DETAILED ACTION
The following Office Action is in response to the Preliminary Amendment filed on October 18, 2024. Claims 1-16 are currently pending.
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 .
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.
Claim Objections
Claims 10 and 13 are objected to because of the following informalities:
Concerning claim 10, lines 1-3 of the claim recite “The catheter system of claim 7, the body is configured to…”, wherein the word “wherein” appears to be missing between “claim 7,” and “the body”.
Concerning claim 13, line 3 of the claim recites the term “pericard material”, wherein the word “pericard” appears to be a misspelling of the word “pericardial”.
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) 1-3, 5-7, 10, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berg et al. (US 6,475,222, hereinafter Berg).
Concerning claim 1, the Berg et al. prior art reference teaches a catheter system for implanting a medical implant to form a medical bypass connection on a vessel or between a first vessel and a second vessel (Figures 30-38), comprising a medical implant comprising a first end, a second end, and a body forming a flow lumen (Figure 30a; 42), a catheter shaft (Figure 30a; 824) defining an inner lumen (Figure 30a; 826) and comprising a distal end (Figure 30a; 820), wherein said inner lumen is configured to receive the medical implant in a delivery state of the medical implant such that the first end is arranged near to said distal end (Figure 3a; 60) and the second end is arranged proximally from the first end (Figure 30a; 50), wherein the catheter shaft is configured to be moved towards a vessel wall to place the first end on the vessel wall (Figure 32), and an actuating catheter (Figure 30a; 810 and 840 together may be interpreted as an actuating catheter) configured to be received in said inner lumen (Figure 30a; distal end of 810 received in lumen 826), wherein the actuating catheter comprises a tip operatively connected to the second end (Figure 30a; 846), wherein the actuating catheter is movable with respect to the catheter shaft to move the second end towards the first end (Figure 30a; catheter shaft 824 and outer shaft of actuating catheter 840 are moveable relative to one another, which would allow second end to be moved towards the first end), wherein said tip is capable of penetrating a vessel wall and move the second end of the medical implant through the vessel wall (Figures 34-35).
Concerning claim 2, the Berg reference teaches the catheter system according to claim 1, wherein the medical implant comprises a first fixation device arranged at the first end configured to anchor said first end to the vessel wall (Figure 30a; 60).
Concerning claim 3, the Berg reference teaches the catheter system according to claim 2, wherein the first fixation device comprises at least one tine arranged at the first end and configured to engage with tissue of the vessel wall (Figure 30a; 62).
Concerning claims 5 and 6, the Berg reference teaches the catheter system according to claim 1, wherein the medical implant comprises a sealing device arranged at the distal end, the sealing device being configured to establish a seal between said first end and the vessel wall, wherein the sealing device may comprise an elastic plastics material (Column 14, Lines 50-66; reference states that first fixation device 60 may have the structure of U.S. Patent App. No. 09/186774 | Column 13, Lines 3-24 of U.S. Patent App. No. 09/186774 patented as U.S. Patent No. 6,113,612; connector may include sealing bands made of elastic polymer).
Concerning claim 7, the Berg reference teaches the catheter system according to claim 2, wherein the medical implant comprises a second fixation device arranged at the second end configured to anchor said second end to tissue at a target location (Figure 30a; 50).
Concerning claim 10, the Berg reference teaches the catheter system according to claim 7, wherein the body is configured to extend between the vessel wall and the target location to form said medical bypass connection in an implanted state of the medical implant (Figure 38).
Concerning claim 12, the Berg reference teaches the catheter system according to claim 1, wherein the tip comprises a cutting edge configured to penetrate the vessel wall (Figure 30a; 822).
Claim(s) 1-2 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sullivan et al. (US 2003/0083541, hereinafter Sullivan).
Concerning claims 1-2 and 4, the Sullivan et al. prior art reference teaches a catheter system for implanting a medical implant to form a medical bypass connection on a vessel or between a first vessel and a second vessel (Figures 15; 400), comprising a medical implant comprising a first end, a second end, and a body forming a flow lumen (Figure 15; 430), a catheter shaft defining an inner lumen and comprising a distal end (Figure 15; 440), wherein said inner lumen is configured to receive the medical implant in a delivery state of the medical implant such that the first end is arranged near to said distal end (Figure 16; 436) and the second end is arranged proximally from the first end (Figure 16; 439), wherein the catheter shaft is configured to be moved towards a vessel wall to place the first end on the vessel wall (Figure 18), and an actuating catheter configured to be received in said inner lumen (Figure 15; 420), wherein the actuating catheter comprises a tip operatively connected to the second end (Figure 15; balloon 422 forms tip of actuating catheter, which may be used to actuate and expand the proximal portion of the medical implant), wherein the actuating catheter is movable with respect to the catheter shaft to move the second end towards the first end (Figure 15; balloon tip 422 is capable of expanding the implant, therein shortening the longitudinal length of the implant, which would bring the second end towards the first end), wherein said tip is capable of penetrating a vessel wall and move the second end of the medical implant through the vessel wall (Figure 15; balloon 422 may be pushed through an opening within a vessel, therein penetrating the vessel, and may expand the second fixation to affix the proximal end to tissue, therein moving the second end through the vessel wall), and a first fixation device arranged at the first end configured to anchor said first end to the vessel wall (Figure 15; 36) and further comprising a sheathing configured, in said delivery state to sheath said first fixation device (Figure 15; distal tip 412 includes an overhang that may ensheathe the first fixation device, therein defining it as a sheathing), the sheathing being moveable with respect to the catheter to unsheathe said first fixation device to engage with the tissue of the vessel wall (Figure 19).
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) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berg et al. (US 6,475,222, hereinafter Berg) in view of Carson et al. (US 6,802,847, hereinafter Carson).
Concerning claims 8 and 9, the Berg reference teaches the catheter system of claim 7, but does not specifically teach the second fixation device comprising a magnet to magnetically interact with a counter element at the target location.
However, the Carson reference teaches reference teaches a medical implant to form a medical bypass connection on a vessel or between a first vessel and a second vessel, therein being in the same field of endeavor as the Berg reference, wherein the Carson reference further teaches a fixation device comprising a magnet (Figure 9A; 80) arranged to magnetically interact with a counter element at a target location (Figure 9A; 78), wherein a secondary catheter may be used to deliver said counter element to the target location (Figures 71A-D, 73A-D).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the medical implant of the Berg reference to have the second fixation device comprise a magnet to magnetically interact with a counter element at the target location, wherein the counter element is delivered via a secondary catheter as in the Carson reference as a simple substitution of one known fixation device for a vessel graft (the fixation device with a plurality of fingers of Berg) for another known fixation device for a vessel graft (the magnetic fixation device of Carson) which would yield the predictable result of having the second fixation device of the Berg reference operate in the same manner as the fixation device of Carson, and wherein the catheter system would largely operate in the same manner.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berg et al. (US 6,475,222, hereinafter Berg) in view of Navia (US 2010/0036401).
Concerning claim 13, the Berg reference teaches the catheter system of claim 1, wherein the reference teaches that the body may be made of natural materials (Column 14, Lines 50-65), but does not specifically teach the body comprising a pericardial material.
However, the Navia reference teaches a graft similar to that of the Berg reference, wherein the graft may be made of pericardial material ([¶ 0040]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the body of the medical implant of the Berg reference comprise a pericardial material as in the Navia reference given the Navia reference teaches that pericardial material is a biological material that may be used in a vascular graft (Navia; [¶ 0040]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berg et al. (US 6,475,222, hereinafter Berg) in view of Ishii et al. (US 2016/0278780, hereinafter Ishii).
Concerning claim 16, the Berg reference teaches the catheter system according to claim 5, but does not teach the sealing device being configured to swell during implantation.
However, the Ishii reference teaches a fixation device for a medical implant, therein being in the same field of endeavor as the Berg reference, wherein the Ishii reference teaches the fixation device including a seal portion including a biocompatible gel that may swell when in contact with a body fluid so that the seal portion fixedly adheres to a vessel wall ([¶ 0066]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention have the sealing device of the Berg reference be configured to swell as in the Ishii reference to allow the sealing portions of the Berg reference further adhere to a vessel wall (Ishii; [¶ 0066]).
Allowable Subject Matter
Claims 14 and 15 are allowed.
Claim 11 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Peterson et al. reference (US 2004/0030348) teaches a catheter system for implanting a medical implant to form a medical bypass connection on a vessel or between a first vessel and second vessel, which includes a medical implant including fixation devices at both sides, a catheter shaft, and an actuation shaft; the Zuidema et al. reference (US 2007/0118157) teaches an anastomotic implant wherein a second end is moved towards and past a first end to turn the body of the implant inside out; and the Quadri reference (US 2015/0032153) further teaches a catheter system for delivering a medical implant including a fixation device, wherein the body of the medical implant may be pulled inside out.
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/MARTIN T TON/Examiner, Art Unit 3771 4/2/2026