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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/13/2026 has been entered.
Priority
This application claims priority from provisional application 63/044,534, filed on 06/26/2020
Status of Claims
Claims 1 and 3-22 are pending.
Claim 2 has been cancelled.
Election/Restrictions
Applicant elected Species 1 (Figures 1AB) with traverse on 02/25/2025.
Terminal Disclaimer
The terminal disclaimer filed on 09/09/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 11,938,022 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the engagement mechanism does not include an arm extending from an outer surface of the tubular body” (Claim 1, see 112 rejections for more details) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to require “the engagement mechanism does not include an arm extending from an outer surface of the tubular body”, which is considered to be new matter. There is no recitation within the original specification supporting this negative limitation that it does not include the arm extending from the outer surface of the body. [0038] is most relevant to this limitation, which identifies the engagement mechanism as comprising groove 45 and shoulder 47. However, reviewing the structure of shoulder element 47 it appears to be showing a plurality of struts, which would appear to qualify as arms, that extend down and away from the groove 45, which appears to be defining the outer surface of the tubular body. This appears to be consistent with the earlier interpretation of the now deleted language from claim 3. Later non-elected embodiments appear to add in additional arms 48/49 in Figures 8 and 9. However, even the elected embodiment shown in Figures 1AB, contradict this claim requirement based on its broad language and no guidance from the original disclosure. Therefore the negative limitation that “the engagement mechanism does not include an arm extending from an outer surface of the tubular body” is considered to be new matter.
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 1 and 3-22 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.
As explained above claim 1 has been amended to require the engagement mechanism does not include an arm extending from an outer surface of the tubular body. In addition to being new matter this requirement is considered indefinite because a person of ordinary skill in the art would not be able to determine the scope of the “arm” or the scope of the “extending from an outer surface” recitation. With respect to an arm, what would and would not qualify as an arm? Does it need to be a single strut or a single structure? Can the strut or component be connected to other components or does it need a free end extending away? Would having multiple arms be ok because the claim only rules out having a single arm? With regards to extending from an outer surface, does this only include extending radially outward from the side surface? Would it permit extending from a lower surface? If the strut is directly welded or monolithic to the tubular body, is it extending away from the outer surface. If the strut or arm is part of the tubular body, how can it extend away from itself? It is known in the art of stent supported heart valves that the struts of the stent sections do not have clearly differential starting and stopping points and that they are extensions of each other. Therefore it is unclear how on strut can be identified as extending from an outer surface of the structure it defines or is defined by.
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.
Claim(s) 1, 3-5, 8, 9, and 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kovalsky US 2014/0046433 A1 in view of Hariton WO 2016/125160 A1.
1. Kovalsky discloses a method for implanting a prosthetic valve in a heart of a patient (Figures 16-20), comprising:
advancing a delivery catheter to a native mitral or tricuspid valve (Figure 16),
the delivery catheter containing a tubular body (Figures 3-4), the tubular body extending in an axial direction from an inflow end to an outflow end (Figure 4), and including a lumen in which the prosthetic valve is disposed (Figure 5);
partially deploying the tubular body from the delivery catheter such that an outflow end portion of the tubular body is deployed from the delivery catheter while an inflow end portion of the tubular body remains inside a lumen of the delivery catheter (Figure 18), the outflow end portion being deployed at a position distal of a junction between a leaflet part and chordae attached to the leaflet part of at least one native valve leaflet of the native mitral or tricuspid valve (Figure 18); and then deploying the inflow end portion of the tubular body such that the tubular body is fully deployed (Figure 20).
wherein the outflow end portion of the tubular body includes an engagement mechanism 122A/B configured to engage the at least one native valve leaflet (Figures 19-20), and the engagement mechanism does not include an arm extending from an outer surface of the tubular body (as explained in the 112 rejections above this recitation has new matter and indefiniteness issues, so it is being rejected as best understood, accordingly as seen in Figures 14 and 19-22B, Kovalsky discloses engagement members comprising curved struts 122A/B that are part of the tubular body. They are not separate arms and do not extend outward from a surface of the tubular body because they define the curved outer surface of the tubular body, these struts read upon the claimed subject matter as much as the applicant’s elected embodiment).
However, Kovalsky does not disclose the step of moving the delivery catheter in a proximal direction towards an atrial chamber of the heart without further deploying the tubular body from the delivery catheter such that the outflow end portion of the partially deployed tubular body engages the at least one native valve leaflet.
Hariton teaches the use of method for implanting a heart valve in a patient comprising the step of moving the delivery catheter in a proximal direction towards an atrial chamber of the heart without further deploying the tubular body from the delivery catheter such that the outflow end portion of the partially deployed tubular body engages the at least one native valve leaflet (Figures 4B-C p39 lines 7-34).
in the same field of endeavor for the purpose of forming a good seal and compressing the native heart valves to provide maximum flow.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the step of moving the delivery catheter in a proximal direction towards an atrial chamber of the heart without further deploying the tubular body from the delivery catheter such that the outflow end portion of the partially deployed tubular body engages the at least one native valve leaflet as taught by Hariton with the method of Kovalsky in order to ensure the engagement mechanism of the outflow end of the heart valve is fully seated within the implant site and that the native leaflets are compressed out of the way to ensure maximum flow.
3. Kovalsky discloses the engagement mechanism includes at least one element selected from the group consisting of: a groove or recess formed in an outer surface of the tubular body (Figure 20 shows the arms 122A/B have a lower groove), a shoulder or bulge formed in the outer surface of the tubular body (Figure 20 shows the arms 122A/B form a shoulder, the lower curve), a clip disposed on the outer surface of the tubular body (Figure 20 shows the arms 122A/B), a hook disposed on the outer surface of the tubular body (Figure 20 shows the arms 122A/B), and a barb disposed on the outer surface of the tubular body.
4. Kovalsky discloses the engagement mechanism includes a groove formed in the outer surface of the tubular body (Kovalsky discloses a frame work that tapers inward adjacent the native leaflets, the examiner is considering this rounded inner section to anticipate the groove Figures 5 and 20), and a shoulder formed on an outflow side of the groove (bottom most loop of arms 122A/B Figure 20).
5. Kovalsky discloses that after the tubular body is fully deployed, the at least one native valve leaflet is captured by the engagement mechanism in an at least partially folded up state proximal of the outflow end of the tubular body along the axial direction (Figure 20 shows the right leaflet is partly folded up by arm 122B).
8. Kovalsky discloses the tubular body is partially deployed starting from the outflow end until the engagement mechanism deploys from the delivery catheter at a position distal of the junction between the leaflet part and the chordae (Figures 18-19).
9. Kovalsky discloses the engagement mechanism is positioned at an axial height of prosthetic leaflets of the prosthetic valve (Figure 20 shows the engagement mechanism 122A is at the axial height of the prosthetic leaflets).
19. Kovalsky discloses the at least one native valve leaflet includes an anterior mitral valve leaflet or an anterior or septal tricuspid valve leaflet (Figure 20), and the patient is at risk of obstruction of a left ventricular outflow tract or a right ventricular outflow tract by the anterior mitral valve leaflet or the anterior or septal tricuspid valve leaflet (every patient is considered to be at risk of these types of obstructions, they are common conditions that could be experienced by anyone, especially in patients needing replacement mitral valves).
20. Kovalsky discloses the tubular body is partially deployed, an entirety of the partially deployed tubular body that is exposed from the delivery catheter is spaced from the junction between the leaflet part and the chordae in a distal direction extending away from the atrial chamber of the heart towards a ventricular chamber of the heart (Figure 18).
21. Kovalsky as modified by Hariton discloses the delivery catheter is moved in the proximal direction towards the atrial chamber of the heart without further deploying the tubular body from the delivery catheter (Figures 4B-C of Hariton) so that the outflow end portion of the partially deployed tubular body captures the at least one native valve leaflet in an at least partially folded up state (Figures 4B-C of Hariton show the leaflet being compressed into a folded up position) on an outer surface of the tubular body at a position that is spaced in the proximal direction from the outflow end of the tubular body (Figures 4B-C of Hariton and Figure 20 of Kovalsky show the body surrounds the leaflets thereby spacing them proximally away from the out end of the body).
In regards to claim 22, Kovalsky discloses the engagement members 122A/B may be formed with V shaped connectors (Figure 14) or the engagement members 2140A/B may include a plurality of interconnected struts that form a tubular lattice structure 2104 (Figures 21A-22B show the tubular shape and Figure 20 shows the lattice struts of the section in more detail) which expands radially outward (Figures 21A-22B).
However, Kovalsky does not disclose the tubular lattice structure expands radially outward when the tubular body is partially deployed from the delivery catheter
It would have been obvious to one having ordinary skill in the art at the time the invention was made to further deploy at least some of the tubular body connected to the engagement members during the partial expansion in order to provide interior support when sandwiching the native leaflets in order to prevent them from collapsing or folding in undesired positions during the initial steps of the implantation.
Claim(s) 6, 7, and 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kovalsky and Hariton (Combination 1) as applied to claims 1, 3-5, 8, 9, and 19-22 above, and further in view of Burtlein et al (Burtlein) US USPN 10,064,719 B2.
In regards to claim 6, Kovalsky discloses the invention substantially as claimed comprising a tubular body with a fabric [0040]. However, Kovalsky does not disclose the use of a fabric cover with lateral openings at the outflow end or a support ring.
Burtlein teaches the use of a stented heart valve comprising a fabric cover with a plurality of separate segments leaving lateral openings therebetween (23:60-63) in the same field of endeavor for the purpose of increasing surface area of the outflow end.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the fabric cover of Burtlein with the lateral openings with the tubular stent body of Kovalsky in order to maximize flow through the outflow end.
In regards to claim 7, Kovalsky discloses a native leaflet is captured by the engagement mechanism (122B captures the native leaflet Figure 20) at a position proximal of the outflow end, and Burtlein discloses the fabric cover comprises 6 spaced apart segments defining lateral openings therebetween. It is inherent that at least one of these segments will be positioned away from or on an opposite side of the prosthesis making it impossible for that leaflet to obstruct the opening.
In regards to claim 11, Burtlein further teaches the use of a delivering a support member (75/80 Figures 13a and 13b) to form a ring around native valve leaflets of the native mitral or tricuspid valve (21:55-63) in the same field of endeavor for the purpose of forcing and further compressing the native leaflets into the engagement members.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the support ring of Burtlein with system of Kovalsky in order to further aid in the compressing and securement of the native leaflets into the engagement members.
12. Kovalsky as modified by Hariton and Burtlein discloses that after the tubular body is fully deployed (Kovalsky Figure 20), the at least one native valve leaflet is captured between the support member and the tubular body in an at least partially folded up state proximal of the outflow end portion along the axial direction (Burtlein 25:54-59 discloses the support ring will compress the native leaflet further into the engagement member).
13. Kovalsky as modified by Hariton and Burtlein discloses the native valve leaflet is pinched or clamped between the support member and an outer surface of the tubular body after the tubular body is fully deployed (Burtlein 26:13-24 discloses the support ring compressed to clamp the native leaflet after full deployment).
14. Kovalsky as modified by Hariton and Burtlein discloses the tubular body includes a groove formed in an outer surface thereof between the inflow end portion and the outflow end, (Kovalsky discloses a frame work that tapers inward adjacent the native leaflets, the examiner is considering this rounded inner section to anticipate the groove Figures 5 and 20) and the at least one native valve leaflet is captured in an at least partially folded up state in the groove between the support member and an outer surface of the groove after the tubular body is fully deployed (by arms 122A/B Figure 20 Kovalsky).
15. Kovalsky as modified by Hariton and Burtlein discloses the tubular body further includes a shoulder formed on an outflow side of the groove along the axial direction (lower most curve near reference number 122B Figure 20 Kovalsky), the tubular body is partially deployed starting from the outflow end until the shoulder deploys from the delivery catheter at a position distal of the junction between the leaflet part and the chordae (Figure 19 Kovalsky), and the shoulder engages the at least one native valve leaflet when the delivery catheter is moved in the proximal direction towards the atrial chamber of the heart (Figures 19-20 Kovalsky).
16. Kovalsky as modified by Hariton and Burtlein discloses the at least one native valve leaflet is captured between the shoulder and the support member after the tubular body is fully deployed (Figures 19-20 Kovalsky).
17. Kovalsky as modified by Hariton and Burtlein discloses the ring formed by the support member is larger in circumference than the groove, but smaller in circumference than the shoulder (Burtlein discloses the ring extends about the groove making it have a larger circumference, and the shoulder extends along the outside of the ring so it must have a larger circumference shown best in Burtlein Figure 13a/b).
18. Kovalsky as modified by Hariton and Burtlein discloses the shoulder has a largest circumference of the outflow end portion of the tubular body (Kovalsky discloses the shoulder extending the entirety of the outflow end portion, so it inherently has the largest circumference of the outflow end portion Figure 20 ).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kovalsky and Hariton (Combination 1) as applied to claims 1, 3-5, 8, 9, and 19-22 above, and further in view of Karapetian et al (Karapetian) US 2015/0148896 A1.
Kovalsky discloses the invention substantially as claimed being described above. However, Kovalsky does not disclose the engagement mechanism has a roughened outer surface for increased friction.
Karapetian teaches the use of a stented heart valve comprising leaflet engagement members with a roughened outer surface ([0283] Lines 20-23) in the same field of endeavor for the purpose of increasing the grip and forming a better connection between the members and the native leaflets.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine roughened outer surface texture of Karapetian with the engagement members of Kovalsky in order to strengthen the connection between the members and the native leaflets.
Response to Arguments
Applicant's arguments filed 01/13/2026 have been fully considered but they are not persuasive. The applicant argues that Kovalsky fails to disclose the engagement mechanism does not include an arm extending from an outer surface of the tubular body. This is not persuasive because as explained above this amendment created multiple 112 issues including new matter and indefiniteness. Furthermore the prior art reads on this limitation in the same manner as the applicant’s own invention. Both disclose struts defining the engagement mechanism that are a continuous part of the tubular body. The struts are directly bonded to the tubular body and therefore cannot extend from its outer surface. Moreso, both engagement mechanisms of the prior art and the applicant’s invention define the curved outer surface of the tubular body and therefore cannot extend from its outer surface.
In regards to new claim 22, the rejection has been explained to show how Kovalsky discloses multiple embodiments of the engagement mechanism and adjacent tubular lattice connections. It also has been modified to show how it would have been obvious to release slightly more of the tubular body during the initial expansion and pulling phase. A person of ordinary skill in the art would recognize that the additional expansion would allow for gripping the native leaflets on the inside and outside during their folding and compressing steps, which would ensure their proper placement and prevent unwanted extra folds or compression.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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