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 .
Claim Status
Claims 22-40 are new, pending, and under examination.
Claims 1-21 are canceled.
No claims are allowed or withdrawn.
Claims 22-40 are rejected.
Claims 22-40 are objected to.
Claims 22 and 40 are independent.
Office Action Outline
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
x
112 Other
IDS
Information Disclosure Statement
x, x
102, 103
JE
Judicial Exception
x
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
x
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed in the 09/22/2022 filing receipt, this application claims priority to Japanese Application JP 2021-133166, filed 08/18/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. See paper entered 10/17/2022.
Drawings
The drawings are objected to because of the following issues:
The drawings do not include numbering of sheets. The sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1. These numbers, if present, must be placed in the middle of the top of the sheet, but not in the margin. The numbers can be placed on the right-hand side if the drawing extends too close to the middle of the top edge of the usable surface. The drawing sheet numbering must be clear and larger than the numbers used as reference characters to avoid confusion. The number of each sheet should be shown by two Arabic numerals placed on either side of an oblique line, with the first being the sheet number and the second being the total number of sheets of drawings, with no other marking. See MPEP 608.02(V) and 37 C.F.R. 1.84(t) for sheet numbering; MPEP 608.02(V) and 37 C.F.R. 1.84(g) for margins.
Regarding FIG. 5A (a), (b), and (c), the use of lower case letters in the numbering of views is objected to. Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." It is suggested to amend to designate the view as FIG.5A on the right side of the figure, while deleting the instances of FIG.5A in the instant drawings. See MPEP 608.02(V) and 37 C.F.R. 1.84(u).
Regarding FIG. 5B (a), (b), and (c), the use of lower case letters in the numbering of views is objected to. Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." It is suggested to amend to designate the view as FIG.5B on the right side of the figure, while deleting the instances of FIG.5B in the instant drawings. See MPEP 608.02(V) and 37 C.F.R. 1.84(u).
Regarding FIG. 6A, FIG. 6B, and FIG. 6C, it is difficult to distinguish which figure is 6A, 6B, or 6C because the figures are so close together. All views of the drawing must be clearly separated from one another. See MPEP 608.02(V) and 37 C.F.R. 1.84(h).
Regarding FIG. 7A, FIG. 7B, FIG. 7C, and FIG.7D, it is difficult to distinguish which figure is 7A, 7B, 7C, or 7D, because the figures are so close together. All views of the drawing must be clearly separated from one another. See MPEP 608.02(V) and 37 C.F.R. 1.84(h).
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.
Objection to the presentation of the claims
The format of the amendment to the claims is objected to. The font annotating changes is not amenable to character recognition (i.e. does not scan -- this effect may be seen by downloading from Patent Center the amendment as actually entered into the record). The font for the changed recitations should be the same as the font for unchanged recitations, except that underlining, strikethrough, etc. should be used per MPEP 714.II.C. Possibly color or grayscale font was used to designate changes, which font does not render solid letters, and those letters do not scan. "Legibility includes ability to be... scanned so that... paper can be electronically reproduced by use of digital imaging and optical character recognition" (MPEP 608.01.I."Paper Requirements," 2nd to last para.). If this issue recurs, the filing may be considered non-responsive. Presently, all claims, 22-40, are objected to for the preceding reason.
Objections to particular claims
Claims 22, 36, and 40 are objected to because of the following informalities:
Claim 36 recites "a translocation of a gene caused by multiple myeloma or malignant lymphoma" which should be corrected to, e.g., "a translocation of a gene which causes multiple myeloma or malignant lymphoma."
Appropriate correction is required.
Claim Interpretation – 112(f)
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”) (or an equivalent, nonce term) 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”) (or an equivalent, nonce term) 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 use the word “means” or “step” (or an equivalent, nonce term) but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are as follows:
Instant claim limitations interpreted as NOT invoking 112(f)
An "image capturer configured to capture...images" recited in claim 22 and 23 recites means (or an equivalent, nonce term, here a "capturer") and function and/or result (here "capture images"), but the recitation does not invoke 112/f because the claim is interpreted as reciting sufficient structure not to invoke. MPEP 2181.I.C pertains.
A "controller programmed to" recited in claim 22, 26-27, 30, 32, and 38-39 recites means (or an equivalent, nonce term, here a "controller") and function and/or result (here "select, extract, identify, generate" in claim 22; "extract" in claim 26; "acquire" in claims 27, 30, 32; "generate" in claim 38; and "calculate" in claim 39), but the recitation does not invoke 112/f because the claims are interpreted as reciting sufficient structure not to invoke. MPEP 2181.I.C pertains.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate.
Claim 22 is to a 101 machine or manufacture, i.e. an "analyzer" and/or a "controller" in this instance, limited according to its claimed physical structure, but it is not clear what is the structure associated with the recited "select a plurality of test cell..." and similar steps. The recited "analyzer" and/or the recited "controller" are not interpreted as requiring structure clearly linking the "analyzer" and /or the "controller" to the recited steps in a structural sense appropriate to a claim to a machine or manufacture. This rejection might be overcome by, for example, reciting a data storage device, comprised by the recited "analyzer" and/or the recited "controller," and instructions stored therein and configured according to the recited elements and steps, as supported at Specification paragraphs [0029, 0030]. Relatedly, MPEP 2173.05(p).II pertains regarding a claim directed to both product and process.
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 22-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 details the following framework to analyze Subject Matter Eligibility:
• Step 1: Are the claims directed to a category of statutory subject matter (a process, machine, manufacture, or composition of matter)? (see MPEP § 2106.03)
• Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. an abstract idea, a law of nature, or a natural phenomenon? (see MPEP § 2106.04(a)). Note, the MPEP at 2106.04(a)(2) & 2106.04(b) further explains that abstract ideas and laws of nature are defined as:
• mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
• certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people);
• mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information);
• laws of nature and natural phenomena are naturally occurring principles and/or relations that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
• Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application? (see MPEP § 2106.04(d))
• Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept? (see MPEP § 2106.05)
Step 1:
Claims 22-39 are directed to a 101 machine or manufacture, here a sample analyzer. Claim 40 is directed to a 101 process, here a method. As such, claims 22-40 are directed to a related analyzer and method, which fall under categories of statutory subject matter. (See MPEP § 2106.03). (Step 1: Yes.)
Step 2A, Prong One:
The claims are found to recite abstract ideas in the form of mental processes and mathematical concepts as follows:
Independent claim 22 recites an analyzer for performing the mental processes of:
• select test cells based on images
• extract bright spots based on the images
• identify cells with and/or without chromosomal abnormalities based on the spots
• generate information of a ratio of based on the identified cells
Independent claim 40 recites a method for performing mental processes similar to those recited in claim 22.
The dependent claims recite mental processes as follows:
• extract bright spots from test cells and not from other cells (claim 26)
• select test cells based on selection information (claim 27)
• calculate the ratio of cells (claim 39) (also considered a mathematical process)
• dividing a number of cells with chromosomal abnormality by a sum of a number of cells with and without chromosomal abnormality (claim 39) (also considered a mathematical process)
Additionally, claims which further limit the abstract ideas of base claims include:
• claims 35-37 further limit the identified chromosomal abnormality of claim 22.
• claim 38 further limits the generating information of a ratio of claim 22.
Step 2A Prong One Summary: The claims recite mental processes and mathematical concepts. When considering the broadest reasonable interpretation (BRI) of the claims, the mental processes recited in independent claims 22 and 40 (e.g., "select a plurality of test cells"; "extract bright spots"; "identify cells", etc.) are directed to processes that may be performed mentally, as there are no particular limitations recited in claim 22 and 40 which would prevent the mental processes from being performed in the human mind or with pen and paper. Additionally, independent claim 39 recites mathematical processes in "to calculate" and "dividing a number." Such analysis performed mentally, or with paper and pencil, may take considerable time and effort, and although a general-purpose computer can perform these calculations at a rate and accuracy that can far exceed the mental performance of a skilled artisan, the nature of the activity is essentially the same, and therefore constitutes an abstract idea. Therefore, the claims recite elements that constitute a judicial exception in the form of an abstract idea(s). (Step 2A, Prong One: Yes.)
Step 2A, Prong Two:
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs). Here at Step 2A, Prong Two, any remaining steps and/or elements not identified as JEs are therefore in addition to the identified JE(s), and are considered additional elements. Because the claims have been interpreted as being directed to judicial exceptions (abstract ideas in this instance) then Step 2A, Prong Two provides that the claims be examined further to determine whether the judicial exception is integrated into a practical application [see MPEP § 2106.04(d)]. A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
MPEP § 2106.04(d)(I) lists the following five example considerations for evaluating whether a judicial exception is integrated into a practical application:
(1) An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a).
(2) Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2).
(3) 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).
(4) Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c).
(5) 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).
The claims recite additional elements as follows:
Additional elements of data gathering, inputting, and outputting steps:
• Claim 22 recites an additional element of: "capture images." Claims 33 and 34 do not further recite additional elements, but further limit the images of claim 22.
• Claim 27 recites an additional element of "acquire selection information;" claims 28-32 do not further recite additional elements, but further limit the selection information (ultimately) of claim 27.
• Claim 40 includes additional elements of labeling chromosomes and nuclei using fluorescent dyes; and capturing images.
Data gathering steps are additional elements which perform functions of inputting, collecting, and outputting the data needed to carry out the abstract idea. These steps are considered insignificant extra-solution activity, and are not sufficient to integrate an abstract idea into a practical application as they do not impose any meaningful limitation on the abstract idea or how it is performed, nor do they provide an improvement to technology (see MPEP § 2106.04(d)(I)).
Additional elements of sample analyzers components: Claims 22-39 recites a sample analyzer, an image capturer, and/or a controller. Claim 23 recites a flow cell. Claim 24 recites a first and a second light source. Claim 25 recites a camera. The claims require only generic sample analyzers components, which do not improve sample analysis technology or computer technology, and do not integrate the recited judicial exception into a practical application (see MPEP § 2106.04(d)(1) and MPEP § 2106.05(f)).
Step 2A Prong Two summary: The claims have been further analyzed with respect to Step 2A, Prong Two, and no additional elements have been found, alone or in combination, that would integrate the judicial exception into a practical application. At this point in examination, it is not yet the case that any of the Step 2A Prong Two considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of: (1) an improvement, (2) a treatment, (3) a particular machine, or (4) a transformation is clear in the record. For example, regarding the first consideration for improvement at MPEP 2106.04(d)(1), the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field, and the claims do not yet clearly result in such an improvement. (Step 2A, Prong Two: No).
Step 2B:
Because the additional claim elements do not integrate the abstract idea into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept. An inventive concept is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself (see MPEP § 2106.05).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are well-understood, routine, and conventional. Those additional elements are as follows:
Additional elements of data gathering, inputting, and outputting steps: The additional elements of capture(ing) images, acquire(ing) selection information, and labeling chromosomes (in claims 22, 27, 40) do not cause the claims to rise to the level of significantly more than the judicial exception. The courts have recognized receiving or transmitting data over a network; storing and retrieving information in memory; determining the level of a biomarker in blood by any means; detecting DNA or enzymes in a sample; analyzing DNA to provide sequence information or detect allelic variants; and amplifying and sequencing nucleic acid sequences, [see MPEP§2106.05(d)(II)], as well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as extra-solution activity.
Additionally, the capturing of images and labeling chromosomes is shown to be well understood, routine, and conventional by the following reference:
Stanley (Cytometry Part B: Clinical Cytometry, vol. 100(5), pp.541-553 (25 May 2021); cited on the attached form PTO-892) presents a review on analyzing human chromosomes using imaging flow cytometry, and discusses labeling and imaging chromosomes (p.549, text and fig2. 7 and 8; and throughout entire document).
Additional elements of sample analyzer components: The additional elements of a sample analyzer, image capturer, controller, flow cell, light sources, and camera. of claims 22-39 do not cause the claims to rise to the level of significantly more than the judicial exception, and as such do not provide an inventive concept; these are conventional sample analyzer components.
Additionally, the sample analyzer, image capturer, controller, flow cell, light sources, and camera are shown to be well understood, routine, and conventional by the following references:
Stanley shows flow cell and light sources (fig.1, p.542); cameras (p.544, cols. 1-2); lasers (p.543, col.2).
Petty (Microscopy research and technique, vol. 70(8), pp.687-709 (2007); cited on the attached form PTO-892) presents a review on fluorescence microscopy and shows a sample analyzer (p.692, fig.2; and throughout document); and controller, light sources, and cameras (p.694, table 2; and throughout document).
Further regarding the conventionality of additional elements, the MPEP at 2106.05(b) and 2106.05(d) presents several points relevant to conventional computers and data gathering steps in regard to Step 2A Prong 2 and Step 2B, including:
• Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more (see 2106.05(b)(II). In the instant claims, the recited controller in claim 22 is used in selecting test cells from images, extracting bright spots, identifying cells from images, etc.; as such, the controller acts only as a tool to perform the steps of data analysis, and does not integrate the judicial exception into a practical application or provide significantly more.
• Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more (see 2106.05(b)(III). The image capturer and controller of claim 22 used in gathering data and performing data analysis do not impose meaningful limitations on the claims.
• The courts have recognized “receiving or transmitting data over a network”, “performing repetitive calculations”, and “storing and retrieving information in memory”, as well-understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (see MPEP 2106.05(d)(II)). The data gathering of capturing images and acquiring selection information in the claims is recited in a generic manner.
All limitations of claims 22-40 have been analyzed with respect to Step 2B, and none provides a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception, and thus do not transform the judicial exception into a patent eligible application of the exceptions. Step2B: NO.
Therefore, the claims, when the limitations are considered individually and as a whole, are rejected under 35 U.S.C. § 101 as being directed to non patent-eligible subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 22-34 and 38-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stanley (Cytometry Part B: Clinical Cytometry, vol. 100(5), pp.541-553 (25 May 2021); cited on the attached form PTO-892).
Stanley teaches application for chromosome analysis using imaging flow cytometry, including Flow-FISH (Fluorescent in situ hybridization by flow cytometry).
Regarding the claim 22 element of an image capturer configured to capture: first images of at least parts of cells with target sites on chromosomes labeled and nuclei respectively labeled with a first and second fluorescent dye; second images of the fluorescence generated from the first dye labeling target sites; and third images of the fluorescence generated from the second dye labeling nuclei, Stanley teaches at least three images and at least two fluorescent probes for labeling chromosomes and nuclei in the analysis of chromosome 17 (p.549, fig.7).
Regarding the claim 22 and 40 elements for selecting test cells having specific morphological characteristics based on first and third images, and the claim 26 elements for extracting bright spots from test cells and not extracting bright spots from other than test cells, Stanley shows: “masks”, or specified regions within the cell of interest, can be selected and digitally “isolated.” For chromosomal analysis, masks have been used to target the cell nucleus or FISH probe signals. restricted to this selected cellular region. Once a mask is determined, parameters within that area of interest can be assessed. For example, the localization, enumeration, size, shape, and fluorescence intensity of an object such as a chromosomal signal can be interrogated (p.544, bridging cols.1-2). Stanley teaches selecting cells using area and aspect ratio (p.545, fig.3(a)). Stanley teaches selected cells with brightfield, fluorescent, and overlay imaging (p.549, fig.7).
Regarding the claim 22 and 40 element for extracting bright spots, identifying cells with chromosomal abnormalities, and generating information related to a ratio of cells with and without the chromosomal abnormality, the controller of claims 22, 26-27, 30, and 31, the claim 38 element of not including tests cells for which bright spots could not be determined, and the claim 39 element of calculating the ratio of cells with chromosomal abnormality by dividing the number of test cells with abnormality over the number of selected test cells, Stanley shows to evaluate the chromosomes, single and nondividing cells (based on nuclear marker intensity) were gated in focus, and used the “Spot Count” feature to count the number of probe "spots" per cell using the FISH probe fluorescence mask (p.546, col.1). Stanley teaches selected cells with brightfield, fluorescent, and overlay imaging in identifying cells with additional copies of chromosome 12 (p.548, fig.6 (c)) and in identifying cells with deletion in chromosome 17p (p.549, fig.7 (b and c)). Stanley teaches the ratio of spot counts comparing the chronic lymphocytic leukemia (CLL) with normal lymphocytes (p.547, cos.1-2; and p.548, fig.6(b)). Stanley teaches the controller programmed elements for selecting, extracting, identifying, and generating information in software tools for analysis of the digital images (p.544, col.1)
Regarding the claim 23 elements of a flow cell and image capturer, and the claim 25 element of a camera, Stanley teaches a flow cell (p.542, fig.1) and cameras used in imaging flow cytometry (p.544, throughout cols.1-2).
Regarding the claim 24 elements for first and second light sources to excite the fluorescent dyes, Stanley teaches instrument configuration in imaging flow cytometry varies in the number of lasers, which can be up to 6 (p.543, col.2).
Regarding the claim 27 elements of selection information is based on the first and third images, and selecting test cells based on the selection information; the claim 28 element of a first, second, or third value relates to cell size, uneven distribution of cell nucleus, or nucleus size; the claim 29 element of the selection information includes the first and second value; the claim 30 element of acquiring the first value from the first image and the second value from the first and third images; the claim 31 element of the selection information includes the first and third values; claim 32 element of acquiring the first value from the first image and the third value from the first and third images, Stanley teaches: “masks”, or specified regions within the cell of interest, can be selected and digitally “isolated.” For chromosomal analysis, masks have been used to target the cell nucleus or FISH probe signals. restricted to this selected cellular region. Once a mask is determined, parameters within that area of interest can be assessed. For example, the localization, enumeration, size, shape, and fluorescence intensity of an object such as a chromosomal signal can be interrogated (p.544, bridging cols.1-2). Stanley teaches selecting cells using area and aspect ratio (p.545, fig.3(a)). Stanley teaches selected cells with brightfield, fluorescent, and overlay imaging (p.549, fig.7).
Regarding the claim 33 element of the first images are bright-field images; and the claim 34 element of a first image contains a cytoplasm and nucleus, Stanley teaches selected cells with brightfield, fluorescent, and overlay imaging in identifying cells with additional copies of chromosome 12 (p.548, fig.6 (c)) and in identifying cells with deletion in chromosome 17p (p.549, fig.7 (b and c)).
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.
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 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Stanley as applied to claims 22-34 and 38-40 above, and further in view of Ma (Molecular cytogenetics, vol. 9(1):63, pp.1-8 (2016); cited on the 02/21/2023 IDS).
While Stanley mentions translocations (p.541-542), one focus of Stanley is analyzing trisomy 12 in CLL as well as 17p deletions in myeloma (respectively p. 548-549, figs. 6 and 7). As such, Stanley does not teach the translocation limitations of claims 35-37.
Regarding the claim 35 element of a translocation; the claim 36 element of translocation of a gene in multiple myeloma or malignant lymphoma; the claim 37 element of an IGH/FGFR3, IGH/CCNDI, IGH/MAF, IGH/BCL2, or IGH/MYC fusion gene, Ma shows a study using Target FISH on 40 plasma cell myeloma patients; and analyzed signals for at least t(11;14) IGH/CCND1, t(4;14) IGH/FGFR; and 3t(14;16) IGH/MAF, (p.2, cols.1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chromosomal analysis method of Stanley to include the analysis translocations and fusions in multiple myeloma of Ma, because Ma states detection of cytogenetic abnormalities in PCM is clinically important as a prognostic marker to risk stratify patients. One of ordinary skill in the art would have understood how to and been motivated to modify Stanley to analyze the translocations and fusion genes of Ma to result in a chromosomal analysis method that includes analysis of translocation and fusion genes in multiple myeloma, and as such, the modification would have been obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 22-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over one or more claims of: reference U.S. Patent No. 10,401,289 (from application 15/608,380); reference U.S. Patent No. 10,852,238 (from application 16/514,789); reference U.S. Patent No. 11,060,134 (from application 15/363,503); reference U.S. Patent No. 11,085,880 (from application 15/951,562); reference U.S. Patent No. 11,340,170 (from application 17/061,255); reference U.S. Patent No. 11,946,866 (from application 17/345,645); and reference U.S. Patent No. 12,026,880 (from application 17/560,924); in view of Stanley (Cytometry Part B: Clinical Cytometry, vol. 100(5), pp.541-553 (25 May 2021); cited on the attached form PTO-892) and Ma (Molecular cytogenetics, vol. 9(1):63, pp.1-8 (2016); cited on the 02/21/2023 IDS).
Each reference application recites analyzer and method claims for analyzing bright spots in cell samples to determine abnormality or positivity using fluorescent dye(s). The reference claims do not show a controller for selecting, extracting, identifying, and generating information of abnormal chromosomes labeled with fluorescent dyes, nor the fusion gene generated by a translocation of IGH/FGFR3, IGH/CCNDI, IGH/MAF, IGH/BCL2, or IGH/MYC fusion gene.
Regarding the controller, Stanley teaches the controller programmed elements for selecting, extracting, identifying, and generating information of abnormal chromosomes labeled with fluorescent dyes in software tools for analysis of the digital images (p.544, col.1)..
Regarding the fusion gene generated by a translocation of IGH/FGFR3, IGH/CCNDI, IGH/MAF, IGH/BCL2, or IGH/MYC fusion gene, Ma shows a study using Target FISH on 40 plasma cell myeloma patients; and analyzed signals for at least t(11;14) IGH/CCND1, t(4;14) IGH/FGFR; and 3t(14;16) IGH/MAF, (p.2, cols.1-2).
It would have been obvious to one of ordinary skill in the art to modify the method of one or more reference claims of Patent Nos. 10,401,289; 10,852,238; 11,060,134; 11,085,880; 11,340,170; 11,946,866 and 12,026,880 to include the controller programmed software tools for analysis of the digital images of chromosomes of Stanley with the analysis of fluorescent dye signals in samples from plasma cell myeloma patients to determine t(11;14) IGH/CCND1, t(4;14) IGH/FGFR; and 3t(14;16) IGH/MAF fusions of Ma. This is because Stanley teaches software tools can be used to facilitate analysis of the digital images, making chromosomal analysis by imaging flow cytometry possible, while Ma teaches the detection of cytogenetic abnormalities in plasma cell myeloma is clinically important.
Conclusion
No claims are allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
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/M.A.V./Examiner, Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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