Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 7, 13 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by anticipated by Kayser (US 8915413).
Regarding claim 1, Kayser teaches a fluid adhesive dispenser device, comprising:
a housing (111) comprising a passageway (112) through the housing and a port (113) at a distal end of the passageway; and
a container (3) at least partially within the housing configured to contain a single-use amount of the fluid adhesive (Col. 6, lines 60-63), wherein the container is configured to be opened allowing the fluid adhesive contained therein to be actively expelled from the container through the passageway and the port of the housing.
Regarding claim 2, Kayser teaches the fluid adhesive is expelled from the housing through the port of the housing in a direction-independent manner (Col. 6, lines 4-8).
Regarding claim 7, Kayser teaches the container is configured to be opened by at least one of compressing the container to create one or more openings in the container, rupturing the container, breaking the container, or piercing a portion of the container (refer to col. 9, lines 15-23).
Regarding claim 13, Kayser teaches further comprising a filter (The filter insert provided at the outlet opening 113, Refer to col.6, lines 60-65) within the passageway of the housing configured to separate broken pieces of the container from the fluid adhesive prior to expulsion of the fluid adhesive from the port of the housing.
Regarding claim 20, Kayser teaches fluid adhesive dispenser device, comprising:
a housing (111) comprising a passageway (112) through the housing and a port (113) at a distal end of the passageway; an ampule (3) at least partially within the housing configured to contain a single-use amount of the fluid adhesive (Refer to col.6, lines 10-11) and configured to be ruptured so that the fluid adhesive passes from an interior of the ampule to the passageway of the housing; and a filter (filter at outlet port 113, Refer to col.6, lines 60-65) within the passageway of the housing configured to separate broken pieces of the ruptured ampule from the fluid adhesive prior to expulsion of the fluid adhesive from the port of the housing.
Claim(s) 1-8, 10-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by anticipated by Russo (US 2019/0099170).
Regarding claim 1, Russo teaches a fluid adhesive dispenser device (Figs 1-9), comprising:
a housing (20/16) comprising a passageway (passage between 28/22/16) through the housing and a port (distal end of 16) at a distal end of the passageway; and a container (14) at least partially within the housing configured to contain a single-use amount of the fluid adhesive, wherein the container is configured to be opened allowing the fluid adhesive contained therein to be actively expelled from the container through the passageway and the port of the housing (Refer to paragraph [0003] “applicator 10 used for the DERMABOND® medical adhesive includes a frangible glass vial 14 held inside a plastic enclosure 16”).
Regarding claim 2, Russo teaches s the fluid adhesive is expelled from the housing through the port of the housing in a direction-independent manner (See Figures 6-9).
Regarding claim 3, Russo teaches the single-use amount of the fluid adhesive is less than about 1.0 mL (refer to paragraph 0032 “DERMABOND®-style applicator, such as the one illustrated in FIG. 1, typically carries 0.36 to 0.8 ml. of adhesives, enough to cover small incisions or wounds).
Regarding claim 4, Russo teaches the fluid adhesive is actively expelled from the container by reducing a fluid-containing volume of the container, thereby forcing fluid from the container into the passageway extending through the housing (see Figure 6).
Regarding claim 5, Russo teaches the fluid adhesive comprises a tissue adhesive configured to be used for securing a vascular access device to skin of a patient, wound closure, and/or insertion site closure (Refer to paragraph [0032]).
Regarding claim 6, Russo teaches the fluid adhesive comprises a cyanoacrylate composition (Refer to paragraphs 10, 29 and 32).
Regarding claim 7, Russo teaches the container (14) is configured to be opened by at least one of compressing the container (Fig. 6) to create one or more openings in the container, rupturing the container, breaking the container, or piercing a portion of the container (refer to paragraph [0028]).
Regarding claim 8, Russo teaches the housing comprises a compressible bellows (bellows portion 24, refer to paragraph [0028]) configured to be compressed by a user to compress the container in order to expel the fluid adhesive from the container.
Regarding claim 10, Russo teaches the port (distal opening 22) comprises an elongated tubular nozzle configured to be manually compressed by a user to control fluid flow through the nozzle (See Figures 6-9).
Regarding claim 11, Russo teaches the housing comprising at least one tab (sides of 22, where pressure is applied) configured to contact an outer surface of the container to rupture the container, wherein applying force to the at least one tab of the housing in a first direction ruptures the container establishing fluid communication between an interior of the container and the passageway of the housing, and wherein applying force to the housing in a second direction moves the container towards the port of the housing, thereby expelling the fluid adhesive from the interior of the container through the passageway and the port of the housing (see paragraph [0028]).
Regarding claim 12, Russo teaches the container (14) comprises at least one pierceable seal (sealed glass vial) that can be pierced (i.e. broken) to establish fluid communication between an interior of the container and the passageway of the housing.
Regarding claim 13, Russo teaches a filter (32) within the passageway (16) of the housing (since 32 is part of 16 which is within 22) configured to separate broken pieces of the container from the fluid adhesive prior to expulsion of the fluid adhesive from the port of the housing (Refer to paragraph [0027] a porous wafer 32 would preferably be placed above the applicator tip 30 to allow accelerator/initiator to be co-eluted with the adhesive 12 before the adhesive 12 exits through the applicator tip 30 and to help prevent glass shards from the frangible glass vial 14 from passing through the applicator tip 3).
Claim(s) 1, 14-15 and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by anticipated by Gelblum et al. (US 2013/0281940) hereinafter Gelblum.
Regarding claim 1, Gelblum teaches a fluid adhesive dispenser device (Figs 1-9), comprising:
a housing (30) comprising a passageway (112) through the housing and a port (distal end of 112) at a distal end of the passageway; and a container (120) at least partially within the housing capable to contain a single-use amount of the fluid adhesive, wherein the container is configured to be opened allowing the fluid adhesive contained therein to be actively expelled from the container through the passageway and the port of the housing. (Note: The examiner is considering the italicized text as a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case the fluid dispenser device of Gelblum is capable of housing an adhesive).
Regarding claim 14, Gelblum teaches the housing comprises a barrel comprising a proximal end, a distal end comprising the port, and a sidewall extending between the proximal end and the distal end (see Figure 3), the device further comprising a plunger (16) capable to move through the barrel to expel the fluid adhesive from the container through the passageway of the housing.
Regarding claim 15, Gelblum teaches the container (Figure 12) comprises proximal and distal pierceable seals (150 and 128 respectively) connected to an inner surface of the sidewall of the barrel, and wherein the fluid adhesive is contained between the first and second seals.
Regarding claim 17, Gelblum teaches a removable cap (180) attached to the port for preventing the fluid adhesive from being expelled through the port until the cap is removed.
Regarding claim 18, Gelblum teaches the container comprises a pierceable seal (Refer to paragraph [0169], “a fracturable closure seal for sterility purposes, such as pierceable foil or elastomeric seal)” for retaining the fluid adhesive in the container, wherein the cap comprises a spike (182) configured to pierce the seal when the spike is inserted into the passageway of the housing, wherein the cap is initially provided in a first orientation with the spike pointing away from the port of the housing (refer to paragraph [0191] “at may have, according to one non-limiting embodiment, a fracturable closure seal (discussed herein) for sterility purposes, such as pierceable foil or elastomeric seal.”, and wherein the cap is configured to be removed from the port and reconnected to the port in a second orientation with the spike inserted into the port to pierce the seal (Refer to paragraph 0191]).
Claim(s) 1, 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by anticipated by Quintero (US 6547467).
Regarding claim 1, Quintero teaches a fluid adhesive dispenser device (Figs 1-9), comprising:
a housing (112) comprising a passageway (Col. 9, line 49) through the housing and a port (tip 120) at a distal end of the passageway; and a container (118) at least partially within the housing capable to contain a single-use amount of the fluid adhesive (Col. 15, line 20), wherein the container is configured to be opened allowing the fluid adhesive contained therein to be actively expelled from the container through the passageway and the port of the housing (Col. 9, 46-48).
Regarding claim 14, Quintero teaches the housing comprises a barrel (112) comprising a proximal end (handle portion 110), a distal end (tip 120) comprising the port, and a sidewall (sidewall of the barrel 112) extending between the proximal end and the distal end, the device further comprising a plunger (116, Col 10, llines 8-9) capable to move through the barrel to expel the fluid adhesive from the container through the passageway of the housing.
Regarding claim 15, Quintero teaches the container (118) comprises proximal and distal pierceable seals (proximal and distal ends of the container 118, Fig.2 ) connected to an inner surface of the sidewall of the barrel, and wherein the fluid adhesive is contained between the first and second seals (Col. 4, lines 13-15).
Regarding claim 16, Quintero teaches the plunger comprises a piercing surface (Fig. 2) configured to pierce the proximal and/or distal seals, and wherein advancing the plunger through the barrel pierces the proximal seal and forces the fluid adhesive through the barrel and through the port (Col. 10, lines 16-20).
Regarding claim 17, Quintero teaches a removable cap (cap or retainer 22, Fig. 4) attached to the port for preventing the fluid adhesive from being expelled through the port until the cap is removed (Col. 7, lines 43-45).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Russo (US 2019/0099170) in view of Nentwick et al. (US 2008/0105580) hereinafter Nentwick.
Regarding claim 9, Russo teaches the container comprises a sealed ampule or bulb positioned in the cavity of the pouch (see paragraph [0028]). Russo fails to explicitly teach the housing comprises a pouch comprising a metal-coated polymer film defining cavity sized to receive the container.
Nentwick teaches an enclosure pouch (403, for an adhesive container 410), the enclosure is formed by heat sealing two panels of aluminum foil coated on the interior surfaces thereof with a heat sealable polymeric composition (refer to paragraph [0060]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use a metal coated polymer film as the material of the housing (20) of Russo, as taught by Nentwick to protect the housing from degrading.
Regarding claim 19., Russo teaches a method of manufacture of the fluid adhesive the method comprising:
providing a fluid adhesive dispenser device (Fig. 2) comprising:
a housing (20/16) comprising a passageway through the housing and a port at a distal end of the passageway, and providing the dispenser device of claim the container at least partially within the housing and filled with then single-use amount of the fluid adhesive, and wherein the container is configured to be opened allowing the fluid adhesive contained therein to be actively expelled from the container through the passageway and the port of the housing:
Russo fails to explicitly disclose sterilizing the filled dispenser device.
Nentwick, teaches sterilizing an adhesive package tip kit (See paragraph [0088]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to sterilize the components of the adhesive dispenser of Russo as taught by Nentwick after manufacture to ensure the dispenser and its contents are free of microorganisms before they are delivered to the patient.
Conclusion
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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