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 Group I, claims 1-11 and 16-20, in the reply filed on 09/10/2026 is acknowledged. Claims 12-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, line 10, “the proximal ed” should read “the proximal end.”
Appropriate correction is required.
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:
“tissue engagement mechanism” recited in claim 1, which has been interpreted as “needles, hooks, anchors, clips, screws, struts” or any structural equivalents thereof, based on the specification (see [0044]).
“visualization mechanism” recited in claims 10 and 20, which has been interpreted as a transducer or any structural equivalent thereof, based on the specification (see [0010]).
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 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.
Claims 6-8 are 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 6 recites “an implant stylet, slidably disposable within a working channel of the working catheter,” which renders the scope of the claim indefinite since it is unclear whether the recited “working channel” is intended to refer to the working channel recited in claim 1 (see claim 1, line 9) or the recitation is intended to introduce additional structure (i.e., a second working channel in the working catheter). For examination purposes, the working channel in claim 6 has been interpreted as the same working channel recited in claim 1.
Claims 7-8 are similarly rejected by virtue of their dependency from claim 6.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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 1-6, 9, and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quill et al. (US 20150018940).
Regarding claims 1, 16 and 17, Quill discloses a system (see Fig. 12A-13I) comprising: an introducer sheath having a lumen extending from a proximal end to a distal end and configured to be transluminally advanced into a treatment site (the system includes a steerable overtube or sheath not shown in the figures, see [0050]); a working catheter (252) configured for longitudinal translation within the introducer sheath to position a distal end of the working catheter proximate to the distal end of the introducer sheath (see [0050]), the working catheter comprising a shaft having a distal end and a proximal end, a tissue engagement mechanism extending from the distalmost end of the shaft (clips 254 and 256 are considered a tissue engagement mechanism as interpreted under 35 U.S.C. 112f since they are clips), and a tissue engagement control portion coupled to the proximal end of the shaft (see [0053]); and a guide catheter (204) translationally movable within a working channel defined by the working catheter, the guide catheter having a proximal end and a distal end, the proximal end of the guide catheter comprising a guide catheter control portion (the proximal end of the needle is considered a guide catheter control portion since it controls advancement of the needle), and the distal end of the guide catheter including a distalmost end configured to anchor to tissue at the treatment site (the distal end of 204 is a needle tip capable of anchoring to tissue); wherein: the guide catheter is distally advanceable through the working channel of the working catheter to advance the distalmost end of the guide catheter through the working channel and distal to the distalmost end of the working catheter to anchor the distalmost end of the guide catheter with tissue at the treatment site and to provide a path to the treatment site for the working catheter (needle 204 is advanceable past the distalmost end of catheter 252, see Fig. 13E); the working catheter is translatable over the guide catheter, once the distalmost end of the guide catheter is anchored to tissue at the treatment site, to a working position with respect to the tissue at the treatment site in which the tissue engagement mechanism of the working catheter is engageable with the tissue at the treatment site (when the distal end of 204 is engaged with tissue, catheter 252 can be withdrawn and readvanced over needle 204 to the position in which clips 254 and 256 are engaged with tissue); and the tissue engagement control portion of the working catheter is operable, with the working catheter positioned at the working position and with the distalmost end of the guide catheter anchored with respect to tissue, to move the tissue engagement mechanism at the distalmost end of the shaft of the working catheter between a first configuration and a second configuration relative to the shaft of the working catheter, the second configuration engaging, contacting, and capturing the tissue to repair or replace the tissue (while needle 204 is engaged with tissue and the working catheter is in the position shown in Fig. 13E, the clips 256 and 254 are movable between a first retracted configuration and a second deployed configuration where they are engaged with tissue in the deployed configuration).
Regarding claim 2, Quill discloses the guide catheter further comprises a distal guidewire anchor (the distal end of 204 is considered an anchor since it is a needle tip) disposed at the distalmost end of the guide catheter and configured to be driven into tissue of the treatment site to secure the guide catheter to the treatment site (the distal end of 204 is configured to puncture tissue, see [0049], and it is the Examiner’s position that the guidewire anchor of Quill meets the structural limitations of the claim and is therefore capable of securing 204 to the treatment site as claimed).
Regarding claims 3 and 18, Quill discloses the distal guidewire anchor comprises at least one of a helical member, a clamp member, a hook member, or a needle member (the distal end of 204 is a needle, see Fig. 12B).
Regarding claim 4, Quill discloses the distal end of the introducer sheath is steerable to guide the distal end of the introducer sheath to the treatment site (catheter 252 is introduced through a steerable overtube or sheath not shown in the figures, see [0050]).
Regarding claims 5 and 19, Quill discloses the tissue engagement mechanism at the distalmost end of the shaft of the working catheter includes at least one of a needle, a hook, a clamp, a screw, a frame, an anchor, a clip, a strut, or a spur configured to engage with and modify the shape of the tissue (opposing clips 254,256 can also be considered hooks or anchors since they hook onto tissue and anchor catheter system, see [0049] and Fig. 13E); and the working channel is located within the working catheter so that the guide catheter and the tissue engagement mechanism of the working catheter do not interfere with each other (needle 204 and clips 254,256 do not interfere with each other, see Fig. 12A).
Regarding claim 6, Quill discloses an implant stylet (214), slidably disposable within a working channel of the working catheter, the implant stylet comprising at least one implant component (202) supported within a distal end of the implant stylet (helical anchor 202 is supported within a slot at the distal end of push rod 214, see Fig. 12B and 13F-13G).
Regarding claim 9, Quill discloses the distal end of the guide catheter is: advanceable distally past the distalmost end of the working catheter to define a path along which the tissue engagement mechanism at the distalmost end of the shaft of the working catheter is distally advanceable to contact tissue; and retractable into the distal end of the working catheter (needle 204 is both distally advanceable past the distal most end of catheter 252 to define a path along which clips 254 and 256 may be advanced and retractable into the distal end of the of catheter 252, see Fig. 13E-13G).
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.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Quill in view of Sheps et al. (US 20150272734).
Regarding claims 7 and 8, Quill discloses the system of claim 6, but fails to teach a staging structure comprising at least one of an introducer sheath support, a working catheter support, or an implant stylet support, wherein the staging structure comprises a catheter stand comprising a rail, and wherein the working catheter support is slideably disposed on the rail of the catheter stand such that movement of the working catheter support along the rail translates the working catheter within the introducer sheath.
Sheps, in the same field of art, discloses a similar catheter system (see Fig. 1) having an introducer sheath (12), a working catheter (14) and a guide catheter (36), the system further comprises a staging structure (mount 92, track 90 and support legs 91, see Fig. 1 and [0482]) comprising at a working catheter support (a working catheter support is provided by mount 92 which supports handle 24 of the working catheter 14, see [0484]) wherein the staging structure comprises a catheter stand comprising a rail (track 90), and wherein the working catheter support (mount 92) is slideably disposed on the rail of the catheter stand such that movement of the working catheter support along the rail translates the working catheter within the introducer sheath (see [0484]).
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 system of Quill to include a staging structure, as taught by Sheps, since doing so would allow a user more control over the axial position of the catheters of the system (see Sheps [0484]).
Claims 10-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Quill in view of Lashinski et al (US 20170086974 A1).
Regarding claim 10, 11 and 20, Quill discloses the catheter system of claims 2 and 16 but fails to teach a visualization mechanism disposed proximate to the distal guidewire anchor upon one of the guide catheter, the distal guidewire anchor, or the working catheter and wherein the visualization mechanism comprises an Intra-Cardiac Echography (ICE) transducer.
Lashinski, in the same field of art, teaches an inner catheter (300, see Fig. 3B) with a visualization mechanism (ICE transducer 302 meets the limitation of a visualization mechanism as interpreted under 35 U.S.C. 112f).
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 inner catheter (guide catheter) of Quill to further include a visualization mechanism as taught by Lashinski since inner catheters provided with visualization mechanisms were known in the art and would have provided the surgeon with the ability to view the catheter system at the treatment site during a cardiac procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
All of the documents cited in the attached PTO-892 teach related catheter systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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, the examiner’s supervisor, Elizabeth Houston can be reached 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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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
