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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/25/2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4, 8-10, 12-14, 16-17, 21-24, and 36-40 rejected under 35 USC § 103 over de Canniere have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Upon further consideration, a new ground(s) of rejection is made in view of Farnan et al. (US 20110196190) and evidenced by Farnan (US 20100249490).
Response to Amendments
Applicants remarks about the claim interpretation of the preamble and the 112(f) interpretation of the fixation mechanism is not found persuasive by the examiner.
First, the new language in the preamble in claims 1 and 4 stating “A vascular access device that is sized and adapted for percutaneous insertion into a blood vessel, namely a vein or an artery, of a patient's vasculature via the Seldinger technique” is still functional. The preamble has not been given patentable weight because it has been held that a preamble is denied the effect of a limitation where the claim is drawn to a structure and the portion of the claim following the preamble is a self-contained description of the structure not depending for completeness upon the introductory clause. Kropa v. Robie, 88 USPQ 478 (CCPA 1951).
The examiner further notes that claims are directed towards an apparatus, not a method. Therefore, the language in the preamble is not interpreted as describing the claimed structural components of the claimed invention, but interpreted as describing the functionality and the intended use of the claimed invention. For example, “a blood vessel” is a part of the body and cannot be claimed as a structural component of the device, but is considered functional language that the device is capable of being used for. Therefore, “sized and adapted for percutaneous insertion into a blood vessel, namely a vein or an artery, of a patient's vasculature via the Seldinger technique” is interpreted as functional language that the vascular access device is capable of being used for. The patentable weight in apparatus and system claims are provided to the structural components of the claim i.e. (“vascular access tube”, “fixation mechanism comprising an intravascular part…and extravascular part”) as recited in claims 1 and 4. If there are dimensions that are claimed in relation to the structural components that would further support the intended use of being “sized and adapted for percutaneous insertion into a blood vessel”, that would be considered as providing structure. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Second, “the fixation mechanism” as recited in claims 1 and 4 “comprises an intravascular part that engages with an inner surface of the wall of the blood vessel through which the tip is inserted to inhibit or prevent withdrawal of the tip from the blood vessel (functional language) and an extravascular part that engages with tissue of the patient outside of the blood vessel to inhibit or prevent over-insertion of the tip into the blood vessel (functional language)”. As stated above and further explained below, the limitation describing the fixation mechanism still fails to include sufficient structure to perform the recited function of "fixation" other than comprising “parts” that engage the internal and external surfaces of the wall of the blood vessel which is functional. Therefore, the 112(f) interpretation is maintained.
Claim Objections
Claims 1 and 4 are objected to because of the following informalities:
Claim 1 (line 9),claim 4 (lines 9 and 21), and claim 38 (line 4): “access tube” should recite “vascular access tube”.
Claim 4, line 13: “blood” should recite “blood vessel”.
Claim 17 (line 7) and claim 18 (lines 5-6): “its respective retracted or non-deployed position to its extending or deployed position” should recite “a respective retracted or non-deployed position to an extended or deployed position”.
Claim 39, line 2: “wherein extravascular part” should recite “wherein the extravascular part”.
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:
“fixation mechanism”, “intravascular part”, and “extravascular part” in claims 1,4, 9-10, 13-14, 16-18, 25, and 38-39. The limitation describing the fixation mechanism member in claims 1 and 4 (“comprises an intravascular part that engages with an inner surface of the wall of the blood vessel through which the tip is inserted to inhibit or prevent withdrawal of the tip from the blood vessel and an extravascular part that engages with tissue of the patient outside of the blood vessel to inhibit or prevent over-insertion of the tip into the blood vessel” fails to include sufficient structure to perform the recited function of "fixation" other than comprising “parts”. The specification describes the fixation mechanism and thereby the intravascular and extravascular parts as framework (stent/mesh like structure) (para. 0026), a disc or flange members comprising a covered mesh structure (para. 0137), prongs or elongate barbs (para. 0141), cantilevered arm members (par. 0153), plurality of elongate arm members (para. 0157). Therefore, the fixation mechanism and thereby the intravascular and extravascular parts are interpreted as the following structures listed above or any structural equivalent thereof that comprises an intravascular part that engages with an inner surface of a wall of tissue that inhibits or prevents withdrawal of the tip from the tissue and an extravascular part that engages with an external surface of the tissue of the patient that inhibits or prevents over-insertion of the tip.
“activation member” in claim 16. The limitation describing the activation member in claim 16 (“operably associated or connected with the distal end region of the vascular access tube, wherein the activation member is configured for operation by a user at a proximal end region of the vascular access tube to activate or operate the fixation mechanism during or upon insertion of the tip of the vascular access tube into the blood vessel”) fails to include sufficient structure to perform the recited function of "activation". The specification describes the activation member as a sheath or sleeve (para. 0031), a flexible member, such as a cord or line, to be drawn (i.e. pulled under tension) by an operator (para. 0032), a rigid member, such as a rod or tube, to be pressed or moved by an operator” (para. 0033). Therefore, the activation member is interpreted as the following structures listed above or any structural equivalent thereof that is operably associated or connected with the distal end region of the vascular access tube and is configured for operation by a user at a proximal end region of the vascular access tube to activate or operate the fixation mechanism during or upon insertion of the tip of the vascular access tube into the blood vessel.
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 13, 17, and 18 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 13 (line 4), claim 17 (line 5-6), and claim 18 (line 4) recites the limitation "an intravascular part" in 4. It is unclear to the examiner if "an intravascular part" is meant to further define the intravascular part introduced in claim 1 or a new, additional, intravascular part. For examination purposes, "an intravascular part" is interpreted as "the intravascular part", further defining the limitation in claim 1.
Claim 17 (line 6) and claim 18 (line 5) recites the limitation "an extravascular part" in 4. It is unclear to the examiner if "an extravascular part" is meant to further define the extravascular part introduced in claim 1 or a new, additional, extravascular part. For examination purposes, "an extravascular part" is interpreted as "the extravascular part", further defining the limitation in claim 1.
Regarding claim 17 (line 2), the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the limitation introducing “a sheath” is interpreted as being a part of the claimed invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4, 9-10, 13-14, 16-18, 21-25, 36, and 38-40 are rejected under 35 U.S.C. 101 because
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 4, 9-10, 13-14, 16-18, 21-25, 36, and 38-40 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claims 1 and 4 recite “the fixation mechanism comprises an intravascular part that engages with an inner surface of the wall of the blood vessel…and an extravascular part that engages with tissue of the patient”. As written, the language describing the structural components of the vascular device (i.e. the intravascular part and the extravascular part) require and therefore positively claim the body (specifically the blood vessel) to meet the limitation. For examination purposes, the limitation is interpreted and should be written as “the fixation mechanism comprises an intravascular part that is configured to engage with an inner surface of the wall of the blood vessel…and an extravascular part that is configured to engage with tissue of the patient”.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4, 9-10, 13-14, 16-18, 21-24, 36, 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Farnan et al. (US 20110196190) [hereinafter Farnan] and evidenced by Farnan (US 20100249490) [hereinafter Farnan ‘490] incorporated therein.
The examiner notes that the embodiment of Figs. 9-9A is relied upon for the rejection. However, other embodiments will be relied upon for shared features not described in the embodiment of Figs. 9-9A (para. 0070-0071, 0081).
Regarding claim 1, Farnan discloses a vascular access device (see Figs. 2, 9-9A, para. 0035, 0070) that is sized and adapted for percutaneous insertion into a blood vessel, namely a vein or an artery, of a patient's vasculature via the Seldinger technique (para. 0028, 0062, 0071 see note below), comprising:
a vascular access tube 50 having a distal end region 250 terminating in a tip 254 (Figs. 9-9A, para. 0070) to be inserted into the blood vessel of a patient's vasculature (para. 0062, 0071 of Farnan; Fig. 1, para. 0026 of Farnan ‘490) and at least one lumen 122 for introducing one or more catheters there-through into the blood vessel (Figs. 6A-D, para. 0056); and
a fixation mechanism 262, 270 operable by a user at a proximal end region of the access tube 120 to secure or fix the tip 254 of the vascular access tube 50 within the blood vessel (Fig. 9. 9A, para. 0071-0073; see Figs. 4B-D, para 0045-0049 of Farnan ‘490), wherein the fixation mechanism (262, 264) operates to secure or fix the tip 254 (Fig. 9A, para. 0072-0073, 0075) at or adjacent a wall of the blood vessel at a point of insertion of the tip into the blood vessel, whereby the proximal end region of the vascular access tube 50 is located extracorporeally of the patient (Figs. 1-2, para. 0029, 0031, 0035; Figs. 1, 2A para. 0026-0027; note that the vascular access tube 50 is analogous to the transeptal cannula 22 in Farnan ‘490);
wherein the tip 254 of the vascular access tube 50 has an opening 258 to provide fluid communication between the at least one lumen 122 of the vascular access tube 50 and the blood vessel (Figs. 9, 9A, para. 0042, 0070), and
wherein the fixation mechanism 262, 270 comprises an intravascular part 262 that engages with an inner surface of the wall of the blood vessel through which the tip 254 is inserted to inhibit or prevent withdrawal of the tip 254 from the blood vessel (Fig. 9A, para. 0072) and an extravascular part 270 that engages with tissue of the patient outside of the blood vessel to inhibit or prevent over-insertion of the tip into the blood vessel Fig. 9A, para. 0073), and wherein the fixation mechanism 262, 270 operates to position and to secure or fix the opening 258 at or adjacent the wall of the blood vessel at the point of insertion of the tip 254 with the vascular access tube 50 extending longitudinally at an angle with respect to a longitudinal extent of the blood vessel at the point of insertion of the tip 254 (Figs. 1-C, 9A, para. 0030-0033, 0072-0073).
However, Farnan fails to disclose a predetermined angle in a range of about 20 degrees to about 70 degrees.
There is no evidence of record that establishes that changing the angle of the vascular access tube at the point of insertion of the tip would result in a difference in function of the Farnan device. Further, a person having ordinary skill in the art, being faced with modifying the vascular access tube of Farnan such that it extends longitudinally at a predetermined angle in a range of about 20 degrees to about 70 degrees, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angle range (see Figs. 1-C, para. 0030-0033 of Farnan which illustrate the vascular access tube in an angled configuration). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that “the predetermined angle may be selected anywhere in the range of 0 to 90 degrees” (see para. 0034 of the instant application). Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Hence, 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 angle of the vascular access tube of Farnan such that it extends longitudinally at a predetermined angle in a range of about 20 degrees to about 70 degrees as an obvious matter of design choice within the skill of the art.
Note: “a vascular access device that is sized and adapted for percutaneous insertion into a blood vessel, namely a vein or an artery, of a patient's vasculature via the Seldinger technique” has not been given patentable weight because it has been held that a preamble is denied the effect of a limitation where the claim is drawn to a structure and the portion of the claim following the preamble is a self-contained description of the structure not depending for completeness upon the introductory clause. Kropa v. Robie, 88 USPQ 478 (CCPA 1951). The claims are directed towards an apparatus, not a method. Therefore, the language in the preamble is not interpreted as describing the claimed structural components of the claimed invention, but interpreted as describing the functionality and the intended use of the claimed invention. Therefore, “sized and adapted for percutaneous insertion into a blood vessel, namely a vein or an artery, of a patient's vasculature via the Seldinger technique” is interpreted as functional components that the vascular access device is capable of being used for. The device of Farnan comprises all of the structure required for the functional language in the preamble (“vascular access tube”, “fixation mechanism comprising an intravascular part…and extravascular part”) and is sized and adapted for percutaneous insertion into a blood vessel, namely a vein or an artery, of a patient's vasculature via the Seldinger technique (para. 0071 incorporates Farnan US 2010/0249490 therein which discloses that the device is percutaneously inserted into a vein to reach an intria-atrial septum of the heart (see Fig. 1, para. 0026 of Farnan ‘490), para. 0062 of Farnan discloses that the Seldinger technique can be used to access the Intria-atrial septum.), and therefore meets the functional language described. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 4, Farnan discloses a vascular access device 250 (Fig. 9, para. 0070) that is sized and adapted for percutaneous insertion into a blood vessel, namely a vein or an artery, of a patient's vasculature via the Seldinger technique (para. 0028, 0062, 0071 see note above), comprising:
a vascular access tube 50 having a distal end region 250 terminating in a tip 254 (Figs. 9-9A, para. 0070) for insertion into the blood vessel (para. 0062, 0071 of Farnan; Fig. 1, para. 0026 of Farnan ‘490) and at least one lumen 122 for introducing one or more catheters there-through into the blood vessel (Figs. 6A-D, para. 0056); and
a fixation mechanism 262, 270 operable by a user at a proximal end region of the access tube 120 to secure or fix the distal end region 250 of the vascular access tube 50 with respect to the patient (Fig. 9. 9A, para. 0071-0073; see Figs. 4B-D, para 0045-0049 of Farnan ‘490), the fixation mechanism 262, 270 comprising an intravascular part 262 that engages with an inner surface of the wall of the blood vessel through which the tip 254 is inserted to inhibit or prevent withdrawal of the tip 254 from the blood vessel (Fig. 9A, para. 0072) and an extravascular part 270 that engages with tissue of the patient outside of the blood vessel to inhibit or prevent over-insertion of the tip into the blood vessel Fig. 9A, para. 0073), whereby the proximal end region of the vascular access tube 50 is located extracorporeally of the patient (Figs. 1-2, para. 0029, 0031, 0035; Figs. 1, 2A para. 0026-0027; note that the vascular access tube 50 is analogous to the transeptal cannula 22 in Farnan ‘490);
wherein the tip 254 of the vascular access tube 50 has an opening 258 to provide fluid communication between the at least one lumen 122 of the vascular access tube 50 and the blood vessel (Figs. 9, 9A, para. 0042, 0070), and
wherein the fixation mechanism 262, 270 positions and fixes the opening 258 at the wall of the blood vessel at the point of insertion of the tip 254 with the vascular access tube 50 extending longitudinally at an angle with respect to a longitudinal extent of the blood vessel at the point of insertion of the tip 254 (Figs. 1-C, 9A, para. 0030-0033, 0072-0073).
However, Farnan fails to disclose a predetermined angle in a range of about 20 degrees to about 70 degrees.
There is no evidence of record that establishes that changing the angle of the vascular access tube at the point of insertion of the tip would result in a difference in function of the Farnan device. Further, a person having ordinary skill in the art, being faced with modifying the vascular access tube of Farnan such that it extends longitudinally at a predetermined angle in a range of about 20 degrees to about 70 degrees, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angle range (see Figs. 1-C, para. 0030-0033 of Farnan which illustrate the vascular access tube in an angled configuration). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that “the predetermined angle may be selected anywhere in the range of 0 to 90 degrees” (see para. 0034 of the instant application). Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Hence, 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 angle of the vascular access tube of Farnan such that it extends longitudinally at a predetermined angle in a range of about 20 degrees to about 70 degrees as an obvious matter of design choice within the skill of the art.
Regarding claims 9 and 38, modified Farnan discloses wherein the intravascular part 262 of the fixation mechanism 262, 270 includes at least one member 262 that is movable between a retracted or non-deployed position for insertion of the tip 254 of the vascular access tube 50 into the blood vessel and an extended or deployed position for engaging the inner surface of the wall of the blood vessel to inhibit or prevent withdrawal of the tip 254 (Figs. 9-9A, para. 0071-0072 of Farnan).
Regarding claim 10, modified Farnan discloses wherein the at least one member 264 of the intravascular part 262 projects laterally or radially outwardly from the vascular access tube 50 in its extended or deployed position (Figs. 9-9A, para. 0071-0072 of Farnan).
Regarding claims 13 and 39, modified Farnan discloses wherein the extravascular part 270 is configured to engage with an outer surface of the wall of the blood vessel through which the tip 254 is inserted or with tissue that adjoins or encases the wall of the blood vessel, with the extravascular part 270 cooperating with an intravascular part 262 to capture or clamp the wall of the blood vessel there-between (Figs. 9-9A, para. 0073, 0075 of Farnan).
Regarding claim 14, modified Farnan discloses wherein the extravascular part 270 of the fixation mechanism 262, 270 includes at least one member 272 that is movable between a non-deployed position for insertion of the tip 254 of the vascular access tube 50 into the blood vessel and a deployed position to inhibit or prevent over-insertion of the tip 264 (Figs. 9-9A, para. 0073, 0075 of Farnan).
Regarding claim 16, modified Farnan discloses wherein the fixation mechanism 262, 270 comprises an activation member (interpreted as delivery sheath 318, Fig. 11A, para. 0079 of Farnan, see note below) operably associated or connected with the distal end region of the vascular access tube 50, wherein the activation member is configured for operation by a user at a proximal end region of the vascular access tube to activate or operate the fixation mechanism 262, 270 during or upon insertion of the tip of the vascular access tube into the blood vessel (Fig. 11A, para. 0079 of Farnan).
Note: The embodiment of Figs. 11-11A of Farnan disclose the first and second anchors as a single element delivered by a single delivery sheath 318. See para. 0081 of Farnan which states embodiments can be combined.
Regarding claim 17, modified Farnan discloses wherein the activation member comprises a sheath, such as a delivery sheath 318 (Fig. 11A, para. 0079 of Farnan), that covers or accommodates the distal end region 250 of the vascular access tube 50 during insertion of the tip into the blood vessel (Figs. 9, para. 0072, 0075; Fig. 11A, para. 0079 of Farnan), wherein the sheath 318 is configured to be withdrawn from the distal end region 250 (Fig. 9, para. 0072, 0075; Fig. 11A, para. 0079 of Farnan), and wherein withdrawal of the sheath 318 operates to cause at least one member 264 of an intravascular part 262 and at least one member 272 of an extravascular part 270 of the fixation mechanism to move from its respective retracted or non-deployed position to its extended or deployed position (Fig. 9, para. 0072, 0075; Fig. 11A, para. 0079 of Farnan).
Alternative interpretation of claim 16 to reject claim 18
Regarding claim 16, modified Farnan discloses wherein the fixation mechanism 262, 270 comprises an activation member (interpreted as the balloon catheter 28 described in para. 0072 and further detailed and shown in Fig. 4D, para. 0047-0048 of Farnan ‘490) operably associated with the distal end region of the vascular access tube 50 (Figs. 4B-4D, para. 0045-0048 of Farnan’490), wherein the activation member is configured for operation by a user at a proximal end region of the vascular access tube to activate the fixation mechanism during or upon insertion of the tip of the vascular access tube into the blood vessel (Figs. 4B-4D, para. 0045-0048 of Farnan ’490).
Regarding claim 18, modified Farnan discloses wherein the activation member is configured for axially slidable movement within the at least one lumen of the vascular access tube (see Figs. 4B-D of Farnan ‘490 which illustrates the balloon catheter 28 slidable moving within lumen of vascular access tube 22), wherein the activation member is slidably movable towards the distal end region to cause at least one member 264 of an intravascular part 262 and at least one member 272 of an extravascular part 270 of the fixation mechanism to move from its respective retracted or non-deployed position to its extended or deployed position (Fig. 9, para. 0072 of Farnan; Figs. 4B-4D, para. 0045-0048 of Farnan ’490).
Regarding claim 21, modified Farnan discloses a vascular access system 50, 168, 170 (Figs. 6A-D, 9-9A, para. 0056-0061, 0070 of Farnan), comprising:
the vascular access device according to claim 1 (Figs. 2, 9-9A, para. 0035, 0070 of Farnan) and
a dilator 170 for gradually widening a breach or an opening formed in the wall of the blood vessel (Figs. 6A-D, para. 0056, 0058 of Farnan), wherein the dilator 170 is adapted to cooperate with the vascular access tube 50 of the vascular access device to guide and/or introduce the tip of the distal end region of the vascular access tube 50 through the breach or opening in the wall of the blood vessel (Figs. 6A-D, 9-9A, para. 0056-0061 of Farnan).
Regarding claim 22, modified Farnan discloses wherein the tip 254 of the vascular access tube 50 is configured to provide a smooth or gradual tapered transition to an outer periphery of the dilator 170 (Figs. 6A-6C, 9-9A, para. 0058-0059, 0070 of Farnan).
Regarding claim 23, modified Farnan discloses wherein the dilator 170 is sized and/or adapted to be withdrawn or removed from the patient through the at least one lumen 122 of the vascular access tube 50 (Fig. 6D, para. 0061 of Farnan).
Regarding claim 24, modified Farnan discloses wherein the dilator 170 includes a channel 175 for accommodating a guidewire 168 to guide a path of the dilator and thereby of the tip of the distal end region of the vascular access tube through the breach or opening formed in the wall of the blood vessel (Figs. 6A-D, para. 0056-0061 of Farnan).
Regarding claims 36 and 40, modified Farnan discloses all of the limitations set forth above in claims 1 and 4. However, modified Farnan fails to disclose wherein the predetermined angle is in a range of about 30 degrees to about 60 degrees with respect to the blood vessel at the point of insertion of the tip.
There is no evidence of record that establishes that changing the angle of the vascular access tube at the point of insertion of the tip would result in a difference in function of the Farnan device. Further, a person having ordinary skill in the art, being faced with modifying the vascular access tube of Farnan such that it extends longitudinally at a predetermined angle in a range of about30 degrees to about 60 degrees, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angle range (see Figs. 1-C, para. 0030-0033 of Farnan which illustrate the vascular access tube in an angled configuration). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that “the predetermined angle may be selected anywhere in the range of 0 to 90 degrees” (see para. 0034 of the instant application). Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Hence, 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 angle of the vascular access tube of Farnan such that it extends longitudinally at a predetermined angle in a range of about 30 degrees to about 60 degrees as an obvious matter of design choice within the skill of the art.
Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Farnan et al. (US 20110196190) [hereinafter Farnan] and evidenced by Farnan (US 20100249490) [hereinafter Farnan ‘490], as applied to claim 21 above, and further in view of Weststrate et al. (US 20050256455) [hereinafter Weststrate].
Regarding claim 25, modified Farnan discloses all of the limitation set forth above in claim 21. However, modified Farnan fails to disclose wherein the dilator includes a cavity or chamber configured to house or accommodate one or more members or parts of the fixation mechanism of the vascular access device.
Weststrate in the same field of endeavor teaches a medical catheter for percutaneous insertion comprising a dilator (interpreted as inner sheath 15 which is structurally analogous to the dilator of modified Farnan Fig. 2, para. 0040), wherein the dilator 15 includes a cavity or chamber 37 configured to house or accommodate a fixation mechanism 14 of a tube 13 (Figs. 1-3, 5(g)-(h), para. 0043, 0047, 0049).
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 dilator in modified Farnan to include the cavity or chamber of Weststrate in order to protect the fixation mechanism and the vascular access tube during insertion of the vascular access device and during navigation of the device to a target site (para. 0043, 0047, 0049 of Weststrate).
Conclusion
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771