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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/24/2026 has been entered.
Priority
This application claims priority from provisional application 62/900,059, filed 09/13/2019.
Status of Claims
Claims 1 and 3-24 are pending.
Claims 5-7, 9-13, 15-16, and 19-24 have been withdrawn from consideration.
Election/Restrictions
Applicant elected Species 1 (Figure 3A) without traverse on 04/09/25.
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 1, 3, 4, 8, 14, 17, and 18 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.
Claim 1 is rendered indefinite for lack of antecedent basis issues:
Lines 17 and 20 both appear to be referring back to the previously defined circumference of the core defined in line 4, but use the term outer circumference in stead of circumference. If the applicant intended to define the outer circumference as an additional component, then line 20 should still have used “the outer circumference”. The applicant is advised to amend lines 17 and 20 to recite the circumference encircling the central core.
Claim 1 is further rendered indefinite by the requirement for each appendage to be independent from other appendages in lines 11-12. All of the appendages shown in the elected embodiment depicted in Figure 3A are directly linked. The appear to be formed from a single wire and are joined to each other. Therefore it is unclear how they can be called independent. A person of ordinary skill in the art would not be able to determine the scop of what would and would not qualify as independent as defined in lines 11-12. The applicant is advised to delete this clause from lines 11-12 and rely on the clause in lines 13-14 which better defines how they independently expand.
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.
Claims 1, 3, 4, 14, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hill US 2010/0036479 A1 B2 in view of Leo et al (Leo) US 2016/0081799 A1.
1. Hill discloses an expandable device (Figures 1-4) for implanting within vasculature, comprising:
a central core (12) comprising a number of struts that form a number of cells (adjacent 302), the cells forming a circumference encircling the central core (Figure 3); wherein the central core is capable of expanding from an unexpanded state radially outward to an expanded state [0009];
wherein when the central core is an expanded state (Figure 3A), the central core has a controlled inner diameter (adjacent 302); and
first and second plurality of appendages (14/16) that extend away from the central core in first and second directions (Left and Right in Figure 3), each appendage is formed by at least one strut and is independent from the other appendages (304 Figure 3A);
wherein each appendage is capable of independently expanding from an unexpanded state radially outward to an expanded state (each appendage has an unattached free end enabling independent movement when other appendages are held stationary).
wherein in the expanded state (Figure 3) each appendage of the first and second plurality of appendages extends radially outward beyond an outer circumference of the central core (both 14 and 16 have greater diameters) and extends axially in the first and second axial directions beyond the central core (both 14 and 16 extend above and below the core);
Hill discloses the invention substantially as claimed being above, but not disclose the specific diameters for the stent frame. However the applicant’s invention and the invention of Hill are both intended to be implanted in the same valves within the heart. They both comprise the same types of frames for placement within the valves. Additionally, the applicant’s original disclosure describes these dimensions in general with no indication of criticality. [0125] and [0133] describe a long list of potential sizes and then explain that any appropriate size can be used.
However, Leo discloses that it is old and well known in the art of expandable heart valves to provide the core of the valve to have an inner diameter of 20 mm and an outer diameter at the end of the stent of 50 mm (9:40-58)
Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made to form the invention of Hill with an inner diameter of the central core in the expanded state of 20 mm and a largest diameter at the apex of 50 mm. This would result in a snug fit adjacent the valves within the patient’s heart.
3. Hill discloses at least one appendage is formed by at least two struts that connect at the apex of the appendage (Figure 2).
4. Hill discloses one appendage forms a V-shape (Figure 2)
14. Hill discloses the central core is configured to engage a prosthesis (central core is capable of engaging any appropriately sized prosthesis such as an previously inserted ring or graft).
17. Hill discloses the central core and the plurality of appendages are in a crimped state, the central core and the plurality of appendages are configured to be inserted within a catheter [0009].
18. Hill discloses when in the expanded state, the apex of each appendage is capable of engaging an inner wall of a vasculature (Figures 25-26).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill and Leo (Combination 1) as applied to claims 1, 3, 4, 14, 17, and 18 above, and further in view of Bailey et al (Bailey) US2001/0021872 A1.
Hill as modified by Leo discloses the invention substantially as claimed being above. However, Hill does not disclose the use of radiopaque markers on stent frame.
Bailey teaches the use of radiopaque markers on the stent body [0055] in the same field of endeavor for the purpose of aiding with orienting the stent during insertion.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the radiopaque markers of Bailey with the stent of Hill in order to ensure the implant is inserted in the precise orientation and position.
Response to Arguments
Applicant's arguments filed 01/21/2026 have been fully considered but they are not persuasive.
The applicant’s argument with respect to Birdsall are moot because the base reference has been switched to Hill, which clearly shows the appendages extending away from the core both beyond the circumference of the core and in 2 axial directions away from the core.
With respect to the teachings of Leo, the applicant argues that the action does not provide a motivation for the modification. This is not persuasive because as previously stated the inventions of record are all being inserted within the same portions of the body and providing the implants with the claimed and taught diameters will provide a snug fit within the implant site. Furthermore it will aid with stopping any leakage or movement away from the desired position after insertion. The applicant goes on to say that the action fails to provide any rational how an ordinary person would combine the sizes of Leo with the base reference. A person of ordinary skill in the art would inherently understand how to modify the narrowest and widest portions of a stent to match the same dimensions as the narrowest and widest portions of a similar stent. The angle of the struts is irrelevant because they will be in the same implant site and engage the walls in the same manner.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R 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.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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