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 of Group I, claims 1-10, and Species C, claims 1-20, in the reply filed on July 30th 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant has designated that Species C reads on claims 1-20. The Examiner finds that claims 2-3 read on unelected Species A; therefore, claims 2-3 will be withdrawn as pertaining to an unelected species.
Claims 2-3 and 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 30th 2025.
Specification
The disclosure is objected to because of the following informalities:
in [0061], actuator 511 should be in reference to actuator 411;
in [0072], sheath 402 should be in reference to sheath 702;
Appropriate correction is required.
Drawings
The drawings are objected to because Figures 2, 3, and 4A have the tear away activator 111 referenced as lumen 110, this should be corrected to 111. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
reference 103 in Figure 4A is not in the written description, it appears reference 103 should be corrected to reference 110;
reference 206 in Figure 5 is not in the written description;
reference 354b in Figure 7 is not in the written description;
reference 654b in Figure 12 is not in the written description;
reference 781b in Figure 19E is not in the written description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-2 and 10 are objected to because of the following informalities:
Regarding claim 1, in line 4, “the guidewire” should be corrected to “the first guidewire” and the second recitation of “a sheath” should be corrected to “the sheath” for claim language consistency. In line 10, “further comprising connection section” should be corrected to “further comprising a connection section” for correctness.
Regarding claim 2, a period must be added to the end of the sentence.
Regarding claim 10, “and separable slit” should be corrected to “and the separable slit” for claim language consistency and “extends” should be corrected to “extend” for correctness.
Appropriate correction is required.
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 6-7 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.
Regarding claim 6, the limitations are unclear. The antegrade sheath cannot have a greater stiffness than itself. Based on the drawings and specification, it appears that the antegrade sheath may have: “the antegrade sheath 202 may for example have tip or end region that is stiffer or more rigid than a bendable portion located proximally from the tip or end region”, [0045]: “In one example implementation, the retrograde sheath 702 may have substantially the same stiffness as the antegrade sheath 802 or may have a greater stiffness than the antegrade sheath 802”, [0072]: or “the antegrade sheath 202 may for example have stiffness that is greater than the retrograde sheath 102”, [0044]. The Examiner is unsure which configuration the Applicant was intending to claim. For purposes of Examination, the Examiner is interpreting the antegrade sheath to …
Regarding claim 7, the claim limitations are unclear. The specification and drawings do not disclose an embodiment of the present invention in which one or more walls of the antegrade sheath are separable via the connection section, as claimed in claim 7. The retrograde sheath is separable via the connection section, not the antegrade sheath. This is being interpreted as a typographical error. The Examiner is interpreting claim 7 to read “…further comprising separating one or more walls of the retrograde sheath via the connection section and removing the retrograde sheath while allowing the antegrade sheath to remain in the femoral artery of the patient.”
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 4-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sadanandan (US 20140135786 A1).
Regarding claim 1, Sadanandan discloses a method of performing an interventional procedure (abstract and [0019] and [0042]), the method comprising: retrograde placement of a needle into a femoral artery of a patient to create an incision (needle 300 inserted into the femoral artery (CFA) 305 in the retrograde direction creating an entry site 304, [0042]-[0043] & Fig. 2A); retrograde advancement of a first guidewire in to the femoral artery (retrograde advancement of guidewire 302 into CFA 305, [0043] & Fig. 2A-2B); advancing a sheath system (introducer sheath 102 and j-tip catheter 150 are being interpreted as the sheath system, [0021] & Fig. 1A) over the guidewire (advancing introducer sheath 102 over guidewire 302, [0044] & Fig. 2C) and inserting a distal end of a sheath system through the incision and into the femoral artery of the patient (inserting distal end 114 of sheath 102 through entry site 304 into CFA 305, [0044]-[0045] & Fig. 2C-2D), wherein the sheath system comprises a retrograde sheath having an antegrade sheath removably connected thereto (introducer sheath 102 is being interpreted as the retrograde sheath and j-tip catheter 150 is being interpreted as the antegrade sheath, which is removably connected to sheath 102, see [0048] & Fig. 2E-2H), wherein the retrograde sheath comprises a lumen extending between a retrograde sheath distal end and a retrograde sheath proximal end (longitudinal opening 116 defined by internal side wall 104 extending from proximal end 112 to distal end 114 of tubular member 103 of sheath 102, [0025] & Fig. 1A) and wherein the antegrade sheath comprises a lumen extending between an antegrade sheath distal end and an antegrade sheath proximal end (longitudinal opening 162 from proximal end 158 to distal end 160 of catheter 150, [0034] & Fig. 1A), the sheath system further comprising connection section connecting the retrograde sheath to the antegrade sheath (weakened structures 128, structures 128 being perforated sections, connecting sheath 102 together and subsequently allowing for connection between sheath 102 and catheter 150, [0030] & Fig. 2F and 2G, and side hole 120 connecting sheath 102 to catheter 150, see [0048] & Fig. 2F; since the diameter 156 of catheter 150 is smaller than diameter 108 of sheath 102, catheter 150 would be connected along the length of structures 128, see [0034]); antegrade advancement of a second guidewire into the femoral artery via the lumen of the antegrade sheath (antegrade advancement of guidewire 130 through CFA 305 via opening 162 in catheter 150, [0034] and [0049] & Fig. 2F-2G); separating the retrograde sheath from the antegrade sheath via the connection section (removing catheter 150 from side hole 120, [0049] & Fig. 2H); and performing an antegrade interventional procedure (work sheath 312 inserted allowing for performance of a medical procedure in the antegrade direction, see [0051] & Fig. 2K-2L).
Regarding claim 4, Sadanandan discloses all the limitations of claim 1. Sadanandan further discloses the method wherein the retrograde sheath is removed after separation from the antegrade sheath (sheath 102 is removed after separating from catheter 150, [0049]-[0050] & Fig. 2H-2I).
Regarding claim 5, Sadanandan discloses all the limitations of claim 4. Sadanandan further discloses the method wherein the retrograde sheath is removed before performing the antegrade interventional procedure (sheath 102 is removed before performing the medical procedure in the antegrade direction using work sheath 312, see [0050]-[0052] & Fig. 2I-2L).
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sadanandan (US 20140135786 A1) as applied to claims 1 and 4-5 above, and further in view of Walther (US 20180272116 A1).
Regarding claim 6, Sadanandan discloses all the limitations of claim 1. Sadanandan discloses a curve in catheter 150 which can be straightened through application of force. However, Sadanandan fails to explicitly disclose the method, as best understood in light of the 122(b) rejection above, wherein the antegrade sheath end region has a greater stiffness than the antegrade sheath bendable portion located proximally from the tip or end region. However, Walther teaches a method (abstract and [0007]) wherein the antegrade sheath end region has a greater stiffness than the antegrade sheath bendable portion located proximally from the end region (body 16 has increased flexibility along bend 44, which is proximal to distal end 20, [0031] & Fig. 3A). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Sadanandan with Walther to include the antegrade sheath end region having a greater stiffness than the antegrade sheath bendable portion located proximally from the end region since such a modification would allow for easier manipulation of the bend in the antegrade sheath upon application of force or other means of control and yield predicable results pertaining to sheath manipulation (see [0031] of Walther).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sadanandan (US 20140135786 A1).
Regarding claim 7, Sadanandan discloses all the limitations of claim 1. Sadanandan further discloses the method, as best understood in light of the 112(b) rejection set forth above, further comprising separating one or more walls of the retrograde sheath via the connection section (structures 128 configured to facilitate separation of tubular member 103 of sheath 102 into two pieces, [0030] & Fig. 2I).
However, Sadanandan fails to explicitly disclose the method comprising removing the retrograde sheath while allowing the antegrade sheath to remain in the femoral artery of the patient.
However, there are a limited number of options available to try regarding the removal of sheath 102 and catheter 150 resulting in guidewire 130 being left alone in the femoral artery, the method step illustrated in Fig. 2J and disclosed in paragraph [0050]. The two options include either:
catheter 150 is removed first and sheath 102 is removed second, as explicitly disclosed in Sadanandan (see [0049]-[0050] & Figs. 2H and 2I);
or sheath 102 is removed first and catheter 150 is removed second.
Considering perforated structures 128 run alongside hole 120 in which catheter 150 is connected (see [0029]-[0030] & Fig. 1A and 2G), sheath 102 is capable of being removed before catheter 150.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the method of Sadanandan to include the step of removing the retrograde sheath while allowing the antegrade sheath to remain in the femoral artery of the patient since this step is one of only two possible options. One of ordinary skill would be able to select from the limited number of options to achieve the desired predictable outcome regarding the insertion of guidewire 130 alone in the femoral artery.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sadanandan (US 20140135786 A1) as applied to claims 1 and 4-5 above, and further in view of Duijisens (WO 2021078446 A1).
Regarding claim 8, Sadanandan discloses all the limitations of claim 1. However, Sadanandan fails to explicitly disclose the method wherein the antegrade sheath is separated from a concave channel in the retrograde sheath. However, Duijisens teaches a method (abstract) wherein the antegrade sheath is separated from a concave channel in the retrograde sheath (preformed channel 24, which is being interpreted as the concave channel, formed in cannula 10, which is being interpreted as the retrograde sheath, allowing for the passage of cannula 28, which is being interpreted as the antegrade sheath, see page 4 paragraph (PG) 1 and Fig. 1-6; cannula 28 is configured for insertion into channel 24, which implies selective removal, page 4 PG 1 & Fig. 1-6; removal of cannula 28 occurring upon removal from channel 24). The Examiner notes that the embodiment of channel l24 in which preformed channel 24 is on the same side as the exit port is being used to still allow for dilator insertion, see page 5 PG 3 & Fig. 3.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Sadanandan with Duijisens to include the antegrade sheath separated from a concave channel in the retrograde sheath since such a modification would provide the antegrade sheath with its own dedicated channel within the retrograde sheath lumen to assist in antegrade sheath placement and/or guidance to a side aperture and yield predictable results pertaining to antegrade sheath insertion (see page 4 PG 1 – page 5 PG 3 of Duijisens). As modified, the longitudinal opening 116 of sheath 102 of Sadanandan would be modified to include a channel, like channel 24 of Duijisens, running the length of sheath 102 to side hole 120.
Regarding claim 9, Sadanandan, as modified, discloses all the limitations of claim 8. Sadanandan, as modified, further discloses the method wherein the connection section comprises the concave channel (channel 24 modified into sheath 102 of Sadanandan, see page 4 PG 1 of Duijisens & Fig. 1-6 and [0048] & Fig. 2F of Sadanandan) and a separable slit for containing the antegrade sheath (perforations 128 are being interpreted as the separable slit, [0030] & Fig. 1A; structure 128 allowing for containment of catheter 150, Fig. 1A & 2G).
However, Sadanandan fails to explicitly disclose the method wherein separating the antegrade sheath from the retrograde sheath comprises removal of the antegrade sheath from the concave channel via the separable slit.
However, there are a limited number of options available to try regarding the removal of sheath 102 and catheter 150 resulting in guidewire 130 being left alone in the femoral artery, the method step illustrated in Fig. 2J and disclosed in paragraph [0050]. The two options include either:
catheter 150 is removed first and sheath 102 is removed second, as explicitly disclosed in Sadanandan (see [0049]-[0050] & Figs. 2H and 2I);
or sheath 102 is removed first and catheter 150 is removed second.
Considering perforated structures 128 run alongside hole 120 in which catheter 150 is connected (see [0029]-[0030] & Fig. 1A and 2G), catheter 150 is capable of being removed from modified channel 24 in sheath 102 via perforated structures 128, which would remain unmodified considering structures 128 facilitate clean separation of sheath 102 for easy removal from a vessel (see [0030] of Sadanandan).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the method of Sadanandan to include the step of separating the antegrade sheath from the retrograde sheath comprising removal of the antegrade sheath from the concave channel via the separable slit since this step is one of only two possible options. One of ordinary skill would be able to select from the limited number of options to achieve the desired predictable outcome regarding the insertion of guidewire 130 alone in the femoral artery.
Regarding claim 10, Sadanandan, as modified, discloses all the limitations of claim 9. Sadanandan further discloses the method wherein the connection section and separable slit extends along a connection section length of the retrograde sheath (modified channel 24 in sheath 102 and structures 128 extending along the proximal end 112 of sheath 102 to side hole 120, this length is being interpreted as the connection section length, see [0025] and [0027] & Fig. 1A and 2F-2G of Sadanandan and Fig. 1-6 of Duijisens), wherein the antegrade sheath is separatable from the retrograde sheath along the connection section length via the separable slit (as modified, catheter 150 is separatable from sheath 102 along the proximal end 112 of sheath 102 to side hole 120 via perforated structures 128, Fig. 1A and 2I of Sadanandan).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. McCurry (WO 2021118933 A1).
McCurry teaches a method (abstract) wherein the antegrade sheath is separated from a concave channel in the retrograde sheath (channel tube 430, which is being interpreted as the concave channel, extending the length of sheath body 108’, [00043] & Fig. 4-6; inner tube 218’, which is being interpreted as the antegrade sheath, configured for selective insertion, implying selective removal as well, see [0040] and [00043] & Fig. 6; removal of inner tube 218’ occurring upon removal from tube 430).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783