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
This is in response to the non-provisional application filed 07/29/2025.
Claim Interpretation - 35 USC § 112(f)
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.
Allowable Subject Matter
Claims 5-8 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.
The following is a statement of reasons for the indication of allowable subject matter: claim 5 recites wherein the distal tube further comprises a compressible distal portion, the method further comprising: compressing the compressible distal portion; translating the pull wire proximally by more than approximately 6 mm; and decompressing the compressible distal portion thereby providing an elastic force against the implantable medical device that facilitates release of the implantable medical device from the tubular body.
Claim 6 recites attaching the proximal attachment point of the elastic loop wire to the pull wire by tying one or more knots between respective ends of the elastic loop wire to the pull wire. Claim 7 recites causing the elastic loop wire to stretch in response to proximal translation of the pull wire by less than approximately 6 mm; and applying tension to the pull wire by the stretched elastic loop wire, thereby inhibiting proximal translation of the pull wire with respect to the loop opening of the elastic loop wire.
Claim 8 recites attaching the proximal attachment point of the elastic loop wire to the pull wire by welding respective ends of the elastic loop wire to the pull wire.
The Office agrees the art of record fails to teach or suggest these features.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Number 6,478,773 (Gandhi et al.)
Regarding claim 1, Gandhi et al. discloses as shown in Figure 4, a method comprising: positioning an implantable medical device (therapeutic device 44, see col. 6, lines 22-39) approximate a distal end of a pull wire (flexible pusher member 42 is interpreted as a pull wire because it is thread or rod that is capable of being pulled which is its plain meaning accord to websters dictionary and is not inconsistent with the specification, see col. 6, lines 22-39); positioning an elastic loop wire (connector thread or fiber 62, see col. 6, lines 40-59) comprising a loop opening, proximate a distal portion of the elastic loop wire approximate a locking portion (connector ring 60, see col. 6, lines 40-59) of the implantable medical device; positioning the loop opening through the locking portion of the implantable medical device; positioning the distal end of the pull wire through the loop opening, thereby securing the implantable medical device to a sub-assembly; and attaching a proximal attachment point of the elastic loop wire to the pull wire (Figure 4 shows a proximal portion of thread 62 is attached to pusher member 42 by being disposed through entry port 52) .
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(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publictaion Number 2020/0397444 (Montidoro et al.) in view of U.S. Patent Publication Number 2020/0229957 (Bardsley et al.)
Regarding claim 1, Montidoro et al. discloses as shown in Figure 1, a method comprising: positioning an implantable medical device (device 200, see paragraph [0039]) approximate a distal end of a pull wire (pull wire 150, see paragraph [0039]); positioning an elastic loop wire (loop wire 140, see paragraph [0039]) comprising a loop opening, proximate a distal portion of the elastic loop wire approximate a locking portion (engagement feature 230, see paragraph [0040]) of the implantable medical device; positioning the loop opening through the locking portion of the implantable medical device; positioning the distal end of the pull wire through the loop opening, thereby securing the implantable medical device to a sub-assembly.
Montidoro fails to disclose attaching a proximal attachment point of the elastic loop wire to the pull wire.
Bardsley et al., from the same field of endeavor teaches a similar method as shown in Figure 36 where the method includes the step of attaching a proximal attachment point of the elastic loop wire (424) to the pull wire (40). See paragraph [0118].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to substitute the means that loop wire 140 is attached from the delivery tube 110 to wrapping around a portion of the pull wire taught by Bardsley et al. because it would only require the simple substitution of one known alternative means for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claim 2, Montidoro et al. discloses positioning the sub-assembly at least partly within a lumen of a tubular body (delivery tube 110, see paragraph [0039]) such that the implantable medical device abuts a distal end of the tubular body; shown in Figure 1; and securing a proximal end of the pull wire to a proximal end of the tubular body, thereby securing the implantable medical device to the tubular body.
Regarding claim 3, Montidoro et al. discloses comprising: translating the pull wire proximally by more than approximately a distance thereby releasing the implantable medical device from the tubular body. See paragraph [0039].
Montidoro is silent on the distance being 6 mm.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the distance pull wire disclosed by Montidoro et al. is translate to be 6 mm because the distance pull wire is translated is a recognized to be result effective variable for the purpose of relating to the implant. See paragraph [0039]. Namely, translating a greater than nominal distance will increase the chances of deploying the implantable device.
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distance pull wire disclosed by Montidoro et al. is translate to be 6 mm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publictaion Number 2020/0397444 (Montidoro et al.) in view of U.S. Patent Publication Number 2020/0229957 (Bardsley et al.) as applied to claim 2 above, and further in view of U.S. Patent Number 4,368,730 (Sharrock)
Regarding claim 4, Montidoro discloses a proximal support tube (hypotube 130, see paragraph [0039]) disposed in the lumen of the tubular body.
Montidoro fails to disclose wherein providing the tubular body further comprises: a proximal tube; a support coil distal to the proximal tube; and a distal tube distal to the support coil.
Sharrock, from a related field of endeavor teaches a similar tubular body as shown in Figure 5, wherein providing the tubular body further comprises: a proximal tube; a proximal support tube (15) disposed in the lumen of the tubular body; a support coil (2) distal to the proximal tube; and a distal tube (11) distal to the support coil. See col. 4, lines 34-45.
It would have been obvious to one of ordinary skill in the art, before effective filing date of the claimed invention to modify the method disclosed by Montidoro to include the proximal tube, distal tube and support coil, taught by Sharrock in order to further support the pull wire.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771