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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/08/2025 has been entered.
Status of the Claims
The amendment filed 09/08/2025 has been entered. Claims 1-3 and 6-22 are pending and under consideration.
Response to Arguments
Applicant's arguments filed 09/08/2025 have been fully considered but they are not persuasive.
In response to applicant’s argument on pages 8-9, that it would not be necessary to remove the guide member of Banik to have a sealing cap because a removable or replaceable sealing cap is already taught by Banik alone. Therefore, there is no reason to look outside of Banik for a replaceable sealing cap that provides protection from needle hazards.
Examiner respectfully disagrees and maintains the previous rejection for the following reasons. The motivation relied upon in the final rejection - for the purpose of utilizing various types of interchangeable attachment with the syringe, for example sealing cap or different shape and/or size of guide member- is not limited to needle protection but encompassing using interchangeable attachment to provide different, predictable function (needle protection, contamination control, utilizing various types of attachment etc.).
Furthermore, applicant argues on page 9 that the user could simply withdraw the needle back into being covered by the outer shield 835 between dose preparation and administration, and therefore there is no reason to look for a replaceable cap, and examiner has not provided sufficient evidence to maintain a prima facie obviousness rejection of independent claims 1, 13 and 20.
Examiner submits that Banik teaches (see [0066]-[0067]) that substantial radial/outward force is required to allow the outer flange 850 to bypass the free ends of the biasing cantilever arms 848 in order to retract and uncover the needle. In practical terms, this appears to be the operator cannot simply and safely retract the shield to cover the needle during typical handling without deliberate manual manipulation (forcing the cantilever arms open and move the shield back to original covered position), which increases the risk of needle hazard. Thus, the removable/replaceable attachment provided by proposed combination, providing a clear motivation to combine the references based on the knowledge generally available to one of skill in the art, even though the combination is made to improve similar devices in the same way (see MPEP 2143.C).
Applicant further argues on pages 9-10 that if the device(s) of Banik were modified as suggested by the examiner, so that the guide member were removable to be able to use a different shape and/or size of guide member, then the intended purpose of the devices of Banik would be defeated, and such a device would not be operable for the intended purpose of Banik, because the intended purpose of Banik is to prevent delivery of erroneous medications caused by interchangeability and compatibly of standard universal medical connector and infusion/injection devices, and interchangeability of the combination would causes error.
Examiner submits that the proposed modification (making the guide member removable to accept alternative attachment) does not change Banik’s core vial-access operation or render it unsatisfactory for its intended purpose. As disclosed in Banik, the system incorporates a syringe (155) equipped with a specific geometrically matching feature (156) that configured to interface with a corresponding female port (105) on the vial attachment apparatus. This design mandates a geometric match for access to the vial’s content, effectively barring incompatible syringes from withdrawing fluid. Even if the guide member were made removable and interchangeable – as proposed in the proposed modification enabling interchangeability - the fundamental safeguarding mechanism remains intact: any attempts use of mismatched geometric feature (whether due to erroneous interchange or otherwise) would still be rejected by the female port, preventing erroneous fluid withdrawal or injection.
In response to applicant’s arguments on pages 12-13, that the modification was made to independent claim 9, and the rationale provided by the office to modify Banik to incorporate Schraga’s teaching “for the purpose of assisting penetrating the syringe needle through the septum” lacks proper motivation because Banik already achieves proper needle positioning through its geometrically-shaped complementary port system.
Examiner respectfully disagrees. Banik’s geometry (e.g., female port 105 with a cylindrical portion configured to mate with geometric feature 156 of the syringe) will center the needle only when the geometrically matching feature of the syringe is inserted into the female port. Because the needle is positioned distal to that geometry, the needle will be centered to the center of the septum unless the geometrically matching feature is inserted. Schraga’s conical (tapered) port, by contrast, provides an initial guiding surface that directs the needle toward the center of the septum prior to full insertion of the geometrically matching feature. The modification therefore improves initial needle alignment and ease of penetration.
For the reasons above, the argument is not persuasive and the rejection is maintained.
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.
Claims 1-3, 6-8, 13, 15-17 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Banik et al (US 20150105745 A1) in view of a second embodiment of Banik (figures 5-14) and Swisher et al (US 20160361497 A1).
Regarding Claim 1, Banik teaches a syringe assembly (figures 23-28, syringe 460) comprising:
a syringe barrel (annotated figure 26, barrel) having a distal end (annotated figure 26, distal end), a needle hub (annotated figure 26, needle hub) coupled to said distal end of syringe barrel, a needle (figure 26, needle 465) extending axially from said needle hub, and a guide member (annotated figure 26, [0053] and [0057] guide member complementary with the geometrically-matched female port 410), said guide member extending in an axial direction form a distal end of said needle hub (unitard figure 26, the guide member extending in axial direction from the distal end of the needle hub); and an adapter (figures 23-28, safety device 400) configured for coupling to a container (figure 25 and [0054] vial 440), said adapter having an axial opening (figure 25 and [0057] female port 410) with a shape complementing a shape of said needle hub having a dimension to receive said needle hub and needle ([0053[ and [0057]-[0058], the female port 410 is configured to permit geometrically compatible needle hub and needle of syringe to access the drug filled vial through female port 410), and wherein said adapter is configured for connecting to said container (as shown figure 28) and aligning the syringe barrel and needle relative to the adapter when needle is advanced to pierce a septum on said container ([0057]-[0058] the adapter is configured to guide needle and the syringe barrel toward vial 440 for proper position of needle relative to the adapter)
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The first embodiment as set forth above does not expressly teach the guide member having at least one rib extending in a radial direction with respect to said guide member.
In the same field of endeavor, namely a drug vial safety device, Banik further teaches alternate embodiments of shapes of a port in figures 5-14, specifically figure 5, that guide member having at least one rib extending in a radial direction with respect to said guide member ([0039], wing portion 174 extending from the circular portion 172).
Banik provides the wing portion extending from the circular portion in a radial direction in order to restrict unintended and improper syringe access to a drug contained within the vial and to prevent end user drug delivery errors ([0013]-[0014]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik to incorporate the alternate embodiment of Banik and provides the guide member having at least one rib extending in a radial direction with respect to said guide member for the purpose of restricting unintended and improper syringe access to a drug contained within the vial and preventing end user drug delivery errors.
The combination is still silent as to the guide member removable from the needle hub.
However, In the same field of endeavor, namely a syringe assembly, Swisher teaches a tube connection portion (figure 2, 24) is removable from the female fitting of the syringe (figure 2, 14).
Swisher provides the removable tube connection portion in order to utilize various types of interchangeable attachment with the syringe ([0020]), for instance the syringe can be used with tube connector for fluid transfer, or a sealing can be used to secure the content of the syringe. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik, to incorporate the teachings of Swisher and provide the guide member removable from the needle hub for the purpose of utilizing various types of interchangeable attachment with the syringe, for example sealing cap or different shape and/or size of guide member.
Regarding Claim 2, Banik, as modified by Swisher, teaches the syringe assembly according to claim 1.
Banik further teaches wherein said adapter has a distal end (Banik; figure 23, collar portion 415) with a coupling member (Banik; figure 23, cantilevered arm 420) for coupling with the container. (Banik; [0054] cantilevers about the vial ap 450 of vial 440)
Regarding Claim 3, Banik, as modified by Swisher, teaches the syringe assembly according to claim 2.
Banik further teaches wherein said coupling member on said distal end of said adapter includes an inwardly extending detent (Banik; figure 23, cantilever arms 420 inwardly extending from the distal end of collar portion 415 abutting the neck of vial 440) configured for engaging a lip of the container.
Regarding Claim 6, Banik, as modified by Swisher, teaches the syringe assembly according to claim 1.
Banik further teaches wherein said guide member includes a plurality of ribs extending axially with respect to said guide member (Banik; figure 5, at least three wings 174 extend axially with the guide member).
Regarding Claim 7, Banik, as modified by Swisher, teaches the syringe assembly according to claim 6.
Banik further teaches wherein said axial opening in said adapter has a plurality of axially extending channels complementing a respective rib of said guide member (Banik; figure 23 and [0039], the geometrically shaped female port 410 shaped to be complementary with the wing of guide member shown figure 5)
Regarding Claim 8, Banik, as modified by Swisher, teaches the syringe assembly according to claim 7.
Banik further teaches that said ribs and guide member are able to slide axially through said axial opening of said adapter (Banik; [0057] the shape and size of the guide member are compatible with the female opening 410 that allow syringe guide slides toward the septum of the vial)
The combination does not specifically teach wherein said axially extending channels have an axial length less than an axial length of said ribs. However, Banik teaches the shape and size of the female opening is compatible with the shape and size of syringe (Banik; [0039] and [0057]).
It would have been obvious to try to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik, as modified by Swisher, with a reasonable expectation of success, to have the channels having an axial length less than an axial length of the ribs, as a person of ordinary skill has good reason to peruse the known options within his or her technical grasp and if the modification meads to the anticipated success, it is like that product was not of innovation but of ordinary skill and common sense (MPEP 2143.I.E). In the instant case, Banik teaches the guide member and the channel having geometrically compatible shape and size (Banik; [0039] and [0057]), and there are finite number of size choice of the channels relative to the length of the ribs (i.e., channel being greater, equal or lesser than the length of ribs), a person in the ordinary skill in the art would modify the length of the channel as claimed to facilitate fitting between the guide member and the adapter. Furthermore, the combination would not operate differently with the claimed dimension as Banik teaches the shape and size of the axial opening is configured to be compatible with the guide member.
Regarding Claim 13, Banik discloses a syringe assembly comprising:
a syringe barrel (annotated figure 26, barrel) having a distal end (annotated figure 26, distal end), a needle bearing hub coupled to said distal end of said syringe barrel (annotated figure 26, needle hub coupled to distal end of the barrel);
a guide member (annotated figure 26, [0053] and [0057], guide member) extending from a distal end of said needle hub (annotated figure 26, the guide member extending from a distal end of the needle hub);
an adapter (figures 23-28, safety device 400) configured for coupling to an open end of a container that contains a medication(figure 23, 400 is configured to be coupled to port 445 of vial 440), said adapter having an axial opening (figure 25 and [0057] female port 410) with an inner surface having a configuration complementing said outer surface of said guide member (figures 23, 28 and [0057], the port comprises an inner surface that having size and/or shape is compatible with proximal portion of the syringe (guide member set forth above).
Banik does not expressly teach the guide member having an outer surface with a non-circular configuration.
However, Banik further teaches alternate embodiments of shapes of a port in figures 5-14, specifically figure 13, that the guide member having an outer surface with a non-circular configuration (figure 13 and [0040], outer surface of the guide member being triangular).
Banik provides the guide member having outer surface with triangular configuration in order to prevent end user drug delivery errors ([0013]-[0014]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik to incorporate the alternate embodiment of Banik and provides the guide member having an outer surface with a non-circular configuration for the purpose of restricting unintended and improper syringe access to a drug contained within the vial and preventing end user drug delivery errors.
The combination is still silent as to where the guide member is removable.
However, in the same field of endeavor, namely a syringe assembly, Swisher teaches a tube connection portion (figure 2, 24) is removable from the female fitting of the syringe (figure 2, 14).
Swisher provides the removable tube connection portion in order to utilize various types of interchangeable attachment with the syringe ([0020]), for instance the syringe can be used with tube connector for fluid transfer, or a sealing can be used to secure the content of the syringe. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik, to incorporate the teachings of Swisher and provide the guide member removable from the needle hub for the purpose of utilizing various types of interchangeable attachment with the syringe, for example sealing cap or different shape and/or size of guide member.
Regarding Claim 15, Banik, as modified by Swisher, teaches the syringe assembly according to claim 13.
Banik further teaches wherein said guide member has at least one radially extending rib (Banik; figure 13 and [0039]-[0040], female port 410 comprises shape of port shown in figure 13 with at least one wings 197 extend radially and have corresponding shape and size of compatible guide member), and said axial opening in said adapter has a shape corresponding to said guide member.
Regarding Claim 16, Banik, as modified by Swisher, teaches the syringe assembly according to claim 13.
Banik further teaches wherein said guide member has a plurality of radially extending ribs, and said axial opening in said adapter has a shape corresponding to said guide member (Banik; figure 13 and [0039]-[0040], female port 410 comprises shape of port shown in figure 13 with plurality of wings 197 extend radially and have corresponding shape and size of compatible guide member)
Regarding Claim 17, Banik, as modified by Swisher, teaches the syringe assembly according to claim 13.
Banik further teaches wherein said axial opening of said adapter has a plurality of radially extending ribs defining a plurality of axially extending channels for receiving a respective rib of said guide member (Banik; figure 13 and [0039] the geometrically shaped female port 410 has channels shaped to be complement with the shape of guide member including wings as shown figure 13, therefore the combination would have the channels corresponding wings 197 and ribs between the channels )
Regarding Claim 20, Banik teaches a method for filling a syringe with a medication, comprising providing a syringe assembly comprising a syringe barrel having a distal end (annotated figure 26, barrel with distal end), a needle hub (annotated figure 26, needle hub) coupled to said distal end of said syringe barrel, a guide member (annotated figure 26, [0053] and [0057] guide member) extending from a distal end of said needle hub (annotated figure 26, guide member extending from a distal end of the needle hub); and an adapter member (figures 23-28, safety device 400) having an axial opening (figure 25 and [0057] female port 410);
Connecting the adapter to an open end of a container (figure 23, connecting the safety device 400 to port 445 of vial 440) having a septum (figure 23, vial cap 450) and that contains the medication ([0018]);
Guiding the guide member through said axial opening of said adapter member ([0057]-[0058] the adapter is configured to guide needle and the syringe barrel toward vial 440 for proper position of needle relative to the adapter) and piercing a septum on said container with said needle ([0008] and [0038]) and filling said syringe barrel with a medication from the container ([0006] syringe for the withdrawal of medicament contained in the medical vial); and
Separating said syringe from said adapter member (as shown figure 26, the syringe 460 being separated from 400)
Banik does not expressly teach the guide member having an outer surface with a non-circular configuration.
However, Banik further teaches alternate embodiments of shapes of a port in figures 5-14, specifically figure 13, that the guide member having an outer surface with a non-circular configuration (figure 13 and [0040], outer surface of the guide member being triangular).
Banik provides the guide member having outer surface with triangular configuration in order to prevent end user drug delivery errors ([0013]-[0014]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik to incorporate the alternate embodiment of Banik and provides the guide member having an outer surface with a non-circular configuration for the purpose of restricting unintended and improper syringe access to a drug contained within the vial and preventing end user drug delivery errors.
The combination is still silent as to the guide member is removable.
However, Swisher teaches a tube connection portion (figure 2, 24) is removable from the female fitting of the syringe (figure 2, 14).
Swisher provides the removable tube connection portion in order to utilize various types of interchangeable attachment with the syringe ([0020]), for instance the syringe can be used with tube connector for fluid transfer, or a sealing can be used to secure the content of the syringe. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik, to incorporate the teachings of Swisher and provide the guide member removable from the needle hub for the purpose of utilizing various types of interchangeable attachment with the syringe, for example sealing cap or different shape and/or size of guide member.
Regarding Claim 21, Banik, as modified by Swisher, teaches the method according to claim 20.
Banik further teaches sliding the guide member and needle through said axial opening in said adapter member whereby said needle pierces the septum on the container (Banik; [0008] and [0038], needle penetrates vial cap 450).
Regarding Claim 22, Banik, as modified by Swisher, teaches the method according to claim 20.
Banik further teaches wherein said guide member has a plurality of radially extending ribs defining said non-circular configuration (Banik; figure 13 and [0039]-[0040], The guide member of syringe would have corresponding the shape of port 196 including wing 197 extending radially), and said axial opening in said adapter member has a plurality of inwardly extending ribs (Banik; figure 23 and [0039], the geometrically shaped female port 410 has channels shaped to be complementary with the shape of guide member including wings as shown figure 13, therefore the port would have rib structures between channels) forming a plurality of axially extending channels (Banik; figure 13, channels between wings 197) for receiving a respective rib of said guide member (Banik; figure 23 and [0039], the female port 410 have a channel shaped to be complementary with the shape of guide member of the syringe)
Claims 9-11, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Banik et al (US 20150105745 A1) in view of a second embodiment of Banik (figures 5-14) Swisher et al (US 20160361497 A1, and Schraga (US 5356406 A)
Regarding Claim 9, Banik teaches a syringe assembly (figures 23-28, syringe 460) comprising:
a syringe barrel (annotated figure 26, barrel) having a distal end (annotated figure 26, distal end), a needle hub (annotated figure 26, needle hub) coupled to said distal end of syringe barrel, a needle (figure 26, needle 465) extending axially from said needle hub, and a guide member (annotated figure 26, [0053] and [0057] guide member complementary with the geometrically-matched female port 410), said guide member extending in an axial direction form a distal end of said needle hub (unitard figure 26, the guide member extending in axial direction from the distal end of the needle hub); and
an adapter (figures 23-28, safety device 400) configured for coupling to a container (figure 25 and [0054] vial 440), said adapter having an axial opening (figure 25 and [0057] female port 410) with a shape complementing a shape of said needle hub having a dimension to receive said needle hub and needle ([0053[ and [0057]-[0058], the female port 410 is configured to permit geometrically compatible needle hub and needle of syringe to access the drug filled vial through female port 410), and wherein said adapter is configured for connecting to said container (as shown figure 28) and aligning the syringe barrel and needle relative to the adapter when needle is advanced to pierce a septum on said container ([0057]-[0058] the adapter is configured to guide needle and the syringe barrel toward vial 440 for proper position of needle relative to the adapter);
wherein said axial opening having an inner surface complementing an outer surface of said guide member (Banik; [0039] and [0057]).
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The first embodiment as set forth above does not expressly teach the guide member having at least one rib extending in a radial direction with respect to said guide member.
In the same field of endeavor, namely a drug vial safety device, Banik further teaches alternate embodiments of shapes of a port in figures 5-14, specifically figure 5, that guide member having at least one rib extending in a radial direction with respect to said guide member ([0039], wing portion 174 extending from the circular portion 172).
Banik provides the wing portion extending from the circular portion in a radial direction in order to restrict unintended and improper syringe access to a drug contained within the vial and to prevent end user drug delivery errors ([0013]-[0014]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik to incorporate the alternate embodiment of Banik and provides the guide member having at least one rib extending in a radial direction with respect to said guide member for the purpose of restricting unintended and improper syringe access to a drug contained within the vial and preventing end user drug delivery errors.
The combination is still silent as to the guide member removable from the needle hub.
However, In the same field of endeavor, namely a syringe assembly, Swisher teaches a tube connection portion (figure 2, 24) is removable from the female fitting of the syringe (figure 2, 14).
Swisher provides the removable tube connection portion in order to utilize various types of interchangeable attachment with the syringe ([0020]), for instance the syringe can be used with tube connector for fluid transfer, or a sealing can be used to secure the content of the syringe. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik, to incorporate the teachings of Swisher and provide the guide member removable from the needle hub for the purpose of utilizing various types of interchangeable attachment with the syringe, for example sealing cap or different shape and/or size of guide member.
The combination does not teach wherein said axial opening has a first section with a top end and a bottom end where said top end has a width greater than said bottom end, and a second section extending from said first section.
However, in the same field of endeavor, namely an adapter for medicine bottle and syringe, Schraga teaches an adapter (figures 1-2, 26) comprising an axial opening formed by guiding surface 36 (figure 2, opening formed by guiding surface 36) has a first section with a top end and a bottom end wherein said top end has a width greater than said bottom end (figure 2, a section formed by guiding surface 36 having greater width at the top end than the bottom end).
Schraga provides the adapter has a guiding surface that forms opening having greater width at top end than the bottom end in order to guide needle to the central bore (col 1 lines 65-col 2 lines 20), which assist in the penetration of the syringe needle through the septum. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik, as modified by Swisher, to incorporate the teachings of Schraga and provide the said axial opening has a first section with a top end and a bottom end where said top end has a width greater than said bottom end, and a second section extending from said first section for the purpose of assisting penetrating the syringe needle through the septum.
Regarding Claim 10, Banik, as modified by Swisher and Schraga, teaches the syringe assembly according to claim 9.
Schraga further teaches wherein said first section of said axial opening in said adapter has a conical shaped surface converging to said second section forming a self-centering surface for centering the needle with respect to said axial opening in said adapter (Schraga; col 1 lines 65-col 2 lines 20, The combination would have the conical section of Schraga converging to the axial opening of Banik). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik, as modified by Swisher, and one of skill would have been motivated to do so, in order to incorporate the teachings of Schraga and provide the above elements and features.
Regarding Claim 11, Banik, as modified by Swisher and Schraga, teaches the syringe assembly according to claim 10.
Banik further teaches wherein said guide member has a plurality of ribs (Banik; figure 5, at least three wings 174 extend axially with the guide member) in the axial direction with respect to said guide member, and wherein said adapter has a plurality of ribs extending radially inward into said opening of said adapter to define axially extending channels for receiving said ribs of said guide member (Banik; figure 23 and [0039], the geometrically shaped female port 410 has channels shaped to be complementary with the shape of guide member including wings as shown figure 5, therefore the port would have rib structures between channels).
Regarding Claim 18, Banik, as modified by Swisher, teaches the syringe assembly according to claim 13.
The combination does not teach wherein said axial opening in said adapter has a first section with a top end and bottom end, where said top end has width greater than said bottom end, and a second section extending from said first section, said axial opening extending through said second section
However, Schraga teaches an adapter (figures 1-2, 26) comprising an axial opening formed by guiding surface (figure 2, 36) has a first section with a top end and bottom end, where said top end has width greater than said bottom end (figure 2, top end of guiding surface 36 having greater width than the bottom end of the guiding surface).
Schraga provides the adapter has a guiding surface that forms opening having greater width at top end than the bottom end in order to guide needle to the central bore (col 1 lines 65-col 2 lines 20), which assist in the penetration of the syringe needle through the septum. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik, as modified by Swisher, to incorporate the teachings of Schraga and provides the said axial opening has a first section with a top end and a bottom end where said top end has a width greater than said bottom end, and a second section extending from said first section for the purpose of assisting penetrating the syringe needle through the septum.
Regarding Claim 19, Banik, as modified by Swisher, teaches the syringe assembly according to claim 18.
Schraga further teaches wherein said first section of said axial opening in said adapter has a conical shaped surface converging to said second section forming a self-centering surface for centering the needle with respect to said axial opening in said adapter (Schraga; col 1 lines 65-col 2 lines 20, The combination would have the conical section of Schraga converging to the axial opening of Banik).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik, as modified by Schraga, and one of skill would have been motivated to do so, in order to incorporate the teachings of Schraga and provide the above elements and features,
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Banik et al (US 20150105745 A1) in view of a second embodiment of Banik (figures 5-14), Swisher et al (US 20160361497 A1), and Schraga (US 5356406 A), and in further view of Cross et al (US 20130231614 A1)
Regarding Claim 12, Banik, as modified by Swisher and Schraga, teaches the syringe assembly according to claim 11
The combination does not teach wherein each of said plurality of ribs on said adapter has a top end with a chamfered edge oriented for guiding said ribs of said guide member into said channels.
In the same field of endeavor, namely a needle assembly, Cross teaches mechanical coupling (figure 11, 414) comprises chamfered edge (figure 11, 490, 496) near opening of groove (figure 11, 434).
Cross provides the chamfered edge at the opening of groove in order to guide the grooves into proper alignment with the receiving protrusions ([0154]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Banik, as modified by Swisher Schraga, to incorporate the teachings of Cross and provide each of said plurality of ribs on said adapter has a top end with a chamfered edge oriented for the purpose of providing proper alignment of guide member with the channels of the axial opening.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Banik et al (US 20150105745 A1) in view of a second embodiment of Banik (figures 5-14) and Swisher et al (US 20160361497 A1), and in further view of Aneas et al (US 20140096862 A1).
Regarding Claim 14, Banik, as modified by Swisher, teaches the syringe assembly according to claim 13.
Banik further teaches wherein said adapter has an axially extending collar (Banik; figure 23, collar portion 415) forming a plurality of legs (Banik; figure 23, cantilevered arms 420).
The combination does not expressly teach legs being sufficiently flexible for coupling to the open end of said container.
However, in the same field of endeavor, namely a device for connection between a recipient and a container, Aneas teaches an adapter having an axially extending collar (Fig 2, annular part 21) forming a plurality of legs (Fig 2, tabs 22), said legs (Fig 2, tabs 22) being sufficiently flexible ([0042] four tabs 22 are elastically deformable) for coupling to an open end of said container (figure 2, taps are coupled to open end of vial)
Aneas provides the elastically deformable taps in order to provide secure snap fit between the adapter and the outer collar of the ([0042]). Therefore, It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Banik, as modified by Swisher, to incorporate the teachings of Aneas and provide legs being sufficiently flexible for coupling to the open end of said container for the purpose of secure snap fit between the adapter and the vial.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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, Nicholas J Weiss can be reached at (571)270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.H./Examiner, Art Unit 3781
/NICHOLAS J. WEISS/Supervisory Patent Examiner, Art Unit 3781
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