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 05/12/26 have been fully considered but they are not persuasive.
On page 7 regarding claim objections, Applicant argues amendments overcome the objections of record, since it is clarified that the leaflets are distinct from one another.
The Examiner respectfully notes that while this clarifies whether or not the leaflets are the same, the response has not clarified whether or not the “second leaflets” belong to the claimed prosthetic device or not, meaning the objection is maintained.
On page 8 regarding 112 rejections Applicant argues amendments overcome the rejections of record for clarifying the first end of the tether can be coupled to at least one of the struts.
The Examiner respectfully notes this does not clarify the claim, since it remains unclear on how a singular end can attach to multiple distinct locations. This rejection is accordingly maintained.
Claim Objections
Claims 1-are objected to because of the following informalities:
Claim 1 is objected to for referring to “one or more second valve leaflets positioned outside the flow channel of the valve body” when it is unclear if these are a part of the claimed prosthetic valve. If these are not a part of the prosthetic valve, it is unclear whether or not these leaflets are a part of the human body or not.
Appropriate correction is required.
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.
Claim 7 is 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 pre-AIA the applicant regards as the invention.
Claim 7 is indefinite for claiming each of the tethers has a first end that is coupled to at least one of the struts, when it is unclear how a single end can be coupled to multiple different elements which occupy different locations. The specification adequately describes how the tether can attach to multiple struts, but it does not support the idea that a single end is coupled to multiple struts. Instead, it appears the tether is coupled to struts along its length. The Examiner is accordingly unclear on whether to interpret the claim consistent with the specification, or consistent with the claim language, since the two differ substantially.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 6-7, 21-22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Moriss et al. (US 20170128209 A1) hereinafter known as Moriss.
Regarding claim 1 Moriss discloses a prosthetic valve (Abstract) comprising:
a valve body (Figure 84a item 130) with a proximal end (Figure 84a-c top of the valve), distal end (Figure 84a-c bottom of the valve), outer surface (Figure 84a-c, exterior of the device 120), and inner surface (Figure 84a-c, inside of item 120) facing a flow channel (Figure 84a-c, inside of the cylinder defined by item 120);
a plurality of first valve leaflets positioned within the flow channel and extending inward from the inner surface of the valve body (Figure 84a-c item 130; [0224]),
one or more protrusions (Figure 84a item 1710) configured to extend outward from the outer surface of the valve body (Figure 84a-c) and being configured to displace, in a distal direction, one or more second valve leaflets positioned outside the flow channel of the valve body (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Moriss discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See at least Figures 84a-c which show how the device contacts the native annulus, which, if it has leaflets attached thereto, would be able to move in response to the presence or pressure of the protrusions 1710),
one or more tethers coupling the valve body to a respective one or more of the protrusions (Figures 84a-c item 1730; “tether” is defined by Merriam-Webster as “a line (as of rope or chain) by which an animal is fastened so as to restrict its range of movement; a line to which someone or something is attached (as for security). The tether 1730 limits the extent the protrusions 1710 can extend (see Figure 84a).) configured to apply a force to the protrusion to rotate it towards the distal direction (Figures 85a shows how the protrusions 1710 can rotate relative to the tether 1730 and how it can rotate distally or proximally.).
Regarding claim 2 Moriss discloses the valve of claim 1 substantially as is claimed,
wherein Moriss further discloses the protrusion is configured to retain the second leaflets in a space distal of the protrusion and outside the outer surface of the valve body (This is likewise a functional limitation (see the explanation regarding functional limitations above). See also Figures 84a-c which show how any leaflets that attach to the native annulus AN would remain outside the valve, if the device is implanted in such a manner).
Regarding claim 6 Moriss discloses the valve of claim 1 substantially as is claimed,
wherein Moriss further discloses the valve body include an expandable frame (Figures 84a-c item 120; see also Figures 11a-d item 120; [0225]), and the tether is coupled to the frame such that expansion of the frame causes the tethers to apply for force to the protrusion (this is considered inherent, since all the elements are connected via structures that convey force).
Regarding claim 7 Moriss discloses the valve of claim 1 substantially as is claimed,
wherein Moriss further discloses the frame has struts (Figure 11a item 124) separated by openings (Figure 11a; [0232]), and wherein each of the tethers has a first end coupled to a strut and a second end coupled to one of the protrusions (see Figures 84a-c and 85a-c.).
Regarding claim 21 Moriss discloses the valve of claim 1 substantially as is claimed,
wherein Moriss further discloses each protrusion includes a head portion (Figure 85a item 1710’) and a neck portion (Figure 85a item 1737), the head portion being sized larger than the neck portion (Figure 85a shows the protrusion 1710’ larger than the hinge 1737), and the neck portion coupling the head portion to the valve body (Figure 85a).
Regarding claim 22 Moriss discloses the valve of claim 21 substantially as is claimed,
wherein Moriss further discloses the neck portion is configured to be bendable to allow the neck to be bend radially outward from the valve body by the force applied by the tether (this is stated as a functional limitation (as is explained in the rejection to claim 1 above). See also [0428]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss as is applied above.
Regarding claim 3 Moriss discloses the valve of claim 1 substantially as is claimed,
wherein Moriss further discloses the protrusion includes a first end coupled to the valve body (Figure 84a-c show the first end of 1730 coupled to the valve body 120), and a second end (Figure 84a-c, 85a shows the tip of item 1730 connected to 1710),
but is silent with regards to whether or not the tip is atraumatic.
However, regarding claim 3 Moriss teaches that tissue-engaging parts of their inventive valve device can be atraumatic ([0297]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Moriss so that the second end tip of the protrusions 1710 are atraumatic as is taught by Moriss as a known alternative in the art for tips which are tissue-engaging ([0297]). The courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known tissue engaging tip would have been obvious to try.
Regarding claim 4 Moriss discloses the valve of claim 3 substantially as is claimed,
wherein Moriss further teaches the second end has a flattened body ([0279] describes their tissue-engaging ends as being able to be blunt. “Blunt” is defined by Merriam-Webster as being “having an edge or point that is not sharp”. A “blunt” end is considered to be flattened in comparison to a body which is not blunt.).
Claim 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss as is applied above in view of Moriss et al. (US 20130310928 A1) hereinafter known as Moriss ‘928.
Regarding claim 23 Moriss discloses the valve of claim 21 substantially as is claimed,
wherein Moriss further discloses the valve body includes an expandable frame having openings (Figures 84a-c item 120; see also Figures 11a-d item 120; [0225]),
but is silent with regards to each head portion being configured to be positioned within a respective opening of the frame.
However, regarding claim 23 Moriss ‘928 teaches that heart valves with outwardly extending projection elements can include a configuration for delivery in which the projection elements are positioned within an opening of the struts of the frame ([0161]). Moriss and Moriss ‘928 are involved in the same field of endeavor, namely prosthetic heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Moriss by having the heads fit within openings of the frame for delivery as is taught by Moriss ‘928 in order to provide a nested delivery configuration that minimizes the delivery profile for extension through the vasculature of the patient.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 05/12/26 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 05/22/26
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