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
In response to the amendment filed on 2/19/2026, no claims have been cancelled, claims 18-20 have been newly added, thus claims 1-20 are pending.
Amendments to the specification to remedy objections have been acknowledged and the objections have been withdrawn.
Amendments to claims 4 and 9-12 to remedy 112(b) issues has been acknowledged and the rejections have been withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim 1 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5, 7, 9-13, 15-16, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20090198107 A1 Park et al. (hereinafter Park) in view of US 20180263614 Lee et al. (hereinafter Lee).
Regarding claim 1, Park discloses a surgical device (Fig. 1-2, 10a-b), for clamping in tissue, wherein the surgical device comprises
- a first clamp (2, Fig. 1) comprising two clamp-legs and a hinge-like articulated spring holding the clamp-legs together, wherein the first clamp comprises a distal clamping portion configured for clamping and holding tissue, and a proximal actuating portion configured for opening and closing the distal clamping portion of the first clamp (paragraph 36),
- a second clamp (2, Fig. 1) comprising two clamp-legs and a hinge-like articulated spring holding the clamp-legs together, wherein the second clamp comprises a distal clamping portion configured for clamping and holding tissue and a proximal actuating portion configured for opening and closing the distal clamping portion of the second clamp (paragraph 36), and
- an elongated dimensionally stable connector (1, 6, Fig. 1; ball and chain of Fig. 10a, plastic coated twisted wire line of Fig. 10b) for connecting the first and second clamps, wherein the connector is fixed to the proximal actuating portion of the first clamp and to the proximal actuating portion of the second clamp to form a stable distance between the first clamp and the second clamp (paragraph 35, 44-45).
Park is silent on wherein the connector is a pre-formed wire that maintains the stable distance between the first and second clamps without external tensioning forces.
However, Lee teaches a tissue retraction device (22, Fig. 1, abstract, paragraph 4) comprising a first clamp (52a, Fig. 2a), a second clamp (52b, Fig. 2a), and an elongated dimensionally stable connector (62, Fig. 2a) that connects the first clamp and second clamp (paragraph 102-103, Fig. 2a) and wherein the connector is a pre-formed wire that maintains the stable distance between the first and second clamps without external tensioning forces (paragraph 102, 105-107, connector 62 is elastomeric and when in the elongated position the tissue retraction device 22 is in tension without external tensioning forces (an internal inherent tension is applied because the connector 62 is elastomeric having elastic properties that provides a retraction force pulling the first clamp 52a towards the second clamp 52b)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Park with the teachings of Lee to have wherein the connector is a pre-formed wire that maintains the stable distance between the first and second clamps without external tensioning forces, in order to minimize the number of devices and steps to maintain a stable distance between the first and second clamps.
Regarding claim 2, the combination of Park and Lee teaches the limitations of claim 1, and Park further discloses wherein the surgical device is configured for and dimensioned for minimally invasive or open surgical insertion into a tissue (paragraph 31-32).
Regarding claim 3, the combination of Park and Lee teaches the limitations of claim 1, and Park further discloses further being designed such, that by actuation of the respective proximal actuating portion the distal clamping portion of the first clamp and the distal clamping portion of the second clamp can be opened (paragraph 36).
Regarding claim 5, the combination of Park and Lee teaches the limitations of claim 1, and Park further discloses wherein the distal clamping portion of the first clamp and/or second clamp is respectively formed through distal portions of the clamp-legs, which each comprise a clamping jaw comprising at least one row of teeth (as seen in Fig. 1-2, 12, paragraph 12, 47, alligator type clips having teeth can be used).
Regarding claim 7, the combination of Park and Lee teaches the limitations of claim 1, and Park further discloses wherein the proximal actuating portion of the first clamp and/or second clamp is respectively formed by proximal portions of the clamp-legs, which are configured and dimensioned for actuation by a surgical and/or endoscopic clamp (paragraph 36).
Regarding claim 10, the combination of Park and Lee teaches the limitations of claim 1, and Park further discloses wherein the first clamp and/or second clamp comprises a length (LK1, LK2) of 0.5 to 4 cm (Fig. 12).
Regarding claim 13, the combination of Park and Lee teaches the limitations of claim 1, and Lee further discloses wherein the first clamp, second clamp and/or the connector is made of or coated with a material that is not or only slightly electrically conductive, wherein the material is selected from plastic, silicone and ceramic (paragraph 105).
Regarding claim 15, the combination of Park and Lee teaches the limitations of claim 1, and Park further discloses a surgical treatment system (paragraph 31-32) comprising the surgical device of claim 1 and a introduction sleeve (Fig. 11a-c, paragraph 46).
Regarding claim 16, the combination of Park and Lee teaches the limitations of claim 15, and Park further discloses being configured for minimally invasive or open surgical treatment, in particular for treatment during a biopsy/endoscopy (paragraph 31-32).
Regarding claims 9, 11-12, 19, the combination of Park and Lee teaches the limitations of claim 1. Regarding claim 12, Park further discloses wherein the surgical device, in a handling state in which the first and second clamps are closed, is dimensioned and configured for being accommodated in an introduction sleeve (Fig. 11a-c, paragraph 46).
The combination is silent on wherein the surgical device comprises a length (L) of 1.5 to 15 cm (claim 9), wherein the surgical device comprises a length (L) of 8 to 9 cm (claim 19), wherein the distance between the first clamp and the second clamp as defined through the connector is from about 5 mm to about 50 mm (claim 11), and wherein the introduction sleeve comprises a diameter of 7 to 15 mm (claim 12).
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified device of Park with Lee to have wherein the surgical device comprises a length (L) of 1.5 to 15 cm, wherein the surgical device comprises a length (L) of 8 to 9 cm, wherein the distance between the first clamp and the second clamp as defined through the connector is from about 5 mm to about 50 mm, and wherein the introduction sleeve comprises a diameter of 7 to 15 mm, since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (See In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A))).
Regarding claim 20, the combination of Park and Lee teaches the limitations of claim 1, and Park further discloses wherein the first clamp and/or second clamp comprises a length (LK1, LK2) of 2.5 to 3.5 cm (Fig. 12).
Claims 4 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Park in view Lee as applied to claim 1 above, and further in view of US 20080132915 Buckman et al. (hereinafter Buckman).
Regarding claim 4 and 18, the combination of Park and Lee teaches the limitations of claim 1, and Park further discloses wherein the spring of the first and second clamp comprises a spring constant (a spring constant is an inherent property of a spring).
The combination is silent on the spring constant being between 0.005 to 0.25 N/mm (claim 4), and the spring constant being between 0.1 to 0.12 N/mm (claim 18).
However, Buckman teaches a clamp (10, Fig. 1) comprising a spring (34, Fig. 1) for clamping tissue (paragraph 10). Buckman teaches that the spring characteristics, such as the spring material, size, thickness, etc., are selected to achieve the desired spring force and resultant clamping force applied by the clip (paragraph 57). An appropriate spring force and resultant clamping force needs to be achieved based on the tissue being clamped.
As such the desired spring force and resultant clamping force applied by the clip is disclosed to be a result effective variable in that changing the spring characteristics, such as the spring material, size, thickness, etc., results in changes in the spring force and clamping force. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the spring constant of Park to have the spring constant within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the spring of modified Park with Lee by adjusting spring characteristics as taught by Buckman as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Park in view Lee as applied to claim 1 above, and further in view of US 20050070758 Wells et al. (hereinafter Wells).
Regarding claim 6, the combination of Park and Lee teaches the limitations of claim 1, and Park further discloses wherein the distal clamping portion of the first clamp and/or second clamp is respectively formed through distal portions of the clamp-legs (as seen in Fig. 1-2, 12).
The combination is silent on which the distal portions of the clamp-legs each comprise a terminal spike, wherein the spikes of the clamp-legs point towards each other.
However, Wells teaches a clip assembly (106, Fig. 1) having a distal portion with clamp legs (208, Fig. 1) each comprising a terminal spike (408, Fig. 1, 11-13, 18, paragraph 66), wherein the spikes of the clamp-legs point towards each other (as seen in Fig. 1, 11-13, 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Park with Lee with the teachings of Wells to have the distal portions of the clamp-legs each comprise a terminal spike, wherein the spikes of the clamp-legs point towards each other, in order to securely attach the clamp to tissue.
Regarding claim 8, the combination of Park and Lee teaches the limitations of claim 1, and Park further discloses wherein the first clamp is embodied as a crocodile clamp comprising two opposing rows of teeth on the clamp-legs (Fig. 1-2, 10-12, paragraph 12, 47), and wherein the second clamp is provided as surgical forceps (paragraph 12).
The combination is silent on wherein the surgical forceps comprises two opposing spikes.
However, Wells teaches a clip assembly (106, Fig. 1) configured as surgical forceps wherein the surgical forceps comprises two opposing spikes (408, Fig. 1, 11-13, 18, paragraph 66).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Park with Lee with the teachings of Wells to have the surgical forceps comprise two opposing spikes, in order to securely attach the clamp to tissue.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Lee as applied to claim 1 above, and further in view of US 20150127362 A1 DeBusk et al. (hereinafter DeBusk).
Regarding claim 14, the combination of Park and Lee teaches the limitations of claim 1.
The combination is silent on wherein the surgical device comprises a removable label.
However, DeBusk teaches medical items that comprise a removable label (abstract, paragraph 110, item wrapper 20 (Fig. 1) has an RFID tag on it and the wrapper is removed from the item) for the purpose of facilitating the tracking and logging of medical items (abstract, paragraph 9-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Park with Lee with the teachings of DeBusk to have wherein the surgical device comprises a removable label in order to keep track and log the use of the surgical device.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Lee as applied to claim 1 above, and further in view of US 20100204727 Dominguez.
Regarding claim 17, the combination of Park and Lee teaches the limitations of claim 15.
The combination is silent on the surgical system being configured for robotic-assisted treatment.
However, Dominguez teaches a similar surgical system (Fig. 2, 3, 16, paragraph 66-68, 80, 110) for clamping in tissue, wherein the surgical system is configured for robotic-assisted treatment (paragraph 15, 48).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Park with Lee with the teachings of Dominguez to have the surgical system being configured for robotic-assisted treatment in order to provide more accurate and controlled movements when performing surgical procedures.
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 KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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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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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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