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 .
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 of this title, 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) 1, 5-8, 12 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenland (US 4,576,594, cited previously) in view of Burke (US 3,316,908, cited previously)
As to claim 1, Greenland discloses a syringe adapter (32, 34; see Figs. 1-4) for coupling with a syringe (12), the syringe adapter comprising:
an adapter body (32) defining a fluid channel (22) configured to permit medical fluid flow from the syringe through the syringe adapter (see para beginning line 21 col. 3) and a vent channel (24) configured to permit air flow into the syringe (see para beginning line 41 col. 3);
a coupling portion (34) defining an adapter portion (lower, enlarged portion) configured to be coupled to the adapter body and a syringe portion (upper portion that includes ears 36) configured to be coupled to the syringe (see para beginning line 53 col. 3); and
a bulb (10) coupled to the adapter body and defining a bulb volume, wherein the bulb volume is in fluid communication with the fluid channel and is movable between a collapsed configuration configured to displace air from the bulb volume and the fluid channel and an expanded configuration configured to draw medical fluid from the syringe into the fluid channel and bulb volume (see paragraph beginning line 5 col. 3; the chamber 10 is capable of being squeezed and thus capable of fulfilling the claimed functional limitations inasmuch as the instantly-described bulb).
Greenland is silent to the adapter body defining a spike portion extending from the adapter body, and thus the fluid channel extending through the spike portion, the vent channel extending through the spike portion, and the adapter portion configured to be coupled to the spiked portion.
Burke discloses an adapter body (20) that defines a spike portion (portion above shoulder portion 28; as seen in Figs. 3-4) extending from the adapter body (20), wherein a fluid channel (36) and a vent channel (40) extend through the spike portion of the adapter body (Figs. 3, 4), and wherein the adapter portion of the coupling portion is configured to be coupled to the spike portion of the adapter body (see para beginning line 48 col. 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Greenland in view of Burke such that the adapter body further defines a spike portion extending from the adapter body, wherein the fluid channel and the vent channel extend through the spike portion of the adapter body, and wherein the adapter portion of the coupling portion is configured to be coupled to the spike portion of the adapter body. One would have been motivated to do so in order to allow the adapter body to be inserted in the hole of an intravenous or blood bottle if desired (see para beginning line 21 col. 5 of Burke).
As to claim 5, Greenland n view of Burke discloses the syringe adapter of Claim 1 as described above, and Greenland further comprising a check valve (44) in fluid communication with the vent channel, wherein the check valve is configured to permit air flow into the syringe and prevent medial fluid flow out of the vent channel (para beginning line 41 col. 3).
As to claim 6, Greenland in view of Burke discloses the syringe adapter of Claim 5 as described above, and Greenland further discloses wherein the check valve comprises a ball mechanism (Figs. 2, 4, para beginning line 41 col. 3).
As to claim 7, Greenland in view of Burke discloses the syringe adapter of Claim 1 as described above, and Greenland further discloses a cannula (20) extending into the vent channel and configured to extend into the syringe, wherein a cannula lumen of the cannula is in fluid communication with the vent channel (Figs. 2-4, paragraphs beginning line 28 col. 3 and line 67 col. 3).
As to claim 8, Greenland in view of Burke discloses the syringe adapter of Claim 1 as described above, and Greenland further discloses wherein the syringe portion of the coupling portion defines a luer connector configured to couple with the syringe (para beginning line 53 col. 3).
As to claim 12, Greenland discloses an intravenous (IV) set (see Figs. 1-4), comprising:
a syringe (12) comprising:
a barrel (not numbered, but seen in Fig. 1); and
a plunger (42) movably disposed in the barrel, wherein the plunger and the barrel cooperatively define a syringe volume (interior of 12; see Fig. 1); and
a syringe adapter (32, 34) comprising:
an adapter body (32) defining a fluid channel (22) in fluid communication with the syringe volume and configured to permit medical fluid flow from the syringe volume through the syringe adapter (see para beginning line 21 col. 3) and a vent channel (24) in fluid communication with the syringe volume and configured to permit air flow into the syringe volume (see para beginning line 41 col. 3);
a coupling portion (34) defining an adapter portion (lower, enlarged portion) coupled to the adapter body and a syringe portion (upper portion that includes ears 36) coupled to the syringe (see Figs. 1-2 and para beginning line 53 col. 3); and
a bulb (10) coupled to the adapter body and defining a bulb volume, wherein the bulb volume is in fluid communication with the fluid channel and the syringe volume and is movable between a collapsed configuration configured to displace air from the bulb volume and the fluid channel and an expanded configuration configured to draw medical fluid from the syringe volume into the fluid channel and bulb volume (see paragraph beginning line 5 col. 3; the chamber 10 is capable of being squeezed and thus capable of fulfilling the claimed functional limitations inasmuch as the instantly-described bulb).
Greenland is silent to wherein the adapter body further defines a spike portion extending from the adapter body, wherein the fluid channel and the vent channel extend from the spike portion of the adapter body, and wherein the adapter portion of the coupling portion is configured to be coupled to the spike portion of the adapter body.
Burke discloses an adapter body (20) that defines a spike portion (portion above shoulder portion 28; as seen in Figs. 3-4) extending from the adapter body (20), wherein the fluid channel (36) and the vent channel (40) extend through the spike portion of the adapter body (Figs. 3, 4), and wherein the adapter portion of the coupling portion is configured to be coupled to the spike portion of the adapter body (see para beginning line 48 col. 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Greenland in view of Burke such that the adapter body further defines a spike portion extending from the adapter body, wherein the fluid channel and the vent channel extend through the spike portion of the adapter body, and wherein the adapter portion of the coupling portion is configured to be coupled to the spike portion of the adapter body. One would have been motivated to do so in order to allow the adapter body to be inserted in the hole of an intravenous or blood bottle if desired (see para beginning line 21 col. 5 of Burke).
As to claim 16, Greenland in view of Burke discloses the IV set of Claim 12, and Greenland further discloses a check valve (44) in fluid communication with the vent channel, wherein the check valve is configured to permit air flow into the syringe volume and prevent medial fluid flow out of the vent channel (para beginning line 41 col. 3).
As to claim 17, Greenland in view of Burke discloses the IV set of Claim 16 as described above, and Greenland further discloses wherein the check valve comprises a ball mechanism (Figs. 2, 4, para beginning line 41 col. 3).
As to claim 18, Greenland in view of Burke discloses the IV set of Claim 12 as described above, and Greenland further discloses a cannula (20) extending into the vent channel and the syringe, wherein a cannula lumen of the cannula is in fluid communication with the vent channel (Figs. 2-4, paragraphs beginning line 28 col. 3 and line 67 col. 3).
As to claim 19, Greenland in view of Burke discloses the IV set of Claim 12 as described above, and Greenland further discloses wherein the syringe portion of the coupling portion defines an adapter luer connector (para beginning line 53 col. 3).
As to claim 20, Greenland in view of Burke discloses the IV set of Claim 19 as described above, wherein the syringe comprises a syringe luer connector coupled to the adapter luer connector (para beginning line 53 col. 3).
Response to Arguments
Applicant’s Remarks submitted 7/10/26 have been considered.
With regard to the arguments concerning the previous claim objections and rejections under 35 U.S.C. § 112, the arguments are moot/persuasive as the amendments have obviated the previous objections/rejections.
With regard to the arguments concerning the previous rejections under 35 U.S.C. § 103 using Greenland and Burke, the arguments are not persuasive.
With regard to claim 1 specifically, the examiner points out that the previous and current rejection state that “It would have been obvious to one having ordinary skill in the art … to have modified Greenland in view of Burke … to allow the adapter body to be inserted in the hole of an intravenous or blood bottle if desired” (emphasis added). While the examiner agrees that Greenland states “There is, therefore, still the need for a vented drip chamber which is engageable with a standard hypodermic syringe or with any fluid container which must be accessed by some means other than through a spike penetrable stopper”, this is not the same as saying a spike portion should never be used on an adapter body and merely refers to a scenario when a spike portion is not needed. The way that the adapter body (32) of Greenland attaches to a syringe is by the inclusion of adapter 34 which has ears 36 which mate with a threaded luer adapter on the syringe. The examiner contends that there may be a scenario wherein attachment to a syringe is not needed (and attachment to a bottle is needed). Furthermore, with regard to both claim 1 and 12, the examiner notes that Greenland states “Adapter 34 is connected to housing 32 by any means well known in the art” (para beginning line 21 col. 3). Burke teaches a way of attaching a guard means 60 to its adapter body/spike portion (see inwardly directed rib 70 adapted to engage the outer tapered surface portion 26 – para beginning line 48 col. 6 & Figs. 3-4). It is within the realm of possibility that one having ordinary skill in the art could have modified the adapter 34 of Greenland to attach to a modified housing 32 (i.e. one comprising a spiked portion) by including similar structure. To say it another way, the presence of a spiked portion on housing 32 does not necessarily prevent attachment of adapter 34. Such a modified version would provide dual functionality to Greenland of being able to attach to a bottle (via disconnection of adapter 34 and use of the spike) and attach to a syringe (via inclusion of the adapter 34).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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/James D Ponton/Primary Examiner, Art Unit 3783
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