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 05/22/26 have been entered in the case. Claims 1-3, 9, 11-12, 14-15, 26-35 are pending for examination; claims 10 & 13 are withdrawn, and claims 4-8, 16-25 are cancelled.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 (filed in 08/05/25) 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 Therefore, the claim 10 is withdrawn from consideration.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 Therefore, claim 13 is withdrawn from consideration.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 Accordingly, claim 10 is withdrawn from consideration as being directed to a non-elected invention.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.
Examiner Note:
Examiner made the Election/Restriction in the previous non-final office action 02/24/26. Examiner provides evidence above that the limitations in claims 10 & 13 do not include in the elected species Fig. 3G. Applicant did not response to the claims 10 & 13 whether belong in the elected Fig. 3G or other non-elected species. Applicant is requested to response this matter. If the claims 10 & 13 are not designed to the elected Fig. 3G, then the claims 10 & 13 should be withdrawn and must be confirmed by the Applicant. If Applicant believes that the limitations in claims 10 & 13 are included in the elected Fig. 3G, then Applicant should provide the evidence that the feature in claims 10 & 13 have described in the elected Fig. 3G.
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 33 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.
The limitation “a separately sealed pouch” in claim 33 is vague. It is unclear to the Examiner that the limitation “a separately sealed pouch” in claim 33 that being referred back to the limitation “a separately sealed pouch” to the independent claim 30 or a second separately sealed pouch?
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.
I) First set of rejection:
Claims 1-2, 9-15, 26-31 & 35 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican (US 2021/0154391) in view of Tennican (US 10,207,098) and Esposito (US 5,997,811).
Regarding claim 1, Tennican’391 discloses a mixing and administration system comprising:
a syringe housing 102 having a first end 104 and a second end 106 opposite the first end, the first end associated with a connector, i.e. Luer-lok fitting, para [0064];
a piston 110 coupled to the second end of the syringe housing, the piston includes a first/distal end portion and a second/proximal end portion opposite the first end portion;
a push-push valve 114 located proximate the second end portion of the piston
Note: the valve 114 is repositioned to an “on/off” position to allow or block fluid communication between vial 120 and syringe barrel 102, paras [0070-0071]. Therefore, the valve 114 can be called as push-push valve. For example: Tennican (US 2007/0265574) discloses a push-push valve 300 (similar to valve 114) being provided in the piston.
an extension housing 116 coupled to the second end portion of the piston, the extension housing having an open end;
a vial 120 coupled to the open end of the extension housing;
a packaging 202 surround at least a portion of the mixing and administration system, see Fig. 2A.
Note: it appears that the packaging 202 is a flexible packaging. A person skilled in the art would recognize that the packaging can be used as a flexible packaging for easy handling.
an interior portion of the packaging that is proximate to the syringe housing and is additionally sealed to a separately sealed pouch of the packaging (para [0082], packaging 202 includes additional compartment(s) for disposing of all or some of the system; para [0083], cap(s) 222 is/are packaged in a packaging 202 in a separate compartment of the packaging. Cap(s) 222 is/are sealed in a separate compartment by a separate removable film or cover. Based on the paras [0082-0083] above, the separate compartment (being apart and formed inside the packaging 202) is considered as an interior portion of the packaging 202 and is additional sealed (by removable film) to separately sealed pouch of the packaging;
a 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 126.
In case Applicant disagrees with the statement above (e.g. additional seal line included in the packaging), the packaging 202 can be modified by Tennican’098 by providing additional seal line, as below.
Tennican’098 discloses a flexible packaging 100 surrounding and being sealed around at least a portion of an administration device 104; wherein an interior, non-peripheral portion of the flexible packaging 100 that is proximate to a housing of the administration device 104 is additionally sealed (via seal line 110) to separately sealed pouch 102 of the flexible packaging.
Since Tennican’391 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’391.
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 of Tennican’391 with obtaining the packaging being flexible packaging and providing an additional seal line within the packaging, as taught by Tennican’098, in order to attach multiple components in the administration system in one big packaging in separate compartments for simply in manufacturing packaging and easy to handling or carrying around.
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Note: the additional seal line separates the large flexible packaging in two separate compartments. Therefore, the separately sealed pouch is a part of the flexible packaging 202 by dividing the additional seal line.
Tennican’391 (or Tennican’391 in view of Tennican’098) does not disclose that the 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. In other words, the device, i.e. needle, needle cover, disinfecting cap are located outside of the flexible packaging without removal of the flexible packaging before, during or after procedure.
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 recognized that modifying the packaging device in Tennican’391 and Tennican’098 with including a device (needle, needle covering, sterile/disinfecting cap) external to flexible packaging, as taught by Esposito, would provide the benefit of allowing to transfer fluid from the syringe during procedure without removal of the flexible packaging to keep the administration device in sterile condition all the time.
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Regarding claim 2, Tennican’391 in view of Tennican’098 and Esposito discloses all claimed subject matter as required. Tennican’098 discloses wherein the separately sealed pouch 102 of the flexible packaging 100 is directly coupled to the flexible packaging and includes a disinfecting cap (located inside a compartment 112) or similar disinfecting cap 200 in Figs. 2A-2B. Therefore, Tennican’391 in view of Tennican’098 and Esposito discloses the separately sealed pouch of the flexible packaging is directly coupled to the flexible packaging and including disinfecting cap.
Regarding claim 9, Tennican’391 in view of Tennican’098 and Esposito discloses all claimed subject matter as required. Both of Tennican’098 and Esposito disclose that the protective cap coupled to the Luer connector; and a disinfecting cap coupled to the protective cap.
Regarding claim 10, Tennican’391 in view of Tennican’098 and Esposito discloses all claimed subject matter as required. Tennican’098 discloses multiple compartments in the flexible packaging; wherein the interior, non-peripheral portion (at seal line 110) is a first interior, non-peripheral portion, and wherein a second internal, non-peripheral portion (at seal line 108) of the flexible packaging 100 is coupled to a section of catheter such that movement of the catheter within the flexible packaging is reduced.
Giving such a teaching by Tennican’098, a person having ordinary skill in the art, prior to the effective filling date of the claimed invention, would have easily recognized that modifying the packaging device 202 in Tennican’391 with including additional seal line 108 (e.g., a second internal, non-peripheral of the flexible packaging) is coupled to a section of the catheter (or the syringe housing), as taught by Tennican’098, for the benefit of reducing or preventing a movement of the syringe housing within the flexible packaging and preventing damage the syringe housing during handling.
Regarding claim 11, Tennican’391 in view of Tennican’098 and Esposito discloses all claimed subject matter as required; wherein the connector associated with the syringe housing is coupled to a disinfecting cap, the disinfecting cap comprising an antimicrobial composition, see para [0076] in Tennican’391.
Regarding claim 12, Tennican’391 in view of Tennican’098 and Esposito discloses all claimed subject matter as required. Esposito discloses that wherein a fitting 50 or luer connector sealed to a section of the flexible packaging located proximate the connector of the syringe housing. In addition, a person skilled in the art would recognize that the fitting 50 can be a luer connector for enhancing connecting to the syringe housing.
Regarding claim 13, Tennican’391 in view of Tennican’098 and Esposito discloses all claimed subject matter as required. Tennican’098 discloses the seal line 108 to seal the catheter. A person skilled in the art would recognize that the seal line 108 can be provided and sealed to any components in the mixing and administration system as considered as rearrangement parts. Therefore, the additional seal line 108 can be provided at push-push valve and sealed to the packaging.
Regarding claim 14, Tennican’391 in view of Tennican’098 and Esposito discloses all claimed subject matter as required; wherein activating the push-push valve (on/off position) causes a channel to open between the syringe housing and the extension housing including the vial.
Regarding claim 15, Tennican’391 in view of Tennican’098 and Esposito discloses all claimed subject matter as required. Tennican’391 discloses that the piston includes a raised ridge 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’391 in view of Tennican’098 and Esposito discloses all 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, Tennican’098 discloses that the sealing line 108 is fused (heat seal), col. 2, lines 47-48.
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’391 in view of Tennican’098 and 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’391 in view of Tennican’098 and Esposito discloses all 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’391 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 medicants 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’391 in view of Tennican’098 and Esposito discloses all claimed subject matter as required. Tennican’391 discloses that the flexible packaging is transparent, para [0084].
Regarding claim 30, Tennican’391 discloses a mixing and administration system comprising:
a syringe housing 102 having a first end 104 and a second end 106 opposite the first end, the firt end associated with a connector, i.e. Luer-lok fitting, para [0064]l
a protective cap 108 coupled to the connector, see Fig. 1A;
a disinfecting cap 120 coupled to the protective cap 108, the disinfecting cap comprising an antimicrobial composition, para [0074];
a piston 110 coupled to the second end of the syringe housing, the piston includes a first/distal end portion and a second/proximal end portion opposite the first end portion;
a push-push valve 114 located proximate the second end portion of the piston
Note: the valve 114 is repositioned to an “on/off” position to allow or block fluid communication between vial 120 and syringe barrel 102, paras [0070-0071]. Therefore, the valve 114 can be called as push-push valve. For example: Tennican (US 2007/0265574) discloses a push-push valve 300 (similar to valve 114) being provided in the piston.
an extension housing 116 coupled to the second end portion of the piston, the extension housing having an open end;
a vial120 coupled to the open end of the extension housing;
a packaging 202 surround at least a portion of the mixing and administration system, see Fig. 2A;
and comprising an interior portion of the packaging that is proximate to the syringe housing and is additionally sealed to a separately sealed pouch of the packaging (para [0082], packaging 202 includes additional compartment(s) for disposing of all or some of the system; para [0083], cap(s) 222 is/are packaged in a packaging 202 in a separate compartment of the packaging. Cap(s) 222 is/are sealed in a separate compartment by a separate removable film or cover. Based on the paras [0082-0083] above, the separate compartment (formed inside the packaging 202) is considered as an interior portion of the packaging 202 and is additional sealed (by removable film) to separately sealed pouch of the packaging;
the packaging 202 encloses the syringe housing, the piston and push-push valve, the extension housing, and the vial, see Fig. 2A.
In case Applicant disagrees with the statement above (e.g. additional seal line included in the packaging), the packaging 202 can be modified by Tennican’098 by providing additional seal line, as below.
Tennican’098 discloses a flexible packaging 100 surrounding and being sealed around at least a portion of an administration device 104; wherein an interior, non-peripheral portion of the flexible packaging 100 that is proximate to a housing of the administration device 104 is additionally sealed (via seal line 110) to separately sealed pouch 102 of the flexible packaging.
Since Tennican’391 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’391.
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 of Tennican’391 with providing an additional seal line within the packaging, as taught by Tennican’098, in order to attach multiple components in the administration system in one big packaging in separate compartments for simply in manufacturing packaging and easy to handling or carrying around to prevent damage the components in the administration system.
Tennican’391 (or Tennican’391 in view of Tennican’098) does not disclose that the packaging does not enclose the protective cap and the disinfecting cap (e.g., the protective cap and the disinfecting cap are located outside of the packaging).
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.
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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’391 (or Tennican’391 in view of Tennican’098) with providing a protective cap and a disinfecting cap being outside of the packaging, as taught by Esposito, for the benefit of transferring fluid from a syringe (or an administration device) inside the packaging into a patient without removal of the flexible packaging to keep the administration device in sterile condition all the time.
Regarding claim 31, Tennican’391 in view of Tennican’098 & Esposito discloses all claimed subject matter; wherein the separately sealed pouch (as modified by Tennican’098) is sealed off from a remainder of the interior portion of the packing and comprising at least one cleaning device 206 (in Figs. 2A-B in Tennican’098), see similar the marked-up figure in the claim 1.
Regarding claim 35, Tennican’391 in view of Tennican’098 & Esposito discloses all claimed subject matter as required. Tennican’391 discloses that one or more caps 108 & 128 coupled to the syringe housing, and wherein the one or more caps are exposed to an environment outside of the flexible packaging (as taught/modified by Esposito) while the push-push valve, extension housing, and the vial are positioned inside the flexible packaging.
Claims 3 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican (US 2021/0154391) in view of Tennican (US 10,207,098) and Esposito (US 5,997,811) and further in view of Tennican et al. (US 2007/0265574).
Regarding claim 3, similar to the rejection in claim 1 above, Tennican’391 in view of Tennican’098 & Esposito discloses all the claimed subject matter. Tennican’391 discloses in paras [0082-0083] that the separately sealed pouch directly coupled to the packaging 202.
Tennican’391 in view of Tennican’098 & Esposito does not disclose a tear strip configured to provide access to the disinfecting cap without exposing the vial to an environment external to the flexible packaging.
Tennican’574 discloses in Fig. 21 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 in Tennican’098 (or Tennican’391 in view of Tennican’098 & Esposito) with providing a tear strip on an exterior surface of the separately sealed pouch of the packaging, 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 separately sealed pouch. The tear strip 921 does not apply to modify nor provide on the larger compartment that contains the syringe housing, the vial…
Regarding claim 33, similar to the rejection in claims 30-31 above, Tennican’391 in view of Tennican’098 & Esposito discloses all the claimed subject matter. Tennican’391 discloses in paras [0082-0083] that the separately sealed pouch directly coupled to the packaging 202.
In addition, Tennican’098 discloses a flexible packaging 100 surrounding and being sealed around at least a portion of an administration device 104; wherein a (second) separately sealed pouch 102 (or formed by a compartment 112 and a sealed-partition 110) directly coupled to the flexible packaging 100. As seen in Fig. 1, the separately sealed pouch(s) 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.
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’391 (or Tennican’391 in view of Tennican’098 & Esposito) with providing a (second) separately 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.
Tennican’391 in view of Tennican’098 & Esposito does not disclose a tear strip configured to provide access to the two more cleaning devices.
Tennican’574 discloses in Fig. 21 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 in Tennican’098 (or Tennican’391 in view of Tennican’098 & Esposito with providing a tear strip on an exterior surface of the separately seal pouch of the packaging, 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 compartment that contains the syringe housing, the vial…
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Tennican (US 2021/0154391) in view of Tennican (US 10,207,098) and Esposito (US 5,997,811) and further in view of Caggiano (US 4,861,632).
Tennican’574 in view of Tennican’098 & Esposito 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 Tennican’098 & Esposito 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.
II) Second set of rejection:
Claims 1-3, 9-10, 12-15, 26-29 & 35 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican et al. (US 2007/0265574) in view of Tennican (US 10,207,098) and Esposito (US 5,997,811).
Regarding claim 1, 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, 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’574 does not disclose that: an interior, non-peripheral portion of the flexible packaging that is proximate to the syringe housing is additionally sealed to a separately sealed pouch of the flexible package 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.
Tennican’098 discloses a flexible packaging 100 surrounding and being sealed around at least a portion of an administration device 104; wherein an interior, non-peripheral portion of the flexible packaging that is proximate to a housing of the administration device 104 is additionally sealed to separately sealed pouch 102 of the flexible packaging.
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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 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.
Tennican’574 in view of Tennican’098 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 recognized that modifying the packaging device in Fig. 20 of Tennican’574 in view of Tennican’098 with including a device external to flexible packaging, as taught by Esposito, would provide the benefit of allowing to transfer fluid from the syringe into a patient without removal of the flexible packaging to keep the administration device in sterile condition all the time by covering the external device.
Note: Tennican’574 in view of Tennican’098 and Esposito comprising: a flexible package 920 (in Fig. 20 in Tennican’574) includes an interior, non-peripheral portion of the flexible packaging 920 is additional sealed (e.g. sealing line 110, as suggested by Tennican’098) to a separately sealed pouch of the flexible package, 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 (e.g., similar to device 50, as modified by Esposito) external to the flexible packaging without removal of the flexible packaging.
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Regarding claim 2, Tennican’574 in view of Tennican’098 and Esposito discloses all claimed subject matter as required. Tennican’098 discloses wherein the separately sealed pouch 102 of the flexible packaging is directly coupled to the flexible packaging and includes a disinfecting cap (located inside a compartment 112) or similar disinfecting cap 200 in Figs. 2A-2B.
Regarding claim 3, Tennican’574 in view of Tennican’098 and Esposito discloses all 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 separately seal pouch of Tennican’574 in view of Tennican’098 and Esposito with providing a tear strip on an exterior surface of the separately 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.
Regarding claim 9, Tennican’574 in view of Tennican’098 and Esposito discloses all the claimed subject matter as required. Esposito discloses that the connector 22 is a Luer connector. Thus, Tennican’574 in view of Tennican’098 and 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 10, as mentioned in claim 1, the interior, non-peripheral portion is a first interior, non-peripheral portion (e.g., the seal line 110, as taught by Tennican’098) and the additional seal line 110 included in the Tennican’574 in view of Tennican’098 and Esposito’s device, in the rejection in claim 1 above).
Tennican’098 discloses multiple compartments in the flexible packaging; wherein the interior, non-peripheral portion (at seal line 110) is a first interior, non-peripheral portion, and wherein a second internal, non-peripheral portion (at seal line 108) of the flexible packaging 100 is coupled to a section of catheter such that movement of the catheter within the flexible packaging is reduced.
Giving such a teaching by Tennican’098, 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 902 in Tennican’574 with including additional seal line 108 (e.g., a second internal, non-peripheral of the flexible packaging) is coupled to a section of the catheter (or the syringe housing), as taught by Tennican’098, for the benefit of reducing or preventing a movement of the syringe housing within the flexible packaging and preventing damage the syringe housing during handling.
Regarding claim 12, Tennican’574 in view of Tennican’098 and Esposito discloses all the claimed subject matter as required. Tennican’574 in view of Tennican’098 and 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 13, Tennican’574 in view of Tennican’098 and Esposito discloses all the claimed subject matter as required. Tennican’098 discloses the seal line 108 to seal the catheter. A person skilled in the art would recognize that the seal line 108 can be provided and sealed to any components in the mixing and administration system as considered as rearrangement parts. Therefore, the additional seal line 108 can be provided at push-push valve and sealed to the packaging.
Regarding claim 14, Tennican’574 in view of Tennican’098 and Esposito discloses all the claimed subject matter as required. Tennican’574 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’574 in view of Tennican’098 and Esposito discloses all the claimed subject matter as required. Tennican’574 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’574 in view of Tennican’098 and 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, Tennican discloses that the sealing line 108 is fused (heat seal), col. 2, lines 47-48.
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’574 in view of Tennican’098 and 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’574 in view of Tennican’098 and 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’574 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 medicants 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’574 in view of Tennican’098 and Esposito discloses all the claimed subject matter as required. Tennican’574 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).
Regarding claim 35, Tennican’574 in view of Tennican’098 and Esposito discloses all the claimed subject matter as required. Esposito ( or Tennican’574 in view of Tennican’098 and Esposito ) discloses that one or more caps 50 & 58 coupled to the syringe housing, and wherein the one or more caps 50 & 58 are exposed to an environment outside of the flexible packaging while the push-push valve, extension housing and the vial are positioned inside the flexible packaging.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tennican et al. (US 2007/0265574) in view of Tennican (US 10,207,098) and Esposito (US 5,997,811) and Tennican (US 2021/0154391).
Regarding claim 11, Tennican’574 in view of Tennican’098 and Esposito discloses all the claimed subject matter as required. Esposito (or Tennican’574 in view of Tennican’098 and 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 Tennican’098 and 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.
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.
1) Applicant argues that the Tennican’098 does not describes an interior seal that is proximate to a syringe housing.
In response, Tennican’098 discloses that a packaging 100 includes a catheter 104, a disinfecting cap 112; wherein an interior seal 110 that is proximate to the catheter to separate the catheter device and the cleaning device in separate compartment. In addition, another interior seal 108 that is proximate to the catheter to hold the catheter to reduce a movement of the catheter within the flexible packaging 100 and to prevent a damage the catheter during handling. It is noted that the portion 102 is a part of the packaging 100 and being separated by the additional seal line 110 to form multiple compartments for holding the disinfecting caps.
Therefore, a person skilled in the art would recognize that the additional-interior seal 110 or 108 can be added in the packaging in Tennican’574 to include the cleaning device or/and to prevent the dislodging of the syringe housing during handling. Please see the rejection and the marked-up figure in the rejection in claim 1 for more details.
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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/QUYNH-NHU H. VU/ Primary Examiner, Art Unit 3783
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