DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim 4 recites the limitation "the plunger" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the liquid extraction device” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-3, 5, 7-11 and 16-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over United States Application Publication No. 2010/0224013, hereinafter Van Berkel in view of WO 00/57153, hereinafter Bing.
Regarding claim 1, Van Berkel teaches an extraction device (figure 1) for selectively extracting biological material from a slide-mounted biological sample (intended use MPEP § 2114 (II)), comprising: a liquid dispensing reservoir (the upper portion of item 36) fluidly coupled through a first fluidic pathway (the lower portion of item 36) to a liquid dispensing port (item 37 which is connected to item 32) and operable to dispense liquid to the sample (intended use MPEP § 2114 (II) and shown in figure 5); a liquid aspiration reservoir (the upper portion of item 34) fluidly coupled through a second fluidic pathway (the lower portion of item 34) to a liquid aspiration port (item 37 which is connected to item 30) and operable to aspirate fluid and disrupted biological material from the sample (intended use MPEP § 2114 (II), figure 5); and a pump (paragraph [0024]) fluidly connected to the liquid dispensing reservoir, the liquid dispensing port, the liquid aspiration reservoir, and the liquid aspiration port (paragraph [0024]) and operable to move fluid from the liquid dispensing reservoir through the liquid dispensing port to the interface between the biological sample and the cutting tip and from the interface between the biological sample and the cutting tip through the aspiration port to the liquid aspiration reservoir (intended use MPEP § 2114 (II) and figure 1).
Van Berkel fails to teach a cutting tip configured to be rotatably driven about a rotating axis and operable to disrupt biological material from a region of the biological sample and the liquid dispensing port and liquid aspiration port is located proximal to the cutting tip.
Bing teaches an extraction device which utilizes a rotating cutting head when it is brought into contact with the sample as it greatly increases the likelihood of successfully removing the sample from the array (Bing, page 4, lines 9-12).
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 rotating cutting head to the device of Van Berkel because it would greatly increase the likelihood of successfully removing a portion of the sample from the sample (Bing, page 4, lines 9-12).
Regarding claim 2, 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 Van Berkel and Bing and the apparatus of modified Van Berkel is capable of having the rotating axis substantially perpendicular to a slide. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Van Berkel (see MPEP §2114).
Regarding claim 3, Van Berkel teaches wherein the pump consists of a single pump (paragraph [0024]).
Regarding claim 5, 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 Van Berkel and Bing and the apparatus of modified Van Berkel is capable of simultaneously dispense liquid and aspirate liquid. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Van Berkel (see MPEP §2114).
Regarding claim 7, 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 Van Berkel and Bing and the apparatus of modified Van Berkel is capable of disrupting an area of biological material from about 10 µm to 1 mm in size. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Van Berkel (see MPEP §2114).
Regarding claim 8, 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 Van Berkel and Bing and the apparatus of modified Van Berkel is capable of disrupting an area of biological material from about 250 µm to 1 mm in size. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Van Berkel (see MPEP §2114).
Regarding claim 9, Van Berkel teaches wherein the second fluidic pathway is interior to the first fluidic pathway (figure 3).
Regarding claim 10, Van Berkel teaches wherein the first fluidic pathway substantially surrounds the second fluidic pathway (figure 3).
Regarding claim 11, modified Van Berkel teaches a system for selectively extracting biological material from a biological sample (see supra), comprising: the extraction device of claim 1 (see supra) positioned to operationally face a support substrate and to engage a slide-mounted biological sample disposed on the support substrate (intended use MPEP § 2114 (II)); a motor operationally coupled to the extraction device and operable to rotate the cutting tip (Bing, page 2, line 21 and column 5, lines 11-17); a liquid holding vessel (item 40) operable to provide liquid to the extraction device (figure 1); and a positional movement system (item 18 and 28) coupled to the extraction device (figure 1) and operable to move either the cutting tip of the extraction device relative to the support substrate or the support substrate relative to the cutting tip (paragraph [0030]).
Regarding claim 16, Van Berkel teaches further comprising a manual manipulation system (item 29) functionally coupled to the positional movement system (figure 1) and operable to allow a user to move the cutting tip and/or the support substrate relative to one another (figure 1 and paragraph [0030]).
Regarding claim 17, Van Berkel teaches further comprising an automatic manipulation system functionally coupled to the positional movement system and operable to automatically move the cutting tip and/or the support substrate relative to one another (paragraph [0029]).
Regarding claim 18, Van Berkel teaches further comprising a processing system (item 16) functionally coupled to the automatic manipulation system (figure 1), the processing system operable to: identify and locate a predetermined region of biological material to be extracted from a biological sample (paragraph [0029]); and move the cutting tip and/or support substrate relative to one another to extract the biological material via the automatic manipulation system (paragraph [0029]).
Regarding claim 19, Van Berkel teaches wherein the liquid holding vessel (item 40) is configured to provide liquid to the liquid extraction device through the liquid dispensing port of the extraction device (figure 1).
Regarding claim 20, (the examiner notes that claim 20 is rejected with claim 11 under a different interpretation) modified Van Berkel teaches a system for selectively extracting biological material from a biological sample (see supra), comprising: the extraction device of claim 1 (see supra) positioned to operationally face a support substrate and to engage a slide-mounted biological sample disposed on the support substrate (intended use MPEP § 2114 (II)); a motor operationally coupled to the extraction device and operable to rotate the cutting tip (Bing, page 2, line 21 and column 5, lines 11-17); a liquid holding vessel (item 23) operable to provide liquid to the extraction device (figure 1); and a positional movement system (item 18 and 28) coupled to the extraction device (figure 1) and operable to move either the cutting tip of the extraction device relative to the support substrate or the support substrate relative to the cutting tip (paragraph [0030]), wherein the liquid holding vessel is configured to receive liquid and biological liquid from the extraction device (figure 1).
Claims 4 and 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Van Berkel and Bing as applied to claim 1 above, and further in view of United States Application Publication No. 2009/0036764, hereinafter Rivas.
Regarding claim 4, (the examiner notes that claim 4 is rejected with claim 1 under a different interpretation) Van Berkel teaches an extraction device (figure 1) for selectively extracting biological material from a slide-mounted biological sample (intended use MPEP § 2114 (II)), comprising: a liquid dispensing reservoir (item 40) fluidly coupled through a first fluidic pathway (the lower portion of item 36) to a liquid dispensing port (item 37 which is connected to item 32) and operable to dispense liquid to the sample (intended use MPEP § 2114 (II) and shown in figure 5); a liquid aspiration reservoir (the upper portion of item 34) fluidly coupled through a second fluidic pathway (the lower portion of item 34) to a liquid aspiration port (item 37 which is connected to item 30) and operable to aspirate fluid and disrupted biological material from the sample (intended use MPEP § 2114 (II), figure 5); and a pump (paragraph [0024]) fluidly connected to the liquid dispensing reservoir, the liquid dispensing port, the liquid aspiration reservoir, and the liquid aspiration port (paragraph [0024]) and operable to move fluid from the liquid dispensing reservoir through the liquid dispensing port to the interface between the biological sample and the cutting tip and from the interface between the biological sample and the cutting tip through the aspiration port to the liquid aspiration reservoir (intended use MPEP § 2114 (II) and figure 1).
Van Berkel fails to teach a cutting tip configured to be rotatably driven about a rotating axis and operable to disrupt biological material from a region of the biological sample and the liquid dispensing port and liquid aspiration port is located proximal to the cutting tip.
Bing teaches an extraction device which utilizes a rotating cutting head when it is brought into contact with the sample as it greatly increases the likelihood of successfully removing the sample from the array (Bing, page 4, lines 9-12).
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 rotating cutting head to the device of Van Berkel because it would greatly increase the likelihood of successfully removing a portion of the sample from the sample (Bing, page 4, lines 9-12).
Van Berkel and Bing fail to teach the pump comprises a plunger.
Rivas teaches a device in which syringe pumps having a plunger is utilized as the pump to move fluid within the system.
Examiner further finds that the prior art contained a device/method/product (i.e., a pump which comprises a plunger) which differed from the claimed device by the substitution of component(s) (i.e., a generic pump) with other component(s) (i.e., a pump which comprises a plunger), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., a generic pump with a pump which comprises a plunger), and the results of the substitution (i.e., moving the fluid) would have been 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 substitute the generic pump of reference Van Berkel with pump which comprises a plunger of reference Rivas, since the result would have been predictable.
The pump as described by Van Berkel is fluidically between the liquid dispensing reservoir and the liquid aspiration reservoir and therefore the pump (and therefore plunger) replaced with Rivas would also be between the liquid dispensing reservoir and the liquid aspiration reservoir.
Regarding claim 6, Van Berkel and Bing teach all limitations of claim 1; however, they fail to teach the pump comprises a plunger.
Rivas teaches a device in which syringe pumps having a plunger is utilized as the pump to move fluid within the system.
Examiner further finds that the prior art contained a device/method/product (i.e., a pump which comprises a plunger) which differed from the claimed device by the substitution of component(s) (i.e., a generic pump) with other component(s) (i.e., a pump which comprises a plunger), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., a generic pump with a pump which comprises a plunger), and the results of the substitution (i.e., moving the fluid) would have been 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 substitute the generic pump of reference Van Berkel with pump which comprises a plunger of reference Rivas, since the result would have been predictable.
Claims 12-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Van Berkel and Bing as applied to claim 11 above, and further in view of United States Application Publication No. 2012/0245596, hereinafter Meenink.
Regarding claims 12, 14 and 15, Van Berkel and Bing teach all limitations of claim 11; however, they fail to teach a visualization system positioned to provide a visual display of a biological sample placed on the support substrate, wherein the visualization system includes a member selected from the group consisting of digital imagers, optical imagers, microscopes, inverted microscopes, and combinations thereof. Hanson further fails to teach the support substrate is transparent and an automatic manipulation system functionally coupled to the positional movement system and operable to automatically move the cutting tip and/or the support substrate relative to one another.
Meenink teaches a surgical robot comprising an extraction device (item 22) comprising a visualization system (microscope) positioned to provide a visual display of a biological sample placed on the support substrate, wherein the visualization system includes a member selected from the group consisting of digital imagers, optical imagers, microscopes, inverted microscopes, and combinations thereof (Meenink, column 5, lines 15-20)
It would have been obvious to one having ordinary skill in the art to provide the device of Van Berkel with a visualization system positioned to provide a visual display of a biological sample in order to increase the versatility of the device and eliminate user error and fully automating the system.
Regarding claim 12, the support surface is not positively claimed and therefore any limitation on the support surface has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Van Berkel, Bing and Meenink.
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