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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-10 (a capsule), and species 3 (figure 6, capsule has a reduced effective length due to proximal and distal end reduced diameters) in the reply filed on 11/13/25 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/13/25.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 is objected to for claiming the distal end portion is arranged at “a distal end” of the capsule, and narrows to “an end of the distal end portion”. It is unclear how the “distal end” of the capsule and “an end of the distal end portion” are related to one another. As the Examiner best understands, the two appear to be the same structure, but since they are distinctly defined, it is unclear.
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 9 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 is indefinite for claiming the capsule comprises an “elastic, self-expanding metallic or polymeric material”, since it is unclear whether the material must be an elastic, self-expanding metallic material, or an elastic, self-expanding polymeric material, OR whether the material must be an elastic, self-expanding metallic material or a polymeric material. The specification [078] states that the capsule can “comprise an elastic, self-expanding (e.g., shape memory) metallic or polymeric material (e.g., a nickel titanium alloy such as Nitinol) as is known in the art. “Alternatively, the capsule 220 or 250 can comprise a plastically deformable material (e.g., stainless steel or a cobalt chromium alloy)”, and in [079] states that in other embodiments, the capsule “can comprise an elastomeric material (e.g., silicone)”. From this, it appears that Applicant believes Nitinol to be an “elastic, self-expanding metallic or polymeric material”, although it is not polymeric. It also appears that polymeric materials are intended to be represented separately, in another embodiment, meaning the “polymeric material” or “elastic, self-expanding polymeric material” (whichever is intended) is not discussed in the specification at any location, leaving the Examiner unclear on what is meant. Since the Examiner does not understand a “polymeric material” to be Nitinol (although this is what is stated in the specification), the Examiner will understand the claims to read that the capsule comprises either an “elastic, self-expanding metallic material” OR “a polymeric material”. However, clarification is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landon et al. (US 20190008639 A1) hereinafter known as Landon in view of Spargias (US 20170333186 A1).
Regarding claim 1 Landon discloses a capsule (Figures 18-19 item 106) of a delivery apparatus configured to deliver a prosthetic medical device to a target implantation site (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 Landon 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 [0008]), the capsule comprising:
a distal end portion arranged at a distal end of the capsule (Figures 18-19 item 107) with an outer diameter of a middle portion of the capsule (Figures 18-19 the diameter of item 106), wherein the end is spaced from the middle portion of the capsule (Figures 18-19), wherein the distal end portion is configured to expand the wider outer diameter in response to a radially outward pressure from the prosthetic medical device during removal of the device from inside the capsule ([0146]-[0147]),
and a proximal end portion arranged at a proximal end of the capsule (Figures 18-19 item 106’s proximal end),
but is silent with regards to the distal end portion narrowing in diameter from a wider outer diameter to a narrower outer diameter at its distal end, and
the proximal end portion narrowing in diameter from a wider outer diameter to a second, narrower diameter at its proximal end.
However, regarding claim 1 Spargias teaches a capsule that includes a distal end portion that narrows in diameter from a wider outer diameter of a middle portion to a first narrower outer diameter at a distal end of the distal end portion, and a proximal end portion that narrows in diameter from the wider outer diameter to a second narrower diameter at its proximal end (Figure 13 shows capsule 35 with tapered proximal and distal ends (see also [0097]). Landon and Spargias are involved in the same field of endeavor, namely delivery capsules. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the capsule of Landon so that its proximal and distal ends are tapered as is taught by Spargias in order to allow smooth tracking forward and backwards during delivery of the medical device.
Regarding claim 5 the Landon Spargias Combination teaches the capsule of claim 1 substantially as is claimed,
wherein Landon further discloses only the distal end portion is configured to expand to the wider outer diameter, and the proximal end portion is configured to remain in its narrowed configuration (Figures 18-19, [0146]-[0147]).
Regarding claim 6 the Landon Spargias Combination teaches the capsule of claim 1 substantially as is claimed,
wherein Landon further discloses the distal end portion comprises a plurality of notches spaced apart from one another around a circumference of the distal end portion and extending in an axial direction from the end of the distal portion to a portion of the capsule that transitions from the distal end portion to the middle portion (Figure 18-19 shows axial notches extending lengthwise to form wings to a transition to the middle section/diameter).
Regarding claim 7 the Landon Spargias Combination teaches the capsule of claim 6 substantially as is claimed,
wherein Landon further discloses the distal end portion further comprises a plurality of wings formed by the notches (Figures 18-19 show axial notches forming wings near item 107), wherein each wing is formed between two adjacent notches and is axially oriented along a central longitudinal axis of the capsule (Figures 18-19),
wherein the distal ends of the wings form the end of the distal end portion of the capsule (Figures 18-19), and
wherein the Combination further teaches the notches angle radially inward from a wider proximal end of the wing to a narrower distal end of the wing (when Landon is modified for its distal end to have a conical shape, the notches would obviously rangle radially inward from a wider proximal end of the wing towards a narrow distal end of the wing in order to fit the conical shape of the Combination).
Regarding claim 8 the Landon Spargias Combination teaches the capsule of claim 6 substantially as is claimed,
wherein Landon further discloses each notch includes an elongate end extending from the end of the distal end portion to the portion of the capsule that transitions, and a bulbous end arranged at the portion of the capsule that transitions (Figures 18-19 show a circular proximal end to the elongate notches).
Regarding claim 9 the Landon Spargias Combination teaches the capsule of claim 1 substantially as is claimed,
wherein Landon further discloses the capsule comprises a polymeric material ([0147] flexible polymer, [0111] plastic or metal material).
Regarding claim 10 the Landon Spargias Combination teaches the capsule of claim 1 substantially as is claimed,
wherein the Combination further teaches the capsule is configured to cover and enclose the medical device in a radially compressed configuration and wherein the medical device in a compressed configuration comprises a tapered end that the end portion is configured to surround (this does not appear to materially change the structure of the claimed capsule, which the Examiner understands to be capable of enclosing such as a medical device, if desired).
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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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 12/15/25