing through the annular body 304; annular body 304 may be removable to leave the instrumentation in place);
a slit (notches 326/328 make up the slit) disposed in and defined by the distal portion of the annular body 304, the slit 326/328 extending through the distal portion of the annular body 304 transversely to the passage, and wherein the slit 326/328 is open and accessible through the distal end of the annular body 304 (figure 9).
Heisler is silent to wherein the proximal portion of the annular body includes a guide structure that remains exposed and visible to the user when the annular body is disposed in the opening in the tissue layer; and
wherein the guide structure identifies an orientation of the slit, enabling the user to guide a separate closure device into a first region of tissue on one side of the suturing guidance device, through the slit, and out from a second region of tissue on an opposing side of the suturing guidance device, then close the opening in the tissue layer using the separate closure device after the annular body is removed from the opening in the tissue layer.
However, in a similar field of endeavor of surgical cannulas, Wan teaches (Figures 1-6 and 13) wherein the proximal portion 58 of the annular body 1/5 includes a guide structure 37 (see Note below) that remains exposed and visible to the user when the annular body 1/5 is disposed in the opening in the tissue layer (figures 6 and 13, Col 7 lines 16-21); and
wherein the guide structure 37 identifies an orientation of the slit 15 (Col 7 lines 16-21; figure 6), enabling the user to guide a separate closure device 20/32 into a first region of tissue on one side of the suturing guidance device, through the slit 15, and out from a second region of tissue on an opposing side of suturing guidance device, then close the opening in the tissue layer using the separate closure device 32 after the annular body is removed from the opening in the tissue layer (functional limitation – guide structure 37 indicates where the slit 15 is located, needle 20 and suture 32 is then inserted through the slit. Although it is not explicitly stated the tissue regions with respect to the suturing guidance device, the limitation is functional and therefore the needle/suture are capable of entering a region of tissue on one side of the suturing guidance device, through the slit (as seen in figure 13), and out through another region of tissue on an opposing side of the suturing guidance device).
Note – 112(f) interpretation – Applicant’s guide structure is a visual or tactile indicator longitudinally aligned with a respective slit (spec. [0011]); Wan’s guide structure is an indicia (arrow) 37 indicating the direction of the slit 15 (Col 7 lines 16-21); therefore both guide structures are equivalent in indicating the orientation of the slit.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Heisler to include the guide structure as taught by Wan for the purpose of enabling the surgeon to observe the direction of the slit even when the suture guide is obscured (Col 7 lines 16-21 of Wan).
With regards to claim 2, Heisler further discloses wherein the annular body 304 includes a plurality of notches 326/328 projecting axially into the distal portion 330 of the annular body 304 from the distal end;
the plurality of notches 326/328 includes a first notch 326 and a second notch 328 arranged diametrically opposite one another (figure 9);
the passage separates the plurality of notches 326/328 from one another; and
the first notch 326 and the second notch 328 define the slit.
With regards to claim 3, Heisler/Wan disclose the device as claimed in claim 2. Heisler further discloses wherein:
the slit is a first slit 326/328. The combination is silent to the plurality of notches further includes a third notch and a fourth notch that define a second slit extending through the distal portion of the annular body transversely to the passage and to the first slit;
the second slit is open and accessible through the distal end of the annular body; and
the guide structure informs the user as to the orientation of the second slit.
However, Heisler teaches in the figure 7 embodiment wherein: the plurality of notches further includes a third notch and a fourth notch (figure 7; Col 4 lines 23-28) that define a second slit extending through the distal portion of the annular body 200 transversely to the passage and to the first slit (figure 7);
the second slit is open and accessible through the distal end of the annular body 200 (figure 7).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the figures 8-11 embodiment of Heisler to include the third notch and fourth notch that define a second slit as taught by the figure 7 embodiment of Heisler for the purpose of providing more of a shearing function (Col 4 lines 39-45 of Heisler) to the surgical cannula.
Wan also teaches it will be understood that the configuration and number of slits in the suture guide can vary, wherein more than two slits may be provided (Col 17 lines 44-50).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Heisler/Wan to include the guide structure informing the user as to the orientation of the second slit since it is already stated in Wan that the visual indicator 37 is used to indicate the direction of one of the slits. According to MPEP 2144.04 VI. B., In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.) There is no new and unexpected result with the addition of the second indicator since the purpose of the indicator is already disclosed by Wan (Col 7 lines 16-21), as well as the slit in the figures 1-6 and 13 embodiment having the same function as the slit in Heisler’s figure 7 embodiment.
With regards to claim 4, Heisler further discloses wherein the proximal portion of the annular body 304 includes a lip or rim (see annotated figure 8 below) adapted to remain outside of the opening in the tissue layer when the annular body 304 is disposed in the opening in the tissue layer (functional limitation – the handle of the annular body is capable of remaining outside the opening of the tissue layer during operation); and
the first and second regions of tissue are disposed on opposing sides of the annular body 304 adjacent to the lip or rim when the annular body 304 is disposed in the opening in the tissue layer (first and second regions would be on opposing sides when the device is in use; first and second regions would be close to in proximity to the lip/rim).
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With regards to claim 5, as rejected above, it would be obvious to modify the device of Heisler to include the guide structure of Wan. Wan further discloses wherein the guide structure 37 includes a visual or tactile indicator disposed on the proximal portion of the annular body (Col 7 lines 16-21; figure 6). Thus, when incorporating the guide structure of Wan, the claimed limitation is considered obvious.
With regards to claim 6, Heisler/Wan disclose the device as claimed in claim 1. Heisler further discloses wherein:
the slit is a first slit 326/328. The combination is silent to a second slit is disposed in and defined by the distal portion of the annular body;
the second slit extends through the distal portion of the annular body transversely to the passage and to the first slit;
the second slit is open and accessible through the distal end of the annular body; and
the guide structure informs the user as to the orientation of the second slit.
However, Heisler teaches in the figure 7 embodiment wherein: a second slit is disposed in and defined by the distal portion of the annular body (figure 7; Col 4 lines 23-28);
the second slit extends through the distal portion of the annular body 200 transversely to the passage and to the first slit (figure 7);
the second slit is open and accessible through the distal end of the annular body 200 (figure 7).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the figures 8-11 embodiment of Heisler to include a second slit as taught by the figure 7 embodiment of Heisler for the purpose of providing more of a shearing function (Col 4 lines 39-45 of Heisler) to the surgical device.
Wan also teaches it will be understood that the configuration and number of slits in the suture guide can vary, wherein more than two slits may be provided (Col 17 lines 44-50).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Heisler/Wan to include the guide structure informing the user as to the orientation of the second slit since it is already stated in Wan that the visual indicator 37 is used to indicate the direction of one of the slits. According to MPEP 2144.04 VI. B., In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.) There is no new and unexpected result with the addition of the second indicator since the purpose of the indicator is already disclosed by Wan (Col 7 lines 16-21), as well as the slit in the figures 1-6 and 13 embodiment having the same function as the slit in Heisler’s figure 7 embodiment.
With regards to claim 7, Heisler further discloses wherein the separate closure device includes a suture (functional limitation – the separate closure device is never positively recited in claim 1 and therefore the suturing guidance device of Heisler is capable of enabling a user to guide a separate closure device, such as a suture, into a first region of tissue, through the slit, and out from a second region of tissue).
With regards to claim 8, Heisler further discloses the proximal portion of the annular body 304 includes a lip (see annotated figure 8 below) adapted to remain outside of the opening in the tissue layer when the annular body 304 is disposed in the opening in the tissue layer (functional limitation – the handle of the annular body is capable of remaining outside the opening of the tissue layer during operation); and Wan further discloses a visual or tactile indicator 37 arranged on the lip in alignment with a corresponding first slit 15 (Col 7 lines 16-21).
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However, the combination is silent to the guide structure including a plurality of visual or tactile indicators disposed on the lip; and the plurality of visual or tactile indicators are each arranged on the lip in alignment with a corresponding one of the first slit and the second slit.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Heisler/Wan to include another visual or tactile indicator disposed on the lip and arranged in alignment with a corresponding second slit since it is already stated in Wan that the visual indicator 37 is used to indicate the direction of one of the slits. According to MPEP 2144.04 VI. B., In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.) There is no new and unexpected result with the addition of the second indicator since the purpose of the indicator is already disclosed by Wan (Col 7 lines 16-21), as well as each slit in the figure 9-10B embodiment having the same function as the slit in the figure 1 embodiment (Col 7 lines 54-56).
With regards to claim 9, Heisler further discloses wherein: the distal end of the annular body 304 has edges or corner structures that at least partially define the slit and that are shaped to minimize interference with insertion of the annular body into the opening in the tissue layer (figure 8 – functional limitation – edges and corner structures that define the slit at the distal end of 304 are capable of minimizing interference with insertion of the annular body 304 into the opening in the tissue layer).
With regards to claim 25, Heisler further discloses wherein the annular body 304 is linear (figures 8-11).
With regards to claim 27, Heisler/Wan disclose the device as claimed in claim 2. The combination is silent wherein:
the proximal portion of the annular body includes a lip adapted to remain outside of the opening in the tissue layer and visible to the user when the annular body is disposed in the opening in the tissue layer;
the guide structure includes a plurality of visual or tactile indicators disposed on the lip; and
the plurality of visual or tactile indicators are each arranged on the lip such that the plurality of notches are each in alignment with a respective visual or tactile indicator of the plurality of visual or tactile indicators.
However, Wan further teaches (Figures 1-6 and 13) wherein:
the proximal portion 72 of the annular body 5/127 includes a lip 3 adapted to remain outside of the opening in the tissue layer and visible to the user when the annular body 2 is disposed in the opening in the tissue layer (figure 31; Col 14 lines 22-27);
the guide structure 37 includes a visual indicator disposed on the lip 3; and
the visual indicator 37 arranged on the lip 3 such that the plurality of notches are each in alignment with a respective visual indicator 37 (Col 7 lines 16-21).
Wan is silent to the guide structure including a plurality of visual of tactile indicators disposed on the lip; and the plurality of visual or tactile indicators are each arranged on the lip such that the plurality of notches are each in alignment with a respective visual or tactile indicator of the plurality of visual or tactile indicators.
Wan teaches it will be understood that the configuration and number of slits in the suture guide can vary, wherein more than two slits may be provided (Col 17 lines 44-50).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Heisler/Wan to include a plurality of visual or tactile indicators that are each arranged on the guidance structure in alignment with a corresponding notch of the plurality of notches since it is already stated in Wan that the visual indicator 37 is used to indicate the direction of one of the slits, and thus the first and second notch that define the slit. According to MPEP 2144.04 VI. B., In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.) There is no new and unexpected result with the addition of the plurality of visual indicators since the purpose of the indicator is already disclosed by Wan (Col 7 lines 16-21), as well as each slit/notch in the figures 1-6 and 13 embodiment having the same function as the slit/notch in the figure 7 embodiment of Heisler.
With regards to claim 28, Heisler further discloses wherein the annular body 300 includes:
a first axial surface and a second axial surface disposed at the distal end and facing axially away from the proximal end (see annotated figure 9 below);
a first U-shaped surface extending between and connecting the first axial surface and the second axial surface, the first U-shaped surface delimiting the first notch (see annotated figure 9 below); and
a second U-shaped surface extending between and connecting the first axial surface and the second axial surface, the second U-shaped surface delimiting the second notch (see annotated figure 9 below).
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With regards to claim 32, Heisler further discloses wherein:
the annular body 304 includes an outer circumferential surface and an inner circumferential surface (figures 8 and 10);
the inner circumferential surface of the annular body 304 delimits at least a portion of the passage (figures 8 and 10 – see 302 traversing through 304); and
the plurality of notches 326/328 each extend radially between and open through the outer circumferential surface and the inner circumferential surface of the annular body 304 (figure 9).
With regards to claim 33, Heisler further discloses wherein:
the annular body 304 includes an outer circumferential surface and an inner circumferential surface (figures 8 and 10);
the inner circumferential surface of the annular body delimits at least a portion of the passage (figures 8 and 10 – see 302 traversing through 304); and
the first axial surface, the second axial surface, the first U-shaped surface, and the second U-shaped surface of the annular body extend radially between and connect the outer circumferential surface and the inner circumferential surface of the annular body 304 (see annotated figure 9 above).
Claims 1, 10-12, 29-31, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Richards et al. (US PGPub 2005/0277811), hereinafter known as “Richards,” in view of Wan.
With regards to claim 1, Richards discloses (Figures 1-7) a suturing guidance device 2 for wound closure procedures (paragraphs 79-80; functional limitation – the device comprises of the structure/elements claimed below and therefore reads on being a suturing guidance device for wound closure procedures), comprising:
an elongated annular body 2 having a proximal portion 31 terminating in a proximal end, a distal portion 5 terminating in a distal end, and a proximal-to-distal passage 4 extending completely through the annular body 2 from the proximal end to the distal end (figures 1-2; paragraphs 47-48);
wherein the annular body 2 is monolithic (see full length of the annular body 2 in figure 1 – no breaks or disruptions along the length of annular body 304 thus being monolithic);
wherein the distal portion 5 of the annular body 2 is adapted for temporary placement within or through an opening in a tissue layer (paragraph 48 – functional limitation – annular body 2 is capable of being temporary placed, as it can be removed after use);
wherein the passage 4 extending through the annular body 2 is hollow (figures 1-2; paragraph 48), thereby enabling a user to access and introduce instrumentation 9 into an anatomical space through the passage 4 in the annular body 2 until the annular body 2 is removed from the opening (functional limitation – paragraphs 48 and 54 – the instrumentation is functionally recited and therefore not structurally required by the claims, thus element 9 is served as an example as instrumentation however any other instrumentation is capable of traversing through the annular body 2; annular body 2 may be removable to leave the instrumentation in place);
a slit 6 disposed in and defined by the distal portion of the annular body 2, the slit 6 extending through the distal portion 5 of the annular body 2 transversely to the passage 4, and wherein the slit 6 is open and accessible through the distal end of the annular body 2 (figure 1; paragraph 48).
Richards is silent to wherein the proximal portion of the annular body includes a guide structure that remains exposed and visible to the user when the annular body is disposed in the opening in the tissue layer; and
wherein the guide structure identifies an orientation of the slit, enabling the user to guide a separate closure device into a first region of tissue on one side of the suturing guidance device, through the slit, and out from a second region of tissue on an opposing side of the suturing guidance device, then close the opening in the tissue layer using the separate closure device after the annular body is removed from the opening in the tissue layer.
However, in a similar field of endeavor of surgical cannulas, Wan teaches (Figures 1-6 and 13) wherein the proximal portion 58 of the annular body 1/5 includes a guide structure 37 (see Note below) that remains exposed and visible to the user when the annular body 1/5 is disposed in the opening in the tissue layer (figures 6 and 13, Col 7 lines 16-21); and
wherein the guide structure 37 identifies an orientation of the slit 15 (Col 7 lines 16-21; figure 6), enabling the user to guide a separate closure device 20/32 into a first region of tissue on one side of the suturing guidance device, through the slit 15, and out from a second region of tissue on an opposing side of the suturing guidance device, then close the opening in the tissue layer using the separate closure device 32 after the annular body is removed from the opening in the tissue layer (functional limitation – guide structure 37 indicates where the slit 15 is located, needle 20 and suture 32 is then inserted through the slit. Although it is not explicitly stated the tissue regions with respect to the suturing guidance device, the limitation is functional and therefore the needle/suture are capable of entering a region of tissue through the suturing guidance device, through the slit (as seen in figure 13), and out through another region of tissue on an opposing side of the suturing guidance device).
Note – 112(f) interpretation – Applicant’s guide structure is a visual or tactile indicator longitudinally aligned with a respective slit (spec. [0011]); Wan’s guide structure is an indicia (arrow) 37 indicating the direction of the slit 15 (Col 7 lines 16-21); therefore both guide structures are equivalent in indicating the orientation of the slit.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Richards to include the guide structure as taught by Wan for the purpose of enabling the surgeon to observe the direction of the slit even when the suture guide is obscured (Col 7 lines 16-21 of Wan).
With regards to claim 12, Richards further discloses wherein the proximal portion 31 of the annular body 2 is an integral lip or rim 3 projecting radially outward from the annular body 2 (figure 1; paragraphs 7 and 58).
With regards to claim 29, Richards further discloses wherein an axial length of the slit 6 is greater than half an axial length of the annular body 2 (see figure 1).
With regards to claim 30, Richards further discloses wherein a proximal end of the slit 6 is disposed closer to the proximal end 31 of the annular body 2 than to the distal end 5 of the annular body 2 (see figure 1).
With regards to claim 10, Richards discloses (Figures 1-7) a suturing guidance device (figure 1) for wound closure procedures (paragraphs 79-80; functional limitation – the device comprises of the structure/elements claimed below and therefore reads on being a suturing guidance device for wound closure procedures), comprising:
an elongated annular body 2 defining a cannula adapted for temporary placement in an opening of a tissue layer during use of the suturing guidance device, the annular body 2 having a proximal end 31 and a distal end 5 disposed opposite one another (paragraph 48 – functional limitation – annular body 2 is capable of being temporary placed, as it can be removed after use);
a guidance body 32 disposed at and connected to the proximal end of the annular body 2, the guidance body 32 remaining exposed and accessible by a user when the cannula 2 is disposed in the opening of the tissue layer (paragraphs 57-58);
a passage 4 defined by and extending completely through the annular body 2 and the guidance body 32 longitudinally (figures 1 and 5-7), the passage 4 enabling the user to access and introduce instrumentation 9 into an anatomical space with the suturing guidance device when the cannula 2 is disposed in the opening of the tissue layer (functional limitation – paragraphs 48 and 54 – the instrumentation is functionally recited and therefore not structurally required by the claims, thus element 9 is served as an example as instrumentation however any other instrumentation is capable of traversing through the annular body 2; annular body 2 may be removable to leave the instrumentation in place);
a plurality of notches (figure 1 – axial line where indicator line 6 is pointed to is one notch; similarly the opposite axial line represents the second notch) disposed in and defined by the annular body 2, the plurality of notches including a first notch (axial line where indicator line 6 is pointed to) and a second notch (opposite axial line) that define a slit 6 adapted to guide a closure device through the annular body 2 in a direction transverse to the passage (functional limitation – slit defined by the first notch and second notch shown in figure 1 is capable of having a closure device through the slit);
wherein the plurality of notches project axially into the annular body 2 from the distal end 5 of the annular body 2 such that (i) the slit 6 has an open axial end at the distal end 5 of the annular body 2 (paragraph 48; figure 1 – see open axial end where 4 is pointed to), and (ii), when the cannula 2 is disposed in the opening of the tissue layer and the closure device is disposed at least partially in the slit 6, the cannula 2 is removable from the opening of the tissue layer without disturbing the closure device (the closure device is functionally recited and therefore not structurally required by the claims, thus element 91 is served as an example as a closure device however any other closure device is capable of traversing through cannula 2; 2 may be removable to leave the closure device in place); and
wherein a closed axial end of the slit 6 is disposed closer to the proximal end 31 of the annular body 2 than to the distal end 5 of the annular body 2 (figures 1 and 2 – see slit 6 extend proximally into the flange portion 3 that has a closed end).
Richards is silent wherein the guidance body includes at least one visual or tactile indicator indicating an orientation of the slit to guide the user in inserting the closure device into and passing the closure device through the slit of the suturing guidance device when i) the cannula is disposed in the opening of the tissue layer and ii) the slit is not visible to the user.
However, in a similar field of endeavor of surgical cannulas, Wan teaches (Figures 1-6 and 13) wherein the guidance body 3 includes at least one visual or tactile indicator 37 indicating an orientation of the slit 15 to guide the user in inserting the closure device 20/32 into and passing the closure device 20/32 through the slit 15 of the suturing guidance device when i) the cannula 2/5 is disposed in the opening of the tissue layer and ii) the slit 15 is not visible to the user (Col 7 lines 16-21; figure 6 shows device 1).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guidance body of Richards to include a visual or tactile indicator as taught by Wan for the purpose of enabling the surgeon to observe the direction of the slit even when the suture guide is obscured (Col 7 lines 16-21 of Wan).
With regards to claim 11, Richards further discloses wherein the cannula 2 is rigid (paragraph 66 - metal).
With regards to claim 31, Richards further discloses wherein the annular body 2 is monolithic (see full length of the annular body 2 in figure 1 – no breaks or disruptions along the length of annular body 304 thus being monolithic).
With regards to claim 34, Richards discloses (Figures 1-7) a suturing guidance device 2 for wound closure procedures (paragraphs 79-80; functional limitation – the device comprises of the structure/elements claimed below and therefore reads on being a suturing guidance device for wound closure procedures), comprising:
an elongated annular body 2 defining a cannula 2 adapted for temporary placement in an opening of a tissue layer during use of the suturing guidance device 2, the annular body 2 having a proximal end 31 and a distal end 5 disposed opposite one another (figures 1-2; paragraphs 47-48 – functional limitation – annular body 2 is capable of being temporarily placed, as it can be removed after use);
a guidance body 3 disposed at and connected to the proximal end 31 of the annular body 2, the guidance body 3 remaining exposed and accessible by a user when the cannula 2 is disposed in the opening of the tissue layer (paragraphs 7 and 58);
a passage 4 defined by and extending completely through the annular body 2 and the guidance body 3 longitudinally (figures 1-2; paragraph 48), the passage 4 enabling the user to access and introduce instrumentation 9 into an anatomical space with the suturing guidance device when the cannula 2 is disposed in the opening of the tissue layer (functional limitation – paragraphs 48 and 54 – the instrumentation is functionally recited and therefore not structurally required by the claims, thus element 9 is served as an example as instrumentation however any other instrumentation is capable of traversing through the annular body 2; annular body 2 may be removable to leave the instrumentation in place);
a plurality of notches (figure 1 – axial line where indicator line 6 is pointed to is one notch; similarly the opposite axial line represents the second notch) disposed in and defined by the annular body 2, the plurality of notches including a first notch (axial line where indicator line 6 is pointed to) and a second notch (opposite axial line) that define a slit 6 adapted to guide a closure device through the annular body 2 in a direction transverse to the passage 4 (figures 1-2; paragraph 48);
wherein the plurality of notches project axially into the annular body 2 from the distal end 5 of the annular body 2 such that (i) the slit 6 is open at the distal end of the annular body 2 (paragraph 48; figure 1 – see open distal end where 4 is pointed to) and (ii), when the cannula 2 is disposed in the opening of the tissue layer and the closure device is disposed at least partially in the slit 6, the cannula 2 is removable from the opening of the tissue layer without disturbing the closure device (the closure device is functionally recited and therefore not structurally required by the claims, thus element 91 is served as an example as a closure device however any other closure device is capable of traversing through cannula 2; 2 may be removable to leave the closure device in place);
wherein the guidance body 3 is an integral lip or rim projecting radially outward from the annular body 2 (figures 1-2; paragraphs 7 and 58 – flange portion).
Richards is silent wherein the guidance body includes at least one visual or tactile indicator disposed on the lip or rim, the at least one visual or tactile indicator indicating an orientation of the slit to guide the user in inserting the closure device into and passing the closure device through the slit of the suturing guidance device when i) the cannula is disposed in the opening of the tissue layer and 11) the slit is not visible to the user.
However, in a similar field of endeavor of surgical cannulas, Wan teaches (Figures 1-6 and 13) wherein the guidance body 3 includes at least one visual or tactile indicator 37 disposed on the lip or rim 3, the at least one visual or tactile indicator 37 indicating an orientation of the slit 15 to guide the user in inserting the closure device 20/32 into and passing the closure device 20/32 through the slit 15 of the suturing guidance device when i) the cannula 2/5 is disposed in the opening of the tissue layer and ii) the slit 15 is not visible to the user (Col 7 lines 16-21; figure 6 shows device 1).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guidance body of Richards to include a visual or tactile indicator as taught by Wan for the purpose of enabling the surgeon to observe the direction of the slit even when the suture guide is obscured (Col 7 lines 16-21 of Wan).
Claims 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Nobles et al. (US Patent 5,284,478), hereinafter known as “Nobles,” in view of Wan.
With regards to claim 10, Nobles discloses (Figures 1-7) a suturing guidance device (figure 1) for wound closure procedures (functional limitation – although Nobles’s device is an optical valvulotome, the device comprises of the structure/elements claimed below and therefore reads on being a suturing guidance device for wound closure procedures), comprising:
an elongated annular body 18 defining a cannula 18 adapted for temporary placement in an opening of a tissue layer during use of the suturing guidance device, the annular body 18 having a proximal end 26 and a distal end 24 disposed opposite one another (Col 5 lines 50-55 – functional limitation – annular body 18 is capable of being temporary placed, as it can be removed after use);
a guidance body 64 disposed at and connected to the proximal end 26 of the annular body 18, the guidance body 64 remaining exposed and accessible by a user when the cannula 18 is disposed in the opening of the tissue layer (figure 1 – see guidance body 64 exposed to the vein 14);
a passage 78 defined by and extending completely through the annular body 18 and the guidance body 64 longitudinally (see figure 5 as the guide wire 12 passes through the annular body 18 and guidance body 64 longitudinally), the passage 78 enabling the user to access and introduce instrumentation 12 into an anatomical space with the suturing guidance device when the cannula 18 is disposed in the opening of the tissue layer (functional limitation – the instrumentation is functionally recited and therefore not structurally required by the claims, thus element 12 is served as an example as instrumentation however any other instrumentation is capable of traversing through the annular body 18; annular body 18 may be removable to leave the instrumentation in place);
a plurality of notches (figures 2 and 5-6 – axial lines of each cutting blade 40/42 that are opposite one another) disposed in and defined by the annular body 18, the plurality of notches including a first notch (axial line of cutting blade 40) and a second notch (opposite axial line of cutting blade 42) that define a slit 44 adapted to guide a closure device through the annular body 18 in a direction transverse to the passage (functional limitation – Col 5 line 65 – Col 6 line 2 - slit defined by the first notch and second notch shown in figures 5-6 is capable of having a closure device through the slit);
wherein the plurality of notches 40/42 project axially into the annular body 18 from the distal end 24 of the annular body 18 such that (i) the slit 44 has an open axial end at the distal end 24 of the annular body 18 (figures 2 and 5-6 – see open axial end where 44 is pointed to in figure 5), and (ii), when the cannula 18 is disposed in the opening of the tissue layer and the closure device is disposed at least partially in the slit 44, the cannula 18 is removable from the opening of the tissue layer without disturbing the closure device (the closure device is functionally recited and therefore not structurally required by the claims, thus element 12 is served as an example as a closure device however any other closure device is capable of traversing through cannula 18; 18 may be removable to leave the closure device in place); and
wherein a closed axial end of the slit 44 is disposed closer to the proximal end 26 of the annular body 18 than to the distal end 24 of the annular body 18 (figures 2 and 6 – see slit 44 extend proximally that has a closed end).
Nobles is silent wherein the guidance body includes at least one visual or tactile indicator indicating an orientation of the slit to guide the user in inserting the closure device into and passing the closure device through the slit of the suturing guidance device when i) the cannula is disposed in the opening of the tissue layer and ii) the slit is not visible to the user.
However, in a similar field of endeavor of surgical cannulas, Wan teaches (Figures 1-6 and 13) wherein the guidance body 3 includes at least one visual or tactile indicator 37 indicating an orientation of the slit 15 to guide the user in inserting the closure device 20/32 into and passing the closure device 20/32 through the slit 15 of the suturing guidance device when i) the cannula 2/5 is disposed in the opening of the tissue layer and ii) the slit 15 is not visible to the user (Col 7 lines 16-21; figure 6 shows device 1).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guidance body of Nobles to include a visual or tactile indicator as taught by Wan for the purpose of enabling the surgeon to observe the direction of the slit even when the suture guide is obscured (Col 7 lines 16-21 of Wan).
With regards to claim 13, Nobles/Wan disclose the cannula as claimed in claim 10. Nobles further discloses wherein:
the slit 44 is a first slit 44;
the plurality of notches further includes a third notch and a fourth notch that define a second slit 44 extending through the distal end 26 of the annular body 18 transversely to the passage and to the first slit 44 (see cross-sections of figures 3-4 – the U-shaped opening 44 is located on both sides of the notches/cutting edges 40/42 as seen through the two respective openings in figures 3 and 4, further figure 5 shows the top view of the device in which the slit 44 is open and accessible from the top-down);
the second slit 44 is open and accessible through the distal end 26 of the annular body 18.
Wan further discloses the visual indicator 37 arranged on the guidance body 3 in alignment with a corresponding notch (Col 7 lines 16-21). The combination is silent to the at least one visual or tactile indicator includes a plurality of visual or tactile indicators that are each arranged on the guidance body in alignment with a corresponding notch of the plurality of notches.
However, Wan also teaches it will be understood that the configuration and number of slits in the suture guide can vary, wherein more than two slits may be provided (Col 17 lines 44-50).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Nobles/Wan to include a plurality of visual or tactile indicators that are each arranged on the guidance body in alignment with a corresponding notch of the plurality of notches since it is already stated in Wan that the visual indicator 37 is used to indicate the direction of one of the slits, and thus the first and second notch that define the slit. According to MPEP 2144.04 VI. B., In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.) There is no new and unexpected result with the addition of the plurality of visual indicators since the purpose of the indicator is already disclosed by Wan (Col 7 lines 16-21), as well as each slit/notch in the figures 1-6 and 13 embodiment having the same function as the slit/notch in the figures 1-6 embodiment of Nobles.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 12/04/2025
/KATHERINE M SHI/Primary Examiner, Art Unit 3771