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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 12th has been entered.
Claim Interpretation
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “wire loop means” in claim 31.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 8-11, 21, 22, 25 and 27-35 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 8 and 11, the only way the claim could be supported under 35 U.S.C. 112(a) is if member 122 is the radially expanded structure and member 124 is the stent body. However, there is no disclosure that the first parts (e.g. 192A) are directly connected to member 124 (as required by claim 1). Applicant has only disclosed that member 122 can be directly connected to member 124 at some unspecified location (pgpub ¶[0056]). Note that claim 1 is only supported under 35 U.S.C. 112(a) if member 122 is regarded as the stent body and the collection of first and second parts are regarded as the radially expandable structure.
Regarding claim 21, there is no original disclosure of the first parts being positioned wider apart from each other than the second parts.
Regarding claims 27, 31 and 35, as shown in the diagram of Applicant’s first and second parts below, the fold does not form a plurality of proximal AND distal peaks for each loop or loop means.
Claims 9, 10, 22, 25, 28-30 and 32-34 are rejected at least due to their dependence from one of the above claims.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 11-16, 21 and 26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Labrecque et al. (US 2020/0405515).
Regarding claim 1, Labrecque et al. disclose a stent body (1010; Figure 18C; see drawing below) having a tubular expanded shape; and, a radially expandable structure (1020b) comprising a plurality of first parts that are each directly connected to the stent body (for the purpose of illustration the M-shaped structure in Figure 18C was used in the drawing below; the M-shaped structure can be shifted up or down by one peak such that each first part is directly connected to the stent body) and extend towards a middle of the stent body, and a plurality of second parts that are each connected to one of the plurality of first parts by a fold or inflection and that extends away from the middle of the stent body, forming a plurality of peaks (peaks defining the fold below) that are positioned radially outward and spaced apart from the stent body (to show how analogous the first and second parts are to Applicant’s, Applicant’s first and second part have been shown below for comparison).
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367
266
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[AltContent: arrow][AltContent: arrow][AltContent: textbox (Fold)][AltContent: arrow][AltContent: textbox (Second Part)][AltContent: textbox (First Part)]
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412
390
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[AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: arrow][AltContent: textbox (First Part)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Second Part)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Fold)]
Regarding claim 11, the radially expandable structure comprises one or more rings positioned circumferentially around the stent body (it is clear from Figure 18C that the collection of first and second parts form a sinusoidal ring around the stent body in a similar manner to Applicant’s).
Regarding claim 12, the radially expandable structure has a memorized angle within an inclusive range of 5 to 90 degrees towards a middle of the stent and relative to a longitudinal axis of the stent (¶[0172]).
Regarding claim 14, portions of the radially expandable structure form flat planes (at least at some of the peaks).
Regarding claim 15, portions of the radially expandable structure form arc shapes curving radially outwards from the stent body (see triangular or arc shape forming each peak or half of the above fold)
Regarding claim 16, the radially expandable structure forms one or more rings having a diameter that is one of 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40% larger (in the expanded state) than a diameter of the stent body (in the compressed state - ¶[0223]).
Regarding claim 20, each of the plurality of first parts are angled at a first angle relative to a longitudinal axis of the stent, and each of the plurality of second parts are angled at a second angle relative to the longitudinal axis of the stent (evident from the drawing above).
Regarding claim 26, the plurality of second parts form a plurality of triangular shapes (evident from drawing above).
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 Labrecque et al. (US 2020/0405515) in view of Carrison (US 2014/0039537).
Regarding claim 19, Labrecque et al. fail to disclose that the radially expanded structure comprises hydrogel.
However, Carrison teaches that it is known in the art to construct stents from hydrogel materials (¶[0079]).
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 used a hydrogel material to construct the entire stent structure of Labrecque et al. in order to take advantage of this known material for stent construction.
Response to Arguments
Applicant's arguments filed March 12th 2026 have been fully considered but they are either moot in view of the new grounds of rejection above or are not persuasive. Applicant has argued that Labrecque et al. fail to disclose a fold or inflection as recited in claim 1. It is respectfully asserted that this structure is disclosed and is shown in the drawing above.
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
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