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 information disclosure statements (IDS) submitted on 3/24/2023 and 5/13/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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, the “elbow” of claim 15 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.
Claim Objections
Claims 1, 5, 6-11 and 15 are objected to because of the following informalities:
For clarity, claim 1, lines 13-17 should be changed to “- said injection needle being arranged such that, of the needle between said retracted and injecting positionsis along an axis of movement parallel to the exterior surface of the base, or at an angle relative to said exterior surface, wherein said axis of movement extending, away from the main body, beyond an exclusion zone surrounding the guide axis (15).”
Claim 5, line 5 recites "this guide axis" which should be --the guide axis--.
Claim 6, lines 2-3 recites "the distance separating the free end of said injection needle" which should be --a distance separating a free end of said injection needle--.
Claim 6, line 4 recites "subcutaneous injection" which should be --a subcutaneous injection--.
Claim 7, lines 2-3 recites "this injection device is configured such that its main body being placed on a flat horizontal surface, the bird is injected in the vertical or substantially vertical position" which should be --the main body is configured for placement on a flat horizontal surface, wherein the bird is injected in the vertical or substantially vertical position--.
Claim 8, line 3 recites "said first part of said body" which should be --said first part of said flared body--.
Claim 8, line 4 recites "the upper part of the body of the bird" which should be --the upper part of the back of the bird--.
Claim 9, line 3 recites "this guide element" which should be --the guide element--.
Claim 9, line 4 recites "this guide element" which should be --the guide element--.
For clarity, Claim 10, line 2 "each injection assembly comprising a linear actuator" which should be --the injection assembly further comprises a linear actuator--.
Claim 11, line 2 recites "the syringe(s)" which should be --the at least one syringe--.
Claim 15, line 2 recites "this elbow" which should be --the elbow--.
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 1-15 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation "characterized in that it" in line 4. There is insufficient antecedent basis for “it” in the claim.
Claim 1 recites the limitation "beyond an exclusion zone surrounding the guide axis" in line 16. It is unclear what delineates the exclusion zone and the guide axis, and thus what constitutes an area beyond an exclusion zone.
Claim 2 recites the limitation "angle of between [0, 4°]" in line 3. It is unclear what the brackets are for and if the intended range is between 0 and 4 degrees.
Claim 3 recites the limitation "extending over 2 to 4 mm around said guide axis" in line 2. The use of the term “over” along with the range of distances is unclear, such that is the exclusion zone over 4 mm around said guide axis or within the range of 2 to 4 mm.
Claim 4 recites the limitation "said guide pin" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "a second part of the body" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "it comprises" in line 2. There is insufficient antecedent basis for “it” in the claim.
Claim 12 recites the limitation "an injection needle" in line 2. There is an injection needle already recited in claim 1, so it is unclear if more than one injection needle is required.
Claim 13 recites the limitation "the lower end of said guide element" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the discharging" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the injection" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the corners of the parts of the device" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the upper end of said main body" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "in position" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 5-7 and 9-11 are rejected as being dependent from a rejected base claim.
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)(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.
Claims 1-7, 10, 13 and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yiournas (U.S. Patent No. 4,276,879, as cited by Applicant in IDS 3/24/2023 as Costas).
For claim 1, as best understood, Yiournas discloses a device for injecting fluid into a bird (as discussed in the abstract), the device having a main body (13), which comprises an injection assembly comprising an injection needle (33) and at least one syringe (20), the needle being movable between a retracted position and an injecting position (Col. 2, lines 34-38) located in an injection zone (Figs. 1-3: through opening 34 and aperture 73) positioned outside the main body (Col. 5, lines 54-60), characterized in that it comprises:- a guide element (Figs. 1-6: 61) placed on an exterior surface of the main body (as shown in Fig. 1), said guide element (61) comprising a base (Figs. 1-4: 62) and side edges (Figs. 1-3: 63) extending from this base, at least the upper part of the back of the bird to be vaccinated being intended to rest against said base (as shown in Figs. 5-6), and to be moved, headfirst, along a guide axis (a longitudinal axis of the guide element 61) defined by the guide element (61), to the injecting position (Col. 5, line 61-Col. 6, lines 3), - said guide element being additionally configured to keep at least the neck of the bird aligned or substantially aligned along said guide axis in the injection zone,- said injection needle being arranged such that, during its movement between said retracted and injecting positions (Col. 6, lines 21-29), it moves along an axis of movement (Col. 6, lines 24-25) parallel to the exterior surface of the base, or at an angle relative to said exterior surface (Col. 2, lines 32-34), said axis of movement extending, away from the main body (Col. 6, lines 21-25), beyond an exclusion zone surrounding the guide axis (outside of the boundaries of the guide element).
For claim 4, Yiournas discloses the injection device according to claim 1, characterized in that the axis of movement of said injection needle (Col. 6, lines 21-25) being contained in a plane parallel to said base (Col. 3, lines 51-53), said axis of movement and said guide pin (Fig. 1: bracket 28 housing bolt 29) are collinear (Col. 3, lines 39-59) or said axis of movement diverges from said guide axis.
For claim 5, Yiournas discloses the injection device according to claim 1, characterized in that said guide element (Figs. 1-6: 61) is configured such that the spine of said bird is placed in said exclusion zone (Figs. 5-6 shows the head of the bird in the guide element 61 and the spine of the bird outside of the boundaries of the guide element 61), when at least the upper part of the back of the bird to be vaccinated is pressed against said base (Figs. 1-6: 62) and that its neck is kept aligned or substantially aligned along this guide axis in said injection zone (Col. 4, line 67-Col. 5, line 10).
For claim 6, Yiournas discloses the injection device according to claim 1, characterized in that, in line with the injecting position, the distance separating the free end of said injection needle from the exterior surface of said base determines subcutaneous injection into the neck of said bird (Col. 4, lines 4-8).
For claim 7, Yiournas discloses the injection device according to claim 1, characterized in that this injection device is configured such that its main body (Fig. 1: 13) being placed on a flat horizontal surface, the bird is injected in the vertical or substantially vertical position (as shown in Fig. 6).
For claim 10, Yiournas discloses the injection device according to claim 1, characterized in that each injection assembly comprising a linear actuator (Fig. 1: 27, 41), said linear actuator is a hydraulic, pneumatic or electric actuator (Col. 4, lines 16-21 and Col. 6, lines 45-50).
For claim 13, Yiournas discloses the injection device according to claim 1, characterized in that the lower end (Col. 4, line 67-Col. 5, line 6: the open end near flange 65) of said guide element (Figs. 1-2: 61) is in communication with a slide (Figs. 1-6: 65) ensuring the discharging of the bird after the injection has been administered (pivoting the guide element to the substantially vertical position as shown in Fig. 1).
For claim 14, Yiournas discloses the injection device according to claim 1, characterized in that the corners of the parts of the device (Fig. 2 shows the corners of the guide element 61 are rounded) with which the bird and the operator are able to come into contact are rounded.
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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Yiournas (U.S. Patent No. 4,276,879, as above).
For claim 2, Yiournas discloses the invention substantially as claimed, but fails to show the axis of movement of said needle between said retracted and injecting positions is inclined by an angle of between [0, 40] relative to the exterior surface of said base. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Yiournas to include the axis of movement of said needle between said retracted and injecting positions inclined by an angle of between [0, 40] relative to the exterior surface of said base for the advantage of administering both subcutaneous and intramuscular injections, since it has been held that where routine testing and general experimental conditions are present, discovering the optimum or workable ranges until the desired effect is achieved involves only routine skill in the art. In re Aller, 105 USPQ 233.
For claim 3, Yiournas discloses the invention substantially as claimed, including the exclusion zone being a distance beyond the boundaries of the guide element (Figs. 1-6: 61), but fails to show said exclusion zone is a space extending over 2 to 4 mm around said guide axis. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Yiournas to include the exclusion zone being a distance beyond the boundaries of the guide element for the advantage of protecting a body part of the bird not to be injected with fluid, since it has been held that where routine testing and general experimental conditions are present, discovering the optimum or workable ranges until the desired effect is achieved involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 8-9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Yiournas (U.S. Patent No. 4,276,879, as above) in view of Raidt (U.S. Patent Application Publication No. 2017/0172718).
For claims 8-9 and 15, as best understood, Yiournas discloses the invention substantially as claimed, characterized in that said guide element comprises a first part of a flared body and a second part of the body forming a narrowing, said first part of the body being arranged to guide the upper part of the body of the bird toward said narrowing; characterized in that said main body comprises recesses arranged laterally to this guide element in order to facilitate the insertion of the bird to be injected by the operator into this guide element; and characterized in that the upper end of said main body has an elbow to impose a particular inclination on the head of the bird, this elbow comprising one or more holding elements configured to keep the head of the bird to be vaccinated in position. Raidt teaches a device for injecting fluid into a bird (as discussed in the abstract), the device having a main body (Fig. 1: 12) comprises a guide element (Fig. 1: 14) placed on an exterior surface of the main body; said guide element comprises a first part of a flared body (Figs. 1 and 3: at 34) and a second part of the body forming a narrowing (Figs. 1 and 3: at 36’), said first part of the body being arranged to guide the upper part of the body of the bird toward said narrowing (as shown in [0079]); characterized in that said main body comprises recesses (Fig. 3: as shown in the upper part of the contact section 34) arranged laterally to this guide element in order to facilitate the insertion of the bird to be injected by the operator into this guide element (Fig. 1: 14); and characterized in that the upper end of said main body has an elbow (Fig. 3: the inverted top part of the contact section 34) to impose a particular inclination on the head of the bird, this elbow comprising one or more holding elements ([0079] and as shown in Fig. 3: recess 36’ of inner pressure application area 36) configured to keep the head of the bird to be vaccinated in position (Fig. 3 shows the contact section 34 provides a stop for the position of the bird). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Yiournas to include a flared body and narrowing of the guide element, the recesses, and the elbow as taught by Raidt for the advantage of conforming and positioning the head of the bird within the guide element when in the injection position for ensuring proper needle placement.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yiournas (U.S. Patent No. 4,276,879, as above) in view of Smith (U.S. Patent Application Publication No. 2007/0093747).
For claims 11-12, as best understood, Yiournas discloses the invention substantially as claimed, but fails to show the injection device characterized in that the needle is offset relative to the syringe(s) and that it comprises two syringes and an injection needle. Smith teaches a device for injecting fluid into a bird (as discussed in the abstract), the device having a main body (Fig. 1: 3), which comprises an injection assembly (as shown in Figs. 2-4) comprising: a needle (Fig. 4: 8), the needle is offset relative to the syringe(s) ([0031] and as shown in Fig. 4: at two outside dosage device plungers 24) and that it comprises two syringes (Fig. 4: 24) and an injection needle (Fig. 4: 8). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Yiournas to include the injection assembly as taught by Smith for the advantage of delivering two injectable fluids through a single needle.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jorna (U.S. Patent Application Publication No. 2011/0054401); Moons (WO 2014170325 A1); and Eid (WO 2018204572 A1) disclose a device for injecting poultry with veterinary products comprising a contoured guide element.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE A CLERKLEY whose telephone number is (571)270-7611. The examiner can normally be reached 8:30AM-5PM.
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/DANIELLE A CLERKLEY/ Examiner, Art Unit 3643