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 .
DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-11, drawn to a valve structure and loading assembly, classified in A61F2/9525.
II. Claims 12-20, drawn to a method of using an implantable medical device, loading assembly and delivery device, classified in A61F2/2427.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the process as claimed can be practiced by another and materially different apparatus. For example, the process could be used to compress a stent not having a valve structure.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Albert Ferro on March 19th 2026 a provisional election was made without traverse to prosecute Invention II, claims 12-20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-11 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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 20 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 20 recites the limitation " the non-circular cross-section of the tapered inner surface". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 12-15, 17 and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Srinimukesh et al. (US 2022/0346993; hereinafter “Srinimukesh”).
Regarding claim 12, Srinimukesh discloses a method of loading an implantable medical device into a delivery device, the method comprising: advancing an implantable medical device (82; Figure 8A) through a loading assembly (10; Figure 1) via relative movement of the implantable medical device and the loading assembly (¶[0134], [0135]), the loading assembly including a first portion (any ridge having surface 24) having a tapered inner surface (24) and a plurality biasing features (ridges with increased taper at bottom portion 52; see drawing below) extending radially inward from the tapered inner surface or from an interior surface of a second portion of the loading assembly;
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[AltContent: arrow][AltContent: arrow][AltContent: textbox (Biasing features)]
wherein the tapered inner surface transitions the implantable medical device from an uncompressed arrangement to a compressed arrangement (¶[0134], [0135]); wherein the biasing features push first struts (struts 90 having tips 92) of the frame further radially inward than second struts (84) of the frame that were not aligned with the biasing features (¶[0133]; Figure 11; the second struts are positioned in slots 30) such that in the compressed arrangement the first struts are disposed further radially inward than the second struts at multiple and pre-selected locations, wherein the locations are separated from each other (¶[0133]-[0135]); and loading the implantable medical device into a delivery device (94/98/110) in the compressed arrangement (¶[0140]-[0142]; Figure 12).
Regarding claim 13, loading the implantable medical device into the delivery device comprises loading the implantable medical device into a capsule (110) of the delivery device (¶[0140]-[0142]).
Regarding claim 14, the method further comprises coupling the implantable medical device to the delivery device prior to advancing the implantable medical device through the loading assembly (¶[0132]).
Regarding claim 15, coupling the implantable medical device to the delivery device comprises coupling paddles (92) of the frame of the implantable medical device to pockets (108) of a spindle (94) of the delivery device (¶[0139]).
Regarding claims 17 and 18, advancing the implantable medical device through the loading assembly comprises advancing the implantable medical device through the first portion of the loading assembly with the tapered inner surface of the first portion having a non-circular cross section without including the biasing features (surfaces 24 are part of ridges and therefore have a non-circular cross section), further comprising advancing the implantable medical device through the second portion (portion between biasing features and protrusions 50) of the loading assembly, the interior surface of the second portion having a constant cross-sectional diameter (any cross section of this portion would be circular and therefore have a constant diameter).
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.
The factual inquiries 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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Srinimukesh.
Regarding claim 19, Srinimukesh fails to disclose that the interior surface of the second portion is non-circular in cross-section.
However, Srinimukesh discloses that the loading assembly can have any interior shape (¶[0112]) and that is can be used to load the medical device into a capsule having a non-circular cross-section (¶[0225]; Figures 52-54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the cross section of the interior of the loading assembly, including the second portion, as a non-circular shape in order to compress the medical device into the shape corresponding to the non-circular capsule.
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771