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 § 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 (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 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 1-7, 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dobashi et al. (US 20190133591 A1—herein referred to as Dobashi1 as previously presented) in view of Dobashi et al. (US 2019/0216463 A1—herein referred to as Dobashi2 as previously presented).
Regarding claim 1, Dobashi1 discloses surgical system (Fig. 16 for example) for performing an endoscopic submucosal dissection (para. [0003]), comprising: a first surgical clip 100 including: first and second jaws 102 configured to move between an open configuration and a closed configuration to grasp tissue therebetween (para. [0035]); a cylindrical magnet 106; and a tether 104 coupling the cylindrical magnet to at least one of the first or second jaws (Fig. 11A); and a second surgical clip 200 including: first and second jaws (Fig. 16) configured to move between an open configuration and a closed configuration to grasp tissue therebetween (para. [0035]); a cylindrical body 206 fabricated from a magnet or a metal (para. [0035]); and a tether (Fig. 16) coupling the cylindrical body to at least one of the first or second jaws of the second surgical clip (Fig. 16).
Dobashi1 doesn’t directly disclose that the magnet and body are spherical, or wherein the spherical magnet and the spherical body have spherical outer surfaces that, when magnetically coupled during use, contact at a specific point and rotate relative to one another about the specific point such that a force vector between the spherical magnet and the spherical body is maintained along respective axes that pass through a radial center of the spherical magnet and a radial center of the spherical body.
Dobashi2 teaches the known interchangeability of cylindrical and spherical magnets (see para. [0080]), wherein either a cylindrical or spherical shape can be used with predictable results to one of ordinary skill.
Therefore, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of using a spherical magnet in Dobashi1’s device, since Dobashi2 teaches that the shape of the magnet is able to be substituted since cylindrical and spherical magnets are known interchangeable equivalents and therefore the simple substitution of a spherical magnet for a cylindrical would be predictable to a person of ordinary skill in the art without any unexpected results.
Further, the court held that a change in shape was a “matter of choice which a person of ordinary skill in the art would have found obvious.” See In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) and MPEP 2144.03 IV(B) and as such, even absent the Dobashi2 reference, a reasonable person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Dobashi1 to have a spherical magnet in place of a cylindrical magnet this is a routine shape change that doesn’t change the function of the device.
Note also, the combination of Dobashi1 and Dobashi2 would also teach or wherein the spherical magnet and the spherical body have spherical outer surfaces that, when magnetically coupled during use, contact at a specific point and rotate relative to one another about the specific point such that a force vector between the spherical magnet and the spherical body is maintained along respective axes that pass through a radial center of the spherical magnet and a radial center of the spherical body at least since by substituting the spherical members of Dobashi2 for the circular members of Dobashi1 and as shown in Fig. 16, upon the magnet and spherical body contacting at any point, they would teach the above simply by way of interacting with one another as spherical objects.
Regarding claim 2, Dobashi1 and Dobashi2 disclose the surgical system according to claim 1. Dobashi1 also discloses wherein the spherical magnet of the first surgical clip defines a channel therethrough, the tether of the first surgical clip extending through the channel (Fig. 16; see also 11A-11B).
Regarding claim 3, Dobashi1 and Dobashi2 disclose the surgical system according to claim 2. Dobashi1 also discloses wherein the tether of the first surgical clip is a closed loop or a single strand (Figs. 11A-11B, 16, para. [0005]).
Regarding claim 4, Dobashi1 and Dobashi2 disclose the surgical system according to claim 1. Dobashi1 discloses the tether is connected to the first surgical clip (see Figs. 13-B) but doesn’t directly disclose that the tether extends through a pair of openings defined in the first jaw of the first surgical clip, the pair of openings defining an axis therebetween that is parallel with a length of the first jaw of the first surgical clip.
Dobashi2 discloses the tether extends through an opening defined in the first jaw of the first surgical clip, the opening defining an axis therebetween that is parallel with a length of the first jaw of the first surgical clip (See Fig. 20).
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 device of Dobashi1 to have the tether extending through an opening defined in the first jaw of the first surgical clip, the opening defining an axis therebetween that is parallel with a length of the first jaw of the first surgical clip for purposes of securing the magnet directly to the jaw instead of a collar (as taught by Dobashi1 and Dobashi2; see para. [0084]).
Dobashi2 doesn’t directly disclose a pair of openings.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the opening to include a second opening in view of the disclosure of Dobashi2 (see paragraph [0084]) since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144. Examiner notes the resulting device would have two openings to further secure the tether to the jaw (para. [0084]).
Regarding claim 5, Dobashi1 and Dobashi2 disclose the surgical system according to claim 4. Dobashi2 also discloses wherein the tether of the first surgical clip has two ends crimped to one another, such that the tether is a closed loop (para. [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dobashi1 to have a crimped end as disclosed by Dobashi2 for purposes of forming a closed of a loop (para. [0084])
Regarding claim 6, Dobashi1 and Dobashi2 disclose the surgical system according to claim 5. Dobasi2 discloses wherein the crimp is disposed at a location between a point of attachment of the tether of the first surgical clip to the first jaw of the first surgical clip and a point of attachment of the tether of the first surgical clip to the spherical magnet (para. [0084]; i.e., note also that the magnet is movable along the tether).
Regarding claim 7, Dobashi1 and Dobashi2 disclose the surgical system according to claim 1. Dobashi1 also discloses wherein the first surgical clip includes an elongated collar configured to be detachably coupled to a surgical instrument (para. [0035] i.e., see Figs. 11A-11B wherein the jaws are coupled to the collar), wherein the first and second jaws of the first surgical clip are coupled to the collar (Figs. 11A-11B).
Regarding claim 10, Dobashi1 and Dobashi2 disclose the surgical system according to claim 1. Dobashi1 also discloses wherein the tether of the first surgical clip is directly attached to the spherical magnet of the first surgical clip (Figs. 11A-11B, 16).
Regarding claim 11, Dobashi1 and Dobashi2 disclose the surgical system according to claim 1. Dobashi1 also discloses wherein each of the tethers is a suture (para. [0035]).
Regarding claim 12, Dobashi1 and Dobashi2 disclose the surgical system according to claim 1. Dobashi2 also discloses wherein each of the first and second jaws and the tether of the first surgical clip are free from magnetically-attractive material (para. [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dobashi1 to have the first and second jaws and the tether of the first surgical clip are free from magnetically-attractive material as disclosed by Dobashi2 for purposes of being free from being magnetically attracted to the components of the hemostatic clip (para. [0081])
Regarding claim 13, Dobashi1 and Dobashi2 disclose the surgical system according to claim 1. Dobashi2 also discloses wherein the tether of the first surgical clip is free from magnetically-attractive material (para. [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dobashi1 to have the first and second jaws and the tether of the first surgical clip are free from magnetically-attractive material as disclosed by Dobashi2 for purposes of being free from being magnetically attracted to the components of the hemostatic clip (para. [0081])
Regarding claim 21, Dobashi1 discloses a surgical system (Fig. 16) for performing an endoscopic submucosal dissection, the system comprising: first surgical clip 100 including first and second jaws 102 (Figs 13A-13B) configured to grasp tissue (para. [0035]); a cylindrical magnet 106 defining a channel therethrough extending through a diameter of the cylindrical magnet (Fig. 16; Fig. 5), the channel defining an axis through a radial center of the spherical magnet (Fig. 5); and a tether 104 extending through the channel to couple the spherical magnet to at least one of the first or second jaws (Fig. 16; para. [0035]; Figs. 13A-13B); a second surgical clip 200 (Fig. 16) including: first and second jaws 202 configured to grasp tissue (para. [0035]-[0036]); a spherical body 206 defining a channel therethrough extending through a diameter of the spherical body (Fig. 16), the channel defining an axis through a radial center of the spherical body (Fig. 16); and a tether (i.e., as shown in Fig. 16 being the same as 104) extending through the channel to couple the spherical body to at least one of the first or second jaws of the second surgical clip (Fig. 16).
Dobashi1 doesn’t directly disclose that the magnet is spherical; wherein the spherical magnet and the spherical body have spherical outer surfaces that, when magnetically coupled during use, contact at a specific point and rotate relative to one another about the specific point such that a force vector between the spherical magnet and the spherical body is maintained along the respective axes that pass through the radial centers of the spherical magnet and the spherical body.
Dobashi2 teaches the known interchangeability of cylindrical and spherical magnets (see para. [0080]), wherein either a cylindrical or spherical shape can be used with predictable results to one of ordinary skill.
Therefore, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of using a spherical magnet in Dobashi1’s device, since Dobashi2 teaches that the shape of the magnet is able to be substituted since cylindrical and spherical magnets are known interchangeable equivalents and therefore the simple substitution of a spherical magnet for a cylindrical would be predictable to a person of ordinary skill in the art without any unexpected results.
Further, the court held that a change in shape was a “matter of choice which a person of ordinary skill in the art would have found obvious.” See In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) and MPEP 2144.03 IV(B) and as such, even absent the Dobashi2 reference, a reasonable person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Dobashi1 to have a spherical magnet in place of a cylindrical magnet this is a routine shape change that doesn’t change the function of the device.
Note also, the combination of Dobashi1 and Dobashi2 would also teach or wherein the spherical magnet and the spherical body have spherical outer surfaces that, when magnetically coupled during use, contact at a specific point and rotate relative to one another about the specific point such that a force vector between the spherical magnet and the spherical body is maintained along respective axes that pass through a radial center of the spherical magnet and a radial center of the spherical body at least since by substituting the spherical members of Dobashi2 for the circular members of Dobashi1 and as shown in Fig. 16, upon the magnet and spherical body contacting at any point, they would teach the above simply by way of interacting with one another as spherical objects.
Regarding claim 22, Dobashi1 and Dobashi2 disclose the surgical system according to claim 21. Dobashi1 discloses the tether is connected to the first surgical clip (see Figs. 13-B) but doesn’t directly disclose that the tether extends through a pair of openings defined in the first jaw of the first surgical clip, the pair of openings defining an axis therebetween that is parallel with a length of the first jaw of the first surgical clip.
Dobashi2 discloses the tether extends through an opening defined in the first jaw of the first surgical clip, the opening defining an axis therebetween that is parallel with a length of the first jaw of the first surgical clip (See Fig. 20).
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 device of Dobashi1 to have the tether extending through an opening defined in the first jaw of the first surgical clip, the opening defining an axis therebetween that is parallel with a length of the first jaw of the first surgical clip for purposes of securing the magnet directly to the jaw instead of a collar (as taught by Dobashi1 and Dobashi2; see para. [0084]).
Dobashi2 doesn’t directly disclose a pair of openings.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the opening to include a second opening in view of the disclosure of Dobashi2 (see paragraph [0084]) since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144. Examiner notes the resulting device would have two openings to further secure the tether to the jaw (para. [0084]).
Regarding claim 23, Dobashi1 and Dobashi2 disclose the surgical system according to claim 21. Dobashi1 also discloses further comprising the first surgical clip includes an elongated collar (i.e., connected to jaws in Fig. 13A) configured to be detachably coupled to a surgical instrument (i.e., as shown in both 11A and 13A), wherein the first and second jaws are movably received within the collar (Fig. 11A, Fig. 13A i.e., at least because a portion of each jaw at the proximal end extends within the collar and can rotate with respect to the hole inside the collar).
Regarding claim 24, Dobashi1 and Dobashi2 disclose the surgical system according to claim 21. Dobashi1 also discloses a cylindrical body 206 fabricated from a magnet or a metal (para. [0035]).
Regarding claim 25, Dobashi1 and Dobashi2 disclose the surgical system according to claim 21. Dobashi2 also discloses wherein the surgical clip further includes a crimp attaching two ends of the tether of the first surgical clip to one another, to form a proximal loop (para. [0084]) and a distal loop (see Figs. 13A-13B), the crimp being disposed closer to the spherical magnet than to the first and second jaws of the first surgical clip (see Figs. 13A-13B), such that the distal loop is smaller than the proximal loop (i.e., see Fig. 13A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dobashi1 to have a crimped end as disclosed by Dobashi2 for purposes of forming a closed of a loop (para. [0084]).
Note also that the crimp being disposed closer to the spherical magnet than to the first and second jaws of the first surgical clip, such that the distal loop is smaller than the proximal loop is a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of the crimp being disposed closer to the spherical magnet than to the first and second jaws of the first surgical clip since the only three choices are [1) the crimp being disposed closer to the spherical magnet than to the first and second jaws of the first surgical clip, 2) the crimp being disposed farther from the spherical magnet than to the first and second jaws of the first surgical clip, or 3) the crimp being disposed equidistant to the spherical magnet and the first and second jaws of the first surgical clip]. These are the only three options apparent to one of ordinary skill in the art, with there being no undue experimentation and there being a reasonable expectation of success at arriving at the crimp being disposed closer to the spherical magnet than to the first and second jaws of the first surgical clip, such that the distal loop is smaller than the proximal loop.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dobashi1 and Dobashi2 as applied to claim 1 and further in view of Davies et al. (US 2007/0123964 A1—previously presented).
Regarding claim 8, Dobashi1 and Dobashi2 disclose the surgical system according to claim 1. Dobashi1 also discloses wherein each of the spherical magnets is fabricated from neodymium (para. [0041]). Dobashi1 and Dobashi2 don’t directly disclose that the magnets are coated with parylene.
In the same field of endeavor of magnetically guidable delivery apparatus, Davis discloses using a magnet with a parylene coating (para. [0043]).
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 neodymium magnet of Dobashi1 and Dobashi2 to have a parylene coating for purposes of ensuring biocompatibility between components and the body (para. [0043]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Dobashi1, Dobashi2, and Davies as applied to claim 8 and further in view of van der Burg et al. (US 2011/0245850 A1—previously presented).
Regarding claim 9, Dobashi1, Dobashi2, and Davies disclose the surgical system according to claim 8. Dobashi1, Dobashi2, and Davies don’t directly disclose wherein each of the tethers is fabricated from polypropylene. Instead, Dobashi1 does disclose that the tether is made from nylon “or any other suitable material” (para. [0034]).
In the same field of endeavor of suture passers, van der Burg discloses a tether made from polypropylene (para. [0108]).
It would have been obvious to one of ordinary skill in the art to modify the tether of Dobashi1, Dobashi2, and Davies such that the tether is made from polypropylene for purposes of having biocompatible and elastomeric properties of the tether (para. [0108]).
Response to Arguments
Applicant's arguments filed October 30, 2025 have been fully considered but they are not persuasive.
Applicant argues that in Dobashi1, the cylindrical magnet and cylindrical body contact at a flat mating face. Examiner agrees since the shape of Dobashi1 is a cylindrical shape such that the shape determines where the specific contact point is. However, Applicant argues that Dobashi2 fails to cure this deficiency and Examiner disagrees. Examiner notes that by substituting the cylindrical shape of Dobashi1 with the spherical shape of Dobashi2, there would no longer be a flat face, but a spherical shape throughout such that the contact between the two spheres would be at some point along the curved region. As such, any contact point between the two would allow rotation along that curved surface about the point such that a force vector between the two is maintained along respective axis that pass through a radial center of the magnet and body since that is how coupling a magnet and metal spheres would interact with each other.
Further, note that the limitations of the independent claims are being interpreted as an intended use limitation. As seen in MPEP section 2114 section 2, a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647. Thus, it' s seen if the prior art has the claimed structure of the invention, it is able to perform the function. As seen here since Dobashi2 discloses the spherical shape of the magnet and body instead of the cylindrical shape with flat faces, the function would also be met.
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 RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771