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 .
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 26 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.
Claim 26 recites the limitation "packaging foil" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-6, 8, 9, 11-14, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boisnard (FR 2293916 A1).
Regarding claim 1, Boisnard discloses an apparatus (Figs. 1-2) for combining a first liquid component stored in a container (12) and a second solid or liquid component stored in a vial (14) by means of negative pressure, comprising a tray (10) having a vial cavity (the cavity formed within 10 that 14 may be inserted within) for accommodating at least a portion of the vial and a container cavity (the cavity formed within 10 that 12 may be inserted within) for accommodating at least a portion of the container, and a transfer needle (24) having a first needle tip (38), a second needle tip (36) and a lumen (the portion of 24 between the ends) for establishing a fluid communication between the vial and the container in a transfer position, in which the first needle tip is engaged with the vial and the second needle tip is engaged with the container (Fig. 2); wherein the transfer needle is fixedly held at the tray at an intermediate needle holding portion of the tray between the vial cavity and the container cavity (Figs. 1-2), wherein the vial cavity is configured for guiding a movement of the vial along an axial direction (AD) from an intermediate position (Fig. 1), in which the first needle tip is not engaged with the vial, towards the transfer position (Fig. 2), and the container cavity is configured for guiding a movement of the container along the axial direction (AD) from an intermediate position (Fig. 1), in which the second needle tip is not engaged with the container, towards the transfer position (Fig. 2).
Regarding claim 2, Boisnard further discloses the apparatus as claimed in claim 1, wherein the vial cavity or the vial cavity and the container cavity each comprises retaining members, which are configured to position the vial and the container, respectively, in the intermediate position and in parallel with the axial direction (AD). (see the shoulder 22 of 10 which is radially recessed in order to help retain the vial/container inside of 10)
Regarding claim 3, Boisnard further discloses the apparatus as claimed in claim 2, wherein the retaining members are further configured to guide an axial movement of at least one of the vial and container from the intermediate position to the transfer position while maintaining an axial alignment of at least one of the vial and container with the needle. (as shown in Fig. 5)
Regarding claim 4, Boisnard further discloses the apparatus as claimed in claim 3, wherein the retaining members comprise pairs of protrusions (the shoulder at 22 is a protrusion which protrudes radially inward from the inner wall of 10) formed on opposite side-walls of the vial cavity and container cavity, respectively, which are configured for contacting side-surfaces of the vial and container, respectively, for positioning the vial and the container, respectively, and guiding the axial movement of the vial and container, respectively, along the axial direction. (Fig. 5)
Regarding claim 5, Boisnard further discloses the apparatus as claimed in claim 4, wherein a height (h2) of contact regions of the protrusions with the side-surfaces of the vial and container, respectively, above a bottom of the vial cavity and container cavity, respectively, is larger than the height of a center line (CL) of the vial and container above the bottom of the vial cavity and container cavity, respectively. (this would necessarily be true as seen in Figs. 2 and 5)
Regarding claim 6, Boisnard further discloses the apparatus as claimed in claim 4, wherein the opposite side-walls on which the protrusions are formed are each upright and planar side-walls. (Fig. 5)
Regarding claim 8, Boisnard further discloses the apparatus as claimed in claim 4, wherein a bottom of the vial cavity is curved with a radius of curvature corresponding to an outer radius of a vial body of at least one of the vial and wherein the profile of a bottom of the container cavity corresponds to an outer profile of the container. (Figs. 2 and 5)
Regarding claim 9, Boisnard further discloses the apparatus as claimed in claim 1, wherein the vial cavity further comprises axial position limiting members (20 and 22) configured for delimiting an axial movement of the vial inside the vial cavity in a storage position. (Figs. 2 and 5)
Regarding claim 11, Boisnard further discloses the apparatus as claimed in claim 1, wherein the vial cavity and the container cavity each comprises a stop surface (the surface 20 is a stop surface for each cavity as shown in Figs. 2-5) for delimiting an axial displacement of the vial and of the container towards the transfer needle by abutment with a front end of the vial and a surface of the container, respectively. (Figs. 2-5)
Regarding claim 12, Boisnard further discloses the apparatus as claimed in claim 1, wherein the vial cavity further comprises a portion that is sufficiently wide to enable access to a vial body of the vial by means of fingers of a user or grippers of a robot in the intermediate position for at least one of driving the axial displacement of the vial towards the transfer position and removal of the vial in the intermediate position from the tray. (Figs. 1-5; the axially outer portions of the vial cavity is wide enough to perform the claimed function)
Regarding claim 13, Boisnard further discloses the apparatus as claimed in claim 1, wherein the vial cavity further comprises a rear end cavity (the axially outer portion of the vial cavity), where a bottom of the vial is sufficiently exposed to enable access to the bottom for a finger of a user or a manipulation member of a robot for driving the axial movement of the vial from the intermediate position to the transfer position. (the apparatus of Boisnard is at least capable of performing this function)
Regarding claim 14, Boisnard further discloses the apparatus as claimed in claim 1, wherein the tray comprises a tray member (the member that is axially outward from 22 as shown in Fig. 5) having a planar upper surface and wherein the retaining members of the cavities are formed integrally with the tray member. (Figs. 2 and 5)
Regarding claim 21, Boisnard further discloses the apparatus as claimed claim 1, wherein the vial is accommodated in the vial cavity of the tray at the intermediate position, in which the first needle tip is not engaged with the vial, and the container is accommodated in the container cavity at the intermediate position, in which the second needle tip is not engaged with the container. (Figs. 1-2)
Claim Rejections - 35 USC § 103
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 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) 10, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boisnard.
Regarding claim 10, Boisnard further discloses the apparatus as claimed in claim 9, but fails to disclose wherein the axial position limiting members are more flexible than the retaining members of the vial cavity.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the material of the axial position limiting members to be made of a more flexible material than the retaining members of the vial cavity since selection of a known material on the basis of its suitability for an intended use involves only routine skill in the art. The motivation for doing so would be to provide known materials that are optimal based on user defined criteria.
Regarding claim 15, Boisnard further discloses the apparatus as claimed in claim 14, but fails to disclose the tray member is made of plastic material.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the material of the tray member to be made of plastic material since selection of a known material on the basis of its suitability for an intended use involves only routine skill in the art. The motivation for doing so would be to provide known materials that are optimal based on user defined criteria.
Note that the limitation of wherein the tray member is made by vacuum thermoforming or pressure thermo-forming of a plastic sheet or by means of plastic injection molding is a product-by process limitation. As set forth in MPEP § 2113(I), "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 16, Boisnard further discloses the apparatus as claimed in claim 14, but fails to disclose wherein the tray member is made of paper or cardboard with a thin film of plastic or bioplastic arranged on inner surfaces of at least one of the vial cavity and container cavity.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the material of the tray member to be made of paper or cardboard with a thin film of plastic or bioplastic arranged on inner surfaces of at least one of the vial cavity and container cavity since selection of a known material on the basis of its suitability for an intended use involves only routine skill in the art. The motivation for doing so would be to provide known materials that are optimal based on user defined criteria.
Claim(s) 19, 20, 22, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boisnard in view of Cowe et al. (US 2019/0366000, hereafter “Cowe”).
Regarding claim 19, Boisnard further discloses the apparatus as claimed in claim 1, wherein a central portion of the transfer needle is accommodated in a needle packaging (the housing of 24) that is fixedly held at the tray at the intermediate needle holding portion, the needle tips protrude into the vial cavity and container cavity, respectively, when the vial cavity and the container cavity is each aligned along the axial direction, but fails to disclose the needle tips are covered by cap members so that the needle is packaged under sterile conditions and the cap members can be removed from the needle packaging or opened for access to the needle tips of the transfer needle for fluid transfer.
Cowe teaches an apparatus comprising needle tips (Fig. 1a; 144) that are covered by cap members (118) so that the needle is packaged under sterile conditions and the cap members can be removed from the needle packaging or opened for access to the needle tips of the transfer needle for fluid transfer. (para. [0005], [0079])
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the apparatus of Boisnard to include a cap as taught by Cowe in order to provide a means to protect the needle when the device is not in operation. (para. [0005], [0079])
Regarding claim 20, Boisnard in view of Cowe further discloses the apparatus as claimed in claim 19, wherein the needle packaging is fixedly held at the tray at the intermediate needle holding portion in a positive-fit manner. (Figs. 1-2)
Regarding claim 22, Boisnard further discloses the apparatus as claimed in claim 21, but fails to disclose wherein the transfer needle is packaged under sterile conditions by a needle packaging.
Cowe teaches an apparatus wherein the transfer needle (144) is packaged under sterile conditions by a needle packaging (118). (para. [0005], [0079])
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the apparatus of Boisnard to include a needle packaging as taught by Cowe in order to provide a means to protect the needle when the device is not in operation. (para. [0005], [0079])
Regarding claim 25, Boisnard discloses a packaging unit for packaging a vial (14) storing a second solid or liquid component together with a container (12) storing a first liquid component, comprising an apparatus (Figs. 1-2) for combining a first liquid component stored in a container and a second solid or liquid component stored in a vial by means of negative pressure, comprising a tray (10) having a vial cavity (the cavity formed within 10 that 14 may be inserted within) for accommodating at least a portion of the vial and a container cavity (the cavity formed within 10 that 12 may be inserted within) for accommodating at least a portion of the container, and a transfer needle (24) having a first needle tip (38), a second needle tip (36) and a lumen (the portion of 24 between the ends) for establishing a fluid communication between the vial and the container in a transfer position (Fig. 2), in which the first needle tip is engaged with the vial and the second needle tip is engaged with the container; wherein the transfer needle is fixedly held at the tray at an intermediate needle holding portion of the tray between the vial cavity and the container cavity (Figs. 1-2), wherein the vial cavity is configured for guiding a movement of the vial along an axial direction (AD) from an intermediate position (Fig. 1), in which the first needle tip is not engaged with the vial, towards the transfer position (Fig. 2), and the container cavity is configured for guiding a movement of the container along the axial direction (AD) from an intermediate position (Fig. 1), in which the second needle tip is not engaged with the container, towards the transfer position (Fig. 2); wherein the vial is accommodated in the vial cavity of the tray at the intermediate position, in which the first needle tip is not engaged with the vial, the container is accommodated in the container cavity at the intermediate position, in which the second needle tip is not engaged with the container (Figs. 1-2), but fails to disclose the transfer needle is packaged under sterile conditions by a needle packaging.
Cowe teaches an apparatus wherein the transfer needle (144) is packaged under sterile conditions by a needle packaging (118). (para. [0005], [0079])
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the apparatus of Boisnard to include a needle packaging as taught by Cowe in order to provide a means to protect the needle when the device is not in operation. (para. [0005], [0079])
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boisnard in view of Cowe and Fathallah (US 2002/0128628).
Regarding claim 26, Boisnard in view of Cowe further discloses the packaging unit as claimed in claim 25, wherein the tray comprises a planar upper surface (Figs. 1-2), but fails to disclose packaging foil is adhesively bonded (product-by-process) to the upper surface of the tray.
Fathallah teaches an apparatus comprising packaging foil is adhesively bonded to the upper surface of the tray. (para. [0027])
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the apparatus of Boisnard to include a packaging foil as taught by Fathallah in order to provide a means to protect the apparatus during transportation. (para. [0027])
Allowable Subject Matter
Claims 7, 17 and 18 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J GRAY whose telephone number is (571)270-0544. The examiner can normally be reached 9:00 am - 5:00 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kenneth Rinehart can be reached at 571 272-4881. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL J GRAY/Primary Examiner, Art Unit 3753
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