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 .
Response to Amendment
The amendment filed on 08/05/25 have been entered in the case. Claims 1-3, 9, 11-12, 14-15, 26-34 are pending for examination; claims 10 & 13 are withdrawn, and claims 4-8, 16-25 are cancelled.
Election/Restrictions
The amended claim 10 and claim 13 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 10 recites that: a second internal, non-peripheral portion of the flexible packaging is coupled to a section of the syringe housing such that movement of the syringe within the flexible packaging is reduced. This claimed feature is designated to non-elected species of Figs. 3B & 3D. The elected Fig. 3G does not include a second internal, non-peripheral portion is coupled to a section of the syringe housing. Therefore, the claim 10 is withdrawn from consideration.
Claim 13 recites that: wherein the push-push valve is at least partially sealed to the flexible packaging. This claimed feature is designated to non-elected species of Fig. 3A-3B. It is noted that the elected Fig. 3G shows that the push-push valve is covered (but not being sealed to) by the flexible packaging. Therefore, claim 13 is withdrawn from consideration.
Note: Should the Applicant disagree with Examiner’s statement above, the Applicant is requested to identify the specific claim limitations supported in the elected Fig. 3G.
Since applicant has received an action on the merits for the originally presented invention (the elected species of Fig. 3G), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 10 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
Claims 1-2, 9, 11-12, 14-15, 26-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Nowhere in the original specification has described the limitation “an interior, non-peripheral portion of the flexible packaging is additionally sealed to at least one of the syringe housing, the piston, the push-push valve, the extension housing, or the vial of the mixing and administration system...” as required in the claim 1.
For example: In the elected Fig. 3G, the seal line is being sealed to the Luer connector 314, but is not being sealed to the syringe housing, the piston, the push-push valve, the extension housing nor the vial, as recited in the claim 1. According to the original specification, the sealed pouch 308 is not a part of the packaging 306G, see paras [0058, 0066]. The para [0058] states: a separate, sealed pouch 308 may be coupled to the packaging 306A via a hermetic seal. The separately sealed pouch 308 includes one or more cleaning devices...
PNG
media_image1.png
542
1200
media_image1.png
Greyscale
PNG
media_image2.png
383
674
media_image2.png
Greyscale
Another example: the non-elected Fig. 3B shows that a seal line A (see marked-up Fig. 3B above) is sealed to the piston 110; however, the seal line A is not located at an interior, non-peripheral portion of the flexible packaging 306B, as required in the claim 1. The flexible packaging 306B is separate with the flexible packaging 306A. In other words, the packaging 306A & 306B are two different packaging. Therefore, the seal line A is located at peripheral portion of the flexible packaging 306G.
Similarly, the Figs. 3A, 3D-3F & 3H show that a seal line (is located at peripheral of the packaging) is sealed to a ridge of the plunger rod 110 (Fig. 3A); or is sealed to a proximal of the syringe 102 (Fig. 3D or 4A & 4C), is sealed to a distal of the syringe 103 (Fig. 3E, 4F), is sealed to a Luer connector 314 (Fig. 3H). However, these Figs. 3A, 3D-3F, 3H, 4A, 4C, 4F are non-elected species. None of these figures show that the seal line is located at an interior, non-peripheral portion of the flexible packaging.
The Fig. 3A shows below here that: the seal line is located in between the packaging 306A and the pouch 310A. In other words, the seal line is located at peripheral of the packaging 306A.
PNG
media_image3.png
385
721
media_image3.png
Greyscale
The other dependent claims 2-9, 11-12, 14-15, 26-29 are being rejected due to their dependency.
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 1-2, 9, 11-15, 26-29 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The limitation “an interior, non-peripheral portion of the flexible package is additionally sealed to at least one of the syringe housing, the piston, the push-push valve, the extension housing or the vial of the mixing and administration system” in claim 1 is vague. It is unclear to Examiner that which portion in interior, non-peripheral portion of the flexible package that included an additional seal. The elected Fig. 3G only shows that the package is being sealed around a peripheral/rim of the housing of the package.
In para [0058] of the original specification, it states that: a separate, sealed pouch 308 maybe coupled to the packaging 306A (similar to packaging 306G in Fig. 3G) via a hermetic seal (see the marked-up Fig. 3G below). In other words, the hermetic seal is not “an interior, non-peripheral portion of the flexible packaging” (i.e., flexible package 306G), as recited in the claim 1. It is noted that the seal pouch 308 is not a part of flexible packaging 306G. The seal pouch 308 is separate pouch (or separate packaging) with the flexible packaging 306G (please see claims 2-3 and para [0058] above). Therefore, the flexible packaging cannot be defined or equivalent to a combination of elements #306A & 308.
PNG
media_image4.png
608
871
media_image4.png
Greyscale
Examiner note: the limitation “... additionally sealed to at least one of the syringe housing, the piston, the push-push valve, the extension housing, or the vial of the mixing and administration system” is not shown in the elected Fig. 3G. It appears to Examiner that the applicant attempts to switch to other non-elected figures. It is noted that the general policy of the Office is not to permit the applicant to shift to claiming another invention after an election is once made and action given on the elected subject matter, see MPEP § 819.
In claim 31, the limitation “the separately sealed pouch being sealed off from a remainder of an interior of the packaging” is vague. It is unclear to Examiner that the separated sealed pouch and the package are two different components or the separated sealed pouch is a part of the packaging.
Having said in the para [0058] of the specification, the seal pouch 308 and the packaging 306G are separated components. According to the elected Fig. 3G, it shows that the hermetic seal line is located at peripheral portion of the flexible package 306G; or the hermetic seal line is located in between the flexible package 306G and the sealed pouch 306. Therefore, it is unclear to Examiner that how is the sealed pouch being sealed off from a remainder of an interior of the packaging. It is unclear to Examiner that which portion is considered as “a remainder of an interior of the packaging”, as recited in claim 31.
Based on the elected Fig. 3G, the packaging 306G and the separated sealed pouch 308 are two separate components, and therefore, the separated sealed pouch 308 does not seal the remainder of an interior of the packaging 306G.
Note: The Applicant is requested to identify the specific claim limitation, i.e., “a remainder of an interior of the packaging” that has supported in the elected Fig. 3G.
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.
Claims 1, 9, 11-12, 14-15, 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican et al. (US 2007/0265574) in view of Pearson (US 4,589,879) and Esposito (US 5,997,811).
Regarding claim 1, Tennican discloses a mixing and administration system in Figs. 1-11 & 20 comprising:
a syringe housing 102 having a first end 106 and a second end 105 opposite the first end, the first end 106 associated with a connector (nose 106 or element 108, see similar Fig. 12);
a piston 200 coupled to the second end of the syringe housing 102, the piston including a first end portion 208 and a second end portion 204 opposite the first end;
a push-push valve 300 located proximate the second end portion 204 of the piston 200;
an extension housing 600 coupled to the second end portion 204 of the piston, the extension housing having an open end 604, see Fig. 11;
a vial 500 coupled to the open end 604 of the extension housing 600; and
a flexible packaging 920 (in Fig. 20) surrounding and being sealed around at least a portion of the mixing and administration system,
Tennican does not disclose that: an interior, non-peripheral portion of the flexible packaging is additionally sealed to at least one of the syringe housing, the piston, the push-push valve, the extension housing, or the vial of the mixing and administration system and the flexible packaging is configured to enable actuation of the piston and the push-push valve to transfer fluid from the mixing and administration system to a device external to the flexible packaging without removal of the flexible packaging. It is noted that this limitation is a functional limitation and only requires to perform a function.
Pearson discloses a mixing and administration system comprising: a vial 36 coupled to an extension housing 46 & 56; a flexible packaging 34 surrounding and being sealed around at least a portion of the mixing and administration system (see Fig. 3 & 6); wherein an interior non-peripheral portion 60 of the flexible packaging is additionally sealed to at least one of the extension housing 56 of the mixing and administration system for securing the extension housing 56 being connected to the vial during handling or during use.
Giving such a teaching by Pearson, a person having ordinary skill in the art, prior to the effective filling date of the claimed invention, would have easily recognizes that modifying the packaging device in Fig. 20 of Tennican with including an additionally seal being sealed to the extension housing of the mixing and administration system; wherein the seal is located at an interior, non-peripheral portion of the packaging, as taught by Pearson, would provide the benefits of securing one of the components, i.e., extension housing in the mixing and administration system and preventing dislodging during handling and during use.
Note: having said from Pearson above, the addition seal can be provided to seal to (or hold to) a syringe housing, or the piston, or the push-push valve or the vial and that is considered as rearrangement part for the same purpose of holding the component more secure and preventing dislodging during handling and during use.
Tennican in view of Pearson does not disclose the limitation that: the flexible packaging is configured to enable actuation of the piston and the push-push valve to transfer fluid from the mixing and administration system to a device external to the flexible packaging without removal of the flexible packaging. It is noted that this limitation is a functional limitation and only requires to perform a function.
Esposito discloses mixing and administration system comprising: a flexible packaging 10 surrounding and being sealed around at least a portion of the administration system, i.e. syringe device 24, (Note: the sterile package 10 can be formed of a pouch. It includes sheath 30 & fitting member 50 which can sealingly enclose the sterile syringe 20, col. 4, lines 1-4); the piston of the mixing and administration system; and the flexible packaging is configured to enable actuation of the piston to transfer fluid from the mixing and administration system to a device (via a fitting 50 in Fig. 1; or a needle and needle covering, col. 6, lines 9-12) without removal of the flexible packaging, see Fig. 1.
Giving such a teaching by Esposito, a person having ordinary skill in the art, prior to the effective filling date of the claimed invention, would have easily recognizes that modifying the packaging device in Fig. 20 of Tennican in view of Pearson with including a device external to flexible packaging, as taught by Esposito, would provide the benefit of allowing to transfer fluid from the syringe (or a mixing and administration system) and/or transfer fluid from external device (outside the package) into the syringe or (a mixing and administration system) without removal of the flexible packaging to keep the administration device in sterile condition all the time.
Note: Tennican in view of Pearson and Esposito comprising: a flexible package 920 (in Fig. 20 in Tennican) includes an interior, non-peripheral portion of the flexible packaging 920 is additional sealed (e.g. sealing line 60, as suggested by Pearson) to at least one of the syringe housing, the piston, the push-push valve, the extension housing, or the vial of the mixing and administration system; the flexible packaging is configured to engable actuation of the piston and the push-push valve to transfer fluid from the mixing and administration system to a device (e.g., similar to device 50, as modified by Esposito) external to the flexible packaging without removal of the flexible packaging.
PNG
media_image5.png
321
704
media_image5.png
Greyscale
Regarding claim 9, Tennican in view of Pearson & Esposito discloses all the claimed subject matter as required. Esposito discloses that the connector 22 is a Luer connector. Thus, Tennican in view of Pearson & Esposito) discloses the mixing and administration system further comprising: a protective cap 50 coupled to the Luer connector 22; and a disinfecting cap 58 coupled to the protective cap 56.
Regarding claim 12, Tennican in view of Pearson & Esposito discloses all the claimed subject matter as required. Tennican in view of Pearson & Esposito discloses that a Luer connector 22 sealed to a portion of the packaging located proximate the connector 52 of the syringe housing, see Figs. 2-3.
Regarding claim 14, Tennican in view of Pearson & Esposito discloses all the claimed subject matter as required. Tennican discloses that wherein activating the push-push valve 300 causes a channel to open between the syringe housing and the extension housing including the vial.
Regarding claim 15, Tennican in view of Pearson & Esposito discloses all the claimed subject matter as required. Tennican discloses that wherein the piston includes a raised ridge 216/216a/217 (in Figs. 4 & 11) positioned proximate the second end of the piston, the raised ridge configured to prevent the syringe housing from abutting the push-push valve.
Regarding claims 26-27, Tennican in view of Pearson & Esposito discloses all the claimed subject matter as required. It is noted that the product-by-process limitation “heat sealed” has not been given weight in determining the patentability of the device claim. See MEPE §2113. In addition, Pearson discloses that the sealing line 60 is heat seal, col. 4, line 27.
Esposito discloses that the sealing line which is prefer an adhesive or heat sealing, col. 2, lines 42-43 or col. 5, lines 5-7. Therefore, Tennican in view of Pearson & Esposito discloses that the interior, non-peripheral portion of the flexible packaging is heat sealed (or adhesive sealed) to at least one of the syringe housing, the piston, the push-push valve, the extension housing or the vial.
Regarding claim 28, Tennican in view of Pearson & Esposito discloses all the claimed subject matter as required. The limitation in claim 28 is considered as functional limitation and only requires performing a function. In this case, Tennican discloses that two medicaments (in the syringe barrel and in the vial); wherein the mixing and administration system is covered by the flexible packaging. Therefore, the flexible packaging enables two medicant to be combined without exposing at least the portion of the mixing and administration system within the flexible packaging to an environment external to the flexible packaging. For example: a user holds one hand at outer surface of the packaging to grip the syringe, and other hand pushes the piston or vial in forward direction. At this point, the two medicants are to be combined without exposing the portion of the mixing and administration to the external environment.
Regarding claim 29, Tennican in view of Pearson & Esposito discloses all the claimed subject matter as required. Tennican discloses that the cover 905 in Fig. 22 (different embodiment) is transparent to allow visual inspection of the contents (device and/or labels), para [0136]. Therefore, a person skilled in the art would recognize that the flexible packaging 920 in Fig. 21 can be formed of a transparent material to allow visual inspection of the contents (device and/or labels).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican et al. (US 2007/0265574) in view of Pearson (US 4,589,879) & Esposito (US 5,997,811) and further in view of Tennican (US 10,207,098).
Regarding claim 2, Tennican’574 in view of Pearson & Esposito discloses all the claimed subject matter as required except for the limitation that a seal pouch directly coupled to the flexible packaging and including a disinfecting cap.
Tennican’098 discloses a flexible packaging 100 surrounding and being sealed around at least a portion of an administration device 104; wherein a sealed pouch 102 (or formed by a compartment 112 and a sealed-partition 110) directly coupled to the flexible packaging and including a disinfecting cap (located inside a compartment 112) or similar disinfecting cap 200 in Figs. 2A-2B.
PNG
media_image6.png
411
1249
media_image6.png
Greyscale
Since Tennican’574 and Tennican’098 are both from the same field of endeavor, i.e., flexible packaging covers an administration device, i.e. catheter or syringe, the purpose disclosed by Tennican’098 would have been recognized in the pertinent art of Tennican’574.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the flexible packaging of Tennican’574 (or Tennican’574 in view of Pearson & Esposito) with providing a sealed pouch that containing a disinfecting cap, as taught by Tennican’098, in order to provide a disinfecting cap and the flexible package in one unitary piece for easy to handling or carrying around and to clean the administration device, i.e., syringe before use.
Regarding claim 3, Tennican’574 in view of Pearson, Esposito &Tennican’098 discloses all the claimed subject matter as required except for the limitation that a tear strip configured to provide access to the disinfecting cap without exposing the vial to an environment external to the flexible packaging.
However, Tennican’574 discloses in Fig. 21 (different embodiment with the Fig. 20) that a seal pouch includes a tear strip 921 configured to provide access an interior space of the seal pouch. A person skilled in the art would recognize that the tear strip can be provided in any seal pouch.
Giving such a teaching by Tennican’574 (in Fig. 21), a person having ordinary skill in the art, prior to the effective filling date of the claimed invention, would have easily recognizes that modifying the seal pouch of Tennican’574 in view of Pearson, Esposito &Tennican’098 with providing a tear strip on an exterior surface of the seal pouch, as taught by Tennican’574, would provide the benefit of opening the seal pouch of the disinfecting cap without exposing other seal pouch (that contains vial and syringe device) to outside of the flexible packaging.
Note: the tear strip 921 only applies to modify the seal pouch 102 (as shown in Tennican’098 and contain the disinfecting cap in the compartment 112 or the disinfecting cap 200 in Figs. 2A-2B in Tennican’098). The tear strip 921 does not apply to modify nor provide on the larger seal pouch that contains the syringe housing, the vial, or other components in the mixing and administration system.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tennican et al. (US 2007/0265574) in view of Pearson (US 4,589,879), Esposito (US 5,997,811) and Tennican (US 2021/0154391).
Regarding claim 11, Tennican’574 in view of Pearson & Esposito discloses all the claimed subject matter as required. Esposito (or Tennican’574 in view of Pearson & Esposito) discloses that the connector 22 (or 22 & 50) associated with the syringe housing is coupled to a disinfecting/sterile cap 58.
Tennican’574 in view of Pearson & Esposito does not disclose that the disinfecting/sterile cap containing an antimicrobial composition.
Tennican’391 discloses that a syringe system or a flexible packaging system comprising: a syringe housing 102; a disinfecting cap 128 comprising: an antimicrobial composition, para [0074].
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the packaging device of Tennican’574 in view of Pearson & Esposito with providing an antimicrobial composition in the disinfecting cap, as taught by Tennican’391, in order to provide the antimicrobial agent to clean and keep the syringe and other device being connected to the syringe in sterile condition before use.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Tennican et al. (US 2007/0265574) in view of Esposito (US 5,997,811) and Tennican (US 2021/0154391).
Regarding claim 30, Tennican’574 discloses a mixing and administration system in Figs. 1-11 & 20 comprising:
a syringe housing 102 having a first end 106 and a second end 105 opposite the first end, the first end 106 associated with a connector (nose 106 or element 108, Fig. 12);
a protective cap 50 coupled to the connector, see Figs. 19-20
a piston 200 coupled to the second end of the syringe housing 102, the piston including a first end portion 208 and a second end portion 204 opposite the first end;
a push-push valve 300 located proximate the second end portion204 of the piston 200;
an extension housing 600 coupled to the second end portion 204 of the piston, the extension housing having an open end 604, see Fig. 11;
a vial 500 coupled to the open end 604 of the extension housing 600; and
a flexible packaging 920 (in Fig. 20) surrounding at least a portion of the mixing and administration system, wherein the packaging encloses the syringe housing 102, the piston 200, the push-push valve 300, the extension housing 600, and the vial 500.
Tennican’574 does not disclose that a disinfecting cap coupled to the protective cap; wherein the disinfecting cap comprising: an antimicrobial composition; wherein the packaging does not enclose the protective cap and the cleaning cap.
Esposito discloses an administration system comprising: a flexible packaging 30; a connector 22/52; a protective cap 50 coupled to the connector 52; a cleaning cap 58 coupled to the protective cap 50; wherein the packaging 30 does not enclose the protective cap and the cleaning cap.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the flexible packaging of Tennican’574 with obtaining a cleaning cap coupled to the protective cap; the packaging does not enclose the protective cap and the cleaning cap, as taught by Esposito, for the benefits of transferring fluid from a syringe (or an administration device) inside the packaging without removal of the flexible packaging to keep the administration device in sterile condition all the time.
Tennican’574 in view of Esposito does not disclose that an antimicrobial composition contained in the disinfecting cap.
Tennican’391 discloses that a syringe system comprising: a syringe housing 102; a protective cap 108 coupled to a connector (at a nose near element 104) of the syringe 102; a disinfecting cap 128 coupled to the protective cap 108; wherein the disinfecting cap 128 comprising: an antimicrobial composition, para [0074].
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the packaging device of Tennican’574 in view of Esposito with providing an antimicrobial composition in the disinfecting cap, as taught by Tennican’391, in order to keep the syringe and other device being connected to the syringe in sterile condition before use.
Claims 31 & 33 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican et al. (US 2007/0265574) in view of Esposito (US 5,997,811) and Tennican (US 2021/0154391) and further in view of Tennican (US 10,207,098).
Regarding claim 31, Tennican’574 in view of Esposito & Tennican’391 discloses all the claimed subject matter as required except for the limitation that a separately sealed pouch coupled to the package; wherein the separately sealed pouch being sealed off from a remainder of an interior of the packaging and comprising at least one cleaning device.
Tennican’098 discloses a flexible packaging 100 surrounding and being sealed around at least a portion of an administration device 104; wherein a sealed pouch 102 (or formed by a compartment 112 and a sealed-partition 110) coupled to the flexible packaging and including a disinfecting cap (located inside a compartment 112) or similar disinfecting cap 200 in Figs. 2A-2B. As seen in Fig. 1, the separately sealed pouch 102 being sealed off from a remainer of an interior of the packaging (by a sealed-partition 110).
PNG
media_image6.png
411
1249
media_image6.png
Greyscale
Since Tennican’574 and Tennican’098 are both from the same field of endeavor, i.e., flexible packaging covers an administration device, i.e. catheter or syringe, the purpose disclosed by Tennican’098 would have been recognized in the pertinent art of Tennican’574.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the flexible packaging of Tennican’574 (or Tennican’574 in view of Esposito & Tennican’391) with providing a sealed pouch that containing a disinfecting cap, as taught by Tennican’098, in order to provide the antimicrobial agent in the disinfecting cap to clean and keep the syringe and other device being connected to the syringe in sterile condition before use. In addition, a disinfecting cap and the flexible package in one unitary piece for easy to handling or carrying around and to clean the administration device, i.e., syringe before use.
Regarding claim 33, similar to the rejection in claim 31 above, Tennican’574 in view of Esposito & Tennican’391 discloses all the claimed subject matter as required except for the limitation in claim 33.
Tennican’098 discloses a flexible packaging 100 surrounding and being sealed around at least a portion of an administration device 104; wherein a sealed pouch 102 (or formed by a compartment 112 and a sealed-partition 110) coupled to the flexible packaging 100. As seen in Fig. 1, the separately sealed pouch 102 being sealed off from a remainer of an interior of the packaging (by a sealed-partition 110) and comprising: two or more cleaning device 102 or similar device 200 in Figs. 2A-2B.
Since Tennican’574 and Tennican’098 are both from the same field of endeavor, i.e., flexible packaging covers an administration device, i.e. catheter or syringe, the purpose disclosed by Tennican’098 would have been recognized in the pertinent art of Tennican’574.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the flexible packaging of Tennican’574 (or Tennican’574 in view of Esposito & Tennican’391) with providing a sealed pouch that containing a disinfecting cap, as taught by Tennican’098, in order to provide a disinfecting cap and the flexible package in one unitary piece for easy to handling or carrying around and to clean the administration device, i.e., syringe before use.
With respect to the limitation, i.e., tear strip, Tennican’574 discloses in Fig. 21 (different embodiment with the Fig. 20) that a seal pouch includes a tear strip 921 configured to provide access an interior space of the seal pouch. A person skilled in the art would recognize that the tear strip can be provided in any seal pouch.
Giving such a teaching by Tennican’574 (in Fig. 21), a person having ordinary skill in the art, prior to the effective filling date of the claimed invention, would have easily recognizes that modifying the seal pouch of Tennican’574 in view of Tennican’574 in view of Esposito & Tennican’391 with providing a tear strip on an exterior surface of the seal pouch, as taught by Fig. 21 in Tennican’574, would provide the benefit of opening the seal pouch of the disinfecting cap without exposing other seal pouch (that contains vial and syringe device) to outside of the flexible packaging.
Note: the tear strip 921 only applies to modify the seal pouch. The tear strip 921 does not apply to modify nor provide on the larger seal pouch that contains the syringe housing, the vial…
Claims 32 & 34 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican et al. (US 2007/0265574) in view of Esposito (US 5,997,811) and Tennican (US 2021/0154391) and further in view of Caggiano (US 4,861,632).
Tennican’574 in view of Esposito and Tennican’391 discloses all the claimed subject matter as required except for the limitation that the packaging comprises a moisture and air resistant barrier coating; wherein the packing is coated in an anticorrosion material.
Caggian discloses a laminated packaging comprising: a moisture and air resistant barrier coating (layers 2-5, col. 4, lines 56), also see col. 2, lines 20-60; wherein the packing is coated in an anticorrosion material (e.g., flexible thermoplastic film, metal foil, aluminum, col. 5, lines 1-5).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the packaging device of Tennican’574 in view of Esposito and Tennican’391 with obtaining a moisture and air resistant barrier coating and an anticorrosion material, as taught by Caggian, in order to maintain the device in dry environment.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 9, 11-15, 26-34 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
As mentioned, claims 10 & 13 are designated to non-elected Fig. 3G and therefore claims 10 & 13 are withdrawn. If the Applicant points out the specific feature in claims 10 & 13 that supported in the elected Fig. 3G, Applicant is aware that the claims 10 & 13 can be rejected under Tennican in view of Pearson & Esposito.
For example:
Regarding claim 10, as mentioned in claim 1, the interior, non-peripheral portion is a first interior, non-peripheral portion (e.g., the seal line 60, as taught by Pearson and included in the Tennican’s device, in the rejection in claim 1 above). It is noted that the seal line (as taught by Pearson) can be provided and sealed to any components in the mixing and administration system as considered as rearrangement parts. Therefore, a second internal, non-peripheral of the flexible packaging can be provided and coupled to a section of the syringe housing that is considered as duplication parts and rearrangement parts for providing benefit of preventing dislodging within the flexible packaging.
Regarding claim 13, as mentioned in claim 1, the seal line (as taught by Pearson) can be provided and sealed to any components in the mixing and administration system as considered as rearrangement parts. Therefore, the additional seal line can be provided at push-push valve and sealed to the packaging.
Although claims 10 & 13 do not include in the rejection above; however, the claims 10 & 13 are disclosed by the Examiner. If Applicant shows the support of claims 10 & 13 shown in the elected Fig. 3G, in that case, the claims 10 & 13 have been addressed and therefore, it is not considered as new ground rejection for the rejection in claims 10 & 13.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783