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 Objections
Claims 1, 11, 15, and 16 are objected to because of the following informalities:
For claim 1, in line 3, the claim recites “inlet 21”. However, all the other reference numerals are removed through amendment and thus lacking uniformity.
Claim 11 is missing a period (.) at the end.
Claim 15 recites “A driving machine according to claim 12”. However, claim 12 recites “A driving system…”. The claims must follow the same terminology to avoid confusion and therefore, the claim is objected.
For claim 16, in line 2, the claim recites “pinch valve 5”. However, all the other reference numerals are removed through amendment and thus lacking uniformity. Claim 16 is also objected to for the same reason as claim 15.
Appropriate corrections are 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, 6, and 17 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 2 recites the broad recitation “the connecting line fastened to the outlet is equipped with an end-needle”, and the claim also recites “preferably inserted into a protective holster” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of examination, only the broad recitation is given patentable weight.
Similarly, claim 6 recites the broad recitation “the nozzles are arranged perpendicular to the axis of the cylinder”, and the claim also recites “preferably in the same plane” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of examination, only the broad recitation is given patentable weight.
Claim 17 recites “the pinching valves” in line 4 and “pinching valve elements” in line 6. Claim 17 depends from claim 1 which does not recite “pinching valves” and “pinching valve elements”. Therefore, there is lack of sufficient antecedent basis for these limitations.
Claim Rejections - 35 USC § 102
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, 4-5, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Connor (US PG PUB 2009/0326457).
Regarding claim 1, O’Connor discloses a kit (figures 1A-1C and 15) comprising
a pump (item 100, figure 1A) with a piston (item 104, figure 1A) slidingly arranged within a cylinder body (item 102, figure 1A), the cylinder body being arranged with an inlet (item 106, figure 1A) and an outlet (item 108, figure 1A) both allowing fluid communication between the outside of the cylinder and a metering chamber (item 114, figure 1A) inside of the cylinder body said metering chamber being further defined by one extremity of the piston lying within the cylinder body (figure 1A) and wherein the other extremity of the piston is protruding from the cylinder body (figure 1C);
a connecting line (the line that connects to inlet 106, figure 1A, also see 1502 in figure 15) fastened to the inlet;
a connecting line (the line that connects to outlet 108, figure 1A. also see 1506 in figure 15) fastened to the outlet;
wherein the connecting lines are made with a flexible material allowing the line to be obturated upon pinching (the line from outlet 1506 is pinched at 1508 thus the lines are made of material that is pinchable, figure 15, also see paragraph [0066] for materials).
Regarding claim 2, O’Connor discloses that the connecting line fastened to the outlet is equipped with an end-needle (i.e., an infusion set, paragraph [0039]).
Regarding claim 4, O’Connor discloses that the connecting line fastened to the inlet is equipped with an aseptic connector for connecting the line to a bulk tank (reservoir, paragraph [0039]).
Regarding claim 5, O’Connor discloses that the inlet and the outlet are arranged with nozzles (inlet and outlet nozzle openings are formed in the cylindrical body 102, figure 1A) protruding from the cylinder body.
Regarding claim 10, O’Connor discloses that the piston and at least part of the cylinder housing are made of ceramic (paragraph [0033]).
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 3, 6-9, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor.
Regarding claim 3, O’Connor is silent to the kit being sterilized and being stored in a sterilized packaging.
However, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have sterilized the pump kit of O’Connor and placed the entire kit in a sterilized packaging prior to use to protect the patient for risk of infection and for the purposes of disease prevention. Sterilizing and use of sterilized packaging is old and well-known in the art and one of ordinary skill in the art would be able to deploy such known techniques.
Regarding claim 6, O’Connor teaches that the inlet nozzle is arranged perpendicular to the axis of the cylinder but not both nozzles.
However, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have modified the invention of O’Connor such that some or all of the nozzles are arranged perpendicular to the axis of the cylinder if such configuration is required for the overall construction of the pump assembly. It has been held that rearranging parts of an invention involves only routine skill in the art. (See MPEP § 2144.04 (VI)).
Regarding claims 7-9, O’Connor teaches that the cylinder body of the pump and piston are two separate components that interact with each other to form a pump assembly but is silent to the cylinder comprises at least two assembled sections with one section containing the inlet and the outlet and the other section comprising a piston housing with both sections being joined by a sanitary fitting.
O’Connor indeed teaches some configurations, in other embodiments, use of multiple sections and components to form a pump assembly and a piston device (see figures 2-21B).
However, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have formed the cylinder of the pump body in two separate sections that are joined together by a fitting in the device of O’Connor since doing so allows for a separate assembly step of attaching the piston to a piston housing portion of the cylinder and the inlets and outlets of the pump to a second portion of the cylinder. It has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (See MPEP § 2144.04 (V)).
Furthermore, it would be obvious to have the fitting be a sanitary or sterilized fitting since the pump device is used in patient infusion and sterilized medical setting. Sterilizing and use of sterilized components is old and well-known in the art and one of ordinary skill in the art would be able to deploy such known techniques.
Regarding claim 11, O’Connor teaches use of several pumps and fluid reservoirs to form a complex insulin metering and infusion assembly (paragraph [0039]).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have modified the invention of O’Connor such that it comprises several pumps, each equipped with an inlet connecting line and an outlet connecting line, and wherein the inlet connecting lines are arranged downstream of a single main inlet line. Doing so involves a minor modification of the disclosure already taught by O’Connor and is within the range of skill of one of ordinary skill in the art. It has been held that mere duplication of the essential working parts of a device involves only routine skill in the art (See MPEP § 2144.04 (VI)).
Regarding claim 12, O’Connor teaches a driving system (figures 7A-7B) adapted to operate the kit of claim 1, comprising: a mobile arm (item 718, figure 7A) arranged to hold the protruding extremity of the piston (item 704, figure 7A) of the pump and to drive a reciprocal translation of said piston within the cylinder body (paragraph [0052]).
O’Connor also teaches pinching means (item 1508, figure 15) arranged to alternatively pinch the connecting line fastened to the inlet and the connecting line fastened to the outlet; wherein the mobile arm and the pinching means are synchronized so as to close the connecting line fastened to the outlet when the piston is translated outwards of the cylinder body and to close the connecting line fastened to the inlet when the piston is translated inwards of the cylinder body (paragraph [0065]).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have combined the teachings of different embodiments of O’Connor to form a device that comprises the driving system and the pinching means as recited in the claims to form a complete pump assembly with an actuator and the pinching valves that coordinate with each other to carryout out a metering and an infusion process.
Allowable Subject Matter
Claims 13-17 are objected to as being dependent upon a rejected base claim, but would be allowable, if the claim objections and 35 U.S.C. 112 rejections are overcome, 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. The following prior arts discloses subject matter related to metering valves and dispensers: US PN 3,670,928, US PN 4,105,146, and US PG PUB 2017/0211959.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VISHAL J PANCHOLI whose telephone number is (571)272-9324. The examiner can normally be reached Monday - Thursday (9 am - 7 pm).
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/Vishal Pancholi/Primary Examiner, Art Unit 3754
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