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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 17, 2026 has been entered.
The amendments of claims 1 and 18; the cancellation of claim 9; and the addition of claims 23-26 are acknowledged.
Response to Arguments
Applicant’s arguments regarding the 35 USC 112(b) rejection for “at least about” are not persuasive. Applicant argues that terms of degree do not make a claim indefinite and it is well established that “about” is not indefinite when the terms serve reasonably to describe the subject matter so that its scope would be understood by persons within the field of invention, citing MPEP 21703.05(b). However, in that same section of the MPEP it states that in another case, the court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991). Similar to in Amgen, the term “at least about” is found as indefinite as there is close prior art and there is nothing in the specification, prosecution history, or prior art to provide any indication as to what range of specific activity is covered by the term “about.” Applicant alleges that someone within the field of invention would understand, but does not explain how so or what “at least about” covers.
Applicant’s arguments with respect to claim(s) 1 and 18 and their dependents regarding prior art 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.
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.
Claims 1-2, 4-8, and 10-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1, 16-18, 21, and 22, the term “at least about” in these claims is a relative term which renders the claim indefinite. The term “at least about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 2, 4-8, 10-17, and 19-26 are rejected as dependents of claims 1 or 18.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-8, 10-11, 14-19, and 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Wallen (US 2003/0191445) in view of Lev (US 2016/0166824) and further in view of Brugger et al. (US 2005/0277906), and further in view of Fangrow, JR. (US 2009/0216212), disclosed by Applicant an IDS filed January 17, 2022.
Regarding claim 1, Wallen discloses a liquid transfer device (see Fig. 2a) comprising: a barrel configured to fluidly connect to an infusion set (see Fig. 1, portion of first portion 107 connecting to second portion 108 and par. 31); an injection port 102 for injection of a second medical fluid connected to a branch lumen (see Fig. 2a, lumen in duct 104 that is directly branched off from lumen in duct 104 that is in spike 114); and an intravenous (IV) spike 114 configured to be sealingly inserted into an intravenous administration port of a container of an infusion liquid (see Fig. 4; par. 38), the IV spike having a first IV spike lumen fluidly connected to the lumen going to injection port 102 with the first IV spike lumen having a first distal aperture (see Fig. 2a, duct 104 includes lumen that is in spike and lumen that is branched off going directly to injection port 102, with aperture being towards tip of spike), and a second IV spike lumen fluidly connected to the infusion set with the second IV spike lumen connected to the barrel and having a second distal aperture (see Fig. 2a, duct 105 includes lumen that is in spike, with second distal aperture being one towards tip of spike), wherein the liquid transfer device defines a first fluid path 104 and a second fluid path 105, the first fluid 104 path is through the branch lumen and the first IV spike lumen to introduce medicament from the injection port for mixing with the infusion liquid to form a medicated infusion liquid (see par. 28), and the second fluid path 105 is through the second IV spike lumen to pass the medicated infusion liquid from the container to the infusion set (see Fig. 2a; par. 28). Wallen further discloses the first IV spike lumen has a first peripherally disposed distal aperture, the second IV spike lumen has a second peripherally disposed distal aperture, and the first peripherally disposed distal aperture is distal of the second peripherally disposed distal aperture along the IV spike (see Figs. 2a and 3, the aperture at the end of the first IV spike lumen is more distal than the aperture at the end of the second IV spike lumen).
Wallen does not disclose the liquid transfer device comprising a vial adapter in communication with a vial adapter lumen and having a vial spike, the vial spike being configured to puncture a stopper of a vial containing a medicament, and the vial adapter being configured to receive the vial, the IV spike having a first IV spike lumen fluidly connected to the vial adapter lumen, and the first fluid path through the vial adapter lumen and the first IV spike lumen to introduce medicament from the vial to the container for mixing.
Lev discloses a liquid transfer device (see Fig. 5B) comprising: a barrel configured to fluidly connect to an infusion set (see Fig. 5B, barrel that holds and attaches to IV port 43)); a vial adapter 102 in communication with a vial adapter lumen (see Fig. 5B, lumen coming from vial adapter to connect with lumen within ) and having a vial spike 106 (see Fig. 5B), the vial spike being configured to puncture a stopper of a vial containing a medicament (see par. 32), and the vial adapter being configured to receive the vial (see par. 32); and an intravenous (IV) spike 22 configured to be sealingly inserted into an intravenous administration port of a container of an infusion liquid (see Fig. 5B; par. 31-33). In Lev, the vial adapter allows for injection of a second fluid (additive) for mixing with a medicament (see par. 33). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the injection port of Wallen that attached with a syringe (see Wallen, Fig. 4) as Lev discloses such a replacement (see par. 25, use of vial adapter instead of syringe), which would predictably result in the addition of a second fluid for mixing. Consequently, the resulting liquid transfer device of Wallen and Lev would have an IV spike having a first IV spike lumen fluidly connected to the vial adapter lumen and the first fluid path through the vial adapter lumen and the first IV spike lumen to introduce medicament from the vial to the container for mixing.
Wallen and Lev do not disclose that the first distal aperture is distally separated from the second distal aperture by a distance of at least about 1.0 mm.
Brugger discloses a spike with a first lumen 17 having a first distal aperture 18 for going into a container and a second lumen 17 with a second distal aperture 20 for removing from the container (see Figs. 3A-4B), the first distal aperture distally separated from the second distal aperture, allowing the first aperture to be well within the container and helps to ensure against short-circuit flow, thereby helping to avoid a suction zone created by an outlet flow through the outlet opening (see par. 40) as well as reducing the amount of bubbles in the fluid leaving through the outlet opening (see Abstract, par. 4). Therefore, Brugger discloses that the distance of the first distal aperture from the second distal aperture needs to be optimized to avoid a suction zone created by an outlet flow through the outlet opening as well as reduce the amount of bubble sin the fluid leaving through the outlet opening, which is the first distal aperture (see par. 4, 40). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device to have the separation of the first distal aperture separated from the second distal aperture by at least 1.0 mm, so within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device by making the first distal aperture separated from the second distal aperture by at least 1.0 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Wallen, Brugger, and Lev do not disclose a flat surface distal of the second distal aperture.
Fangrow, JR. discloses a vial adaptor with a spike 14 having a first spike lumen having a first distal aperture 24b (see Figs. 1, 6, 9) and a second spike lumen having a second distal aperture 24a (see Figs. 1, 7, 9), and a flat surface distal of the second distal aperture (see Figs. 1, 5, 7, 9 showing area below line under second aperture 24a in Figure 7 would be flat as evidenced by Figure 9 and further supported by the line between the flat line between the apertures 24a, 24b in Figure 5). In Fangrow, JR., air travels through first spike lumen to enter and fill container (see par. 109) and contents travel through second spike to exit container (see par. 63), therefore fluid flows from the first spike lumen towards the first distal aperture and then fluid flows from the second distal aperture towards and out of the second spike lumen. It would have been obvious to a person having ordinary skill in the art before the effective filing date to substitute such spike configuration with the lumens as disclosed by Wallen with that disclosed by Fangrow, JR., as doing so would have yielded predictable results, mainly a way for allowing fluids out of the first spike lumen and fluids into the second spike lumen as well as allowing for puncture via the spike.
Regarding claim 2, Wallen, Brugger, Lev, and Fangrow, JR. disclose the liquid transfer device of claim 1, and Wallen discloses a monolithic connector body including at least one of the barrel, the vial adapter, and/or the IV spike (see Fig. 2a).
Regarding claim 4, Wallen, Brugger, Lev, and Fangrow, JR. disclose the liquid transfer device of claim 1, and Wallen further discloses an IV port 108 connected to the barrel, wherein the IV port is configured to sealingly receive a port spike 214 of the infusion set to connect to the infusion set (see par. 32, 40).
Regarding claim 5, Wallen, Brugger, Lev, and Fangrow, JR. disclose the liquid transfer device of claim 4, and the IV port is capable of being permanently secured to the barrel (see Fig. 4, IV port can be left permanently on the barrel).
Regarding claim 6, Wallen, Brugger, Lev, and Fangrow, JR. disclose the liquid transfer device of claim 4, and Wallen further discloses the IV port includes a septum 118 configured to be punctured by the port spike of the infusion set (see Fig. 4 and par. 32, 40).
Regarding claim 7, Wallen, Brugger, Lev, and Fangrow, JR. disclose the liquid transfer device of claim 6, and Wallen further discloses the IV port includes a removable member 129 proximal of the septum (see Fig. 1 and par. 44).
Regarding claim 8, Wallen, Brugger, Lev, and Fangrow, JR. disclose the liquid transfer device of claim 1, and Wallen further discloses the first IV spike lumen and the second IV spike lumen extend parallel to one another (see Fig. 2a).
Regarding claim 10, Wallen, Brugger, Lev, and Fangrow, JR. disclose the liquid transfer device of claim 1, and Lev further discloses the vial adapter has a flexible and/or flared skirt (see Fig. 5B; par. 32).
Regarding claim 11, Wallen, Brugger, Lev, and Fangrow, JR. disclose the liquid transfer device of claim 1, and Lev further discloses the vial adapter is configured to snap onto the vial (see par. 32).
Regarding claim 14, Wallen, Brugger, Lev, and Fangrow, JR. disclose the liquid transfer device of claim 1, and the resulting liquid transfer device would have the barrel aligned with the IV spike, and the vial adapter angularly bifurcated form the IV spike (see Wallen, Fig. 2a and Lev, Fig. 5B, with Lev showing vial adapter angularly bifurcated from IV spike and barrel aligned with IV spike).
Regarding claim 15, Wallen, Brugger, Lev, and Fangrow, JR. disclose the liquid transfer device of claim 1 and Lev further discloses the vial spike is integral to the vial adapter (see Fig. 5B).
Regarding claim 16, Wallen, Brugger, Lev, and Fangrow, JR. do not disclose that the first distal aperture is distally separated from the second distal aperture by a distance of at least about 2.5 mm.
Brugger discloses a spike with a first lumen 17 having a first distal aperture 18 for going into a container and a second lumen 17 with a second distal aperture 20 for removing from the container (see Figs. 3A-4B), the first distal aperture distally separated from the second distal aperture, allowing the first aperture to be well within the container and helps to ensure against short-circuit flow, thereby helping to avoid a suction zone created by an outlet flow through the outlet opening (see par. 40) as well as reducing the amount of bubbles in the fluid leaving through the outlet opening (see Abstract, par. 4). Therefore, Brugger discloses that the distance of the first distal aperture from the second distal aperture needs to be optimized to avoid a suction zone created by an outlet flow through the outlet opening as well as reduce the amount of bubble sin the fluid leaving through the outlet opening, which is the first distal aperture (see par. 4, 40). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device to have the separation of the first distal aperture separated from the second distal aperture by at least 2.5 mm, so within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device by making the first distal aperture separated from the second distal aperture by at least 2.5 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 17, Wallen, Brugger, Lev, and Fangrow, JR. do not disclose that the first distal aperture is distally separated from the second distal aperture by a distance of at least about 4 mm.
Brugger discloses a spike with a first lumen 17 having a first distal aperture 18 for going into a container and a second lumen 17 with a second distal aperture 20 for removing from the container (see Figs. 3A-4B), the first distal aperture distally separated from the second distal aperture, allowing the first aperture to be well within the container and helps to ensure against short-circuit flow, thereby helping to avoid a suction zone created by an outlet flow through the outlet opening (see par. 40) as well as reducing the amount of bubbles in the fluid leaving through the outlet opening (see Abstract, par. 4). Therefore, Brugger discloses that the distance of the first distal aperture from the second distal aperture needs to be optimized to avoid a suction zone created by an outlet flow through the outlet opening as well as reduce the amount of bubble sin the fluid leaving through the outlet opening, which is the first distal aperture (see par. 4, 40). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device to have the separation of the first distal aperture separated from the second distal aperture by at least 4 mm, so within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device by making the first distal aperture separated from the second distal aperture by at least 4 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 18, Wallen discloses a liquid transfer device (see Fig. 2a) comprising: a barrel configured to fluidly connect to an infusion set (see Fig. 1, portion of first portion 107 connecting to second portion 108 and par. 31); an injection port 102 for injection of a second medical fluid connected to a branch lumen (see Fig. 2a, lumen in duct 104 that is directly branched off from lumen in duct 104 that is in spike 114); and an intravenous (IV) spike 114 configured to be sealingly inserted into an intravenous administration port of a container of an infusion liquid (see Fig. 4; par. 38), the IV spike having a first IV spike lumen fluidly connected to the lumen going to injection port 102 with the first IV spike lumen having a first distal aperture (see Fig. 2a, duct 104 includes lumen that is in spike and lumen that is branched off going directly to injection port 102, with aperture being towards tip of spike), and a second IV spike lumen fluidly connected to the infusion set with the second IV spike lumen connected to the barrel and having a second distal aperture (see Fig. 2a, duct 105 includes lumen that is in spike, branch lumen, and intravenous spike; wherein the liquid transfer device defines a first fluid path 104 and a second fluid path 105, the first fluid 104 path is through the branch lumen and the first IV spike lumen to introduce medicament from the injection port for mixing with the infusion liquid to form a medicated infusion liquid (see par. 28), and the second fluid path 105 is through the second IV spike lumen to pass the medicated infusion liquid from the container to the infusion set (see Fig. 2a; par. 28). Wallen further discloses the first IV spike lumen has a first peripherally disposed distal aperture, the second IV spike lumen has a second peripherally disposed distal aperture, and the first peripherally disposed distal aperture is distal of the second peripherally disposed distal aperture along the IV spike (see Figs. 2a and 3, the aperture at the end of the first IV spike lumen is more distal than the aperture at the end of the second IV spike lumen). Wallen further discloses an IV port 108 connected to the barrel, wherein the IV port is configured to sealingly receive a port spike 214 of the infusion set to connect to the infusion set (see par. 32, 40).
Wallen does not disclose the liquid transfer device comprising a vial adapter in communication with a vial adapter lumen and having a vial spike, the vial spike being configured to puncture a stopper of a vial containing a medicament, and the vial adapter being configured to receive the vial, the IV spike having a first IV spike lumen fluidly connected to the vial adapter lumen, and the first fluid path through the vial adapter lumen and the first IV spike lumen to introduce medicament from the vial to the container for mixing.
Lev discloses a liquid transfer device (see Fig. 5B) comprising: a barrel configured to fluidly connect to an infusion set (see Fig. 5B, barrel that holds and attaches to IV port 43)); a vial adapter 102 in communication with a vial adapter lumen (see Fig. 5B, lumen coming from vial adapter to connect with lumen within ) and having a vial spike 106 (see Fig. 5B), the vial spike being configured to puncture a stopper of a vial containing a medicament (see par. 32), and the vial adapter being configured to receive the vial (see par. 32); and an intravenous (IV) spike 22 configured to be sealingly inserted into an intravenous administration port of a container of an infusion liquid (see Fig. 5B; par. 31-33). In Lev, the vial adapter allows for injection of a second fluid (additive) for mixing with a medicament (see par. 33). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the injection port of Wallen that attached with a syringe (see Wallen, Fig. 4) as Lev discloses such a replacement (see par. 25, use of vial adapter instead of syringe), which would predictably result in the addition of a second fluid for mixing. Consequently, the resulting liquid transfer device of Wallen and Lev would have an IV spike having a first IV spike lumen fluidly connected to the vial adapter lumen and the first fluid path through the vial adapter lumen and the first IV spike lumen to introduce medicament from the vial to the container for mixing.
Wallen and Lev do not disclose that the first distal aperture is distally separated from the second distal aperture by a distance of at least about 1.0 mm.
Brugger discloses a spike with a first lumen 17 having a first distal aperture 18 for going into a container and a second lumen 17 with a second distal aperture 20 for removing from the container (see Figs. 3A-4B), the first distal aperture distally separated from the second distal aperture, allowing the first aperture to be well within the container and helps to ensure against short-circuit flow, thereby helping to avoid a suction zone created by an outlet flow through the outlet opening (see par. 40) as well as reducing the amount of bubbles in the fluid leaving through the outlet opening (see Abstract, par. 4). Therefore, Brugger discloses that the distance of the first distal aperture from the second distal aperture needs to be optimized to avoid a suction zone created by an outlet flow through the outlet opening as well as reduce the amount of bubble sin the fluid leaving through the outlet opening, which is the first distal aperture (see par. 4, 40). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device to have the separation of the first distal aperture separated from the second distal aperture by at least 1.0 mm, so within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device by making the first distal aperture separated from the second distal aperture by at least 1.0 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Wallen, Brugger, and Lev do not disclose a flat surface distal of the second distal aperture.
Fangrow, JR. discloses a vial adaptor with a spike 14 having a first spike lumen having a first distal aperture 24b (see Figs. 1, 6, 9) and a second spike lumen having a second distal aperture 24a (see Figs. 1, 7, 9), and a flat surface distal of the second distal aperture (see Figs. 1, 5, 7, 9 showing area below line under second aperture 24a in Figure 7 would be flat as evidenced by Figure 9 and further supported by the line between the flat line between the apertures 24a, 24b in Figure 5). In Fangrow, JR., air travels through first spike lumen to enter and fill container (see par. 109) and contents travel through second spike to exit container (see par. 63), therefore fluid flows from the first spike lumen towards the first distal aperture and then fluid flows from the second distal aperture towards and out of the second spike lumen. It would have been obvious to a person having ordinary skill in the art before the effective filing date to substitute such spike configuration with the lumens as disclosed by Wallen with that disclosed by Fangrow, JR., as doing so would have yielded predictable results, mainly a way for allowing fluids out of the first spike lumen and fluids into the second spike lumen as well as allowing for puncture via the spike.
Regarding claim 19, Wallen discloses the connector body being monolithic (see Fig. 2a).
Regarding claim 21, Wallen, Brugger, Lev, and Fangrow, JR. do not disclose that the first distal aperture is distally separated from the second distal aperture by a distance of at least about 2.5 mm.
Brugger discloses a spike with a first lumen 17 having a first distal aperture 18 for going into a container and a second lumen 17 with a second distal aperture 20 for removing from the container (see Figs. 3A-4B), the first distal aperture distally separated from the second distal aperture, allowing the first aperture to be well within the container and helps to ensure against short-circuit flow, thereby helping to avoid a suction zone created by an outlet flow through the outlet opening (see par. 40) as well as reducing the amount of bubbles in the fluid leaving through the outlet opening (see Abstract, par. 4). Therefore, Brugger discloses that the distance of the first distal aperture from the second distal aperture needs to be optimized to avoid a suction zone created by an outlet flow through the outlet opening as well as reduce the amount of bubble sin the fluid leaving through the outlet opening, which is the first distal aperture (see par. 4, 40). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device to have the separation of the first distal aperture separated from the second distal aperture by at least 2.5 mm, so within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device by making the first distal aperture separated from the second distal aperture by at least 2.5 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 22, Wallen, Brugger, Lev, and Fangrow, JR. do not disclose that the first distal aperture is distally separated from the second distal aperture by a distance of at least about 4 mm.
Brugger discloses a spike with a first lumen 17 having a first distal aperture 18 for going into a container and a second lumen 17 with a second distal aperture 20 for removing from the container (see Figs. 3A-4B), the first distal aperture distally separated from the second distal aperture, allowing the first aperture to be well within the container and helps to ensure against short-circuit flow, thereby helping to avoid a suction zone created by an outlet flow through the outlet opening (see par. 40) as well as reducing the amount of bubbles in the fluid leaving through the outlet opening (see Abstract, par. 4). Therefore, Brugger discloses that the distance of the first distal aperture from the second distal aperture needs to be optimized to avoid a suction zone created by an outlet flow through the outlet opening as well as reduce the amount of bubble sin the fluid leaving through the outlet opening, which is the first distal aperture (see par. 4, 40). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device to have the separation of the first distal aperture separated from the second distal aperture by at least 4 mm, so within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device by making the first distal aperture separated from the second distal aperture by at least 4 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 23, Wallen, Brugger, Lev, and Fangrow, JR. discloses the liquid transfer device of claim 1 and Fangrow, JR. further discloses the flat surface has a width that narrows to a tip of the spike (see Fig. 7), which would be the IV spike of Wallen, Brugger, Lev, and Fangrow, JR.
Regarding claim 24, Wallen, Brugger, Lev, and Fangrow, JR. discloses the liquid transfer device of claim 23, though Fangrow, JR. does not disclose the width of the flat surface arcuately narrows to the tip as Fangrow, JR. shows the narrowing as straight all around the spike like a cone going towards the tip (see Figs. 1, 6-9). Alternatively, both Wallen and Lev disclose the tip narrowing in an arcuate manner as opposed to a straight manner (see Wallen, Fig. 1 and Lev, Figs. 4, 5B). Therefore, it seems that having the tip narrow in an arcuate manner towards the narrowest point of the spike is a well-known alternative to having the tip narrow in a straight manner. Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date to substitute having the tip of the spike narrow in an arcuate manner towards the narrowest spike as a substitute/alternative to having it narrow in a straight manner, as doing so would have yielded predictable results, mainly a way for the tip to narrow towards the narrowest point creating a spike for access to fluids via openings. Consequently, as the tip would be arcuately narrowed, the flat surface would also be arcuately narrowed due to the shape of the outer edges of the tip.
Regarding claim 25, Wallen, Brugger, Lev, and Fangrow, JR. discloses the liquid transfer device of claim 1 and Fangrow, JR. further discloses the flat surface extends along a longitudinal axis of the spike (see Figs. 7, 9), which would be the IV spike of Wallen, Brugger, Lev, and Fangrow, JR.
Regarding claim 26, Wallen, Brugger, Lev, and Fangrow, JR. discloses the liquid transfer device of claim 1 and Fangrow, JR. further discloses the second distal aperture is through a surface that extends at an angle with respect to the longitudinal axis of the spike (see Figs. 7, 9), which would be the IV spike of Wallen, Brugger, Lev, and Fangrow, JR.
Claim(s) 12-13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wallen in view of Lev and further in view of Brugger and further in view of Fangrow, JR. as applied to claims 1 or 18 above, and further in view of Merchant et al. (US 2020/0330326). Merchant is considered prior art as the priority date of claim 12 is January 13, 2020.
Regarding claim 12, Wallen, Brugger, Lev, and Fangrow, JR. disclose the liquid transfer device of claim 1, but neither reference discloses the liquid transfer device further comprising a valve in the first fluid path or the second fluid path.
Merchant discloses a liquid transfer device with a first fluid path 220, 142 and a second fluid path 210 (see Fig. 10), the first fluid path including a valve 150-1 to ensure more mixing of the reconstituted medicine before patient delivery (see par. 38). Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the first flow path include a valve as disclosed by Merchant, ensuring more mixing of the reconstituted medicine before patient delivery.
Regarding claim 13, Wallen, Brugger, Lev, Fangrow, JR. and Merchant disclose the limitations required by claim 12 and Wallen further discloses an IV port 108 fluidly connected with the IV lumen (see Fig. 4), and due to the positioning of the valve disclosed in Merchant (see Fig. 10), the IV port would be fluidly connected with the valve in an open position and fluidly disconnected from the second IV spike lumen with the valve in a closed position.
Regarding claim 20, Wallen, Brugger, Lev, and Fangrow, JR. disclose the liquid transfer device of claim 18, but neither reference discloses the liquid transfer device further comprising a valve in the first fluid path or the second fluid path.
Merchant discloses a liquid transfer device with a first fluid path 220, 142 and a second fluid path 210 (see Fig. 10), the first fluid path including a valve 150-1 to ensure more mixing of the reconstituted medicine before patient delivery (see par. 38). Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the first flow path include a valve as disclosed by Merchant, ensuring more mixing of the reconstituted medicine before patient delivery.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Denenburg et al. (WO 2018/212480) disclose a flat surface distal of a second distal aperture, as in Figure 3.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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