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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered:
U.S. Patent No. 10,136,978 (paragraph [0004])
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, a V-shaped spring (claim 16, line 7) and a transparent window (claim 18, line 2) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The abstract of the disclosure is objected to because:
In line 1, “a mammal includes” should be changed to “a mammal, the mammary-dosing system includes”
In line 3, “the techniques” should be changed to “techniques”
In line 5, “a fluid” should be changed to “the fluid”
In line 7, “the cavity” should be changed to “the internal cavity”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 4-5, 10, 13-14, and 16-20 are objected to because of the following informalities:
In regards to claim 1, line 2, “each medicament cartridge” should be changed to “each medicament cartridge of the plurality of medicament cartridges”.
In regards to claim 1, line 6, “the cavity” should be changed to “the internal cavity”.
In regards to claim 4, line 1, “each medicament cartridge” should be changed to “each medicament cartridge of the plurality of medicament cartridges”.
In regards to claim 4, lines 3-4, “adjacent cartridges” should be changed to “adjacent cartridges of the plurality of medicament cartridges”.
In regards to claim 5, line 2, “claws, and counterpart pair of upper tabs” should be changed to “claws and a counterpart pair of upper tabs”.
In regards to claim 10, line 4, “an upper-most cartridge” should be changed to “the upper-most cartridge”.
In regards to claim 13, line 3, “the dosing gun” should be changed to “the doser gun”.
In regards to claim 13, line 5, “an upper-most cartridge” should be changed to “the upper-most cartridge”.
In regards to claim 13, line 6, “the dosing gun” should be changed to “the doser gun”.
In regards to claim 13, line 7, “the dosing gun” should be changed to “the doser gun”.
In regards to claim 14, line 1, “the dosing gun” should be changed to “the doser gun”.
In regards to claim 14, line 2, “the magazine” should be changed to “the cartridge magazine”.
In regards to claim 14, line 2, “an upper-most cartridge” should be changed to “the upper-most cartridge”.
In regards to claim 14, lines 2-3, “the plurality of cartridges” should be changed to “the plurality of medicament cartridges”.
In regards to claim 16, line 1, “the dosing gun” should be changed to “the doser gun”.
In regards to claim 17, line 1, “the dosing gun” should be changed to “the doser gun”.
In regards to claim 18, line 3, “withing” should be changed to “within”.
In regards to claim 19, line 7, “the cavity” should be changed to “the internal cavity”.
In regards to claim 20, line 2, “actuating” should be changed to “the actuating”.
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.
Claim 15 is 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.
In regards to claim 15, line 2 recites “a prophylactic or therapeutic mastitis product”. Claim 15 depends upon claim 1. Claim 1, line 3 recites “a fluid”. It is unclear whether the two recitations are the same or different.
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 1-6, 10-12, 14-17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holmes et al (US 10,786,342).
In regards to claim 1, Holmes et al teaches a mammary-dosing system (Figures 1-25) comprising:
a plurality of medicament cartridges (12/12/12/12), each medicament cartridge comprising:
a cartridge body (16) defining an internal cavity (22) configured to retain a fluid
a cannula (26) extending radially upward from an upper surface of the cartridge body and communicatively connected to the internal cavity for dispensing the fluid from the cavity
a horizontal-alignment device (26/28/32/34)
a doser gun (14) comprising:
a cartridge magazine (46) configured to retain the plurality of medicament cartridges
a plunger assembly (44) configured to dispense the fluid from an upper-most cartridge (12) of the plurality of medicament cartridges
In regards to claim 2, Holmes et al teaches wherein the horizontal-alignment device (26/32/34) extends outward from the cartridge body.
In regards to claim 3, Holmes et al teaches wherein the horizontal-alignment device comprises a pair of wedge-shaped tabs (32) coupled to a lower surface of the cartridge body.
In regards to claim 4, Holmes et al teaches wherein each medicament cartridge further comprises an interlocking mechanism (32/34) disposed at a proximal portion of the cartridge body, the interlocking mechanism configured to removably couple adjacent cartridges into a vertical stack (Figure 5).
In regards to claim 5, Holmes et al teaches wherein the interlocking mechanism comprises a lower pair of inverted-U-shaped claws (32), and counterpart pair of upper tabs (34).
In regards to claim 6, Holmes et al teaches wherein the interlocking mechanism extends fully around a circumference of the cartridge body (Figure 3).
In regards to claim 10, Holmes et al teaches wherein the plunger assembly comprises:
a plunger head (82B) configured to extend distally into the cartridge body to eject the fluid from the cannula
a wedge-shaped blade (106) configured to separate an upper-most cartridge of the plurality of medicament cartridges from an adjacent lower cartridge of the plurality of medicament cartridges
an elongated shaft (66) defining a longitudinal axis
a slide (78) disposed overtop of the plunger head and in sliding contact with the plunger head
a spring (80) disposed between a distal end of the slide and an interior surface of a main body of the doser gun
In regards to claim 11, Holmes et al teaches wherein a distal-most tip of the wedge-shaped blade extends distally past a leading edge of the plunger head (column 5, lines 57-61).
In regards to claim 12, Holmes et al teaches wherein the plunger assembly further comprises:
a plunger knob (88) extending downward from the elongated shaft
a grooved block (76) defining a guide track configured to receive the plunger knob (Figures 20-21)
In regards to claim 14, Holmes et al teaches wherein the dosing gun further comprises a release tab (100) enabling a user to eject, from the magazine, an upper-most cartridge (12) of the plurality of cartridges without dispensing the fluid from the cannula (column 6, lines 28-32).
In regards to claim 15, Holmes et al teaches wherein the system enables a user to administer a prophylactic or therapeutic mastitis product to a teat of a mammal (column 8, lines 54-56), wherein the cannula is configured to engage the teat of the mammal (column 8, lines 56-57).
In regards to claim 16, Holmes et al teaches wherein the dosing gun further comprises:
an ergonomic handle (60)
a trigger (62) having a lower end hingeably connected to a bottom portion of the ergonomic handle, and an upper end coupled to a proximal end of the plunger assembly
a V-shaped spring (68) extending through the ergonomic handle and the trigger, wherein the V-shaped spring is configured to bias the trigger into a retracted configuration (Figure 8)
In regards to claim 17, Holmes et al teaches wherein the dosing gun further comprises a cartridge cap (56) configured to removably couple to a bottom end of the cartridge magazine.
In regards to claim 19, Holmes et al teaches a method comprising:
loading a plurality of medicament cartridges (12/12/12/12) into a cartridge magazine (46) of a dosing gun (14) (Figure 1 to Figure 22), wherein each of the plurality of medicament cartridges comprises:
a cartridge body (16) defining an internal cavity (22) configured to retain a fluid
a cannula (26) extending radially upward from an upper surface of the cartridge body and communicatively connected to the internal cavity for dispensing the fluid from the cavity
a horizontal-alignment device (26/32/34) extending outward from the cartridge body
actuating a plunger assembly (44) of the dosing gun to dispense the fluid from the cannula of an upper-most cartridge (12) of the plurality of medicament cartridges (Figures 24-25)
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes et al (US 10,786,342), as applied to claim 1 above, and further in view of Dasbach et al (US 9,060,758).
In regards to claim 7, Holmes et al does not teach wherein the horizontal-alignment device comprises an adhesive label coupled across a proximal end of each of the plurality of medicament cartridges, as Holmes et al teaches wherein the horizontal-alignment device comprises coupled cannulas (26) and indentations 28 and coupled hooks 32 and tabs 34. Dasbach et al teaches a system (Figure 14A) wherein a horizontal-alignment device comprises an adhesive label (5/T) coupled across a proximal end of each of a plurality (1) of cartridges (2). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the horizontal-alignment device, of the system of Holmes et al, to comprise an adhesive label coupled across a proximal end of each of the plurality of medicament cartridges, as taught by Dasbach et al, as such will provide a sterile seal for unused cartridges (column 4, lines 58-60).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes et al (US 10,786,342) and Dasbach et al, as applied to claim 7 above, and further in view of Holmes et al (US 10,583,252).
In regards to claim 8, in the modified system of Holmes et al (US 10,786,342) and Dasbach et al, Holmes (US 10,786,342) does not teach wherein the adhesive label comprises a horizontal perforation line between each adjacent pair of cartridges of the plurality of medicament cartridges. Dasbach et al is silent about wherein the adhesive label comprises a horizontal perforation line between each adjacent pair of cartridges of the plurality of medicament cartridges. Holmes et al (US 10,583,252) teaches a system (Figure 18B) wherein a label (305) comprises a horizontal perforation line (326) between each adjacent pair of cartridges of a plurality of medicament cartridges (syringe cartridges). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the label, of the modified system of Holmes et al (US 10,786,342) and Dasbach et al, to comprise a horizontal perforation line between each adjacent pair of cartridges of the plurality of medicament cartridges, as taught by Holmes et al (US 10,583,252), as such will provide indexing means between each of the spaced apart medicament cartridges to accommodate an index pawl of the dosing gun (column 23, lines 61-66), wherein indexing is adapted to move the next medicament cartridge into the dispensing position after the contents of the preceding medicament cartridge have been dispensed such that subsequent movement of a trigger from an extended position to a retracted position results in the plunger assembly driving the fluid from the next medicament cartridge (column 4, lines 1-10).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes et al (US 10,786,342), as applied to claim 1 above, and further in view of Lane (US 2007/0114200).
In regards to claim 9, Holmes et al does not teach wherein the horizontal-alignment device comprises a label extending around lateral sides of the plurality of medicament cartridges, as Holmes et al teaches wherein the horizontal-alignment device comprises coupled cannulas (26) and indentations 28 and coupled hooks 32 and tabs 34. Lane teaches a system (Figure 5) wherein a horizontal-alignment device comprises a label (54) extending around lateral sides of a plurality of cartridges (2/2/2/2). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the horizontal-alignment device, of the system of Holmes et al, to comprise a label extending around lateral sides of the plurality of medicament cartridges, as taught by Lane, as such will allow for packaging and shipping by packaging of the cartridges without the use of paper or other firm packaging support material, thereby reducing packaging costs (paragraph [0034]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes et al (US 10,786,342), as applied to claim 1 above, and further in view of Sandhage et al (US 4,077,406).
In regards to claim 18, Holmes et al does not teach wherein the cartridge magazine comprises a transparent window for viewing the plurality of medicament cartridges housed withing the cartridge magazine, as Holmes et al instead teaches wherein the cartridge magazine comprises an aperture 50 for viewing the plurality of medicament cartridges housed withing the cartridge magazine. Sandhage et al teaches a system (Figures 1-5) wherein a cartridge magazine (30) comprises a transparent window (both faces of the magazine should be transparent) for viewing a plurality of medicament cartridges (52) housed withing the cartridge magazine (column 6, lines 34-36). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge magazine, of the system of Holmes et al, to comprise a transparent window, as taught by Sandhage et al, as such will permit visual inspections of contents of the cartridge magazine (column 6, lines 34-36).
Allowable Subject Matter
Claims 13 and 20 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.
In regards to dependent claim 13, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a mammary-dosing system, as claimed, specifically including wherein a second manual actuation of the dosing gun causes the plunger knob to travel through the second track portion to eject the upper-most cartridge from the dosing gun.
Holmes et al (US 10,786,342) teaches wherein the guide track comprises a first track portion (92C to 92D to 92A), an intermediate resting point (92A), and a second track portion (92A to 92B to 92C), wherein a first manual actuation of the dosing gun (14) causes the plunger knob (88) to travel through the first track portion and catch at the intermediate resting point to dispense the fluid from the cannula (26) of an upper-most cartridge (12) of the plurality of medicament cartridges (12/12/12/12) (column 5, lines 20-26)(column 6, lines 19-32), and wherein a second manual actuation of the dosing gun causes the plunger knob to travel through the second track portion (column 5, lines 13-20)(column 6, lines 16-19).
However, Holmes et al (US 10,786,342) does not teach wherein a second manual actuation of the dosing gun causes the plunger knob to travel through the second track portion to eject the upper-most cartridge from the dosing gun, as Holmes et al (US 10,786,342) instead teaches wherein a first manual actuation of the dosing gun (14) causes the plunger knob (88) to travel through the first track portion (92C to 92D to 92A) and catch at the intermediate resting point (92A) to dispense the fluid from the cannula (26) of an upper-most cartridge (12) of the plurality of medicament cartridges (12/12/12/12) and to eject the upper-most cartridge from the dosing gun (column 5, lines 20-26)(column 6, lines 19-32), and wherein a second manual actuation of the dosing gun causes the plunger knob to travel through the second track portion to remove a cap 18 from the cannula of the upper-most cartridge (column 5, lines 13-20)(column 6, lines 16-19).
Thus, dependent claim 13 is 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 1 and intervening claims 10 and 12.
In regards to dependent claim 20, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a method, as claimed, specifically including wherein the method further comprises squeezing the trigger of the dosing gun a second time to eject the upper-most cartridge from the cartridge magazine.
Holmes et al (US 10,786,342) teaches wherein actuating the plunger assembly (44) comprises squeezing a trigger (62) of the dosing gun (14) a first time to dispense the fluid from the cannula (26) of the upper-most cartridge (12) (column 5, lines 20-26)(column 6, lines 19-32); and wherein the method further comprises squeezing the trigger of the dosing gun a second time (column 5, lines 13-20)(column 6, lines 16-19).
However, Holmes et al (US 10,786,342) does not teach wherein the method further comprises squeezing the trigger of the dosing gun a second time to eject the upper-most cartridge from the cartridge magazine, as Holmes et al (US 10,786,342) instead teaches wherein actuating the plunger assembly (44) comprises squeezing a trigger (62) of the dosing gun (14) a first time to dispense the fluid from the cannula (26) of the upper-most cartridge (12) and to eject the upper-most cartridge from the cartridge magazine (46) (column 5, lines 20-26)(column 6, lines 19-32), and wherein the method further comprises squeezing the trigger of the dosing gun a second time to remove a cap 18 from the cannula of the upper-most cartridge (column 5, lines 13-20)(column 6, lines 16-19).
Thus, dependent claim 20 is 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 19.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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