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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
24 as recited in [0018], [0020], and [0021].
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. 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.
Specification
The disclosure is objected to because of the following informalities:
[0023] should be amended to recite “The pump and valve actuator 62 can be a DC motor and gearbox assembly or other pump driving mechanism for controlling the plunger [[22]] or piston 22 and other related pump parts, such as the sleeve 14, that may rotate relative to the translational movement of the piston 22” to correct what structure reference numeral 22 is referring to.
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 – 5 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.
Claim 2 recites:
The pump of claim 1, wherein the piston is configured to rotate and axially move relative to the housing and the sleeve, and wherein the piston is configured to rotate together with the sleeve relative to the housing.
Claim 2 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it cannot be determined how the “piston is configured to rotate and axially move relative to the housing and the sleeve” and “wherein the piston is configured to rotate together with the sleeve relative to the housing.” If the piston is configured to rotate together with the sleeve relative to the housing then the piston would be unable to be configured to rotate relative to the housing and the sleeve because any rotation of the sleeve would also rotate the housing and vice versa.
Claims 3 – 5 are rejected under 35 U.S.C. § 112(b) because of their dependency of rejected Claim 2.
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.
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.
Claim(s) 1 – 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Focht et al. (US 2017/0184091 A1) (hereinafter referred to as “Focht”) and Manska (US 5,113,571 A).
With regards to claim 1, Focht discloses (see Fig. 1 and Figs. 40 – 43C) a pump (4000) (see [0148]) for a medical injector (100) (see [0083]) comprising a reservoir (124) (see [0084]) and a cannula (129) (see [0087]), the metering pump comprising:
a housing (4014) (see [0148]);
a sleeve (4002) (see [0148]) at least partially received within the housing (see Fig. 42);
a piston (4010) (see [0148]) at least partially received within the sleeve (see Fig. 42), the piston and the sleeve defining a chamber (see [0148] “pump volume” and Fig. 42), the piston having a first position where the chamber has a first volume and a second position where the chamber has a second volume (the second volume is the pump volume when the piston 4010 is extended as shown in Fig. 42 and the first volume is the pump volume when the piston 4010 is retracted as described in [0148]), the first volume larger than the second volume (see [0148], [0149] where the first volume is larger because the piston 4010 is retracted versus when the piston 4010 is extended like what is shown in Fig. 42), the sleeve having a first rotational position where an inlet (326) (see Fig. 8C, [0148] “FIG. 40 is an exploded view of another exemplary embodiment of a metering assembly 4000. This embodiment shares substantial similarities with the embodiments described above so the following description focuses on the differences,” and [0095]) is in fluid communication with the chamber (see Fig. 43A and [0149] “a first position (side hole aligned with reservoir pump)”), a second rotational position where an outlet (328) (see Fig. 8C, [0148] “FIG. 40 is an exploded view of another exemplary embodiment of a metering assembly 4000. This embodiment shares substantial similarities with the embodiments described above so the following description focuses on the differences,” and [0095]) is in fluid communication with the chamber (see Fig. 43C and [0149] “At the completion of rotation of the sleeve 4008 such that the side hole is oriented with the cannula port, the detent 4020 moves past the bump 4022 in interlock 4018. This is illustrated in FIG. 43C.”), and a third rotational position where the inlet and outlet are isolated from the chamber (see Fig. 43B and [0149]); and
an interlock member (4018) (see [0148]) configured to restrict movement of the sleeve until the sleeve overcomes a predetermined torque value (see [0149] “This could result in an incomplete volume of liquid being pumped per stroke. In order to prevent this situation, interlock 4018 prevents sleeve 4002 from rotating until the torque passes a predetermined threshold.”).
However, Focht is silent with regards to wherein the interlock member is formed integrally with a portion of the housing.
Rather Focht discloses that the interlock member 4018 is mounted onto the housing 4014 (see [0149]).
Nonetheless Manska, which is within the analogous art of medical devices (see abstract and title), teaches the interlock member (27) is formed integrally with a portion of the housing (18) (see Col. 2, lines 22 – 57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the interlock member of Focht in view of a teaching of Manska such that the interlock member is formed integrally with a portion of the housing. One of ordinary skill in the art would have been motivated to make this modification because Manska teaches that it is common to integrally form the interlock member with the housing. See Col. 2, lines 22 – 57 of Manska. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to form the interlock member integrally with a portion of the housing as taught by Manska, since it has been held that the use of a one piece construction instead of the mounting structure disclosed in Focht would be merely a matter of obvious engineering choice. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965); MPEP 2144.04(V)(B).
The pump of Focht modified in view of a teaching of Manska will hereinafter be referred to as the pump of Focht and Manska.
With regards to claim 2, the pump of Focht and Manska teaches the claimed invention of claim 1, and Focht further teaches wherein the piston (4010) (see [0148]) is configured to rotate and axially move relative to the housing (4014) (see [0148]) and the sleeve (4002) (see [0148] and [0149]), and wherein the piston is configured to rotate together with the sleeve relative to the housing (see [0148] “FIG. 40 is an exploded view of another exemplary embodiment of a metering assembly 4000. This embodiment shares substantial similarities with the embodiments described above so the following description focuses on the differences” and [0134] “the sleeve 1308 and piston 1306 to rotate together.”).
With regards to claim 3, the pump of Focht and Manska teaches the claimed invention of claim 2, and Focht further teaches wherein the piston (4010) (see [0148]) is connected to the sleeve (4002) (see [0148] and [0149]) via a pin (4012) (see [0148]) received within a helical groove (4004) (see [0148]) defined by the sleeve.
With regards to claim 4, the pump of Focht and Manska teaches the claimed invention of claim 3, and Focht further teaches (see [0148] “FIG. 40 is an exploded view of another exemplary embodiment of a metering assembly 4000. This embodiment shares substantial similarities with the embodiments described above so the following description focuses on the differences”) wherein the inlet (326) (see Fig. 8C and [0096]) is configured to be in fluid communication with the reservoir (124) (see [0084]) of the medical injector (100) (see [0083]), and wherein the outlet (328) (see Fig. 8C and [0096]) is configured to be in fluid communication with the cannula (129) (see [0087]) of the medical injector (see Fig. 1).
With regards to claim 5, the pump of Focht and Manska teaches the claimed invention of claim 4, and Focht further teaches see [0148] “FIG. 40 is an exploded view of another exemplary embodiment of a metering assembly 4000. This embodiment shares substantial similarities with the embodiments described above so the following description focuses on the differences”) wherein rotation of the piston (4010) (see [0148]) in a first rotational direction is configured to aspirate a fluid within the chamber (see [0148] “pump volume” and Fig. 42) and move the sleeve (4002) (see [0148]) from the first rotational position to the second rotational position (see [0133] “ The output gear 1326 turns the pump piston 1306 in the direction shown by the arrow in FIG. 27B…The pump piston 1306 translates toward the gearbox, pulling fluid from the reservoir into the pump chamber 1352,” [0148], and [0149]), and wherein rotation of the piston in a second rotational direction is configured to pump a fluid within the chamber and move the sleeve from the second rotational position to the first rotational position (see [0130] “. The output gear 1326 turns the pump piston 1306 in a first rotational direction (see arrow in FIG. 24B),…The pump piston 1306 translates away from the gearbox while rotating, expelling fluid from the pump chamber 1352 and out of the cannula port 1356,” [0148], and [0149]), the second rotational direction being opposite from the first rotational direction (see [0130] – [0134]).
With regards to claim 6, the pump of Focht and Manska teaches the claimed invention of claim 1, and Focht further teaches the sleeve (4002) (see [0148]) comprises a detent (4020) (see [0149]) and the interlock member (4018) (see [0148]) comprises a protrusion (4022) (see [0149]), the detent configured to deflect the protrusion and rotate past the protrusion when the sleeve overcomes the predetermined torque value (see [0149]).
With regards to claim 7, the pump of Focht and Manska teaches the claimed invention of claim 6, and Focht further teaches wherein the interlock member (4018) (see [0148]) comprises a first arm (see Examiner annotated Fig. 43A below hereinafter referred to as “Fig. A”) extending from the housing (4014) (see [0148]) and a second arm (see Fig. A below) extending from the housing, the protrusion (4022) (see [0149]) positioned between the first and second arms.
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With regards to claim 8, the pump of Focht and Manska teaches the claimed invention of claim 7, and Focht further teaches wherein the first and second arms (see Fig. A above) are configured to allow movement of the protrusion (4022) (see [0149]) between a deflected position (see Fig. 43B) and an undeflected position (see Figs. 43A and 43C), and wherein the first and second arms bias the protrusion toward the undeflected position (see [0148] “flexible interlock 4018”).
With regards to claim 9, the pump of Focht and Manska teaches the claimed invention of claim 8, and Focht further teaches wherein the first and second arms (see Fig. A above) each comprise a recessed portion (see Examiner annotated Fig. 43A below hereinafter referred to as “Fig. B”) where the first and second arms extend from the housing (4014) (see [0148]).
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With regards to claim 10, the pump of Focht and Manska teaches the claimed invention of claim 8, and Focht further teaches wherein the first and second arms (see Fig. A above) each comprise a curved portion (see Examiner annotated Fig. 43A above hereinafter referred to as “Fig. C”) where the first and second arms extend from the protrusion (4022) (see [0149]).
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With regards to claim 11, the pump of Focht and Manska teaches the claimed invention of claim 7, and Focht further teaches wherein the first and second arms (see Fig. A above) are each L-shaped (see the shape at the annotated curved portions in Fig. C above; alternatively the L-shape of the first and second arm is along the portion of the manifold 4014 and interlock 4018 which have been made integral within the rejection of claim 1 above see Examiner annotated Fig. 43A below hereinafter referred to as “Fig. D”).
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With regards to claim 12, the pump of Focht and Manska teaches the claimed invention of claim 1, and Focht further teaches wherein the interlock member (4018) (see [0148]) comprises a living hinge (see Figs. 43A – 43C and [0148] “flexible interlock 4018”).
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Focht and Manska as applied to claim 1 above, and further in view of Ivinson et al. (US 2016/0354581 A1) (hereinafter referred to as “Ivinson”).
With regards to claim 13, the pump of Focht and Manska teaches the claimed invention of claim 1, however Focht is silent with regards to the predetermined torque value is 5-15 millinewton meters.
Nonetheless Ivinson, which is within the analogous art of torque limiting devices (see abstract and title), teaches the predetermined torque value is 5-15 millinewton meters (see [0064] “the predetermined torque limit may be at least about 1 inch-ounce. In other instances, the predetermined torque limit may be between about 5 inch-ounces and about 40 inch-ounces” wherein 1 inch-ounce is equal to 7.062 millinewton meters).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the predetermined torque value of the pump of Focht and Manska in view of a teaching of Ivinson such that the predetermined torque value is 5-15 millinewton meters. One of ordinary skill in the art would have been motivated to make this modification because Focht is silent with regards to what the predetermined torque value is. See [0149] and Claims 14 – 15 of Focht. Ivinson provides guidance to a person having ordinary skill in the art about what the predetermined torque value may be. See [0018], [0064], and [0067] of Ivinson. Furthermore, Ivinson teaches that the torque limiting value may be selected depending on the operation. See [0064] of Ivinson. Here, a person having ordinary skill in the art would refer to the teaching of Ivinson and modify the predetermined torque value of the pump of Focht and Manska such that the predetermined torque value is between 5 – 15 millinewton meters to address the specific type of operation being conducted.
With regards to claim 14, the pump of Focht and Manska teaches the claimed invention of claim 1, however Focht is silent with regards to the predetermined torque value is 5-9 millinewton meters.
Nonetheless Ivinson, which is within the analogous art of torque limiting devices (see abstract and title), teaches the predetermined torque value is 5-9 millinewton meters (see [0064] “the predetermined torque limit may be at least about 1 inch-ounce. In other instances, the predetermined torque limit may be between about 5 inch-ounces and about 40 inch-ounces” wherein 1 inch-ounce is equal to 7.062 millinewton meters).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the predetermined torque value of the pump of Focht and Manska in view of a teaching of Ivinson such that the predetermined torque value is 5-9 millinewton meters. One of ordinary skill in the art would have been motivated to make this modification because Focht is silent with regards to what the predetermined torque value is. See [0149] and Claims 14 – 15 of Focht. Ivinson provides guidance to a person having ordinary skill in the art about what the predetermined torque value may be. See [0018], [0064], and [0067] of Ivinson. Furthermore, Ivinson teaches that the torque limiting value may be selected depending on the operation. See [0064] of Ivinson. Here, a person having ordinary skill in the art would refer to the teaching of Ivinson and modify the predetermined torque value of the pump of Focht and Manska such that the predetermined torque value is between 5 – 9 millinewton meters to address the specific type of operation being conducted.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pizzochero et al. (US 2019/0125962 A1).
Pizzochero et al. (US 2024/0058528 A1).
Cole et al. (US 2023/0366386 A1).
O’ Reilly et al. (US 2026/0115381 A1).
Zheng et al. (US 2021/0213199 A1).
Stewart et al. (US 2024/0017006 A1).
Stewart et al. (US 2024/0001031 A1).
Stewart (US 2024/0009389 A1).
Pizzochero (US 2023/0313787 A1).
Coleman et al. (US 2024/0009383 A1).
Pizzochero et al. (US 2019/0344010 A1).
Zheng et al. (US 2021/0030953 A1).v
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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, 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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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
06/26/2026
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