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 .
Response to Amendment
The Amendment filed 10/24/2025 has been entered. Claims 1, 4-7, 9, 11, 12, 15, 18 and 21-30 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 7/24/2025.
Election/Restrictions
Newly submitted claims 21-30 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Previously submitted claim 1 and its dependent claims were drawn to an embodiment with the base piece and the cover piece connected by hinge as shown in figures 1-6. Newly added claims require a single body which is non-rigid and can include tear lines as shown in figures 10A-12. The embodiment shown in figures 10A-12 is forming a pouch like structure which is different from the embodiment shown in figures 1-6 which is forming a box like structure.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-30 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 “cover piece and the base piece include a detachment portion demarcated by a tear line … or base piece along the tear line” as claimed 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
Claim 1 is objected to because of the following informalities:
Regarding claim 1, last line, the recitation “base piece” appears to be amended to recite “the base piece” in order to refer to “a base piece” recited in claim 1, line 3.
Regarding claim 1, lines 8-9, the recitation “closed configuration” appears to be amended to recite “the closed configuration” in order to refer to “a closed configuration” recited in claim 1, lines 4-5.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-7, 9, 11, 12, 15 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites a catheter security device comprising a cover piece and a base piece having a detachment portion demarcated by a tear line that intersects at least one of the first opening and the second opening, and wherein the detachment portion can be detached from the remained of the cover or base piece along the tear line. However, the original disclosure discloses a catheter security device in figures 1-6 comprising a base piece and a cover piece without disclosing a tear line as claimed. The original disclosure discloses a catheter security device in figures 10A-12 comprising a tear line 112 without disclosing a base piece and a cover piece in a manner disclosed in claim 1. One can argue that a portion of element 102 in figure 10A could be construed as a base piece and remaining portion of element 102 can be construed as a cover piece. However, the original disclosure does not describe separation of element 102 into portions to identify a portion as a cover piece and as a base piece. Accordingly, the original disclosure fails to disclose the claimed invention as claimed in amended claim 1.
Claims 4-7, 9, 11, 12, 15 and 18 being dependent on claim 1 are also rejected.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1, 4, 5, 9, 11, 12, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Peters et al. (US 6,217,564 B1) in view of Elsamahy et al. (US 2012/0109070 A1).
Regarding claim 1, Peters discloses a catheter security device (figures 21, 22 and 26) comprising:
a cover piece (one of the two elements 80, 84, 110 located on top);
a base piece (other of the two elements 80, 84, 110 located at bottom), wherein the catheter security device (figures 21, 22 and 26) is in an open configuration (a configuration where both elements 80, 84 and 110 are not closed allowing accessing the interior of both elements 80, 84, 110) when the cover piece and the base piece are not mated, and wherein the catheter security device is in a closed configuration (configuration shown in figures 21, 22 and 26) when the cover piece and the base piece are mated;
a locking part (column 6, lines 65-67, column 7, lines 3-5, column 8, lines 1-11, portion of element 116 or component keeping element 116 engaged with one of the two elements 110) on the cover piece;
a locking counterpart (column 6, lines 65-67, column 7, lines 3-5, column 8, lines 1-11, portion of element 116 or component keeping element 116 engaged with other of two elements 110) on the base piece, wherein the locking part and the locking counterpart engage as a locking mechanism 114 (column 6, lines 65-67, column 7, lines 3-5, column 8, lines 1-4) to lock the catheter security device in closed configuration;
wherein the closed configuration forms an enclosure (enclosure formed as shown in figures 21, 22 and 26) that has a first opening (see “FO” in figure 21 below, examiner has indicated opening in single embodiment but similar openings are present in other embodiments) at one side of the enclosure and a second opening (see “FO” in figure 21 below, examiner has indicated opening in single embodiment but similar openings are present in other embodiments) at another side of the enclosure;
wherein the first and second openings (see “FO” and “SO” in figure 21 below, examiner has indicated opening in single embodiment but similar openings are present in other embodiments) each, independently, have a width in the range of certain dimension but does not expressly disclose a width in the range in 1.0-6.0 mm. As shown in figures 21, 22 and 26, the first and second openings is sized enough to accommodate the catheter/tube of appropriate diameter and as such a width of the first and second openings is disclosed to be a result effective variable in that changing the width of the first and second openings would change the ability to hold the catheter/tube through the openings. Further, it appears that the one of ordinary skill in the art would have a reasonable expectation of success in modifying the Peters to have a width within the claimed range, as it involves only adjusting the width of the first and second openings disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the width of the first and second openings of Peters by making the width of 1.0-6.0 mm and 2.0 to 4.0 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1995).
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Peters is further silent regarding wherein at least one of the cover piece and the base piece include a detachment portion demarcated by a tear line that intersects with at least one of the first opening and the second opening, and wherein the detachment portion can be detached from the remainder of the cover piece or base piece along the tear line.
However, Elsamahy teaches a design of a catheter securement device (figure 1) comprising wherein the at least one of the cover piece 20, 22 and the base piece 18 include a detachment portion (portion separated by element 52) by a tear line 52 that intersects with at least one of the first opening (see “O” in figure 1 below) and the second opening, and wherein the detachment portion can be detached from the remainder of the cover piece or base piece along the tear line (paragraph 0021, lines 5-8) for the purpose of removing/separating the cover piece and/or base piece at the end of the use (paragraph 0021, lines 5-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the catheter security device of Peters to incorporate wherein at least one of the cover piece and the base piece include a detachment portion demarcated by a tear line that intersects with at least one of the first opening and the second opening, and wherein the detachment portion can be detached from the remainder of the cover piece or base piece along the tear line as taught by Elsamahy for the purpose of removing/separating the cover piece and/or base piece at the end of the use (paragraph 0021, lines 5-8).
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Regarding claim 4, Peters discloses wherein the catheter security device (figure 26) is a clamshell design (design shown in figure 26) with the cover piece being a first shell (one of the two elements 110) and the base piece being a second shell (other of the two elements 110), and the catheter security device further comprises a hinged spine 112 connecting the first shell and the second shell.
Regarding claim 5, Peters discloses wherein the first shell (one of the two elements 110) comprises a first pair of notches (see “N” in figure 27 below, although a single notch is visible in figures 26 and 27, the other end will have same structure as evidenced by different embodiments shown in figures 21 and 25) and the second shell (other of two elements 110) comprises a second pair of notches (see “N1” in figure 27 below, although a single notch is visible in figures 26 and 27, the other end will have same structure as evidenced by different embodiments shown in figures 21 and 25), wherein the first pair of notches and the second pair of notches are configured to match the openings (see figure 27) for the enclosure.
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Regarding claim 9, Peters discloses wherein the locking mechanism is a snap lock 114 (column 8, lines 1-4).
Regarding claim 11, Peters discloses a method (column 1, lines 7-11) of infusing a medical fluid through a patient’s venous catheter;
wherein the medical fluid is received through an infusion line (see “L” in figure 25 below) that comprises an infusion tubing (tubing shown by “L” in figure 25 below);
wherein the venous catheter 105 comprises a catheter tubing (tubing of element 105), wherein the venous catheter is connected to the infusion line at a catheter coupling 100;
wherein the method comprises the steps of:
(a) having a catheter security device (figures 21, 22, 26, column 6, lines 60-64, examiner will refer to figure 25 for referring the tubing arrangements because figure 25 shows clear depiction of the tube arrangement inside the catheter security device however, all the other embodiments appear to be disclosing similar arrangement except for the presence of valve structures 108, 106);
(b) placing the catheter coupling 100 onto the base piece (element 102 on which element 100 is placed);
(c) mating the cover piece (other of two elements 102) to the base piece so that the catheter security device is in the closed configuration (column 7, lines 42-46, configuration when two elements 102 are brought into contact with each other by closing one element 102 over other element 102);
(d) engaging (column 7, lines 3-6, column 8, lines 1-4) the locking part and the locking counterpart to lock the catheter security device in the closed configuration and form the enclosure;
wherein the catheter coupling 100 is contained in the enclosure;
wherein the catheter tubing (tubing of element 105) exits out of the enclosure at the first opening (opening from which element 105 exits in figure 25);
wherein the infusion tubing (tubing of “L” in figure 25 below) exits out of the enclosure at the second opening (opening of which tubing of “L” in figure 25 below exits);
(e) administering (column 7, lines 29-32, column 1, lines 7-11, column 6, lines 60-63, from the cited portions, one of ordinary skill in the art would construe that the medical fluid through the infusion line is administered and into the venous catheter while the catheter security device is locked) the medical fluid through the infusion line and into the venous catheter while the catheter security device is locked;
(f) permanently breaking (column 8, lines 6-12) the locking mechanism and opening the enclosure to expose the catheter coupling 100.
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Regarding claim 12, Peters discloses comprising stopping (at the end of the delivery or when the reservoir gets empty, it will be obvious to one of ordinary skill in the art to have the administration stopped. Additionally, Peters teaches in column 7, lines 37-40 to stop the fluid supply) the administration of the medical fluid. Peters does not explicitly cite the step of further comprising uncoupling the infusion line from the venous catheter in one embodiment. However, one of ordinary skill in the art would construe that it would be obvious to disconnect the infusion line from the venous catheter when discarding at least one of the infusion line and the venous catheter.
Additionally, Peters discloses in a different figure (figure 18) wherein further comprising uncoupling the infusion line from the venous catheter (column 6, lines 46-50) for the purpose of connecting fresh liquid supplies to the venous catheter (column 6, lines 46-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the method of one embodiment of Peters to incorporate further comprising uncoupling the infusion line from the venous catheter as taught by different figure of Peters for the purpose of connecting fresh liquid supplies to the venous catheter (column 6, lines 46-50).
Regarding claim 15, Peters discloses wherein the step of breaking of the locking mechanism is performed by one of cutting the locking mechanism (column 8, lines 5-11, by tearing using element 116, the locking mechanism no longer remains functional thereby indirectly cutting the locking mechanism) and twisting off the locking mechanism (column 8, lines 5-11, in order to tear away the element 116, element 116 has to be pulled away i.e. twisted).
Regarding claim 18, Peters discloses wherein the catheter security device (figure 26) is a clamshell design (design shown in figure 26) with the cover piece being a first shell (one of the two elements 110) and the base piece being a second shell (other of the two elements 110), and the device further comprises a hinged spine 112 connecting the first shell and the second shell.
Claims 1 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hasler (US 2007/0270765 A1) in view of Elsamahy et al. (US 2012/0109070 A1).
Regarding claim 1, Hasler discloses a catheter security device (figure 1A) comprising:
a cover piece 13;
a base piece (see “B” in figure 6 below), wherein the catheter security device is in an open configuration (configuration shown in figure 1A) when the cover piece 13 and the base piece are not mated, and wherein the catheter security device is in a closed configuration (configuration shown in figure 6) when the cover piece and the base piece are mated;
a locking part 30 (figure 7) on the cover piece 13;
a locking counterpart 29 on the base piece, wherein the locking part 29 and the locking counterpart 30 engage as a locking mechanism 29, 30 (paragraph 0063) to lock the catheter security device in closed configuration;
wherein the closed configuration forms an enclosure (enclosure shown in figure 6) that has a first opening (see “FO” in figure 6 below) at one side of the enclosure and a second opening (see “SO” in figure 6 below) at another side of the enclosure;
wherein the first and second openings each, independently, have a width in the range of a certain dimension but does not expressly disclose a width in the range in 1.0-6.0 mm. As shown in figures 1 and 6, the first and second openings is sized enough to accommodate the catheter/tube of appropriate diameter and as such a width of the first and second openings is disclosed to be a result effective variable in that changing the width of the first and second openings would change the ability to hold the catheter/tube through the openings. Further, it appears that the one of ordinary skill in the art would have a reasonable expectation of success in modifying the Hasler to have a width within the claimed range, as it involves only adjusting the width of the first and second openings disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the width of the first and second openings of Hasler by making the width of 1.0-6.0 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1995).
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Hasler is further silent regarding wherein at least one of the cover piece and the base piece include a detachment portion demarcated by a tear line that intersects with at least one of the first opening and the second opening, and wherein the detachment portion can be detached from the remainder of the cover piece or base piece along the tear line.
However, Elsamahy teaches a design of a catheter securement device (figure 1) comprising wherein the at least one of the cover piece 20, 22 and the base piece 18 include a detachment portion (portion separated by element 52) by a tear line 52 that intersects with at least one of the first opening (see “O” in figure 1 above) and the second opening, and wherein the detachment portion can be detached from the remainder of the cover piece or base piece along the tear line (paragraph 0021, lines 5-8) for the purpose of removing/separating the cover piece and/or base piece at the end of the use (paragraph 0021, lines 5-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the catheter security device of Hasler to incorporate wherein at least one of the cover piece and the base piece include a detachment portion demarcated by a tear line that intersects with at least one of the first opening and the second opening, and wherein the detachment portion can be detached from the remainder of the cover piece or base piece along the tear line as taught by Elsamahy for the purpose of removing/separating the cover piece and/or base piece at the end of the use (paragraph 0021, lines 5-8).
Regarding claim 6, Hasler discloses wherein the catheter security device is a box design (see design in figure 6) with the cover piece being a top lid 13 (element 14 of Hasler could be placed on floor such that element 13 is located on top and element “B” is located on beneath element 13) and the base piece being a bottom box (see “B” in figure 6 above) having a compartment (hollow portion inside element “B” that accommodates element 12), and wherein the top lid 13 is configured to be fitted over the bottom box.
Regarding claim 7, Hasler discloses wherein the bottom box has a pair of notches (see notches of “FO” and “SO” in figure 6 above where figure 1A shows more clearly the presence of pair of notches in the bottom box only) that form an opening for the enclosure.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the arguments do not apply in view of the present rejection.
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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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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/NILAY J SHAH/Primary Examiner, Art Unit 3783