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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16175698i, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The prior filed application fails to provide support for a kit to further comprise a sleeve (claim 11), a subcutaneous access vessel (claims 12-15), a skin marking device (claim 16), and a spacer (claim 17). The examiner notes that claims 11-17 are examined with a filing date of 1/31/2024.
Response to Amendment
This office action is responsive to the amendment filed on March 23, 2026. As directed by the amendment: claims 1-4, 9, 10, 12-14, and 16-18 have been amended and claim 15 has been cancelled. Thus, claims 1-14 and 16-18 are presently pending in this application.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every 101 and 112(b) rejections and most objections previously set forth in the Non-Final Office Action mailed January 13, 2026. The examiner notes that some objections do not appear to have been addressed and are repeated below.
Response to Arguments
Applicant's arguments filed March 23, 2026 have been fully considered but they are not persuasive.
Applicant argues on pg. 6 of the Remarks that “The Office Action notes that Rowe's "holes" collectively equate to the claimed "opening" and each hole is a "zone." However, Rowe discloses a plurality of holes at various locations; therefore, the plurality of holes do not create a single opening that is partitioned into different zones such that the opening as amended”. The examiner notes that the interpretation that Rowe teaches a single opening collectively formed by the plurality of holes appears aligned with Applicant’s own invention. Paragraph 55 of the published application and fig. 6 discloses “the cannulation template 110 has physical features 112 spanning the opening”. Fig. 6 shows a single, ovular opening which is separated into a plurality of smaller holes via the physical features 112. This indicates that “an opening” is not limited to a single, continuous opening but instead is intended to be interpreted more broadly in that “an opening” can comprise “physical features” which span the opening which separate the opening into a plurality of zones (fig. 6 of the Drawings). Applying similar logic to Rowe, Rowe teaches “a single opening” which is formed by the collection of holes/notches in the template (paragraph 64) with the single opening being spanned by physical features in the form of material of the template to separate the “single opening” into a plurality of zones in the form of the individually formed notches/holes. As such, the rejection is maintained below.
The examiner further notes that even if Applicant amends the structure of the single opening to overcome the interpretation by the Examiner. It is the examiner’s opinion that Rowe would still disclose a single opening since Rowe discloses a plurality of holes/notches with one of the holes/notches being a “single opening”. One of the holes/notches can be subdivided into a plurality of zones since the zones are not further defined and would be capable of receiving a series of cannulations since the claim does not presently require that each zone be configured to be simultaneously cannulated.
Claim Objections
Claims 2 and 17 are objected to because of the following informalities:
Regarding claim 2, the claim recites that the template includes an inner surface and an outer surface in line 1. This limitation is already present in claim 1. It is recommended to delete the limitation from claim 2.
Regarding claim 17, the claim should be amended to recite “a last cannulation site” in line 2 to provide antecedent basis for the claim terminology.
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 5 and 16 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 5, the claim is drawn to a template comprising “at least one passage opening”. This claim is dependent on claim 1 which recites the template comprises “a single opening”. It is unclear if this passage opening is an additional opening to the single opening or if the passage opening is distinct from the single opening.
Claim 16 is also rejected by virtue of being dependent on claim 5.
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.
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) 1-8, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe (US 20180185059) in view of Borchard (US 20040078000).
Regarding claim 1, Rowe discloses:
at least one dialysis needle for accessing a subcutaneous vascular access vessel in a body of a patient (needle 312 in fig. 3C);
a dispenser (tubing 314 in fig. 3C dispenses blood through tubing 314 and to needle 312); and
a template (cannulation site selection apparatus 200 in fig. 3C) having an inner surface and an outer surface (the surface shown in fig. 3C is the “outer surface” and the surface opposite to the surface shown is the “inner surface”), the template defining a single opening for a plurality of zones for a series of cannulations (paragraph 64 and 65 disclose holes in the template, a subset of these holes/notches collectively are equated to the “single opening” with each individual hole/notch being a zone; see response to arguments); and
a plurality of visible markings on the outer surface of the template (cannulation site selection markings 210 in fig. 3C),
wherein the template is adapted to be disposed adjacent the subcutaneous vascular access vessel such that the plurality of visible markings align with cannulation sites along the vascular access vessel for selecting a site for cannulation with the needle into the vascular access vessel (fig. 3C shows the markings aligning with cannulation sites 308).
However, Rowe does not teach or disclose the elements above are a kit.
Borchard teaches a kit (fig. 10; paragraph 24 discloses “a kit”) comprising a needle (needles 310 and 312 in fig. 10), a dispenser (extension set 320 in fig. 10), and a template (template 260 in fig. 10). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified Rowe so that the elements set forth in claim 1 above are part of a kit, as taught by Borchard, so that a user conveniently has all of the necessary components in a sterile packing container (paragraph 24).
Regarding claim 2, in the modified kit of Rowe, Rowe discloses the template includes an inner surface and an outer surface (the surface shown in fig. 3C is the “outer surface” and the surface opposite to the surface shown is the “inner surface”), wherein each of the plurality of zones configured for receiving a plurality of simultaneous cannulations accessing the vascular access vessel (paragraph 65).
Regarding claim 3, in the modified kit of Rowe, Rowe discloses the plurality of visible markings on the outer surface of the template defining each of the plurality of zones for use as cannulation sites along the vascular access vessel (fig. 3C; paragraphs 40 and 64).
Regarding claim 4, in the modified kit of Rowe, Rowe discloses the plurality of visible markings are configured for selecting a first zone as a cannulation site for cannulation into a vascular access vessel such that the cannulation site in the first zone is spaced from and not adjacent to a second zone (paragraph 18).
Regarding claim 5, in the modified kit of Rowe, Rowe discloses the template has at least one passage opening (paragraph 65 discloses “holes” in the body of the flexible member).
Regarding claim 6, in the modified kit of Rowe, Rowe discloses the plurality of visible markings are on a first side and a second side of a longitudinal axis of the template (fig. 6 shows an equivalent template 600 in which markings are on a first and second side of a longitudinal axis of the template; see below, the dotted line is the “longitudinal axis”).
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Regarding claim 7, in the modified kit of Rowe, Rowe discloses the template is translucent (paragraph 13).
Regarding claim 8, in the modified kit of Rowe, Rowe discloses a key on the template (first marking 204 in fig. 3C), the key configured to facilitate alignment of the template for rotation of the plurality of visible markings (paragraph 39).
Regarding claim 17, in the modified kit of Rowe, Rowe discloses a spacer defining a hole to be aligned with the last cannulation site for marking the arm beyond the periphery of the spacer (paragraph 15 discloses holes in the template with one of these holes being a “spacer” which is capable of being aligned with the last cannulation site and the remainder of the holes reading on the opening).
Regarding claim 18, in the modified kit of Rowe, Rowe discloses the template defines holes along an edge of the template (paragraph 64 discloses “holes/notches along an edge of the flexible member”, the examiner notes that a subset of these are interpreted to form “the single opening” of claim 1 and another subset is interpreted to be the “holes”), the holes spaced at set distances from one another (it is understood that the notches would be spaced at set distances), and wherein the template is adapted to be disposed adjacent a subcutaneous vascular access vessel such that the holes align with the cannulation sites along the vascular access vessel for selecting a site for cannulation with a needle into the vascular access vessel (paragraph 64).
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe in view of Borchard, as applied to claims 1 and 8 above, and further in view of Van Kaauwen (US 20040153031).
Regarding claim 9, modified Rowe teaches all of the claimed limitations set forth in claims 1 and 8, as discussed above. Rowe further discloses that the templates disclosed are discussed in the context of cannulating an arm (paragraph 70); however, Rowe further discloses that the template may be used in other cannulation sites (paragraph 70). However, modified Rowe does not teach or disclose the key includes a reproduction of an image of a forearm and a wrist of a patient.
Van Kaauwen teaches a template (1 in fig. 1a) having a key (17, 18 in fig. 1a) which includes a reproduction of an image of the entire human body, including an image of a forearm and wrist (fig. 1a). Van Kaauwen further teaches that this key assists the user in positioning the template (paragraph 21). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the key of modified Rowe to include the reproduction of an image of the entire human body with the appropriate body location designated, as taught by Van Kaauwen, since Van Kaauwen teaches that this modification would assist the user in orienting the template (paragraph 21).
Regarding claim 10, in the modified kit of Rowe, Van Kaauwen discloses the key further includes a reproduction of an image of a torso of a patient (fig. 1a).
Claim 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe in view of Borchard, as applied to claim 1 above, and further in view of Katz (US 4642096).
Regarding claim 11, modified Rowe teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose a sleeve defining a pocket for receiving the template.
Katz teaches a position location device (fig. 2) comprising a template (12) and a sleeve (sleeve formed by clamping unit 26/28 and straps 30; figs. 3 and 4). Katz further teaches that the sleeve defines a pocket for receiving a template (clamps 26 and 28 form a pocket for receiving the template; 4:24-27). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the kit of modified Rowe to include the sleeve defining a pocket for receiving the template, as taught by Katz. This modification would ensure that the template is securely fastened to the patient in a releasable manner to prevent any unintended movements (2:60-66).
Claims 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe in view of Borchard and in view of Katz, as applied to claims 1 and 11 above, and further in view of Young (US 20100191191).
Regarding claim 12, modified Rowe teaches all of the claimed limitations set forth in claim 1 and 11, as discussed above. Rowe further teaches that the components of claim 1 are intended to be used with a subcutaneous vascular access vessel (paragraph 38 discloses an AV graft or fistula). However, modified Rowe does not explicitly teach or disclose that the subcutaneous vascular access vessel is part of a kit.
Young is directed towards a kit (paragraph 200 discloses “kits”) which can include a subcutaneous vascular access vessel configured to be subcutaneously implanted in the body of the patient (paragraph 200 discloses “one or more synthetic grafts”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the kit of modified Rowe to include the subcutaneous vascular access vessel, as taught by Young, to ensure a user has all of the components necessary for cannulation.
Regarding claim 13, in the modified kit of Rowe, Katz discloses the sleeve is configured to accommodate the body of the subject adjacent the subcutaneous graft such that the markings align with the cannulation sites along the vascular access vessel for selecting a site for cannulation with a needle into the graft (fig. 2 shows body part 2 being accommodated in the sleeve indicating that the sleeve is fully capable of being positioned adjacent a subcutaneous graft so that the markings align at the cannulation sites).
Regarding claim 14, in the modified kit of Rowe, Rowe discloses the vascular access vessel is an arteriovenous dialysis access graft subcutaneously implanted in a body of a patient (paragraph 38 discloses the vascular access can be an AV graft).
Claims 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe in view of Borchard, as applied to claims 1 and 5 above, and further in view of Buckman (US 20030051362).
Regarding claim 16, modified Rowe teaches all of the claimed limitations set forth in claim 1, as discussed above. Rowe further discloses the template is adapted to be disposed adjacent the subcutaneous vascular access vessel such that the opening aligns with a cannulation site along the vascular access vessel for selecting the site for cannulation into the vascular access vessel by marking through the opening with the skin marking device (paragraph 65 discloses the template can have “holes” which align with cannulation sites; fig. 3C shows the template is adapted to be disposed adjacent a subcutaneous access vessel so that the holes are aligned with cannulation sites; the examiner notes that a user would be able to mark the site through the holes with a skin marking device, such as a pen or marker).
However, modified Rowe does not teach or disclose the skin marking device.
Buckman is directed towards a kit (fig. 10) which includes a skin marking device (surgical marking pen 38 in fig. 10). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the kit of modified Rowe to further comprise the skin marking device of Buckman for the purpose of marking the incision site (paragraph 45).
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 COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783