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 without traverse of claims 1-9 in the reply filed on December 18, 2025 is acknowledged. Claims 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claim Objections
The claim 6 is objected to due to the following informalities: In claim 6, line 8, the term “linear” should be inserted before the phrase “attachment/detachment direction”. 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 2-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (preAIA ), 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 2, recites “a closing position” in line 6 and “an opening position” in line 9. Claim 2 is dependent on claim 1. However, claim 1 introduced “a closing position” in lines 10-11 and “an opening position” in lines 12. It is unclear if the Applicant intended for the “closing position” and “opening position” of claim 2 to refer to those of claim 1, or introduce new closing and opening positions in claim 2. For the sake of examination and in light of the specification, lines 6 and 9 are interpreted to recite “a closing position of the tube pressing portion” and “an opening position of the tube pressing portion”. Applicant is therefore suggested to amend claim 2 in this manner to overcome rejection.
Claim 2 further recites “the closing position” in lines 11, 13 and 15 and “the opening position” in lines 13 and lines 15-16. Since both claim 1 and claim 2 introduces “a closing position” and “an opening position”, the antecedent basis for “the closing position” and “the opening position” is therefore ambiguous. For the sake of examination and in light of the specification, each of these phrases are interpreted as referring to the positions introduced on lines 6 and 9 of claim 2. Applicant is therefore suggested to amend the phrases “the closing position” and “the opening position” on lines 11, 13, 15 and 16 in the same manner set forth above.
Claims 3 and 4 are rejected by virtue of their dependency on claim 2.
Claim 5, line 4 recites “a distal end” of the “tube main body” of the “tube member”. Claim 5 is dependent on claim 1. However claim 1 introduced “a distal end” of the “tube member”. It is unclear if the Applicant intended for the “distal end” of claim 5 to refer to that of claim 1, or introduce a new distal end in claim 5. For the sake of examination, “a distal end” of claim 5 is being interpreted to refer to the “distal end” of claim 1. Applicant is therefore suggested to amend claim 5 to overcome rejection.
Claims 6 and 7 are rejected by virtue of their dependency on claim 5.
Allowable Subject Matter
Claim 1, 8 and 9 are allowable and claims 2-7 are allowable except for the presence of the objection and 112(b) rejections set forth above.
The following is an examiner’s statement of reasons for allowance:
Upon consideration of the prior art of record, the limitations recited in independent claim 1 are not taught or suggested by prior art and therefore define allowable subject matter.
Regarding claim 1, Robert et al (US 20130267899 A1, herein Robert) discloses an infusion cartridge (cassette 14 in Fig. 1) comprising:
a cartridge main body (container portion 16 in Fig. 1) that defines a housing space configured to house an infusion solution (cassette 14 includes a container portion 16 which defines a space for housing and generally enclosing a bag or reservoir of medication [0026], medication bag 24 in Fig. 2);
a tube member (tubing 22 Fig. 2) having a proximal end connected to the cartridge main body (see annotated Fig. 2 below) and defining a flow path communicating with the housing space (tubing 22 is connected to medication bag 24);
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Annotated Fig. 2 from Robert
the cartridge main body comprises a flow path closing portion (flow stop assembly 20 with flow stop arm 30 in Fig. 3) configured to be changed between (i) a closing position in which the flow path closing portion closes the flow path of the tube member (Release of the arm 30 will result in an upward movement of the arm 30 and upper surface 130 to provide a smaller passageway for an inserted infusion tube and will accordingly result in occlusion of the tube when the arm 30 is not being depressed [0036]) and (ii) an opening position in which the flow path closing portion does not close the flow path of the tube member (Accordingly, depression of the flow stop arm 30 will provide a greater opening through which an infusion tube 22 can pass [0036]);
Robert however failed to explicitly disclose a cap member attachable to and detachable from a distal end of the tube member; wherein:
the cap member is attachable to the cartridge main body so as to maintain the flow path closing portion in one position among the closing position and the opening position;
and the flow path closing portion is configured to change from said one position to the other position among the closing position and the opening position, in conjunction with an operation of detaching the cap member from the cartridge main body.
Rhinehart et al (WO 2014201358 A2, herein Rhinehart) teaches a cap 34 is provided on the distal end 24 of the housing 20. The cap 34 has a generally quadrilateral shape that is adapted to envelop the flange 28 of the housing 20. A finger tab 36 is provided on one or more sides of the cap 34 to facilitate removal of the cap 34 from the housing 20. The cap 34 engages the seal 30 (shown in FIG. 18) to maintain a sterile interface at the flange 28. The cap 34 is slidably mounted on the flange 28 such that it can slide substantially perpendicularly relative to the longitudinal axis of the housing 20 [0093].
Claim 1 requires the flow path closing portion to change between an opening position and a closing position in conjunction with the feature of the cap attaching on or detaching from the cartridge main body. Robert does not disclose this feature, as the flow stop arm 30 of the flow stop assembly 20 is operable by a user pressing vertically downward against the top surface of the flow stop arm 30 [0036] and fails to disclose an operation of a cap pressing the flow stop arm.
The cap 34 from Rhinehart would be incapable of performing this function since Rhinehart teaches cap 34 to be slidably mounted on the cartridge (see Fig. 20B). Therefore, modifying the flow stop assembly of Robert to open or close in conjunction with attachment or detachment of the cap from Rhinehart would render Robert inoperable as it requires cap of Rhinehart to be attached or detached in a way that is different from what is taught by Rhinehart.
Lee et al (US 20220362461 A1, herein Lee) also teaches an infusion device 100 with a pressure member 130 which allows infusion tube 200 to be in a flattened or hollow state in response to the operation of the pressure member 130, however Lee suffers from the same issue as Robert by failing to disclose a cap member to push or release the pressure member.
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
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/M.F./Patent Examiner, Art Unit 3783 /KAMI A BOSWORTH/Primary Examiner, Art Unit 3783