CTNF 18/599,811 CTNF 79593 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 § 112 07-30-02 AIA 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. 07-34-01 Claims 4, 5, 11, and 17-20 are 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. Claims 4 and 5 recite a function of the claimed invention based on a “desired insertion depth” and “actual insertion depth”. As known in the art, the particular size and shape of the native annulus varies widely dependent on patient age, height, health, race, gender, etc. Since the “desired insertion depth” and “actual insertion depth” would vary widely depending on patient anatomy, the limitation is rendered indefinite, as the meets and bounds of the claimed device cannot be determined. Claim 11 recites a “remaining radial material thickness” which renders the claim indefinite, since it is unclear what is “remaining.” The claims have not defined a removed material forming any particular structural feature. Claim 17 recites the step: “…visualizing a secondary visual indicator of the implant delivery system under fluoroscopy using the imaging device when the primary visual indicator is aligned with the reference plane to verify alignment of the imaging device with the reference plane…” This limitation renders the claim indefinite, as the specification appears to be based on viewing the secondary visual indicator (the recess 78) to verify alignment with the reference plane, as shown in Figure 3. Claims 18-20 depend from claim 17 and are indefinite for the same reason. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim (s) 1-9 and 12-16 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by USPAP 2018/0116790 (Ratz et al.) . Ratz discloses an implant delivery system for delivering a replacement heart valve implant to a native valve annulus, comprising: an elongate shaft assembly including an implant holding portion (see implant positioned over shaft 124 within the distal portion of the sheath 114; fig. 22) comprising a proximal sheath (114) and a distal sheath (219); wherein the implant holding portion is configured to constrain a replacement heart valve implant in a radially collapsed configuration (see Fig. 22); wherein the elongate shaft assembly includes a primary visual indicator (radiopaque marker 117) configured to be visible under fluoroscopy with an imaging device [0123]; wherein the elongate shaft assembly includes a secondary visual indicator (annular recess 239 of retention member 132; wherein Ratz discloses the entire nosecone assembly can be radiopaque and viewable under fluoroscopy [0067]). The phrase “ configured to be visible under fluoroscopy with the imaging device when the imaging device is aligned with a reference plane associated with the native valve annulus; wherein the secondary visual indicator is not visible under fluoroscopy with the imaging device when the imaging device is misaligned with the reference plane associated with the native valve annulus” is a functional recitation that is not given full patentable weight, in that the prior art is not required to explicitly disclose the function but merely have the capability of performing the recited function. In this case, Applicant has disclosed an annular recess is capable of performing the recited function. Therefore, the annular recess (239) on the stent holder of Ratz having all the structural requirements of a secondary visual indicator is considered to be capable of indicating alignment with a reference plane of a target valve. The Examiner notes that the term “reference plane associated with the native valve annulus” is given its broadest reasonable interpretation to encompass any arbitrarily assigned plane, as the limitation does not specify a particular direction of the plane relative to any particular patient anatomy. Regarding claim 2, the phrase “a desired insertion depth of the replacement heart valve implant relative to the reference plane associated with the native valve annulus is about 7 millimeters from the reference plane associated with the native valve annulus to an inflow end of the replacement heart valve implant” is directed towards an intended use of the device and not given patentable weight. The capability of the Ratz assembly to place the prosthetic heart valve such it is 7 mm from a reference plane of the native annulus meets the claim requirement. Regarding claim 3, the primary visual indicator (117) is capable of indicating to the operator the actual insertion depth of the replacement heart valve implant relative to the reference plane associated with the native valve annulus, since it indicates a position of the heart valve in the delivery configuration of Fig. 1. Regarding claim 4, the phrase “wherein when the secondary visual indicator is visible under fluoroscopy and the primary visual indicator is aligned with the reference plane under fluoroscopy, the actual insertion depth is within 10% of the desired insertion depth” is a functional recitation that is not given full patentable weight, in that the prior art is not required to explicitly disclose the function but merely have the capability of performing the recited function. In this case, the assembly is capable of being placed relative to some existing heart valve such that the secondary indicator (annular recess 239) is visible and the primary marker (117) is aligned with a reference plane of the valve, such that the actual insertion depth is within 10% of the desired insertion depth. As known in the art, the particular size and shape of the native annulus varies widely dependent on patient age, height, health, race, gender, etc. Regarding claim 5: similar to claim 4, the claim is not given full patentable weight. The Ratz device is capable of being positioned relative to some existing valve and some assigned “reference plane” such that the secondary visual indicator (annular recess 239) is not be visible under fluoroscopy and the primary visual indicator is aligned with the reference plane when an actual insertion depth deviates from desired insertion depth by at least 10%. Regarding claim 6: the elongate shaft assembly includes a stent holder (132) configured to engage an expandable framework of the replacement heart valve implant (70) in the radially collapsed configuration (Fig. 21; [0130]). Regarding claim 7, the secondary visual indicator comprises an annular recess (239) formed within the stent holder (132) [0131]. Regarding claim 8: the phrase “wherein when the imaging device is aligned with the reference plane associated with the native valve annulus and the primary visual indicator is aligned with the reference plane under fluoroscopy, the annular recess is visible to the imaging device as a void oriented generally parallel to the reference plane” is functional recitation that is not given full patentable weight, in that the prior art is not required to explicitly disclose the function but merely have the capability of performing the recited function. In this case, Applicant has disclosed an annular recess is capable of performing the recited function. Therefore, the annular recess (239) on the stent holder (132) of Ratz having all the structural requirements of a secondary visual indicator is considered to be capable of being visible as a void oriented generally parallel to some assigned reference plane of a valve when the marker (117) and an imaging device are aligned with the reference plane. Regarding claim 9, similar to claim 8, the annular recess is capable of being at least partially obscured from viewing by the imaging device wherein when an imaging device is misaligned with the reference plane associated with the native valve annulus and the primary visual indicator is aligned with the reference plane under fluoroscopy. Regarding claim 12, the primary visual indicator (117) is axially spaced apart from the secondary visual indicator (239) (as the marker 117 is moveable relative to the recess 239, as in Fig. 23). Regarding claim 13, Ratz discloses a replacement heart valve implant (70) comprising an expandable framework (71) and a plurality of valve leaflets (92) secured to the expandable framework [0048-0050], the expandable framework being configured to shift between a radially collapsed configuration (Figure 2A) and a radially expanded configuration (Fig. 10, 14). The implant assembly is described above in regards to claim 1. The phrase “a secondary visual indicator configured to be visible under fluoroscopy with the imaging device when the imaging device is aligned with a reference plane associated with the native valve annulus; wherein the secondary visual indicator is not visible under fluoroscopy with the imaging device when the imaging device is misaligned with the reference plane associated with the native valve annulus” is a functional recitation that is not given full patentable weight, in that the prior art is not required to explicitly disclose the function but merely have the capability of performing the recited function. In this case, Applicant has disclosed an annular recess is capable of performing the recited function. Therefore, the annular recess (239) on the stent holder of Ratz having all the structural requirements of a secondary visual indicator is considered to be capable of indicating alignment with a reference plane of a target valve. Regarding claim 14, the imaging device is not positively recited here and only recited as part of the intended use of the delivery system. Therefore, the prior art is not required to disclose an imaging system. Nonetheless, Ratz discloses the use of fluoroscopy during delivery [0067; 0088; 0092]). Regarding claim 15, the phrase “configured to position the replacement heart valve implant within the native valve annulus at an actual insertion depth relative to a reference plane assosciated with the native valve annulus that is within 10% of a desired insertion depth” is a functional recitation that is not given full patentable weight, in that the prior art is not required to explicitly disclose the function but merely have the capability of performing the recited function. In this case, the assembly is capable of being placed relative to some existing heart valve such that the secondary indicator (annular recess 239) is visible and the primary marker (117) is aligned with a reference plane of the valve, such that the actual insertion depth is within 10% of the desired insertion depth. As known in the art, the particular size and shape of the native annulus varies widely dependent on patient age, height, health, race, gender, etc. Regarding claim 16: similar to claim 15, the claim is not given full patentable weight. The Ratz device is capable of being positioned relative to some existing valve and some assigned “reference plane” such that the secondary visual indicator (annular recess 239) is not be visible under fluoroscopy and the primary visual indicator is aligned with the reference plane . 07-15 AIA Claim (s) 17 and 18 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by USPAP 2022/0331132 (Cohen et al.) . Cohen discloses a method of delivering a replacement heart valve implant (120) to a native valve annulus, comprising: advancing an implant delivery system to a position adjacent the native valve annulus [0004], wherein the replacement heart valve implant is constrained within an implant holding portion of the implant delivery system (see delivery configuration of Fig. 5); positioning an imaging device in alignment with a reference plane associated with the native valve annulus (Cohen states the delivery is viewed with fluoroscopy [0327], [0332]; it is understood that the imaging device must be aligned with some plane associated with the annulus in order to obtain images of the annulus); aligning a primary visual indicator (882a-c) (see Fig 13A-14A) of the implant delivery system with the reference plane under fluoroscopy using the imaging device (a reference plane can be arbitrarily drawn to be aligned with both the annulus and at least one marker 882 at some point during positioning of the valve implant); visualizing a secondary visual indicator (880) of the implant delivery system under fluoroscopy using the imaging device when the primary visual indicator (882) is aligned with the reference plane to verify alignment of the imaging device with the reference plane (see [0298] and Fig. 13A-B) (the secondary visual indicator 880 aids in aligning portions of the implant with the valve annulus and may be viewed through a cut-out window of a shaft using the imaging device [0298-0304] while the primary indicator is aligned with the reference plane); and deploying the replacement heart valve implant from the implant delivery system within the native valve annulus [0134]. Regarding claim 18, in a position wherein the secondary (880) and primary visual indicators (882) are positioned adjacent the native valve annulus while being viewed with an imaging device, an imaginary reference plane can be drawn to be aligned along some axis in 3-D space with the secondary visual indicator (880) and at least one primary visual indicator (882) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of USPAP 2014/0277340 (White et al.) . Although Ratz is silent with respect to the width of the recess 239, Ratz does disclose the recess is configured to receive struts of a stent frame. White discloses another implant delivery system with a stent retaining feature (8610; Fig. 86A) having grooves configured to receive stent struts (8620) in a delivery configuration (see Fig. 86E; [0245]). White teaches that the width of the struts is approximately 0.016 0.018 inch [0227], which converts to 0.4 – 0.46 mm, wherein it can be seen that the strut receiving recesses (between bosses 8612) approximate this width. Since White teaches that it is known for stent strut width to be on the order of 0.4 mm, it would have been obvious to one of ordinary skill in the art to configure the annular recess of the Ratz device to have a width of 0.3 – 0.4 mm, in order to closely approximate the width of stent struts for retention purposes. In regards to claim 11, it would have been further obvious to configure the annular recess of Ratz to have a radial depth defining a “remaining radial material thickness” of 0.07 +/- 0.01 millimeters. Since the claims have not defined a removed or remaining material, the limitation “remaining radial material” is given its broadest reasonable interpretation to encompass at least some portion of the boss or material surrounding the recess having a thickness of at least 0.07 mm . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure : USPAP 2021/0275299 discloses an implant with a series of radiopaque markers that indicate alignment of the prosthesis with a plane of the native valve annulus (see Fig. 3B-D; [0101]). USPAP 2020/0323634 discloses a delivery device with a radiopaque marker on a nosecone that indicate alignment with a plane of the native valve annulus [0013]. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm. 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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SARAH W ALEMAN/Primary Examiner, Art Unit 3774 Application/Control Number: 18/599,811 Page 2 Art Unit: 3774 Application/Control Number: 18/599,811 Page 3 Art Unit: 3774 Application/Control Number: 18/599,811 Page 4 Art Unit: 3774 Application/Control Number: 18/599,811 Page 5 Art Unit: 3774 Application/Control Number: 18/599,811 Page 6 Art Unit: 3774 Application/Control Number: 18/599,811 Page 7 Art Unit: 3774 Application/Control Number: 18/599,811 Page 8 Art Unit: 3774 Application/Control Number: 18/599,811 Page 9 Art Unit: 3774 Application/Control Number: 18/599,811 Page 10 Art Unit: 3774 Application/Control Number: 18/599,811 Page 11 Art Unit: 3774 Application/Control Number: 18/599,811 Page 12 Art Unit: 3774
Prosecution Insights