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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/06/2026 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
claim 21 – “a visualization system” is revealed in the specification (paragraph 27) to be “a visualization system configured to track the one or more tissue sections from the microtome to the one or more slides” and is deemed to read on a generic computer
claims 29, 31, and 33 – recite “a transfer medium” and revealed in the specification (paragraph 78) to be a tape or any transfer medium to transfer tissue sections from the block to the slide
claim 39 – “a visualization system” is revealed in the specification (paragraph 27) to be “a visualization system configured to track the one or more tissue sections from the microtome to the one or more slides” and is deemed to read on a generic computer
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-33 and 39-44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to mental steps and abstract ideas without significantly more.
Claim 21 recites “reading identifying data”, “associating the one or more tissue sections on the one or more slides with the tissue block”, and “comparing, with a visualization system, an image of the one or more tissue sections” are directed to mental steps and abstract ideas. This judicial exception is not integrated into a practical application, because integrating with a computer (a visualization system) does not move the claim outside the realm of an abstract idea (see MPEP 2106.04(a)(2)III). The steps prior to the abstract ideas are insignificant pre-solution activity (see MPEP 2106.05(g)) and are also generally linking the abstract idea to a particular technological environment or field of use (see MPEP 2106.05(h)).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception, because the cutting, printing, and transferring steps are well-understood, routine, and conventional as seen in Voneiff (US20030022271A1), Bolles (US Pat No. 5,746,855A), and Torre-Bueno (US20090110253A1). Claims 22-34 are also rejected because they do not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 39 recites “reading identifying data”, “comparing, with a visualization system, a tissue sample in one or more first images”, and confirming association between the identifying data” are directed to mental steps and abstract ideas. This judicial exception is not integrated into a practical application, because integrating with a computer (a visualization system) does not move the claim outside the realm of an abstract idea (see MPEP 2106.04(a)(2)III). The steps prior to the abstract ideas are insignificant pre-solution activity (see MPEP 2106.05(g)) and are also generally linking the abstract idea to a particular technological environment or field of use (see MPEP 2106.05(h)).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception, because the cutting and printing steps are well-understood, routine, and conventional as seen in Voneiff (US20030022271A1), Bolles (US Pat No. 5,746,855A), and Torre-Bueno (US20090110253A1). Claims 39-44 are also rejected because they do not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
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 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.
Claims 21-28, 32, 39-44 are rejected under 35 U.S.C. 103 as being unpatentable over Voneiff et al (US20030022271A1 published 01/30/2003; hereinafter Voneiff) and Bolles (US Pat No. 5,746,855A published 05/05/1998) which is incorporated by reference in its entirety by Voneiff (Paragraph 62)) in view of Torre-Bueno (US20090110253A1 published 04/30/2009).
Regarding claim 21, Voneiff teaches a method for tracking samples in microtomy, the method comprising:
reading identifying data from a tissue block (a sample block's code must be read before it can be processed – paragraph 38);
cutting one or more tissue sections from the tissue block (sample block is moved to blade assemblies for cutting – paragraph 87);
printing one or more labels for one or more slides (information may be bar coded, and may be printed on the slide directly, or printed on a label and then affixed to the slide – paragraph 66), the one or more labels comprising information associating the one or more tissue sections on the one or more slides with the tissue block (include information regarding the sample slice sequence where several sample slices are taken e.g., "slice 7 of 20" – paragraph 66);
transferring the one or more tissue sections to the one or more slides (the histologic grade slice is transferred to a suitable receiving medium, which may be a slide – paragraph 60) and labeling the one or more slides with the one or more labels (information may be bar coded, and may be printed on the slide directly, or printed on a label and then affixed to the slide – paragraph 66); and
comparing, with a visualization system, to confirm association between the identifying data from the tissue block and the one or more labels on the one or more slides (a system controller 316 matches the code on the sample block with the codes on the slide – paragraph 81).
However, Voneiff does not teach comparing an image of the one or more tissue sections on the one or more slides to an image of the one or more tissue sections in or on the tissue block.
Torre-Bueno teaches an evaluation device with an image processing program (paragraph 33) comparing an image of the one or more tissue sections on the one or more slides to an image of the one or more tissue sections in or on the tissue block (to image the block when it is first received and to check that image against images of the tissue on the slides at various steps in the workflow – paragraph 19) (The image of the tissue is also extracted, and preprocessed. The image and the order number may be stored in a database at 215 – paragraph 27 and Fig. 2). Torre-Bueno teaches to check the images for a mismatch so that mismatch slides may be relabeled (paragraph 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method, as taught by Voneiff, by checking the image of the block against images of the tissue on the slides, taught by Torre-Bueno, so that mismatch slides may be relabeled. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Voneiff and Torre-Bueno teach method for processing tissue slices and slides.
Regarding claim 22, Voneiff, modified by Torre-Bueno, teaches the method of claim 21, further comprising cutting additional one or more tissue sections (histologic grade slices are produced from sample blocks that have been brought to the desired depth for producing histologic grade slices – Voneiff paragraph 53) only after the one or more tissue sections are placed on the one or more slides and labeled with the one or more labels (a given or pre-set number of histologic grade slices are automatically taken from the sample block's working surface – Voneiff paragraph 53) (Voneiff teaches multiple sample blocks and takes slices from a sample block after a previous sample block has been sliced and mounted to slides – paragraph 53 and Figs. 1A-B).
Regarding claim 23, Voneiff, modified by Torre-Bueno, teaches the method of claim 21, wherein the comparing the one or more tissue sections on the one or more slides to the one or more tissue sections in or on the tissue block is based on a size (Slices are removed until the sensor determines that a sufficient cross-sectional area of the tissue sample – Voneiff paragraph 52), a shape (a sufficient cross-sectional area of the tissue sample is a shape – Voneiff paragraph 52), and an outline (a sufficient cross-sectional area of the tissue sample comprises an outline – Voneiff paragraph 52) of a tissue sample in the one or more tissue sections.
Regarding claim 24, Voneiff, modified by Torre-Bueno, teaches the method of claim 21, wherein the one or more labels are printed individually for the one or more tissue sections (information may be bar coded, and may be printed on the slide directly, or printed on a label and then affixed to the slide – Voneiff paragraph 66).
Regarding claim 25, Voneiff, modified by Torre-Bueno, teaches the method of claim 21, wherein the one or more slides are labeled with the one or more labels prior to transferring the one or more tissue sections to the one or more slides (When system 300 is ready to process a given sample block, the corresponding slides will be sequentially labeled with some or all of this information – Voneiff paragraph 106).
Regarding claim 26, Voneiff, modified by Torre-Bueno, teaches the method of claim 21, wherein the identifying data comprises at least one of an accession number, a block ID, a patient name, a date when a specimen contained in the tissue block was obtained, a number of tissue sections to be cut from the tissue block (include information regarding the sample slice sequence where several sample slices are taken e.g., "slice 7 of 20" – Voneiff paragraph 66), or a thickness of the one or more tissue sections to be cut.
Regarding claim 27, Voneiff, modified by Torre-Bueno, teaches the method of claim 21, wherein the information associating the one or more tissue sections on the one or more slides with the tissue block is the identifying data (include information regarding the sample slice sequence where several sample slices are taken e.g., "slice 7 of 20" – Voneiff paragraph 66).
Regarding claim 28, Voneiff, modified by Torre-Bueno, teaches the method of claim 21, wherein the identifying data from the tissue block is read with a barcode reader (information may be fixed to the block in machine-readable form. For example, this information may be provided in a scannable bar code – Voneiff paragraph 37) (the slices that are removed from the sample block and monitored by a sensor – Voneiff paragraph 52) while the one or more tissue sections are cut from the tissue block (the histologic grade slice taken from the sample block is then applied directly to a transfer roller mechanism – Voneiff paragraph 54).
Regarding claim 32, Voneiff, modified by Torre-Bueno, teaches the method of claim 21, further comprising comparing the one or more tissue sections on the one or more slides (an optical imaging system, may be provided to determine the location of the sample slice relative to a slide – Voneiff paragraph 61) and the one or more tissue sections on the tissue block (Optical imaging system 348 in conjunction with a robotic clamp 350 adjusts the paraffin block's working surface relative to blades at the next processing station to level the tissue sample and formulate its depth from the working surface of the surface of the paraffin block – Voneiff paragraph 85) with a baseline image of a tissue sample in the tissue block generated by imaging the tissue block prior to removing the one or more tissue sections from the tissue block (The image of the tissue is also extracted, and preprocessed. The image and the order number may be stored in a database at 215 – Torre-Bueno paragraph 27 and Fig. 2) to confirm association between the one or more tissue sections on the one or more slides, the one or more tissue sections on the tissue block, and the tissue block (a software-driven electronic network for connecting lab instruments and computers so that at a minimum their statuses may be monitored through one or more centrally-located computers. Elements of the software allow common control and communication amongst a group of instruments – Voneiff paragraph 28).
Regarding claim 39, Voneiff teaches a method for tracking samples in microtomy, the method comprising:
reading identifying data from a tissue block (a sample block's code must be read before it can be processed – paragraph 38);
cutting one or more tissue sections from the tissue block (sample block is moved to blade assemblies for cutting – paragraph 87);
comparing, with a visualization system, a tissue sample (a system controller 316 matches the code on the sample block with the codes on the slide – paragraph 81);
printing one or more labels for the one or more slides (printing in step 114 is after cutting in step 110 – Fig. 1A and paragraphs 60), the one or more labels comprising information associating the one or more tissue sections on the one or more slides with the tissue block (slides are printed to correspond to a given sample block and the number of slide samples required of that sample block – paragraphs 81 and 100); and
However, Voneiff does not teach comparing one or more first images of the tissue block to one or more tissue samples in one or more second images of the one or more tissue sections, confirming association between the identifying data from the tissue block and the one or more labels on the one or more slides based on the comparison of the tissue sample in the one or more first images of the tissue block to the one or more tissue samples in the one or more second images of the one or more tissue sections.
Torre-Bueno teaches an evaluation device with an image processing program (paragraph 33) comparing one or more first images of the tissue block to one or more tissue samples in one or more second images of the one or more tissue sections (to image the block when it is first received and to check that image against images of the tissue on the slides at various steps in the workflow – paragraph 19),
confirming association between the identifying data from the tissue block (by reading the barcode, or OCRing the label on the block – paragraph 27) and the one or more labels on the one or more slides (This image is associated with the order number, e.g., an order form on the slide at 210 – paragraph 27) based on the comparison of the tissue sample in the one or more first images of the tissue block to the one or more tissue samples in the one or more second images of the one or more tissue sections (step 250 reads the label, and compares the images of tissue 100 on the slide to the images of the block as stored in the database – paragraph 29). Torre-Bueno teaches to check the images for a mismatch so that mismatch slides may be relabeled (paragraph 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method, as taught by Voneiff, by checking the image of the block against images of the tissue on the slides, taught by Torre-Bueno, so that mismatch slides may be relabeled. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Voneiff and Torre-Bueno teach method for processing tissue slices and slides.
Regarding claim 40, Voneiff, as modified by Torre-Bueno, teaches the method of claim 39, further comprising cutting additional one or more tissue sections (histologic grade slices are produced from sample blocks that have been brought to the desired depth for producing histologic grade slices – Voneiff paragraph 53) only after the one or more tissue sections are placed on the one or more slides and labeled with the one or more labels (a given or pre-set number of histologic grade slices are automatically taken from the sample block's working surface – Voneiff paragraph 53) (Voneiff teaches multiple sample blocks and takes slices from a sample block after a previous sample block has been sliced and mounted to slides – paragraph 53 and Figs. 1A-B).
Regarding claim 41, Voneiff, modified by Walter, teaches the method of claim 39, wherein printing the one or more labels for the one or more slides (information may be bar coded, and may be printed on the slide directly, or printed on a label and then affixed to the slide – Voneiff paragraph 66) is based on the comparison of the tissue sample in the one or more first images of the tissue block to the one or more tissue samples in the one or more second images of the one or more tissue sections (the slides a labeled after the sample slices are made – Voneiff paragraph 60).
Regarding claim 42, Voneiff, as modified by Torre-Bueno, teaches the method of claim 39, further comprising:
transferring the one or more tissue sections to the one or more slides (At 220, the blocks are then sectioned to make slides. The slides are labeled, either before or after this operation – Torre-Bueno paragraph 28); and
after transferring the one or more tissue sections to the one or more slides, labeling the one or more slides with the one or more labels (The slides are labeled, either before or after this operation – Torre-Bueno paragraph 28).
Regarding claim 43, Voneiff, as modified by Torre-Bueno, teaches the method of claim 39, further comprising:
labeling the one or more slides with the one or more labels (The slides are labeled, either before or after this operation – Torre-Bueno paragraph 28); and
after labeling the one or more slides with the one or more labels, transferring the one or more tissue sections to the one or more slides (At 220, the blocks are then sectioned to make slides. The slides are labeled, either before or after this operation – Torre-Bueno paragraph 28).
Regarding claim 44, Voneiff, as modified by Torre-Bueno, teaches the method of claim 39, wherein the printing of the one or more labels is performed subsequently to the cutting (slide barcodes printed on a label and then affixed to the slide include information regarding the sample slice sequence where several sample slices are taken; “taken” indicates the cutting step occurs before the printing step – Voneiff paragraph 66) and before transferring the one or more tissue sections to one or more slides (At 220, the blocks are then sectioned to make slides. The slides are labeled, either before or after this operation – Torre-Bueno paragraph 28).
Claims 29-31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Voneiff, as modified by Torre-Bueno, in view of Stephens et al (US20070141711A1 published 06/21/2007; hereinafter Stephens).
Regarding claim 29, Voneiff, as modified by Torre-Bueno, teaches the method of claim 21.
However, Voneiff, as modified by Torre-Bueno, does not teach further comprising marking a transfer medium with markings indicative of the identifying data, wherein: the markings are configured to associate the one or more tissue sections with the tissue block; and the one or more tissue sections are transferred to the one or more slides via the transfer medium.
Stephens teaches laboratory information systems comprising methods for sample processing comprising marking a transfer medium (a tissue cassette – paragraph 19) with markings indicative of the identifying data (The cassettes must have some form of data element written or encoded upon them in either indelible ink, or in a machine-readable label such as a barcode – paragraph 32), wherein:
the markings are configured to associate the one or more tissue sections with the tissue block (cassette must have at least one unique identifier such as a cassette number, case number, accession no., or a combination of the them in order for the lab to track the tissue sample within – paragraph 32); and
the one or more tissue sections are transferred to the one or more slides via the transfer medium (the tissue cassette is placed into a microtome for subsequent cutting operations – paragraph 27) (the histologic grade slices part of a sample in the tissue cassette, and the tissue cassette is used to transfer the sample to the microtome and then histologic grade slices are cut and transferred to the slide – paragraphs 27-28) (the tissue cassette is therefore interpreted as a part of the system that transfers tissue sections to slides). Stephens teaches to use a computer controlled LIS to process more/better/faster samples while unambiguously tracking samples so that mix-ups and errors do not occur (paragraph 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the microtomy method, as taught by Voneiff as modified by Torre-Bueno, with the tissue cassette and computer controlled LIS, taught by Stephens, for more/better/faster sample processing while tracking samples so that mix-ups and errors do not occur. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Voneiff, Torre-Bueno, and Stephens teach systems for processing sliced tissue sections.
Regarding claim 30, Voneiff, modified by Stephens, teaches the method of claim 29, further comprising verifying correspondence between each of the identifying data from the tissue block, the one or more labels for the one or more slides, and the markings (a software-driven electronic network for connecting lab instruments and computers so that at a minimum their statuses may be monitored through one or more centrally-located computers. Elements of the software allow common control and communication amongst a group of instruments – Stephens paragraph 28).
Regarding claim 31, Voneiff, modified by Stephens, teaches the method of claim 21.
However, Voneiff, modified by Stephens, does not teach further comprising transferring the one or more tissue sections to the one or more slides using a transfer medium and comparing the one or more tissue sections in or on the transfer medium and the one or more tissue sections in or on the tissue block to the one or more tissue sections on the one or more slides to confirm association of the one or more tissue sections on the one or more slides to the one or more tissue sections on the tissue block and the one or more tissue sections on the transfer medium.
Stephens teaches laboratory information systems comprising methods for sample processing comprising transferring the one or more tissue sections to the one or more slides using a transfer medium (a tissue cassette – paragraph 19) and comparing (cassette must have at least one unique identifier such as a cassette number, case number, accession no., or a combination of the them in order for the lab to track the tissue sample within – paragraph 32) the one or more tissue sections on the transfer medium and the one or more tissue sections on the tissue block to the one or more tissue sections on the one or more slides to confirm association of the one or more tissue sections on the one or more slides to the one or more tissue sections on the tissue block and the one or more tissue sections on the transfer medium (a software-driven electronic network for connecting lab instruments and computers so that at a minimum their statuses may be monitored through one or more centrally-located computers. Elements of the software allow common control and communication amongst a group of instruments – paragraph 28). Stephens teaches to use a computer controlled LIS to process more/better/faster samples while unambiguously tracking samples so that mix-ups and errors do not occur (paragraph 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the microtomy method, as taught by Voneiff as modified by Torre-Bueno, with the tissue cassette and computer controlled LIS, taught by Stephens, for more/better/faster sample processing while tracking samples so that mix-ups and errors do not occur. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Voneiff, Torre-Bueno, and Stephens teach systems for processing sliced tissue sections.
Regarding claim 33, Voneiff, modified by Torre-Bueno, teaches the method of claim 21, further comprising comparing the one or more tissue sections on the one or more slides (an optical imaging system, may be provided to determine the location of the sample slice relative to a slide – paragraph 61), the one or more tissue sections on the tissue block (optical imaging system 348 in conjunction with a robotic clamp 350 adjusts the paraffin block's working surface relative to blades at the next processing station to level the tissue sample and formulate its depth from the working surface of the surface of the paraffin block – paragraph 85) , and a baseline image of a tissue sample in the tissue block generated by imaging the tissue block prior to removing the one or more tissue sections from the tissue block (The image of the tissue is also extracted, and preprocessed. The image and the order number may be stored in a database at 215 – Torre-Bueno paragraph 27 and Fig. 2) to confirm association between the one or more tissue sections on the one or more slides, the one or more tissue sections on the tissue block, the tissue block (to image the block when it is first received and to check that image against images of the tissue on the slides at various steps in the workflow – paragraph 19).
However, Voneiff, modified by Torre-Bueno, does not teach to confirm association the one or more tissue sections on a transfer medium and confirm association between the one or more tissue sections on the transfer medium.
Stephens teaches laboratory information systems comprising one or more tissue sections on a transfer medium ("cassette data" refers to the unique identifying number for the cassette, if any. Cassette data would be used by the histology lab to track cassettes – paragraph 33) to confirm association the one or more tissue sections on a transfer medium and confirm association between the one or more tissue sections on the transfer medium (a software-driven electronic network for connecting lab instruments and computers so that at a minimum their statuses may be monitored through one or more centrally-located computers. Elements of the software allow common control and communication amongst a group of instruments – paragraph 28). Stephens teaches to use a computer-controlled LIS to process more/better/faster samples while unambiguously tracking samples so that mix-ups and errors do not occur (paragraph 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the microtomy method, as taught by Voneiff as modified by Torre-Bueno, with the tissue cassette and computer-controlled LIS, taught by Stephens, for more/better/faster sample processing while tracking samples so that mix-ups and errors do not occur. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Voneiff, Torre-Bueno, and Stephens teach systems for processing sliced tissue sections.
Response to Arguments
Applicant’s arguments with respect to claims 21 and 39 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.
Conclusion
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/T.C.S./Examiner, Art Unit 1796
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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