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 .
Response to Amendments
Receipt of Applicant’s preliminary Amendment filed on 11 June 2025 is/are acknowledged and entered.
By this Amendment, the Applicant amended Claims 1-8, 11-15, 20-21, and 23-27, and canceled Claims 9-10, 16-19, 22, and 28. Claims 1-8, 11-15, 20-21, and 23-27 remain pending in the application.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-13, 20, and 23-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tribble et al. (US 2005/0224137).
Regarding Claim 1, Tribble et al. discloses a device for filling a syringe, the device comprising:
- a frame (see at least Fig 9 and; and para 37, fluid transfer station 170)
- a buffer member (the combination of drug vial 300 and transfer device 400; see at least Figs 4-5 and paras 38 and 41), comprising:
a buffer body (300) defining an intermediate volume for receiving a fluid therein,
a fluid inlet (atmospheric air vent/second channel 428) in fluid communication with the intermediate volume (see at least para 48),
a fluid outlet (first channel 426) in fluid communication with the intermediate volume (see at least para 46), and
a syringe connector (cannula connector 500) for connecting a syringe to the buffer member such that the syringe is in fluid communication with the fluid outlet;
- wherein the buffer member is rotationally connected to the frame (this action shown at Figs 8-9, which shows rotation of the buffer member by robotic device 530) such that the buffer member can be rotated relative to the frame between
a first rotation position wherein the fluid outlet can be positioned above a liquid level in the intermediate volume (see Fig 8), and
a second rotational position wherein the fluid outlet can be positioned below the liquid level in the intermediate volume (see Fig 9. The Tribble reference additional provides written guidance for the rotation/inversion of the buffer member by item 530 at least at paras 76, 86-88, and at Claim 28).
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Regarding Claim 2, Tribble et al. discloses a device for filling a syringe, wherein the buffer member is partially filled with a liquid medicament (Tribble et al. describes the invention as drawn to "an automated medication preparation system...in the form of an automated syringe preparation that includes reconstitution of the medication and delivery of the reconstituted medication to a syringe." See Abstract).
Regarding Claim 3, Tribble et al. discloses a device for filling a syringe, wherein the buffer member is partially filled with air (this is a known practical matter of physics, necessary to push fluid out of the vial/buffer member with negative pressure. See at least para 14, which describes "a vent that is formed as part of the transfer device to permit air to flow into the drug vial.").
Regarding Claim 4, Tribble et al. discloses a device for filling a syringe, wherein in the second rotational position the fluid inlet is positioned above the syringe connector and/or the fluid inlet is positioned above the fluid outlet (see Fig 9. Examiner notes that male luer fitting 490 of Fig 9 is shown attached to syringe connector 500 at Fig 4).
Regarding Claim 5, Tribble et al. discloses a device for filling a syringe, wherein the device further comprises a receptacle (a "gripping device" as part of item 530, shown at Figs 8-9 and described at paras 19, 25-26, and 76), which receptacle is rotationally connected to the frame, and the buffer member is at least partially positioned in the receptacle such that the buffer member is rotationally connected to the frame via the receptacle (see Figs 8-9 and the paras cited above and in the rejection of Claim 1).
Here, Examiner applies broadest reasonable interpretation to the word "receptacle", which is defined at vocublary.com as "any object, container, or device used to receive, hold, or store something else."
Regarding Claim 6, Tribble et al. discloses a device for filling a syringe, wherein the buffer member is rotationally connected to the frame such that the buffer member can be rotated between the first rotational position and the second rotational position relative to the frame about a generally horizontal rotation axis (shown at Figs 8-9).
Regarding Claim 7, Tribble et al. discloses a device for filling a syringe, further comprising a plunger guide (syringe driver 640) arranged to engage a plunger of a syringe, which plunger guide is moveably connected to the frame such that the plunger guide can be translated between a proximal position and a distal position, wherein in the proximal position, a distance between the plunger guide and the buffer member is smaller than the distance between the plunger guide and the buffer member in the distal position of the plunger guide (this configuration and associated actions are described at least at Fig 14 and para 65).
Regarding Claim 8, Tribble et al. discloses a device for filling a syringe, wherein the device further comprises a stopping member defining the distal position of the plunger guide (syringe driver 640 is explicitly described as having a stepper motor as part of "a larger automated system that is in communication with a master controller that serves to monitor and control the operation of the various components". Said stepper motor serves as a "stopping member", as is known to one of ordinary skill in the art.
Regarding Claim 11, Tribble et al. discloses a device for filling a syringe, wherein the device further comprises a plunger guide actuator, for moving the plunger guide relative to the frame (syringe driver 640 is explicitly described as having a stepper motor as part of "a larger automated system that is in communication with a master controller that serves to monitor and control the operation of the various components". Per para 65, "the driver 640 is mechanically linked to the plunger 638 so that controlled actuation thereof causes precise movements of the plunger 638 relative to the barrel of the syringe", and is therefore considered to be a "plunger guide actuator").
Regarding Claim 12, Tribble et al. discloses a device for filling a syringe, further comprising a rotational actuator (as part of robotic device 530), for rotating the buffer member relative to the frame (see the description of item 530 with regards to rotating/inverting the buffer member at Figs 8-9 and at least at paras 62 and 76).
Regarding Claim 13, Tribble et al. discloses an assembly for filling a syringe, the assembly comprising: the device according to claim 1 (see the rejection of Claim 1 above); and a syringe (first and second syringes 632 and 634 are disclosed), which syringe is connected or connectable to the syringe connector of the buffer member (via main conduit 620 and cannula unit 520; see at least Fig 11 and para 65).
Regarding Claim 20, Tribble et al. discloses A method of filling a syringe, comprising steps of:
- connecting a syringe to a syringe connector of a buffer member (via main conduit 620 and cannula unit 520; see at least Fig 11 and para 65), such that a main volume of the syringe is in fluid communication with an intermediate volume of the buffer member, which intermediate volume is at least partially filled with a liquid (para 7 and Fig 3);
- rotating the syringe and the buffer member from a first rotational position to a second rotational position relative to a frame of a device for filling a syringe, to which frame the buffer member is rotationally connected (see Figs 8-9 and the rejection of Claim 1 above), such that a fluid outlet of the buffer member is positioned below a liquid level of liquid in the buffer member (shown at Fig 9);
- drawing a volume of liquid from the intermediate volume into the main volume of the syringe through the fluid outlet, such that the main volume is essentially free of gasses such as air (accomplished through the normal operation of the disclosed apparatus, which is explicitly describes as a "syringe filling apparatus" at para 3, and as explained in the rejection of Claim 1 above); and
- disconnecting the syringe from the buffer member (accomplished through the normal use of the disclosed apparatus once the syringe is filled and ready for use).
Regarding Claim 23, Tribble et al. discloses a method of filling a syringe, wherein the liquid is a liquid medicament (Tribble et al. describes the invention as drawn to "an automated medication preparation system...in the form of an automated syringe preparation that includes reconstitution of the medication and delivery of the reconstituted medication to a syringe." See Abstract).
Regarding Claim 24, Tribble et al. discloses a method of filling a syringe, further comprising positioning at least part of the buffer member (300/400, as described in the rejection of Claim 1 above) in a receptacle (gripping device of item 530, as shown at Figs 8-9 and described at paras 19, 25-26, and 76) of the device for filling the syringe.
Regarding Claim 25, Tribble et al. discloses a method of filling a syringe, further comprising allowing a flow of air into the intermediate volume (via the atmospheric air vent of transfer device 400; see para 48-49) while drawing the volume of liquid from the intermediate volume into the main volume of the syringe (this is a well-known concept of physics utilizing negative pressure necessary in enabling fluid flow from a container, and further described at least at paras 45-46 and 87).
Regarding Claim 26, Tribble et al. discloses a method of filling a syringe, wherein the volume of liquid is drawn from the intermediate volume into the main volume of the syringe through the fluid outlet by moving a plunger (para 87, plunger 50) of the syringe relative to a body of the syringe.
Regarding Claim 27, Tribble et al. discloses a method of filling a syringe, wherein in the second rotational position, the liquid in the in the intermediate volume contacts a piston of the syringe, at least prior to the drawing of the volume of liquid from the intermediate volume into the main volume of the syringe through the fluid outlet (see paras 86-87).
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Tribble et al.
Regarding Claims 14-15, the Tribble reference teaches the claimed invention, to include a buffer volume and syringe, but does not explicitly recite the relative volume capacities of these two components. The tribble reference is therefore silent on an assembly wherein “a size of the intermediate volume corresponds to more than two times a size of a main volume of the syringe”, as claimed at Claim 14, and/or wherein “the intermediate volume of the buffer member is filled with a volume of liquid medicament which exceeds the size of the main volume of the syringe”, as claimed at Claim 15.
However, 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. In the present case, Applicant has not provided any reason for establishing the relative sizes of the component volumes, and provides no novel or unexpected results for doing so. Examiner concludes that it would be an obvious matter of design choice to one of ordinary skill in the art to appropriately size the buffer member and syringe components (and their relative volumes) to whatever ratio was desired, if only to gain the ability to fill multiple syringes from one buffer member.
Tribble et al., therefore, reads upon Claims 14-15.
Allowable Subject Matter
Claim 21 is 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: the prior art fails to disclose or render obvious
(Claim 20) A method of filling a syringe, comprising steps of: connecting a syringe to a syringe connector of a buffer member…rotating the syringe and the buffer member from a first rotational position to a second rotational position relative to a frame of a device for filling a syringe, to which frame the buffer member is rotationally connected…
(Claim 21) …wherein in the first rotational position, the syringe is oriented generally horizontally, and in the second rotational position, the syringe is oriented generally vertically.
in combination with the other limitations set forth in the independent claims.
Tribble et al. (US 2005/0224137) is the closest prior art of record. However, the Tribble reference is silent on these above recited features. Furthermore, it would not have been obvious to modify the Tribble reference to arrive at these above recited features without improper hindsight reasoning. In addition, amending the Tribble reference to include the above recited features would improperly change the principle of operation of the Tribble reference.
Specifically, although Tribble et al. teaches rotation and inversion of the buffer member 300/400, the reference does not explicitly teach rotation from a starting horizontal position as required by Applicant’s Claim 21. It appears that the invention of the Tribble reference is predicated on vials 300 being upright (and therefore vertical) for capture by the gripping device for further rotation/inversion. Examiner concludes that it would amount to improper hindsight to modify the invention of Tribble et al. to meet the requirements of Applicant’s Claim 21, as there would be no motivation to do so, and doing so would likely “break” the operations of Tribble et al.
Examiner offers the following further comments on the patentability of the concept of the present invention:
Applicant’s Fig 8 clearly depicts a buffer member with a separate inlet and outlet at opposite ends of said buffer member. However, Applicant’s claims do not require this separation; the claims instead merely require an inlet and outlet in fluid communication with the inner volume of the buffer member. Since it is well-known to provide a venting mechanism to any closed container in order to promote fluid flow, this very generically-claimed concept is anticipated by any functionally-described “member” that provides a separate ventilation fluid path, such as that of the Tribble reference.
In an interview with Attorney Spehlmann conducted 29 May 2026, an initial consensus was reached that an amendment drawn to separate inlet and outlet at opposite ends of the buffer member would overcome the 35 USC 102(a)(1) rejections as cited above.
Additionally, Applicant’s Specification (see pg. 1) indicates that the claimed invention is drawn to “the field of syringes, in particular for administering liquid medication”. However, the independent claims are not limited to this area, but are instead broad enough to be anticipated by any device that enables fluid flow with the required “buffer member” structure and related rotational equipment. As an example, US 2018/0154035 A1 (not currently relied upon) is drawn towards an air freshener, yet meets the requirements of at least the current apparatus Claim 1. Applicant is advised to consider further limitation of the independent claims to medical purposes, by amending the subject matter of Claims 2 and 23 (“the liquid is a liquid medicament”) into Claims 1 and 20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
- US 2018/0154035 A1 (as mentioned above) is drawn towards an air freshener and meets the requirements of at least the current apparatus Claim 1.
- US 2016/0144105 A1 additionally fills syringes in a manner similar to the Tribble reference above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M AFFUL whose telephone number is (571)272-8421. The examiner can normally be reached Monday - Thursday: 7:30 AM - 5:00 PM Eastern Time.
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, Craig Schneider can be reached at 5712723607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M AFFUL/Primary Examiner, Art Unit 3753
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