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 .
Specification
The disclosure is objected to because of the following informalities:
“stoppers 230a,240b” should be corrected to “stoppers 230a,230b” on page 5, and
“stems 224a,224b” should be corrected to “stems 212a,212b” on page 5 line 33.
Appropriate correction is required.
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:
Fig. 6 and 7 are not provided; therefore, none of the reference numerals directed to Fig. 6 are included in the drawings,
Reference numeral 225 provided on page 5 line 24 is not provided in the drawings, and
References R1 and R2 provided on page 6, second paragraph, are not provided in the drawings.
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.
The drawings are objected to because Fig. 4 includes reference numeral 203, which should be corrected to 303. 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 Objections
Claim 18 is objected to because of the following informalities: “each of the pair of stems” should be corrected to “a pair of stems”, or similarly, for claim language consistency. Appropriate correction is required.
Applicant is advised that should claim 1 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-10, 12-16, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Villain (US 20200171243 A1).
Regarding claims 1, 13, and 19-20, Villain discloses a multi-cartridge injector (application device 10, [0216] & Fig. 1a-1d) comprising: a plunger having a main brace and a pair of stems (plunger assembly 42 having a thumb plate 15 and two plungers 14, [0236] & Fig. 6a-6e), each of the pair of stems having a coupler (proximal tips 43 having an outer contour with snap-fit locking hooks, [0236] & Fig. 6a-6e); a pair of stoppers coupled to each coupler of the pair of stems (each tip 43 coupled to a formed piston 30, [0236] & Fig. 1d, 5d, and 6d);
a containment unit having a pair of barrels (body 11 having two mono-chambers 24 and 25, [0226] & Fig. 1d and 5d); and a Y-shaped conduit having a pair of branches and a common shaft (first and second fluid inlet channels 27 and 28, which are being interpreted as the branches, and mixing zone 29, [0220], [0223], and [0248] & Fig. 1a-1d and 4a-4d; outlet channel 26 may be interpreted as part of the Y-shaped channel, see Fig. 4d), the Y-shaped conduit defining a passageway that extends through the common shaft and the pair of branches (channels 27, 28, and 29 define a fluid passageway, [0220]-[0221] & Fig. 1a-1d and 4a-4d), each of the pair of branches being in communication with an interior of one of the pair of barrels (first fluid inlet channel 27 being in fluid communication with an interior of chamber 24 and second fluid inlet channel 28 being in fluid communication with an interior of chamber 25, [0220] and [0227] & Fig. 1d and 4a-4d).
Regarding claims 2 and 14, Villain discloses all the limitations of claims 1 and 13. Villain further discloses the multi-cartridge injector further comprising a cap coupled to an end of the containment unit to seal the pair of barrels (nozzle 12 coupled to an end of body 11 and configured to seal outlet channels 37 and 38, which are part of chambers 24 and 25, [0224] and [0226]-[0227] & Fig. 1d, 4d, and 5d).
Regarding claims 3 and 15, Villain discloses all the limitations of claims 2 and 14. Villain further discloses the multi-cartridge injector wherein the cap includes a funnel portion at a first end and a luer fitting at a second end (nozzle 12 includes a funnel portion at a fist end, proximal nozzle part 23B having a funnel shape, and luer lock connector 19 at a second end, [0222]-[0223] & Fig. 4a-4d).
Regarding claims 4 and 16, Villain discloses all the limitations of claims 3 and 15. Villain further discloses the multi-cartridge injector wherein the cap is coupled to the Y-shaped conduit (nozzle 12 is coupled to distal pat 23A, which includes the y-shaped conduit defined by inlets 27 and 28 and mixing zone 29, [0248] & Fig. 1a-1d and 4a-4d).
Regarding claim 5, Villain discloses all the limitations of claim 3. Villain further discloses the multi-cartridge injector further comprising a disposable probe needle coupleable to the luer fitting (“an outlet channel 26 connectable to an injection needle having a lumen extending along a first longitudinal axis A,”, [0220] & Fig. 1a-1d; “the mixing nozzle 12 further comprises connection means 19, particularly a Luer-lock-connector 19, for connecting an injection needle (not shown) to the mixing nozzle 12, wherein in an established connection between the mixing nozzle 12 and the injection needle the outlet channel 26 of the mixing nozzle 12 is fluidly connected to a lumen of the injection needle.”, [0220]).
Regarding claims 7 and 18, Villain discloses all the limitations of claims 1 and 13. Villain further discloses the multi-cartridge injector multi-cartridge injector further comprising a flange having a pair of apertures, each of the pair of stems passing through at least one of the pair of apertures (disc-shaped distal rim 20 having a pair of apertures, which are being interpreted as spaces, or gaps, in which chambers 24 and 25 are placed, cut flanges 24C and 25C of chambers 24 and 25 interacting with the apertures of distal rim 20, [0228] and [0230] & as best seen in Fig. 5a and 5e; each of plungers 14 pass through the gaps in distal rim 20, see Fig. 1d).
Regarding claim 8, Villain discloses all the limitations of claim 7. Villain further discloses the multi-cartridge injector wherein the flange and the containment unit are unitary (the distal rim 20 and body 11 may be interpreted as making up a single entity, or being unitary, see Fig. 1d).
The limitation of “…are unitary” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 9, Villain discloses all the limitations of claim 1. Villain further discloses the multi-cartridge injector wherein each of the pair of barrels is generally cylindrical (chambers 24 and 25 are seen to be generally cylindrical, see Fig. 1d and 5a-5e and [0035]).
Regarding claim 10, Villain discloses all the limitations of claim 1. Villain further discloses the multi-cartridge injector wherein the main brace is concave (as seen in Fig. 6a and 6d, thumb plate 15 is slightly concave).
Regarding claim 12, Villain discloses all the limitations of claim 1. Villain further discloses the multi-cartridge injector wherein each of the containment unit and the plunger is symmetrical about a longitudinal central axis (plunger unit 42 and body 11 are symmetrical about longitudinal axis A, see Fig. 5a-6e).
Claim(s) 13-14 and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cannon (US 3767085 A).
Regarding claims 13 and 17, Cannon teaches a multi-cartridge injector (abstract) comprising: a containment unit having a pair of barrels, wherein the pair of barrels share a common wall (cradle 11 includes a pair of parallel, concaved grooves 14 and 15, which are being interpreted as a pair of barrels, which merge along a central ridge 16, Col 3 lines 5-10 & Fig. 1; pair of juxtaposed semi-cylindrical surfaces 37 and 38 may also be interpreted as part of the pair of barrels, Col 3 lines 50-55 & Fig. 1); and a Y-shaped conduit having a pair of branches and a common shaft (eduction tubes 102 and 103, channels 106 and 107, and nozzle 80 form a y-shaped conduit with nozzle 80 being a common shaft, Col 5 lines 49-65 & Fig. 1-2), the Y-shaped conduit defining a passageway that extends through the common shaft and the pair of branches (Col 5 line 65-Col 6 line 13 & Fig. 1-4), each of the pair of branches being in communication with an interior of one of the pair of barrels (ends 104 and 105 in communication with an interior of the barrels formed by concave grooves 14 and 15 and surfaces 37 and 38, see Fig. 3 & Col 5 lines 49-65 and Col 7 lines 40-47).
Regarding claim 14, Cannon discloses all the limitations of claim 13. Cannon further discloses the multi-cartridge injector further comprising a cap coupled to an end of the containment unit to seal the pair of barrels (cap 50 coupled to an end of body 10, sealing the barrels formed by grooves 14 and 15 and surfaces 37 and 38, Col 3 line 65-Col 4 line 4 and lines 42-50 & Fig. 1-4).
Regarding claim 18, Cannon discloses all the limitations of claim 13. Cannon further discloses the multi-cartridge injector further comprising a flange having a pair of apertures, each of the pair of stems passing through at least one of the pair of apertures (handle 60 having a pair of apertures in which piston rods 67 and 68 pass through, Col 4 lines 14-26 & Fig. 1-4).
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.
Claim(s) 1-2 and 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cannon (US 3767085 A) in view of Villain (US 20200171243 A1).
Regarding claims 1 and 6, Cannon teaches a multi-cartridge injector (abstract) comprising: a plunger having a main brace and a pair of stems (piston rods 67 and 68 connected to handle 73, Col 4 lines 26-45 & Fig. 1); a pair of stoppers coupled to each of the pair of stems (pistons 71 and 72 coupled to the end of rods 67 and 68, Col 4 lines 26-45 & Fig. 1); a containment unit having a pair of barrels, wherein the pair of barrels share a common wall (cradle 11 includes a pair of parallel, concaved grooves 14 and 15, which are being interpreted as a pair of barrels, which merge along a central ridge 16, Col 3 lines 5-10 & Fig. 1; pair of juxtaposed semi-cylindrical surfaces 37 and 38 may also be interpreted as part of the pair of barrels, Col 3 lines 50-55 & Fig. 1); and a Y-shaped conduit having a pair of branches and a common shaft (eduction tubes 102 and 103, channels 106 and 107, and nozzle 80 form a y-shaped conduit with nozzle 80 being a common shaft, Col 5 lines 49-65 & Fig. 1-2), the Y-shaped conduit defining a passageway that extends through the common shaft and the pair of branches (Col 5 line 65-Col 6 line 13 & Fig. 1-4), each of the pair of branches being in communication with an interior of one of the pair of barrels (ends 104 and 105 in communication with an interior of the barrels formed by concave grooves 14 and 15 and surfaces 37 and 38, see Fig. 3 & Col 5 lines 49-65 and Col 7 lines 40-47).
However, Cannon fails to explicitly disclose each of the pair of stems having a coupler and a pair of stoppers coupled to each coupler of the pair of stems.
However, Villain teaches a multi-cartridge injector (abstract) comprising a pair of stems having a coupler and a pair of stoppers coupled to each coupler of the pair of stems (proximal tips 43 of plungers 14 having an outer contour with snap-fit locking hooks, [0236] & Fig. 6a-6e; each tip 43 coupled to a formed piston 30, [0236] & Fig. 1d, 5d, and 6d).
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 pair of stems of Cannon with Villain to include each of the pair of stems having a coupler and a pair of stoppers coupled to each coupler of the pair of stems since such a modification would provide for secure connection between the stems and the stoppers and is taught by Villain to be an art effective configuration for connection between stems of a multi-cartridge injector and corresponding stoppers (see [0236]-[0237] and [0268] of Villain).
Regarding claim 2, Cannon, as modified, discloses all the limitations of claim 1. Cannon further discloses the multi-cartridge injector further comprising a cap coupled to an end of the containment unit to seal the pair of barrels (cap 50 coupled to an end of body 10, sealing the barrels formed by grooves 14 and 15 and surfaces 37 and 38, Col 3 line 65-Col 4 line 4 and lines 42-50 & Fig. 1-4).
Regarding claim 7, Cannon, as modified, discloses all the limitations of claim 1. Cannon further discloses the multi-cartridge injector further comprising a flange having a pair of apertures, each of the pair of stems passing through at least one of the pair of apertures (handle 60 having a pair of apertures in which piston rods 67 and 68 pass through, Col 4 lines 14-26 & Fig. 1-4).
Regarding claim 8, Cannon, as modified, discloses all the limitations of claim 7. Cannon further discloses the multi-cartridge injector wherein the flange and the containment unit are unitary (“Furthermore, the rear end of body 10 is provided with a flat transversely extending handle or finger grip, denoted generally by numeral 60,”, Col 4 lines 3-5 & Fig. 1-4; flange 60 and body 11 are unitary).
However, the Examiner notes that the limitation of “…are unitary” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 9, Cannon, as modified, discloses all the limitations of claim 1. Cannon further discloses the multi-cartridge injector wherein each of the pair of barrels is generally cylindrical (the pair of barrels defined by grooves 14 and 15 and surfaces 37 and 38 are seen being cylindrical, see Fig. 1; “It will be understood that when the cover member 12 is closed against the cradle member 11, the surfaces 38 and 14 define a cylinder having a longitudinal axis and adapted to confine the cylinder 21. In like manner, the opposed concaved surfaces 15 and 37 confine the cylinder 22.”, Col 3 lines 56-61).
Regarding claim 10, Cannon, as modified, discloses all the limitations of claim 1. Cannon further discloses the multi-cartridge injector wherein the main brace is concave (handle 73 having a concave surface, see Fig. 1).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Villain (US 20200171243 A1) as applied to claim 1 above, and further in view of Wirt (US-20030187387-A1).
Regarding claim 11, Villain discloses all the limitations of claim 1. Villain further discloses the multi-cartridge injector of claim 1, wherein each of the pair of stems has a cruciform cross-sectional shape.
However, Wirt teaches a multi-cartridge syringe (abstract) comprising a pair of stems, wherein each of the pair of stems has a cruciform cross-sectional shape (dual piston 62 having a pair of push rods 92 and 94 having a cruciform cross-section shape, [0079] and see Fig. 6-7).
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 pair of stems of Villain with Wirt to include each of the pair of stems having a cruciform cross-sectional shape since Wirt teaches such a cruciform shape to be an art effective shape for a pair of plunger stems.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lucas (US-4738660-A) and Arocha (US-20150065993-A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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