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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/374,161, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim 9 recites the limitation “the length of each of the first and second gripping elements is about 3.18 times the width of the central portion.”. Para. 0035 of the written description in U.S. application 17/374,161 states “The ratio of the width to the length W1:L1 can be about 1:3”. Therefore, the written description does have support for the length of each of the first and second gripping elements to be about 3 times the width of the central portion, but not for the 3.18 ratio as claimed. Furthermore, “3.18” is not found anywhere in the disclosure.
Claim 10 recites the limitation “the length of each of the first and second gripping elements is about 1.85 times the height”. Para. 0012 of the written description in U.S. application 17/374,161 states “The ratio of the height to the length H1:L1 can be about 1:1.8.”. Therefore, the written description does have support for the length of each of the first and second gripping elements is about 1.8 times the height, but not for the 1.85 ratio as claimed. Furthermore, “1.85” is not found anywhere in the disclosure.
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.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez et al. (US 20150257877) in view of Jacobs et al. (US 20050119694) [hereinafter Jacobs].
Regarding claim 1, Hernandez discloses a fixation device 14 for engaging tissue (Fig. 7, para. 0068: “The valve devices of the present invention may be anchored to such a fixation device, or may incorporate a grasping mechanism for engaging the mitral valve leaflet tissue similar to fixation device 14”) comprising:
a first fixation element and a second fixation element (interpreted as distal elements 18) each having a first end 52, a second end 54 opposite the first end 52, and an engagement surface 50 extending therebetween (Fig. 7, para. 0068); and
a first gripping element and a second gripping element (interpreted as proximal elements 16) each moveable relative to a respective one of the first and second fixation elements 18 (see Figs. 9A-11B) and each having a fixed end, a free end, and a length extending therebetween (see annotated Fig. 17 of Hernandez below, para. 0070),
wherein each of the first and second gripping elements 16 includes a plurality of friction elements 60 angled toward the engagement surface 50 of the respective fixation element 18 (Fig. 7, para. 0071: “The proximal elements 16 optionally include frictional accessories, frictional features or grip-enhancing elements to assist in grasping and/or holding the leaflets. The frictional accessories may comprise barbs 60 having tapering pointed tips extending toward engagement surfaces 50”).
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Annotated Fig. 17 of Hernandez
Hernandez further discloses that the friction elements 60 each have a uniform length between the fixed end and the free end of the gripping element (see annotated Fig. 17 of Hernandez above). However, Hernandez fails to disclose the friction elements each having a length which varies between the fixed end and the free end of the gripping element.
Jacobs in the same field of endeavor of fixation devices teaches that it is known in the art for friction elements 515 to each have a length which varies towards a center of the device 516 (Fig. 5E, para. 0130: “in FIG. 5E, the attachment points (515) are progressively shorter the closer they are to the center of the device (516)”).
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 length of the friction elements in Hernandez to get progressively shorter the closer the friction elements are to a central portion of the device, thereby having an increase in length from the fixed end to the free end of the gripping elements as taught by Jacobs in order to make it harder for the friction elements to dislodge when situated in the body in an area where to and fro movement is expected (such as a heart valve) (para. 0130 of Jacobs: “ These variations are more difficult to dislodge when situated in an area of the body having both to-and-fro movement”).
Regarding claim 16, Hernandez discloses a fixation device 14 for engaging tissue (Fig. 7, para. 0068: “The valve devices of the present invention may be anchored to such a fixation device, or may incorporate a grasping mechanism for engaging the mitral valve leaflet tissue similar to fixation device 14”) comprising:
a pair of fixation elements 18 each having a first end 52 and a second end 54 opposite the first end 52, and an engagement surface 50 extending therebetween (Fig. 7, para. 0068); and
a pair of gripping elements 16 each moveable relative to a respective one of the fixation elements 18 and each having a fixed end, a free end, and a length extending therebetween (see annotated Fig. 17 of Hernandez above, para. 0070),
wherein each gripping element 16 includes a plurality of friction elements 60 arranged in a series of rows (best shown in Fig. 10B), each of the plurality of friction elements 60 having a length and being angled toward the engagement surface 50 of the respective fixation element 18 (Fig. 7, para. 0071: “The proximal elements 16 optionally include frictional accessories, frictional features or grip-enhancing elements to assist in grasping and/or holding the leaflets. The frictional accessories may comprise barbs 60 having tapering pointed tips extending toward engagement surfaces 50”), the rows being spaced along the length of the gripping element such that the length of the friction elements 60 in the rows are uniform in length (see Fig. 10B of Hernandez).
However, Hernandez fails to disclose wherein the length of the friction elements in rows positioned closer to the fixed end is shorter than the length of the friction elements in rows positioned closer to the free end.
Jacobs in the same field of endeavor of fixation devices teaches that it is known in the art for friction elements 515 to each have a length which varies towards a center of the device 516 (Fig. 5E, para. 0130: “in FIG. 5E, the attachment points (515) are progressively shorter the closer they are to the center of the device (516)”).
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 length of the friction elements in Hernandez to get progressively shorter the closer the friction elements are to a central portion of the device, thereby having an increase in length from the fixed end to the free end of the gripping elements as taught by Jacobs in order to make it harder for the friction elements to dislodge when situated in the body (para. 0130 of Jacobs: “ These variations are more difficult to dislodge when situated in an area of the body having both to-and-fro movement, e.g., the inside of an elbow or back of the knee, or during placement of the device.”).
Regarding claim 2, modified Hernandez discloses wherein the length of the friction elements of each of the first and second gripping elements increases toward the free end of the gripping element (see Fig. 5E of Jacobs and the resulting combination above in claim 1).
Regarding claim 3, modified Hernandez discloses wherein the increase in length of the friction elements is linear (see Fig. 5E of Jacobs which illustrates a linear increase of length).
Regarding claim 4, modified Hernandez discloses all of the limitations set forth above in claim 2. As stated above, Jacobs expressly teaches the advantages of having friction elements with various lengths such that it would increase the difficulty of dislodgment of the friction elements upon insertion (Fig. 5E, para. 0130 of Jacobs: “attachment points of various lengths emanate from a single backing. For example, in FIG. 5E, the attachment points (515) are progressively shorter the closer they are to the center of the device (516)…These variations are more difficult to dislodge when situated in an area of the body having both to-and-fro movement, e.g., the inside of an elbow or back of the knee, or during placement of the device.”). Jacobs further highlights a variation of friction elements which would result in the length of the friction elements of each of the first and second gripping elements increasing towards the free end of the gripping element as discussed above in the rejection of claim 2. However, modified Hernandez fails to disclose wherein the increase in length of the friction elements is parabolic.
There is no evidence of record that establishes that increasing the length of the friction elements parabolically would result in a difference in function of the modified Hernandez device. Further, a person having ordinary skill in the art, being faced with modifying the length of the friction elements of modified Hernandez, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed length variation which is to grip and capture leaflet tissue (para. 0059 of Hernandez: “The fixation device 14 typically comprises proximal elements 16 (or gripping elements) and distal elements 18 (or fixation elements) which protrude radially outward and are positionable on opposite sides of the leaflets LF as shown so as to capture or retain the leaflets therebetween”). Lastly, applicant has not disclosed that the claimed length variation solves any stated problem other than being a known alternative to lengths increasing linearly (para. 0042 of the instant application: “The increase in length can be linear or parabolic”) and therefore there appears to be no criticality placed on the length variation as claimed such that it produces an unexpected result.
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 length of friction elements of modified Hernandez to increase parabolically as an obvious matter of design choice within the skill of the art.
Regarding claim 5, modified Hernandez discloses wherein the variation in length of the friction elements is continuous along the length of the respective gripping element (see Fig. 5E of Jacobs).
Regarding claim 6, modified Hernandez discloses all of the limitations set forth above in claim 1. As stated above, Jacobs expressly teaches the advantages of having friction elements with various lengths such that it would increase the difficulty of dislodgment of the friction elements upon insertion (Fig. 5E, para. 0130 of Jacobs: “attachment points of various lengths emanate from a single backing. For example, in FIG. 5E, the attachment points (515) are progressively shorter the closer they are to the center of the device (516)…These variations are more difficult to dislodge when situated in an area of the body having both to-and-fro movement, e.g., the inside of an elbow or back of the knee, or during placement of the device.”). Jacobs further highlights a variation of friction elements which would result in the length of the friction elements of each of the first and second gripping elements increasing continuously towards the free end of the gripping element (See Fig. 5E of Jacobs). However, modified Hernandez fails to disclose wherein the variation in length of the friction elements is staggered in alternating rows of friction elements, thereby producing an undulating profile.
There is no evidence of record that establishes that increasing the length of the friction elements in a staggered manner as described in claim 6 would result in a difference in function of the modified Hernandez device. Further, a person having ordinary skill in the art, being faced with modifying the length of the friction elements of modified Hernandez, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed length variation which is to grip and capture leaflet tissue (para. 0059 of Hernandez: “The fixation device 14 typically comprises proximal elements 16 (or gripping elements) and distal elements 18 (or fixation elements) which protrude radially outward and are positionable on opposite sides of the leaflets LF as shown so as to capture or retain the leaflets therebetween”). Lastly, applicant has not disclosed that the claimed length variation solves any stated problem other than being a known alternative to lengths increasing linearly (para. 0042 of the instant application: “This length variation may be continuous or staggered in alternating rows of gripping elements to produce an undulating profile.) and therefore there appears to be no criticality placed on the length variation as claimed such that it produces an unexpected result.
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 length of friction elements of modified Hernandez to increase staggered in alternating rows of friction elements, thereby producing an undulating profile as an obvious matter of design choice within the skill of the art.
Regarding claim 7, modified Hernandez discloses wherein the friction elements are selected from the group consisting of projections, barbs, and teeth (Fig. 7, para. 0071 of Hernandez: “The frictional accessories may comprise barbs 60 having tapering pointed tips extending toward engagement surfaces 50”).
Regarding claims 8 and 17, modified Hernandez discloses wherein the fixed ends of the first and second gripping elements 16 are each coupled to a central portion of a gripping device and extend outwardly therefrom (see annotated Fig. 17 [a] of Hernandez below).
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Annotated Fig. 17 [a] of Hernandez
Regarding claims 9 and 18, modified Hernandez discloses all of the limitations set forth above in claims 1 and 16. Modified Hernandez further discloses wherein: the central portion includes a distal end and a width proximate the distal end, the width extending in a direction toward each of the first and second gripping elements 16, and the length of each of the first and second gripping elements 16 is longer than the width of the central portion (see annotated Fig. 17 [b] of Hernandez below).
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Annotated Fig. 17 [b] of Hernandez
However, modified Hernandez fail to disclose that the length of each of the first and second gripping elements are about 3.18 times the width of the central portion.
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 length of the gripping elements of modified Hernandez to be about 3.18 times the width of the central portion since it has been held that “where the only difference between the prior art and the claims was 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 was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
In the instant case, the gripping elements of modified Hernandez would not operate differently with the claimed ratio and since the gripping elements are intended to grip and capture leaflet tissue (para. 0059 of Hernandez: “The fixation device 14 typically comprises proximal elements 16 (or gripping elements) and distal elements 18 (or fixation elements) which protrude radially outward and are positionable on opposite sides of the leaflets LF as shown so as to capture or retain the leaflets therebetween”) having the length of the gripping elements be about 3.18 times the width of the central portion would function appropriately having the claimed ratio. Furthermore, Hernandez discloses that the fixation elements are configured to engage a length of tissue of about 4-10 mm (para. 0069 of Hernandez: “Arms 53 and engagement surfaces 50 are configured to engage a length of tissue of about 4-10 mm, and preferably about 6-8 mm along the longitudinal axis of arms 53”) and para. 0037 of the instant application’s specification provides a preferential length of 0.35 inches (8.89 mm). Therefore, one of ordinary skill in the art would have reasonable success with gripping elements having a length of 8.89 mm to grip and capture leaflet tissue. Further, it appears that applicant places no criticality on the ratio claimed, indicating simply that “As disclosed herein, the length L1 is at least about three times the width W1. The ratio of the width to the length W1:L1 can be about 1:3” (para. 0036 of the instant application) and fails to include the specific length of “of about 3.18” as claimed.
Regarding claim 10, modified Hernandez discloses wherein the distal end of the central portion defines a reference plane perpendicular to a central axis of the central portion and a height is defined by a vertical dimension between the reference plane and the fixed ends of the gripping elements (see annotated Fig. 17[c] of Hernandez below).
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Annotated Fig. 17 [c] of Hernandez
Although Hernandez illustrates the length L being longer than the height defined by the vertical dimension between the reference plane and the fixed ends of the gripping elements (see annotated Fig. 17 [c] of Hernandez above). Modified Hernandez fails to disclose that the length of each of the first and second gripping elements is about 1.85 times the height.
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 length of the gripping elements of modified Hernandez to be about 1.85 times the height defined by the vertical dimension between the reference plane and the fixed ends of the gripping elements since it has been held that “where the only difference between the prior art and the claims was 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 was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
In the instant case, the gripping elements of modified Hernandez would not operate differently with the claimed ratio and since the gripping elements are intended to grip and capture leaflet tissue (para. 0059 of Hernandez: “The fixation device 14 typically comprises proximal elements 16 (or gripping elements) and distal elements 18 (or fixation elements) which protrude radially outward and are positionable on opposite sides of the leaflets LF as shown so as to capture or retain the leaflets therebetween”) having the length of the gripping elements be about 1.85 times the height would function appropriately having the claimed ratio. Furthermore, Hernandez discloses that the fixation elements are configured to engage a length of tissue of about 4-10 mm (para. 0069 of Hernandez: “Arms 53 and engagement surfaces 50 are configured to engage a length of tissue of about 4-10 mm, and preferably about 6-8 mm along the longitudinal axis of arms 53”) and para. 0037 of the instant application’s specification provides a preferential length of 0.35 inches (8.89 mm). Therefore, one of ordinary skill in the art would have reasonable success with gripping elements having a length of 8.89 mm to grip and capture leaflet tissue. Further, it appears that applicant places no criticality on the ratio claimed, indicating simply that “For example, the length L1 can be at least 1.8 times the height H1. Thus, the ratio of the height to the length H1:L1 can be about 1:1.8.” (para. 0037 of the instant application) and fails to include the specific length “of about 1.85” as claimed.
Regarding claim 11, modified Hernandez discloses wherein the friction elements 60 of each of the first and second gripping elements 16 are arranged in a plurality of rows along the length thereof (see Fig. 10B of Hernandez), and the length of the friction elements differs from row to row (as taught by Jacobs, see Fig. 5E of Jacobs).
Regarding claims 12 and 19, modified Hernandez discloses all of the limitations set forth above in claims 11 and 16. Modified Hernandez further discloses wherein each of the first and second gripping elements 16 includes four rows of friction elements (best shown in Fig. 10B of Hernandez).
However, modified Hernandez wherein each of the first and second gripping elements includes six rows of friction elements.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the first and second gripping elements with six rows of friction elements instead of four, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 13, modified Hernandez discloses wherein the length of the friction elements incrementally increases in a direction from the fixed end of the respective first and second gripping element to the free end thereof (see Fig. 5E of Jacobs and the resulting combination above in claim 1).
Regarding claims 14 and 20, modified Hernandez discloses all of the limitations set forth above in claims 12 and 19. Modified Hernandez further disclose that the length of each of the first and second gripping elements are longer than a height defined by the vertical dimension between a reference plane and the fixed ends of the gripping elements (see annotated Fig. 17 [c] of Hernandez above) and longer than a width of a central portion (see annotated Fig. 17 [b] of Hernandez above) which is similar to the construction of the length in the instant application (see para. 0036-0037 of the instant application which discusses the desire for the length to be longer than the width of the central portion and the height defined by the vertical dimension between the reference plane and the fixed ends of the gripping elements). However, Hernandez fails to disclose wherein the length of each of the first and second gripping elements is about 0.35 inches.
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 length of the gripping elements of modified Hernandez to be about 0.35 inches since it has been held that “where the only difference between the prior art and the claims was 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 was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
In the instant case, the gripping elements of modified Hernandez would not operate differently with the claimed length and since the gripping elements are intended to grip and capture leaflet tissue (para. 0059 of Hernandez: “The fixation device 14 typically comprises proximal elements 16 (or gripping elements) and distal elements 18 (or fixation elements) which protrude radially outward and are positionable on opposite sides of the leaflets LF as shown so as to capture or retain the leaflets therebetween”) having the length of the gripping elements be about 0.35 inches would function appropriately having the claimed length. Furthermore, Hernandez discloses that the fixation elements are configured to engage a length of tissue of about 4-10 mm (para. 0069 of Hernandez: “Arms 53 and engagement surfaces 50 are configured to engage a length of tissue of about 4-10 mm, and preferably about 6-8 mm along the longitudinal axis of arms 53”). Therefore, one of ordinary skill in the art would have reasonable success with gripping elements having a length of 0.35 inches (8.89 mm) to grip and capture leaflet tissue. Further, it appears that applicant places no criticality on the length claimed, indicating simply that “The length L1 can be about 0.35 inches” (para. 0037 of the instant application) without further explanation of the criticality of the length.
Regarding claim 15, modified Hernandez discloses wherein each of the first and second gripping elements 16 includes a first surface and a second surface (see annotated Fig. 16 of Hernandez below), the friction elements 60 extending from the second surface and each having a terminal end such that the terminal ends of the friction elements and the second surface form a triangular profile in a perspective parallel to the length of the first and second gripping elements (best shown in Figs. 16-17 of Hernandez, para. 0071 of Hernandez: “The frictional accessories may comprise barbs 60 having tapering pointed tips extending toward engagement surfaces 50”).
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Annotated Fig. 16 of Hernandez
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 9 of U.S. Patent No. 12295846 in view of Hernandez et al. (US 20150257877) and Jacobs et al. (US 20050119694) [hereinafter Jacobs].
Regarding claims 1 and 16, U.S. Patent No. 12295846 claims a fixation device for engaging tissue comprising: a pair of fixation elements each having a first end and a second end opposite the first end (claim 1: “A fixation device for engaging tissue comprising: a pair of fixation elements, each fixation element having a first end and a second end opposite the first end, the first ends being moveable between a closed position and an open position”), and an engagement surface extending therebetween (claim 1: “each gripping element moveable with a respective fixation element and disposed in opposition to at least a portion of the respective fixation element to capture tissue therebetween”. Therefore, the pair of fixation elements must include an engagement surface to engage with the pair of gripping elements to capture tissue therebetween); and
a pair of gripping elements each moveable relative to a respective one of the fixation elements (claim 1: “a pair of gripping elements, each gripping element moveable with a respective fixation element and disposed in opposition to at least a portion of the respective fixation element to capture tissue therebetween”) and each having a fixed end, a free end, and a length extending therebetween (claim 1: “each gripping element being cantilevered to the central portion at its respective central portion-gripping element interface and having a free end opposite its respective central portion-gripping element interface and a length “L1” defined between the respective central portion-gripping element interface and the free end).
However, U.S. Patent No. 12295846 fails to claim wherein each gripping element includes a plurality of friction elements arranged in a series of rows, each of the plurality of friction elements having a length and being angled toward the engagement surface of the respective fixation element.
Hernandez in the same field of endeavor of fixation devices teaches that it is known in the art for a pair of gripping elements 16 to include a plurality of friction elements 60 arranged in a series of rows (best shown in Fig. 10B), each of the plurality of friction elements 60 having a length and being angled toward an engagement surface 50 of respective fixation element 18 (Fig. 7, para. 0071: “The proximal elements 16 optionally include frictional accessories, frictional features or grip-enhancing elements to assist in grasping and/or holding the leaflets. The frictional accessories may comprise barbs 60 having tapering pointed tips extending toward engagement surfaces 50”).
Since U.S. Patent No. 12295846 claimed that the pair of gripping elements in combination with the fixation elements are configured to assist in capture leaflet tissue, 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 pair of gripping elements in U.S. Patent No. 12295846 to include the plurality of friction elements formed as barbs having a length and being angled toward the engagement surface of the respective fixation element as taught by Hernandez in order to assist in grasping and holding the leaflet tissue during capture (para. 0071 of Hernandez).
However, modified U.S. Patent No. 12295846 fails to claim the rows being spaced along the length of the gripping element such that the length of the friction elements in rows positioned closer to the fixed end is shorter than the length of the friction elements in rows positioned closer to the free end.
Jacobs in the same field of endeavor of fixation devices teaches that it is known in the art for friction elements 515 to be spaced along a length of the device such that the length of the friction elements in rows positioned closer to a center of the device 516 is shorter than the length of friction elements in rows posited further away from the center of the device 516 (Fig. 5E, para. 0130: “in FIG. 5E, the attachment points (515) are progressively shorter the closer they are to the center of the device (516)”).
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 length of the friction elements in Hernandez to get progressively shorter the closer the friction elements are to the central portion of the device, thereby having an increase in length from the fixed end to the free end of the gripping elements as taught by Jacobs in order to make it harder for the friction elements to dislodge when situated in an area of the body having to and fro movement (such as a heart valve) (para. 0130 of Jacobs: “These variations are more difficult to dislodge when situated in an area of the body having both to-and-fro movement,”).
Regarding claim 2, modified U.S. Patent No. 12295846 claims wherein the length of the friction elements of each of the first and second gripping elements increases toward the free end of the gripping element (see Fig. 5E of Jacobs and the combination of modified U.S. Patent No. 12295846 in view of Jacobs above).
Regarding claim 3, modified U.S. Patent No. 12295846 claims wherein the increase in length of the friction elements is linear (see Fig. 5E of Jacobs and the combination of modified U.S. Patent No. 12295846 in view of Jacobs above).
Regarding claim 4, modified U.S. Patent No. 12295846 claims all of the limitations set forth above in claim 2. As stated above, Jacobs expressly teaches the advantages of having friction elements with various lengths such that it would increase the difficulty of dislodgment of the friction elements upon insertion (Fig. 5E, para. 0130 of Jacobs: “attachment points of various lengths emanate from a single backing. For example, in FIG. 5E, the attachment points (515) are progressively shorter the closer they are to the center of the device (516)…These variations are more difficult to dislodge when situated in an area of the body having both to-and-fro movement, e.g., the inside of an elbow or back of the knee, or during placement of the device.”). Jacobs further highlights a variation of friction elements which would result in the length of the friction elements of each of the first and second gripping elements increasing towards the free end of the gripping element as discussed above in the rejection of claim 2. However, modified Hernandez fails to disclose wherein the increase in length of the friction elements is parabolic.
There is no evidence of record that establishes that increasing the length of the friction elements parabolically would result in a difference in function of the modified U.S. Patent No. 12295846 device. Further, a person having ordinary skill in the art, being faced with modifying the length of the friction elements of modified U.S. Patent No. 12295846, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed length variation which is to grip and capture leaflet tissue (claim 1 of U.S. Patent No. 12295846: “each gripping element moveable with a respective fixation element and disposed in opposition to at least a portion of the respective fixation element to capture tissue therebetween”. Therefore, the pair of fixation elements must include an engagement surface to engage with the pair of gripping elements to capture tissue therebetween). Lastly, applicant has not disclosed that the claimed length variation solves any stated problem other than being a known alternative to lengths increasing linearly (para. 0042 of the instant application: “The increase in length can be linear or parabolic”) and therefore there appears to be no criticality placed on the length variation as claimed such that it produces an unexpected result.
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 length of friction elements of modified U.S. Patent No. 12295846 to increase parabolically as an obvious matter of design choice within the skill of the art.
Regarding claim 5, modified U.S. Patent No. 12295846 claims wherein the variation in length of the friction elements is continuous along the length of the respective gripping element (see Fig. 5E of Jacobs).
Regarding claim 6, modified U.S. Patent No. 12295846 claims all of the limitations set forth above in claim 1. As stated above, Jacobs expressly teaches the advantages of having friction elements with various lengths such that it would increase the difficulty of dislodgment of the friction elements upon insertion (Fig. 5E, para. 0130 of Jacobs: “attachment points of various lengths emanate from a single backing. For example, in FIG. 5E, the attachment points (515) are progressively shorter the closer they are to the center of the device (516)…These variations are more difficult to dislodge when situated in an area of the body having both to-and-fro movement, e.g., the inside of an elbow or back of the knee, or during placement of the device.”). Jacobs further highlights a variation of friction elements which would result in the length of the friction elements of each of the first and second gripping elements increasing continuously towards the free end of the gripping element (See Fig. 5E of Jacobs). However, modified Hernandez fails to disclose wherein the variation in length of the friction elements is staggered in alternating rows of friction elements, thereby producing an undulating profile.
There is no evidence of record that establishes that increasing the length of the friction elements in a staggered manner as described in claim 6 would result in a difference in function of the modified U.S. Patent No. 12295846 device. Further, a person having ordinary skill in the art, being faced with modifying the length of the friction elements of modified U.S. Patent No. 12295846, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed length variation which is to grip and capture leaflet tissue (claim 1 of U.S. Patent No. 12295846: “each gripping element moveable with a respective fixation element and disposed in opposition to at least a portion of the respective fixation element to capture tissue therebetween”. Therefore, the pair of fixation elements must include an engagement surface to engage with the pair of gripping elements to capture tissue therebetween). Lastly, applicant has not disclosed that the claimed length variation solves any stated problem other than being a known alternative to lengths increasing linearly (para. 0042 of the instant application: “This length variation may be continuous or staggered in alternating rows of gripping elements to produce an undulating profile.) and therefore there appears to be no criticality placed on the length variation as claimed such that it produces an unexpected result.
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 length of friction elements of modified U.S. Patent No. 12295846 to increase staggered in alternating rows of friction elements, thereby producing an undulating profile as an obvious matter of design choice within the skill of the art.
Regarding claim 7, modified U.S. Patent No. 12295846 claims wherein the friction elements are selected from the group consisting of projections, barbs, and teeth (Fig. 7, para. 0071 of Hernandez: “The frictional accessories may comprise barbs 60 having tapering pointed tips extending toward engagement surfaces 50”).
Regarding claims 8 and 17, modified U.S. Patent No. 12295846 claims wherein the fixed ends of the first and second gripping elements are each coupled to a central portion of a gripping device and extend outwardly therefrom (claim 1 of U.S. Patent No. 12295846: “a central portion operatively connected to each gripping element at a respective central portion-gripping element interface…each gripping element being cantilevered to the central portion at its respective central portion-gripping element interface and having a free end opposite its respective central portion-gripping element interface and a length “L1” defined between the respective central portion-gripping element interface and the free end”,
Regarding claims 9 and 18, modified U.S. Patent No. 12295846 claims wherein: the central portion includes a distal end and a width proximate the distal end, the width extending in a direction toward each of the first and second gripping elements, and the length of each of the first and second gripping elements is about 3.18 times the width of the central portion (claim 1 of U.S. Patent No. 12295846: “the central portion having a width “W1” proximate the distal end and extending in a direction toward each gripping element, each gripping element being cantilevered to the central portion at its respective central portion-gripping element interface and having a free end opposite its respective central portion-gripping element interface and a length “L1” defined between the respective central portion-gripping element interface and the free end, wherein a ratio of the length to the width L1:W1 is about 3.18:1”)
Regarding claim 10, modified U.S. Patent No. 12295846 claims wherein the distal end of the central portion defines a reference plane perpendicular to a central axis of the central portion and a height is defined by a vertical dimension between the reference plane and the fixed ends of the gripping elements, and the length of each of the first and second gripping elements is about 1.85 times the height (claims 2-3 of U.S. Patent No. 12295846: “The fixation device of claim 1, wherein the distal end defines a reference plane perpendicular to a central axis of the central portion and wherein a height “H1” is defined by a vertical dimension between the reference plane and the central portion-gripping element interfaces. The fixation device of claim 2, wherein a ratio of the height to the length H1:L1 is about 1:1.85”).
Regarding claim 11, modified U.S. Patent No. 12295846 claims wherein the friction elements of each of the first and second gripping elements are arranged in a plurality of rows along the length thereof (see Fig. 10B of Hernandez), and the length of the friction elements differs from row to row (as taught by Jacobs, see Fig. 5E of Jacobs).
Regarding claims 12 and 19, modified U.S. Patent No. 12295846 claims all of the limitations set forth above in claims 11 and 16. Modified U.S. Patent No. 12295846 further claims “wherein each gripping element has at least four rows of friction elements extending from a gripping element surface” (see claim 9 of U.S. Patent No. 12295846).
However, modified U.S. Patent No. 12295846 fails to claim wherein each of the first and second gripping elements includes six rows of friction elements.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the pair of gripping elements with six rows of friction elements instead of four, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 13, modified U.S. Patent No. 12295846 claims wherein the length of the friction elements incrementally increases in a direction from the fixed end of the respective first and second gripping element to the free end thereof (see Fig. 5E of Jacobs and the resulting combination above in claim 1).
Regarding claims 14 and 20, modified U.S. Patent No. 12295846 claims wherein the length of each gripping element is about 0.35 inches (claim 4 of U.S. Patent No. 12295846: “The fixation device of claim 1, wherein the length L1 is about 0.35 inches”).
Regarding claim 15, modified U.S. Patent No. 12295846 claims all of the limitations above in claim 1. However, modified U.S. Patent No. 12295846 fails to claim wherein each of the first and second gripping elements includes a first surface and a second surface, the friction elements extending from the second surface and each having a terminal end such that the terminal ends of the friction elements and the second surface form a triangular profile in a perspective parallel to the length of the first and second gripping elements.
Hernandez further teaches that it is known in the art for each of the first and second gripping elements 16 includes a first surface and a second surface (see annotated Fig. 16 of Hernandez above), the friction elements 60 extending from the second surface and each having a terminal end such that the terminal ends of the friction elements and the second surface form a triangular profile in a perspective parallel to the length of the first and second gripping elements (best shown in Figs. 16-17 of Hernandez, para. 0071: “The frictional accessories may comprise barbs 60 having tapering pointed tips extending toward engagement surfaces 50”).
Thus, 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 pair of gripping elements in modified U.S. Patent No. 12295846 to have the plurality of friction elements extend from the second surface of the pair of gripping elements and each have the terminal end that forms the triangular profile in the perspective parallel to the length of the first and second gripping elements as taught by Hernandez since such a modification would yield predictable results, namely a friction element configuration that would allow the plurality of friction elements to extend toward the tissue being captured and pierce the tissue being captured (para. 0071 of Hernandez); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Conclusion
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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