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 Amendment
Applicant’s amendments filed on 12/15/2025 has been fully considered. Claims 1-16 and 18-20 are pending. Claims 1, 15, and 18 are amended. Claim 17 is cancelled.
Response to Arguments
Applicant’s arguments with respect to amended independent claims 1, 15, and 18 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.
Claim 13 is 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.
Claim 13 recites the limitation "a plurality of cutouts" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if “a plurality of cutouts” recited in claim 13 is the same “a plurality of cutouts” in claim 1. For the purposes of examination, the claim limitation of “a plurality of cutouts” recited in claim 13 is the same “a plurality of cutouts” recited in claim 1.
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.
Claim(s) 1-8 and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zinger et al. (Publication No. US 2002/0087141 A1) in view of Davis et al. (Publication No. US 2016/0367439 A1).
Regarding claim 1, Zinger teaches a device (adapter 18; Figure 3; Paragraph 0030-0032), comprising:
a cannula having an inner diameter (cannula 22 having an inner diameter; Figure 3; Paragraph 0030), the cannula comprising:
a top portion comprising a surface to correspond with a Luer connector (top portion of cannula 22 is connector 24 which is a male Luer connector; Figure 3; Paragraph 0030 and 0032);
a bottom portion, wherein a distal end of the bottom portion is configured to pierce a cap of a bottle (bottom portion of cannula 22 has a sharp distal tip to pierce a cap of container; Paragraph 0030; Figure 3); and
a guide component coupled to the cannula (guide component comprises a lateral and vertical portion; annotated Figure 3 below), the guide component comprising:
a lateral portion that extends radially out from the cannula (lateral portion extends radially from cannula 22; annotated Figure 3 below); and
a vertical portion coupled to an outer edge of the lateral portion (vertical portion connects to outer edge of lateral portion; annotated Figure 3 below), wherein the vertical portion extends down from the lateral portion substantially parallel to the cannula and past the distal end of the bottom portion (vertical portion is parallel with cannula 22 and extends past the distal end of the bottom portion; annotated Figure 3 below), and wherein the vertical portion includes a plurality of cutouts configured to provide visual access to the distal end of the bottom portion of the cannula (slits 26a are in the vertical portion and is capable of providing visual access to the distal end of the bottom portion of the cannula; annotated Figure 3 below; Paragraph 0031).
Zinger does not teach the top portion comprising the surface that is tapered.
However, Davis teaches the top portion comprising the surface that is tapered (male tip 32 of a first end 12 of a hub 30 is tapered; Paragraph 0061; Figure 1).
Zinger and Davis are both considered to be analogous to the claimed invention because they are in the same field of adapter devices for extracting fluids. 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 Zinger to incorporate the teachings of Davis and have the cannula of Zinger to have a top portion where the surface is tapered, as taught by Davis. This allows for the sufficient frictional engagement a female connector (Davis; Paragraph 0061).
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Annotated Figure 3
Regarding claim 2, Zinger in view of Davis teaches the device of claim 1. The combination of Zinger in view of Davis does not teach wherein the inner diameter is constant throughout the cannula.
However, Davis teaches wherein the inner diameter is constant throughout the cannula (lumen 140 has an inner diameter that is constant; Paragraph 0067-0068; Figure 7-8).
Zinger and Davis are both considered to be analogous to the claimed invention because they are in the same field of adapter devices for extracting fluids. 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 Zinger in view of Davis to incorporate the teachings of Davis and have the cannula of Zinger in view of Davis to have a constant diameter, as taught by the embodiment of Figures 7-8 of Davis. This allows for the lumen to have a priming space to ensure that no dosing inaccuracies occur during the transfer of fluids (Davis; Paragraph 0068).
Regarding claim 3, Zinger in view of Davis teaches the device of claim 2. The combination of Zinger in view of Davis further teaches wherein the constant inner diameter of the cannula allows for transfer of droplets of a sample (Davis; Paragraph 0068).
Regarding claim 4, Zinger in view of Davis teaches the device of claim 2. The combination of Zinger in view of Davis further teaches wherein a collar surrounds at least a portion of the top portion of the cannula (Zinger; collar is protruding thread on a portion of the top portion of cannula 22 at the connector 24; annotated Figure 3 above; Paragraph 0032), wherein the collar comprises threading that is configured to couple to a syringe (Zinger; male luer connector has threading at connector is able to connect to a syringe 42; annotated Figure 3 above and Figures 7-8; Paragraph 0030 and 0037), and wherein a surface of the top portion of the cannula is tapered to correspond with a connector of the syringe (Davis; male tip 32 of a first end 12 of a hub 30 is tapered to correspond to the connector of a syringe; Paragraph 0061; Figure 1; see rejection of claim 1 above).
Regarding claim 5, Zinger in view of Davis teaches the device of claim 4. The combination of Zinger in view of Davis further teaches wherein the top portion of the cannula extends above the collar (top portion of cannula 22 extends past collar/protruding threads of connector 24; annotated Figure 3 above).
Regarding claim 6, Zinger in view of Davis teaches the device of claim 1. Zinger further teaches wherein a grip area is defined, at least in part, by the lateral portion of the guide component (the user is fully capable of holding the side of the lateral portion of the guide component that is connected to the vertical portion of the guide component to manipulate the device for connection, the area of the side of the lateral portion and a portion of the vertical portion is the grip area; annotated Figure 3 above).
Regarding claim 7, Zinger in view of Davis teaches the device of claim 1. The combination of Zinger in view of Davis further teaches wherein the tapered surface of the top portion of the cannula is an outer surface (Davis; male tip 32 of a first end 12 of a hub 30 is tapered; Paragraph 0061; Figure 1) and the top portion of the cannula comprises a portion of a male Luer slip connector (Davis; male tip 32 on a first end 12 of a hub 30 that has a tapering that is for a slip-fit connection; Paragraph 0059-0060; Figure 1).
Regarding claim 8, Zinger in view of Davis teaches the device of claim 1. The combination of Zinger in view of Davis further teaches wherein the tapered surface of the top portion of the cannula is an outer surface (Davis; male tip 32 of a first end 12 of a hub 30 is tapered; Paragraph 0061; Figure 1). The combination of Zinger in view of Davis does not teach the top portion of the cannula comprises a portion of a male Luer lock connector.
However, Davis teaches the top portion of the cannula comprises a portion of a male Luer lock connector (tapered male luer lock with collar connection 332 of the coupler 300 that is “configured to removably engage… with a second syringe with a threaded coupling (see Figure 12)” has taper at its outer surface to connect to a female connector FC; Paragraph 0057, 0071, and 0090; Figure 10).
Zinger and Davis are both considered to be analogous to the claimed invention because they are in the same field of adapter devices for extracting fluids. 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 Zinger in view of Davis to incorporate the teachings of Davis and have the luer connector at the top portion of the cannula of Zinger in view of Davis to be the with a threading male luer lock, as taught of Davis. This allows for the top portion to be connected to a female luer lock connecting syringe (Davis; Paragraph 0071).
Regarding claim 10, Zinger in view of Davis teaches the device of claim 1. Zinger further teaches wherein the top portion of the cannula is configured to couple with each of a venting cap and a syringe (top portion of adapter 18 is connected to a syringe 42 - top portion of cannula is fully capable of connecting to syringe or venting cap since the top portion contains a Luer lock connection; Figure 7-8; Paragraph 0032).
Regarding claim 11, Zinger in view of Davis teaches the device of claim 1. Zinger further teaches wherein the guide component locates the distal end of the bottom portion of the cannula near the center of a vial cap (guide component locates/aligns the distal end of the bottom portion of cannula 22 near the center of the elastomeric stopper opening of the container; Paragraph 0030; annotated Figure 3 above; Figure 5-6).
Regarding claim 12, Zinger in view of Davis teaches the device of claim 1. Zinger further teaches wherein the guide component further comprises a circular flange portion coupled to a distal end of the vertical portion (circular flange at the bottom of the vertical portion; annotated Figure 3 above).
Regarding claim 13, Zinger in view of Davis teaches the device of claim 1. Zinger further teaches herein the guide component comprises a plurality of cutouts such that the distal end of the bottom portion of the cannula is visible (slits 26a are in the vertical portion and is capable of providing visual access to the distal end of the bottom portion of the cannula; annotated Figure 3 below; Paragraph 0031).
Regarding claim 14, Zinger in view of Davis teaches the device of claim 2. The combination of Zinger in view of Davis does not expressly teach wherein the constant inner diameter is 1.2 millimeters + 0.5 millimeters.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the constant inner diameter to be 1.2 millimeters ± 0.5 millimeters since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Zinger in view of Davis would not operate differently with the claimed inner diameter since the device has the same function of connecting devices for extracting fluids. Further, applicant places no criticality on the inner diameter, indicating simply that inner diameter “may be” the given range (specification, paragraph 036 and 063).
Regarding claim 15, Zinger discloses a system (Paragraph 0032; Figure 7-8), comprising:
a sampling device (adapter 18; Figure 3 and 7-8; Paragraph 0032), comprising:
a top portion configured to be coupled to a syringe (top portion has connector 24 to connect to syringe 42; Figure 7-8; Paragraph 0032);
a bottom portion, wherein a distal end of the bottom portion is configured to puncture a cap of a bottle (bottom portion has a distal pointed end that is configured to puncture the elastomeric seal of a container 14; Paragraph 0032-0034; Figures 7-8);
a cannula having an inner diameter (cannula 22 having an inner diameter; Figure 3; Paragraph 0030), wherein the cannula extends through the top portion and the bottom portion (cannula 22 extends through the top and bottom portion; Figure 3 and 7-8); and
a guide component coupled to the cannula (guide component comprises a lateral and vertical portion; annotated Figure 3 above), the guide component comprising:
a lateral portion that extends radially out from the cannula (lateral portion extends radially from cannula 22; annotated Figure 3 above); and
a vertical portion coupled to an outer edge of the lateral portion (vertical portion connects to outer edge of lateral portion; annotated Figure 3 above), wherein the vertical portion extends down from the lateral portion substantially parallel to the cannula and past the distal end of the bottom portion (vertical portion is parallel with cannula 22 and extends past the distal end of the bottom portion; annotated Figure 3 above), and wherein the vertical portion includes a plurality of cutouts configured to provide visual access to the distal end of the bottom portion of the cannula (slits 26a are in the vertical portion and is capable of providing visual access to the distal end of the bottom portion of the cannula; annotated Figure 3 above; Paragraph 0031); and
the syringe (syringe 42; Figures 7-8; Paragraph 0032), wherein the top portion of the sampling device comprises a Luer connector configured to mate with a corresponding connector of the syringe (top portion of device 18 has a luer connector 24 that mates with the connector of a syringe 42; Paragraph 0032; Figures 3 and 7-8). Zinger does not teach the cannula having a constant inner diameter.
However, Davis teaches wherein the inner diameter is constant throughout the cannula (lumen 140 has an inner diameter that is constant; Paragraph 0067-0068; Figure 7-8).
Zinger and Davis are both considered to be analogous to the claimed invention because they are in the same field of adapter devices for extracting fluids. 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 Zinger to incorporate the teachings of Davis and have the cannula of Zinger to have a constant diameter, as taught by the embodiment of Figures 7-8 of Davis. This allows for the lumen to have a priming space to ensure that no dosing inaccuracies occur during the transfer of fluids (Davis; Paragraph 0068).
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Zinger et al. (Publication No. US 2002/0087141 A1) in view of Davis et al. (Publication No. US 2016/0367439 A1), as applied to claim 1 above, and further in view of Finke et al. (Publication No. US 2012/0078215 A1).
Regarding claim 9, Zinger in view of Davis teaches the device of claim 1. The combination of Zinger in view of Davis does not teach wherein the top portion of the cannula comprises a portion of a female Luer lock connector.
However, Zinger teaches wherein the top portion of the cannula comprises a portion of a female Luer lock connector (adapter 30 can have a female luer lock connector 38; Figure 3; Paragraph 0032).
Zinger is analogous to the claimed invention because they are in the same field of adapter devices for extracting fluids. 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 Zinger in view of Davis to incorporate the teachings of Zinger and have the luer connector at the top portion of the cannula of Zinger in view of Davis to be a female luer lock connector, as taught by Zinger. This allows for the top portion to be connected to a male luer lock connector (Zinger; Paragraph 0032). The combination of Zinger in view of Davis does not teach wherein the tapered surface of the top portion of the cannula is an interior surface.
However, Finke teaches wherein the tapered surface of the top portion of the cannula is an interior surface (distal portion 30b is a luer taper in the inner surface; Paragraph 0030; Figure 2).
Zinger in view of Davis and Finke are both considered to be analogous to the claimed invention because they are in the same field of adapter devices for extracting fluids. 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 Zinger in view of Davis to incorporate the teachings of Finke and have the female luer connector at the top portion of the cannula of Zinger in view of Davis to have a tapered inner surface, as taught by Finke. This allows for the luer connection of multiple devices in the device, such as syringes, catheters, and needles (Finke; Paragraph 0039).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zinger et al. (Publication No. US 2002/0087141 A1) in view of Davis et al. (Publication No. US 2016/0367439 A1), as applied to claim 15 above, and further in view of Ding et al. (Publication No. US 2020/0222281 A1).
Regarding claim 16, Zinger in view of Davis teaches the system of claim 15. The combination of Zinger in view of Davis does not teach further comprising, a filter cap, wherein the filter cap is couplable to the top portion of the sampling device, wherein the filter cap is configured to filter contaminants when the distal end of the bottom portion of the sampling device punctures the cap.
However Ding teaches further comprising, a filter cap (second end cap 20 with filter 19; Paragraph 0291; Figure 45), wherein the filter cap is couplable to the top portion of the sampling device (cap 20 is attachable to the inlet port 20 of the device; Paragraph 0291; Figure 45), wherein the filter cap is configured to filter contaminants (Paragraph 0291).
Zinger in view of Davis and Ding are both considered to be analogous to the claimed invention because they are in the same field of adapter devices for extracting fluids. 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 Zinger in view of Davis to incorporate the teachings of Ding and have the cap and filter of Ding to be on the top portion of the device of Zinger in view of Davis. This allows for the device to ensure that contaminants is captured before fluid enters through the system (Ding; Paragraph 0291).
The combination of Zinger in view of Davis and Ding further teaches wherein the filter cap is configured to filter contaminants when the distal end of the bottom portion of the sampling device punctures the cap (see combination above).
Claim(s) 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zinger et al. (Publication No. US 2002/0087141 A1) in view of Finke et al. (Publication No. US 2012/0078215 A1).
Regarding claim 18, Zinger teaches a device (adapter 18; Figure 3; Paragraph 0030-0032), comprising:
a cannula comprising (cannula 22; Figure 3; Paragraph 0030):
a top portion having an inner surface (top portion of cannula 22 is connector 24 which has an inner surface; Figure 3; Paragraph 0030 and 0032);
a bottom portion coupled to the top portion, wherein a distal end of the bottom portion is configured to pierce a cap of a bottle (bottom portion of cannula 22 has a sharp distal tip to pierce a cap of container; Paragraph 0030; Figure 3); and
a guide component (guide component comprises a lateral and vertical portion; annotated Figure 3 above) comprising:
a lateral flange that extends radially out from the cannula (lateral portion extends radially from cannula 22; annotated Figure 3 above);
a vertical portion coupled to the lateral flange (vertical portion connects to outer edge of lateral portion; annotated Figure 3 above), wherein the vertical portion extends down from the lateral portion substantially parallel to the cannula and past the distal end of the bottom portion (vertical portion is parallel with cannula 22 and extends past the distal end of the bottom portion; annotated Figure 3 above), and wherein the vertical portion includes a plurality of cutouts configured to provide visual access to the distal end of the bottom portion of the cannula (slits 26a are in the vertical portion and is capable of providing visual access to the distal end of the bottom portion of the cannula; annotated Figure 3 above; Paragraph 0031); and
a distal flange that extends radially out from a distal end of the vertical portion (flange/protrusion extends radially from distal end of vertical portion; annotated Figure 3 above), wherein the lateral flange, vertical portion, and the distal flange define a channel (channel comprises lateral portion, vertical portion, and distal flange; annotated Figure 3 above). Zinger further teaches a top portion to correspond with a female Luer connector (adapter 30 can have a female luer lock connector 38; Figure 3; Paragraph 0032).
Zinger is analogous to the claimed invention because they are in the same field of adapter devices for extracting fluids. 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 Zinger in view of Davis to incorporate the teachings of Zinger and have the luer connector at the top portion of the cannula of Zinger to be a female luer lock connector, as taught by Zinger. This allows for the top portion to be connected to a male luer lock connector (Zinger; Paragraph 0032). The modified Zinger does not teach the inner surface tapered.
However, Finke teaches the inner surface tapered (distal portion 30b is a luer taper in the inner surface; Paragraph 0030; Figure 2).
Zinger and Finke are both considered to be analogous to the claimed invention because they are in the same field of adapter devices for extracting fluids. 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 Zinger to incorporate the teachings of Finke and have the female luer connector at the top portion of the cannula of Zinger to have a tapered inner surface, as taught by Finke. This allows for the luer connection of multiple devices in the device, such as syringes, catheters, and needles (Finke; Paragraph 0039).
Regarding claim 19, Zinger in view of Finke teaches the device of claim 18. The combination of Zinger in view of Finke further teaches wherein the channel surrounds the bottom portion of the cannula (Zinger; channel comprising lateral portion, vertical portion, and distal flange surrounds the bottom portion of cannula 22; annotated Figure 3 above).
Regarding claim 20, Zinger in view of Finke teaches the device of claim 19. The combination of Zinger in view of Finke further teaches wherein the channel provides a grip area (Zinger; the user is fully capable of holding the side of the lateral portion of the guide component that is connected to the vertical portion of the guide component to manipulate the device for connection, the area of the side of the lateral portion and a portion of the vertical portion is the grip area; annotated Figure 3 above).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781