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 04/02/2026.
Election/Restrictions
Applicant’s election without traverse of Species VI: Figs. 7A-7E in the reply filed on April 2, 2026 is acknowledged. Applicant’s election withdraws claims 1-10 from further consideration. Claims 11-20 are pending and examined.
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: "snap feature" in claims 11-12, 14, 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.
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 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dorr (US 4,627,841).
Regarding claim 11, Dorr teaches (Figs. 1-4) a catheter system (10 – Fig. 1), comprising:
a catheter hub (11 and 12), comprising a distal end (left end where 11 is located), a proximal end (right end where 12 is located), a lumen (as evidenced in Fig. 4 by catheter 17 extending through hubs 11 and 12) extending through the distal end (11) and the proximal end (12), and a snap feature (Figs. 1 and 4: grooves between 11 and 12. Fig. 4: the snap feature is shown by wedges 23 being forced into the grooves between hubs 11 and 12 – see col. 2, ll. 56-58);
a first wing (one of the two wings 21) extending from the catheter hub (11, 12);
a second wing (the other of the two wings 21) opposite the first wing (21) and extending from the catheter hub (11, 12), wherein the first wing and the second wing (21) are movable between a collapsed position (Fig. 1) and a folded position (Figs. 2-4), wherein in the folded position (Figs. 2-4), the first wing and the second wing (21) are configured to snap (via wedges 23) to the snap feature (grooves b/t 11 and 12) to secure the first wing and the second wing (21) in the folded position (Figs. 2-4); and
a catheter (17 – Figs. 1 and 4) extending from the distal end (11) of the catheter hub (11, 12) – (as shown in Figs. 1-2).
Regarding claim 12, Dorr teaches the invention as claimed and as discussed above for claim 11, and Dorr further teaches (Fig. 1) the snap feature (grooves b/t 11 and 12) is disposed on a top (where spring 13 is located) of the catheter hub (11, 12) between the first wing (21) and the second wing (21) – (as shown in Fig. 1, the grooves are found on the top surface of hub 11, 12).
Regarding claim 13, Dorr teaches the invention as claimed and as discussed above for claim 11, and Dorr further teaches (Fig. 2) the first wing (21) comprises a fold line and the second wing (21) comprises a fold line, wherein the first wing (21) is folded at the fold line of the first wing (21) and the second wing (21) is folded at the fold line of the second wing (21) in the folded position (Fig. 2) – (see annotated Fig. 2 on next page for the fold line).
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Regarding claim 14, Dorr teaches the invention as claimed and as discussed above for claim 13, and Dorr further teaches (Figs. 1 and 3) in the collapsed position (Fig. 1), the first wing (21) comprises a first portion (winged portion 21) extending outwardly from the catheter hub (11, 12) and the second wing (21) comprises a first portion (winged portion 21) extending outwardly from the catheter hub (11, 12), wherein the first portion of the first wing and the first portion of the second wing (winged portions 21 of both wings 21) are configured to rest on skin of a patient (col. 2, l. 68 – col. 3, l. 3), wherein in the collapsed position (Fig. 3), the first wing (21) further comprises a second portion (23) extending upwardly (Fig. 3 shows wedge 23 extending in the up direction) from the first portion of the first wing (21) and the second wing comprises a second portion (23) extending upwardly from the first portion of the second wing (21), wherein the second portion (23) of the first wing (21) and the second portion (23) of the second wing (21) are configured to snap to the snap feature (grooves b/t 11 and 12) in the folded position (Fig. 3).
Claims 11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reiterman (US 3,670,727).
Regarding claim 11, Reiterman teaches (Fig. 7) a catheter system, comprising:
a catheter hub (4), comprising a distal end (left end of 4), a proximal end (right end of 4), a lumen (as evidenced by catheter 1 extending through hub 4) extending through the distal end and the proximal end, and a snap feature (ribs 25, 26, and 27 – see col. 3, ll. 37-39);
a first wing (20) extending from the catheter hub (4);
a second wing (21) opposite the first wing (20) and extending from the catheter hub (4), wherein the first wing (20) and the second wing (21) are movable between a collapsed position (Fig. 7) and a folded position (Fig. 8), wherein in the folded position (Fig. 8), the first wing (20) and the second wing (21) are configured to snap (via grooves b/t adjacent ribs 25, 26, and 27) to the snap feature (ribs 25, 26, and 27) to secure the first wing (20) and the second wing (21) in the folded position (Fig. 8); and
a catheter (1) extending from the distal end (left end of 4) of the catheter hub (4).
Regarding claim 15, Reiterman teaches the invention as claimed and as discussed above for claim 11, and Reiterman further teaches (Fig. 7) the snap feature (25, 26, 27) comprises a first ridge (25, 26) and a second ridge (27) opposing the first ridge (25, 26), wherein the first wing (20) comprises a groove (between adjacent ribs 27) configured to snap to the first ridge (25, 26) and the second wing (21) comprises a groove (between adjacent ribs 25, 26) configured to snap to the second ridge (27).
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.
Claims 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Natesan (US 2021/0060307 A1: IDS reference), in view of Dorr (US 4,627,841).
Regarding claim 11, Natesan teaches (Fig. 2D) a catheter system, comprising:
a catheter hub (12), comprising a distal end (left end of 12), a proximal end (right end of 12), a lumen (as evidenced in Fig. 2F by catheter 14 extending through hub 12) extending through the distal end and the proximal end,
a first wing (one of the two wings 18) extending from the catheter hub (12);
a second wing (the other of the two wings 18) opposite the first wing (18) and extending from the catheter hub (12), wherein the first wing and the second wing (18) are movable between a collapsed position (shown in Figs. 2B-2C) and a folded position (Figs. 2D); and
a catheter (14) extending from the distal end (left end of 12) of the catheter hub (12) – (as shown in Fig. 2D).
However, Natesan does not teach a snap feature;
wherein in the folded position, the first wing and the second wing are configured to snap to the snap feature.
Dorr teaches (Figs. 1-4) a similar catheter system (10 – Fig. 1), comprising:
a catheter hub (11 and 12), comprising a distal end (left end where 11 is located), a proximal end (right end where 12 is located), a lumen (as evidenced in Fig. 4 by catheter 17 extending through hubs 11 and 12) extending through the distal end (11) and the proximal end (12), and a snap feature (Figs. 1 and 4: grooves between 11 and 12. Fig. 4: the snap feature is shown by wedges 23 being forced into the grooves between hubs 11 and 12 – see col. 2, ll. 56-58);
a first wing (one of the two wings 21) extending from the catheter hub (11, 12);
a second wing (the other of the two wings 21) opposite the first wing (21) and extending from the catheter hub (11, 12), wherein the first wing and the second wing (21) are movable between a collapsed position (Fig. 1) and a folded position (Figs. 2-4), wherein in the folded position (Figs. 2-4), the first wing and the second wing (21) are configured to snap (via wedges 23) to the snap feature (grooves b/t 11 and 12) to secure the first wing and the second wing (21) in the folded position (Figs. 2-4).
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 Natesan by including a snap feature such that, in the folded position, the first wing and the second wing are configured to snap to the snap feature, in order to secure the wings to the catheter hub such that no relative movement of these elements occurs, as taught by Dorr (col. 2, ll. 58-60).
Regarding claim 20, Natesan, in view of Dorr, teaches the invention as claimed and as discussed above for claim 11, and Natesan further teaches (Fig. 2F) a needle hub (26) coupled to the proximal end (Fig. 2F: left end of 12) of the catheter hub (12); and an introducer needle (28) extending distally (Fig. 2F: right direction) from the needle hub (26) through the catheter (14).
Allowable Subject Matter
Claims 16-19 are 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 dependent claim 16, prior art does not teach that the first ridge and the second ridge are disposed on a top of the catheter hub. As shown in Fig. 1 of Dorr, the top of catheter hub 11, 12 comprises grooves, not ridges. Instead, the ridges (wedges 23) are disposed on wings 21. As shown in Fig. 7 of Reiterman, the top of catheter hub 4 does not comprise ridges. Instead, the ridges (ribs 25, 26, 27) are disposed on the wings 20, 21.
Regarding dependent claim 17, neither Dorr nor Reiterman teaches a second fold line on each of the two wings. As shown in Dorr and Reiterman, each of the wings comprises only one fold line, not two. This is shown in the folded positions of the wings in Dorr (Fig. 2) and Reiterman (Fig. 8).
Dependent claims 18-19 are allowed by virtue of dependence upon allowable claim 17.
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.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure: see attached form PTO-892 “Notice of References Cited”.
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/Examiner, Art Unit 3741 /DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741
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