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
Claims 52-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/21/2026.
Applicant’s election without traverse of Group I, Claims 1, 49-51, and 63-67 in the reply filed on 05/21/2026 is acknowledged.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference number 212 of Figures 2 and 3. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 63 are objected to because of the following informalities:
Claim 1, line 5: “a vial” should read “the vial”;
Claim 63, line 3: “a vial adaptor” should read “the vial adaptor”;
Claim 63, line 3: “a vial” should read “the vial”. Appropriate correction is required.
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, 49-51, 63, and 65-67 are rejected under 35 U.S.C. 103 as being unpatentable over Arnissolle (Patent No. US 6,746,438 B1) in view of Smith et al. (Publication No. US 2019/0374721 A1).
Regarding claim 1, Arnissolle teaches a vial adaptor configured to facilitate transfer of fluid from a vial to a receiving device (device 200 that transfers fluid from cartridge 12 with cap 18, or vial, to device 14, or receiving device; Figure 8; Abstract; Column 6, line 56 to Column 7, line 3), the vial adaptor comprising:
a cap member (inner tube 220; Figure 8; Column 7, lines 22-31) comprising a proximal opening (proximal opening at end of tubular portion 224 of inner tube 220; Figure 8; Column 7, lines 22-31), a distal opening (distal opening of inner tube 220 is opposing end from proximal opening; Figure 8), and a threaded portion configured to removably couple with a corresponding threaded portion formed on an opening of a vial (threaded portion of cartridge 202 is to be axially fixed to the receiving threaded portion of cap 18 of the cartridge 12; Column 7, lines 1-3; Figure 8);
a piston (shuttle 20; Figure 8; Column 6, lines 63-67) comprising a cover (piston 34; Figure 8; Column 7, lines 14-15), a distal end (distal end at protuberance 92 of shuttle 20; Figure 8; Column 7, lines 14-15), a proximal end (proximal end is opposing end from the distal end of shuttle 20; Figure 8), a channel (needle 22; Figure 8; Column 3, lines 59-67), and a body extending between the distal end and the proximal end and comprising a head (threaded protuberance 92; Figure 8; Column 7, lines 14-15), the cover configured to surround the head and abut an inner surface of the vial (piston 34 surrounds protuberance 92 and abut an inner surface of cartridge 12; Figure 8; Column 7, lines 14-15), the channel extending between the distal end and the proximal end of the piston (needle 22 extends between distal end and proximal end of shuttle 20; Figure 8; Claim 1; Column 2, lines 60-67), wherein the channel is configured to allow flow of fluid through the piston between the distal end and the proximal end (needle 22 allows for flow of fluid between distal and proximal end of shuttle 20; Abstract; Figure 8; Claim 1; Column 2, lines 60-67). A “vial” is interpreted to be a small closeable vessel for liquids, as defined by Merriam-Webster Dictionary (see attached PTO-892). The cartridge with the cap of Arnissolle is a vessel that holds the fluid, thus is a vial. Arnissolle does not teach a ratchet system comprising:
a first arm formed about the proximal opening of the cap member, at least a portion of the first arm extending inward towards a center of the proximal opening of the cap member, the first arm comprising a tip; and
a first rack formed along the body of the piston, the first rack configured to engage the first arm, wherein the engagement between the first rack and the first arm allows the piston to translate in a first direction.
However, Smith teaches a ratchet system (ratchet teeth 34 engaged with ratchet arms 38; Paragraph 0155-0157; Figure 3-4 and 6) comprising:
a first arm formed about the proximal opening of the cap member (first arm 38 formed on the proximal opening of drive sleeve 2; Figure 6; Paragraph 0155-0157), at least a portion of the first arm extending inward towards a center of the proximal opening of the cap member (a portion of arm 38 extends inwards towards the center of the proximal opening of drive sleeve 2; Paragraph 0155-0157; Figure 6), the first arm comprising a tip (end of arm 38 is the tip; Figure 6); and
a first rack formed along the body of the piston (first rack is ratchet teeth 34 formed along the body of the piston rod 4; Paragraph 0155-0157; Figure 4), the first rack configured to engage the first arm (ratchet teeth 34 engages with first ratchet arm 38; Figures 4 and 6), wherein the engagement between the first rack and the first arm allows the piston to translate in a first direction (engagement between ratchet teeth 34 with first ratchet arm 38 translates the rod 4 in the first direction; Paragraph 0155-0157; Figures 4 and 6).
Arnissolle and Smith are both considered to be analogous to the claimed invention because they are in the same field of fluid transferring devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arnissolle to incorporate the teachings of Smith to have the ratcheting system of Smith applied to the cap member and the piston of Arnissolle, with the ratchet teeth of Smith on the piston of Arnissolle and the arm of Smith on the cap member of Arnissolle, to allow for the piston to move only towards the vial, as taught by Smith. This would allow for the user to control the dosage of fluid to be transferred through the device and prevent the rod to move in the opposing direction (Smith; Paragraph 0155-0157). The combination of Arnissolle in view of Smith further teaches wherein a translation of the piston in the first direction is configured to cause a positive pressure change in the vial and withdrawal of fluid stored in the vial through the channel of the piston (Arnissolle; shuttle 20 is translated in a first direction into a cartridge 12 which creates a positive pressure in the vial 12 and withdraws fluid through the needle 22 of the shuttle 20; Figure 8; Column 5, line 61 to Column 6, line 9 and Column 6, lines 39-60).
Regarding claim 49, Arnissolle in view of Smith teaches the vial adaptor of claim 1. The combination of Arnissolle in view of Smith further teaches wherein the first direction is a direction towards the vial (Arnissolle; first direction is when shuttle 20 moves into the vial 12; Figures 5-6; Column 5, line 61 to Column 6, line 9).
Regarding claim 50, Arnissolle in view of Smith teaches the vial adaptor of claim 1. The combination of Arnissolle in view of Smith further teaches wherein the engagement between the first rack and the first arm prevents the piston from translating in a second direction (Smith; first rack 34 and first arm 38 prevents piston 4 to move in a second direction; Paragraph 0155-0156; Figure 4 and 6).
Regarding claim 51, Arnissolle in view of Smith teaches the vial adaptor of claim 50. The combination of Arnissolle in view of Smith further teaches wherein the second direction is a direction away from the vial (Smith; second direction is a direction away from the vial of Arnissolle; Paragraph 0155; see rejection of claim 1 above).
Regarding claim 63, Arnissolle teaches a method of withdrawing fluid stored in a vial via a vial adaptor (method of using the device 200 that transfers fluid from cartridge 12 with cap 18, or vial, to device 14, or receiving device; Figure 8; Abstract; Column 6, line 56 to Column 7, line 3), the method comprising:
coupling a distal opening of a cap member of a vial adaptor to an opening of a vial (distal opening of inner tube 220 is end that is opposing to tubular portion 224 receiving the opening of the cap member 18 of vial 12; Figure 8; Column 7, lines 1-3), the cap member comprising a proximal opening opposite of the distal opening (proximal opening at end of tubular portion 224 of inner tube 220; Figure 8; Column 7, lines 22-31);
coupling a proximal end of a piston of the vial adaptor to an opening of a receiving device (proximal end is opposing end of protuberance 92 of shuttle 20 is coupled to opening of device 14 through end 114 of needle 22; Column 7, lines 4-12; Figure 8);
distally translating the piston towards the vial and through the proximal opening and the distal opening of the cap member (shuttle 20 is translated in a first distal direction into a cartridge 12 through the distal and proximal openings of the inner tube 220; Figure 8; Column 5, line 61 to Column 6, line 9 and Column 6, lines 39-60), a head of the piston configured to abut an inner surface of the vial to create a water-tight seal between the head of the piston and the inner surface of the vial (piston 34 abuts the inner surface of cartridge 12 of vial to create a water-tight seal between piston 34 and inner surface of the cartridge 12 of vial; Figure 8; Column 7, lines 14-15), a distal translation of the piston towards the vial configured to generate positive pressure change in the vial and cause a flow of fluid stored in the vial (shuttle 20 is translated in a first distal direction into a cartridge 12 which creates a positive pressure in the cartridge 12 of vial and withdraws fluid through the needle 22 of the shuttle 20; Figure 8; Column 5, line 61 to Column 6, line 9 and Column 6, lines 39-60). Arnissolle does not teach wherein the piston is configured to resist motion in a direction opposite the distal translation.
However, Smith teaches wherein the piston is configured to resist motion in a direction opposite the distal translation (engagement between first ratchet teeth 34 with first ratchet arm 38 translates the rod 4 in the first direction and resists motion in the second direction; Paragraph 0155-0157; Figures 4 and 6).
Arnissolle and Smith are both considered to be analogous to the claimed invention because they are in the same field of fluid transferring devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arnissolle to incorporate the teachings of Smith to have the ratcheting system of Smith applied to the cap member and the piston of Arnissolle, with the ratchet teeth of Smith on the piston of Arnissolle and the arm of Smith on the cap member of Arnissolle, and the method to allow for the piston to move only towards the vial, as taught by Smith. This would allow for the user to control the dosage of fluid to be transferred through the device and prevent the rod to move in the opposing direction (Smith; Paragraph 0155-0157).
Regarding claim 65, Arnissolle in view of Smith teaches the method of claim 63. The combination of Arnissolle in view of Smith further teaches wherein the cap member comprises an arm (first arm 38 of Smith formed on the proximal opening of cap member of Arnissolle; Smith; Figure 6; Paragraph 0155-0157; see rejection of claim 63 above) and the piston comprises a rack comprising a plurality of teeth (first rack has plurality of ratchet teeth 34, as taught by Smith, formed along the body of the piston of Arnissolle; Smith; Paragraph 0155-0157; Figure 4; see rejection of claim 63 above), and wherein the arm of the cap member and the plurality of teeth of the piston are configured to engage during the distal translation of the piston (Smith; engagement between ratchet teeth 34 with first ratchet arm 38 translates the rod 4 in the first translation, which is the distal direction towards the vial of Arnissolle; Paragraph 0155-0157; Figures 4 and 6; see rejection of claim 63 above).
Regarding claim 66, Arnissolle in view of Smith teaches the method of claim 65. The combination of Arnissolle in view of Smith further teaches wherein each of the plurality of teeth of the rack comprises a leading edge and a stopping edge (Smith; ratchet tooth 34 has a leading edge 34a and stopping edge 34b; Paragraph 0155; Figure 4), wherein the arm slides along the leading edges of the plurality of teeth of the rack during the distal translation of the piston (Smith; arms 38 slides along leading edge 34a of rack having plurality of teeth 34 during distal translation of piston, as taught by Arnissolle; Paragraph 0155-0156; Figure 4), and wherein the stopping edges of the plurality of teeth of the rack are configured to prevent a proximal translation of the piston away from the vial (Smith; stopping edges 34b of rack having a plurality of teeth 34 prevents the piston of Arnissolle to move away from the vial in the opposing direction; Paragraph 0155-0156; Figure 4).
Regarding claim 67, Arnissolle in view of Smith teaches the method of claim 63. The combination of Arnissolle in view of Smith further teaches wherein the piston comprises a channel extending between a distal aperture formed about a distal end of the piston and a proximal aperture formed about the proximal end of the piston (Arnissolle; needle 22 extends between distal end and proximal end of shuttle 20 and needle 22 has a proximal opening and distal opening at its ends; Figure 8; Claim 1; Column 2, lines 60-67).
Claim(s) 64 is rejected under 35 U.S.C. 103 as being unpatentable over Arnissolle (Patent No. US 6,746,438 B1) in view of Smith et al. (Publication No. US 2019/0374721 A1), as applied to claim 63 above, and further in view of Reynolds (Patent No. US 5,554,125 A).
Regarding claim 64, Arnissolle in view of Smith teaches the method of claim 63. The combination of Arnissolle in view of Smith does not teach wherein the head of the piston is a molded elastomer.
However, Reynolds teaches wherein the head of the piston is a molded elastomer (head of piston 8 is formed of molded rubber, a type of elastomer; Figure 3; Column 6, lines 38-45 and Column 8, lines 40-52).
Arnissolle in view of Smith and Reynolds are both considered to be analogous to the claimed invention because they are in the same field of fluid transferring devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arnissolle in view of Smith to incorporate the teachings of Reynolds to have the head of the piston of Arnissolle in view of Smith be made of a molded rubber material, as taught by Reynolds. This would allow for the rigidity of the material to maintain the hermetic seal within the body of the device (Reynolds; Column 8, lines 40-52).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
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