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 .
Election/Restrictions
Applicant's election without traverse of Group I (claims 1-10, 12, 15, 20-22) in the reply filed on 09/16/2026 is acknowledged. Claims 16-19 are withdrawn.
Claim Objections
Claim 15 is objected to because of the following informalities:
In claim 15, line 1, ‘The dual-purpose vial’ should read “The apparatus”
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 9, 12, 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Riner (US 5,261,881) in view of Rossignol (US 2019/0366376) and Leinsing (US 2003/0153895).
Regarding claims 1, 12, Riner discloses that, as illustrated in Figs. 1-5, an apparatus comprising:
a dual-purpose integral injection molded plastic vial (item 10, Fig. 1 (col. 3, lines 19-21 and lines 40-57)) having a squeezable body portion (item 25, Fig. 1 (col. 3, lines 48-57)) with an internal chamber (item 37, Fig. 5 (col. 3, lines 48-57)) and an integral neck portion (item 35, Fig. 1 (col. 3, lines 46-46)) with a male lock fitting connector (item 42, Fig. 1 (col. 4, line 1)) for introducing and dispensing a fluid product FP to and from the internal chamber,
the neck portion having an inner radial cone member (item 35, Fig. 1 (col. 3, line 46)) open at both ends (item 43, Fig. 1 or 5 (col. 4, line 2)) and a cylindrical outer bushing (item 50, Fig. 1 or 2 or 3 (col. 4, line 5)) radially spaced from the inner cone member, the cylindrical outer bushing having an-internal thread (col. 4, lines 8-10 (i.e., formed by ridges 53 defining grooves 54)) configured to engage an external thread on a female lock fitting FLF connection (e.g., as shown in Fig. 1, the flange 16 has caused to travel in the groves 54 of the collar (col. 4, lines 60-61)),
wherein the dual-purpose vial is configured to function as:
b. a dispensing apparatus by then squeezing the body portion to drop dose the fluid product FP from the internal chamber of the vial via the cone member (col. 5, lines 23-37 (e.g., pressing the sidewalls 36 of the housing 25)).
However, Riner does not disclose a male and female luer fitting(s) for fluid connection and a separate closure member having a deformable portion.
In the same field of endeavor, vial adapter, Leinsing discloses that, as illustrated in Figs. 1, 2, 3, 4, 15, 16, 17, at the second end 35, the resealable needle-free valve 37 includes a female luer connector 41. The luer connector 41 is configured to receive all ANSI standard male luer fittings, as well as other blunt cannulas or fluid conduit devices ([0036], lines 1-6).
Leinsing discloses that, turning now also to FIG. 3, a side, cross-sectional view is seen of the adapter of the perspective views of FIGS. 1 and 2. The piston element 45 has a hollow interior 53 that provides a fluid flow path completely through the needle free valve 37 and into fluid communication with the lumen 55 of the sharpened cannula 33 ([0037], lines 1-6).
Leinsing discloses that, FIG. 4 illustrates the application of the vial adapter 21 to a vial 71 having a closure 73. The sharpened cannula 33 will be moved through the opening 75 of the closure 73 and will be pressed through the rubber stopper 77 to establish fluid communication with the contents of the vial ([0041], lines 1-5).
Leinsing discloses that, referring particularly now to FIG. 5, the first step in using the vial adapter 21 is to place the end of the adapter including the sharpened cannula 33 surrounded by the shroud 27 next to the rubber stopper 77 of a vial 71. Next the vial adapter is manually pressed onto the closure 73 of the vial 71 with force directed axially through the centerline 91 of the sharpened cannula 33 sufficient to drive the sharpened cannula 33 into and through the rubber stopper. If the diameter of the vial closure is relatively large, for example 20 mm or greater, the second set of hinged claws 31 will deform plastically during the mounting motion of the adapter to the vial and bend up to a vertical or near-vertical position approximately parallel with the centerline 91 of the vial as shown in FIG. 5, and while the first set of shorter and rigid claws 29 will engage the larger vial closure (related to claim 12) ([0045]).
Here, the vial adapter 21 is considered as the separate closure member.
Thus, Leinsing discloses that, the apparatus comprises a separate closure member having a connector for sealing the one open end of the cone member, and wherein the cone member has an inner frangible membrane (e.g., the rubber stopper 77) for sealing the internal chamber prior to breaking the frangible membrane and unsealing the internal chamber, and the separate closure member has a deformable portion (e.g., the second set of hinged claws 31) and a rigid portion (e.g., the shroud 27) wherein the rigid portion can be compressed onto the deformable portion to break the inner frangible membrane of the cone member.
It would have been obvious to use the apparatus of Riner to have the dual-purpose integral injection molded plastic vial as Leinsing teaches that it is known to have the male and female luer fitting(s) for fluid connection and the separate closure member having a deformable portion. It has been held that the combination of known techniques to improve similar devices is likely to be obvious when it does not more than yield predictable results to one of ordinary skills in the art. KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007) (See MPEP 2143- exemplary rationales).
However, Riner does not disclose a suction pump to draw a fluid product FP into the internal chamber via the cone member by first squeezing on the body portion and then releasing the body portion to create suction in the chamber that draws fluid product FP into the chamber via the cone member.
In the same field of endeavor, pump for dispensing a fluid product, Rossignol discloses that, certain cosmetic product vials are provided with a pump configured to suction the cosmetic product contained in the tank of the vial in order to dispense it, for example by means of a nozzle or by a simple opening. The product can thus be extracted or sprayed from the vial in order to allow its application. The pump is often actuated by means of a pushbutton on which the user exerts a pressure to trigger the functioning of the pump. A pump includes, in particular, a pumping chamber, of which the volume varies to make it possible for the suctioning of the product into the chamber through an inlet orifice, when the volume increases, then the expulsion thereof outside of the chamber through an outlet orifice, when the volume of the chamber decreases. The product exits from the chamber into a dispensing conduit, which leads it to the opening or the nozzle usually arranged on the pushbutton ([0003]).
Thus, Rossignol discloses that, the suction pump to draw a fluid product FP into the internal chamber via the cone member by first squeezing on the body portion and then releasing the body portion to create suction in the chamber that draws fluid product FP into the chamber via the cone member.
It would have been obvious to use the apparatus of Riner to have the dual-purpose integral injection molded plastic vial as Rossignol teaches that it is known to have the suction pump to draw a fluid product FP into the internal chamber via the cone member by first squeezing on the body portion and then releasing the body portion to create suction in the chamber that draws fluid product FP into the chamber via the cone member. It has been held that the combination of known techniques to improve similar devices is likely to be obvious when it does not more than yield predictable results to one of ordinary skills in the art. KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007) (See MPEP 2143- exemplary rationales).
Regarding claim 3, Riner discloses that, the dispensing apparatus 10 is stored in the conditions shown in Figs. 2 and 3 as a sealed container (col. 4, lines 23-25).
Thus, Riner discloses that, the squeezable body portion is injection molded with an open end for subsequent sealing of the open end to form the internal chamber.
Claim 3 is a product by process claim. Product by process claims are evaluated based on the structure the process is reasonably suggested to impart on the resulting product. In the instant case, the structure imparted on the product is a container formed from a synthetic plastic material in injection modeling process including using a forming device (for instance, an extruder) in concert with a vacuum to use air pressure to help form the resulting container.
Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “[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). The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). Once a product appearing to be substantially identical is found and a 35 USC 102/103 rejection is made, the burden shifts to the Applicant to show an unobvious difference. “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974).
Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP § 2113.
Regarding claim 9, Riner discloses that, the vial is injection molded with a closure member (item 40, Fig. 2 or 3 (col. 3, line 61)) for sealing one open end of the cone, and the closure member includes a frangible connecting portion for disconnecting the closure member from the cone to open the one end of the cone (as shown in Fig. 1 (col. 3, line 68 and col. 4, lines 1-4)).
Claim 9 is a product by process claim. Product by process claims are evaluated based on the structure the process is reasonably suggested to impart on the resulting product. In the instant case, the structure imparted on the product is a container formed from a synthetic plastic material in injection modeling process including using a forming device (for instance, an extruder) in concert with a vacuum to use air pressure to help form the resulting container.
Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “[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). The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). Once a product appearing to be substantially identical is found and a 35 USC 102/103 rejection is made, the burden shifts to the Applicant to show an unobvious difference. “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974).
Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP § 2113.
Regarding claim 20, Riner discloses that, the vial is configured for the dosage of medicinal and pharmaceutical fluid products (col. 1, lines 9-14).
Regarding claim 21, Riner discloses that, as illustrated in Fig. 1, the cylindrical outer bushing (item 50, Fig. 1) has an outer base surface which projects laterally outwardly (as shown in Fig. 1) from the inner radial cone member (item 35, Fig. 1).
Claims 2, 4, 5, 6, 7, 8, 10, 15 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Riner (US 5,261,881), Rossignol (US 2019/0366376), and Leinsing (US 2003/0153895) as applied to claim 1 above, further in view of Salvarani et al. (US 2022/0081147).
Regarding claim 2, the combination does not disclose that, the vial is injection molded from a plastic material that is recyclable in a single plastic recycle stream.
In the same field of endeavor, containing and dispending fluids, Salvarani discloses that, the entire strip of vials made of a single recyclable material ([0044]). The vial has the superior quality of an injection molded article ([0047]).
It would have been obvious to use the apparatus of the combination to have the dual-purpose integral injection molded plastic vial as Salvarani teaches that it is known to have the vial is injection molded from a plastic material that is recyclable in a single plastic recycle stream. It has been held that the combination of known techniques to improve similar devices is likely to be obvious when it does not more than yield predictable results to one of ordinary skills in the art. KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007) (See MPEP 2143- exemplary rationales).
Regarding claims 4, 15, the combination does not disclose that, the vial is further configured to function as: c. a container by filling the squeezable body portion with the fluid product FP via the open end and then sealing the open end for later dispensing of the fluid product FP via the cone member.
Salvarani discloses that, as illustrated in Fig. 9 (in last two steps), filling vials (from open bottom, each vial filled with one dose) and heating/sealing to close bottom end of each vial.
It would have been obvious to use the apparatus of the combination to have the dual-purpose integral injection molded plastic vial as Salvarani teaches that it is known to have the vial is further configured to function as: c. a container by filling the squeezable body portion with the fluid product FP via the open end and then sealing the open end for later dispensing of the fluid product FP via the cone member. It has been held that the combination of known techniques to improve similar devices is likely to be obvious when it does not more than yield predictable results to one of ordinary skills in the art. KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007) (See MPEP 2143- exemplary rationales).
Regarding claim 5, Riner discloses that, the vial is further provided with a removable closure (item 40, Fig. 2 or 3 (col. 3, line 61)) on the cone member to seal the fluid product in the internal chamber, and wherein removal of the closure enables dispensing of the fluid product from the cone member (as shown in Fig. 1 (col. 3, line 68 and col. 4, lines 1-4)).
Regarding claims 6, 7, 8, the combination does not disclose that, the vial is injection molded as a strip of multiple such vials.
Salvarani discloses that, as illustrated in Fig. 1, on the left hand side is shown a single integral injection molded strip (10) comprising a plurality of single-dose vials ([0009], lines 1-4).
Salvarani discloses that, as illustrated in Fig. 9 (in last two steps), filling vials (from open bottom, each vial filled with one dose) and heating/sealing to close bottom end of each vial (related to claims 7, 8).
It would have been obvious to use the apparatus of the combination to have the dual-purpose integral injection molded plastic vial as Salvarani teaches that it is known to have the vial is injection molded as a strip of multiple such vials and filling vials (from open bottom, each vial filled with one dose) and heating/sealing to close bottom end of each vial. It has been held that the combination of known techniques to improve similar devices is likely to be obvious when it does not more than yield predictable results to one of ordinary skills in the art. KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007) (See MPEP 2143- exemplary rationales).
Regarding claim 10, the combination does not disclose that, the vial is filled by filling the squeezable body portion with the fluid product FP via the open end, and the open end is then sealed for later dispensing of the fluid product FP via the cone member.
Salvarani discloses, as illustrated in Fig. 9 (in last two steps), filling vials (from open bottom, each vial filled with one dose) and heating/sealing to close bottom end of each vial.
It would have been obvious to use the apparatus of the combination to have the dual-purpose integral injection molded plastic vial as Salvarani teaches that it is known to have the vial is filled by filling the squeezable body portion with the fluid product FP via the open end, and the open end is then sealed for later dispensing of the fluid product FP via the cone member. It has been held that the combination of known techniques to improve similar devices is likely to be obvious when it does not more than yield predictable results to one of ordinary skills in the art. KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007) (See MPEP 2143- exemplary rationales).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Riner (US 5,261,881), Rossignol (US 2019/0366376), and Leinsing (US 2003/0153895) as applied to claim 1 above, further in view of Hulon (US 4,889,249).
Regarding claim 22, the combination does not explicitly disclose that, the cylindrical outer bushing has a series of grip lines.
In the same field of endeavor, sample bottle, Hulon discloses that, as illustrated in Fig. 5, the cap 12 has a plurality of vertical grip lines 70 for enhancing the ability of the user of the urine bottle to handle (col. 5, lines 28-32).
It would have been obvious to use the apparatus of the combination to have the dual-purpose integral injection molded plastic vial as Hulon teaches that it is known to have the cylindrical outer bushing has a series of grip lines. It has been held that the combination of known techniques to improve similar devices is likely to be obvious when it does not more than yield predictable results to one of ordinary skills in the art. KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007) (See MPEP 2143- exemplary rationales).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIBIN LIANG whose telephone number is (571)272-8811. The examiner can normally be reached on M-F 8:30 - 4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alison L Hindenlang can be reached on 571 270 7001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIBIN LIANG/Examiner, Art Unit 1741
/ALISON L HINDENLANG/Supervisory Patent Examiner, Art Unit 1741
