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 .
Claim Status
Claims 1-12 are pending and examined.
Information Disclosure Statement
The information disclosure statements (IDS) received on 10/4/2024, 10/10/2025, and 5/18/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 4 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.
Regarding claim 4, Ln. 1 recites, “the step of applying a vacuum to an internal space”. However, it is unclear if the vacuum and internal space recited are the same as or different from the vacuum and internal space previously recited in claim 1. For purposes of compact prosecution, the above limitation has been examined as, “the step of applying the vacuum to the internal space”.
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.
Claims 1-4, 8-9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (US Pub. No. 2015/0346231; hereinafter Mori) in view of Blouin et al. (US Pub. No. 2006/0263250; hereinafter Blouin; already of record on the IDS received 10/4/2024).
Regarding claim 1, Mori discloses a method of performing a wash cycle on a needle assembly ([0045]-[0049], see Fig. 4), the method comprising the steps of:
introducing the needle assembly to a wash tower having an elongate body defining an opening in a top surface thereof and a passageway extending downwardly therefrom, wherein at least a portion of the needle assembly is inserted into the passageway ([0045]-[0049], see Fig. 4 at reagent probe 7a lowered into washing tank).
Applying a vacuum to an internal space defined by the needle assembly ([0045]-[0049], see Fig. 4 at vacuum nozzles 212, 213 for removing washing water adhered to the reagent probe. See also Fig. 6A, which shows that suctioning occurs simultaneously to internal washing of the reagent probe). and
Introducing a wash solution via a pumping system to the wash tower, wherein the wash solution is directed to a first port disposed proximate the top surface of the wash tower and a second port disposed proximate a bottom surface of the wash tower ([0045]-[0049], see Fig. 4 at washing nozzles 201, 202, and 203 for washing the reagent probe. See also Fig. 6A).
Mori fails to explicitly disclose that the needle assembly comprises a first needle and a second needle.
Blouin is in the analogous field of needle washing (Blouin; [0049], see Fig. 2B at washing station 9 for cleaning piercing probe 36 and sample probe 30). Blouin teaches a needle assembly comprising a first needle and a second needle, where the first needle is a puncture needle having an outer diameter and the second needle is a sample needle disposable within the inner diameter of the puncture needle (Blouin; [0049], see Fig. 2B). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Mori with the teachings of Blouin so that the needle assembly comprises a first needle and a second needle, where the first needle is a puncture needle having an outer diameter and the second needle is a sample needle disposable within the inner diameter of the puncture needle, as Blouin teaches that a piercing probe in combination with a sampling probe can be used to break a seal on a container using the piercing probe so that the sampling probe can aspirate a fluid sample within the container (Blouin [0004]), and further that such needle assemblies require periodic washing (Blouin; [0049], see Fig. 2B).
Regarding claim 2, modified Mori discloses the method of claim 1. Modified Mori further discloses that the first needle is a puncture needle having an outer diameter and an inner diameter and the second needle is a sample needle disposable within the inner diameter of the puncture needle (see Claim 1 above at Blouin teaching the claimed needle assembly in [0049], see Fig. 2B).
Regarding claim 3, modified Mori discloses the method of claim 2. Modified Mori further discloses that the step of directing the wash solution to the first port and the second port is carried out simultaneously (Mori; [0045]-[0049]. See Fig. 6A, which shows that washing nozzles 201, 202, and 203 are operated simultaneously).
Regarding claim 4, modified Mori discloses the method of claim 2. Modified Mori further discloses that the step of applying the vacuum to the internal space comprises activating an aspiration system that is in fluid communication with the inner diameter of the puncture needle so as to evacuate any wash solution or solution vapors resident in the needle assembly or the wash tower (Mori; [0045]-[0049], see Figs. 4, 6A. When the needle assembly previously taught by Blouin is used in the method of Mori, the aspiration system will be in fluid communication with the inner diameter of the puncture needle).
Regarding claim 8, modified Mori discloses the method of claim 2. Modified Mori further discloses the step of stopping a flow of the wash solution after a user set wash protocol has been completed (Mori; [0045]-[0049], see Figs. 4, 6A. The time chart implies that a user has set the wash protocol).
Regarding claim 9, modified Mori discloses the method of claim 8, and all limitation recited therein.
Modified Mori fails to explicitly disclose the step of removing the vacuum from the internal space after about 0.1 to about 30 seconds have elapsed since the flow of the wash solution has stopped.
However, Mori teaches removing the vacuum from the internal space after the flow of wash solution has stopped (Mori; [0045]-[0049], see Figs. 4, 6A, where suctioning continues in vacuum nozzles 211, 212, 213 a set time after washing nozzles 201, 202, and 203 finish discharging, and after internal washing of reagent probe 7a finishes discharging). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the method include removing the vacuum from the internal space after about 0.1 to about 30 seconds have elapsed since the flow of the wash solution has stopped, since selecting the amount of time after stopping the flow of wash solution to remove the vacuum from the internal space would have been a matter of routine experimentation. The motivation would have been to optimize the operation of the method to ensure that the wash solution is sufficiently removed from the wash tower while also minimizing suction time and thereby improving throughput.
Regarding claim 12, modified Mori discloses the method of claim 2, and all limitations recited therein.
Modified Mori fails to explicitly disclose that the step of introducing the needle assembly to the wash tower comprises extending the puncture needle into the passageway a set distance beyond a pierce stroke length of the puncture needle.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the step of introducing the needle assembly to the wash tower comprise extending the puncture needle into the passageway a set distance beyond a pierce stroke length of the puncture needle, since selecting the distance that the needle assembly must enter into the wash tower would have been a matter of routine experimentation. The motivation would have been to ensure that the needle assembly is sufficiently inserted into the passageway that the entire needle assembly can be cleaned by the wash tower.
Allowable Subject Matter
Claims 5-7 and 10-11 are 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:
Mori, Blouin, Burnett et al. (US Pub. No. 2019/0302066; hereinafter Burnett; already of record on the IDS received 10/4/2024) and Champseix et al. (US Pat. No. 4,817,443; hereinafter Champseix; already of record on the IDS received 10/4/2024) teach a method similar to that claimed. However, Mori, Blouin, Burnett, and Champseix do not teach or suggest, either alone or in combination with the prior art, that the step of introducing the needle assembly to the wash tower comprises: inserting the puncture needle into the passageway; inserting the sample needle into the puncture needle inner diameter after the wash solution has been introduced to the wash tower; and moving the sample needle through the puncture needle and into the passageway, wherein the distal end of the sample needle engages with a seal assembly disposed at a distal end of the passageway.
Specifically, Blouin, which is considered to be the closest prior art, teaches washing a needle assembly comprising a puncture needle having an outer diameter and an inner diameter and a sample needle disposable within the inner diameter of the puncture needle ([0049], see Fig. 2B at washing station 9 for cleaning piercing probe 36 and sample probe 30). However, neither Blouin nor any of the other prior art of record teaches or suggest inserting the puncture needle into the passageway, inserting the sample needle into the puncture needle inner diameter after the wash solution has been introduced to the wash tower, and moving the sample needle through the puncture needle and into the passageway, where the distal end of the sample needle engages with a seal assembly disposed at a distal end of the passageway. This claimed method, where the sample needle is introduced into the wash tower after placing the puncture needle in the wash tower for a period of time, would provide a more effective washing of the needle assembly, particularly the sample needle, compared to that which is known in the prior art.
Claims 6-7 and 10-11 would be allowable for depending on claim 5, an allowable claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John McGuirk whose telephone number is (571)272-1949. The examiner can normally be reached M-F 8am-530pm.
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/JOHN MCGUIRK/Examiner, Art Unit 1798
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