FINAL 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 second office action on the merits. This office action is in response to the amendment filed on 05/26/2026. Applicant has amended claims 1-6, 9-10, 16-18, 21, and 24-26 and canceled claims 8, 11-15, 19-20, and 22. Claims 1-7, 9-10, 16-18, 21, and 23-26 are pending and examined.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: "220" (see paragraphs [0071], [0073], and [0074] of specification. Note that Fig. 11 shows ref. nos. "220A", "220B", "220C", and "220D", which are not the same as "220").
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. 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 and 9 are objected to because of the following informalities:
Claim 1, line 5: “a portion of the catheter” is believed to be in error for --the portion of the catheter-- (see claim 1, lines 1-2)
Claim 9, lines 3-4: “a first gripping feature the second clip member…” is believed to be in error for --a first gripping feature, the second clip member…-- (note the addition of a comma)
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, and 16
“biasing member” in claim 9
“catheter containment device” in claim 21.
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 § 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 21 is rejected under 35 U.S.C. 103 as being unpatentable over Fenton, Jr. (US 4,769,010), in view of and as evidenced by Sivananthan (US 2022/0218952 A1).
Regarding claim 21, Fenton, Jr. teaches (Figs. 1-3) a method of placing a catheter (see annotated Fig. 1 on next page), comprising:
providing a catheter placement system including a needle (12 – Fig. 1), the catheter (see annotated Fig. 1 on next page), and a guidewire (as evidenced by Sivananthan in ¶ [0003], ll. 14-17, “Tubular medical devices, such as catheters or cannulas, are used with guidewires by introducing a guidewire into a body, such as through a sharp hollow needle”);
releasably engaging a portion of the catheter placement system (12) with a catheter containment device (30) – (col. 3, ll. 27-29);
transitioning an anchor (comprising 32 and 34 – Fig. 1. Note that 32 comprises portions 38 and 42, and 34 comprises portions 48 and 52) from a substantially flat configuration (as shown by the position of 38, 42, 48, and 52 in Fig. 2) to an extended configuration (as shown by the position of 38, 42, 48, and 52 in Fig. 3) by changing position of a first foot plate (42) relative to a second foot plate (52) of the anchor (32, 34) – (the distances between 42 and 52 differ between Fig. 2 and Fig. 3, as shown by distance D1 in Fig. 2 and distance D2 in Fig. 3); and
securing the catheter containment device (30) with the anchor (32, 34) – (as shown in Figs. 1-3).
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However, Fenton, Jr. does not teach that the anchor is adhered to 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 Fenton, Jr. teaches “portions 42 and 52 may be affixed to the skin, for example, by means of tape, or by the use of an adhesive layer on the underside of portions 42 and 52” (col. 4, ll. 18-20).
Sivananthan teaches (Figs. 1 and 3) a catheter (50.1, 50.2, 50.3 – Fig. 1) and a catheter containment device (10.1, 10.2, 10.3 – Fig. 1), and further teaches:
securing (via adhesive layer 24 – Fig. 3) the catheter containment device (10.1, 10.2, 10.3) with an anchor (base 12 acts as an anchor – Fig. 3) that is adhered to 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 Fenton, Jr. by substituting the object to which the anchor is adhered (e.g., skin) 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, the example of skin, as taught by Fenton, Jr.) to obtain predictable results (in this case, to provide an interchangeable object to adhere Fenton Jr.’s anchor 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 the catheter containment device (Fenton, Jr., 30) with the anchor (Fenton, Jr., 32, 34) that is adhered to a portion of a sterile field (Sivananthan, 52); and
placing the catheter (Fenton, Jr., see annotated Fig. 1 on previous page) within a vasculature through an insertion site (as taught by Sivananthan) within the sterile field (52).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Fenton, Jr. (US 4,769,010), in view of and as evidenced by Sivananthan (US 2022/0218952 A1), and in further view of East (US 2022/0241559 A1).
Regarding claim 23, Fenton, Jr., in view of and as evidenced by Sivananthan, teaches the invention as claimed and as discussed above for claim 21, except for the catheter containment device 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.
East teaches (Figs. 27-29) a method of placing a catheter (10 – Fig. 29), comprising a catheter containment device (700) that 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 (Figs. 27-29 show a spring clip 700 comprising of a biasing member 732 that can be a torsion spring – see ¶ [0107], l. 12).
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 Fenton, Jr., in view of and as evidenced by Sivananthan, by replacing the existing catheter containment device with another such device that 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, a spring clip), in order to allow the catheter containment device to have an open configuration where the catheter can be placed, and a closed configuration where the catheter is enclosed and retained within the bore of the catheter containment device, as taught by East (¶ [0106], ll. 6-11).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Lundgaard (US 2007/0142785 A1: IDS reference), in view of and as evidenced by Sivananthan (US 2022/0218952 A1) and in view of Wine (US 2023/0211071 A1).
Regarding claim 24, Lundgaard teaches (Figs. 1a-2d) a catheter containment system, comprising:
a catheter placement device including a catheter defining a catheter lumen, and a guidewire slidably engaged with the catheter lumen (¶ [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 a catheter inherently comprises a lumen), a proximal end of the guidewire disposed proximally of a proximal end of the catheter lumen (as evidenced by Sivananthan in ¶ [0003], ll. 14-17, “Tubular medical devices, such as catheters or cannulas, are used with guidewires by introducing a guidewire into a body, such as through a sharp hollow needle”. Note that Fig. 1 shows a curved path 56 of a “guidewire and/or tubular medical device” – ¶ [0049], ll. 17-18); and
a catheter containment device (10 – Figs. 2a and 2c-2d), comprising:
a body (11 – Figs. 1a-2c) affixed to the proximal end of the 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.”); 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).
However, Lundgaard, in view of and as evidenced by Sivananthan, does not teach that the body is permanently affixed to the proximal end of the guidewire to prevent the proximal end of the guidewire from entering the proximal end of the catheter lumen.
Wine teaches (Fig. 6) a catheter containment device (1100), comprising:
a body (1102) permanently affixed to the proximal end of a guidewire (16) – (¶ [0077], ll. 5-10: “the tubing anchor 1100 can be affixed to the tubing 16 by adhering the tubing anchor 1100 and tubing 16 together, such as by an adhesive or weld between an outer surface of the tubing 16 and the inner surface that forms a tubing passage 1104”. Note that an adhesive or weld provides permanent affixing).
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, in view of and as evidenced by Sivananthan, by permanently affixing the body to the proximal end of the guidewire, in order to resist movement of the body along the guidewire, as taught by Wine (¶ [0077], ll. 4-5), therefore providing:
the body (Lundgaard, 11) permanently affixed (per Wine’s teaching) to the proximal end of a guidewire (discussed in ¶ [0116], ll. 13-15 of Lundgaard) to prevent the proximal end of the guidewire from entering the proximal end of the catheter lumen (desired result – see below).
The limitation “to prevent the proximal end of the guidewire from entering the proximal end of the catheter lumen” is a statement of desired result and the structure of the device as taught by Lundgaard, in view of and as evidenced by Sivananthan and in view of Wine, can achieve the desired result. It has been held that “While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function”, In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959); “[A]pparatus claims cover what a device is, not what a device does” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), MPEP 2114 (I). “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977), MPEP 2112.01.
Regarding claim 25, Lundgaard, in view of and as evidenced by Sivananthan and in view of Wine, teaches the invention as claimed and as discussed above for claim 24, and Lundgaard further teaches (Fig. 2c) the handle (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, 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).
Allowable Subject Matter
Claims 1-7, 9-10, and 16-18 are allowed, provided that the claims are rewritten to overcome the claim objections listed above.
Claim 26 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance:
Regarding independent claims 1 and 16 and dependent claim 26, the prior art of record does not teach, in combination with the other limitations of each respective claim, “a containment device comprising: a securement feature coupled to the body; and an anchor having a first foot plate including a first adhesive surface and coupled to a first tab along a first fold line, a second foot plate including a second adhesive surface coupled to a second tab along a second fold line, the first tab and the second tab coupled along a third fold line”.
The closest prior art references that could be found for the limitations of independent claims 1 and 16 and dependent claim 26 are Lundgaard (US 2007/0142785 A1) and Bell (US 6,247,211 B1).
As stated in the prior office action, Lundgaard teaches (Figs. 1a-2d) a containment device (10) comprising a body (11) defining a channel (12) configured to retain a portion of the catheter, and a securement feature (below body 11 in Fig. 2c) coupled to the body (11). Lundgaard does not teach that the containment device comprises an anchor. Bell teaches (Fig. 10) a securement feature (clip 4), and an anchor (82). While the anchor (82) comprises a first foot plate and a second foot plate (two “86” are shown), the anchor (82) does not comprise a first tab and a second tab coupled along a third fold line. As shown in Fig. 10 of Bell, there is only one attachment tab (84). The attachment tab (84) does not comprise a first tab and a second tab coupled along a third fold line.
Additionally, the claim 1 limitation “to transition the first tab and the second tab between a first position extending substantially parallel to the sterile field and a second position where the first tab and the second tab extend at an angle to the surface of the sterile field” and the claim 16 limitation “to transition the first tab and the second tab between a flat configuration and an extended configuration” are supported by paragraphs [0095] and [0096] and Figs. 7A-7C of the disclosure.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments regarding the new limitations in claims 21 and 24 have been considered but are moot in view of the new ground(s) of rejection, necessitated by Applicant's amendments. To the extent possible, Applicant's arguments have been addressed in the body of the rejections at the appropriate locations.
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 HENRY NG whose telephone number is (571)272-2318. The examiner can normally be reached M-F 9:30 AM - 6:30 PM.
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, 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/ /GERALD L SUNG/ Primary Examiner, Art Unit 3741 Examiner, Art Unit 3741
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