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
The text of those sections of Title 35, U.S. Code not included in this action can be found in the prior Office action.
Claims 1, 2, 12, 16, 17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2010/0274158 to Teirstein in view of U.S. Patent Publication No. 2012/0029484 to Gusmao (“Gusmao”), U.S. Patent Publication No. 2019/0307990 to Fogg et al. (“Fogg”), and U.S. Patent No. D453,294 to Bitzer.
Regarding claim 1, Teirstein teaches a support device (Figs. 18(A) & 18(B)) for supporting an elongated medical instrument comprising a base (170), a gripping system for securing the base to a surgical towel (gripper embodiment of Figs. 12(A) & 12(B)), and a first retaining member (160) disposed on the base and extending upwardly from the base (Fig. 18(B)), the first retaining member having a first slit (Figs. 19(A-C)) capable of receiving a first part of the elongated medical instrument so that the first part is supported by the first retaining member (abstract), the first slit including a first segment (as shown in annotated Fig. 19(A) below) having a constant width (see annotated Fig. 19(A) below) and a second segment (as shown in annotated Fig. 19(A) below) having at least a partially V-shaped cross-section (see the top part of the second segment in annotated Fig. 19(A) below), the first segment being located directly below the second segment and the first segment being narrower than the second segment (as shown in annotated Fig. 19(A) below), the first segment being a lowest segment in at least the first slit, each of the first and second slits comprising a third segment, the second segment being located below the third segment of at least the corresponding first slit (see annotated Fig. 19(A) below), the first segment being configured to retain a first guidewire, the second segment being configured to retain a second guidewire ([0008], the grooves are intended for guide wires), the third segment being configured to retain a catheter (the third segment would be capable of retaining at least some type of catheter, given that no details of the catheter are claimed), wherein the gripping system is formed by a first opening (Fig. 12(B), the opening formed between 68 and 66’) in the base and extending from the front edge of the base towards the rear edge of the base (Fig. 12(B), the portions of 68 and 66’ would form the first edge, assuming the same orientation as the gripper embodiment of Fig. 18(B)), but does not teach the second retaining member, the entirely V-shaped cross-section of the second segment, the rounded cross section of the third segment, and the sinusoidal shape of the opening of the gripping system.
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Gusmao teaches a second retaining member (17’, Figs. 1 & 2) disposed on and extending upwardly from a base (11) and spaced-apart from a first retaining member (17). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Teirstein to have a second retaining member in addition to the first retaining member as taught by Gusmao in order to provide support and maintain stability ([0014]) as well as promoting an overall reduced procedure time for greater patient care ([0016]). Additionally or in the alternative, such a modification is considered a mere duplication of parts yielding predictable results such as enhanced stability as would be understood by a skilled artisan. It is well settled that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04(VI)(B)).
Once modified, the second retaining member of Teirstein and Gusmao would have a second slit including a first segment and a second segment, the first segment being located below the second segment and the first segment being narrower than the second segment, the first segment being a lowest segment, and the second segment being located directly below the third segment just as the first retaining member, the second retaining member would be capable of receiving a second part of the elongated medical instrument (just as the first retaining member is capable of receiving a part of the elongated medical instrument) so that the second part is supported by the second retaining member, and the first and second slits of the device of Teirstein and Gusmao would be aligned with one another along a first direction (direction between the first and second retaining members) such that when the elongated medical instrument extends through the first and second slits, a portion of an elongated medical instrument located between the first and second slits extends along the first direction, (the first direction and the direction where the elongated medical instrument would lie is the same), the first direction pointing from a front edge of the base to a rear edge of the base (the first direction can be defined as pointing from an associated front edge of the base to an opposite rear edge of the base).
Fogg teaches a second segment entirely comprising a V-shaped cross section and a third segment having a rounded or an ovaloid cross section (see annotated Fig. 4 below) configured to retain a catheter ([0033]) in a similar device that also has an analogous first and second segment. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second and third segment of the device of Teirstein and Gusmao as taught by Fogg in order to accommodate standard sizes of wires, catheters, and/or tubing to pass therethrough (Fogg, [0025]).
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Bitzer teaches an opening of a gripper system having a sinusoidal shape (Figs. 1-2). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the clip of Teirstein to have a sinusoidal shape as taught by Bitzer because both clips are art-recognized equivalent towel clips absent any unexpected results for providing fastening upon a towel. Additionally or in the alternative, such a modification would be considered a simple change in shape and it has been held that the configuration of an object is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration claimed was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 2, Teirstein, Gusmao, and Fogg teach the support device of claim 1 as shown above, Teirstein further teaching the first retaining member being formed integrally with the base (160, Fig. 18(B)) and the second retaining member of the device of Teirstein, Gusmao, and Fogg would likewise be formed integrally with the base inasmuch as the first retaining member.
Regarding claim 12, Teirstein, Gusmao, and Fogg teach the support device of claim 10 as shown above, Teirstein further teaching the gripper system comprising a second opening extending from the rear edge of the base (the alternative gripper embodiment of Fig. 12(A/B) would be placed at opposite ends of the base as demonstrated in the generic gripper embodiment of Figs. 18(A) & 18(B) with both grippers having openings extending along the first direction).
Regarding claim 16, Teirstein teaches a support device (Figs. 18(A) & 18(B)) for supporting an elongated medical instrument comprising a base (170), a gripping system for securing the base to a surgical towel (gripper embodiment of Figs. 12(A) & 12(B)), and at least a first retaining member (160) disposed on the base and extending upwardly from the base, the first retaining member having a first slit (Figs. 19(A-C)) configured to receive a first part of the elongated medical instrument so that the first part is supported by the first retaining member (abstract), the first slit including a first segment (as shown in annotated Fig. 19(A) above) a second segment (as shown in annotated Fig. 19(A) above), and a third segment (as shown in annotated Figs. 19(A) above), the first segment being located directly below the second segment, and the second segment being located directly below the third segment, the first segment having a constant width, the second segment having a V-shaped cross-section (as shown in annotated Fig. 19(A) above), wherein the gripping system is formed by a first opening (Fig. 12(B), the opening formed between 68 and 66’) in the base and extending from the front edge of the base towards the rear edge of the base (Fig. 12(B), the portions of 68 and 66’ would form the first edge, assuming the same orientation as the gripper embodiment of Fig. 18(B)), but does not teach the second retaining member the entirely V-shaped cross-section of the second segment, the rounded cross section of the third segment, and the sinusoidal shape of the opening of the gripping system.
Gusmao teaches a second retaining member (17’, Figs. 1 & 2) disposed on and extending upwardly from a base (11) and spaced-apart from a first retaining member (17), the first retaining member (17) being disposed behind the second retaining member (17’) along a first direction (direction between 17 and 17’). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Teirstein to have a second retaining member in addition to the first retaining member as taught by Gusmao in order to provide support and maintain stability ([0014]) as well as promoting an overall reduced procedure time for greater patient care ([0016]). Additionally or in the alternative, such a modification is considered a mere duplication of parts yielding predictable results such as enhanced stability as would be understood by a skilled artisan. It is well settled that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04(VI)(B)).
Once modified, the second retaining member of Teirstein and Gusmao would have a second slit including a first segment, a second segment, and a third segment, the first segment being located directly below the second segment, and the second segment being located directly below the third segment, the first segment having a constant width, and the second segment having a V-shaped cross-section, just as the first retaining member, the second retaining member would be capable of receiving a second part of the elongated medical instrument (just as the first retaining member is capable of receiving a part of the elongated medical instrument) so that the second part is supported by the second retaining member, and the first and second slits of the device of Teirstein and Gusmao would be aligned with one another along the first direction such that when the elongated medical instrument extends through the first and second slits, a portion of an elongated medical instrument located between the first and second slits extends along the first direction (the first direction and the direction where the elongated medical instrument would lie is the same).
While Gusmao does not disclose the first and second retaining members at respective edges of the base, it would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the first retaining member at a front edge of the base and arrange the second retaining member at a rear edge of the base, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed arrangement would not perform differently than the prior art device (MPEP 2144.04(VI)(C)).
Fogg teaches a second segment entirely comprising a V-shaped cross section and a third segment having a rounded or an ovaloid cross section (see annotated Fig. 4 below) configured to retain a catheter ([0033]) in a similar device that also has an analogous first and second segment. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second and third segment of the device of Teirstein and Gusmao as taught by Fogg in order to accommodate standard sizes of wires, catheters, and/or tubing to pass therethrough (Fogg, [0025]).
Bitzer teaches an opening of a gripper system having a sinusoidal shape (Figs. 1-2). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the clip of Teirstein to have a sinusoidal shape as taught by Bitzer because both clips are art-recognized equivalent towel clips absent any unexpected results for providing fastening upon a towel. Additionally or in the alternative, such a modification would be considered a simple change in shape and it has been held that the configuration of an object is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration claimed was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 17, Teirstein, Gusmao, Fogg, and Bitzer teach the support device of claim 16 as shown above, Fogg further teaching an angle between a first surface and a second surface forming the second segment is between 20 and 200 (annotated Fig. 4 of Fogg above).
Regarding claim 19, Teirstein teaches a support device (Figs. 18(A) & 18(B)) for supporting a guidewire and a catheter comprising a base having a front edge and a rear edge (170), a gripping system for securing the base to a surgical towel (gripper embodiment of Figs. 12(A) & 12(B)), and a second retaining member (160) disposed on the base and extending upwardly from the base (Fig. 18(B)), the second retaining member having a second slit configured to receive a part of the catheter so that the part of the catheter is supported by the second retaining member ([0069]), the second slit including a first segment (as shown in annotated Fig. 19(A) above), a second segment (as shown in annotated Fig. 19(A) above), and a third segment (as shown in annotated Fig. 19(A) above), the first segment being located directly below the second segment, and the second segment being located directly below the third segment, the first segment being narrower than the second segment (as shown in annotated Fig. 19(A) above), wherein the gripping system is formed by a first opening (Fig. 12(B), the opening formed between 68 and 66’) in the base and extending from the front edge of the base towards the rear edge of the base (Fig. 12(B), the portions of 68 and 66’ would form the first edge, assuming the same orientation as the gripper embodiment of Fig. 18(B)), but does not show the first retaining member, the rounded cross section of the third segment, and the sinusoidal shape of the opening of the gripping system.
Gusmao teaches a first retaining member (17, Figs. 1 & 2) disposed on and extending upwardly from a base (11) and spaced-apart from a second retaining member (17’). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Teirstein to have a first retaining member in addition to the second retaining member as taught by Gusmao in order to provide support and maintain stability ([0014]) as well as promoting an overall reduced procedure time for greater patient care ([0016]). Additionally or in the alternative, such a modification is considered a mere duplication of parts yielding predictable results such as enhanced stability as would be understood by a skilled artisan. It is well settled that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04(VI)(B)).
Once modified, the first retaining member of Teirstein and Gusmao would have a first slit capable of receiving a part of the guidewire so that the part of the guidewire is supported by the first retaining member (just as the second retaining member is capable of receiving a guidewire as explain in the abstract and paragraph [0069] of Teirstein), and the first and second slits of the device of Teirstein and Gusmao would be aligned with one another along a first direction (direction between the first and second retaining members) such that when the guidewire or catheter extends through the first and second slits a portion of the guidewire or catheter located between the first and second slits extends along the first direction (the first direction and the direction where the guidewire or catheter would lie is the same), and the first retaining member would closer to front edge of the base than to the rear edge of the base and the second retaining member would be closer to the rear edge of the base than to the front edge of the base.
Fogg teaches a third segment having a rounded or an ovaloid cross section (see annotated Fig. 4 below) capable of retaining a neck of a hub of a catheter (catheter necks can vary greatly in size, the third segment of Fogg is capable of retaining at least one variation of a neck of a catheter) in a similar device that also has an analogous first and second segment. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the third segment of the device of Teirstein and Gusmao to be round as taught by Fogg because such a modification involves a simple change in shape/design which is known in the art in order to accommodate standard sizes of wires, catheters, and/or tubing to pass therethrough (Fogg, [0025]).
Bitzer teaches an opening of a gripper system having a sinusoidal shape (Figs. 1-2). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the clip of Teirstein to have a sinusoidal shape as taught by Bitzer because both clips are art-recognized equivalent towel clips absent any unexpected results for providing fastening upon a towel. Additionally or in the alternative, such a modification would be considered a simple change in shape and it has been held that the configuration of an object is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration claimed was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 20, Teirstein, Gusmao, Fogg, and Bitzer teach the support device of claim 19 as shown above, Teirstein ([0069]) and/or Fogg ([0025]) further teaching the first segment being configured to retain a guidewire.
Regarding claim 21, Teirstein, Gusmao, Fogg, and Bitzer teach the support device of claim 1 as shown above, Fogg further teaching the first segment and the second segment are vertically aligned (see annotated Fig. 4 of Fogg above.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Teirstein, Gusmao, Fogg, and Bitzer as applied to claim 1 above, and further in view of U.S. Patent No. 4,250,880 to Gordon.
Regarding claim 9, Teirstein, Gusmao, Fogg, and Bitzer teach the support device of claim 1 as shown above, but do not teach the first retaining member having a different shape/dimension.
Gordon teaches at least a first retaining member (62/64, Fig. 11) having a different shape and/or different dimensions than a second retaining member (60) in a similar type of medical stabilization device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first retaining member of Teirstein, Gusmao, Fogg, and Bitzer to have a different shape or dimension from the second retaining member of Teirstein, Gusmao, Fogg, and Bitzer as taught by Gordon, in order to obtain the predictable result of accommodating different types of medical devices/catheters which come in a plethora of different shapes, sizes, and configurations. Gordon teaches an example of the use of various sized retaining members in order to properly match the different components of a matching catheter (column 4, lines 43-47) which one of ordinary skill would understand to be necessary in order to establish a proper fit with the catheter and thereby promote and optimize stability.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Teirstein, Gusmao, Fogg, and Bitzer as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2010/0010475 to Teirstein et al., (“Teirstein ‘475”).
Regarding claim 13, Teirstein, Gusmao, Fogg, and Bitzer teach the support device of claim 1 as shown above, Teirstein references Teirstein ‘475 in paragraph [0074] incorporating any management device (i.e., retaining member) 160 from Teirstein ‘475. Teirstein ‘475 teaches at least a first retaining member (67a, Fig. 8(A)) and a third or adjacent retaining member (67b, Fig. 8(A)), but does not teach a fourth retaining member (i.e., another retaining member paired with the third retaining member).
Gusmao teaches a fourth retaining member (18’, Figs. 1 & 2) disposed on a base and spaced-apart from a third retaining member (18). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Teirstein to have a fourth retaining member in tandem to the third retaining member as taught by Gusmao in order to provide support and maintain stability ([0014]) as well as promoting an overall reduced procedure time for greater patient care ([0016]). Additionally or in the alternative, such a modification is considered a mere duplication of parts yielding predictable results such as enhanced stability as would be understood by a skilled artisan. It is well settled that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04(VI)(B)).
In the alternative, Teirstein, Gusmao, Fogg, and Bitzer teach the support device of claim 1 as shown above, but do not show the third and fourth retaining members. Teirstein ‘475 teaches at least a first retaining member (67a, Fig. 8(A)) and a third or adjacent retaining member (67b, Fig. 8(A)). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Teirstein, Gusmao, Fogg, and Bitzer to have a third retaining member as taught by Teirstein ‘475, because such a modification is considered a mere duplication of parts yielding predictable results such as the ability to hold additional guidewires or catheters to suit various needs and treatment regimens as would be understood by a skilled artisan. It is well settled that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04(VI)(B)).
Regarding the fourth retaining member, Gusmao teaches a fourth retaining member (18’, Figs. 1 & 2) disposed on a base and spaced-apart from a third retaining member (18). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Teirstein and Teirstein ‘475 to have a fourth retaining member in tandem to the third retaining member as taught by Gusmao in order to provide support and maintain stability ([0014]) as well as promoting an overall reduced procedure time for greater patient care ([0016]). Additionally or in the alternative, such a modification is considered a mere duplication of parts yielding predictable results such as enhanced stability as would be understood by a skilled artisan. It is well settled that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04(VI)(B)).
Once combined, the third and fourth retaining members of Teirstein, Gusmao, Fogg, Bitzer, and Teirstein ‘475 would be spaced-apart from one another on the base and extend upwardly from the base, the third and fourth retaining members disposed to be aligned with one another along the first direction (direction between the third and fourth retaining members).
Response to Arguments
The drawings were received on 12/30/2025. These drawings are acceptable.
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments and amendments with respect to claim objections have been fully considered and are persuasive. The claim objections have been withdrawn.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
Applicant’s arguments and amendments with respect to art rejections have been fully considered but they are not persuasive. Applicant argues that none of the prior art teach the first and second slit features of claim 1. Examiner respectfully disagrees. As shown above in annotated Fig. 4 of Fogg, Fogg teaches a first segment below a second segment, the first segment being narrower than the second segment, and the second segment having an entirely V-shaped cross segment, both segments being vertically aligned. Applicant argues that transition point cannot retain an elongate medical instrument. Examiner respectfully disagrees. Paragraph [0025] teaches all the slits and openings are used to hold medical devices and given a particular size, the so-called transition point or second segment of Fogg is clearly capable of retaining at least some type of elongate medical device. Applicant argues that the segments of Teirstein and Fogg are not analogous. Examiner respectfully disagrees. As stated above, the segments of both Teirstein ([0069]) and Fogg ([0025]) are used to hold elongate medical devices and are therefore analogous. Applicant argues that none of the prior art teach a sinusoidal opening extending from the front edge of the base towards the rear edge of the base. Examiner respectfully disagrees. As shown above, in Fig. 12(B) of Teirstein, the opening has been defined as the opening formed between 68 and 66’ extending through the page, and the visible surfaces of 68 and 66’ in Fig. 12(B) represent the front (or rear) surface of the gripper element, assuming the same type of gripper orientation as is shown in the embodiment of Fig. 18(B) of the device which uses a similar gripper element on a front edge. Once the gripper of Fig. 12(B) of Teirstein is modified by sinusoidal clip of Bitzer, the sinusoidal opening would extend from the front edge to the rear edge or vice versa. Applicant has made similar arguments regarding claims 16 and 19 which have been fully considered and are not persuasive for similar reasons as set forth above regarding claim 1.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783