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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the Republic of India on 26 December 2022. It is noted, however, that applicant has not filed a certified copy of the IN202241075524 application as required by 37 CFR 1.55.
Drawings
The drawings are objected to because FIGs. 3-11 have a hand-drawn line quality that is too light to be reproduced (weight of all lines and letters must be heavy enough to permit adequate reproduction) or text that is illegible.
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 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.
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(s) 1-5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miyasaka (US 20130274702 A1) in view of Slepicka et al. (US 20090012452 A1).
Regarding Claims 1 & 15, Miyasaka discloses a medical fluid container tubing assembly ("transfusion line set 1" [0028]; FIG. 1) comprising:
a medical fluid container ("fluid container 2" [0028]; FIG. 1);
a first luer connector ("male connector 40" [0028] & "male connector having a circulation tube on which a luer part is formed on the front end side" [0059]);
a tube ("tube" 3/5 [0030]; FIG. 1) extending from the medical fluid container and terminating at the first luer connector ("male connector 40 is attached to the end on the downstream side of the tube 5" [0032]; FIG. 1);
a cap fitted onto the first luer connector ("connector cap 10 is connected to the downstream side of the male connector 40" [0033]; FIG. 1), the cap including a hydrophobic filter ("hydrophobic filter 31" [0056]; FIG. 4) positioned and arranged to allow air to aseptically enter the tube to equalize pressure inside and outside of the tube ("air is exhausted via the hydrophobic filter 31" [0056]; FIG. 4); and
a second luer connector ("female connector" [0032]), the second luer connector configured to mate with the first luer connector when the cap is removed from the first luer connector ("connecting the male connector 40 to a female connector" [0032]); and
a tubing assembly comprising:
a first luer connector ("male connector 40" [0028] & "male connector having a circulation tube on which a luer part is formed on the front end side" [0059]);
a cap fitted onto the first luer connector ("connector cap 10 is connected to the downstream side of the male connector 40" [0033]; FIG. 1), the cap including a hydrophobic filter ("hydrophobic filter 31" [0056]; FIG. 4) positioned and arranged to allow air to aseptically enter a tube to equalize pressure inside and outside of the tube ("air is exhausted via the hydrophobic filter 31" [0056]; FIG. 4); and
a second luer connector ("female connector" [0032]), the second luer connector configured to mate with the first luer connector when the cap is removed from the first luer connector ("connecting the male connector 40 to a female connector" [0032]).
Miyasaka fails to specify a supply line ("tubes 38a" [0039]; FIG. 1) extending from a medical fluid destination ("dialysis instrument 12" [0036]; FIG. 1). However, Slepicka teaches a dialysis instrument comprising tubing connectors ([0010]) further comprising a supply line ("tubes 38a" [0039]; FIG. 1) extending from a medical fluid destination ("dialysis instrument 12" [0036]; FIG. 1). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Miyasaka to incorporate the teachings of Slepicka to suitably deliver “a proper solution or properly mixed solution to the patient” ([0040]).
Regarding Claims 2 and 4-5, Miyasaka fails to specify the medical fluid container is a multi-chamber medical fluid container including at least one peel seal separating at least two chambers; wherein the second luer connector is configured to connect to a connector of a medical fluid machine to form part of a disinfection loop; wherein the supply line is configured at its medical fluid destination end to be connected fluidically within a medical fluid machine or to a disposable cassette operated by the medical fluid machine. However, Slepicka teaches the medical fluid container is a multi-chamber medical fluid container including at least one peel seal separating at least two chambers ("supply bags 32 or individually, generally as supply bag 32) shown here as dual or multi-chamber supply bags separating two fluids via a peel or frangible seal 34" [0037]; FIG. 1); wherein the second luer connector is configured to connect to a connector of a medical fluid machine ("cassette 50 connects to supply bags 32" [0039]; "rigid fluid ports 56" [0081]; FIG. 12) to form part of a disinfection loop ("liquid pathway 104" [0044]; FIG. 12); wherein the supply line is configured at its medical fluid destination end to be connected fluidically within a medical fluid machine or to a disposable cassette operated by the medical fluid machine ("cassette 50 connects to supply bags 32, drain bag and warmer bag 36 via tubes 38a, 38b and 38c" [0039]). Therefore, it would have been obvious modify the device of Miyasaka to incorporate the teachings of Slepicka to suitably “hold different solutions depending on the type of therapy employed” ([0038]) and deliver “a proper solution or properly mixed solution to the patient” ([0040]).
Regarding Claim 3, Miyasaka discloses the first luer connector is a male luer connector ("male luer part 82" [0060]; FIGs. 5A-5B) and the second luer connector is a female luer connector ("connection side end part of a female connector" [0063]).
Claim(s) 6-13 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miyasaka/Slepicka in view of Grimm et al. (US 20130338588 A1).
Regarding Claims 6-13 & 16-20, Miyasaka/Slepicka fails to specify the cap and the first luer connector are configured such that the cap translates onto and off of the first luer connector; the cap and the first luer connector are configured such that the cap threads onto and off of the first luer connector; the first luer connector includes a luer port, and wherein the cap includes a port sized to provide an interference fit with the luer port of the first luer connector; the luer port is a male luer port, and wherein an inner surface of the port of the cap is sized and shaped to provide an interference fit with an outer surface of the male luer port; the first luer connector includes an outer shroud, and wherein an outer surface of the port of the cap includes at least one rib sized to provide a second interference fit with an inner surface of the outer shroud of the first luer connector; the first luer connector includes a first outer shroud, the cap includes a second outer shroud, and wherein the first and second outer shrouds are sized such that a clearance space exists between an outer surface of the first outer shroud and an inner surface of the second outer shroud; an outer surface of the second outer shroud includes at least one rib for grasping the cap to connect and remove the cap from the first luer connector; the cap defines a lumen that communicates fluidly with the tube, and wherein the hydrophobic filter covers and opening formed by the lumen.
However, Grimm teaches “a connector (such as a Luer connector) … connectable to a catheter or any other infusion line” ([0006]) wherein the cap and the first luer connector are configured such that the cap translates onto and off of the first luer connector ("end cap assembly 214 is friction fitted onto the frustoconical portion 217 of the male Luer connector 212" [0076]; FIG. 7); wherein the cap and the first luer connector are configured such that the cap threads onto and off of the first luer connector ("end cap assembly 114 is threaded onto the shroud 64 of the male Luer connector 112" [0072]; FIGs. 5A-5B); wherein the first luer connector includes a luer port ("frustoconical portion 17" [0033]; FIG. 1B), and wherein the cap includes a port sized to provide an interference fit with the luer port of the first luer connector (see FIG. 1A); wherein the luer port is a male luer port ("male Luer connector 12" [0032]; FIG. 1B), and wherein an inner surface of the port of the cap is sized and shaped to provide an interference fit with an outer surface of the male luer port (see FIG. 1A); wherein the first luer connector includes an outer shroud ("shroud 64" [0033]; FIG. 1B), and wherein an outer surface of the port of the cap includes at least one rib sized to provide a second interference fit with an inner surface of the outer shroud of the first luer connector ("female threads of the shroud 64 are configured for coupling with mating threads of either the end cap assembly 14 (as shown in FIG. 1A) or a female Luer connector (not shown)" [0033]; FIG. 1B); wherein the first luer connector includes a first outer shroud ("shroud 64" [0033]; FIG. 1B), the cap includes a second outer shroud ("body portion 18" [0035]; 1A), and wherein the first and second outer shrouds are sized such that a clearance space ("annular fluid passageway 20" [0035]) exists between an outer surface of the first outer shroud and an inner surface of the second outer shroud (see FIG. 1A); wherein an outer surface of the second outer shroud includes at least one rib for grasping the cap to connect and remove the cap from the first luer connector (see Annotated FIG. 6C); wherein the cap defines a lumen that communicates fluidly with the tube ("annular fluid passageway 20" [0035]; FIG. 1A), and wherein the hydrophobic filter covers and opening formed by the lumen ("delimited by the hydrophobic filter vent 19" [0041]; FIG. 1A).
Annotated FIG. 6C
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Therefore, it would have been obvious modify the device of Miyasaka/Slepicka to incorporate the teachings of Grimm to suitably simplify “the process of priming”, reduce or eliminate fluid discharge from the end of the cap during priming, and provide an anti-siphon feature to prevent runaway of fluid if the tubing clamp is not closed ([0005]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miyasaka/Slepicka in view of Taylor (US 20180050183 A1).
Regarding Claim 14, Miyasaka/Slepicka discloses the cap and the first luer connector but fails to specify a maximum force needed to remove the cap is 37 Newtons. However, Taylor teaches an end cap adapter 300 ([0051]; FIG. 6) wherein a maximum force needed to remove the cap is 37 Newtons ("removal force may be in a range having an upper value, a lower value, or upper and lower values including any of 2.0 Newtons (N), 3.0 N, 4.0 N, 5.0 N, 7.5 N, 10 N, 20 N, 30 N, 40 N, 50 N, 75 N, 100 N, 125 N, 150 N, 175 N, 200 N, or any values therebetween" [0056]). Therefore, it would have been obvious modify the device of Miyasaka/Slepicka to incorporate the teachings of Taylor to suitably have a large removal force and decrease the chance of an accidental removal ([0056]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781