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 .
Election/Restrictions
Applicant’s election with traverse of Claims 1-7 and 10-14 in the reply filed on July 22nd, 2026, is acknowledged.
Applicant argues that the species restriction does not encompass undue search burden (see Applicant remarks filed July 22nd, 2026).
This is not found persuasive because, as stated in the requirement for election/restriction mailed on May 27th, 2026, there is a burden due to searches required by Species IV-VIII as follows:
Species IV-VI require unique text searches for hinge and outer protrusion that form a snap-fit of the label plate.
Species VII-VIII require investigation into CPC areas related to guidewire insertions not covered by catheter connectors/hubs.
Claims 8-10 are also withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 22nd, 2026.
Claims 1-7 and 11-14 are being examined in this application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “outer shell surface” in claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 4 are objected to because of the following informalities: typographical errors.
Claim 1 recites “configured to be mounted around outer shell surface”. Examiner recommends amending the claim to read “configured to be mounted around an outer shell surface”.
Claim 4 recites “at least one plate-like connecting web the at least one first plate-like leg”. Examiner recommends amending the claim to read “at least one plate-like web connecting the at least one first plate-like leg” for grammatical reasons and to align with the language set forth in the specification in at least [0040] of the current Application’s PG Publication.
Appropriate correction is required.
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 1-7 and 11-12 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.
Claim 1 recites “outer shell surface of the catheter connector” and an “outer surface of at least a section of the catheter connector” rendering the claim indefinite because it is unclear whether the “outer shell surface” and the “outer surface” are referring to the same structural component of the catheter connector.
Claim 6 recites “a writable or printable material located at the upper side”. There is insufficient antecedent basis for this limitation in the claim.
All remaining claims are also rejected as they depend from rejected independent claims.
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: “appendage providing a secondary function” in claim 7.
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
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 1-7 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schweikert et al. (US 20080051731 A1, herein, Schweikert).
Regarding claim 1, Schweikert discloses a label plate for a catheter connector (“information-bearing articles or devices applicable to flexible tubing, particularly to medical tubing such as catheters”, see para [0009]) comprising a label plate (indicia-bearing device 10 – Fig.1) body configured to be mounted around outer shell surface of the catheter connector (“the device is securable directly to and around the flexible tubing and/or to a clamp member that itself is securable directly to and around the flexible tubing”, see para [0009]), wherein a shape of an inner surface of at least a segment of the label plate body corresponds to a shape of an outer surface of at least a section of the catheter connector (“the device is so shaped and dimensioned to at least partially conform to and to be positioned along one or more outer surfaces of the clamp member”, see para [0011]).
Regarding claim 2, Schweikert discloses the label plate of claim 1, wherein the label plate body (indicia-bearing device 10 – Fig.1) comprises an intermediate space (clearance 24 – Fig.1) configured for exposure of a central portion of the connector (see annotated Fig.2).
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Regarding claim 3, Schweikert discloses the label plate of claim 2, wherein the label plate body (indicia-bearing device 10 – Fig.1) comprises a U-shape and the intermediate space is defined in a middle of the U-shape (“separated by a clearance 24 that each include a C-shaped channel 18,20 extending therethrough”, see para [0038], intermediate space in annotated Fig.2).
Regarding claim 4, Schweikert discloses the label plate according to claim 3, wherein the U-shape (C-shaped channel 18,20 – Fig.1) comprises at least one first plate-like leg, at least one second plate-like leg (side walls 30,32 – Fig.1), and at least one plate-like connecting web (body 12 – Fig.1) the at least one first plate-like leg and the at least one second plate-like leg (“a pair of side walls 30,32, one on either side of the device and that are joined by the device body 12”, see para [0037]).
Regarding claim 5, Schweikert discloses the label plate according to claim 1, wherein the label plate body (indicia-bearing device 10 – Fig.1) is configured to define a form-fitting connection, a force-fitting connection and/or a firmly bonded connection with the catheter connector (“device is so shaped and dimensioned to at least partially conform to and to be positioned along one or more outer surfaces of the clamp member and includes a connection section that self-secures or clips to portions of the framework of the clamp member”, see para [0011]).
Regarding claim 6, Schweikert discloses the label plate according to claim 1, comprising a writable or printable material located at the upper side or outer surface of the label plate body (“each inventive device has at least one outwardly facing surface sufficiently large to contain easily readable indicia or information with”, see para [0009]).
Regarding claim 7, Schweikert discloses the label plate according to claim 1, wherein the label plate body (indicia-bearing device 10 – Fig.1) comprises an appendage providing a secondary function (under broadest reasonable interpretation, examiner interprets appendage to be a smaller extension/secondary part attached to a larger main structure hence, a latching arm connected to the device body (“the end of the arm 46 latching to the clamp body at latch 48 to hold it in the clamping state”, see para 0037, Fig.2)).
Regarding claim 12, Schweikert discloses a catheter system, comprising a catheter connector and a label plate (indicia-bearing device 10 – Fig.1) according to claim 1, as recited above.
Regarding claim 13, Schweikert discloses a catheter system comprising a catheter having an elongated, flexible shaft (flexible tubing 38 – Fig.2) and a catheter connector (“the device is securable directly to and around the flexible tubing and/or to a clamp member that itself is securable directly to and around the flexible tubing”, see para [0009]) at the proximal end of the shaft, wherein the system further comprises a label plate (indicia-bearing device 10 – Fig.1) according to claim 1, the label plate being mounted around the catheter connector.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Schweikert in view Powell (US 20090264866 A1, herein, Powell).
Regarding claim 11, Schweikert discloses the label plate according to claim 1, as recited above.
Schweikert does not appear to expressly disclose an RFID tag embedded within the label plate body.
Powell teaches an RFID tag (RFID chip 38 – Fig.4) embedded within the label plate body (“as an alternative to the visual display of information on the hub, an RFID (radio frequency identification) microchip may disposed in the hub”, see para [0022]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Schweikert so the label plate body comprises an RFID tag embedded within as taught by Powell to further provide “much more information about the catheter than could be legibly printed on the surface of the hub and can be easily read by an electronic device and displayed” (Powell para [0019]).
Claim 14 are rejected under 35 U.S.C. 103 as being unpatentable over Schweikert.
Regarding claim 14, the embodiments of Schweikert as depicted in Figs. 1-12 discloses the system of claim 13, as recited above.
The embodiments do not appear to expressly disclose wherein the catheter connector is a Luer connector.
However, the embodiments of Schweikert as depicted in Figs. 14-16 disclose wherein the catheter connector is a Luer connector (“a luer connector (on the left) and a catheter hub (on the right) that joins the extension tube to a catheter”, see para [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the catheter connector disclosed in Schweikert (embodiments depicted in Figs.1-12) with a Luer connector taught by Schweikert (embodiments depicted in Figs. 14-16). A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (catheter connector) for another known element (luer connector) in the art to obtain the predictable result of forming a connector for the catheter (see MPEP § 2143.I.B), thus achieving a catheter hub for the label plate to mount on.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAGWA M ABU-DAYEH whose telephone number is (571)270-0389. The examiner can normally be reached 8am-5pm.
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, CHELSEA STINSON can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.A./Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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