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 1-22 are pending and under examination.
Claims 1-22 are rejected.
Claims 1 and 20-22 are independent.
No claims are allowed, amended, canceled, new, objected to, or withdrawn.
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
x
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x, x
102, 103
JE
Judicial Exception
(see note below)
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 12/20/2024 filing receipt, this application is a 371 of PCT/JP2021/031725, filed 08/30/2021, which claims priority to U.S. Provisional No. 63/090,676, filed 10/12/2020.
Claim Interpretation
Claims 1-22 recite a "biological particle sorting device" which is interpreted as a cell sorter or microparticle sorter, as discussed in Specification [0002-0003].
Claims 20-22 recite an "information processing device" which is interpreted as a physical device which might include a CPU, a RAM, and a ROM, as discussed in Specification [0033].
The terms "designed to" in claims 5, 20, and 21 and "designed such that" in claim 14 are respectively interpreted as "configured to" and "configured such that."
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”) 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 use the word “means” or “step” 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 limitations are as follows:
Instant claim limitations interpreted as NOT invoking 112(f):
A "first display mode for receiving," recited in claim 1, recites means (or an equivalent, nonce term, here a "mode") and function and/or result (here "receiving"), but the recitation does not invoke 112(f) because "receiving" would be understood as a basic, simple operation by a PHOSITA.
A "second display mode in which ....a....screen is displayed" recited in claim 1, recites means (or an equivalent, nonce term, here a "mode") and function and/or result (here "a screen is displayed"), but the recitation does not invoke 112(f) because "a screen is displayed" would be understood as a basic, simple operation by a PHOSITA.
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(b)
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 1-22 are 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 1 is rejected as directly reciting a machine and a process in the same claim. A claim to a machine, e.g. here a "biological particle sorting device," cannot directly recite a process step such as "that operates." MPEP 2173.05(p).II pertains. Possibly such a step may be claimed indirectly via the structure of stored computer instructions and reciting "configured to" before the process step. MPEP 2173.05(p).II, pertains regarding a claim directed to both product and process.
Similar to above, the following claims are rejected for limitations which recite a machine (e.g., the "biological particle sorting device") and a process in the same claim:
• a first display mode for receiving (claim 1)
• a second display mode in which a...operation screen is displayed (claim 1)
• a processing condition setting screen...is displayed (claim 2)
• operation control data is received (claim 2)
• operates the biological particle sorting device (claim 3)
• performing one or more of moving a position of a gate (claim 5)
• the biological particle sorting device controls display (claim 6)
• a display device that displays (claim 19)
• biological particle sorting device that executes (claim 20)
• information processing device that operates the sorting device (claim 20)
• device that operates (twice in claim 22)
In step (a) of claim 3, it is not clear what the term "adopted" means in "data adopted in sorting processing." For examination purposes, the term "adopted" will be interpreted as "used."
Similarly, in claim 20, it is not clear what the term "adopted" means in "data adopted by the biological particle sorting device." For examination purposes, the term "adopted" will be interpreted as "used."
In step (b) of claim 3, it is not clear what the relationship is between the recited terms "related to display" and "display control data."
In claim 7, the recited term "can adjust" includes unclear optionality or conditionality. MPEP 2111.04 and 2173.05(h).II pertain.
Similarly, in claim 14, the recited term "can be included" includes unclear optionality or conditionality. MPEP 2111.04 and 2173.05(h).II pertain.
Claim 21 recites "the biological particle sorting device" which requires but lacks clear antecedent. If this recitation refers to a previously instantiated instance, then it is not clear which instance that is. If this recitation instantiates this claim element, this is not clear. This rejection might be overcome by for example amending to recite "a biological particle sorting device.
In the step beginning with "that is designed" of claim 21, there is recitation of "and display...," then a further recitation of "and cause..." The recitation of "and cause..." is unclear if it is meant to bridge to a next step, or if "and cause..." is a further step of "that is designed to..." There is further lack of clarity when considering the two instances of "and." It may help by possibly amending by deleting the indentation of "cause..." as well as deleting the first "and," such that the step beginning with "that is designed" recites "that is designed to receive operation control data related to biological particle sorting processing, [[and]] display a processing execution operation screen generated on a basis of the operation control data, and cause..."
In step beginning with "the operation control data includes," claim 21 recites "sorted in the processing". This instance of "the processing" in the phrase "sorted in the processing" requires but lacks clear antecedent. If this recitation refers to a previously instantiated instance, then it is not clear which instance this is. If this recitation instantiates the claim element, this is not clear. This rejection might be overcome by for example amending to recite "sorted in the biological particle sorting processing."
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed 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.
Claims 1-22 recite the following limitations, listed below with their corresponding specification paragraphs which disclose the limitations. However, the specification paragraphs do not provide adequate detail to describe the limitations, and therefore, the written description provided is not clearly commensurate with the recited limitations.
• biological particle sorting device that operates (claim 1), at [0008], [0238]
• a first display mode for receiving (claim 1), at [0008], [0238]
• a second display mode in which ... is displayed (claim 1), at [0008], [0238]
• a processing condition setting screen...is displayed (claim 2), at [0238]
• operation control data is received (claim 2) , at [0238]
• operates the biological particle sorting device (claim 3), at [0017], [0238]
• performing one or more of moving a position of a gate (claim 5), at [0238]
• the biological particle sorting device controls display (claim 6), at [0238]
• a display device that displays (claim 19) , at [0238]
• information processing device ...to receive...and transmit (claim 20), at [0008], [0238]
• biological particle sorting device that executes (claim 20), at [0008], [0225], [0238]
• information processing device that operates (claim 20), at [0008], [0238]
• information processing device ...to receive...and display (claim 21), at [0008], [0238]
• device that operates (twice in claim 22), at [0008], [0238]
As appropriate, these rejections may be overcome, for example, (i) by narrowing to clearly supported embodiments and/or (ii) by clarifying on the record where support can be found and how that support relates to the recitations.
Note about Patent-Eligible Subject Matter under 35 USC § 101
Claims 1-22 recite patent-eligible subject matter under 35 U.S.C. 101.
Regarding Step 1 of the 101 analysis:
Claims 1-19 are directed to a 101 machine or manufacture, here a biological particle sorting device. The "biological particle sorting device" is interpreted as a cell sorter or microparticle sorter, as discussed in Specification [0002-0003].
Claim 20 is directed to a 101 machine or manufacture, here an information processing device. The "information processing device" is interpreted to as requiring physical computer hardware, as discussed in Specification [0033].
Claim 21 is directed to a 101 machine or manufacture, here an information processing device. The "information processing device" is interpreted to as requiring physical computer hardware, as discussed in Specification [0033].
Claim 22 is directed to a 101 machine or manufacture, here a biological particle sorting system. The "biological particle sorting system" is interpreted as a cell sorter or microparticle sorter, as discussed in Specification [0002-0003].
As such, claims 1-22 are directed to a device and system, which fall under categories of statutory subject matter. (See MPEP § 2106.03). (Step 1: Yes.)
At Step 2A Prong One of the 101 analysis, no judicial exceptions (JEs) are recited in claims 1-22. (See MPEP § 2106.04(a).) (Step 2A, Prong One: No.) As such, the claims are not directed to a JE; the claims recite patent-eligible subject matter under 35 U.S.C. 101.
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 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moschell (US 2017/0176480 A1, published 06/22/2017; cited on the 03/30/2023 IDS).
Regarding claim 20, the recited "information processing device... designed to..." is taught by the "processing device" (Moschell, [0006]). The claim recites intended use of the claimed "information processing device," interpreted as a 101 machine or manufacture, without recitation of structural elements clearly limiting the claimed "device." A claim to a 101 machine or manufacture is interpreted strictly according to its claimed structure. Moschell's processing device comprises all of the structure actually and clearly required by the instant claim.
Regarding claim 21, the recited "information processing device... designed to..." is taught by the "processing device" (Moschell, [0006]). The claim recites intended use of the claimed "information processing device," interpreted as a 101 machine or manufacture, without recitation of structural elements clearly limiting the claimed "device." A claim to a 101 machine or manufacture is interpreted strictly according to its claimed structure. Moschell's processing device comprises all of the structure actually and clearly required by the instant claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Moschell (US 2017/0176480 A1, published 06/22/2017; cited on the 03/30/2023 IDS), in view of Alcorn (US 2019/0369001A1, published 12/05/2019; cited on the 10/28/2025 IDS), in view of Tatsutani (US 2020/0103333 A1, published 04/02/2020; cited on the 03/30/2023 IDS).
Regarding claim 1, the recited biological particle sorting device reads on "the instrument 102 is a flow cytometer" (Moschell, [0026]).
Regarding claim 1, the recited a first display mode for receiving operation control data reads on "the interface controls generator 264 operates to generate and display in the user interface 114 controls that are selectable by the operator to adjust the operation of the instrument 102 (Moschell, [0067]); and "the modes 280 include a setup mode 282" (Moschell, [0071]).
Regarding claim 1, the recited second display mode for displaying an execution screen reads on "acquisition data...is then fed to the acquisition data display engine 262 where the data is plotted or otherwise displayed to the operator" (Moschell, [0070], and figure 7) ; and "the modes 280 include ...a run mode 284" (Moschell, [0071]).
Regarding claim 2, the recited processing condition screen and related control data read on (Moschell, [0074], emphasis added):
"...the... interface... provides instructions... to cause the instrument... to... analyze the samples according to the operator's instructions..."
Regarding claim 3, the recited operation control data includes processing condition data, display control data, or operator oriented instructions, reads on "the instrument...also displays the current status of the instrument." (Moschell, [0074]).
Regarding claim 4, the recited processing condition data includes gate information reads on "gates or other tools are provided to allow further customization of the displays... Examples of gates...include: linear, quadrant, hinged,...." (Moschell, [0082]).
Regarding claim 5, the recited gate information is designed to be adjusted, and the adjusting includes performing moving, enlarging or reducing, and/or changing inclination of a gate reads on (Moschell, [0082]):
"gates...are provided to allow further customization of the displays...Examples of gates and tools include: linear, quadrant, hinged, polygon, freehand, rectangle, and ellipse."
Regarding claim 6, the recited display of the processing execution operation screen in second display mode is controlled on a basis of operation control data reads on (Moschell, [0067], emphasis added):
"the interface controls generator 264 operates to generate and display in the user interface 114 controls that are selectable by the operator to adjust the operation of the instrument 102."
Regarding claim 7, the recited operator can adjust the processing condition data according to the operator-oriented instruction data reads on (Moschell, [0067], emphasis added):
"the interface controls generator 264 operates to generate and display in the user interface 114 controls that are selectable by the operator to adjust the operation of the instrument 102."
Regarding claim 10, the recited operator-oriented instruction data includes reference data related to confirmation and/or adjustment of the processing condition data reads on (Moschell, [0082], emphasis added):
"A variety of data displays...are available for inclusion in the acquisition data display,...such as including histograms, dot plots, and density plots...the data displays 308 are selectable from a menu of available options, or by dragging and dropping the data displays...from the menu into the desired location... The data displays...are adjustable by the operator."
Regarding claim 11, the recited reference data includes specifying data for specifying plot data to be adjusted; confirmation graph data; statistical data; and/or image data reads on (Moschell, [0082], emphasis added):
"A variety of data displays...are available for inclusion in the acquisition data display,...such as including histograms, dot plots, and density plots...the data displays...are selectable... The data displays...are adjustable by the operator."
Regarding claim 12, the recited display control data includes data related to control of display of plot data reads on (Moschell, [0082], emphasis added):
"A variety of data displays...are available for inclusion in the acquisition data display,...such as including histograms, dot plots, and density plots...the data displays...are selectable... "
Regarding claim 13, the recited display control data includes adjustment order data and/or display necessity data reads on "The data displays...are adjustable by the operator." (Moschell, [0082].)
Regarding claim 14, the recited aliquot acquisition instruction data related to aliquot acquisition in the sorting processing can be included in the operation control data reads on (Moschell, [0112], emphasis added):
"...as the sample from the container position 1843 is being processed, the instrument interface engine 112 generates an estimate of a progress percentage... and generates a progress indicator at the container position 1843 graphically depicting the progress percentage."
Regarding claim 15, the recited processing execution operation screen includes a third display area for displaying an operation flow; and a fourth display area for displaying operation content reads on (Moschell, [0019-0020], emphasis added):
"FIG. 9 is another schematic diagram of the example user interface shown in FIG. 7, operating in the setup mode and including a completed worklist"... "FIG. 10 is a schematic diagram illustrating an example of the user interface, shown in FIG. 7, operating in a run mode"
Regarding claim 16, the recited third and fourth display areas are arranged respectively on upper and lower sides of the processing execution operation screen, or vice versa, reads on Figures 9 and 10 of Moschell.
Regarding claim 17, the recited processing condition setting screen includes: first and second display areas for respectively displaying an operation flow and displaying measurement data related to a biological particle-containing sample reads on Figures 9 and 10 of Moschell.
Regarding claim 18, the recited first and second display areas are arranged respectively on a left and right side of the processing condition setting screen, or vice versa, reads on Figures 9 and 10 of Moschell.
Regarding claim 19, the recited biological particle sorting device includes a display device that displays a processing execution operation screen displayed in the second display mode reads on Figures 9 and 10 of Moschell.
Regarding claim 22, the recited biological particle sorting system comprising ...a(n) information processing device(s) reads on the "processing device" (Moschell, [0006]) and "the instrument 102 is a flow cytometer" (Moschell, [0026]).
While Moschell shows a flow cytometer [0026] which can read on a sorting device, Moschell does not explicitly state a "sorting device" as recited in claims 1-22.
Moschell does not show the recited (device that operates...) on a basis of identification information of claim 1 (shown by Tatsutani).
Moschell does not show the recited adjustment of part of the gate information is restricted of claim 8 (shown by Alcorn).
Moschell does not show the recited change of a shape of the gate in the gate information is restricted of claim 9 (shown by Alcorn).
Regarding claims 1-22, the recited sorting device reads on "A particle analyzer 102 such as...a flow cytometer may be configured to acquire data...The particle analyzer 102 may include a cell sorting system such as the cell sorter system 100 shown in FIG. 1." (Alcorn, [0041]).
Regarding claim 8, the recited adjustment of part of the gate information is restricted reads on "The features also allow for backwards compatibility by associating current scaling parameters with a predefined gate." (Alcorn, [0031].)
Regarding claim 9, the recited change of a shape of the gate in the gate information is restricted reads on (Alcorn, [0031], emphasis added):
"The gating control method ...includes creating a first gate in a scaled data space. The scaling properties may be stored or associated with the gate... The features also allow for backwards compatibility by associating current scaling parameters with a predefined gate."
Regarding claim 1, the recited (device that operates...) on a basis of identification information reads on (Tatsutani, [0238], emphasis added):
"... in FIG. 1, a user's access right is preferably restricted. For example, only a user ...preferably manages a password to be inputted in the log-on screen L shown in FIG. 5. Thus, for example, the evaluation criterion, for quality control, having been once set can be prevented from being recklessly rewritten."
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 flow cytometer display interface of Moschell with the cell sorter and gating methods of Alcorn, with the logon capability of Tatsutani. This is because the method of Alcorn allows for backwards compatibility by associating current scaling parameters with a predefined gate; additionally, Alcorn adds further motivation to modify Moschell by showing isolation of biological particles, such as cells, is valuable and has a wide range of applications. Tatsutani adds further motivation to modify by showing use of identification information such as logon and password can prevent criterion from being overwritten. One of ordinary skill in the art would have understood how to and been motivated to modify Moschell with Alcorn and Tatsutani, as the references are generally drawn to related teaching of biological particle analysis, and as such, the combination 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.
NSDP rejection:
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over one or more claims of reference Application Nos. 18/030,305; 18/293,658; and 18/702,447 in view of Moschell (US 2017/0176480 A1, published 06/22/2017; cited on the 03/30/2023 IDS), in view of Alcorn (US 2019/0369001A1, published 12/05/2019; cited on the 10/28/2025 IDS), in view of Tatsutani (US 2020/0103333 A1, published 04/02/2020; cited on the 03/30/2023 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because each reference application as well as the instant application recites claims which involve a biological particle sorting device (or equivalent, e.g., bioparticle sorting apparatus) with a first and second display mode (or equivalent, e.g., first display area and second display area; or display modes) for input of operational control data which includes a processing condition setting screen (or equivalent, e.g., parameter reception screen; or setting panel) and a processing execution operation screen (or equivalent, e.g., display area for displaying measurement data pertaining to the bioparticle-containing sample).
Although the instant application recites limitations for basing device operation in first or second display mode on identification information (shown by Tatsutani [0238]); restricting gate information and gate shape changes (shown by Alcorn [0031]); an operator who operates and can adjust (shown by Moschell [0067], [0070], and figure 7); and third and fourth display areas (shown by Moschell [0019-0020] and figs. 7 and 9-10), this narrowing versus the reference claims is now interpreted as obvious, such that the instant invention would have been prima facie obvious in view of the cited art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/M.A.V./Examiner, Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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