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 .
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 3 and 13-14 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.
Claims 3 and 13-14 are indefinite because there are no known pressure units such as newtown and newtons. There are various pressure units such as Newton per square meter (N/m2 ), Newton per square centimeter (N/cm2 ), and Newton per square millimeter (N/mm2), among others, but not newtown and newtons. The claims do not specifically point out which one of the correct unit applicants is referring to.
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, 2, 5, 9-12, 16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burnard et al (US 20210146044 A1).
Regarding claims 1 and 11, Burnard discloses a cassette (102; figures 1A-3B) with free-flow prevention that is insertable into an infusion pump (100) having a peristaltic actuator (106), and a method of manufacturing the cassette, the cassette and method comprising:
a free-flow prevention device 110 including a clamping section (112c) having a first side and a second side, a first elongate section (112a) extending from the first side, and a second elongate section (112b) extending from the second side; and
a housing ("the housing of the cassette 102"; [0017]) configured to receive and support the free-flow prevention device 110, the housing defining a channel ("the channel receiving the tube", [0015,0017]; fig 1A) for receiving a tube, the first elongate section 112a and the second elongate section 112b of the free-flow prevention device 110, when received, extending parallel to the channel and the clamping section extending across the channel (fig. 1B), and moving toward the housing for insertion [0021] and pressing the free-flow prevention device 110 into engagement with the housing [0025] ;
the housing comprising:
an external face (fig 1B);
a press plate (the hatched bottom plate in fig. 3A, which is identical to fig. 3A of the present application; also see fig 2A bottom under tube 108) coupled to the external face;
a lever arm retention system ([0022]: override fulcrums (200a, b) and occlusion fulcrums (202a, b)) configured to retain the free-flow prevention device when received, the lever arm retention system including a first lever arm (200a) configured to engage the first elongate section and a second lever arm (200b) configured to engage the second elongate section;
vertical sidewalls ([0020]: sidewall and opposite sidewall) extending from the external face, the vertical sidewalls including a first vertical sidewall spaced from the first lever arm and a second vertical sidewall spaced from the second lever arm; and
cutouts (118a, 118b) in the external face adjacent the first and second vertical sidewalls that permit outward bending of the first and second vertical sidewalls during press-fit insertion of the free-flow prevention device in a direction perpendicular to the press plate.
Although there is no explicitly mention "outward bending of the first and second sidewalls during press-fit insertion of the free-flow prevention device", this appears to be implicitly also disclosed by Burnard given the identical figures, e.g. 3B, which show identical cutouts (118a, 118b) as those disclosed in the present application. Moreover, the free-flow prevention device (112a, 112b, 112c) is received in the cassette housing.
Regarding claim 2, Burnard further comprising: a first channel wall 130 extending from the press plate that at least partially defines the channel, the first lever arm integrated into the first channel wall; and a second channel wall 130 extending from the press plate that at least partially further defines the channel, the second lever arm integrated into the second channel wall (fig. 1D).
Regarding claim 5, Burnard discloses wherein the first lever arm 200a comprises a first retaining surface facing the first elongate section and the second lever arm 200b comprises a second retaining surface facing the second elongate section to retain the free-flow prevention device after insertion.
Regarding claim 9, Burnard further comprising: a first positioning hook 206a and a second positioning hook 206b extending away from the press plate, each positioning hook having a surface configured to engage the clamping section during insertion to assist in positioning the free-flow prevention device (fig. 2B).
Regarding claim 10, Burnard discloses an infusion system (fig 1A), the system comprising:
an infusion pump 100 having a peristaltic actuator 106, and the cassette 102 with free-flow prevention of claim 1.
Regarding claim 12, Burnard discloses the housing further comprising a first channel wall extending from the press plate that at least partially defines the channel, the first lever arm integrated into the first channel wall; and a second channel wall extending from the press plate that at least partially further defines the channel, the second lever arm integrated into the second channel wall.
Regarding claim 16, Burnard discloses wherein the first lever arm comprises a first retaining surface 202a facing the first elongate section and the second lever arm comprises a second retaining surface 202b facing the second elongate section to retain the free-flow prevention device after the pressing into engagement.
Regarding claim 20, the housing further comprising a first positioning hook 206a and a second positioning hook 206b extending away from the press plate, each positioning hook having a surface configured to engage the clamping section during insertion to assist in positioning the free-flow prevention device (figs 2a-2b).
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.
Claims 3, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Burnard et al. (US 20210146044 A1).
Note: the pressure unit is incorrect for these claims. See 112 rejection above.
Burnard discloses the free-flow prevention device is press-fit inserted in the direction perpendicular to the press plate. However, it fails to disclose an insertion force of between 100 newtons and 400 newtown, or an insertion force of between 140 newtown and 200 newtons. This claimed pressure parameter is deemed matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Allowable Subject Matter
Claims 4, 6-8, 15, 17-19 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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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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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
Prosecution Insights