DETAILED ACTION
Claims 1,2,4,5,6,3,7,8,9,14,15 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated1 by MIN et al. (US 2021/0209757 A1).
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated2 by MIN et al. (US 2021/0209757 A1).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1,2,4,5,6,3,7,8,9,14,15 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
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Step zero: make broadest reason interpretation (BRI) in footnotes.
Step 1: claim 1 is machine.
Step 2A, prong 1:The claim(s) recite(s) mental process:
analyze…data…
selection of a location…
the selected location…
the selected location…
selection of the location:
1. A coronary artery disease (CAD) analysis system comprising:
a CAD analysis device arranged to analyse received patient CT scan data that includes a patient's coronary arteries3 the CT scan data associated with a CT volume;
the CAD analysis system comprising a user interface configured to:
facilitate selection of a location on a coronary artery;
display a multiplanar reconstruction (MPR) representation of the coronary artery, the MPR representation including a vessel identifier that indicates the selected location on the coronary artery; and
simultaneously display at least one CT volume representation of the CT volume the selected location on the coronary artery;
wherein selection of the location on the MPR representation of the coronary artery causes synchronised display of the common CT volume location on the at least one CT volume representation.
Step 2A, prong 2: This judicial exception is not integrated into a practical application because the additional elements (imaging stuff in claim 1) do not improve the functioning of a computer (quick, speed, user-friendly, convenient, easy, simple user-interface) in combination with accurate analysis results as, for example, indicated in the disclosed fig. 25’s CAD CT analysis scroll bar:
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Step 2B: The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (imaging stuff such as CT, MPR) individually or in combination with the mental process adheres to the conventional in view of applicant’s disclosure, page 1:
Background of the Invention
Coronary Artery Calcium (CAC) scores are an important indicator of Coronary Artery Disease (CAD) and are commonly calculated using Agatston's method of density20 weighted area calculation.
Atherosclerosis is a disease of the coronary arteries wherein atheromatous plaque ("plaque") accumulates abnormally in the inner layer of an arterial wall. Significant accumulation of plaque can cause a narrowing of an artery, referred to as arterial stenosis, and consequently a reduction of blood flow. Significant arterial stenosis in the context of coronary arteries can result in heart attack and death. Accumulation of vulnerable plaque in a coronary artery also poses a significant health risk as it tends to be unstable and prone to rupture, which can cause an acute cardiovascular event such as a heart attack or a stroke.
It is known to provide a coronary artery disease (CAD) analysis system that includes a user interface usable to communicate patient coronary artery disease related informationto a user.
However, such CAD analysis system can be relatively cumbersome to use and in some
cases it is difficult for a user to quickly obtain relevant CAD information for a patient
using the system.
No need to explain “in detail in the patent specification”4 “CT” of “coronary computer tomography (CT)” to one of conventional, routine skill in the art “under 35 USC 112(a)” via applicant’s specification, page 14,ll.15-25 and page 3:
Detailed Description of Embodiments
The present disclosure relates to a coronary artery disease (CAD) analysis system that
is arranged to identify CAD, in the present example using coronary computed
tomography (CT) data, communicate patient CAD related information to a user and facilitate interaction with the user, for example so as to receive instructions from the
user, information from the user and/or edits from the user that aim to improve the
accuracy of the CAD results presented to the user. In this example, the system is able
to determine a CAC score for a patient, detect the presence and severity of individual
stenosis lesions, and identify early stages of coronary artery disease and/or high patient
risk by identifying vulnerable plaques (sometimes referred to in this specification as 'plaque features') including spotty calcification, low attenuation plaques and positive25 remodelng of the vessel walls.
In contrast claim 10,11,12,13 reflect the disclosed improvement at page 37,ll.15-20:
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Claim Rejections - 35 USC § 102
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.
(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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated5 by MIN et al. (US 2021/0209757 A1).
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated6 by MIN et al. (US 2021/0209757 A1).
Re 1., MIN discloses A coronary artery disease (CAD) analysis system (likewise) comprising7:8
a CAD analysis device arranged to9 analyse received patient CT scan data that includes a patient's coronary arteries10 the CT scan data associated with a CT volume;
the CAD analysis system comprising a user interface11 configured to12: (or likewise:
[0311] In some embodiments, the system is configured as a web-based software application that is intended to be used by trained medical professionals as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques (i.e., atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of coronary artery disease (CAD), or suspected CAD. This system post processes CT images obtained using a CT scanner. The system is configured to generate a user interface that provides tools and functionality for the characterization, measurement, and visualization of features of the coronary arteries.):
facilitate selection of a location on a coronary artery (or likewise:
[0074] FIG. 8B illustrates an example of a portion of a panel displayed on the user interface that allows selection of a territory or combination of territories (e.g., left main artery (LM), left anterior descending artery (LAD), left circumflex artery (LCx), right coronary artery (RCA), according to various embodiments.
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);
display a multiplanar reconstruction (MPR) representation of the coronary artery
, the MPR representation including a vessel identifier that indicates the selected location on the coronary artery (or likewise:
[0051] FIG. 7H illustrates an example of a panel of the user interface that can be displayed while using the segment tool which allows for marking the boundaries13 between individual coronary segments on the MPR.
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; and
simultaneously display at least one CT volume representation of the CT volume
14 and the displayed CT volume representation including a common CT volume location that includes the selected location on the coronary artery;
wherein selection of the location on the MPR representation of the coronary artery causes synchronised display of the common CT volume location on the at least one CT volume representation (or likewise:
“By simultaneously displaying a portion of the coronary vessel in, for example, two, three, four, five or six views simultaneously, and allowing a practitioner to explore particular15 locations of a coronary vessel in one view while the other 2-6 views correspondingly show the exact same location provides an enormous amount of insight into the condition of the vessel and allows the practitioner/analyst to quickly and easily visually integrate the presented information to gain a comprehensive and accurate understanding of the condition of the coronary vessel being examined.” [0294] last S:
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).
Re 2, MIN discloses The CAD analysis16 system as claimed in claim 1, wherein the user interface is configured to17 simultaneously display multiple CT volume representations of the CT volume, the CT volume representations taken along respective planes that extend through the CT volume at different orientations, and the multiple displayed CT volume representations each including the common CT volume location18(or said likewise:
“By simultaneously displaying a portion of the coronary vessel in, for example, two, three, four, five or six views simultaneously, and allowing a practitioner to explore particular locations of a coronary vessel in one view while the other 2-6 views correspondingly show the exact same location provides an enormous amount of insight into the condition of the vessel and allows the practitioner/analyst to quickly and easily visually integrate the presented information to gain a comprehensive and accurate understanding of the condition of the coronary vessel being examined.” [0294] last S:
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“By simultaneously displaying a portion of the coronary vessel in, for example, two, three, four, five or six views simultaneously, and allowing a practitioner to explore particular locations of a coronary vessel in one view while the other 2-6 views correspondingly show the exact same location provides an enormous amount of insight into the condition of the vessel and allows the practitioner/analyst to quickly and easily visually integrate the presented information to gain a comprehensive and accurate understanding of the condition of the coronary vessel being examined.” [0294] last S).
Re 3., MIN discloses The CAD analysis system as claimed in claim 1, wherein the user interface is19 (fig. 6A) 20 2122 23 (via:
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Re 4. The CAD analysis24 system as claimed in claim 2, wherein the user interface is configured to25 enable a user to move (fig. 6A:605: “rotation tool” [0337] penult A) the selected coronary artery location, wherein movement of the selected coronary artery location causes the multiple displayed CT volume representations of the CT volume to change in synchronisation26 (or likewise “Locations in the CT images displayed on portions (or “panels”) of the user interface are correlated precisely by the system such that the same locations are displayed concurrently in a different views.” [0294] penult S: fig. 6A) with the selected location on the vessel MPR so that the common CT volume location changes in accordance with the moved selected coronary artery location (fig. 6A:605 is a “tool” performs a “same location…concurrent…rotation” [0294] to [0337]:
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Re 5., MIN discloses The CAD analysis system as claimed in claim 2, wherein the CT volume representations correspond to planes extending through the CT volume at mutually orthogonal orientations (or likewise:
[0039] FIG. 6H illustrates examples of panels of the user interface for viewing DICOM images in three anatomical planes: axial, coronal, and sagittal.
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Claim 6 is rejected like claim 5:
Re 6., MIN discloses The CAD analysis system as claimed in claim 5, wherein the CT volume representations correspond to an axial plane, a coronal plane and a sagittal plane.
Claim 7 is rejected like claim 3:
Re 7. , MIN discloses The CAD analysis system as claimed in claim 1, wherein the user interface is 27 28 29.
Re 8., MIN discloses The CAD analysis system as claimed in claim 1, wherein the MPR representation includes a vessel slice identifier that indicates a selected slice of the coronary artery displayed in the MPR representation (or likewise: “CT…’slices’ of…particular30 locations of a coronary vessel” [0294] last sentences:
Accordingly, the use of the term “CT images” herein may refer to any type of imaging system having any type of imaging source that produces a set of images depicting “slices” of structures within a body, unless otherwise indicated. One key aspect of the user interface described herein is the precise correlation of the views and information that is displayed of the CT images. Locations in the CT images displayed on portions (or “panels”) of the user interface are correlated precisely by the system such that the same locations are displayed concurrently in a different views. By simultaneously displaying a portion of the coronary vessel in, for example, two, three, four, five or six views simultaneously, and allowing a practitioner to explore particular locations of a coronary vessel in one view while the other 2-6 views correspondingly show the exact same location provides an enormous amount of insight into the condition of the vessel and allows the practitioner/analyst to quickly and easily visually integrate the presented information to gain a comprehensive and accurate understanding of the condition of the coronary vessel being examined.).
Re 9., MIN discloses The CAD analysis system as claimed in claim 1, wherein the MPR representation is a curved multiplanar reconstruction (CPR)
[0056] FIG. 7M illustrates the stenosis markers on segments on a curved multiplanar vessel (CMPR) view.
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Re 10., MIN discloses The CAD analysis system as claimed in claim 2, wherein the interface is configured to31 display plane indicia32 (or likewise “MPR”-“marking” [0350]) on a CT volume representation, the plane indicia indicative of a plane associated with another CT volume representation, and to enable a user to interact with the plane indicia to modify the plane (or likewise “edit the...segment” [0350]: fig. 7H:625,626) associated with the other CT volume representation and thereby modify the displayed other CT volume representation (via [0350]:
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[0350] FIG. 7H illustrates an example of the second panel 602 that can be displayed while using the Segment tool 705 which allows for marking the boundaries between individual coronary segments on the MPR. The user interface 600 is configured such that when the Segment tool 705 is selected, lines (e.g., lines 623, 624) appear on the vessel image in the second panel 602 on the vessels in the SMPR view. The lines indicate segment boundaries that were determined by the system. The names are displayed in icons 625, 626 adjacent to the respective line 623, 624. To edit the name of the segment, click on an icon 625, 626 and label appropriately using the name panel 611, illustrated in FIG. 7I. A segment can also be deleted, for example, by selecting a trashcan icon. The lines 623, 624 can be moved up and down to define the segment of interest. If a segment is missing, the user can add a new segment using a segment addition button, and labeled using the labeling feature in the segment labeling pop-up menu 611.
Re 11., MIN discloses The CAD analysis system as claimed in claim 10, wherein the plane indicia is modifiable so as to change the orientation of the plane associated with the other CT volume representation (or likewise “Tracker tool 712 orients …the SMPR, CMPR, cross-section, axial, coronal, sagittal, and the 3D artery tree views. …on the editing toolbar” [0347]:
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[0347] FIGS. 7B and 7C illustrate certain functionality of the Tracker tool. The Tracker tool 712 orients and allows user to correlate the views shown in the various panels of the user interface 600, for example, in the SMPR, CMPR, cross-section, axial, coronal, sagittal, and the 3D artery tree views. To activate, the tracker icon is selected on the editing toolbar. When the Tracker tool 712 is activated, the user interface generates and displays a line 616 (e.g., a red line) on the SMPR or CMPR view. The system generates on the user interface a corresponding (red) disc 617 which is displayed on the 3D artery tree in the first panel 601 in a corresponding location as the line 616. The system generates on the user interface a corresponding (red) dot which his displayed on the axial, sagittal and coronal views in the fourth panel 608 in a corresponding location as the line 616. The line 616, disc 617, and dots 618 are location indicators all referencing the same location in the different views, such that scrolling any of the trackers up and down will also result in the same movement of the location indicator in other views. Also, the user interface 600 displays the cross-sectional image in panel 606 corresponding to the location indicated by the location indicators.
Re 12., MIN discloses The CAD analysis system as claimed in claim 11, wherein the plane indicia includes at least one rotation handle (or likewise “scrolling”) selectable by a user and usable to rotate the plane associated with the other CT volume representation (via [0347]:
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[0347] FIGS. 7B and 7C illustrate certain functionality of the Tracker tool. The Tracker tool 712 orients and allows user to correlate the views shown in the various panels of the user interface 600, for example, in the SMPR, CMPR, cross-section, axial, coronal, sagittal, and the 3D artery tree views. To activate, the tracker icon is selected on the editing toolbar. When the Tracker tool 712 is activated, the user interface generates and displays a line 616 (e.g., a red line) on the SMPR or CMPR view. The system generates on the user interface a corresponding (red) disc 617 which is displayed on the 3D artery tree in the first panel 601 in a corresponding location as the line 616. The system generates on the user interface a corresponding (red) dot which his displayed on the axial, sagittal and coronal views in the fourth panel 608 in a corresponding location as the line 616. The line 616, disc 617, and dots 618 are location indicators all referencing the same location in the different views, such that scrolling any of the trackers up and down will also result in the same movement of the location indicator in other views. Also, the user interface 600 displays the cross-sectional image in panel 606 corresponding to the location indicated by the location indicators.
Re 13., MIN discloses The CAD analysis33 system as claimed in claim 10, wherein the plane indicia includes a line normal3435 (or likewise a “line”-“normal” via “a normalization algorithm based in a linear regression model” [0412] 3rd S) to the plane associated with the other CT volume representation.
Re 14., MIN discloses The CAD analysis system as claimed in claim 1, wherein the interface is configured to enable a user to modify a current displayed CT volume representation (or likewise “rotate a displayed linear view” [0302]) associated with a current plane so as to display a different CT volume representation associated with a different plane parallel (via “a linear36 view” [0302] 2nd S) to the current plane (fig. 7JKL:
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Re 15., MIN discloses The CAD analysis system as claimed in claim 14, wherein the interface is configured to modify the location of plane indicia on another CT volume representation in response to display of the different CT volume representation associated with the different plane (or likewise:
“the system can be configured to allow a user to rotate in a 360° fashion an artery in order to allow the user to see different portions of the artery at different angles37” [0303], last S, via figs. 7J,K,L:
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Conclusion
The prior art “nearest to the subject matter defined in the claims” (MPEP 707.05) made of record and not relied upon is considered pertinent to applicant's disclosure.
The following table lists several references that are relevant to the subject matter claimed and disclosed in this Application. The references are not relied on by the Examiner, but are provided to assist the Applicant in responding to this Office action:
Citation
Relevance
IDS (9/23/2024) cited Dachille et al. (US 2011/0206247 A1): a D1 & X reference
Dachille teaches an easy scroll interface:
[0042] The 2D views (61, 62, 63) allow a user to scroll through the corresponding MPR slices (using e.g., mouse wheel), which enables the user to determine orientation, contextual information and easy selection of calcified regions.
as the closest to applicant’s fast scroll disclosure, page 34,ll.30-35:
“As shown in FIG. 27, a vessel label 224 may be displayed adjacent the calcified volume 222, for example in response to hovering a mouse over the calcified volume 222.
It will be understood that a user is able to use the scroll bar 26 to:
quickly receive an indication of the extent of coronary artery calcification by virtue of the number and distribution of lines 220;
quickly receive an indication of the respective axial locations of coronary artery calcified volumes for a patient based on the respective locations of the calcium indicia 210;
quickly identify the coronary arteries that include calcifications by virtue of the colour of the calcium indicia 210; and
determine the relative size of the calcifications by virtue of the size of the lines 220.”
Dachille et al. (US 2007/0276214 A1) same inventor name as IDS (9/23/2024) cited Dachille et al. (US 2011/0206247 A1): a D1 & X reference
Dachille (US 2007/0276214 A1) teaches “synchronized views” ([0021] penult S) & “simultaneously displayed” ([0043] 3rd S) & a “coronary arteries…seed point at a…selected location…to interactively grow parts of the dataset that are similar to the selected location and nearby” ([0048) 2nd & 3rd Ss):
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as the closest to the claimed “simultaneously display…the selected location on the coronary artery…synchronized display” of claim 1.
IDS (9/23/2024 & 5/23/2025) cited MIN et al. (WO 2021/141921 A1): an X & D2 reference corresponding to MIN et al. (US 2021/0217165 A1): a D2 reference corresponding to MIN et al. (US 2021/0209757 A1) as applied above under 35 USC 102 regarding claims 1-15
MIN (WO 2021/141921 A1) teaches “scrolling…quickly” [0346]:
[0346] Figure 6M illustrates a panel that can be displayed on the user interface 600 to add a new vessel on the image, according to one embodiment. To add a new vessel on the image, the user interface 600 can receive a user input via a “+Add Vessel” button on the toolbar 612. The user interface will display a “create Mode” 615 button appear in the fourth panel 608 on the axial, coronal and sagittal view. Then the vessel can be added on the image by scrolling and clicking the left mouse button to create multiple dots (e.g., green dots). As the new vessel is being added, it will preview as a new vessel in the MPR, cross-section, and 3D artery tree view. The user interface is configured to receive a “Done” command to indicate adding the vessel has been completed. Then, to segment the vessels utilizing the system’s semi-automatic segmentation tool, click “Analyze” on the tool bar and the user interface displays suggested segmentation for review and modification. The name of the vessel can be chosen by selecting “New” in the 3D artery tree view in the first panel 601, which activates the name panel 611 and the name of the vessel can be selected from panel 611, which then stores the new vessel and its name. In an embodiment, if the software is unable to identify the vessel which has been added by the user, it will return straight vessel lines connecting the user-added green dots, and the user can adjust the centerline. The pop-up menu 611 of the user interface allows new vessels to be identified and named according to a standard format quickly and consistently.
as the closest to applicant’s fast scroll disclosure, page 34,ll.30-35:
“As shown in FIG. 27, a vessel label 224 may be displayed adjacent the calcified volume 222, for example in response to hovering a mouse over the calcified volume 222.
It will be understood that a user is able to use the scroll bar 26 to:
quickly receive an indication of the extent of coronary artery calcification by virtue of the number and distribution of lines 220;
quickly receive an indication of the respective axial locations of coronary artery calcified volumes for a patient based on the respective locations of the calcium indicia 210;
quickly identify the coronary arteries that include calcifications by virtue of the colour of the calcium indicia 210; and
determine the relative size of the calcifications by virtue of the size of the lines 220.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS ROSARIO whose telephone number is (571)272-7397. The examiner can normally be reached Monday-Friday, 9AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Henok Shiferaw can be reached at 571-272-4637. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from 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.
/DENNIS ROSARIO/Examiner, Art Unit 2676
/Henok Shiferaw/Supervisory Patent Examiner, Art Unit 2676
1 MPEP 2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017], 2nd para, 2nd to last S: The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).
2 MPEP 2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017], 2nd para, 2nd to last S: The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).
3 The crossed text is not limiting under BRI as being in the alternative and thus not selected
4 MPEP 2106.05(d) Well-Understood, Routine, Conventional Activity [R-07.2022] I. EVALUATING WHETHER THE ADDITIONAL ELEMENTS ARE WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY, 5th txt blk:
As such, an examiner should determine that an element (or combination of elements) is well-understood, routine, conventional activity only when the examiner can readily conclude, based on their expertise in the art, that the element is widely prevalent or in common use in the relevant industry. The analysis as to whether an element (or combination of elements) is widely prevalent or in common use is the same as the analysis under 35 U.S.C. 112(a) as to whether an element is so well-known that it need not be described in detail in the patent specification. See Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1546 ( Fed. Cir. 2016) (supporting the position that amplification was well-understood, routine, conventional for purposes of subject matter eligibility by observing that the patentee expressly argued during prosecution of the application that amplification was a technique readily practiced by those skilled in the art to overcome the rejection of the claim under 35 U.S.C. 112, first paragraph); see also Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984) ("[T]he specification need not disclose what is well known in the art."); In re Myers, 410 F.2d 420, 424, 161 USPQ 668, 671 (CCPA 1969) ("A specification is directed to those skilled in the art and need not teach or point out in detail that which is well-known in the art."); Exergen Corp., 725 Fed. App’x. 959, 965 (Fed. Cir. 2018) (holding that "[l]ike indefiniteness, enablement, or obviousness, whether a claim is directed to patent eligible subject matter is a question of law based on underlying facts," and noting that the Supreme Court has recognized that "the inquiry 'might sometimes overlap' with other fact-intensive inquiries like novelty under 35 U.S.C. § 102"). If the element is not widely prevalent or in common use, or is otherwise beyond those elements recognized in the art or by the courts as being well-understood, routine or conventional, then the element will in most cases favor eligibility. For example, even if a particular technique (e.g., measuring blood glucose via an earring worn by a person with diabetes) would have been obvious to one of ordinary skill in the art because it was discussed in several widely-read scientific journals or used by a few scientists, mere knowledge of the particular technique or use of the particular technique by a few scientists is not necessarily sufficient to make the use of the particular technique routine or conventional in the relevant field. The examiner in this situation would already know, based on the examiner's expertise in the field, that blood glucose is routinely and conventionally monitored by other techniques (e.g., via placing a small droplet of blood on a diagnostic test strip, or via an implanted insulin pump with a glucose sensor). Thus, the examiner would not need to perform a prior art search in order to determine that the particular claimed technique using the glucose-sensing earring was not well-understood, routine, conventional activity previously engaged in by scientists in the field.
5 MPEP 2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017], 2nd para, 2nd to last S: The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).
6 MPEP 2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017], 2nd para, 2nd to last S: The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).
7 BROAD CLAIM LANGUAGE: -ing (of “comprising”): a suffix of nouns formed from verbs, expressing the action of the verb or its result, product, material, etc. (the art of building; a new building; cotton wadding ), wherein etc. is defined: and others; and so forth; and so on (used to indicate that more of the same sort or class might have been mentioned, but for brevity have been omitted)., wherein so is defined: likewise or correspondingly; also; too.(Dictionary.com)
8 colon: the sign (:) used to mark a major division in a sentence, to indicate that what follows is an elaboration, summation, implication, etc., of what precedes (“A coronary artery disease (CAD) analysis system”) (Dictionary.com)
9 MEANING & PURPOSE 1I: “analyse received patient CT scan data”
10 The crossed-out text “does not limit” via MPEP 2143.03 All Claim Limitations Must Be Considered [R-01.2024], 3rd para: As a general matter, the grammar and ordinary meaning of terms (“and”) as understood by one having ordinary skill in the art used in a claim will dictate whether, and to what extent, the language limits the claim scope. Language (“analyse received patient CT scan data that includes a patient's coronary arteries, and produce CAD analysis data indicative of presence of coronary artery disease in the patient CT scan data”) that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. In addition, when a claim requires selection of an element from a list of alternatives (“analyse received patient CT scan data that includes a patient's coronary arteries, and produce CAD analysis data indicative of presence of coronary artery disease in the patient CT scan data”), the prior art teaches the element if one of the alternatives is taught by the prior art. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009), wherein and is defined: (used to connect alternatives). (Dictionary.com)
11 user interface: Digital Technology. the interface features through which users interact with the hardware and software of computers and other electronic devices. UI (Dictionary.com)
12 MEANING & PURPOSE II: to: (used for expressing aim, purpose, or intention). (Dictionary.com)
13 boundaries: (tr) to put identifying or designating labels, stamps, etc, on, esp to indicate price (Dictionary.com)
14 The crossed-out text “does not limit” via MPEP 2143.03 All Claim Limitations Must Be Considered [R-01.2024], 3rd para: As a general matter, the grammar and ordinary meaning of terms as understood by one having ordinary skill in the art used in a claim will dictate whether, and to what extent, the language limits the claim scope. Language (“at least one CT volume representation”) that suggests or makes a feature (“each CT volume representation taken along a plane that extends through the CT volume”) or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. In addition, when a claim requires selection of an element from a list of alternatives, the prior art teaches the element if one of the alternatives is taught by the prior art. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009), wherein each is defined: every one of two or more considered individually or one by one. (Dictionary.com)
15 particular: exceptionally selective, attentive, or exacting; fastidious; fussy. (Dictionary.com)
16 MEANING AND PURPOSE I: analysis: the separating of any material or abstract entity into its constituent elements (opposed to synthesis). (Dictionary.com)
17 MEANING AND PURPOSE II: to: (used for expressing aim, purpose, or intention). (Dictionary.com)
18 Claim 2 is “a limitation…that… gave ‘meaning and purpose to the manipulative steps’ ” via MPEP 2111.04 "Adapted to," "Adapted for," "Wherein," "Whereby," and Contingent Clauses [R-10.2019]
I. "ADAPTED TO," "ADAPTED FOR," "WHEREIN," and "WHEREBY":
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps").
19 “is” essentially means look at a figure (Dictionary.com).
20 MEANING AND PURPOSE II: to: (used for expressing aim, purpose, or intention). (Dictionary.com)
21 Regarding “on” via applicant’s disclosure very last S: “Modifications and variations as would be apparent to a skilled addressee are deemed to be within the scope of the present invention.”. wherein scope is defined: Linguistics, Logic. the range of words or elements of an expression over which a modifier (e.g. a patent examiner) or operator (e.g., me) has control. (Dictionary.com)
22 on: 31 definitions/senses of “on” via Dictionary.com such as sense 4 (one of the broadest senses/definitions): in connection, association, or cooperation with; as a part or element of. (Dictionary.com)
23 The crossed out text (claim 3’s “on” has 31 senses/definitions via Dictionary.com) is not “a limitation…that… gave ‘meaning and purpose to the manipulative steps’ ” via MPEP 2111.04 "Adapted to," "Adapted for," "Wherein," "Whereby," and Contingent Clauses [R-10.2019]
I. "ADAPTED TO," "ADAPTED FOR," "WHEREIN," and "WHEREBY":
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps").
24 MEANING AND PURPOSE I (claim 4 is not directed to meaning and purpose I): analysis:
1 the separating of any material or abstract entity into its constituent elements (opposed to synthesis).
2 this process as a method of studying the nature of something or of determining its essential features and their relations.
3 a presentation, usually in writing, of the results of this process. (Dictionary.com)
25 MEANING AND PURPOSE II: to: (used for expressing aim, purpose, or intention). (Dictionary.com)
26 synchronization: synchronize: to cause to indicate the same time, as one timepiece with another. (Dictionary.com)
27 MEANING AND PURPOSE II: to: (used for expressing aim, purpose, or intention). (Dictionary.com)
28 in: (used to indicate motion or direction from outside to a point within) into, wherein into is defined: to a point of contact with; against, wherein against is defined: into contact or collision with; toward; upon, wherein upon is defined: on (in any of various senses [i.e., 31 definitions of “on”], used as an equivalent of on with no added idea of ascent or elevation, and preferred in certain cases only for euphonic or metrical reasons). (Dictionary.com)
29 The crossed out text is not “a limitation…that… gave ‘meaning and purpose to the manipulative steps’ ” via MPEP 2111.04 "Adapted to," "Adapted for," "Wherein," "Whereby," and Contingent Clauses [R-10.2019]
I. "ADAPTED TO," "ADAPTED FOR," "WHEREIN," and "WHEREBY":
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps").
30 particular: exceptionally selective, attentive, or exacting; fastidious; fussy. (Dictionary.com)
31 MEANING AND PURPOSE II: to: (used for expressing aim, purpose, or intention). (Dictionary.com)
32 indicia: distinguishing markings or signs; indications (Dictionary.com)
33 MEANING AND PURPOSE I (claim 13 is not directed to meaning and purpose I but is directed to meaning and purpose II): analysis:
1 the separating of any material or abstract entity into its constituent elements (opposed to synthesis).
2 this process as a method of studying the nature of something or of determining its essential features and their relations.
3 a presentation, usually in writing, of the results of this process. (Dictionary.com: AMERICAN)
1 the division of a physical or abstract whole into its constituent parts to examine or determine their relationship or value Compare synthesis (Dictioanry.com: BRITISH)
34 Regarding “line normal” via applicant’s disclosure very last sentence: “ Modifications and variations as would be apparent to a skilled addressee are deemed to be within the scope of the present invention.”
35BROAD CLAIM LANGUAGE normal: the usual state, amount, level, etc., especially the average or mean. (Dictionary.com)
36 linear: narrow and having parallel edges (Dictionary.com)
37 angle: a viewpoint; standpoint. (Dictionary.com)
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