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 .
Status of Claims
The claim set submitted on 22 MAY 2026 is acknowledge and considered. In the claim set, Claims 1-6 are ‘Cancelled’; and Claims 7-15 and 17-18 are ‘Previously Presented’; and Claim 16 is ‘Currently Amended’.
Current pending claims are Claims 7-18 and are considered on the merits below.
Response to Arguments
Applicant’s arguments, see REMARKS, filed 22 MAY 2026, with respect to the claim objection have been fully considered and are persuasive. The claim objection has been withdrawn.
Applicant's arguments filed 22 MAY 2026 have been fully considered but they are not persuasive.
In the REMARKS, Applicant asserts that the “claim 7 is expressly directed to a "computer-implemented method" with a processor being programmed to perform a series of operations. The claim recites operative verbs requiring action such as "receive ... a first identification," "receive ... a second identification," and "cause instructions to be provided ... to a laboratory computing system." These are process steps, not a static program listing.”
Under the broadest reasonable interpretation, this ‘computer-implemented method’ covers performance of the limitation in the mind including steps of receiving a pathology stain of the tissue. That is, other than reciting “computer implemented,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “computer implemented” language, “cause instructions to be provide” in the context of this claim encompasses the user to these tasks.
The courts have identified limitations that do not integrate the judicial exception into a practical application:
• Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
• Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and
• Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
In response to Applicant’s assertion that “claims are not directed to an abstract idea. Rather, the claims are directed to a concrete, computer-implemented laboratory process that controls handling of tangible articles.”
It is notable that mere physicality or tangibility of an additional element or elements is not a relevant consideration in Step 2A Prong Two in the 101 analysis. As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) (“The fact that a computer ‘necessarily exist[s] in the physical, rather than purely conceptual, realm,’ is beside the point”).
In response to Applicant’s assertion that “even if certain elements were characterized as information handling, the claims integrate any such information into a practical application in a specific technological context.”
Applicant’s claim do not integrate invention into a practical application as it does not include an improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a); implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b); effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
Furthermore, the Court considered the additional elements individually, noting that all the computer functions were “‘well-understood, routine, conventional activit[ies]’ previously known to the industry," each step “does no more than require a generic computer to perform generic computer functions”, and the recited hardware was “purely functional and generic” (573 U.S. at 225-26, 110 USPQ2d at 1984-85); and the Court considered the additional elements “as an ordered combination,” and determined that “the computer components … ‘[a]dd nothing … that is not already present when the steps are considered separately’” and simply recite intermediated settlement as performed by a generic computer.” 573 U.S. at 225 (citing Mayo, 566 U.S. at 79, 101 USPQ2d at 1972).
In response to Applicant’s assertion that: Chu discloses a "tray" for "simultaneously holding multiple . . . slides" to allow for "concurrent processing of the multiple slides." See, e.g., para. 19. However, while Chu discloses a tray that holds multiple slides, Chu does not disclose one slide on which multiple tissue samples, from different patients, are positioned.
Examiner respectfully disagrees.
As characterized in the rejection below; Examiner has interpreted the tray 400 as the ‘slide’; and each of the wells 410 divided by troughs 420 are where each tissue sample is to be placed. While CHU uses different terminology, the concept of a single holder with multiple samples is known in the art.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “408” in Figure 4. In Figure 4, the reference character “408” point to two different things. It appear the “408” on the right is correct as it points to a first region, but is unclear what the “408” on the left is referring to. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
In addition to the 101 rejection by the previous Examiner, the current examiner has performed a 101 analysis as well of the pending claims.
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Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The independent claim, Claim 7 recites: a claim(s) recites a computer-implemented method for biopsy tissue sample processing performed by a processor of a pathology, computing system, the processor being is programmed to: receive, from a user via user input to a graphical user interface of the pathology computing system, a first identification of a pathology stain and of a first tissue sample to be stained with the pathology stain, the first tissue sample originating from a first patient; receive, from the user via user input to the graphical user interface of the pathology computing system, a second identification of the same pathology stain and of a second tissue sample to be stained with the same pathology stain, the second tissue sample originating from a second, different patient; cause instructions to be provided, through an electronic communication network to a laboratory computing system, for a first section of the first tissue sample to be positioned on a pathology slide in a first region of the pathology slide, wherein the first region is on a first side of a visibly perceptible separation mark on or in a substantially transparent substrate of the pathology slide; and cause instructions to be provided, through the electronic communication network to the laboratory computing system, for a second section of the second tissue sample to be positioned on the same pathology slide in a second region of the same pathology slide, wherein the second region is on a second, opposite side of the visibly perceptible separation mark.
The limitations of ‘receive …a first identification from a pathology stain…’ and ‘receive … a second identification from a pathology stain…’ , as drafted is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but the recitation in the preamble of computer-implemented method. That is, other than recited a ‘computer implemented’, nothing in the claim elements precludes the step from practically being performed in the mind. Even the ‘cause instructions to be provided, through an electronic communication network…’ covers performance of the limitation in the mind but for the recitation of generic computer components.
For example, but for the “the processor being programmed to” language, “programmed to” in the context of this claim encompasses the user thinking what tasks should be performed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, in Claim 7, because the elements in all the claims do not impose any meaningful limits on practicing the abstract idea. The computer or processor in both steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of causing instructions based on the first and second identification) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea..
This does not appear to have ‘significantly’ more; all steps in the method are WURC. The elements in Claim 7 (and its dependent claims directed to what the processor is programmed to do ) are all steps are WURC (well understood routine and conventional). The method is claimed at a high level of generality, there is no meaningful limitation claimed, such as a particular or unconventional machine or transformation of a particular article.
Dependent Claim 15 does not impose any meaningful limits on practicing the abstract idea and only further define where the visibly perceptible separation mark is located.
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a computer or even a processor or a network to perform both the instruction steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Dependent claims 8-14 and 16-18 further define abilities/capabilities or programmed functions which are at least obvious and/or anticipated by the prior art or are abilities that are well understood, routine and convention. The limitations in the above mentioned claims are do not impose any meaningful limits on practicing the abstract idea.
Below is the 101 analysis.
Step 1: The claim recites at least one step or act. Thus, the claim is to a method, which is one of the statutory categories of invention (Step 1: YES).
Step 2A Prong One: The claim recites a judicial exception and identify the abstract idea/law of nature/natural phenomenon. The steps ‘receive …a first identification from a pathology stain…’ and ‘receive … a second identification from a pathology stain…’ ; it is an abstract idea; this can be done mentally or by the human eye. This can also be done with a look up table, would be considered an evaluation (mental step) and therefore an abstract idea.
In addition, the limitations in the ‘cause instruction’ steps are insignificant and the limitation in Claim 9 of tracking information as well as Claim 11 to split the image obtained , Claims 12-14 describes how the processor obtains, processes or stores the images; is a judicial exception, (an abstract idea that falls within the mathematical concept and mental process groupings in the 2019 PEG, and a law of nature). This claim identifies the recited exception as an abstract idea.
This claim attempts to process the information associated with information associated with the first and second digital images, Claim 18, but then nothing is done. This can be performed by a human using metal steps or basic critical thinking, which is an abstract idea (Step 2A: YES). Also consider MPEP 2106.040 (a)(2)(III).
This judicial exception is not integrated into a practical application because the elements in all the claims do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2A Prong Two: The claim as a whole integrates the recited judicial exception into a practical application of the exception; No. After Claim 7 and the ‘cause’ steps there does not appear to have any additional steps which are significantly more than the abstract idea.
The other steps in dependent at least Claims 8 and 10-13 are anticipated by the previous Examiner. I will conduct a new search for all other claims and new claims.
Step 2B: does the claim recite any elements which are significantly more than the abstract idea? This does not appear to have ‘significantly’ more; all steps in the method are WURC. The elements in Claim 7 (and its dependent claims directed to what the processor is programmed to do )are all steps are WURC (well understood routine and conventional). The method is claimed at a high level of generality, there is no meaningful limitation claimed, such as a particular or unconventional machine or transformation of a particular article.
The claim is ineligible.
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 7-18 are rejected under 35 U.S.C. 103 as being unpatentable over EHLKE, US Publication No. 2011/0060766 A1, and further in view of CHU, US Publication No. 2006/0216744 A1.
Applicant’s invention is directed towards a method.
Regarding Claim 7, the EHLKE reference discloses a computer-implemented method, Figure 1, 4 and 25, Claim 23, for biopsy tissue sample processing performed by a processor of a pathology, [0026], computing system, [0029, 0087], computer 410, Figure 4, the processor being is programmed to:
receive, from a user via user input to a graphical user interface of the pathology computing system, [0017, 0027, 0059, 0092], user input is entered, a first identification of a pathology stain, [0117], Figure 7, and of a first tissue sample to be stained with the pathology stain, [0004, 0024, 0117], tissue sample are obtained, the first tissue sample originating from a first patient, [0004, 0024];
receive, from the user via user input to the graphical user interface of the pathology computing system, [0017, 0027, 0059, 0092], user input is entered, a second identification of the same pathology stain and of a second tissue sample to be stained with the same pathology stain, [0117, 0211], the second tissue sample originating from a second, different patient, [0004, 0024];
cause instructions to be provided, through an electronic communication network to a laboratory computing system, [0095], execution of program from a network, for a first section of the first tissue sample to be positioned on a pathology slide in a first region of the pathology slide, [0005, 0006], known in the art of pathology, slide trays have multiple slots with multiple samples, which include tissue, wherein the first region is on a first side of a visibly perceptible separation mark on or in a substantially transparent substrate of the pathology slide, [0005] slide are standard glass rectangles; and
cause instructions to be provided, through the electronic communication network to the laboratory computing system, [0095], execution of program from a network, for a second section of the second tissue sample to be positioned on another pathology slide in a second region of the same pathology slide, wherein the second region is on a second, [0005, 0006].
The EHLKE discloses the claimed method, but is silent in regards to a second section of the second tissue sample to be positioned on the same pathology slide in a second region of the same pathology slide, wherein the second region is on a second, opposite side of the visibly perceptible separation mark.
The CHU reference discloses a computer-implemented method, abstract, for biopsy tissue sample processing performed by a processor of a pathology, [0072, 0081-0088], Example 7, processing unit, cause instructions to be provided, through an electronic communication network to a laboratory computing system, [0081-0088], Example 7, processing unit, for a first section of the first tissue sample to be positioned on a pathology slide in a first region of the pathology slide, [0015], Figure 6A-E, tray 400 with at least well 410 for a first sample such as tissue, [0019, 0023], wherein the first region is on a first side of a visibly perceptible separation mark on or in a substantially transparent substrate of the pathology slide, Figure 6A-E, trough 420 is visible and is interpreted to be a mark or marks/color [0027]; and
cause instructions to be provided, through the electronic communication network to the laboratory computing system, [0081-0088], Example 7, processing unit, for a second section of the second tissue sample to be positioned on the same pathology slide in a second region of the same pathology slide, [0015], Figure 6A-E, tray 400 with at least well 410 for a first sample such as tissue, [0019, 0023], wherein the second region is on a second, opposite side of the visibly perceptible separation mark, Figure 6A-E, another one of well 410 and trough 420 is visible and is interpreted to be a mark or marks/color [0027].
It would be obvious to one having ordinary skill in the art before the effective filing to modify the EHLKE so that a second section of the second tissue sample to be positioned on the same pathology slide in a second region of the same pathology slide, wherein the second region is on a second, opposite side of the visibly perceptible separation mark, which would allow one to recover the reaction fluid and to assay this fluid, prior to continuing the work-up of the tissue sample, to determine whether the PCR has worked properly or has been contaminated and allows more than one set of data to be view simultaneously, [0086, 0087].
Additional Disclosures Included by the combination includes : Claim 8: wherein the method of claim 7, wherein the processor is further programmed to transmit, through the electronic communication network to the laboratory computing system, an instruction to apply the pathology stain to the first section and to the second section, EHLKE [0095].; Claim 10: wherein the method of claim 7, wherein at least one of the processor of the pathology computing system or the processor of the laboratory computing system is programmed to cause an image sensor, communicatively coupled to at least one of the laboratory computing system or the pathology computing system, to take a digital image of the pathology slide, the digital image comprising the first section of the first tissue sample, positioned in the first region of the pathology slide, and the second section of the second tissue sample, positioned in the second region of the pathology slide, EHLKE Figure 3, [0011, 0012, 0018, 0019].; Claim 11: wherein the method of claim 10, wherein at least one of the processor of the pathology computing system, the processor of the laboratory computing system, or a processor of a server is further programmed to split the digital image into a first digital image including the first section and a second digital image including the second section, EHLKE [0019, 0024], Claim 28. ; Claim 12: wherein the method of claim 11, wherein at least one of the processor of the pathology computing system, the processor of the laboratory computing system, or the processor of the server is further programmed to cause a storage system, in communication with the pathology computing system, the laboratory computing system, and the server, to: associate, within the storage system, the first digital image with a first digital file corresponding to the first patient; and associate, within the storage system, the second digital image with a second digital file corresponding to the second, different patient, EHLKE Figure 4, memory, [0023, 0079, 0086, 0094, 0095]. ; Claim 13: wherein the method of claim 10, wherein the processor of the pathology computing system is further programmed to digitally analyze at least a portion of the digital image to identify at least one feature in the digital image, EHLKE [0009], Claim 23.; Claim 14: wherein the method of claim 10, wherein the processor of the pathology computing system is further programmed to present, via the graphical user interface of the pathology computing system, at least a portion of the digital image to the user for review, EHLKE [0115-0117], Figure 7 and 13-16A, 17B-19. ; Claim 15: wherein the method of claim 7, wherein the visibly perceptible separation mark is located on a bottom major surface of the pathology slide, EHLKE [0119]. ; Claim 16: wherein the method of claim 7, wherein the processor of the pathology computing system is programmed to receive at least one of the first identification or the second identification by decoding identification information from at least one of a printed slide label, a barcode, a two-dimensional scannable code, or an RFID chip located in a tracking region of the pathology slide, EHLKE [0119], Figure 15A-D, top of slide where it is labeled example : “1AHHEL1”.; Claim 17: wherein the method of claim 10, wherein at least one of the processor of the pathology computing system or the processor of the laboratory computing system is programmed to cause the image sensor to capture, in the digital image, a tracking region of the pathology slide that includes identification information, Claims 4-7, [0119, 0151, 0168, 0210].; and Claim 18: wherein the method of claim 12, wherein at least one of the processor of the pathology computing system, the processor of the laboratory computing system, or the processor of the server is programmed to associate the first digital image and the second digital image with respective patient digital files based at least in part on identification information obtained from a tracking region of the pathology slide, Claims 4-7, [0119, 0151, 0168, 0210].
Regarding Claim 9 , the combination above suggests the claimed invention, but is silent in regard to wherein at least one of the processor of the pathology computing system, a processor of the laboratory computing system, or a processor of a server is further programmed to transmit, through the electronic communication network to a printing device, instructions to print a label on the pathology slide with information, the information identifying at least one of: tracking information for the first tissue sample and for the second tissue sample; the pathology stain to be applied to the first section and to the second section; a date; the first tissue sample and the second tissue sample; or the first patient and the second, different patient.
EHLKE shows in Figure 1 information is to be transmitted as well as displayed, Figure 4, displays 428/430. In addition, it is well known in the art that in physical pathology systems, slides are labeled near one end, [0119, 0124, 0151], in addition, slides are typically labeled as to sample identity, and may be associated with other slides for the same patient as well as with a patient file containing other information such as patient history information and test results, [0004].
It would be obvious to one having ordinary skill in the art before the effective filing date to have the processor actually instruct a printing device to have instructions to print a label on the pathology slide with information to identify sample and other sample/patient information, [0004].
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kampf, C., Olsson, I., Ryberg, U., Sjöstedt, E., Pontén, F. Production of Tissue Microarrays, Immunohistochemistry Staining and Digitalization Within the Human Protein Atlas. J. Vis. Exp. (63), e3620, doi:10.3791/3620 (2012).
The Kampf reference is cited as known art of tissue microarray technology is used for high-throughput analysis. Kampf teaches a plurality of tissue samples on a single TMA block/slide. The advantage of using TMA technology is that large amount of data can rapidly be obtained using a single immunostaining protocol to avoid experimental variability.
Conclusion
THIS ACTION IS MADE FINAL. 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 CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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