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 .
This is the first office action on the merits in response to Applicant’s election filed on 12/30/2025.
Election/Restrictions
Applicant’s election without traverse of Species I (FIGS. 4A-4C and 6A-7D), subspecies AI (FIG. 4A), and subspecies BI (FIG. 7A) in the reply filed on December 30, 2025 is acknowledged. Applicant’s election withdraws claims 11-15, 19-20, and 22 from further consideration. Claims 1-10, 16-18, 21, and 23-26 are pending and examined.
Claim Objections
Claims 5 and 21 are objected to because of the following informalities:
Claim 5, line 2: the acronym “RICC” should be defined first before using it. This should be to --rapidly insertable central catheter (RICC)—
Claim 5, line 2: based on the above definition for “RICC”, “RICC catheter placement system” is believed to be in error for --RICC placement system-- (“catheter” is redundant)
Claim 21, line 2: “a catheter” is believed to be in error for --the catheter-- (see claim 21, line 1)
Claim 21, lines 4-5: “the catheter containment device” lacks antecedent basis and is believed to be in error for --a catheter containment device--
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: "securement feature" in claims 1, 6, 8, 10, 16, and 18.
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.
A review of the specification shows that “securement feature” includes one of “a spring clip, butterfly clip, beret clip, alligator clip, clothes pin, safety pin, or suction cup” (¶ [0011]). Therefore, “securement feature” will be interpreted as one of a spring clip, butterfly clip, beret clip, alligator clip, clothes pin, safety pin, or suction cup.
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 § 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.
Claims 1-4, 6-7, and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lundgaard (US 2007/0142785 A1: IDS reference), as evidenced by Sivananthan (US 2022/0218952 A1).
Regarding claim 1, Lundgaard teaches (Figs. 1a-2d) a catheter containment system for retaining a portion of a catheter placement system within a sterile field (preamble, see *Note below. As evidenced by Sivananthan in ¶ [0004], ll. 5-8, “such guidewires, catheters and other tubular medical devices are prone to fall off the sterile field of a surgical table or platform”. Furthermore, Sivananthan teaches a similar device 10 that “can be attached to a support surface defined by, for example, a sterile drape” (¶ [0043], ll. 6-7)), comprising:
a containment device (10 – Figs. 2a and 2c-2d) comprising:
a body (11 – Figs. 1a-2c) defining a channel (12 – Figs. 1a-2b) extending longitudinally along a first axis (Fig. 2a: up/down along “12”), the channel (12) configured to retain the portion of the catheter placement system (¶ [0116], ll. 13-15: “such a groove 12 may serve to hold or retain elongated elements such as lines in the form of tubes, catheters, wires etc.”), and having an opening (top portion of 12, as shown in Fig. 2a) extending longitudinally and configured to allow ingress or egress along a second axis extending at an angle to the first axis of the channel (12) – (since both the channel and the opening extend longitudinally, the first axis and the second axis are the same, and the angle between them is 0); and
a securement feature (comprising 14, 16, 19, 20, 22, 24, 26, and 29 – Fig. 2c) coupled to the body (11) and configured to releasably engage a portion of the sterile field (via opening and closing of jaws 19 and 29) proximate an insertion site (of the catheter mentioned in ¶ [0116], ll. 13-15).
*Note: the recited limitation of “for retaining a portion of a catheter placement system within a sterile field” is intended use, in other words the environment in which the containment device is used, and is given little patentable weight. (see MPEP 2111.02(II)). If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999).
Regarding claim 2, Lundgaard, as evidenced by Sivananthan, teaches the invention as claimed and as discussed above for claim 1, and Lundgaard further teaches the portion of the catheter placement system includes one of a catheter body, catheter hub, extension leg, luer lock, or guidewire (¶ [0116], ll. 13-15: “such a groove 12 may serve to hold or retain elongated elements such as lines in the form of tubes, catheters, wires etc.”).
Regarding claim 3, Lundgaard, as evidenced by Sivananthan, teaches the invention as claimed and as discussed above for claim 1, and Lundgaard further teaches (Figs. 1a-2b) the body (11) includes a first channel (12 on the left) configured to retain a first extension leg (of the catheter mentioned in ¶ [0116], ll. 13-15) and a second channel (12 on the right) configured to retain a second extension leg (of the catheter mentioned in ¶ [0116], ll. 13-15).
Regarding claim 4, Lundgaard, as evidenced by Sivananthan, teaches the invention as claimed and as discussed above for claim 1, and Lundgaard further teaches (Figs. 1a-2b) the body (11) includes a first channel (12) configured to retain a first extension leg and a second extension leg (intended use – a single channel 12 is capable of retaining more than extension legs, as taught in ¶ [0116], ll. 13-15).
Regarding claim 6, Lundgaard, as evidenced by Sivananthan, teaches the invention as claimed and as discussed above for claim 1, and Lundgaard further teaches (Figs. 1a-1b) the body (11) is rotatably, hingedly or pivotably coupled to the securement feature (as shown in Figs. 1a-1b, body 11 is coupled to a hinge part 14 of the securement feature).
Regarding claim 7, Lundgaard, as evidenced by Sivananthan, teaches the invention as claimed and as discussed above for claim 1, and Lundgaard further teaches (Fig. 2c) the securement feature (comprising 14, 16, 19, 20, 22, 24, 26, and 29) includes one of a spring clip, butterfly clip, beret clip, alligator clip, clothes pin, safety pin, or suction cup (in this case, it is a spring clip due to the presence of spring 22).
Regarding claim 9, Lundgaard, as evidenced by Sivananthan, teaches the invention as claimed and as discussed above for claim 1, and Lundgaard further teaches (Fig. 2c) the securement feature (comprising 14, 16, 19, 20, 22, 24, 26, and 29) includes a first clip member (16 and 19) hingedly coupled (via hinge part 14) to a second clip member (20, 26, and 29), the first clip member (16 and 19) including a first gripping feature (jaw 19) configured to engage a second gripping feature (jaw 29) of the second clip member (20, 26, and 29) to secure the containment device (10) to the portion of the sterile field (as discussed in ¶ [0118], ll. 15-18).
Regarding claim 10, Lundgaard, as evidenced by Sivananthan, teaches the invention as claimed and as discussed above for claim 1, and Lundgaard further teaches (Fig. 2c) the securement feature (comprising 14, 16, 19, 20, 22, 24, 26, and 29) further includes a biasing member (spring 22) configured to bias the securement feature to a closed position (Fig. 2C shows a closed position), the biasing member (22) including one of a spring, compression spring, leaf spring, O-ring, rubber grommet, or magnetic element (in this case, it is a spring per ¶ [0118], l. 6).
Claim 5 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lundgaard (US 2007/0142785 A1: IDS reference), as evidenced by Sivananthan (US 2022/0218952 A1) and Teirstein (US 2010/0010475 A1: IDS reference).
Regarding claim 5, Lundgaard, as evidenced by Sivananthan, teaches the invention as claimed and as discussed above for claim 1, and Lundgaard further teaches the catheter placement system (see *Note below) includes a RICC catheter placement system for placing a rapidly insertable central catheter (¶ [0116], ll. 13-15: “such a groove 12 may serve to hold or retain elongated elements such as lines in the form of tubes, catheters, wires etc.”).
*Note: as stated in the rejection of claim 1, the “catheter placement system” was introduced in the preamble and is considered intended use, in other words the environment in which the containment device is used, and is given little patentable weight. (see MPEP 2111.02(II)). Since the catheter placement system includes the RICC, the RICC is also intended use. As evidenced by Teirstein in ¶ [0007], ll. 1-2, “The catheter prior art is replete is variations. For example, rapid exchange catheters are also used”. Furthermore, Teirstein teaches a similar device used in a method of “deploying rapid exchange catheters” (¶ [0090], ll. 6-7)).
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.
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lundgaard (US 2007/0142785 A1: IDS reference), as evidenced by Sivananthan (US 2022/0218952 A1), in view of Bell (US 6,247,211 B1).
Regarding claim 8, Lundgaard, as evidenced by Sivananthan, teaches the invention as claimed and as discussed above for claim 1, except for an anchor having a foot plate and a tab extending at an angle thereto, the foot plate include an adhesive layer and the tab configured to be engaged by the securement feature.
It is noted that Lundgaard teaches “placing the securing device 10 at an appropriate location using the clamping force of the jaws, for example on a piece of clothing or another article in the vicinity of the patient” (¶ [0118], ll. 15-18).
Bell teaches (Fig. 10) a medical tubing tethering device comprising a securement feature (clip 4), and further teaches:
an anchor (82) having a foot plate (86) and a tab (84) extending at an angle thereto, the foot plate (86) include an adhesive layer (88) and the tab (84) configured to be engaged by the securement feature (4).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Lundgaard, as evidenced by Sivananthan, by including an anchor having a foot plate and a tab extending at an angle thereto, the foot plate include an adhesive layer and the tab configured to be engaged by the securement feature, in order to facilitate attachment of Lundgaard’s containment device to virtually any desired object, as taught by Bell (col. 6, ll. 62-64).
Claims 16-17, 21, and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Lundgaard (US 2007/0142785 A1: IDS reference), in view of Sivananthan (US 2022/0218952 A1).
Regarding claim 16, Lundgaard teaches (Figs. 1a-2d) a catheter placement and containment system for placing a catheter (Abstract, l. 1) within a vasculature of a patient, comprising:
a catheter placement device, comprising:
a needle (¶ [0028], ll. 7-8: “a catheter needle”);
a catheter including an extension leg (inherent in a catheter – see also below “elongated elements”); and
a guidewire (¶ [0116], ll. 13-15: “such a groove 12 may serve to hold or retain elongated elements such as lines in the form of tubes, catheters, wires etc.”);
a catheter containment system (10 – Figs. 2a and 2c-2d), comprising:
a body (11 – Figs. 1a-2c) defining a channel (12 – Figs. 1a-2b) configured to engage a portion of the catheter placement device (as discussed in ¶ [0116], ll. 13-15); and
a securement feature (comprising 14, 16, 19, 20, 22, 24, 26, and 29 – Fig. 2c) coupled to the body (11).
However, Lundgaard does not teach a sterile drape configured to define a sterile field around the insertion site; and
the securement feature configured to secure the catheter containment system to the sterile drape.
It is noted that Lundgaard teaches “the base part may be clamped to a piece of clothing, a piece of textile etc. or another article at or near the patient” (¶ [0055]).
Sivananthan teaches (Fig. 1) a catheter placement device (50.1, 50.2, 50.3);
a sterile drape (52 – see ¶ [0043], ll. 5-8: “The device 10 can be attached to a support surface defined by, for example, a sterile drape, towel, or table, using an adhesive base 12”) configured to define a sterile field around an insertion site (58); and
a catheter containment system (10.1, 10.2, 10.3), comprising:
a securement feature (adhesive base 12) configured to secure the catheter containment system to the sterile drape (as discussed in ¶ [0043], ll. 5-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lundgaard by substituting the object to which the base part of the catheter containment device is clamped (e.g., a piece of clothing or textile) for a sterile drape, because it has been held that a simple substitution of one known element (in this case, a sterile drape, as taught by Sivananthan) for another (in this case, Lundgaard’s piece of clothing or textile) to obtain predictable results (in this case, to provide an interchangeable object to clamp the base part of Lundgaard’s catheter containment device onto), was an obvious extension of prior art teachings, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), MPEP 2143 (I) (B), therefore providing:
the securement feature (Lundgaard, comprising 14, 16, 19, 20, 22, 24, 26, and 29) configured to secure the catheter containment system (Lundgaard, 10) to the sterile drape (Sivananthan, 52).
Regarding claim 17, Lundgaard, in view of Sivananthan, teaches the invention as claimed and as discussed above for claim 16, and Lundgaard further teaches (Fig. 2c) the securement feature (comprising 14, 16, 19, 20, 22, 24, 26, and 29) includes one of a spring clip, butterfly clip, beret clip, alligator clip, clothes pin, safety pin, or suction cup (in this case, it is a spring clip due to the presence of spring 22).
Regarding claim 21, Lundgaard teaches (Figs. 1a-2d) a method of placing a catheter (Abstract, l. 1), comprising:
providing a catheter placement system including a needle (¶ [0028], ll. 7-8: “a catheter needle”), a catheter, and a guidewire (¶ [0116], ll. 13-15: “such a groove 12 may serve to hold or retain elongated elements such as lines in the form of tubes, catheters, wires etc.”);
releasably engaging a portion of the catheter placement system with the catheter containment device (10 – Figs. 2a and 2c-2d).
However, Lundgaard does not teach securing the catheter containment device with a portion of a sterile field; and
placing the catheter within a vasculature through an insertion site within the sterile field.
It is noted that Lundgaard teaches “the base part may be clamped to a piece of clothing, a piece of textile etc. or another article at or near the patient” (¶ [0055]).
Sivananthan teaches (Fig. 1) a catheter (50.1, 50.2, 50.3) and a catheter containment device (10.1, 10.2, 10.3), and further teaches:
securing (via adhesive base 12) the catheter containment device (10.1, 10.2, 10.3) with a portion of a sterile field (52 – see ¶ [0043], ll. 5-8: “The device 10 can be attached to a support surface defined by, for example, a sterile drape, towel, or table, using an adhesive base 12”); and
placing the catheter (50.1, 50.2, 50.3) within a vasculature through an insertion site (58) within the sterile field.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lundgaard by substituting the object to which the base part of the catheter containment device is clamped (e.g., a piece of clothing or textile) for a sterile drape, because it has been held that a simple substitution of one known element (in this case, a sterile drape, as taught by Sivananthan) for another (in this case, Lundgaard’s piece of clothing or textile) to obtain predictable results (in this case, to provide an interchangeable object to clamp the base part of Lundgaard’s catheter containment device onto), was an obvious extension of prior art teachings, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), MPEP 2143 (I) (B), therefore providing:
securing (via Lundgaard’s jaws 19 and 29) the catheter containment device (Lundgaard, 10) with a portion of a sterile field (Sivananthan, 52); and
placing the catheter (Lundgaard, ¶ [0116], ll. 13-15) within a vasculature through an insertion site (as taught by Sivananthan) within the sterile field (52).
Regarding claim 23, Lundgaard, in view of Sivananthan, teaches the invention as claimed and as discussed above for claim 21, and Lundgaard further teaches (Fig. 2c) the catheter containment device (10) includes one of a spring clip, butterfly clip, beret clip, alligator clip, clothes pin, safety pin, suction cup, string, cord, wire, twist tie, or zip tie (in this case, it is a spring clip due to the presence of spring 22).
Regarding claim 24, Lundgaard teaches (Figs. 1a-2d) a catheter containment device (10 – Figs. 2a and 2c-2d) for retaining a portion of a catheter placement system (preamble, see *Note below), comprising:
a body (11 – Figs. 1a-2c) defining a channel (12 – Figs. 1a-2b) extending along a longitudinal axis (Fig. 2a: up/down along “12”), the channel (12) configured to permanently retain the portion of the catheter placement system (¶ [0116], ll. 13-15: “such a groove 12 may serve to hold or retain elongated elements such as lines in the form of tubes, catheters, wires etc.”. Note that “permanently retain” is achieved by leaving the tubes, catheters, or wires in groove 12 indefinitely), and
a handle (comprising 14, 16, 19, 20, 22, 24, 26, and 29 – Fig. 2c) coupled to the body (11).
However, Lundgaard does not teach a sterile field, wherein the handle is configured to releasably engage a portion of the sterile field proximate an insertion site.
It is noted that Lundgaard teaches “the base part may be clamped to a piece of clothing, a piece of textile etc. or another article at or near the patient” (¶ [0055]).
Sivananthan teaches (Figs. 1 and 3) a similar catheter containment device (10.1, 10.2, 10.3 – Fig. 1), and further teaches:
a handle (25 – Fig. 3) is configured to releasably engage a portion of a sterile field (52 – Fig. 1, see ¶ [0043], ll. 5-8: “The device 10 can be attached to a support surface defined by, for example, a sterile drape, towel, or table, using an adhesive base 12”) proximate an insertion site (58 – Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lundgaard by substituting the object to which the base part of the catheter containment device is clamped (e.g., a piece of clothing or textile) for a sterile drape, because it has been held that a simple substitution of one known element (in this case, a sterile drape, as taught by Sivananthan) for another (in this case, Lundgaard’s piece of clothing or textile) to obtain predictable results (in this case, to provide an interchangeable object to clamp the base part of Lundgaard’s catheter containment device onto), was an obvious extension of prior art teachings, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), MPEP 2143 (I) (B), therefore providing:
the handle (Lundgaard, comprising 14, 16, 19, 20, 22, 24, 26, and 29) is configured to releasably engage (via opening and closing of jaws 19 and 29) a portion of a sterile field (Sivananthan, 52) proximate an insertion site (of Lundgaard’s catheter mentioned in ¶ [0116], ll. 13-15).
*Note: the recited limitation of “for retaining a portion of a catheter placement system” is intended use, in other words the environment in which the catheter containment device is used, and is given little patentable weight. (see MPEP 2111.02(II)). If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999).
Regarding claim 25, Lundgaard, in view of Sivananthan, teaches the invention as claimed and as discussed above for claim 24, and Lundgaard further teaches (Figs. 1a-2b) the portion of the catheter placement system includes a proximal end of a guidewire permanently affixed to the body (11) – (¶ [0116], ll. 13-15: “such a groove 12 may serve to hold or retain elongated elements such as lines in the form of tubes, catheters, wires etc.”. Note that “permanently affixed” is achieved by leaving the wires in groove 12 indefinitely).
Regarding claim 26, Lundgaard, in view of Sivananthan, teaches the invention as claimed and as discussed above for claim 24, and Lundgaard further teaches (Figs. 1a-2b) the portion of the catheter placement system includes a proximal portion of a guidewire slidably engaged with the body (11) – (¶ [0116], ll. 13-15: “such a groove 12 may serve to hold or retain elongated elements such as lines in the form of tubes, catheters, wires etc.”. Note that the shape of groove 12 enables the wires to “slidably engage” with body 11).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Lundgaard (US 2007/0142785 A1: IDS reference), in view of Sivananthan (US 2022/0218952 A1), and in further view of Bell (US 6,247,211 B1).
Regarding claim 18, Lundgaard, in view of Sivananthan, teaches the invention as claimed and as discussed above for claim 16, except for an anchor having a foot plate and a tab extending at an angle thereto, the foot plate include an adhesive layer and the tab configured to be engaged by the securement feature.
It is noted that Lundgaard teaches “placing the securing device 10 at an appropriate location using the clamping force of the jaws, for example on a piece of clothing or another article in the vicinity of the patient” (¶ [0118], ll. 15-18).
Bell teaches (Fig. 10) a medical tubing tethering device comprising a securement feature (clip 4), and further teaches:
an anchor (82) having a foot plate (86) and a tab (84) extending at an angle thereto, the foot plate (86) include an adhesive layer (88) and the tab (84) configured to be engaged by the securement feature (4).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Lundgaard, in view of Sivananthan, by including an anchor having a foot plate and a tab extending at an angle thereto, the foot plate include an adhesive layer and the tab configured to be engaged by the securement feature, in order to facilitate attachment of Lundgaard’s containment device to virtually any desired object, as taught by Bell (col. 6, ll. 62-64).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure: see also attached form PTO-892 “Notice of References Cited”.
Florence (US 2017/0087296 A1): Figs. 1-6 teaches a similar containment device (10 – Fig. 1) comprising a body (26 – Fig. 2) defining channels (36 – Fig. 2) configured to receive tubes (28 – Fig. 5) of a catheter placement system, and a securement feature comprising spring clips (52 – Fig. 4)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY NG whose telephone number is (571)272-2318. The examiner can normally be reached M-F 9:30 AM - 6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at 571-272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY NG/Examiner, Art Unit 3741 /DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741