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
As of the reply filed 9/05/2025, claims 1-16 and 21-25 are pending. Claims 17-20 have been cancelled and claims 21-25 are new. Claim 1 has been amended.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument in view of Applicant’s amendments to the claims.
Claim Objections
Claim 24 is objected to because of the following informalities:
Claim 24, second to last line: the limitation ”is rotatable relative to proximal structure” is missing an article and should be amended to recite “is rotatable relative to the proximal structure” instead.
Appropriate correction is required.
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.
(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 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okada (US PGPub 2013/0197535 A1).
With respect to claim 21, Okada discloses an apparatus (1 in Figs. 2A-B), comprising:
(a) a proximal structure (2 in Figs. 2A-B) configured to be positioned extracorporeally relative to a patient (see “external form” 2b in PP [0082], see also Fig. 1), wherein the proximal structure (2 in Fig. 1) defines a primary axis (A2); and
(b) a distal structure (6 and 4 in Fig. 2B) extending distally from the proximal structure (2b) and configured to be passed through a body wall and into a body cavity of the patient (see Fig. 1), wherein the distal structure (6 and 4 in Fig. 2B) cooperates with the proximal structure (2) to define a working channel (2a and 4a) sized and configured to receive and guide a surgical instrument distally therethrough (see Figs. 1 and 2B), wherein the distal structure (6 and 4) includes:
(i) a proximal portion (6), the proximal portion (6) being aligned with the primary axis (A2), and
(ii) an angled distal portion (4, see Fig. 1 for angled position), wherein the angled distal portion (4 in Fig. 1) defines a secondary axis (A4) that defines a nonzero angle relative to the primary axis (see Fig. 1, when 4 is bent at 7 relative to 6 it defines a nonzero angle relative to A2),
wherein at least the angled distal portion (4) of the distal structure (6 and 4) is rotatable relative to the proximal structure (2) about the primary axis (A2, see Figs. 1 and 2B, 4 rotates via 3) while maintaining the nonzero angle between the secondary axis (A4) and the primary axis (A2, 4 can rotate via 3 at a nonzero angle relative to the primary axis).
Regarding claim 22, Okada further discloses the distal structure (6 and 4 in Fig. 2B) being rigid (PP [0097]: “As materials for the distal end-side tube member 4, the intermediate coupler 3, and the distal end-side tube member 4, an arbitrary synthetic resin or a combination of a synthetic resin and a metal may be employed”, 4 can be considered to be rigid since it is made from a rigid material), such that the angled distal portion (4) of the distal structure (6 and 4) is rigidly formed with the proximal portion of the distal structure (6, see Fig. 2B, 4 is rigidly fixed to 6 via 7 therefore they can be considered to be rigidly formed).
Regarding claim 23, Okada further discloses the distal structure (6 and 4 in Fig. 2B) including a tube (tube of 4 and 6) defining a curve (4 and 6 can be curved when 7 is angled), the curve providing an arcuate transition (see the curve of 7 in Fig. 2B, this is an arcuate transition) from the proximal portion of the distal structure (6) to the angled distal portion of the distal structure (4).
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 1-10 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Okada (US PGPub 2013/0197535 A1) in view of Buess et al. (US Patent No. 5,800,451).
With respect to claim 1, Okada discloses an apparatus (1 in Figs. 2A-B), comprising:
(a) a proximal structure (2 in Figs. 2A-B) configured to be positioned extracorporeally relative to a patient (see “external form” 2b in PP [0082], see also Fig. 1), wherein the proximal structure (2 in Fig. 1) defines a primary axis (A2); and
(b) a distal structure (7 and 4 in Fig. 2B) extending distally from the proximal structure (2b) and configured to be passed through a body wall and into a body cavity of the patient (see Fig. 1), wherein the distal structure (7 and 4 in Fig. 2B) cooperates with the proximal structure (2) to define a working channel (2a and 4a) sized and configured to receive and guide a surgical instrument distally therethrough (see Figs. 1 and 2B), wherein the distal structure (7 and 4) includes:
(i) a proximal portion (7), the proximal portion (7) being aligned with the primary axis (A2), and
(ii) an angled distal portion (4, see Fig. 1 for angled position), wherein the angled distal portion (4 in Fig. 1) defines a secondary axis (A4) that is angled relative to the primary axis (A2),
wherein the angled distal portion (4) of the distal structure (7 and 4) is rotatable relative to the proximal structure (2) about the primary axis (A2, see Figs. 1 and 2B, 4 rotates via 3).
However, Okada fails to disclose wherein the proximal portion of the distal structure and the angled distal portion of the distal structure are together rotatable relative to the proximal structure about the primary axis.
In the same field of trocars for minimally invasive surgery (abstract), Buess et al. teaches an apparatus (see Figs. 1-2) comprising a proximal structure (13) configured to be positioned extracorporeally relative to a patient and a distal structure (11) configured to be passed through the body of a patient. Buess et al. further discloses wherein the distal structure (11) comprises a proximal portion (proximal end of 11 near 13) and a distal portion (distal end of 11 near 21), wherein the proximal portion of the distal structure (11) and the distal portion of the distal structure (11) are together rotatable relative to the proximal structure (13) about a primary axis (axis that runs through 11, col. 1, lines 59-61: “it would also be possible for the trocar tube [11] to be held within the valve housing [13] in a rotatable manner”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Okada reference according to the teachings of Buess et al. to include wherein the proximal portion of the distal structure and the angled distal portion of the distal structure are together rotatable relative to the proximal structure about the primary axis. One of ordinary skill in the art would have been motivated to perform this modification because it would have included applying a known technique (rotating a distal tube structure relative to the proximal housing structure in a trocar) to a known device (the device of Okada) ready for improvement to yield predictable results (the device of Okada such that the pipe portion (6, 7, and 4) are able to rotate relative to the seal housing 2). Furthermore, making elements 6 and 2 be rotationally attached to one another (as opposed to the fixed attachment shown in Fig. 2B) would have been obvious to one of ordinary skill in the art since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (Newin v. Erlichman, 168 USPQ 177 (BdPatApp&Int 1969)).
Regarding claim 2, Okada as modified by Buess et al. further discloses wherein the proximal structure (2 in Fig. 2B of Okada) has a first maximum thickness (see width of 2) in a direction transverse to the primary axis (A2), wherein the distal structure (7 and 4) has a second maximum dimension (width of 6) in a direction transverse to the primary axis (A2), wherein the first maximum dimension is greater than the second maximum dimension (see Fig. 2B, 2 is the widest part of the entire device).
Regarding claim 3, Okada as modified by Buess et al. further discloses wherein the proximal structure (2 in Fig. 2B of Okada) houses a seal member (8) configured to form an air-tight seal against a shaft of the surgical instrument (PP [0087]: “The insertion passage 2a is provided with an airtight valve 8 at a proximal end side thereof which keeps the inside of the insertion passage 2a in an airtight and liquid-tight manner with the medical forceps 5 inserted thereinto”, PP [0106]: “When an endoscope is inserted in place of the medical forceps 5”).
Regarding claim 4, Okada as modified by Buess et al. further discloses wherein the distal structure (7 and 4 in Fig. 2B of Okada) comprises a rigid tube (4 is a rigid tube).
Regarding claim 5, Okada as modified by Buess et al. further discloses wherein the angled distal portion (4 in Fig. 2B of Okada, see Fig. 1 for angled position) extends distally along a path that deviates from the primary axis (A2, see 4 deviate in Fig. 1 when bent), wherein a distal-most end of the angled distal portion (4b) defines the secondary axis (A4).
Regarding claim 6, Okada as modified by Buess et al. further discloses wherein the angled distal portion (4 in Fig. 1 of Okada) extends distally along an arcuate path (see angle theta in Fig. 1 showing the arc between A2 and A4, 4 extends distally along that rotational arcuate path).
Regarding claim 7, Okada as modified by Buess et al. further discloses wherein the proximal portion (7 in Fig. 2B of Okada) of the distal structure (7 and 4) is rotatably coupled with the proximal structure (2, 7 and 2 rotatably couple via 6), wherein the distal structure (7 and 4) in its entirety is rotatable relative to the proximal structure (2) about the primary axis (A2, 7 and 4 each rotate relative to 2 about A2, see rotation in Fig. 1).
Regarding claim 8, Okada as modified by Buess et al. further discloses an actuator (9 in Fig. 2B of Okada) operatively coupled with the angled distal portion (4, 9 is operatively coupled via 7), wherein the actuator (9) is operable to rotate the angled distal portion (4) relative to the proximal structure (2) about the primary axis (A2, PP [0088]: “when the handled screw 9 is fastened, the relative position between the female coupler 6 and the male coupler 7 is fixed. When the handled screw 9 is loosened, the female coupler 6 and the male coupler 7 are kept unfixed“).
Regarding claim 9, Okada as modified by Buess et al. further discloses wherein the actuator (9 in Fig. 2B of Okada) is configured to be gripped by a user to drive rotation of the angled distal portion (4) relative to the proximal structure (2, PP [0088]: “when the handled screw 9 is fastened, the relative position between the female coupler 6 and the male coupler 7 is fixed. When the handled screw 9 is loosened, the female coupler 6 and the male coupler 7 are kept unfixed“, fastening and unfastening of 9 drives rotation of 4).
Regarding claim 10, Okada as modified by Buess et al. further discloses wherein the actuator (9 in Fig. 2B of Okada) comprises at least one of a rotatable member (9 is a rotatable screw, therefore it is a rotatable member) or a rudder movably coupled with the proximal structure (2).
Claims 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Okada (US PGPub 2013/0197535 A1) over Buess et al. (US Patent No. 5,800,451), as applied to claim 1 above, and further in view of Romo et al. (US Patent No. 9,737,371 B2).
With respect to claim 11, Okada as modified by Buess et al. further discloses a system, comprising:
(a) the apparatus of claim 1 (see the rejection of claim 1 above, see also Fig. 2B of Okada); and
(b) a surgical scope (PP [0060]: “Examples of the medical instrument may include surgical instruments such as a medical forceps, a treatment tool, and an endoscope”).
However, since the Okada reference fails to provide any details on the scope, Okada fails to explicitly disclose a surgical scope, including:
(i) a scope base configured to be positioned extracorporeally relative to the patient, and
(ii) a scope shaft that is actuatable relative to the scope base, wherein the scope shaft includes a proximal shaft portion and a deflectable distal shaft portion, wherein the deflectable distal shaft portion is deflectable relative to the proximal shaft portion and is sized and configured to be directed through the working channel of an apparatus.
In the same field of surgical scopes (abstract), Romo et al. discloses a surgical scope (200 in Fig. 2E), including:
(i) a scope base (208) configured to be positioned extracorporeally relative to the patient (see Fig. 2E, 208 is located outside of patient 211), and
(ii) a scope shaft (212) that is actuatable relative to the scope base (208, col. 13, lines 64-66: “Distal end 220 of leader 212 may then be navigated to an operative site and tools are deployed through a longitudinally-aligned working channel within leader 212 to perform desired procedures”), wherein the scope shaft (212) includes a proximal shaft portion (portion of 212 near 208) and a deflectable distal shaft portion (220), wherein the deflectable distal shaft portion (220) is deflectable relative to the proximal shaft portion (portion of 212 near 208) and is sized and configured to be directed through the working channel of an apparatus (220 can be directed through 210).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Okada and Buess et al. combination to further incorporate the scope as taught by the Romo et al. reference. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have been a simple substitution that would have yielded predictable results, since Okada already contemplates the use of an endoscope with the access device as claimed (Okada PP [0060]: “Examples of the medical instrument may include surgical instruments such as a medical forceps, a treatment tool, and an endoscope”).
Regarding claim 12, Okada as modified by Buess et al. and Romo et al. further discloses wherein the deflectable distal shaft portion (220 in Fig. 2E of Romo et al.) is flexible (col. 13, lines 35-36: “Tool base 208 has flexible endoscope leader 212”).
Regarding claim 13, Okada as modified by Buess et al. and Romo et al. further discloses wherein the proximal structure (2 in Fig. 2B of Okada) is configured to receive the scope shaft therethrough (see 2a, see also Fig. 1 with 5 going through 2) along an introductory axis that is angled (the scope shaft can be inserted at an angled introductory axis through 8a into 2) relative to each of the primary axis (A2) and the secondary axis (A4).
Regarding claim 14, Okada as modified by Buess et al. and Romo et al. further discloses a drive mechanism (Romo et al. col. 13, lines 28-34: “Tool bases 206 and 208 may provide other desired utilities for the sheath and endoscope, such as pneumatic pressure, electrical, data communication (e.g., for vision), mechanical actuation (e.g., motor driven axels) and the like. These utilities may be provided to the tool bases through the arms, from a separate source or a combination of both”, emphasis added) operatively coupled with the scope base (208) and separated from the apparatus by a portion of the scope shaft (see Fig. 2E, 208 and 204 is separated from 210 by a length of 212, the combination as proposed would separate the drive mechanism from the apparatus of Okada), wherein the drive mechanism is operable to actuate the scope shaft relative to the apparatus (the drive mechanism within 208 actuates the scope shaft relative to comparable apparatus 210, the combination as proposed would yield 212 within the apparatus of Okada such that the drive mechanism within 208 solely actuates the scope shaft 212).
Regarding claim 15, Okada as modified by Buess et al. and Romo et al. further discloses wherein the deflectable distal shaft portion (220 in Fig. 2E of Romo et al.) includes an articulation section (see curved loop of 220, see also Figs. 2A-B and D for other views, col. 13, lines 64-67: “Other modes of navigation may be used, such as and not by way of limitation using a guidewire through the working channel of the leader 212”, the guidewire creates the articulation section) configured to articulate a distal end of the scope shaft (212) relative to a remainder of the deflectable distal shaft portion (220, see curve of 220 in Figs. 2A-B and D-E), wherein the drive mechanism is operable to drive articulation of the articulation section (col. 13, lines 28-34: “Tool bases 206 and 208 may provide other desired utilities for the sheath and endoscope, such as pneumatic pressure, electrical, data communication (e.g., for vision), mechanical actuation (e.g., motor driven axels) and the like. These utilities may be provided to the tool bases through the arms, from a separate source or a combination of both”, emphasis added).
Regarding claim 16, Okada as modified by Buess et al. and Romo et al. further discloses a robotic arm (204 in Fig. 2E of Romo et al.) that presents the drive mechanism (col. 13, lines 28-34: “Tool bases 206 and 208 may provide other desired utilities for the sheath and endoscope, such as pneumatic pressure, electrical, data communication (e.g., for vision), mechanical actuation (e.g., motor driven axels) and the like. These utilities may be provided to the tool bases through the arms, from a separate source or a combination of both”, emphasis added).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Robich (US PGPub 2019/0231388 A1) over Buess et al. (US Patent No. 5,800,451).
With respect to claim 24, Robich discloses an apparatus (10 in Fig. 3), comprising:
(a) a proximal structure (14) configured to be positioned extracorporeally relative to a patient (see Figs. 12-13), wherein the proximal structure (14) defines a primary axis (22A in Fig. 6); and
(b) a distal structure (16) extending distally from the proximal structure (14) and configured to be passed through a body wall and into a body cavity of the patient (see Figs. 12-13), wherein the distal structure (16) cooperates with the proximal structure (14) to define a working channel sized and configured to receive and guide a surgical instrument distally therethrough (see 32 in Figs. 12-13), wherein the distal structure (16) includes a curved tube (16 has curve 12):
(i) a proximal portion (proximal portion of 16), the proximal portion being aligned with the primary axis (see Fig. 6),
(ii) a distal end (distal end of 16 with 26), and
(iii) a rigidly curved region (12) extending between the proximal portion and the distal end (12 is between proximal end of 16 and 26), the rigidly curved region (12) providing an orientation of the distal end (end of 16 near 26) whereby the distal end (end of 16 near 26) is aligned with a secondary axis (24A in Fig. 6) that defines a nonzero angle relative to the primary axis (22A).
However, Robich fails to disclose wherein the distal structure is rotatable relative to proximal structure about the primary axis.
In the same field of trocars for minimally invasive surgery (abstract), Buess et al. teaches an apparatus (see Figs. 1-2) comprising a proximal structure (13) configured to be positioned extracorporeally relative to a patient and a distal structure (11) configured to be passed through the body of a patient. Buess et al. further discloses wherein the distal structure (11) comprises a proximal portion (proximal end of 11 near 13) and a distal portion (distal end of 11 near 21), wherein the proximal portion of the distal structure (11) and the distal portion of the distal structure (11) are together rotatable relative to the proximal structure (13) about a primary axis (axis that runs through 11, col. 1, lines 59-61: “it would also be possible for the trocar tube [11] to be held within the valve housing [13] in a rotatable manner”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Robich reference according to the teachings of Buess et al. to include wherein the proximal portion of the distal structure and the angled distal portion of the distal structure are together rotatable relative to the proximal structure about the primary axis. One of ordinary skill in the art would have been motivated to perform this modification because it would have included applying a known technique (rotating a distal tube structure relative to the proximal housing structure in a trocar) to a known device (the device of Robich) ready for improvement to yield predictable results (the device of Robich such that the pipe portion (6, 7, and 4) are able to rotate relative to the seal housing 2). Furthermore, making elements 14 and 16 be rotationally attached to one another (as opposed to the fixed attachment shown in Fig. 6) would have been obvious to one of ordinary skill in the art since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (Newin v. Erlichman, 168 USPQ 177 (BdPatApp&Int 1969)).
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 Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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