DETAILED ACTION
I. ACKNOWLEDGEMENTS
This non-final Office action addresses U.S. reissue application No. 18/937,501 (“501 Reissue Application” or “instant application”). Based upon a review of the instant application, the actual filing date is Nov. 5, 2024 (“501 Actual Filing Date”). Because the instant application was filed on or after September 16, 2012, the statutory provisions of the America Invents Act (“AIA ”) will govern this reissue application proceeding. The 501 Reissue Application contained, among other things: Reissue Application Declarations by the Inventor and a preliminary amendment.
The 501 Reissue Application is a reissue application of U.S. Patent No. 10,363,018 (“’018 Patent”) titled “MEDICAL PROCESSING APPARATUS AND MEDICAL PROCESSING METHOD.” The ‘018 Patent was filed on Jul. 18, 2017 and assigned by the Office US patent application number 15/652,463 (“463 Application”) and issued on Jul. 30, 2019 with claims 1-21 (“Originally Patented Claims”).
Because the parent reissue application, i.e., 17/388,803, of the instant reissue application was filed within two years after the ‘018 Patent was issued, broadening of claim scope is allowed. See MPEP § 1401 and 35 USC § 251.
II. OTHER PROCEEDINGS
Based on the result of litigation search related to the ‘018 Patent and after the Examiner's independent review of the ‘018 Patent itself, its prosecution history and litigation search report, the Examiner could not find any litigation and IPR related to the ‘018 Patent.
Also the Examiner could not find any reexamination proceedings related to the ‘018 Patent.
III. PRELIMINARY AMENDMENT
The 501 Reissue Application contains a preliminary amendment (“501 Preliminary Amendment”) that was filed on the 501 Actual Filing Date.
The 501 Preliminary Amendment is hereby entered. The 501 Preliminary Amendment contained, among other things, “REMARKS” (“2024 Remarks”), “AMENDMENTS TO THE SPECIFICATION” (“2024 Specification Amendment”), an IDS, “AMENDMENTS TO THE CLAIMS”. On Nov. 15, 2024, Applicant submitted another “AMENDMENTS TO THE CLAIMS” (“2024 Claim Amendment”). The IDS is entered.
The 2024 Claim Amendment canceled claims 1-21 and added new claims 22-31.
IV. STATUS OF CLAIMS
In light of the above:
Claims 22-31 are currently pending (“Pending Claims”).
Claims 22-31 are examined.
As a result of the instant office action:
Claims 22-31 are rejected.
V. PRIORITY CLAIMS
Based upon a review of the instant application and ‘018 Patent, the Examiner finds that the instant application is a continuation reissue application of 17/388,803, now US RE50229, which is a reissue application of the ‘018 Patent, matured from the 463 Application, which claims foreign priority to JP2016-141398, filed on Jul. 19, 2016 and JP2017-122988, filed on Jun. 23, 2017. The foreign priority documents are in the file of the 463 Application. However, the claims to the foreign priority have not been perfected because no English translation of the certified foreign priority documents has been provided.
Because the effective filing date of the instant application is on or after March 16, 2013, the AIA First Inventor to File (“AIA -FITF”) provisions apply (to the invention or claims of the instant reissue application). Instead, the earlier ‘First to Invent’ provisions do not apply.
VI. CLAIM INTERPRETATION
A. Lexicographic Definitions
After careful review of the original specification and unless expressly noted otherwise by the Examiner, the Examiner cannot locate any lexicographic definitions in the original specification with the required clarity, deliberateness, and precision. Because the Examiner cannot locate any lexicographic definitions in the original specification with the required clarity, deliberateness, and precision the Examiner concludes the Patent Owner is not their own lexicographer. See MPEP § 2111.01 IV.
B. 'Sources' for the 'Broadest Reasonable Interpretation'
For terms not lexicographically defined by Applicant, the Examiner hereby adopts the following interpretations under the broadest reasonable interpretation standard. In other words, the Examiner has provided the following interpretations simply as express notice of how she is interpreting particular terms under the broadest reasonable interpretation standard. Additionally, these interpretations are only a guide to claim terminology since claim terms must be interpreted in context of the surrounding claim language.1 In accordance with In re Morris, 127 F.3d 1048, 1056, 44 USPQ2d 1023, 1029 (Fed. Cir. 1997), the Examiner points to these other “sources” to support his interpretation of the claims. Finally, the following list is not intended to be exhaustive in any way:
1. Processor: "1: one that processes 2. a: (1) a computer (2) The part of a computer system that operates on data – called also a central processing unit b : a computer program (as a compiler) that puts another program into a form acceptable to the computer " Microsoft Press Computer Dictionary , 2nd Edition, Microsoft Press, Redmond, WA, 1994.
2. Configuration: “(C) The physical and logical elements of an information processing system, the manner in which they are organized and connected, or both. Note: May refer to a hardware configuration or software configuration.” The Authoritative Dictionary of IEEE Standards Terms, 7th Ed., IEEE, Inc., New York, NY, 12/2000.
3. Processing: "Manipulation of data within a computer system. Processing is the vital step between receiving data (input) and producing results (output) – the task for which computers are designed" Microsoft Press Computer Dictionary , 2nd Edition, Microsoft Press, Redmond, WA, 1994..
4. Circuitry: “1: the detailed plan or arrangement of an electric circuit. 2: the components of an electric circuit.” Merriam - Webster's Collegiate Dictionary, 10th Edition, Merriam-Webster Inc., 1994.
5. Controller: “(5) (A) A functional unit in a computer system that controls one or more units of the peripheral equipment.” IEEE 1000 The Authoritative dictionary of IEEE Standards Terms, Seventh Edition, 2000.
6. circuit (1) (A) The physical medium on which signals are carried across the AUI. The data and control circuits consist of an A circuit and a B circuit forming a balanced transmission system so that the signal carried on the B circuit is the inverse of the signal carried on the A circuit. (B) (data transmission) A network providing one or more closed paths. (C) An arrangement of interconnected components that has at least one input and one output terminal, and whose purpose is to pro- duce at the output terminals a signal that is a function of the signal at the input terminals. Synonyms: physical circuit; net- work. See also: expansion board; channel; telecommunication circuit. (D) An arrangement of interconnected electronic components that can perform specific functions upon application of proper voltages and signals. IEEE 1000 The Authoritative dictionary of IEEE Standards Terms, Seventh Edition, 2000.
7. Configuration: “(C) The physical and logical elements of an information processing system, the manner in which they are organized and connected, or both. Note: May refer to a hardware configuration or software configuration.” The Authoritative Dictionary of IEEE Standards Terms, 7th Ed., IEEE, Inc., New York, NY, 12/2000.
8. computer: “n. Any device capable of processing information to produce a desired result. No matter how large or small they are, computers typically perform their work in three well-defined steps: (1) accepting input, (2) processing the input according to predefined rules (programs), and (3) producing output.” Microsoft Computer Dictionary, Fifth Edition, Microsoft Press, Redmond, WA, 2002.
9. program “n. A sequence of instructions that can be executed by a computer. The term can refer to the original source code or to the executable (machine language) version. Also called: software.” Microsoft Computer Dictionary, Fifth Edition, Microsoft Press, Redmond, WA, 2002.
10. instruction “n. An action statement in any computer language, most often in machine or assembly language. Most programs consist of two types of statements: declarations and instructions.” Microsoft Computer Dictionary, Fifth Edition, Microsoft Press, Redmond, WA, 2002.
11. Algorithm: a step-by-step procedure for accomplishing a given result: An algorithm may be expressed “in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure.” Typhoon Touch [Techs., Inc. v. Dell, Inc., 659 F.3d 1376, 1385 (Fed. Cir. 2011)] (quoting Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008)). Even described “in prose,” an algorithm is still “a step-by-step procedure for accomplishing a given result.” Id. at 1385. Ergo Licensing, LLC v. CareFusion 303, Inc., 673 F.3d 1361, 1365 (Fed. Cir. 2012).2
C. Claims Not Invoking 35 U.S.C. §112 (f) (§ 112 (f))
The Examiner finds that claim 31 does not invoke § 112 (f). For support of this position the Examiner notes the following;
Claim 31 is a method claim. Claim 31 recites neither "step for" nor "means for," nor a generic placeholder for "step for" or "means for." Therefore claim 31 fails Prong (A) as set forth in MPEP §2181 I. Because claim 31 fails Prong (A) as set forth in MPEP §2181 I, the Examiner concludes that claim 31 does not invoke § 112 (f). See also Ex parte Miyazaki, 89 USPQ2d 1207, 1215-16 (B.P.A.I. 2008) (precedential).
D. Claims Invoking 35 U.S.C. § 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 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) 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) (“§ 112 (f)”):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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), 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), 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), 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.
In what follows, the Examiner takes the primary position that at least one functional phrase of claims 22-30 invoke 35 U.S.C. § 112 (f). For support of the Examiners position the Examiner notes the appropriate 3-prong analysis. See MPEP §2181 I. See Williamson v. Citrix Online, L.L.C., 115 USPQ2d 1105, 1112 (Fed. Cir. 2015).
Functional Phrases
“the processing circuitry configured to acquire, by performing wall motion analysis for time series images of each of a plurality of parts in a heart information on kinds of the parts in the heart and analysis result images for the parts, the time series images being obtained by analyzing medical data”--Functional phrase #1 or FP#1, as recited in claim 22.
“the processing circuitry configured to arrange at least two of the analysis result images in display areas so that the at least two of the analysis result images are adjacent to each other according to an anatomical arrangement of corresponding parts based on the information on the kinds of the parts” --Functional phrase #2 or FP#2, as recited in claim 22.
“the processing circuitry configured to display the arranged at least two of the analysis result images based on a heart time phase” --Functional phrase #3 or FP#3, as recited in claim 22.
“the processing circuitry is further configured to merge the at least two of the analysis result images to generate a composite image” --Functional phrase #4 or FP#4, as recited in claim 25.
“the processing circuitry is further configured to generate the composite image by merging the analysis result images corresponding to all of the parts” --Functional phrase #5 or FP#5, as recited in claim 26.
“ the processing circuitry is further configured to display the arranged at least two of the analysis result images in synchronization with the heart time phase” --Functional phrase #6 or FP#6, as recited in claim 27.
“the processing circuitry is further configured to map, to each pixel of the analysis result images, a color phase corresponding to a value of an analysis parameter indicating a movement of the respective part” --Functional phrase #7 or FP#7, as recited in claim 28.
“the processing circuitry is further configured to: acquire, by the wall motion analysis. a value of an analysis parameter of wall motion for each of the parts in the heart and display a graph indicating a temporal change of the value of the analysis parameter and an electrocardiogram of the heart” --Functional phrase #8 or FP#8, as recited in claim 29.
“the processing circuitry is further configured to display a bar, the bar being movable along a time axis of the graph and the electrocardiogram according to the heart time phase” --Functional phrase #9 or FP#9, as recited in claim 30.
3-Prong Analysis
i. 3-Prong Analysis Prong (A):
In accordance with the MPEP, Prong (A) requires:
(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 ....
MPEP § 2181 I. — Prong (A).
As an initial matter, the Examiner finds that the above Functional Phrases do not use the phrase “means for.” The issue arising under Prong (A) then becomes whether or not the claimed “processing circuitry” is a generic placeholder for the phrase ‘means for,’ i.e., being applied as a generic means for performing the function. See MPEP 2181 I.C.
First, the Examiner has reviewed the specification and concludes that the specification does not provide a description sufficient to inform a person having ordinary skill in the art (“PHOSITA”) that the term “processing circuitry” denotes sufficient structure to perform the claimed function. However, the Examiner finds that A PHOSITA understands that an ordinary “processing circuitry” cannot perform the entire claimed function respectively. Other structural elements are needed.
Second, the Examiner has reviewed both general dictionaries and subject matter specific dictionaries for evidence to establish that the term “processing circuitry” has achieved recognition as noun denoting structure. Based upon a review of these dictionaries, the Examiner is unable to locate sufficient evidence that “processing circuitry” has achieved recognition as a noun denoting structure for performing the claimed function. For example, see the section of Sources for BRI above, showing that processor commonly has enough structure to perform a general computer function (See MPEP § 2181.II.B). However, the Examiner finds that A PHOSITA understands that ordinary processors with CPU and memory, cannot perform the entire claimed function. Other structural elements are needed.
Finally, the Examiner has reviewed the prior art of record for evidence that “processing circuitry” has an art-recognized structure to perform the claimed function. Based upon a review of the prior art now of record, the Examiner is unable to locate sufficient evidence to establish that term “processing circuitry” has an art-recognized structure to perform the claimed function respectively.
Accordingly the Examiner concludes that the phrase “processing circuitry” as set forth in the above Functional Phrases is being used as a generic term for a structure performing the function, and therefore a place holder for the phrase "means for" performing the recited function respectively. Because “processing circuitry” is merely a generic placeholder having no specific structure associated therewith, the Examiner concludes that above Functional Phrases meets invocation Prong (A).
ii. 3-Prong Analysis Prong (B):
In accordance with the MPEP prong (B) requires:
(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” ....
MPEP § 2181 I. — Prong (B).
Based upon a review of claims 22-30 and FP#1-FP#9, the Examiner finds that the functions associated with the Functional Phrases #1-#9 are listed below:
to acquire, by performing wall motion analysis for time series images of each of a plurality of parts in a heart information on kinds of the parts in the heart and analysis result images for the parts, the time series images being obtained by analyzing medical data –Function of Functional phrase #1 or FP#1, as recited in claim 22.
to arrange at least two of the analysis result images in display areas so that the at least two of the analysis result images are adjacent to each other according to an anatomical arrangement of corresponding parts based on the information on the kinds of the parts -- Function of Functional phrase #2 or FP#2, as recited in claim 22.
to display the arranged at least two of the analysis result images based on a heart time phase -- Function of Functional phrase #3 or FP#3, as recited in claim 22.
to merge the at least two of the analysis result images to generate a composite image -- Function of Functional phrase #4 or FP#4, as recited in claim 25.
to generate the composite image by merging the analysis result images corresponding to all of the parts -- Function of Functional phrase #5 or FP#5, as recited in claim 26.
to display the arranged at least two of the analysis result images in synchronization with the heart time phase -- Function of Functional phrase #6 or FP#6, as recited in claim 27.
to map, to each pixel of the analysis result images, a color phase corresponding to a value of an analysis parameter indicating a movement of the respective part -- Function of Functional phrase #7 or FP#7, as recited in claim 28.
to acquire, by the wall motion analysis, a value of an analysis parameter of wall motion for each of the parts in the heart and display a graph indicating a temporal change of the value of the analysis parameter and an electrocardiogram of the heart -- Function of Functional phrase #8 or FP#8, as recited in claim 29.
to display a bar, the bar being movable along a time axis of the graph and the electrocardiogram according to the heart time phase -- Function of Functional phrase #9 or FP#9, as recited in claim 30.
iii. 3-Prong Analysis: Prong (C)
In accordance with the MPEP, Prong (C) requires:
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
MPEP § 2181 I — Prong (C)
Based upon a review of each of the entire Functional Phrases above, the Examiner finds that the above Functional Phrases do not contain sufficient structure for performing the entire claimed functions that is set forth within the Functional Phrases. In fact, the Examiner finds that the Functional Phrases recites very little structure (if any) for performing the claimed function.
Because the above Functional Phrases do not contain sufficient structure for performing the entire claimed function, the Examiner concludes that the above Functional Phrases meet invocation Prong (C).
Corresponding Structure for Functional Phrases
Based upon a review of the original disclosure, the Examiner finds that the corresponding structure/algorithms for functional phrases as follows:
FP#1
the processing circuitry configured to acquire, by performing wall motion analysis for time series images of each of a plurality of parts in a heart information on kinds of the parts in the heart and analysis result images for the parts, the time series images being obtained by analyzing medical data --Functional phrase #1 or FP#1, as recited in claim 22.
--The corresponding structure/algorithm for performing the claimed function of FP#1 is shown in Fig. 2 and involves executing the following for a common time series image, i.e., volume data, regarding the first heart chamber and the second heart chamber (see column 14:18-25):
Sa1 – transmitting/receiving ultrasounds with respect to each of the heart chambers, generating medical images in a time series over the period of one or more heartbeats, and setting the patient ID, kind of heart chamber, an image mode, and an analysis parameter name (see column 7:65 – 8:8);
Sa2 – setting formation points indicating an initial outline in a medical image of a predetermined heart time phase among the medical images obtained in the time series by:
(1) Analyzing a wall motion of each heart chamber by applying a predetermined wall motion analysis to the medical image group for each heart chamber; and
(2) Setting as an initial outline a plurality of formation points indicating an outline of a tunica intima of a heart wall and a plurality of formation points indicating an outline of a tunica externa of a heart wall on the medical image corresponding to a predetermined heart time phase from the medical image group
(see column 8:9-14; see also column 6:14-39);
Sa3 – tracking and analyzing formation points across the medical images and acquiring an analysis result of wall motion for each heart chamber based on the set image mode and the value of the calculated analysis parameter by:
(1) tracking positions of the formation points in the other medical images included in the medical image group in a time series from the medical image in which the initial outline is set;
(2) calculating a value of various kinds of analysis parameters regarding the wall motion of the heart chamber based on the result of the tracking;
(3) generating a surface rendering image, an MPR image, and a polar map, etc. to which a color phase corresponding to a value of the analysis parameter is mapped, and which are segmented, wherein the segment is a segmented area of a heart wall recommended by the American Society of Echocardiography and the American Heart Association; and
(4) acquiring an image generated by such mapping as an analysis result of the wall motion of each heart chamber; and
(5) storing the generated analysis result
(see column 8:17-37; see also column 6:39-64).
Sa4 – generating incidental information, including information regarding a kind of heart chamber, by using various information regarding wall motion analysis of heart chamber (see column 8:38-54); and
Sa5 – adding the incidental information to analysis result and storing incidental information together with analysis result (see column 9:4-17).
FP#2
the processing circuitry configured to arrange at least two of the analysis result images in display areas so that the at least two of the analysis result images are adjacent to each other according to an anatomical arrangement of corresponding parts based on the information on the kinds of the parts --Functional phrase #2 or FP#2, as recited in claim 22.
-The corresponding structure/algorithm for performing the claimed function of FP#2 is described at column 9:59-67 and involves:
(1) determining the display position of the analysis result of each region in accordance with the anatomical positional relationship of each region based on the scanning order in the incidental information; and
(2) displaying the analysis results in series at the display position in accordance with the scanning order.
See also Figs. 4-5 and associated descriptions.
FP#3
the processing circuitry configured to display the arranged at least two of the analysis result images based on a heart time phase --Functional phrase #3 or FP#3, as recited in claim 22.
-The corresponding structure/algorithm for performing the claimed function of FP#3 is described at column 9:59-67 and involves:
determining the display position of the analysis result of each region in accordance with the anatomical positional relationship of each region based on a heart time phase in the incidental information; and
displaying the analysis results in series at the display position in accordance with the a heart time phase.
See also Figs. 4-5 and associated descriptions.
FP#4
the processing circuitry is further configured to merge the at least two of the analysis result images to generate a composite image --Functional phrase #4 or FP#4, as recited in claim 25.
The corresponding structure/algorithm for performing the claimed function of FP#3 is described at column 15:16-52 and involves:
(1) Acquiring the coordinates of each segment of surface rendering images corresponding to each of the heart chambers;
(2) Registering the surface rendering images to which a color phase corresponding to a value of an analysis parameter indicating movement of the heart chamber is mapped; and
(3) Displaying the generated composite image.
See also Fig. 15 and associated descriptions.
FP#5
the processing circuitry is further configured to generate the composite image by merging the analysis result images corresponding to all of the parts --Functional phrase #5 or FP#5, as recited in claim 26.
The corresponding structure/algorithm for performing the claimed function of FP#3 is described at column 15:16-52 and involves:
(1) Acquiring the coordinates of each segment of surface rendering images corresponding to each of the heart chambers;
(2) Registering the surface rendering images to which a color phase corresponding to a value of an analysis parameter indicating movement of the heart chamber is mapped; and
(3) Displaying the generated composite image.
See also Fig. 15 and associated descriptions.
FP#6
the processing circuitry is further configured to display the arranged at least two of the analysis result images in synchronization with the heart time phase --Functional phrase #6 or FP#6, as recited in claim 27.
-The corresponding structure/algorithm for performing the claimed function of FP#3 is described at column 9:59-67 and involves:
determining the display position of the analysis result of each region in accordance with the anatomical positional relationship of each region in the incidental information; and
displaying the analysis results in series at the display position in synchronization with the heart time phase.
See also Figs. 4-5 and associated descriptions.
FP#7
the processing circuitry is further configured to map, to each pixel of the analysis result images, a color phase corresponding to a value of an analysis parameter indicating a movement of the respective part --Functional phrase #7 or FP#7, as recited in claim 28.
The corresponding structure/algorithm for performing the claimed function of FP#7 is described at column 11:6-38 and involves:
obtaining a value of an analysis parameter of the rendering image;
mapping the pixel of the rendering image to a color phase value corresponding to the value.
See also description associated with Figs. 5-6.
FP#8
the processing circuitry is further configured to: acquire, by the wall motion analysis. a value of an analysis parameter of wall motion for each of the parts in the heart and display a graph indicating a temporal change of the value of the analysis parameter and an electrocardiogram of the heart --Functional phrase #8 or FP#8, as recited in claim 29.
--The corresponding structure/algorithm for performing the claimed function of FP#8 is shown in Fig. 2 and involves executing the following for a common time series image, i.e., volume data, regarding the first heart chamber and the second heart chamber (see column 14:18-25):
Sa1 – transmitting/receiving ultrasounds with respect to each of the heart chambers, generating medical images in a time series over the period of one or more heartbeats, and setting the patient ID, kind of heart chamber, an image mode, and an analysis parameter name (see column 7:65 – 8:8);
Sa2 – setting formation points indicating an initial outline in a medical image of a predetermined heart time phase among the medical images obtained in the time series by:
(1) Analyzing a wall motion of each heart chamber by applying a predetermined wall motion analysis to the medical image group for each heart chamber; and
(2) Setting as an initial outline a plurality of formation points indicating an outline of a tunica intima of a heart wall and a plurality of formation points indicating an outline of a tunica externa of a heart wall on the medical image corresponding to a predetermined heart time phase from the medical image group
(see column 8:9-14; see also column 6:14-39);
Sa3 – tracking and analyzing formation points across the medical images and acquiring an analysis result of wall motion for each heart chamber based on the set image mode and the value of the calculated analysis parameter by:
(1) tracking positions of the formation points in the other medical images included in the medical image group in a time series from the medical image in which the initial outline is set;
(2) calculating a value of various kinds of analysis parameters regarding the wall motion of the heart chamber based on the result of the tracking;
(3) generating a surface rendering image, an MPR image, and a polar map, etc. to which a color phase corresponding to a value of the analysis parameter is mapped, and which are segmented, wherein the segment is a segmented area of a heart wall recommended by the American Society of Echocardiography and the American Heart Association; and
(4) acquiring an image generated by such mapping as an analysis result of the wall motion of each heart chamber; and
(5) storing the generated analysis result
(see column 8:17-37; see also column 6:39-64).
Sa4 – generating incidental information, including information regarding a kind of heart chamber, by using various information regarding wall motion analysis of heart chamber (see column 8:38-54); and
Sa5 – adding the incidental information to analysis result and storing incidental information together with analysis result (see column 9:4-17).
See also description associated with Figs. 5-8.
FP#9
the processing circuitry is further configured to display a bar, the bar being movable along a time axis of the graph and the electrocardiogram according to the heart time phase --Functional phrase #9 or FP#9, as recited in claim 30.
The corresponding structure/algorithm for performing the claimed function of FP#9 is described at column 11:39-52 and involves:
(1) graphing time change in the values of the analysis parameters for each segment;
(2) having a bar showing the heart time phases of the analysis results;
(3) moving the bar along a horizontal axis of the graphs;
(4) displaying results corresponding to the position of the moved bar based on the heart time phase. See Fig. 5 and associated descriptions.
Graphs 5G1 and 5G2 in FIG. 5 show time change in the values of the analysis parameters for each segment. 5PT in FIG. 5 is a bar that shows the heart time phases of the analysis results 5RV, 5RA, 5LV, and 5LA. The bar 5PT moves along a time axis of the graphs 5G1 and 5G2 and the electrocardiogram 5ECG in accordance with the heart time phase of the analysis results in the moving display of the analysis results. When the bar 5PT is instructed by the operator to move along the horizontal axis of the graphs or the electrocardiogram, the analysis results 5RV, 5RA, 5LV, and 5LA are displayed as display results corresponding to the position of the moved bar based on the heart time phase in the incidental information and the heart time phase indicated by the moved bar.
-column 11: 39-52 of the ‘018 Patent.
4) Analysis of other dependent claims
Claims 23-30 depends on claim 22. The Functional Phrases FP#1-#3 in claims 23-30 also invoke 35 U.S.C. § 112 (f). Therefore analysis of the corresponding structures for Functional Phrases FP#1-FP#3 modified by claims 23-30 are the same as identified above for the corresponding Functional Phrases.
VII. CLAIM OBJECTIONS
A. Explanation of support
CFR 1.173(c) states:
(c) Status of claims and support for claim changes. Whenever there is an amendment to the claims pursuant to paragraph (b) of this section, there must also be supplied, on pages separate from the pages containing the changes, the status ( i.e., pending or canceled), as of the date of the amendment, of all patent claims and of all added claims, and an explanation of the support in the disclosure of the patent for the changes made to the claims.
Claims 22-31 are objected to because there is no sufficient explanation of support of the new claims, i.e., claims 22-31, by the Applicant. Applicant provides support for the new claims 22-31 by lumping all the limitation together. However the explanation of support should be for each change or each amended or each new limitation.
Appropriate correction is required.
Although the presentation of the amended claim need not contain any indication of what is changed from the previous version of the claim, applicant must point out what is changed in the "Remarks" portion of the amendment along with the support for the change. See MPEP §1453(V) (D).
The Examiner note that the indication can be via a separate appendix to the remarks showing the changes with respect to the last submission. Although the official claim amendments must only show markings with respect to the original patent, an appendix to the remarks showing changes with respect to the last submission would satisfy the requirement of the Remarks pointing out what has changed.
Applicant is notified that any amendment or subsequent amendment to the specification and/or claims must comply with 37 C.F.R. §1.173, which sets forth the manner of making amendments in reissue applications. For example, matter deleted should be enclosed with brackets and added subject matter should be identified by underlining. Furthermore, all amendments to the original patented claims must be made with respect to the patent. For the new claims, amendment must preserve the claim ordering as they were first presented during the prosecution. Finally, claims must have proper status identifiers.
B. Note
In order to facilitate compact prosecution, the Examiner has, this one time only, entered the 2024 Claim Amendment. Nevertheless, should Applicant(s) submit any subsequent claim amendment that does include an explanation of support, the Examiner may indicate that the claim amendment(s) are improper and therefore not completely responsive.
VIII. SPECIFICATION
37 CFR 1.177 states:
(a) The Office may reissue a patent as multiple reissue patents. If applicant files more than one application for the reissue of a single patent, each such application must contain or be amended to contain in the first sentence of the specification a notice stating that more than one reissue application has been filed and identifying each of the reissue applications by relationship, application number and filing date. The Office may correct by certificate of correction under § 1.322 any reissue patent resulting from an application to which this paragraph applies that does not contain the required notice.
The Examiner finds that there are multiple reissue applications filed for the ‘018 Patent, i.e., 18/937,501 and 17/388,803. The specification is objected to because the specification has been not amended to state more than one application for the reissue of the ‘018 Patent has been filed and the specification fails to identify each of the reissue applications by relationship, application number and filing date.
IX. REJECTION 35 U.S.C. §251
A. Original Patent Requirement
MPEP §1412.01 states that the reissue claims must be for the same invention as that disclosed as being the invention of the original patent. MPEP 1412.01 further provides guidelines for determining whether the reissue claims are “for the invention disclosed in the original patent” as:
(A) the claims presented in the reissue application are described in the original patent specification and enabled by the original patent specification such that 35 U.S.C. 112, first paragraph is satisfied;
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(B) nothing in the original patent specification indicates an intent not to claim the subject matter of the claims presented in the reissue application; and
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(C) the newly claimed invention is clearly and unequivocally disclosed in the specification as a separate invention with the claimed combination of features.
The Fed. Cir. addressed the “original patent” requirement in Antares Pharma, Inc. v. Medac Pharma Inc., 112 USPQ2d 1865 (Fed. Cir. 2014). The court stated that “a reissue claim is for the ‘same invention’ if the original patent specification fully describes the claimed inventions, but not if the broader claims ‘are [] merely suggested or indicated in the original specification.” Antares, 112 USPQ2d at 1868 (citing U.S. Supreme Court’s decision in U.S. Industrial Chemicals). Further, the court stated “‘it is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification.’ Rather, the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention.” Antares, 112 USPQ2d at 1871 (citing U.S. Supreme Court’s decision in U.S. Industrial Chemicals) (citation omitted), or that “the exact embodiment claimed on reissue [be] expressly disclosed in the specification.” Id.
Recently, the Fed. Cir. stated:
Thus, for broadening reissue claims, the specification of the original patent must do more than merely suggest or indicate the invention recited in reissue claims; “[I]t must appear from the face of the instrument that what is covered by the reissue was intended to have been covered and secured by the original.” Indus Chems, 315 US at 676 (emphasis in Forum US). Stated differently, the original patent “must clearly and unequivocally disclose the newly claimed invention as a separate invention.” Antares, 771 F.3d at 1362. Forum US Inc. v. Flow Valve LLC (decided: June 17, 2019).
Claims 22-31 are rejected under 35 U.S.C. §251 because they do not comply with the original patent requirement. In summary, the invention as now claimed was not unequivocally disclosed in the specification of the ‘018 Patent as a separate invention or not for the same invention as that disclosed as being the invention in the original patent. In more detail the Examiner notes the following:
As provided in §251, the Director shall issue reissue the patent for the invention disclosed in the “original patent.” To meet the original patent requirement, the specification of the original patent “must clearly and unequivocally disclose the newly claimed invention as a separate invention.” See Antares Pharma, Inc. v. Medac Pharma Inc., 771 F.3d 1354, 1362 (Fed. Cir. 2014). “[I]t is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification.” Id. Specifically, the invention now being claimed in reissue must be expressly disclosed in the specification of the original patent. Id. at 1363.3
Based on these decisions, Examiners find this analysis involves a simple two-step process: (1) determine what is the new invention now being claimed, i.e., how the claims have been broadened, and (2) is that new invention or new scope of invention unequivocally disclosed in the specification as a separate invention.
As to (1), the Examiners finds that the original patent claims have been broadened and also been broaden via claims 22-31. For example, independent claims 22 and 31 of this instant reissue application no longer require the following claim elements: “adding incidental information including information regarding a kind of each of a plurality of regions in a heart to a corresponding analysis result of each of the regions…; determining a display position of the corresponding analysis result of each of the regions based on the incidental the incidental information.”
The invention being claimed now does not require “adding incidental information…” nor “determining a display position of the corresponding analysis result ….”
As to (2), after the Examiners reviewed the ‘018 Patent, the Examiners could not find an equivocal disclosure in the ‘018 Patent that does not perform the above two steps. Further, without the above two steps, the Examiners do not find the method or the processing circuitry would operate as intended. Rather the method or the processing circuitry is dependent on the above steps to display the result. In other words, the Examiner could not find an embodiment that does not require the above two steps.
Because claims 22-31 are broader in scope than the patented claims of the ‘018 Patent, and because the new scope of claims 22-31 is directed to an invention not unequivocally disclosed in the ‘018 Patent as a separate invention, claims 22-31 are rejected under 35 U.S.C. §251 as not complying with the original patent requirement.
Examiners further find this situation is analogous to the recent Federal Circuit decision in Forum US, Inc. v. Flow Valve, LLC, 926 F.3d 1346 (Fed. Cir. 2019). In Forum US, the original patent claims were drawn to a workpiece having a body member and a plurality of arbors (arbors circled in FIGS. 4 and 5 at issue):
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Forum US, 926 F.3d at 1348-49. In reissue, patentee broadened the claims to simply remove the requirement as to arbors. Id. at 1349. The Federal Circuit determined that the new claims did not comply with the original patent requirement of section 251 because the face of the patent did not disclose any arbor-less embodiment, and the abstract, summary of invention, and all disclosed embodiments including arbors. Id. at 1352. The Court concluded that the specification did not clearly and unequivocally disclose an embodiment without arbors, thus the original patent requirement was violated by broadening the claims to no longer require arbors. Id. Similarly, the 800 Patent here does not clearly and unequivocally disclose a chuck assembly with an electrostatic puck without the electrode and heating element. Thus, to broaden the claims to permit Applicant to claim such an invention runs afoul of the original patent requirement in the same manner as at issue in Forum.
B. Defective Oath and Declaration
The Reissue Application Declaration by the Inventor filed on Jan. 6, 2025 is defective because the same errors were cited to be corrected compared to the parent reissue application. See MPEP 1414.II.(D). A different error must be corrected for the instant reissue application. Therefore a new error statement is required and the new error statement can be in the Remark section in the forthcoming response.
X. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
A. Claim 31 is rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Abe (US Patent Pub. 2012/0165674, “Abe”).
Regarding claim 31, Abe teaches a medical processing method, comprising:
acquiring, by performing wall motion analysis for time series images of each of a plurality of parts in a heart information on kinds of the parts in the heart and analysis result images for the parts, the time series images being obtained by analyzing medical data; and
…The motion information generating unit generates first motion information on cardiac wall motion of at least one of a left ventricle and a left atrium and second motion information on cardiac wall motion of at least one of a right ventricle and a right atrium, each of the first motion information and the second motion information being temporal change information that is made up of a plurality of measured values along a time axis and that indicates temporal change in cardiac wall motion, on the basis of a first volume data group including a region related to a left side of a heart of a subject and a second volume data group including a region related to a right side of the heart, each of the first volume data group and the second volume data group being obtained from volume data that is generated by three-dimensionally scanning the heart of the subject with an ultrasound wave for a duration of one or more heartbeats.
-[0024] of Abe, emphasis added.
See [0024], [0031], [0052]-[0054], [0072]-[0075], Figs. 4A-4B and associated descriptions.
arranging at least two of the analysis result images in display areas so that the at least two of the analysis result images are adjacent to each other according to an anatomical arrangement of corresponding parts based on the information on the kinds of the parts; and
See Figs. 2, 11, 13 and 14 and associated descriptions.
displaying the arranged at least two of the analysis result images based on a heart time phase.
See Figs. 2, 11, 13 and 14 and associated descriptions.
XI. 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.
A. Claim 31 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Abe (US Patent Pub. 2012/0165674).
Regarding claim 31, Abe teaches a medical processing method, comprising:
acquiring, by performing wall motion analysis for time series images of each of a plurality of parts in a heart information on kinds of the parts in the heart and analysis result images for the parts, the time series images being obtained by analyzing medical data; and
…The motion information generating unit generates first motion information on cardiac wall motion of at least one of a left ventricle and a left atrium and second motion information on cardiac wall motion of at least one of a right ventricle and a right atrium, each of the first motion information and the second motion information being temporal change information that is made up of a plurality of measured values along a time axis and that indicates temporal change in cardiac wall motion, on the basis of a first volume data group including a region related to a left side of a heart of a subject and a second volume data group including a region related to a right side of the heart, each of the first volume data group and the second volume data group being obtained from volume data that is generated by three-dimensionally scanning the heart of the subject with an ultrasound wave for a duration of one or more heartbeats.
-[0024] of Abe.
See [0024], [0031], [0052]-[0054], [0072]-[0075], Figs. 4A-4B and associated descriptions.
It is Examiner’s position that time series images are acquired in Abe. To the extent that Abe does not expressly anticipate this limitation, Abe discloses:
[0101] The control unit 18 controls so that the first correction information and the second correction information generated by the motion information generating unit 17a are displayed on the monitor 2. Specifically, the motion information generating unit 17a generates a motion information image, in which the first correction information and the second correction information are arranged along the time axis such that time phases are aligned on the basis of a predetermined cardiac phase. More specifically, the motion information image is a graph or a distribution image as explained below. The control unit 18 controls so that the motion information image is displayed on the monitor 2.
[0109] A case will be explained that a distribution image is displayed as the motion information image. As described above, the distribution image is used to output the information on the regional cardiac wall motion. The motion information generating unit 17a generates a first distribution image group, in which the information on the regional cardiac wall motion in the first correction information is mapped along the time axis, under the control by the control unit 18. Furthermore, the motion information generating unit 17a generates a second distribution image group, in which the information on the regional cardiac wall motion in the second correction information is mapped along the time axis, under the control by the control unit 18.
[0110] …the control unit 18 controls display of moving images of the first distribution image group and the second distribution image group such that they are substantially synchronized with the cardiac phase. FIG. 9 and FIG. 10 are diagrams for explaining examples of the distribution images that are displayed in the embodiment.
-[0101], [0109] and [0110] of Abe.
As can be seen above, images corresponding to different time phase are acquired and aligned or synchronized before displaying.
It is desirable to “three-dimensionally analyze a difference in the interventricular wall motion synchrony, the interatrial wall motion synchrony, and the atrioventricular wall motion synchrony” ([0008] of Abe). Therefore it would have been obvious to one of ordinary skills in the art, at the time the invention of the ‘018 Patent was effectively filed, to acquire time series images by analyzing medical data to analyze interventricular wall motion synchrony, the interatrial wall motion synchrony, and the atrioventricular wall motion synchrony.
arranging at least two of the analysis result images in display areas so that the at least two of the analysis result images are adjacent to each other according to an anatomical arrangement of corresponding parts based on the information on the kinds of the parts; and
See Figs. 2, 11, 13 and 14 and associated descriptions.
displaying the arranged at least two of the analysis result images based on a heart time phase.
See Figs. 2, 11, 13 and 14 and associated descriptions.
XII. ALLOWABLE SUBJECT MATTER
Claims 22-30 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 251 Original Patent Requirement set forth in this Office action.
The following is an examiner’s statement of reasons for allowance:
The functional phrases FP#1 and FP#3 invoke § 112 (f) and prior art including Abe does not teach or make obvious the corresponding structure of FP#1 and FP#2 identified in the Section VI above.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
XIII. CONCLUSION
A. Reissue Application Reminders
Disclosure of other proceedings. Applicants are reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which the Patent Under Reissue is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation.
Disclosure of material information. Applicant is further reminded of the continuing obligation under 37 C.F.R. § 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Manner of making amendments. Applicant is reminded that changes to the Instant Application must comply with 37 C.F.R. § 1.173, such that all amendments are made in respect to the Patent Under Reissue as opposed to any prior changes entered in the Instant Application. All added material must be underlined, and all omitted material must be enclosed in brackets, in accordance with Rule 173. Applicant may submit an appendix to any response in which claims are marked up to show changes with respect to a previous set of claims, however, such claims should be clearly denoted as “not for entry.”
B. Suggested Examples: Preventing Both New Matter Rejections & Objections to the Specification in the Future
Applicants are respectfully reminded that any suggestions or examples of claim language provided by the Examiner are just that—suggestions or examples—and do not constitute a formal requirement mandated by the Examiner. To be especially clear, any suggestion or example provided in this Office Action (or in any future office action) does not constitute a formal requirement mandated by the Examiner.
Should Applicants decide to amend the claims, Applicant is also reminded that—like always—no new matter is allowed. The Examiner therefore leaves it up to Applicants to choose the precise claim language of the amendment in order to ensure that the amended language complies with 35 U.S.C. § 112 1st paragraph.
Independent of the requirements under 35 U.S.C. § 112 1st paragraph, Applicants are also respectfully reminded that when amending a particular claim, all claim terms must have clear support or antecedent basis in the specification. See 37 C.F.R. § 1.75(d)(1) and MPEP § 608.01(o). Should Applicants amend the claims such that the claim language no longer has clear support or antecedent basis in the specification, an objection to the specification may result. Therefore, in these situations where the amended claim language does not have clear support or antecedent basis in the specification and to prevent a subsequent ‘Objection to the Specification’ in the next office action, Applicants are encouraged to either (1) re-evaluate the amendment and change the claim language so the claims do have clear support or antecedent basis or, (2) amend the specification to ensure that the claim language does have clear support or antecedent basis. See again MPEP § 608.01(o) (¶3). Should Applicants choose to amend the specification, Applicants are reminded that—like always—no new matter in the specification is allowed. See 35 U.S.C. § 132(a). If Applicants have any questions on this matter, Applicants are encouraged to contact the Examiner via the telephone number listed below.
C. Contact Information
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to YUZHEN GE whose telephone number is (571)272-7636. The Examiner can normally be reached on Monday-Thursday 8:00-6:00.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor Andrew J. Fischer can be reached on 571-272-6779. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of reissue applications may be obtained from the USPTO’s “Patent Center.” Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov.
Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at (866) 217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/Yuzhen Ge/
Primary Examiner, Art Unit 3992
Conferees:
/JACOB C. COPPOLA/Primary Examiner, Art Unit 3992
/ANDREW J. FISCHER/Supervisory Patent Examiner, Art Unit 3992
1 While most interpretations are cited because these terms are found in the claims, the Examiner may have provided additional interpretations to help interpret words, phrases, or concepts found in the interpretations themselves, the ‘018 Patent, or in the prior art.
2 See also “An algorithm is defined, for example, as ‘a finite sequence of steps for solving a logical or mathematical problem or performing a task.’” MPEP § 2181 II. B. (quoting Microsoft Computer Dictionary, Microsoft Press, 5th edition, 2002).
3 See also Forum US, Inc. v. Flow Valve, LLC, 926 F.3d 1346 at 1351 (Fed. Cir. 1029, precedential) (For broadening reissue claims, “the specification of the original patent must do more than merely suggest or indicate the invention recited in the reissue claims,” rather “it must appear from the face of the instrument that what is covered by the reissue was intended to have been covered and secured by the original.”).
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