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 Species 2, A in the reply filed on 5/29/2026 is acknowledged. Claims 3-5 and 9 are withdrawn since they are drawn to a non-elected species.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “user-actuated control mechanism” in claims 1-2, 6-8, and 10-20, and “sliding mechanism” in claim 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 12 is objected to because of the following informalities: “the distal portion of the delivery device” in line 2 should read “the distal portion of the delivery element”, noting that a distal portion of the delivery element has been previously recited (but not a distal portion of the delivery device) and it is clear to the examiner that this is merely a typographical error. Appropriate correction is required.
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.
Claim(s) 1, 6-8, and 10-19 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Clerc et al. (US 2005/0256562). Clerc discloses an implant delivery device comprising a handle (12) having an internal track (21; fig. 5) with a bend (note bend in track 21 at proximal end of handle), a delivery element (16) having a distal portion distal to the handle and a proximal portion within the handle positioned on or within the internal track (figs. 5-7), and a user-actuated control mechanism (20/18, noting corresponding 35 USC 112f structure includes a rotatable knob) engaged with the delivery element, wherein actuation of the user-actuated control mechanism advances or retracts the proximal portion of the delivery element around the bend of the internal track.
Regarding claim 6, retracting the delivery element deploys an implant (72) (best shown in figs. 13-14).
Regarding claim 7, the delivery element is a delivery sheath or catheter (16).
Regarding claim 8, the internal track includes one or more mechanical rollers (26; fig. 5).
Regarding claims 10 and 11, the internal track includes a recess and has a u-shape (best shown in fig. 5).
Regarding claim 12, retracting or advancing the distal portion of the delivery element (noting claim objection above) causes the proximal portion (once on upper portion of track 21) to move in a direction opposite the distal portion. For example, once the proximal portion of the catheter 16 has moved around the bend in the handle and into the upper portion of the track, it moves in the distal direction when the distal portion of the delivery element (16) is moved proximally.
Regarding claim 13, the entire delivery element is distal to a proximal end of the handle (see fig. 5).
Regarding claim 14, the handle has a first longitudinal length and the actuation of the user-actuated control mechanism advances or retracts the proximal portion of the delivery element a distance having a second length greater than the first length (i.e., the second length is the length of the track (21) which is greater than that of the handle due to its bend).
Regarding claim 15, Clerc discloses an implant delivery device comprising a handle (12), a delivery element (16) having a distal portion distal to the handle and a proximal portion within the handle, and a user-movable control mechanism (20/18) engaged with the delivery element. In a first configuration, the distal portion of the delivery element is in a first position and the proximal portion of the delivery element is in a second position. For example, during retraction of the catheter, consider when a proximal portion of catheter 16 is positioned on the lower portion of track, adjacent to u-bend, but not on u-bend. This is being considered the claimed second position. In a second configuration, the distal portion of the delivery element is in a third proximal to the first position and the proximal portion of the delivery element is in a fourth position distal to the second position. For example, after retraction of the delivery element via rotation of knob 20, the distal portion has moved proximally to a third position while the proximal portion has been advanced around u-bend toward (58) to a fourth position distal of the second position.
Regarding claim 16, the handle further comprises an internal track (21) with a bend and the proximal portion of the delivery element is positioned on or within the internal track (figs. 5-7, noting 16 can be retracted into the handle along the internal track 21the length of the channel as disclosed in [0027]).
Regarding claim 17, the internal track is a guide for the proximal portion of the delivery element between the first and second configurations ([0027]).
Regarding claim 18, Clerc discloses an implant delivery device comprising a handle (12) having a first longitudinal length, a delivery element (16) having a distal portion distal to the handle and a proximal portion within the handle (see figs. 5-7), a user-actuated control mechanism (20) engaged with the delivery element, wherein actuation of the user-actuated control mechanism advances or retracts the proximal end of the delivery element a distance having a second length, wherein the second length is greater than the first longitudinal length (noting delivery element can be retracted the distance of the track 21, which is greater than the length of the handle due to the U shape of the track).
Regarding claim 19, actuation of the user-actuated mechanism retracts the proximal end of the delivery element along an internal track having one or more bends ([0025]-[0027]).
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.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clerc. Clerc discloses the invention substantially as state above including an implant (72) pre-loaded within the delivery element (see figs. 13-16). Clerc does not expressly disclose that, when in a compressed configuration, the implant has a fourth longitudinal length greater than the first longitudinal length of the handle. However, Clerc discloses that the length of the internal track is greater than the length of the handle. Clerc further discloses that the length of the track is sufficient to permit deployment of the stent (i.e., allows enough retraction of catheter to fully uncover stent) and to prevent unnecessary movement of the catheter (i.e., further retraction after stent is fully uncovered) ([0027]). Thus, it would have been obvious to size the implant and track such that the implant has the same length as the track, which is longer than the length of the handle, in order to allow the catheter to be retracted a length sufficient to permit the stent to be deployed (i.e., long enough that the amount of retraction is at least the length of the stent) while preventing any further retraction of the catheter beyond the length of the implant.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clerc in view of Pryor (US 2007/0244540). Clerc discloses the invention substantially as stated above including a user-actuated control mechanism (20/18) engaged with the delivery element (catheter), wherein actuation of the user-actuated control mechanism advances or retracts the proximal portion of the delivery element around the bend of the internal track, but fails disclose that the user-actuated control mechanism is a sliding mechanism. Instead, Clerc discloses a rotating knob and driver (20/18) forming part of a ratchet mechanism with the catheter.
Pryor discloses another implant delivery device comprising a handle (212B; fig. 6) and a user-actuated control mechanism (704, fig. 6, noting corresponding 35 USC 112f structure is a sliding button) that retracts an outer catheter (206B) in order to deliver a stent. The user-actuated control mechanism is a thumb slider (704) that interacts with teeth (706) on the catheter to form a ratchet mechanism (702) to retract the catheter. The slider can be moved distally in a manner that does not advance the catheter such that the slider can be retracted multiple times in a proximal direction in order to retract the catheter a distance greater than the length of the handle ([0049]-[0056]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Clerc to use a sliding mechanism (thumb slider with ratchet teeth) as taught by Pryor in place of the rotatable mechanism (20/18) of Clerc as such a modification is considered a substitution of one user-actuated control mechanism for retraction of an outer catheter that allows a handle to be relatively short, for another, wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 6/24/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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