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 .
Election/Restrictions
Applicant’s election without traverse of Species IA, figure 4 in the reply filed on 07/24/2026 is acknowledged.
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) 1-3,7-8,10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brand EP 0521460, hereafter Brand in view of Okiyama US 2015/0083950, hereafter Okiyama.
Regarding Claim 1, Brand discloses a device for transferring liquid medicine from a low-pressure sealed container to a high-pressure sealed container (abstract, figure 3A-D, para. 0002)comprising: a first channel configured to be able to communicate the low-pressure sealed container with the high-pressure sealed container in gas (22, see figure 3a, para. 0022, where channel 22 is connected with an atmospheric vent)); a second channel configured to be able to communicate the low-pressure sealed container with the high-pressure sealed container in liquid (21, see figure 3a, para. 0022, where channel 22 is connected with a liquid extraction channel).
Brand further discloses a first puncture end configured to pierce the low-pressure sealed container (“bottom” puncture end), wherein first ends of the first channel and the second channel are located at the first puncture end (See figure 3a);a second puncture end configured wherein second ends of the first channel and the second channel are located at the second puncture end (“top” figure 3a); an on-off valve (5) arranged on the first channel and the second channel (see figure 3a), and configured to control the opening and closing of the first channel and the second channel (see rotation to closed position in figure 3b).
However, there is no disclosure in Brand where the first channel is opened before the second channel
Okiyama discloses a fluid transfer device and is thus considered analogous to the claimed invention. Okiyama teaches a defined first channel (gas channel portion (42, see figure 24a, para. 0180) of the valve) wraps around a rotatable valve further than the liquid channel portion (41). This is best seen in figure 18. Due to this circumferential arrangement, and the fact that the valve is rotated into a position to function, it is interpreted that, depending on the starting position of the valve the gas channel portion (thus the first channel) would open first. Therefore, as Okiyama teaches a rotatable valve in which the gas channel comprises a groove, further extending circumferentially than the liquid channel opening, where the valve still serves to open/close the channels for fluid transfer between containers, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the gas channel opening of Brand as a further extending groove, as Okiyama teaches that such construction is suitable in the art. As such, doing so would merely involve the simple substitution of one known element for another to obtain predictable results, that being the opening and closing of channels in a transfer apparatus. As detailed above, as the gas channel opening (now of the combined invention) extends further circumferentially than the liquid channel opening, depending on the starting position of the valve the gas channel portion (thus the first channel) would open first.
Regarding Claim 2, Brand and Okiyama teach the device for transferring liquid medicine from a low-pressure sealed container to a high-pressure sealed container according to claim 1, wherein the on-off valve comprises a valve core (5) ,configured with a first through hole and a second through hole (openings corresponding to the two channels, best seen in figure 3a, where the closed position is best seen in figure 3b), the first through hole and the second through hole are respectively located in a middle position of the first channel and the second channel (see figure 3a), and the first channel is opened before the second channel by driving the valve core. The examiner notes that per the rejection of claim 1, in view of Okiyama, the defined first channel wraps around the valve further than the liquid channel portion (41) due to this circumferential arrangement, and the fact that the valve is rotated into a position to function, it is interpreted that, depending on the starting position of the valve the gas channel portion (thus the first channel) would open first.
Regarding Claim 3, Brand and Okiyama teach the device for transferring liquid medicine from a low-pressure sealed container to a high-pressure sealed container according to claim 2, wherein the valve core is a rotary shaft (where the valve (5) of Brand is rotated, as seen in figures 3a-d and para. 0023), the first through hole and the second through hole are arranged side by side on the rotary shaft (see figure 3a of Brand), the rotary shaft is configured with an extension groove along a rotation direction at the first through hole (where, in combination with Brand the first hole (communicating with the gas channel has a circumferential extension), the extension groove is communicated to the first through hole, so that the first channel is opened before the second channel (see rejection of claim 1 and 2 “the defined first channel wraps around the valve further than the liquid channel portion due to this circumferential arrangement, and the fact that the valve is rotated into a position to function, it is interpreted that, depending on the starting position of the valve the gas channel portion (thus the first channel) would open first”).
Regarding Claim 7, Brand and Okiyama teach the device for transferring liquid medicine from a low-pressure sealed container to a high-pressure sealed container according to claim 2, wherein the device further comprises a housing (see annotated figure 3a of Brand below) connecting the first puncture end and the second puncture end (where the housing provides a structure through which the channels run through), the valve core is arranged in the housing (see 3a of Brand).
However, Brand fails to specifically disclose that the housing and the valve core are matched through a groove and a buckle. Okiyama, however, as previously applied teaches a stopcock holding portion (36) (see also annotated figures below, and figure 21), to determine the driving position of the valve core (where the valve core can only be entered into space 36, due to the seen shape corresponding with the valve core). Therefore, as Okiyama teaches a suitable means for providing a valve core (that is rotatable) within a housing which connects fluid channels is a holding portion, in the form of a groove and buckle, it would have been obvious to one having ordinary skill in the art to provide the valve core of Brand with a buckle to correspond with a groove in the housing to ensure engagement of the valve within the housing. As such, doing so would merely involve the simple substitution of one known element for another to obtain predictable results, that being the securing of a valve within a housing, and thus a prima facie case of obviousness exists.
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Annotated Brand figure 3a
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Annotated Okiyama figures
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Regarding Claim 8, Brand and Okiyama teach the device for transferring liquid medicine from a low-pressure sealed container to a high-pressure sealed container according to claim 7. While Brand does teach attachment to a bag of bottle (para. 0002), there is no specific disclosure of having the housing is configured with a holder extending toward the first puncture end, the holder is configured to fix or clamp the low-pressure sealed container.
Okiyama, combined previously teaches this limitation. Okiyama’s bottom puncture end comprises a pair of claws (222) seen in figure 16a and 16b, seen clamping the low-pressure sealed container vial aiding in connection (see paras. 0128-0130 of Okiyama). Therefore, as both Brand and Okiyama teach a puncture member for inserting into a container (including a bottle), and Okiyama teaches that claws may be used to allow for a better connection to the bottle, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the puncture ends of Brand with claws for gripping to the bottles. Doing so would merely require combining prior art elements according to known methods to yield predictable results, that being secure connection to a bottle for puncturing, and thus a prima facie case of obviousness exists.
Regarding Claim 9, Brand and Okiyama teach the device for transferring liquid medicine from a low-pressure sealed container to a high-pressure sealed container according to claim 2, wherein the first end of the first channel is higher than the first end of the second channel, wherein the end of the first channel is located above liquid in the low-pressure sealed container (see Brand figure 3a, where the second channel (22) at a first end (bottom) is higher [extends shorter than] than the first channel (21)). While there is not explicit disclosure that this configuration allows an end of a first communication tube to contact the gas in the low-pressure sealed container and the end of the second channel is submerged in the liquid in the low-pressure sealed container, the examiner notes that per MPEP 2114, "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. The examiner notes that the liquid level may be different in different use cases and is thus functional language (as the device is used to connect to a vial, thus is functioning to meet this limitation), and thus as the structure of the prior art is equivalent to the claim, in that the gas channel is higher than the liquid channel, the prior art reads to the claimed invention
Regarding Claim 10, Brand and Okiyama teach the device for transferring liquid medicine from a low-pressure sealed container to a high-pressure sealed container according to claim 2, wherein the second end of the first channel is higher than the second end of the second channel (see figure 3a of Brand, where the second channel (22) at a second end (top) extends higher than the first channel (21)). The examiner notes however that no specific distance between the ends is detailed and thus the height difference being compared to the height of a rubber stopper is not disclosed (“the height difference between them is greater than a height of a rubber stopper of the high-pressure sealed container”). However, per MPEP section 2144.04 IV A In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The examiner notes that per applicant’s specification, this height difference ensures gas is pulled out first. The arrangement seen in the prior art also has the first channel extending higher than the second channel into a bottle. As such the devices are interpreted to be performing the same function based on their equivalent structure. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Brand and Okiyama to have the openings at the second end have a height difference greater than the height of a rubber stopper, in view of Gardner v Tec.
Allowable Subject Matter
Claim objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 11, Brand and Okiyama teach a method for transferring liquid medicine from a low- pressure sealed container to a high-pressure sealed container by means of the device for transferring liquid medicine from a low-pressure sealed container to a high-pressure sealed container according to claim 1 (see rejection of claim 1 for device rejection). While Brand could be argued to teach: Step l, ensuring that the on-off valve is closed (see figure 3b), the first channel and the second channel are blocked and Step 2, piercing the first puncture end and the second puncture end into the low-pressure sealed container and the high-pressure sealed container respectively, wherein the low-pressure sealed container is located above the high-pressure sealed container (the examiner notes that the device is configured to connect to fluid containers to transfer fluid), Okiyama fails to discloses Step 3, driving the on-off valve, so that the first channel is first in an open state, so that the gas in the high-pressure sealed container flows to the low-pressure sealed container, the second channel is in a closed state at this time. Rather Brand appears to disclose an open portion in which both channels are simultaneously open, or a close position, in which both channels are closed. While it was found obvious to provide an extension groove on the device of Brand (in view of Okiyama), such that the first channel could open first. This limitation was based on the structure and intended function of the structure and thus the prior art read. However, claim 11 is directed to a method claim of specific rotatable positions, and there is no disclosure of a specific step to open the gas channel first, the structural limitations of the claim cannot be read into the method step of claim 11. Further as Brand, from the examiner’s opinion, is directed toward a simultaneous opening, one having ordinary skill in the art would not reasonably apply the method of claim 11 to the divide of Brand.
Further, Okiyama discloses a step of first position (first position para. 0023 shown in figure 21). As seen in this figure, the gas channel (First channel per the claim) is not open in this position, as opening (42) is not connected with channel (23) This is seen in figure 22A, whereas figure 24a shows the second rotation position in which the gas channel valve opening can be seen to connect the two portions and is thus open. In the first position, the syringe portion of the liquid channel is open to the top container. Then, Okiyama goes to a second rotation position, in which the bottom liquid channel portion is open to the container, and the gas channel is opened. The examiner notes that in this position it can be argued that Okiyama teaches Step 4, continuing to drive the on-off valve, so that the first channel and the second channel are simultaneously in an open state, so that the liquid in the low-pressure sealed container flows into the high-pressure sealed container, as the gas channel is open, and liquid is flowing into the bottom container. However, as Okiyama does not teach step 3, it can also not teach step 4, as the claim requires a specific order of operations. Further, it would not have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the rotational positions of Okiyama to has a state in which only the first (gas) channel is open, as this would have an unknown effect on the operation of the device of Okiyama, as Okiyama clearly teaches defined first and second rotational positions.
The examiner makes note of alternate prior art references, but none, alone or in combination teach the claimed limitation.
Wu et al. US 12171719 teaches a fluid transfer device, in which multiple pathways are opened by a rotatable valve (see figure 4). However, the pathways are independent of one another and are merely used to move fluid from one bottle to another. Thus, there is no second channel (per each valve) that is used for gas flow.
Jurilj US 20230310277 teaches a vial adaptor, where a valve is rotated to open/close access from a syringe (port 10) and a vial (port 20). However, as clearly seen, there is no second channel opened/closed by the valve. Even if combined with Okiyama to teach a gas only channel, the specific method of operating the valve in different steps each with a different rotation position would not be met by said combination, as Jurilj only depicts an open/closed state for a single channel. It would be unknown if the device of Jurilj would have the capability to only open one channel at a time and then later have both channels opened.
Panick et al. US 20210069063, provided in the IDS fails for similar reasons as Jurilj. Panick’s device has a rotatable valve configured to open/close connection between two containers, but there is only one channel in the valve.
Feng CN 105616159 is noted by the examiner to be a close prior art reference, as Feng discloses a rotatable (para. 0010, 0012), where the valve connects to an air channel (9) and the fluid channel (1). Per paragraphs 0010 and 0012, the valve can be rotated to close the channels, but it is not clear from the citation if the channels can be closed individually based on the rotation. Further, the air channel does not connect through to a “bottom” connector, as channel (1) is the only channel seen to exit the bottom of the device. Thus, even when open, the air channel is not connected between the top and bottom connected piece through an independent channel. Rather, based on the figures, the examiner interprets that both gas and liquid would be moved through the channel (1). Therefore, even as Feng teaches a gas pathway and a fluid pathway, where said pathways are closed by a rotatable valve, Feng would not read to the method steps of claim 11.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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