DETAILED ACTION
Response to Amendment
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 68 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.
In regard to claim 68, the claim is rendered indefinite because the orientation of the materials to the rest of the limitations is not clear. It is not clear if these recited materials are part of the already recited device (materials of the body, connector, cover layer?) or materials of a yet to be recited structure.
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.
(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) 65 and 68-81 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raab et al. (US 2018/0071484; hereafter Raab).
In regard to claim 65, Raab discloses a cannula (10) comprising: a hollow body (12) comprising a continuous channel (30) in a longitudinal direction of the hollow body and between opposing ends of the hollow body (see at least Fig. 4), a connector (46) comprising at least one first layer which is in flush alignment with an end face of the hollow body (see Fig. 4; the proximal end face of 12 is flush with the portion of 46), the connector comprising a continuous channel (54) which is fluidically connected to the channel of the hollow body (see Fig. 4 and par. [0078]), and a cover layer (18 which includes 20 and 24; see par. [0063]), which is formed (product-by-process limitation) over the at least one first layer and extends over an adjacent end region of the hollow body (see Fig. 4 and par. [0075]; strain relief is separate from insert 46), the cover layer being in flush alignment with the circumference of the end region of the hollow body and/or the circumference of a portion of the hollow body leading away from the end region (at 61; see Fig. 4; the strain relief tapers to a flush end with the circumference of the hollow body in the same manner as the applicant’s invention).
In regard to claim 68, Raab discloses comprising at least two material layers (34, 36, and/or 38) arranged on top of another, wherein the at least two material layers are formed of a same material or different materials (see par. [0060]-[0070]).
In regard to claim 69, Raab discloses wherein the cover layer (18) and the first layer (46) are formed from different materials (see par. [0072]-[0074]).
In regard to claim 70, Raab discloses wherein the hollow body (12) and/or the channel of the hollow body has a substantially continuous circumference, cross-section, and/or diameter (see par. [0077]).
In regard to claim 71, Raab discloses wherein the hollow body (12; specifically, part 34 of 12) and the first layer (46) are formed from the same material (silicone; see par. [0066] and [0074]).
In regard to claim 72, Raab discloses wherein the hollow body (12) is wire-reinforced (40) at least in portions of the hollow body (see par. [0069]-[0070]).
In regard to claim 73, Raab discloses wherein the hollow body is wire-reinforced (40) over an entire length of the hollow body (see par. [0069]-[0070]).
In regard to claim 74, Raab discloses, wherein the connector (46) has a circular cross-section in a longitudinal direction (see Fig. 2 and 4; par. [0077]).
In regard to claim 75, Raab discloses wherein a diameter of the cross-section of the connector (46) increases in a direction away from the hollow body (12) (see Fig. 4 at 60; 46 opens proximally).
In regard to claim 76, Raab discloses wherein the connector (46) is tapered or conical in shape (see Fig. 4).
In regard to claim 77, Raab discloses wherein the connector (46) comprises a substantially continuous wall thickness in the longitudinal direction (see Fig. 4, a small portion in the proximal end has a continuous wall thickness).
In regard to claim 78, Raab discloses wherein a thickness of the cover layer (18) increases in a direction leading away from the end region of the hollow body (see Fig. 4; thickness of portion 44 increases in the proximal direction).
In regard to claim 79, Raab discloses wherein a coupling part (50) is attached to an end of the connector opposite the hollow body (see Fig. 4; par. [0052]).
In regard to claim 80, Raab discloses, adapted for circulatory support of a patient (functional limitation).
In regard to claim 81, Raab discloses adapted for insertion into a carotid artery, a jugular vein, an inguinal vein, and/or a vena cava of a patient (functional limitation).
In regard to claim 82, Raab discloses wherein the cover layer (18) is applied by dipping the at least one first layer in a liquid cover layer material (product-by-process limitation) in such a way that the cover layer (18) is flush with a circumference of the end region of the hollow body (see Fig. 4).
Claim(s) 65, 68-71, and 74-82 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yokota et al. (US 2021/0402143; hereafter Yokota).
In regard to claim 65, Yokota discloses a cannula (see at least Fig. 2), comprising: a hollow body (34) comprising a continuous channel in a longitudinal direction of the hollow body and between opposing ends of the hollow body (see at least Fig. 2; 34 is an open-ended body with a lumen extending therethrough), a connector (12) comprising at least one first layer which is in flush alignment with an end face of the hollow body (see Fig. 2; the distal end face of 34 is flush with a portion of 12), the connector (12) comprising a continuous channel which is fluidically connected to the channel of the hollow body (lumen of 12 is fluidly connected to the lumen of 34), and a cover layer (20), which is formed (product-by-process limitation) over the at least one first layer and extends over an adjacent end region of the hollow body (see Fig. 2), the cover layer being in flush alignment with the circumference of the end region of the hollow body and/or the circumference of a portion of the hollow body leading away from the end region (see flush alignment of the proximal end of the hollow body 34 and 20 at 12a2 in Fig. 2).
In regard to claim 68, Yokota discloses comprising at least two material layers (56 and 100) arranged on top of another (top is a relative term that depends on orientation of the device), wherein the at least two material layers are formed of a same material or different materials (the materials have to be the same or different).
In regard to claim 69, Yokota discloses wherein the cover layer (20) and the first layer (12) are formed from different materials (see par. [0028], [0030], [0032]).
In regard to claim 70, Yokota discloses wherein the hollow body (34) and/or the channel of the hollow body has a substantially continuous circumference, cross-section, and/or diameter (see Fig. 2).
In regard to claim 71, Yokota discloses wherein the hollow body (34) and the first layer (12) are formed from the same material (see par. [0028], [0030], [0032]).
In regard to claim 74, Yokota discloses, wherein the connector (12) has a circular cross-section in a longitudinal direction (see Fig. 1).
In regard to claim 75, Yokota discloses wherein a diameter of the cross-section of the connector (12) increases in a direction away from the hollow body (12) (see Fig. 2).
In regard to claim 76, Yokota discloses wherein the connector (12) is tapered or conical in shape (see Fig. 2).
In regard to claim 77, Yokota discloses wherein the connector (12) comprises a substantially continuous wall thickness in the longitudinal direction (see Fig. 2).
In regard to claim 78, Yokota discloses wherein a thickness of the cover layer (20) increases in a direction leading away from the end region of the hollow body (see Fig. 2; 20 has multiple zones of increasing thickness).
In regard to claim 79, Yokota discloses wherein a coupling part (37) is attached to an end of the connector opposite the hollow body (see par. [0035]).
In regard to claim 80, Yokota discloses, adapted for circulatory support of a patient (functional limitation).
In regard to claim 81, Yokota discloses adapted for insertion into a carotid artery, a jugular vein, an inguinal vein, and/or a vena cava of a patient (functional limitation).
In regard to claim 82, Yokota discloses wherein the cover layer (20) is applied by dipping the at least one first layer in a liquid cover layer material (product-by-process limitation) in such a way that the cover layer (20) is flush with a circumference of the end region of the hollow body (see Fig. 2).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 66-67 are rejected under 35 U.S.C. 103 as being unpatentable over Raab or Yokota.
The instant disclosure describes the parameters of the ratio of the length of the end region to a length of first layer as being merely preferable, and does not describe ratio as contributing any unexpected results to the system. In fact, applicant specifically states at par. [0029] of the pg-publication that the “cover layer can be used both to connect the at least one material layer to the hollow body and to facilitate the insertion of the cannula into a patient, such that the ratio can be selected appropriately, for example, based on a predetermined structural stability and/or suitability for an anatomical dimensioning.” As such, parameters such as the recited ratio are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the limitation of the recited ratio would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Claim(s) 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over Yokota in view of Raab.
Yokota fails to disclose the specific material set forth in claim 72-73. Raab teaches at par. [0069]-[0070] that it is known in the art of cannulas to use the wire-reinforced material to manufacture the cannula. In view of the teaching of Raab, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select wire-reinforced material as the specific type of material from which to manufacture the cannula of Yokota, because it amounts to selection of a known material based on its known suitability for the purpose.
Response to Arguments
Applicant's arguments filed 4/20/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Raab and Yokota each fail to disclose a cover layer formed over the first layer, the examiner respectfully disagrees. The applicant argues that the hub assembly is connected to or disposed at the proximal end of the shaft and therefore is not formed over the at least one layer. The limitation of “formed” is considered a product-by-process limitation that fails to patentably distinguish over Raab. The end result of the claimed limitations results in a cover layer over the first layer which is the same structure disclosed by Raab. The examiner notes that the limitation of “formed” is a generic limitation for a process and therefore no specific structural limitation can be inferred from the limitation. The applicant argues the same point against Yokota and is therefore not persuasive for the same reasons discussed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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