DETAILED ACTION
In application filed on 09/08/2023, Claims 1-9 are pending. The claim set submitted on 04/16/2026 is considered because this is the most recent claim set with some preliminary amendments. Claims 1-9 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/08/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on04/16/2026 is acknowledged. The traversal is on the ground(s) that
Applicant does not acquiesce to or agree with the Examiner's characterization of the applicability of Alkandry to the pending claims. In particular, to the extent Alkandry can generally be characterized as describing monitoring changes in reagent concentration (see, e.g., Abstract), Alkandry discloses a system (10) that includes a refractometer and an optical sensor for measuring a refractive index of a solution (14) and describes measuring the concentration of a known solution in real-time by collecting image data periodically and processing the image data to return a discrete concentration value that can be recorded or displayed to allow visualization of the change in concentration over time (1 [0038]). In contrast, the present application states:
A concentration change rate can also be determined by determining an absolute concentration in conjunction with an evaluation of its temporal course. For this purpose, for example, a derivative of a suitably filtered and/or smoothed temporal concentration course can be formed. It may also be possible to evaluate a concentration change rate without determining an actual concentration, since in principle the raw data course of a sensor signal generated by the sensor 107 can also be used for this purpose. If the sensor signal is constant, the underlying concentration is also constant and thus its change rate is zero. If the sensor signal change rate is high, on the other hand, a high concentration change rate can also be assumed. U.S. Pub. No. 2024/0159630A1, [0029] (emphasis added). Alkandry does not teach, suggest, or disclose determining a concentration change rate as such. Thus, the common technical feature shared between the claims of Group I and Group II is also a special technical feature in view of Alkandry, and the restriction requirement should be withdrawn. Alternatively, non-elected claims 6-7 are eligible for rejoinder upon allowance of the elected claims.
Examiner finds this argument persuasive and the restriction requirement is withdrawn.
Drawings
The drawings are objected to because Figures including Fig. 1 is not legible.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 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:
The claim set uses a substitute “means”
The claim set generic placeholder is modified by functional language: “for moving”; “configuring the tissue processor to perform a method”
In the claim set, the generic placeholder is not modified by sufficient structure: the “means”, is not modified by sufficient structure.
Claim 6 recites “means configuring the tissue processor to perform a method according to claim 1”.
Based on the instant specification:
The “means” has been interpreted in light of the Specification to comprise a a computing unit 150…for example, using a dedicated computing unit of the sensor, which may be provided, for example, in the form of an integrated circuit, microprocessor, or other suitable device for data processing (See Pages 6-7).
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. All claims are directed to statutory categories, i.e., a method (Claim 1) (Step 1: YES).
Analysis:
Claim 1: Ineligible.
Step 1:
The claim recites a series of steps or acts, including “method for tissue processing of at least one biological tissue”. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1: YES).
Step 2A, Prong 1:
Claim 21 recites “determining a concentration change rate in the at least one fluid”; and “performing a measure depending on the determined concentration change rate”. Therefore, the claim is directed towards an abstract idea, and more specifically to
the abstract idea group of a math or mental process since claim 1 relates to using a mental or math process to perform the steps reciting the abstract ideas.
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claim recites ‘additional elements’ which are the steps performed before and after the recited abstract ideas. However, the steps before the abstract ideas are performed in order to gather data necessary to perform the determination step. Thus, these steps do not add a meaningful limitation since these steps are insignificant pre-solution activity.
Once the determination is done, the step of “performing a measure depending on the determined concentration change rate.” is carried out. This appears to be merely “applying” the abstract idea. MPEP 2106.05 (f).
Accordingly, these steps are ‘additional elements’ which do not integrate the abstract ideas into a practical application because they do not impose meaningful limits on practicing the abstract ideas (Step 2A, Prong Two: NO).
Step 2B:
Furthermore, the courts have found that limitations adding insignificant extrasolution activity to the judicial exception, such as mere data gathering in conjunction with a law of nature or abstract idea, are limitations found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception (see the 2014 Interim Guidance on Patent Subject Matter Eligibility of the Federal Register dated December 16, 2014; and MPEP 2106.05(I)(A)). Note that mere data gathering is not significantly more than the abstract idea. See MPEP 2106.05(g).
Here, there are no additional elements which are significantly more than the abstract idea.
The steps of the steps of “processing the at least one tissue using at least one fluid” appear to be well-understood, routine, and conventional (WURC) in the field of Clinical Diagnostics as evidenced by Bauer et al. (US20190293525A1).
Thus, the claims do not amount to significantly more (Step 2B: NO).
Therefore, Claim 1 is ineligible.
Moreover, Claims 2-10 are rejected by virtue of dependency on Claim 1. Also, each of the dependent claims do not solve the issues of claim 1.
Claims 4-5, 7 and 9: Ineligible.
Step 2A, Prong One: Claim 4 recites “…a progressing to a respective following method step if the concentration change rate falls below a predeterminable threshold value.” (math or mental step);
Claim 5 recites “determining at least one absolute concentration in the at least one fluid… when the determined absolute concentration reaches a predeterminable threshold value” (math or mental step).
Claim 7 recites “recites “determine the concentration and/or concentration change rate…”; and
Claim 9 recites ““determining at least one absolute concentration in the fixing fluid…when the respective determined absolute concentration thereof reaches a predeterminable threshold value.”
Step 2A, Prong Two: The additional elements in Claims 4-5, 7 and 9 are recited at a high level of generality that it amounts to mere data gathering (insignificant extra-solution activity). See MPEP 2106.05(g).
Step 2B: The claims do not recite any elements which are significantly more.
Therefore, Claims 4-5, 7 and 9 are ineligible.
Claims 2-3, 6, 8 and 10: Ineligible.
Step 2A, Prong One and Prong Two: Claims 2-3, 6, 8 and 10 further define the data gathering steps which appear to be generic and WURC.
Step 2B: The claims do not recite any elements which are significantly more.
Therefore, Claims 2-3, 6, 8 and 10 are ineligible.
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 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.
Claims 1-3, 6-7 and 10 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Bauer et al. (US20190293525A1).
Regarding Claim 1, Bauer teaches a method for tissue processing of at least one biological tissue, comprising
processing the at least one tissue using at least one fluid (‘reagent’; or referred to as formaldehyde [Abstract]) (See Abstract…a tissue sample as the sample is immersed in the reagent and the reagent diffuses into the tissue sample),
determining a concentration change rate in the at least one fluid (See Para 0008…determining the concentration of a reagent (such as formaldehyde) at a particular spatial point(s) at particular time(s) within a biological sample,…; See Para 0009… the concentration at a particular point or points within the sample at a particular time can be calculated, thereby teaching “a concentration change rate”), and
performing a measure (referred to as the hot step of the fixation protocol [Abstract]) depending on the determined concentration change rate (See Abstract… once a formaldehyde concentration at all points within a tissue sample exceeds about 90 mM during a cold step of a cold+hot fixation protocol, the hot step of the fixation protocol can be commenced to provide reliable detection of molecular targets and preservation of tissue morphology in downstream analyses).
Regarding Claim 2, Bauer teaches that the processing (See Abstract…a tissue sample as the sample is immersed in the reagent and the reagent diffuses into the tissue sample) comprises at least partially staining the at least one tissue (See Para 0002…ensuring that a cellular sample is sufficiently fixed to provide consistently good staining of tissue and/or cellular components).
Regarding Claim 3, Bauer teaches wherein the processing of the at least one tissue comprises sequentially one or more of the following steps, in the order indicated:
fixing of the at least one tissue using at least one fixing fluid (referred 10% NBF [Para 0049]), wherein the at least one tissue is hardened (See Claim 8… contacting the tissue sample with a hot formalin solution once formaldehyde concentration at the point at the center of the tissue sample is determined to be above 90 mM for a time sufficient to form cross-links, thereby fixing the tissue sample; Examiner submits that under BRI, Yes, cross-linking causes significant tissue hardening in tissue preparation and histology).
Examiner submits that the limitations below are optional in light of the recitation “comprises sequentially one or more of the following steps” and thus not required by the Claim.
“fluid exchange using a polar non-aqueous exchange solvent, wherein water is displaced from the at least one tissue and replaced by the exchange solvent,
clarifying using a clarifying fluid comprising in particular a less polar organic solvent than the exchange solvent, wherein the exchange solvent is replaced by the clarifying fluid in the at least one tissue, and
impregnating the at least one tissue using an impregnating agent, wherein the clarifying fluid in the at least one tissue is replaced by the impregnating agent,
wherein said determining of the concentration change rate in said fixing fluid and/or said exchange solvent and/or said clarifying fluid and/or said impregnating agent is performed during the respective using, and
at least one measure is performed depending on at least one of the determined concentration change rates”.
Regarding Claim 6, Bauer teaches a tissue processor (referred to as tissue processing system [Fig.1, ref. 100; Para 0014, 0086]; or a commercial dip-and-dunk tissue processor [Para 0090]) comprising at least one sensor (referred to as acoustic sensors in the acoustic monitoring device [Para 0095]; or signal analyzer [Para 0069]) arranged to detect a concentration and/or a concentration change rate in a fluid (See Para 0069…a system of calculating a formaldehyde concentration or other reagent is provided, the system including a signal analyzer having a processor; See Claim 13…system…and calculating a spatial dependence of reagent concentration within the sample at a particular time ; See Para 0077… cause the processor to calculate a formalin concentration based at least in part on an acoustic data set generated by an acoustic monitoring system as discussed above.) used in the tissue processor (referred to as tissue processing system [Fig.1, ref. 100; Para 0014]; or a commercial dip-and-dunk tissue processor [Para 0090]), and
means (See Para 0086… a memory 110 for storing a plurality of processing modules or logical instructions that are executed by processor 105 coupled to computer 101.) configuring the tissue processor (referred to as tissue processing system [Fig.1, ref. 100; Para 0014]; or a commercial dip-and-dunk tissue processor [Para 0090]) to perform a method according to claim 1 (See Claim 1 rejection).
Regarding Claim 7, Bauer teaches wherein the sensor (referred to as acoustic sensors in the acoustic monitoring device [Para 0095]; or signal analyzer [Para 0069]) is adapted to determine the concentration and/or concentration change rate (See Para 0069…a system of calculating a formaldehyde concentration or other reagent is provided, the system including a signal analyzer having a processor; See Claim 13…system…and calculating a spatial dependence of reagent concentration within the sample at a particular time ; See Para 0077… cause the processor to calculate a formalin concentration based at least in part on an acoustic data set generated by an acoustic monitoring system as discussed above.) based on a speed of sound in the fluid and/or an acoustic impedance of the fluid and/or a temperature of the fluid and/or a chemical and/or an electrochemical and/or an electrical behavior of the fluid and/or optical properties of the fluid (See Para 00194…in summary, determination reagent concentrations with any sample material may be provided by calculating the speed of sound in a reagent at a given temperature, pressure, etc.,; See Para 0069, 0077… including calculation of a formalin concentration from a set of acoustic data).
Regarding Claim 10, Bauer teaches wherein determining the concentration change rate in the at least one fluid comprises determining the concentration change rate based on:
a sensed speed of sound in the at least one fluid;
and/or a sensed acoustic impedance of the at least one fluid;
and/or a sensed temperature of the at least one fluid;
and/or a sensed chemical, electrochemical, and/or electrical behavior of the at least one fluid;
and/or sensed optical properties of the at least one fluid (See Claim 13…A system, comprising: an acoustic monitoring device that detects acoustic waves that have traveled through a tissue sample; one or more processors communicatively coupled to the acoustic monitoring device, wherein the one or more processors are configured to evaluate a speed of the acoustic waves based on a time-of-flight...and calculating a spatial dependence of reagent concentration within the sample at a particular time from the identified diffusivity constant and the identified porosity of the sample; Also see Claim 14-16)
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 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over by Bauer et al. (US20190293525A1) in view of Bauer et al. (US20170284920A1, hereinafter Bauer’920).
Regarding Claim 4, Bauer does not teach wherein the measure comprises an ending of a respective method step during which the concentration change rate was determined and a progressing to a respective following method step if the concentration change rate falls below a predeterminable threshold value.
In the analogous art of analysis of tissue specimens. More particularly, the present subject disclosure relates to monitoring processing of tissue samples, Bauer’920 teaches “wherein the measure (See Para 0097… allowing the tissue sample to warm to a temperature in the range of 20° C. to 55° C. for a period of time sufficient to permit fixation of the tissue sample, thereby teaching “the measure”) comprises an ending of a respective method step during which the concentration change rate was determined (See Para 0097…”c) after the rate of diffusion falls below the predetermined threshold, thereby teaching “an ending of a respective method step during which the concentration change rate was determined”) and a progressing to a respective following method step (See Para 0097…‘allowing the tissue sample to warm to a temperature in the range of 20° C. to 55° C. for a period of time sufficient to permit fixation of the tissue sample.’, thereby teaching “a progressing to a respective following method step”) if the concentration change rate falls below a predeterminable threshold value (See Para 0097… (c) after the rate of diffusion falls below the predetermined threshold, allowing the tissue sample to warm to a temperature in the range of 20° C. to 55° C. for a period of time sufficient to permit fixation of the tissue sample.)”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bauer to incorporate the step of “wherein the measure comprises an ending of a respective method step during which the concentration change rate was determined and a progressing to a respective following method step if the concentration change rate falls below a predeterminable threshold value”, as taught by Bauer’920, for the benefit of fixing a tissue sample by a rate of diffusion of the fixative solution into the tissue sample (Bauer’920, Para 0097), allowing for the provision of systems and methods for dynamically tracking and quantifying the fixative diffusion. The active state of the fixative diffusion is then correlated with staining results to develop a metric to determine precisely when a sample has sufficient fixative penetration to stain well (Bauer’920, Para 0008).
Regarding Claim 8, Bauer does not teach wherein the measure comprises an ending of a respective processing step during which the concentration change rate was determined and a progressing to a respective following processing step if the concentration change rate falls below a predeterminable threshold value.
In the analogous art of analysis of tissue specimens. More particularly, the present subject disclosure relates to monitoring processing of tissue samples, Bauer’920 teaches “wherein the measure (See Para 0097… allowing the tissue sample to warm to a temperature in the range of 20° C. to 55° C. for a period of time sufficient to permit fixation of the tissue sample, thereby teaching “the measure”) comprises an ending of a respective processing step during which the concentration change rate was determined (See Para 0097…”c) after the rate of diffusion falls below the predetermined threshold, thereby teaching “an ending of a respective method step during which the concentration change rate was determined”) and a progressing to a respective following processing step (See Para 0097…‘allowing the tissue sample to warm to a temperature in the range of 20° C. to 55° C. for a period of time sufficient to permit fixation of the tissue sample.’, thereby teaching “a progressing to a respective following processing step”) if the concentration change rate falls below a predeterminable threshold value (See Para 0097… (c) after the rate of diffusion falls below the predetermined threshold, allowing the tissue sample to warm to a temperature in the range of 20° C. to 55° C. for a period of time sufficient to permit fixation of the tissue sample.)”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bauer to incorporate the step of “wherein the measure comprises an ending of a respective processing step during which the concentration change rate was determined and a progressing to a respective following processing step if the concentration change rate falls below a predeterminable threshold value”, as taught by Bauer’920, for the benefit of fixing a tissue sample by a rate of diffusion of the fixative solution into the tissue sample (Bauer’920, Para 0097), allowing for the provision of systems and methods for dynamically tracking and quantifying the fixative diffusion. The active state of the fixative diffusion is then correlated with staining results to develop a metric to determine precisely when a sample has sufficient fixative penetration to stain well (Bauer’920, Para 0008).
Claims 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over by Bauer et al. (US20190293525A1) in view of Erben et al. (US20100112625A1, submitted in IDS 09/08/2023).
Regarding Claim 5, Bauer teaches:
determining at least one absolute concentration in the at least one fluid (See Claim 8… formaldehyde concentration at the point at the center of the tissue sample is determined to be above 90 mM for a time sufficient to form cross-links, thereby fixing the tissue sample; See Para 0008…In one aspect of the present disclosure is a method is provided for determining a reagent concentration at a particular point(s) within a sample immersed within a reagent, at a given time; See Para 0059… In some embodiments, tissue preparation systems and methods disclosed herein may be adapted to monitor the diffusion of fixative fluid into a tissue sample until a pre-determined concentration level is reached, thereby teaching “absolute concentration”).
Bauer does not teach “initiating a replacement of the respective at least one fluid when the determined absolute concentration reaches a predeterminable threshold value”.
In the analogous art of a method and an apparatus for processing tissue samples, which easily contribute to a high quality of the finished tissue samples, Erben teaches “initiating a replacement of the respective at least one fluid (See Abstract…‘replace the alcohol or xylene’) when the determined absolute concentration (‘purity level’) reaches a predeterminable threshold value” (See Para 0009…wherein the first sensor and the valve are configured to depending on the measured value of the parameter that represents the purity level.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bauer to incorporate the step of ““initiating a replacement of the respective at least one fluid when the determined absolute concentration reaches a predeterminable threshold value”, as taught by Erben, for the benefit of recognizing when the process medium either has to be replaced for performing a predetermined process step or has to be used for another process step and thus has to be re-classified (Erben, Para 0012), allowing for provision of a method and an apparatus for processing tissue samples, which easily contribute to a high quality of the finished tissue samples (Erben, Para 0008).
Regarding Claim 9, Bauer teaches
determining at least one absolute concentration in the fixing fluid and/or the exchange solvent and/or the clarifying fluid and/or the impregnating agent(See Claim 8… formaldehyde concentration at the point at the center of the tissue sample is determined to be above 90 mM for a time sufficient to form cross-links, thereby fixing the tissue sample; See Para 0008…In one aspect of the present disclosure is a method is provided for determining a reagent concentration at a particular point(s) within a sample immersed within a reagent, at a given time; See Para 0059… In some embodiments, tissue preparation systems and methods disclosed herein may be adapted to monitor the diffusion of fixative fluid into a tissue sample until a pre-determined concentration level is reached, thereby teaching “absolute concentration”).
Bauer does not teach “initiating a replacement of the fixing fluid and/or the exchange solvent and/or the clarifying fluid and/or the impregnating agent when the respective determined absolute concentration thereof reaches a predeterminable threshold value”
In the analogous art of a method and an apparatus for processing tissue samples, which easily contribute to a high quality of the finished tissue samples, Erben teaches “initiating a replacement of the fixing fluid and/or the exchange solvent and/or the clarifying fluid and/or the impregnating agent (See Abstract… ‘replace the alcohol or xylene’) when the respective determined absolute concentration (‘purity level’) thereof reaches a predeterminable threshold value (See Para 0009…wherein the first sensor and the valve are configured to depending on the measured value of the parameter that represents the purity level.).”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bauer to incorporate the step of “initiating a replacement of the fixing fluid and/or the exchange solvent and/or the clarifying fluid and/or the impregnating agent when the respective determined absolute concentration thereof reaches a predeterminable threshold value”, as taught by Erben, for the benefit of recognizing when the process medium either has to be replaced for performing a predetermined process step or has to be used for another process step and thus has to be re-classified (Erben, Para 0012), allowing for provision of a method and an apparatus for processing tissue samples, which easily contribute to a high quality of the finished tissue samples (Erben, Para 0008).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (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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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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