DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 10/01/2025 have been fully considered but they are not persuasive.
Applicant argues that a person skilled in the art would not be motivated to modify Ben-Muvhar by the teachings of Jang to produce "the central body having a single continuous profile angle along the length of the central body from a first end of the central body to a second end of the central body, wherein the central body includes a plurality of segments, each of the plurality of segments having a profile angle that is a same angle and each of the plurality of segments having a greatest diameter that is different than a greatest diameter of each other of the plurality of segments; and a plurality of imaging markers each configured to indicate a position of the greatest diameter of a respective one of the plurality of segments to thereby indicate a diameter that the implant will be dilated to at the greatest diameter" at least because Ben-Muvhar appears to state the balloon 200 and the device 100 are already precisely fit to each other and to the desired deployment site.
The examiner respectfully acknowledges and considers applicant’s arguments. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). The examiner reminds applicant that Ben-Muvhar was only modified to include the plurality of imaging markers taught by Jang. In this case, Ben-Muvhar discloses a tapered balloon used for deploying an implant into a body passage (para. 0007 of Ben-Muvhar). One of ordinary skill in the art would be motivated to modify the device of Ben-Muvhar to include the plurality of imaging markers as taught by Jang to allow a user to visually identify a plurality of segments along the length of the balloon during use (para. 0036 of Jang), thereby increasing the accuracy of the placement of the implant (para. 0045, 0053 of Jang).
Applicant argues that Ben-Muvhar in view of Jang fails to disclose, teach, or suggest “indicating a position of the greatest diameter of a respective one of the plurality of segments of a central body having a single continuous profile angle along the length of the central body from a first end of the central body to a second end of the central body”.
The examiner respectfully disagrees. As shown in annotated Fig. 2 of Ben-Muvhar below, Ben-Muvhar discloses the central body having a single continuous profile angle along the length of the central body from a first end of the central body to a second end of the central body. Second, the limitation “wherein each imaging marker is configured to be indicative of a position of the greatest diameter of a respective one of the plurality of segments to thereby indicate a diameter that the implant will be dilated to at the greatest diameter” is functional and is not a structural requirement of the claimed device. The claim only structurally requires “a plurality of imaging markers” which is taught by Jang (para. 0036, 0045, 0053 of Jang) and “a plurality of segments each having a greatest diameter” which is disclosed by Ben-Muvhar (see annotated Fig. 2 [a] below) to meet the functional limitation. The limitations “a position of the greatest diameter of a respective one of the plurality of segments” and “a diameter that the implant will be dilated to at the greatest diameter” are not positively claimed and are interpreted as functional components that the plurality of imaging markers is capable of indicating. For example, depending on the placement of the plurality of imaging markers by the user, the plurality of imaging markers is capable of indicating the positioning of the greatest diameter of the respective one of the plurality of segments to thereby indicate the diameter that the implant will be dilated to at the greatest diameter. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114).
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Annotated Fig. 2 of Ben-Muvhar
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Annotated Fig. 2 [1] of Ben-Muvhar
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-20, and 26-28 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "the central portion" in line 7. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the central portion” is interpreted as “the central body”.
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.
Claim(s) 1-3, 8-9, 11-13, 16-21, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Muvhar (US 20060030920) in view of Jang (US 20080188803).
Regarding claims 1 and 11, Ben-Muvhar discloses a dilation device (Fig. 2) for an implant (para. 0040), the dilation device comprising:
an inflatable body 200 having a first end 220 and a second end 210 (Fig. 2, para. 0040) and a central body positioned between the first end 220 and the second end 210 (see annotated Fig. 2 below, para. 0040) and having a length (Fig. 2, para. 0007), the central body configured to press an inner surface of the implant to dilate the implant (para. 0038, 0040) and having a profile that decreases in diameter along the length of the central body from the first end 220 to the second end 210 (Fig. 2, para. 0040), the central body having a single continuous profile angle along the length of the central body from a first end of the central body to a second end of the central body (see annotated Fig. 2 below), wherein the central body includes a plurality of segments (see annotated Fig. 2 [1] below), each having a different profile (due to the tapered shape, such that the profile decreases in diameter along the length of the balloon from the most proximal segment to the most distal segment) and being tapered (Fig. 2, para. 0040), each of the plurality of segments having a profile angle that is a same angle (see Fig. 2 of Ben-Muvhar) and each of the plurality of segments having a greatest diameter that is different than a greatest diameter of each other of the plurality of segments (due to the tapered shape, such that the profile angle of each of the plurality of segments decreases in diameter along the length of the balloon, the greatest diameters of each of the plurality of segment would be different from each other).
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Annotated Fig. 2 of Ben-Muvhar
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Annotated Fig. 2 [1] of Ben-Muvhar
However, Ben-Muvhar fails to disclose a plurality of imaging markers each configured to indicate a position of the greatest diameter of a respective one of the plurality of segments to thereby indicate a diameter that the implant will be dilated to at the greatest diameter.
Jang in the same field of endeavor teaches a dilation device 10 for an implant 150 (Figs. 1, 3A-B, para. 0038), the dilation device comprising a central body including a plurality of segments 110, 112, 114 (Figs. 1-2, para. 0034); and further comprising a plurality of imaging markers 120, 122, 124, 126 on a catheter shaft 38 (Fig. 1, para. 0038), each configured to indicate a position of a respective one of the plurality of segments (Fig. 2, para. 0034, 0038).
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 in Ben-Muvhar to include the plurality of imaging markers of Jang in order to allow the user to visually identify the plurality of segments along the length of the balloon during use (para. 0036 of Jang), thereby increasing the accuracy of the placement of the implant (para. 0045, 0053 of Jang).
The combination of Ben-Muvhar in view of Jang would result in a product wherein the plurality of imaging markers of Jang (Figs. 1-2, para. 0034, 0038 of Jang), each configured to indicate a position of the greatest diameter of a respective one of the plurality of segments of Ben-Muvhar (see annotated Fig. 2 [a] of Ben-Muvhar below) to thereby indicate a diameter that the implant will be dilated to at the greatest diameter (Figs. 1-2, para. 0034, 0038 of Jang, see note below).
Note: “configured to indicate a position of the greatest diameter of a respective one of the plurality of segments to thereby indicate a diameter that the implant will be dilated to at the greatest diameter” is interpreted as functional language that describes the functionality and the intended use of the claimed invention. Therefore, “a position of the greatest diameter of a respective one of the plurality of segments” and “a diameter that the implant will be dilated to at the greatest diameter” are not positively claimed and are interpreted as functional components that the plurality of imaging markers are capable of indicating. The device of modified Ben-Muvhar comprises all of the structure required for the functional language in the limitation (“a plurality of imaging markers” and “a plurality of segments each having a greatest diameter”). For example, depending on the placement of the plurality of imaging markers by the user, the plurality of imaging markers are capable of indicating the positioning of the greatest diameter of the respective one of the plurality of segments to thereby indicate the diameter that the implant will be dilated to at the greatest diameter. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114).
Regarding claim 2, modified Ben-Muvhar discloses wherein the profile is a tapered profile (Fig. 2, para. 0040 of Ben-Muvhar).
Regarding claim 3, modified Ben-Muvhar discloses wherein the profile is an angled profile (Fig. 2, para. 0040 of Ben-Muvhar).
Regarding claims 8 and 12, modified Ben-Muvhar discloses wherein at least one of the plurality of imaging markers 120, 122, 124, 126 comprises radiopaque markers (Fig. 2, para. 0034, 0038 of Jang).
Regarding claim 9, modified Ben-Muvhar discloses wherein at least one of the plurality of imaging markers 120, 122, 124, 126 is positioned within an interior cavity 40 of the inflatable body 100 (Fig. 2, para. 0034, 0038 of Jang).
Regarding claim 13, modified Ben-Muvhar discloses wherein the imaging markers are spaced from each other along a longitudinal axis of the inflatable body (Fig. 2, para. 0034, 0038 of Jang).
Regarding claim 21, modified Ben-Muvhar discloses wherein each of the plurality of segments has a conical frustum shape (annotated Fig. 2 of Ben-Muvhar above, para. 0040 of Ben-Muvhar).
Regarding claim 23, modified Ben-Muvhar discloses wherein the plurality of imaging markers are positioned between the first end of the central body and the second end of the central body (Fig. 2, para. 0034, 0038 of Jang).
Regarding claim 24, modified Ben-Muvhar discloses wherein the plurality of imaging markers 120, 122, 124, 126 includes three imaging markers each configured to indicate the position of the greatest diameter of the respective one of the plurality of segments (Fig. 2, para. 0034, 0034 of Jang; see note above in regards to functional language).
Regarding claim 25, modified Ben-Muvhar discloses all of the limitations set forth above in claim 23. However, modified Ben-Muvhar fails to disclose wherein the plurality of imaging markers are spaced equally from each other.
There is no evidence of record that establishes that changing the spacing between each imaging marker would result in a difference in function of the modified Ben-Muvhar device. Further, a person having ordinary skill in the art, being faced with modifying the plurality of imaging markers of modified Ben-Muvhar, 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 spacing would still result in the user being able to identify the position of the plurality of segments via. the plurality of imaging markers during the procedure (Fig. 2, para. 0034, 0034 of Jang). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating simply that “The imaging markers 60 may be equally spaced from each other or another spacing may be utilized.”. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Hence, 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 distance between each imaging marker of modified Ben-Muvhar to be equidistant of each other as an obvious matter of design choice within the skill of the art.
Regarding claim 16, Ben-Muvhar discloses an implant system (Fig. 4, para. 0040, 0043) comprising:
an implant 100 configured to be deployed to a deployment site within a subject (Figs. 1A-B, para. 0037) and having an angled interior profile that faces an interior cavity of the implant (Fig. 1B, para. 0037); and an inflatable body 200 having a central body configured to be positioned within the interior cavity of the implant 100, the central portion having a single continuous profile angle along a length of the central body from a first end of the central body to a second end of the central body (see annotated Fig. 2 above), and configured to press towards the implant to dilate the implant 100 (Fig. 4, para. 0038, 0040, 0044-0045), the central body having a profile that is angled to fit the angled interior profile of the implant (Fig. 4., para. 0044-0045), wherein the central body includes a plurality of segments (see annotated Fig. 2 above), each of the plurality of segments having a profile angle that is a same angle (see Fig. 2 of Ben-Muvhar) and each of the plurality of segments having a greatest diameter that is different than a greatest diameter of each other of the plurality of segments (due to the tapered shape, such that the profile angle of each of the plurality of segments decreases in diameter along the length of the balloon, the greatest diameters of each of the plurality of segment would be different from each other).
However, Ben-Muvhar fails to disclose a plurality of imaging markers each configured to indicate a position of the greatest diameter of a respective one of the plurality of segments to thereby indicate a diameter that the implant will be dilated to at the greatest diameter.
Jang in the same field of endeavor teaches a dilation device 10 for an implant 150 (Figs. 1, 3A-B, para. 0038), the dilation device comprising a central body including a plurality of segments 110, 112, 114 (Figs. 1-2, para. 0034); and further comprising a plurality of imaging markers 120, 122, 124, 126 on a catheter shaft 38 (Fig. 1, para. 0038), each configured to indicate a position of a respective one of the plurality of segments (Fig. 2, para. 0034, 0038).
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 in Ben-Muvhar to include the plurality of imaging markers of Jang in order to allow the user to visually identify the plurality of segments along the length of the balloon during use (para. 0036 of Jang), thereby increasing the accuracy of the placement of the implant (para. 0045, 0053 of Jang).
The combination of Ben-Muvhar in view of Jang would result in a product wherein the plurality of imaging markers of Jang (Figs. 1-2, para. 0034, 0038 of Jang), each configured to indicate a position of the greatest diameter of a respective one of the plurality of segments of Ben-Muvhar (see annotated Fig. 2 [a] of Ben-Muvhar below) to thereby indicate a diameter that the implant will be dilated to at the greatest diameter (Figs. 1-2, para. 0034, 0038 of Jang, see note above in the rejection of claims 1 and 11 in regards to functional language).
Regarding claim 17, modified Ben-Muvhar discloses wherein the implant 100 has a length and the length of the central body is greater than the length of the implant 100 (see Fig. 4, para. 0045 of Ben-Muvhar).
Regarding claim 18, modified Ben-Muvhar discloses wherein the plurality of segments each have a different profile (see annotated Fig. 2 of Ben-Muvhar above; The examiner notes that the different profiles are due to the tapered shape of the balloon, such that the profile decreases in diameter along the length of the balloon from the most proximal segment to the most distal segment).
Regarding claim 19, modified Ben-Muvhar discloses wherein the inflatable body 200 is configured to be in an undeployed configuration (interpreted as the inflatable body in a deflated state, para. 0040) and is configured to be inflated to a deployed configuration (Figs. 2, 5, para. 0040, 0045 of Ben-Muvhar).
Regarding claim 20, modified Ben-Muvhar discloses wherein the inflatable body 200 is configured to not expand beyond a defined profile of the inflatable body upon inflation of the inflatable body (Fig. 2, para. 0040 of Ben-Muvhar).
Claim(s) 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Muvhar (US 20060030920) in view of Jang (US 20080188803), as applied to claim 16 above, and further in view of Klein (US 20040088043).
Regarding claim 26, modified Ben-Muvhar discloses all of the limitations set forth above in claim 16. Modified Ben-Muvhar further discloses “Similarly, balloons of the general type described above may be used to deliver not only device 100, but also other implantable devices for implantation in other body passages of variable diameter, as are otherwise known in the art” (para. 0047 of Ben-Muvhar). However, modified Ben-Muvhar fails to disclose wherein the implant is a prosthetic heart valve.
Klein in the same field of endeavor teaches that it is known in the art to use a tapered dilation balloon 90 for delivering and deploying a prosthetic heart valve 208 (Fig. 20A, para. 0004-0005, 0073, para. 0080 teaches that the prosthesis may be sized as appropriate for use in the aorta in the body and therefore is interpreted as a prosthetic heart valve).
The substitution of one known implant (prosthetic heart valve as shown in Klein) for another (stent as shown in modified Ben-Muvhar) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the prosthetic heart valve shown in Klein would have yielded predictable results, namely, allow the dilation balloon of modified Ben-Muvhar to inflate and expand the prosthetic heart valve for use in heart valve replacement surgery (para. 0073, 0080 of Klein).
Regarding claim 27, modified Ben-Muvhar discloses wherein the implant has a tapered interior profile (Fig. 20A, para. 0075 of Klein).
Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Muvhar (US 20060030920) in view of Jang (US 20080188803), as applied to claim 16 above, and further in view of Byrne et al. (US 20150112256) [hereinafter Byrne].
Regarding claim 28, modified Ben-Muvhar discloses all of the limitations set forth above in claim 16. However, modified Ben-Muvhar fails to disclose wherein at least one of the plurality of imaging markers is positioned on a wall of the inflatable body.
Byrne in the same field of endeavor of balloon catheters teaches that it is known in the art to position at least one of a plurality of imaging markers on a wall of an inflatable body (Figs. 10-11, para. 0027-0029).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the location of at least one of the plurality of imaging markers in modified Ben-Muvhar to the wall of the inflatable body, as taught by Byrne (see para. 0027, 0029 of Byrne), since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). MPEP 2144.04 VI. C. Shifting the location of the imaging markers of modified Bev-Muvhar would not have modified the operation of the dilation device because the imaging markers would still indicate the position of the greatest diameter of the plurality of segments whether they are located on the catheter shaft or the wall of the inflatable body as the location change does not move the markers along the longitudinal axis, rather it moves them vertically. Thus, the position of the markers relative to the plurality of segments along the longitudinal axis would not change.
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771