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 statement (IDS) submitted on 3/20/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for two syringes and an injection needle, does not reasonably provide enablement for “a single injection needle common to said two syringes”. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The breadth of the claims – claim limitation “a single injection needle common to said two syringes”
The nature of the invention – providing a compact injection device
The state of the prior art – The state of the art recognizes that syringe(s) contain injection needles to administer a liquid substance
The level of one of ordinary skill – An operator with sufficient skill and experience using an injection device for administering a substance to a bird
The level of predictability in the art – The injection needle is predictable with regards to the correlation to a syringe being used
The amount of direction provided by the inventor – The disclosure expressly teaches “one or two syringes and an injection needle”, “each injection needle is thus not placed in the extension of its syringe”
The existence of working examples – One working example is provided in the specification [0078] “the actuation of a control button placed on the main body of the injection device makes it possible to switch from a single to a double injection (activation of one or both cylinders)”
The quantity of experimentation needed to make or use the invention based on the content of the disclosure – the quantity of experimentation would be substantial as the specification fails to show how the syringes are actuated and able to share a single needle or performing a double injection
Analysis of the preceding Wands factors supports the conclusion that one having ordinary skill in the art could not make and use the claimed invention without exercising undue experimentation; therefore the claimed invention is not enabled.
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, 4, 5, 6, 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, 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), the device comprising:- 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, movement of the needle between said retracted and injecting positions (Col. 6, lines 21-29), 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: needle 33 at acute angle to exterior surface 35), wherein said axis of movement extending, away from the main body (Col. 6, lines 21-25: movement of the needle 33, away and interior of the main body in the retracted position, as shown in Fig. 1), beyond an exclusion zone (Fig. 1: below aperture 73, outside of the boundary of the walls of the guide element 61) surrounding the guide axis.
For claim 4, Yiournas discloses the injection device according to claim 1, wherein 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 axis (a longitudinal axis of the guide element 61) 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, wherein 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 the bird’s neck is kept aligned or substantially aligned along the 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, wherein, in line with the injecting position, a distance separating a free end of said injection needle from the exterior surface of said base determines a 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, wherein the main body (Fig. 1: 13) is configured for placement on a flat horizontal surface, wherein 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, wherein the injection assembly further comprises 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, wherein a 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 a discharging of the bird after an 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, wherein 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Yiournas (U.S. Patent No. 4,276,879, as above).
For claim 3, Yiournas discloses the invention substantially as claimed, including wherein 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 within the range of 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, Yiournas discloses the invention substantially as claimed, but fails to show wherein said guide element comprises a first part of a flared body and a second part of said flared body forming a narrowing, said first part of said flared body being arranged to guide the an upper part of the back of the bird toward said narrowing; wherein said main body comprises recesses arranged laterally to the guide element in order to facilitate the insertion of the bird to be injected by the operator into the guide element; and wherein an upper end of said main body has an elbow to impose a particular inclination on the head of the bird, the elbow, or bent part, comprising one or more holding elements configured to keep the head of the bird to be vaccinated in a fixed 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 said flared body forming a narrowing (Figs. 1 and 3: at 36’), said first part of said flared body being arranged to guide an upper part of the back of the bird toward said narrowing (as shown in [0079]); wherein said main body comprises recesses (Fig. 3: as shown in the upper part of the contact section 34) arranged laterally to the guide element in order to facilitate the insertion of the bird to be injected by the operator into the guide element (Fig. 1: 14); and wherein an 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, the elbow, or bent part, 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 a fixed 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, Yiournas discloses the invention substantially as claimed, but fails to show wherein the needle is offset relative to the at least one syringe and that it wherein the injection device comprises two syringes and a single injection needle common to said two syringes. 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 at least one syringe ([0031] and as shown in Fig. 4: at two outside dosage device plungers 24) and wherein the injection device comprises two syringes (Fig. 4: 24) and a single injection needle (Fig. 4: 8) common to said two syringes (as shown in Fig. 4). 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.
Allowable Subject Matter
Claim 2 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 and any intervening claims.
Response to Arguments
Applicant's arguments filed 4/21/2026 have been fully considered but they are not persuasive.
With regard to the rejection of claim 1, Applicant’s argument A: “The Office Action maps the "longitudinal orientation of the retention plate" to the recited guide axis (Office Action, p. 7), but Yiournas's retention plate (61) is oriented horizontally: the bird is placed laterally into the curved trough, not moved headfirst along any defined longitudinal axis toward an injection zone. Indeed, Yiournas explicitly teaches the opposite orientation: the bird is held stationary while a downward force is applied to lower the retention plate onto the work surface and actuate the switch.”
In response to applicant's argument above, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
With regard to the rejection of claim 1, Applicant’s argument B: “While the retention plate positions the animal's neck generally within the trough, it does not align the neck along any defined guide axis in an injection zone because Yiournas defines no such guide axis and no such injection zone distinct from the retracted position of the needle. Yiournas's retention plate merely holds the animal still while the needle, oriented at an acute angle of 15° to 40° to the work surface, penetrates through aperture (73). This is very different from a guide element that keeps the neck aligned along a longitudinal guide axis in a specific injection zone defined by the guide element's geometry. This limitation is absent from Yiournas.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “an injection zone distinct from the retracted position of the needle”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The examiner maintains that the reference to Yiournas teaches the guide element (61) is configured to keep at least the neck of the bird aligned or substantially aligned (as shown in Figs. 5-6) along said guide axis in the injection zone (Figs. 1-3: through opening 34 and aperture 73 along the guide axis).
With regard to the rejection of claim 1, Applicant’s argument C. “Yiournas Does Not Disclose an Exclusion Zone Surrounding a Guide Axis From Which the Needle's Axis of Movement Extends Beyond… The Office Action maps Yiournas's aperture (73) to the claimed "exclusion zone," reasoning that the area "outside of the boundaries of the guide element" constitutes such a zone (Office Action, p. 7). However, this mapping is legally and factually incorrect.”.
The Applicant is incorrect, Yiournas's aperture (73) was not mapped to the claimed "exclusion zone". The examiner mapped the claimed guide element to the trough (61) having a guide axis (along a longitudinal axis of the guide element 61). The claim requires movement of the injection needle (Fig. 1: 33) between said retracted and injecting positions is along an axis of movement at an angle (of needle 33 as shown in Fig. 1) relative to the exterior surface (Fig. 6: at 35), wherein said axis of movement extending, away from the main body (movement of the needle 33, interior of the main body in the retracted position, as shown in Fig. 1), beyond an exclusion zone (below aperture 73) surrounding the guide axis (interior of the main body in the retracted position, as shown in Fig. 1), as claimed.
Further, Applicant argues no motivation to modify Yiournas to arrive at the combination of limitations of claim 1 would have existed. The examiner maintains the 35 U.S.C. § 102(a)(2) rejection of claim 1 above, see response to arguments above.
Applicant argues, with regard to claim 3 “Moreover, as amended, claim 3 recites the exclusion zone as "within the range of 2 to 4 mm," which directly corresponds to the specification's specific teaching at paragraphs [0044]- [0045]. This specific numerical range, grounded in a technical purpose of protecting the vertebral column, is not the product of routine optimization over prior art that lacks the underlying concept entirely.”
The ”exclusion zone” merely being an area of space, such that one having ordinary skill in the art would clearly recognize that a range of 2 to 4 mm from the guide axis would be an area close to a bird in position within the injection device. Thus, movement of the needle away from the guide axis at 2 to 4 mm would prevent any accidental contact, 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.
Applicant’s argument, with regard to claims 8, 9 and 15, “The field of endeavor of the claimed invention is a subcutaneous neck-injection device for birds in which the bird is guided headfirst along a guide axis to an injection zone, with a defined exclusion zone protecting the cervical spine. Raidt is directed to a fundamentally different device: one that administers injections into the breast muscle of a chicken via a shaped contact plate whose geometry conforms to the bird's breast/breastbone anatomy. (Raidt, [0007]-[0010]; Figs. 1, 3-5.)”.
In response, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the references to Yiournas and Raidt et al., and applicant’s instant invention, are directed to an injection device for administering an injection to a bird. The injection devices include a syringe and a needle, and an actuator that can move the syringe to discharge a vaccine or desired substance.
Applicant argues, with regard to claims 11 and 12 “Smith's inventive concept is the simultaneous delivery of two or more incompatible injectable substances through a single needle, which is a pharmaceutical delivery architecture problem. This is not the field of endeavor of the claimed invention, which concerns the structural configuration of a guide element and injection assembly for safe, precise neck vaccination of birds.”
In response, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the references to Yiournas and Smith, and applicant’s instant invention, are directed to an injection device for administering an injection to a bird. The injection devices include a syringe and a needle, and an actuator that can move the syringe to discharge a vaccine or desired substance.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, Peter Poon can be reached at 571-272-6891. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIELLE A CLERKLEY/ Examiner, Art Unit 3643
/PETER M POON/ Supervisory Patent Examiner, Art Unit 3643
Prosecution Insights