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 13 July 2026 have been fully considered but they are not persuasive.
Regarding the argument that “it is improper to provide a basis for modifying the retrieval legs using a passage directed to the distal transition struts”, paragraph [0053] was cited to explicitly show that a lower thickness imparts lower bending stiffness and a greater width imparts greater torsional stiffness, regardless of the strut type. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Regarding the argument that “Neither of these components is mapped to the retrieval legs of the instant claims”, it is noted 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). In this case, Forcucci teaches the effects of modifying the width and thickness of the struts and the reasons for doing so. Forcucci does not explicitly teach away from modifying the width and thickness of the retention portion or the retrieval portion.
Regarding the argument that “Paragraph [0124] addresses a different design variable than what is instantly claimed”, the paragraph was cited to show the source of the twisting forces and an additional reason for modification.
Regarding the argument that “These are both deliberate engineering and design choices that are not disclosed, taught, or suggested by Forcucci”, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding the argument that “the word "stiffness" does not appear anywhere in Forcucci's specification”, it is obvious to one of ordinary skill in the art that “the curving and bending” of an element is directly related to the stiffness of the element despite the lack of the word “stiffness” in the disclosure. Stiffness is also directly proportional to the thickness/width of the element.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 7-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forcucci et al. (US 20160022970 A1).
Regarding Claim 7, Forcucci discloses a device for implanting into an atrial septum of a patient ("Device 10 may be delivered via a delivery catheter (not shown) for deployment in the atrial septum of the patient's heart" [0041]; FIG. 1), the device comprising:
a core region with a distal end, a proximal end ("central core region 16" [0041]; FIG. 6), and a plurality struts ("strut 26" [0048]; FIG. 6) joining their adjacent struts forming a continuous rounded zigzag pattern ("continuous strut 26 in a wavy profile with hairpin turns" [0048]) between the distal and the proximal ends ("strut 26 extends longitudinally from a first end 28 of the core region 16 toward the second end 30" [0048]);
a distal retention portion ("distal retention region 12" [0041]; FIG. 6) joining the distal end of core region ("extends distally from a central core region 16 via a distal transition region 14" [0041]), wherein the distal retention portion comprises a plurality of distal retention segments ("plurality of flexible retention segments 46" [0042]) each formed by two adjacent struts ("each including or formed by two adjacent distal retention struts 40" [0054]);
a proximal retention portion ("proximal retention region 20" [0041]; FIG. 6) with a first end joining the proximal end of core region ("extends proximally from core region 16 via a proximal transition region 18" [0041]), wherein the proximal retention portion comprises a plurality of proximal retention segments ("proximal retention segments 60" [0044]) each formed by two adjacent struts ("two adjacent proximal retention struts 66" [0044]);
a retrieval portion ("retrieval portion 22" [0065]; FIG. 6) having a plurality of retrieval legs ("retrieval legs 76" [0066]) joining a second end of the proximal retention portion ("each of the distal ends connecting to the proximal end of a deployed proximal retention segment 60" [0066]).
Forcucci fails to specify the plurality of retrieval legs are configured to have a low bending stiffness and a high torsional stiffness to impede the retrieval legs from twisting about a longitudinal axis thereof. However, Forcucci teaches that the width and thickness of the struts/legs are result effective variables in that a lower thickness imparts lower bending stiffness and a greater width imparts greater torsional stiffness (“width and thickness of the strut 26 may vary at in some locations, either for the purposes of ease of manufacturing or reduced stress concentration” [0048] & “to control the bending direction, the width of the distal transition struts 34 can be greater than the thickness” [0053]; “the curving and bending of such portions can be achieved in a controlled manner, without risking the struts being twisted during the process” ¶ [0067]; “Device 510 shown in FIG. 18 is less likely to twist during retrieval than the device 610 shown in FIG. 19 due at least in part to the different locations of these connection points” ¶ [0124]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Forcucci’s device to arrive at the claimed invention since it involves only adjusting the dimension of a disclosed component. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Forcucci to arrive at the claimed invention as a matter of routine optimization “for the purposes of ease of manufacturing or reduced stress concentration after implantation” ([0048]) since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claims 8-10, Forcucci fails to specify the two struts forming each proximal retention segment are configured to have a low bending stiffness and a high torsional stiffness; at least one of the plurality of retrieval legs has a wider middle section; at least one of the two struts forming each proximal retention segment has a wider middle section. However, Forcucci teaches that the width and thickness of the struts/legs are result effective variables in that a lower thickness imparts lower bending stiffness and a greater width imparts greater torsional stiffness (“width and thickness of the strut 26 may vary at in some locations, either for the purposes of ease of manufacturing or reduced stress concentration” [0048] & “to control the bending direction, the width of the distal transition struts 34 can be greater than the thickness” [0053]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Forcucci’s device to arrive at the claimed invention since it involves only adjusting the dimension of a disclosed component. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Forcucci to arrive at the claimed invention as a matter of routine optimization “for the purposes of ease of manufacturing or reduced stress concentration after implantation” ([0048]) since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 11, Forcucci discloses the at least one of the plurality of retrieval legs has a ladder profiled distal portion ([0103]; FIG. 17).
Regarding Claim 12, Forcucci discloses at least two adjacent retrieval legs have ladder profiled distal portions in mirror symmetrical configuration to each other ([0103]; FIG. 17).
Regarding Claim 13, Forcucci discloses a delivery configuration ("collapsed delivery configuration" [0045]; FIG. 3) where both the distal retention portion, the core region, the proximal retention portion, and the retrieval portion collapse radially and orient longitudinally along a longitudinal axis of the core region (see FIG. 3).
Regarding Claim 14, Forcucci discloses a deployed configuration ("deployed configuration" [0041]; FIGs. 1-2) where both the distal and the proximal retention portions extend radially away from the longitudinal axis of the core region, and the retrieval portion extends radially away from the proximal retention portion with a proximal end of the retrieval portion radially outside of the proximal end of the core region ([0041-0043]; FIG. 2).
Conclusion
THIS ACTION IS MADE FINAL. 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 Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
Prosecution Insights