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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
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 feature “the pinch valve body” having “a distal end sheathed over the catheter tube” and “spring-loaded plunger” must be shown or the feature canceled from the claims. No new matter should be entered.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show “spring-loaded plunger 54” as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
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, Hiejima discloses 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 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:
“trigger mechanism configured to: trigger the needle withdrawal mechanism to fully proximally withdraw the needle into the needle enclosure, and disconnect the automatic needle withdrawal device from the catheter hub after the needle is fully proximally withdrawn into the needle enclosure; and before the needle is fully proximally withdrawn into the needle enclosure, prevent either: the needle being withdrawn inadvertently or prematurely; or the automatic needle withdrawal device being disconnected from the catheter hub inadvertently or prematurely.” in claim 14.
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 § 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.
Claim 16 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 16, the limitation “the leaf spring arm” lacks antecedent basis in the claim.
For the purpose of examination, this limitation will be interpreted to mean “the spring arm”.
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, 3, 9, 13 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hiejima et al (U.S. Pat. 7,347,839, hereinafter “Hiejima”).
Regarding claim 1, Hiejima discloses an assembly, comprising:
a catheter hub 2 (see Fig. 11) defining a hub cavity extending axially between proximal and distal ends of the catheter hub (see Fig. 11 showing the hub cavity inside which is placed the catheter 1, valve body 3 and optionally connector 21);
a female luer connector (at portion 9; although Hiejima does not explicitly refer to this connector as a luer connector, a skilled artisan would recognize it to be a luer slip connector) extending from within the proximal end of the catheter hub;
a catheter tube 1 (see Fig. 16) extending from within the distal end of the catheter hub;
and a pinch valve body 3 (see Fig. 11) axially movable in the hub cavity (see movement depicted in Figs. 11 and 12) and defining a valve conduit (the interior of the valve through which a needle 4 can be placed) that fluidly connects the female luer connector and the catheter tube;
wherein the pinch valve body has a distal end sheathed over the catheter tube (see Fig. 11; the distal end is adjacent to an adhesive 8), and a proximal end comprising proximal and distal pinch valves (see annotated Fig. 11, below);
wherein the female luer connector has internal pinch surfaces (see annotated Fig. 11, below) configured so that axial movement of the pinch valve body in the hub cavity positively opens and closes the proximal and distal pinch valves in predetermined succession or order as either a needle is proximally withdrawn from the catheter tube, or a male luer connector is distally inserted into, or proximally withdrawn from, the female luer connector (as the needle is inserted, as shown in Fig. 11, the two pinch valves abut the pinch surfaces to cause the valves to open; and upon withdrawal of the needle, the valves close again, as shown in Fig. 12; this action is also illustrated in Figs. 15-16, where a male luer connector 21 is used instead of a needle).
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Hiejima, Fig. 11, annotated.
Regarding claim 3, Hiejima discloses assembly of claim 1, wherein the proximal and distal pinch valves are closed initially (see Fig. 12), and a needle is pre-inserted in the catheter hub with a proximal portion in the valve conduit of the pinch valve body and a distal portion in the catheter tube (the configuration shown in Fig. 11, where the needle has been inserted).
Regarding claim 9, Hiejima discloses assembly of claim 8, wherein:
the catheter hub has an inwardly projecting tube portion at the distal end of the catheter hub (i.e., the portion that forms the pinch surface);
the catheter tube extends distally from within the inwardly projecting tube portion (see Fig. 11, showing the catheter tube extending out of the distal end of the portion that forms the pinch surface);
and the pinch valve body is axially movable on the inwardly projecting tube portion (see Figs. 11-12, showing the movement of the pinch valve body along the tube portion where the pinch surface is located).
Regarding claim 13, Hiejima discloses assembly of claim 12, wherein the manual needle withdrawal device comprises a flashback chamber 6 (see Fig. 12) configured to allow visualisation of an initial flow of blood upon insertion of a distal tip of the needle into a vein.
Regarding claim 18. Hiejima discloses a method, comprising:
providing a needle 4 (see Fig. 11) inside a catheter tube 1 (see Fig. 11) at a distal end of a catheter hub 2 (see Fig. 11) having a female luer connector at a proximal end (at portion 9; although Hiejima does not explicitly refer to this connector as a luer connector, a skilled artisan would recognize it to be a luer slip connector), wherein the catheter tube and female luer connector are fluidly connected by a pinch valve body 3 (see Fig. 11) that is proximally movable inside a hub cavity of the catheter hub (see movement depicted in Figs. 11 and 12), and wherein the pinch valve body has a distal end sheathed over the catheter tube (see Fig. 11; the distal end is adjacent to an adhesive 8), and a proximal end comprising proximal and distal pinch valves (see annotated Fig. 11, above) configured to be closed in succession by internal pinch surfaces of the female catheter connector by proximal movement of the pinch valve body (as the needle is inserted, as shown in Fig. 11, the two pinch valves abut the pinch surfaces to cause the valves to open; and upon withdrawal of the needle, the valves close again, as shown in Fig. 12; this action is also illustrated in Figs. 15-16, where a male luer connector 21 is used instead of a needle);
proximally withdrawing the needle from the catheter tube to proximally move the pinch valve body and closing the proximal and distal pinch valves in succession upon full proximal withdrawal of the needle from the catheter hub (see the movement of the needle depicted in Figs. 11 and 12; as the needle is withdrawn, the first valve would expectedly close before the second valve closes, as force is off-loaded from the first valve).
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.
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hiejima in view of Teoh (U.S. Pub. 2011/0319820 A1, hereinafter “Teoh”).
Regarding claim 12, Hiejima discloses assembly of claim 1, further comprising a manual needle withdrawal device 5 (needle hub, used to withdraw the needle) removably connected to the female luer connector of the catheter hub, wherein the manual needle withdrawal device has a low form factor (as shown in the various figures) and it is configured so that disconnection from the catheter hub manually distally withdraws the needle from the catheter hub, but does not appear to disclose that it automatically applies a safety clip to the distal tip of the needle when fully distally withdrawn from the catheter hub.
Teoh discloses a manual needle withdrawal device for a male-female connector, which is configured to automatically apply a safety clip 130 (see Fig. 1B) to the distal tip 116 (see Fig. 1B) of the needle when fully distally withdrawn from a catheter hub 106 (see Fig. 1B).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hiejima, so that its manual needle withdrawal device is configured to automatically apply a safety clip to the distal tip of the needle when fully distally withdrawn from the catheter hub, in order to protect the user from accidental needle sticks, with a reasonable expectation of success (see Teoh at para [0027]).
Regarding claim 14, Hiejima discloses assembly of claim 1, further comprising an automatic needle withdrawal device removably connected to the female luer connector of the catheter hub, wherein the automatic needle withdrawal device comprises:
a flashback chamber 6 (see Fig. 10) configured to allow visualisation of an initial flow of blood upon insertion of a distal tip of the needle into a vein, but does not appear to disclose:
a needle enclosure configured to enclose the needle when fully distally withdrawn from the catheter hub;
a needle withdrawal mechanism configured to be triggered to automatically distally withdraw the needle from the catheter hub and move the needle to the needle enclosure when fully distally withdrawn from the catheter hub;
and a trigger mechanism configured to: trigger the needle withdrawal mechanism to fully proximally withdraw the needle into the needle enclosure, and disconnect the automatic needle withdrawal device from the catheter hub after the needle is fully proximally withdrawn into the needle enclosure;
and before the needle is fully proximally withdrawn into the needle enclosure, prevent either: the needle being withdrawn inadvertently or prematurely;
or the automatic needle withdrawal device being disconnected from the catheter hub inadvertently or prematurely.
Teoh discloses a needle enclosure 130 (see Fig. 1B) configured to enclose the needle when fully distally withdrawn from the catheter hub;
a needle withdrawal mechanism configured to be triggered to automatically distally withdraw the needle from the catheter hub and move the needle to the needle enclosure when fully distally withdrawn from the catheter hub;
and a trigger mechanism configured to: trigger the needle withdrawal mechanism to fully proximally withdraw the needle into the needle enclosure, and disconnect the automatic needle withdrawal device from the catheter hub after the needle is fully proximally withdrawn into the needle enclosure (see para [0027] disclosing that the needle withdrawal mechanism is described in U.S. Pat. 6,117,108, which shows a needle guard having a pointed end 46 that mates with a groove 48 in the hub chamber, in order to keep the needle guard in place until the needle can be fully retracted from the catheter hub);
and before the needle is fully proximally withdrawn into the needle enclosure, prevent either: the needle being withdrawn inadvertently or prematurely, or the automatic needle withdrawal device being disconnected from the catheter hub inadvertently or prematurely (see U.S. Pat. 6,117,108, col. 6, lines 41-55).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hiejima in the manner described above with respect to claim 14, in order to prevent accidental contact with the needle, thus improving safety by preventing accidental needle sticks, with a reasonable expectation of success.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hiejima, in view of Teoh, further in view of Shaw et al (U.S. Pat. 5,989,220 A, hereinafter “Shaw”).
Regarding claim 15, Hiejima discloses assembly of claim 14, but does not appear to disclose that the needle withdrawal mechanism comprises a spring-loaded plunger arranged inside the needle enclosure, wherein the spring-loaded plunger is configured to mount to a proximal end of the needle and is spring-biased to proximally withdraw the needle into the needle enclosure.
Further, Hiejima does not appear to disclose the limitations of claims 16 and 17:
wherein the trigger mechanism comprises a spring arm integrally formed on a distal end of the automatic needle withdrawal device, and wherein the leaf spring arm is configured to be activated automatically upon proximal withdrawal of the needle enclosure from the catheter hub to trigger automatic proximal withdrawal of the needle (claim 16); and
the trigger mechanism comprises a non-integrally formed spring-loaded reciprocating arm arranged between a distal end of the automatic needle withdrawal device and the proximal end of the catheter hub, wherein the spring-loaded reciprocating arm is configured to be activated automatically upon proximal withdrawal of the needle enclosure from the catheter hub to trigger automatic proximal withdrawal of the needle (claim 17).
Shaw discloses an assembly, comprising a needle withdrawal mechanism for withdrawing a needle from a catheter and a catheter hub, the needle withdrawal mechanism comprising a spring-loaded plunger 58’ (see Fig. 9) arranged inside a needle enclosure 14’ (see Fig. 9), wherein the spring-loaded plunger is configured to mount to a proximal end of the needle and is spring-biased to proximally withdraw the needle into the needle enclosure (see Figs. 8-0).
As to claims 16 and 17, Shaw also discloses:
the trigger mechanism comprises a spring arm 96 (see Fig. 9) integrally formed on a distal end of the automatic needle withdrawal device, and wherein the spring arm is configured to be activated automatically upon proximal withdrawal of the needle enclosure from the catheter hub to trigger automatic proximal withdrawal of the needle (see col. 7, lines 42-55); and
the trigger mechanism comprises a non-integrally formed spring-loaded reciprocating arm 96 (see Fig. 9; the reciprocating arm is non-integral with the catheter hub) arranged between a distal end of the automatic needle withdrawal device and the proximal end of the catheter hub, wherein the spring-loaded reciprocating arm is configured to be activated automatically upon proximal withdrawal of the needle enclosure from the catheter hub to trigger automatic proximal withdrawal of the needle (see col. 7, lines 42-55).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hiejima in the manner described above with respect to claims 16 and 17, in order to facilitate high-speed needle withdrawal from the catheter, with a reasonable expectation of success in preventing or reducing accidental needle sticks.
Allowable Subject Matter
Claims 2, 4-8, 10, 11 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. Examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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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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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 12/05/2025