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 .
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 9, 11-12, 17-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (KR-20150012545-A). Note that the following parenthetical citations to Lee are taken from the English language translation provided with this Office Action.
Regarding claim 1, Lee discloses a method of retracting tissue during a surgical procedure (using retractor 200 in Figs. 5 and 6; para. 0021-0022), the method comprising:
pressing a first tissue contact surface on a distal portion of a blade of a retractor against tissue of a patient (pressing convex surface of distal portion of blade 231, i.e. near free end 233 thereof, identified in Fig. 5, against tissue of a patient as shown in Fig. 6; para. 0021-0222); and
pulling a handle (pulling handle 210/220 to provide traction force in the direction F1; Figs. 5-6; para. 0022) extending from the blade so that the blade is pulled in a retraction direction (F2 of blade 231; Fig. 6; para. 0022; see Examiner’s Annotated Fig. 5 below) that is normal to a first plane coincident with lateral edges of the distal portion of the blade such that tissue is retracted in the retraction direction (see Fig. 6 and Examiner’s Annotated Fig. 5 below; para. 0022 teaches that that the traction force F1 applied to shaft 220 uniformly distributes and acts on each of the blades 231 and 241 (F2) and the free ends of the blades 231 and 241, so that the force is applied in the direction in which the skin tissue between the blades 231 and 241 is gathered by the respective dispersed pulling force”, where F2 identified in Fig. 6 understood as the retraction direction, i.e. of blade 231, the retraction direction is normal to radius R2 identified in Fig. 5, and R2 corresponds to the lateral edges of the distal portion at free end 233 of blade 231),
wherein the handle (210/220; Figs. 5-6) is outside of a second plane coincident with a central longitudinal axis of the distal portion and the retraction direction (see Examiner’s Annotated Fig. 5 below, where the second plane coincides with the longitudinal axis of distal portion at free end 233 and is perpendicular to first plane defined by lateral edges of free end 233 of blade 231).
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Examiner’s Annotated Fig. 5 of Lee
Regarding claim 2, Lee teaches the method of claim 1, wherein pulling the handle involves pulling the handle while an elongate dimension of the handle is transverse to the second plane (see Examiner’s Annotated Fig. 5 above, and Fig. 6, where the handle 210/220 remains transverse to second plane while pulling in direction F1).
Regarding claim 3, Lee teaches the method of claim 1, wherein pulling the handle further comprises pulling a proximal portion of the blade to retract tissue, the proximal portion of the blade having a second tissue contact surface transverse to the first tissue contact surface (pulling handle 210/220 in the direction F1 shown in Fig. 6, also identified in Examiner’s Annotated Fig. 5 above, pulls a proximal portion of blade 231 defined between free/distal end portion 233 and shaft 220 to retract tissue as shown in Fig. 6, the proximal portion having a second tissue contact surface visible as a portion of traction surface 235b in Fig. 5 which is transverse to the curved surface of free/distal end portion 233; para. 0021-0022).
Regarding claim 4, Lee teaches the method of claim 3, wherein at least part of the first plane above the distal portion of the blade is unobstructed by any part of the retractor (see Examiner’s Annotated Fig. 5 above).
Regarding claim 5, Lee teaches the method of claim 1, wherein the handle is fixed relative to the blade (handle 210/220 is shown to be fixed relative to blade 231; Figs. 5-6).
Regarding claim 9, Lee teaches a method of retracting tissue during a surgical procedure (using retractor 200 in Figs. 5 and 6; para. 0021-0022) comprising:
advancing a retractor (200; Figs. 5-6) into a body of a patient (as shown in Fig. 6; para. 0022);
contacting a tissue within the patient using a distal portion of a blade of the retractor (as shown in Fig. 6, contacting oral tissue using a distal portion of blade 231, i.e. at free end 233 thereof identified in Fig. 5; para. 0021-0022); and
pulling a handle (pulling handle 210/220 to provide traction force in the direction F1; Figs. 5-6; para. 0022) attached to the blade so that the distal portion of the blade translates in a retraction direction against the tissue (see Examiner’s Annotated Fig. 5 above, and Fig. 6, where pulling handle in F1 direction translates distal free end portion 233 of blade 231 in a retraction direction aligned with traction force direction F2 against tissue; para. 0022), wherein a central longitudinal axis (C1; Fig. 5) of the handle is transverse to a plane coincident with an elongate centerline of the distal portion of the blade and the retraction direction (as shown, axis C1 transverse to “2nd Plane” identified in Examiner’s Annotated Fig. 5 above, which is coincident with a centerline of distal free end portion 233 and the retraction direction).
Regarding claim 11, Lee teaches the method of claim 9, wherein when the handle is pulled, a front surface of the distal portion of the blade is orthogonal to the retraction direction (see Examiner’s Annotated Fig. 5 above).
Regarding claim 12, Lee teaches the method of claim 11, wherein when the handle is pulled, a front surface of a proximal portion of the blade is oriented at an oblique angle relative to the retraction direction, the proximal portion being in between the handle and the distal portion (when handle 210/220 is pulled in the direction F1 shown in Fig. 6, where the blade 231 is twisted, a front surface a proximal portion of blade 231, visible in Fig. 6 and defined between the distal free end portion 233 and the shaft 220 of the handle, is oriented at an oblique angle relative to retraction direction aligned with traction force direction F2; also see Examiner’s Annotated Fig. 5 above and para. 0022).
Regarding claim 17, Lee teaches a method (using retractor 200 in Figs. 5 and 6; para. 0021-0022) comprising:
advancing a retractor (200; Figs. 5-6) into a tissue of a patient (as shown in Fig. 6; para. 0022); and
pulling a handle of the retractor such that a distal portion of a blade of the retractor moves in a retraction direction and presses against the tissue, the retraction direction being non-parallel to a central longitudinal axis of the handle (handle 210/220 is pulled in direction of traction force F1 identified in Fig. 6, also noted in Examiner’s Annotated Fig. 5 above, so that distal free end portion 233 of a blade 231 moves in a retraction direction aligned with traction force F2 which is non-parallel to central axis C1 of the handle; para. 0021-0022),
wherein a plane (see “1st Plane” identified in Examiner’s Annotated Fig. 5 above) is coincident with a body of the distal portion of the blade over a full width of the distal portion extending between lateral sides of the body of the distal portion (as shown in Examiner’s Annotated Fig. 5 above).
Regarding claim 18, Lee teaches the method of claim 17, wherein the retraction direction is normal to the plane (see Examiner’s Annotated Fig. 5 above, and Fig. 6, where the retraction direction aligned with traction force F2 is perpendicular to the plane defined above, i.e. the identified “2nd Plane”).
Regarding claim 20, Lee teaches the method of claim 17, wherein when the handle is pulled, a front surface of the distal portion of the blade is orthogonal to the retraction direction (front surface, i.e. the right surface as viewed in Fig. 5, of the distal free end portion 233, is perpendicular to the retraction direction; see Examiner’s Annotated Fig. 5 above and Fig. 6).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6, 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (KR-20150012545-A).
Regarding claims 6, 10 and 19, Lee teaches the method of claims 1, 9 and 17, respectively.
Lee also teaches that when the handle is pulled (in direction of traction force F1, Fig. 6), a central longitudinal axis (C1; Fig. 5) of the handle is at an acute angle relative to the retraction direction (see Examiner’s Annotated Fig. 5 above, showing an acute angle between the “Handle Pulling Direction” and the “Retraction Direction”).
However, Lee does not specifically disclose wherein the angle is in a range from 5 degrees to 55 degrees relative to the retraction direction.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed Lee’s retractor so that the acute angle between the central axis of the handle relative to the retraction direction is within the claimed range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 7-8 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (KR-20150012545-A), as applied to claims 1 and 9 above, further in view of Zagatsky (WO 2021/055882 A1).
Regarding claim 7-8 and 14-15, Lee teaches the method of claims 1 and 9, respectively.
Lee does not disclose the method [Claims 7 and 14] further comprising inserting a cable configured to emanate light into an elongate slot in the handle and [Claim 8 and 15] wherein inserting the cable includes passing the cable at least partially through a narrowed portion of the slot to secure the cable within the elongate slot.
Zagatsky, in analogous art, teaches a method of using a retractor (the retractor 100 shown in Figs. 1A-E) that comprises inserting a cable (light guide 130; Figs. 1B, 2A-2B; para. 0047, 0052) configured to emanate light into an elongate slot in the handle (inserted into elongate slot defined by light conduit 128; Figs. 1B-1D; para. 0052) and wherein inserting the cable includes passing the cable at least partially through a narrowed portion of the slot to secure the cable within the elongate slot (para. 0063 teaches that the light conduit 128 defining the elongate slot can “narrow and/or taper towards the center 133 along the direction from the first end 110A toward the second end 110B”, the center 133 identified in Fig. 1A defining a narrowed portion in which cable 130 is inserted to secure the cable therein).
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 Lee’s retractor handle to have the structure of Zagatsky, with an elongate slot for a light guide cable, so that the method includes inserting the cable into the slot and at least partially through a narrowed portion of the slot to secure the cable therein as claimed, because Zagatsky teaches that providing a retractor handle with a light-emanating cable positioned therein aids in illuminating a surgical site while the retractor retracts tissue to improve visibility (see Zagatsky, para. 0047, 0049)
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (KR-20150012545-A), as applied to claims 1 and 9 above, further in view of Vayser (US 2012/0116170 A1).
Regarding claim 13, Lee teaches the method of claim 9.
While Lee also teaches the retractor being used during surgery to retract multiple locations of an incision site with a uniform retracting force (see para. 0012, 0022; Figs. 5-6), Lee does not specifically disclose the method further comprising, subsequent to pulling the handle, advancing an instrument into a portal formed in the body of the patient at least in part based on the pulling of the handle, the instrument being advanced into a space directly between an entry into the portal and the distal portion of the blade along the retraction direction.
Vayser teaches a method of using a surgical retractor (shown in Fig. 7; para. 0021-0022) that comprises, subsequent to pulling the handle, advancing an instrument into a portal formed in the body of the patient at least in part based on pulling of the handle (as shown in Fig.7, after retractor 12 is inserted into an incision “I” and used to retract tissue “T”, e.g. by pulling handle 12a identified in Fig. 1, a surgical instrument “S” is inserted into the surgical field at a portal formed by pulling of the handle; para. 0039), the instrument being advanced into a space directly between an entry into the portal and the distal portion of the blade along the retraction direction (as shown; Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated Vayser’s step of inserting a surgical instrument through a portal formed in the patient in the claimed manner with Lee’s method of retracting tissue during a surgical procedure, because where Lee is concerned with using the retractor during surgery, Vayser recognizes that inserting surgical instruments in a portal formed by pulling a retractor to retract tissue at the surgical site is a known, typical step in performing surgical procedures (see Vayser, Fig. 7, para. 0030).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (KR-20150012545-A) and Zagatsky (WO 2021/055882 A1), as applied to claim 14, further in view of Williams (WO 2021/102474 A2).
Regarding claim 16, Lee and Zagatsky, in combination, disclose the method of claim 14.
While Zagatsky also discloses positioning a distal end of the cable proximate a distal portion of a retractor blade (see distal end 130b of light guide cable 130 positioned in light aperture 138; Figs. 1A-B, 2A; para. 0047), neither Lee nor Zagatsky teach the method further comprising attaching the cable into a groove on a front surface of the distal portion of the blade.
Williams, in analogous art, is directed towards a retractor (shown in Figs. 7-8; para. 0063-0064) having a handle (700; Figs. 7-8) with a cable (750; Figs. 7-8; para. 0063) configured to emanate light attached thereto (illumination cable 750 shown attached to a portion of releasable handle 700; Figs. 7-8; para. 0063-0064), and discloses attaching the cable into a groove on a front surface of the distal portion of the blade (see Figs. 7-8, where a distal end of cable 750 is attached in a groove 630 on a front surface of a distal portion of blade 500; para. 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Lee’s retractor comprising the handle and light emanating cable of Zagatsky positioned therein so that Zagatsky’s cable extends beyond the handle and is attached in a groove on a front surface of Lee’s blade, as taught by Williams, because William recognizes that such a configuration allows a surgeon to better visualize the particular area where the retractor blade has been inserted (see Williams, para. 0063).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant references can be found in the attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA V. LITTLE/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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