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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/19/26 has been entered.
Response to Arguments
Applicant's arguments filed 01/19/26 have been fully considered but they are not persuasive.
On page 8 regarding prior art rejections Applicant argues the prior art fails to fold valve leaflets as the claim requires, Applicant argues the fingers extend a particular distance in order to engage with and fold the leaflets, and hints that since Morin does not describe engaging with/folding leaflets, it would not be obvious to modify Morin.
The Examiner respectfully disagrees and points out the claimed invention is for an apparatus for compressing a valve and does not include the heart valve which is being compressed. Accordingly, arguments that the arms must extend a certain distance in order to contact leaflets does not take into account any structural differences that might exist within heart valves that are being compressed (in other words, this feature is not linked exclusively to the claimed apparatus for compressing as Applicant appears to argue). The Examiner also notes that Applicant's statements appear unsupported by any evidence in the record, which also renders arguments unpersuasive.
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 1-7 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is rejected for having new matter for claiming the “apparatus for compressing a replacement heart valve” appears to include the valve itself. As the Examiner best understands however (see 112 rejections below), the apparatus for compressing a valve is simply an apparatus, which does not actually structurally include the heart valve it is intended to compress itself.
Remaining claims are rejected for depending on a claim with 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 1-7 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 pre-AIA the applicant regards as the invention.
Claim 1 is indefinite for claiming the “apparatus for compressing a replacement heart valve” comprises “a replacement heart valve implant” when it appears from the specification/figures (as well as the first part of the claim) that the apparatus for compressing a valve does not actually include the valve itself. As the Examiner best understands, an apparatus to compress an item does not include the item itself. In appears Applicant may be attempting to claim a combination or system which includes both the originally presented “apparatus for compressing” and a heart valve, but it is unclear from the language of the claim.
Remaining claims are rejected for depending on an indefinite claim.
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.
Claims 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morin et al. (US 20190117394 A1) hereinafter known as Morin.
Regarding claims 1-2 Landon discloses an apparatus for compressing a replacement heart valve implant (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 Morin discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example the Abstract, as well as Figure 4 and [0040]] regarding the valve that is intended for compression being capable of including leaflets.) the implant comprising leaflets which are not folded before being placed within the apparatus and the leaflets being folded by placing the implant inside the apparatus (this is does not appear to be a part of the claimed apparatus) comprising:
a tubular member (1600) having a wall having an outer surface and an inner surface defining a lumen (Figure 15b-c, and/or 16a-b), wherein the inner surface includes a tapered portion having a radially inward taper in a distal direction (Figure 15b shows the taper from end 1608 to end 1610); and
a plurality of flexible arms projecting radially inward from the tapered portion (Figure 16a-b; [0063]),
wherein the arms project radially inward from the inner surface at to the central longitudinal axis in an unbiased configuration (Figure 16a-b) in order to engage with and fold the leaflets (This is stated as a functional limitation of the arms (see the explanation regarding functional limitations above). See also [0063] which details how the arms extend radially inward to urge fabrics from the interior of the stent (214) to fold further inwardly. See [0040] and Figure 4 to show how arms which engage the inner cuff 214 would also be capable of engaging leaflets 112),
but is silent with regards to how far the arms project inward.
However, regarding claims 1-2 it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the extent the arms project inward, so that they project at least 50% (claim 1) or at least 75% (claim 2) inwards towards the longitudinal axis of the tubular member a since 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 person of ordinary skill would attempt to have the arms extend inward any percentage in order to achieve the desired results of compression of the valve while appropriately guiding folding of interior and exterior fabric materials of the valve.
Regarding claim 3 Morin teaches the apparatus of claim 1 substantially as is claimed,
wherein Morin further discloses the arms are fixedly attached to the wall (Figure 16a-b).
Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morin as is applied above in view of Kubena et al. (US 20100121424 A1) hereinafter known as Kubena, further in view of Ferry (US 20080200874 A1).
Regarding claim 4 Morin teaches the apparatus of claim 1 substantially as is claimed,
but is silent with regards to the arm material.
However, regarding claim 4 Kubena teaches a valve compression apparatus which is made of nylon ([0031], and Ferry teaches nylon can be in a monofilament form ([0020]).
Morin, Kubena, and Ferry are involved in the same field of endeavor, namely valve compression apparatuses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify he material of the arms of Morin so they are a monofilament polymeric material as is taught by Kubena and Ferru, since 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), and since it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. In this case, the person of ordinary skill would have been motivated to try any material configuration of arms that might be successful.
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morin as is applied above in view of Derus et al. (US 20030225445 A1) hereinafter known as Derus.
Regarding claim 5 Morin teaches the apparatus of claim 1 substantially as is claimed,
but is silent with regards to the arm material.
However, regarding claim 5 Derus teaches various parts of a delivery tool can be made of different materials ([0055]).
Morin and Derus are involved in the same field of endeavor, namely valve compression apparatuses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify he material of the arms so they are a different material from the tubular member as is taught by Derus since 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), and since it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. In this case, the person of ordinary skill would have been motivated to try any material configuration of arms that might be successful, and to minimize the weight of the tool overall.
Allowable Subject Matter
Claims 21-25 are allowed.
Conclusion
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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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/28/26
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