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 with traverse of Group I in the reply filed on 12/9/2025 is acknowledged. The traversal is on the ground(s) that the restriction requirement does not show any examples of a materially different apparatus or process. This is not found persuasive because the restriction requirement has shown a materially different process which is that the apparatus can be used with a materially different method which does not require the sample comprising at least a first and at least a second component
The traversal is on the ground(s) that the restricted inventions are not independent inventions and that examination of both claimed invention together would not present a serous burden on the U.S. Patent and Trademark Office. This is not found persuasive because the issue as to the meaning and intent regarding “independent and distinct” as used in 35 U.S.C 121 and 37 CFR 1.41 has been adequately addressed in MPEP §802.01. Therein, it is stated that the legislative intent was to maintain the substantive law on the subject of restriction practice prior to enactment of 35 USC 121. Such practice permitted restriction between distinct, albeit dependent inventions. If the intent had been otherwise, then only the term “independent” would have been used. Thus, restriction between the distinct inventions set forth in this application is proper even though these inventions are clearly related.
Therefore, based on the additional work involved in searching and examining both distinct inventions together, restriction of the distinct inventions is clearly proper and is therefore made FINAL.
Claim 25 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 (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 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.
Claim(s) 21, 22, 30-33 and 35-39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2015/0346075, hereinafter Andreev.
Regarding claim 21, Andreev teaches an analysis and/or sorting system (item 100), comprising: a probe (item 110), a flow cytometer (item 200) and a connection between the probe and the flow cytometer (item 172), configured to convey a fluid stream from the probe to the flow cytometer (figure 1), wherein the probe comprises an open end (item 114), a fluid supply (item 120) configured to convey a fluid to the open end (figure 3B), and a fluid exhaust (item 112) configured to convey the fluid stream away from the open end (paragraph [0030]).
Regarding claim 22, Andreev teaches wherein the fluid supply and the fluid exhaust are coaxial (figure 3B).
Regarding claim 30, these limitations are directed to the material worked upon by the apparatus, all the structural limitations of the claim has been disclosed by Andreev and the apparatus of Andreev is capable of working on a fluid stream which is substantially free of bubbles. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Andreev (see MPEP §2115).
Regarding claim 31, Andreev teaches wherein the system is not configured to transmit a sample to the open end of the probe by directing acoustic energy into the sample (paragraph [0031], the vibration is performed to agitate the fluid, but is not used to transmit the sample to the open end of the probe).
Regarding claim 32, Andreev teaches further comprising a plurality of sample containers (paragraph [0030]).
Regarding claim 33, Andreev teaches wherein the plurality of sample containers are wells in a plate or in a plurality of plates (paragraph [0030] and [0036]).
Regarding claim 35, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Andreev and the apparatus of Andreev is capable of sorting components into at least two containers. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Andreev (see MPEP §2114).
Regarding claim 36, Andreev teaches wherein the flow cytometer is configured to detect a label in a sample in an optical manner (paragraph [0026]).
Regarding claim 37, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Andreev and the apparatus of Andreev is capable of detecting a fluorescent label. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Andreev (see MPEP §2114).
Regarding claim 38, Andreev teaches further comprising: a probe input pump (item 156) configured to convey the fluid through the fluid supply (paragraph [0029]), and a probe to flow cytometer pump (item 170), configured to convey the fluid stream away from the open end and/or to the flow cytometer (paragraph [0030]).
Regarding claim 39, Andreev teaches further comprising a control system (paragraph [0032]) configured to monitor and/or control a flow into the probe and/or a flow between the probe and the flow cytometer (paragraph [0032]).
Claim Rejections - 35 USC § 103
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) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andreev in view of United States Application Publication No. 2005/0032241, hereinafter Coassin.
Regarding claim 23, Andreev teaches all limitations of claim 21; however, Andreev is silent as to the width of the probe at the open end.
Coassin teaches that the relative dimension of the tip of a probe is related to the size of the well and that a tip diameter is approximately 0.2 mm (paragraph [0067]).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., the size of the probe), and that in combination, each element merely would have performed the same function as it did separately (i.e., retrieving a sample), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to combine probe of reference Andreev with 0.2 mm diameter of the probe of reference Coassin, since the result would have been predictable. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum probe diameter to a range of less than 3.3 mm which would allow for the probe to be inserted into the desired well/receptacle (MPEP § 2144.05 (II)).
Regarding claim 24 Andreev teaches all limitations of claim 21; however, Andreev is silent as to the width of the probe at the open end.
Coassin teaches that the relative dimension of the tip of a probe is related to the size of the well and that a tip diameter is approximately 0.2 mm (paragraph [0067]).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., the size of the probe), and that in combination, each element merely would have performed the same function as it did separately (i.e., retrieving a sample), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to combine probe of reference Andreev with 0.2 mm diameter of the probe of reference Coassin, since the result would have been predictable. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum probe diameter to a range of less than 1.3 mm which would allow for the probe to be inserted into the desired well/receptacle (MPEP § 2144.05 (II)).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andreev in view of United States Application Publication No. 2002/0170365, hereinafter Sklar.
Regarding claim 34, Andreev teaches all limitations of claim 21; however, Andreev fails to teach an autosampler configured to move the probe between multiple sampling points and/or to position multiple sampling points for sampling by the probe.
Sklar teaches a flow cytometry device which utilizes an autosampler which has an adjustable arm which moves back and forth and side to side so that the probe can be lowered into individual source wells (Sklar, paragraph [0043]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added an autosampler which moves the probe because it would allow for the probe to be lowered into individual source wells (Sklar, paragraph [0043]).
Claim(s) 35 and 37 is/are additionally rejected under 35 U.S.C. 103 as being unpatentable over Andreev in view of United States Application Publication No. 2010/0178666, hereinafter Leshansky.
Regarding claim 35, Andreev teaches all limitations of claim 21; however, if it is determined that Andreev fails to teach the flow cytometer is configured to sort components of the fluid stream into at least two containers, then Andreev fails to teach this limitation.
Leshansky teaches a flow cytometry device which puts biological cells of a heterogeneous mixture into or more containers because it would sort the biological cells (Leshansky, paragraph [0004]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have sorted components of the fluid stream from the flow cytometer into at least two containers because it would sort the cells (Leshansky, paragraph [0004]).
Regarding claim 37, Andreev teaches all limitations of claim 26; however, if it is determined that Andreev fails to teach the flow cytometer is configured detect a fluorescent label in a sample, then Andreev fails to teach this limitation.
Leshansky teaches a flow cytometry device which utilizes fluorescence to sort biological cells of a heterogeneous mixture into or more containers (Leshansky, paragraph [0004]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the flow cytometer detect fluorescence because it would allow sorting of biological cells from a heterogeneous mixture into or more containers (Leshansky, paragraph [0004]).
Claim(s) 40 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andreev in view of United States Application Publication No. 2006/0023207, hereinafter Cox.
Regarding claim 40, Andreev teaches all limitations of claim 39; however, Andreev fails to teach the control system comprises at least one flow meter and/or at least one light-based sensor.
Cox teaches a flow cytometry device which utilizes flow sensors connected to a computer/processor to control the pumps so that the stream can be controlled (Cox, paragraph [0018]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a flow meter to the device of Andreev because it would allow for the controlling of the pumps and thereby the flow stream (Cox, paragraph [0018]).
Regarding claim 41, Andreev teaches all limitations of claim 39; however, Andreev fails to teach the control system is configured to adjust power to one or more pumps.
Cox teaches a flow cytometry device which utilizes flow sensors connected to a computer/processor to control the pumps so that the stream can be controlled (Cox, paragraph [0018]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have adjusted power to one or more pumps because it would allow for the controlling of the flow stream (Cox, paragraph [0018]).
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andreev in view of United States Application Publication No. 2004/0117124, hereinafter Kiros.
Regarding claim 42, Andreev teaches all limitations of claim 39; however, Andreev fails to each the control system comprises a graphical user interface.
Kiros teaches an automated system in which a graphical user interface is utilized so that the status of the algorithm analysis can be displayed and so the user can modify the process’s status (Kiros, paragraph [0206]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a graphical user interface because it would allow for the status of the algorithm analysis can be displayed and so the user can modify the process’s status (Kiros, paragraph [0206]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796