DETAILED ACTION
Contents
I. Notice of Pre-AIA or AIA Status 4
II. Priority 4
III. Pertinent Prosecution History 5
IV. Claim Status 8
V. Reissue Requirements 8
VI. Information Disclosure Statement(s) 10
VII. Oath/Declaration 10
VIII. Claim Interpretation 12
A. Lexicographic Definitions 12
B. 35 U.S.C § 112 6th Paragraph 12
(1) Functional Phrase – “Processor I” 13
(2) Functional Phrase – “Processor II” 19
(3) Functional Phrase – “Processor III” 24
(4) Functional Phrase – “Processor IV” 30
(5) Functional Phrase – “Processor V” 34
(8) Functional Phrase – “Instructions I” 37
(9) Functional Phrase – “Instructions II” 42
(10) Functional Phrase – “Instructions III” 47
(11) Functional Phrase – “Instructions IV” 52
(12) Functional Phrase – “Instructions V” 56
(13) Functional Phrase – “Processor VI” 59
(14) Functional Phrase – “Instructions VI” 63
IX. Claim Rejections – 35 U.S.C. § 112 67
A. 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph 67
(1) Written Description 67
B. 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph 68
X. Claim Rejections – 35 U.S.C. § 251 70
A. Oath/Declaration 70
XI. Allowable Subject Matter 71
A. Claims 20 and 41 71
B. Claims 21 and 42 72
C. Claims 138 and 148 73
XII. Response to Arguments 74
A. Oath/Declaration Objection(s) 74
B. Specification Objection(s) 75
C. Claim Objection(s) 75
D. Claim Interpretation 75
E. 35 U.S.C. § 112 for Written Description and Essential Steps 76
F. Original Patent Requirement 76
XIII. Conclusion 77
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. In the event the determination of the status of the application as subject to pre-AIA 35 U.S.C. 102 and 103 (or as subject to AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Applicant filed the instant reissue application 17/566,572 (“‘572 Reissue Application”) on 30 December 2021 for U.S. Application No. 15/802,293 (“‘293 Application"), filed 02 November 2017, now U.S. Patent No. 10,517,504 (“‘504 Patent”), issued 31 December 2019, which is a continuation of U.S. Application No. 15/061,798 (“‘798 Application"), filed 04 March 2016, now U.S. Patent No. 9,808,177 (“‘934 Patent”), issued 17 November 2017, which is a continuation of U.S. Application No. 13/830,632 (“‘632 Application"), filed 14 March 2013, now U.S. Patent No. 9,280,718 (“‘718 Patent”), issued 08 March 2016, which is a continuation-in-part of PCT Application No. PCT/US2011/062137 (“‘137 PCT Application"), filed 23 November 2011, which claims domestic priority to Provisional Application No. 61/417,182 (“’182 Prov Application”), filed 24 November 2010.
Thus, the Examiner concludes that for examination purposes the instant ‘572 Reissue Application claims a priority date of 24 November 2010.
Pertinent Prosecution History
As set forth supra, Applicant filed the application for the instant ‘572 Reissue Application on 30 December 2021. The Examiner finds that the instant ‘572 Reissue Application included a preliminary amendment (“Dec 2021 Preliminary Amendment”) to the claims (“Dec 2021 Claim Amendment”), and the specification (“Dec 2021 Spec Amendment”). The Dec 2021 Claim Amendment includes an amendment: providing original claims 1-42; and adding new claims 43-77.
The Office issued a non-Final Office action on 23 February 2024 (“Feb 2024 Non-Final Office Action”). In particular, the Feb 2024 Non-Final Office Action provided: 1) a restriction requirement providing original patent claims 1-42 being constructively elected by original presentation and claims 43-77 being withdrawn as being directed to a non-elected invention;1 2) rejections for claims 1-42 (“Rejected Claims”) under 35 U.S.C. §§ 112(a), 112(b), 103(a), 251 and Double Patenting; 2 and 3) an indication of allowable subject matter.3
On 26 August 2024, Applicant filed a response to the Feb 2024 Non-Final Office Action (“Aug 2024 Applicant Response”). The Aug 2024 Applicant Response contained: “Remarks,” “Amendments to the Specification” (“Aug 2024 Spec Amendment”), “Amendments to the Drawings” (“Aug 2024 Drawings Amendment”) and “Amendments to the Claims” (“Aug 2024 Claim Amendment”) including: original claims 20, 21, 41 and 42; canceled original claims 1-19 and 22-40; canceled new claims 43-77; and new claims 78-137.
The Office issued a second non-Final Office action on 17 September 2024 (“Sept 2024 Non-Final Office Action”). In particular, the Sept 2024 Non-Final Office Action provided rejections for claims 20, 21, 41, 42 and 78-137 (“Rejected Claims”) under 35 U.S.C. §§ 112, 103, and Double Patenting.4 In addition, the Sept 2024 Non-Final Office Action indicated an indication of allowable subject matter for all independent claims (i.e., claims 20, 21, 41, 42, 78, 93, 108 and 123).
On 14 March 2025, Applicant filed a response to the Sept 2024 Non-Final Office Action (“March 2025 Applicant Response”). The Mar 2025 Applicant Response contained: “Remarks,” “Amendments to the Specification” (“Mar 2025 Spec Amendment”), and “Amendments to the Claims” (“Mar 2025 Claim Amendment”) including: original claims 20, 21, 41 and 42; amended5 new claims 84, 88-92, 97-99, 103-107, 114, 118-122, 127-129 and 133-137; new6 claims 78-83, 85, 86, 93-96, 100, 101, 108-113, 115, 116, 123-126, 130 and 131; canceled7 original claims 1-19 and 22-40; and canceled8 new claims 43-77, 87, 102, 117 and 132.
On 17 March 2025, Applicant filed a Terminal Disclaimer to overcome the Obvious Double Patenting rejection provide in the Sept 2024 Non-Final Office Action (“Mar 2025 Terminal Disclaimer”).
The Office issued a non-compliant notification to Applicant on 24 March 2025 indicating that the status identifier of the “”New” non-amended claims was improper. (Mar 2025 Non-Compliant Notice”).
On 01 May 2025, Applicant filed a response to the Mar 2025 Non-Compliant Notice (“May 2025 Applicant Response”). The May 2025 Applicant Response contained: “Remarks,” and “Amendments to the Claims” (“May 2025 Claim Amendment”). With respect to the claim requirements, the Examiner finds that May 2025 Claim Amendment is the same as the Mar 2025 Claim Amendment with the only different being the status identifier for the “New” claims.
The Office issued a Final Office action on 20 June 2025 (“June 2025 Final Office Action”). In particular, the June 2025 Final Office Action provided rejections for claims 20, 21, 41, 42, 78-86, 88-101, 103-116, 118-131 and 133-137 (“Rejected Claims”) under 35 U.S.C. §§ 112 and 251.9 In addition, the June 2025 Final Office Action indicated an indication of allowable subject matter for all independent claims (i.e., claims 20, 21, 41, 42, 78, 93, 108 and 123).
On 20 November 2025, Applicant filed a response to the June 2025 Final Office Action (“Nov 2025 Applicant Response”). The Nov 2025 Applicant Response contained: “Remarks,” “Amendments to the Specification” (“Nov 2025 Spec Amendment”), and “Amendments to the Claims” (“Nov 2025 Claim Amendment”) including: amended10 original claims 20, 21 and 41; original claim 42; twice amended11 new claims 84, 97-99, 114 and 127-129; amended12 new claims 79-83, 85, 86, 88-92, 94-96, 100, 101, 103-107, 109-113, 115, 116, 118-122, 124-126, 130, 131 and 133-137; new13 claims 138-157; canceled14 original claims 1-19 and 22-40; and canceled15 new claims 43-78, 87, 93, 102, 108, 117, 123 and 132.
Claim Status
The Examiner finds that the claim status in the instant ‘572 Reissue Application is as follows:
Claim(s) 20, 21 and 41 (Original and amended)
Claim(s) 42 (Original)
Claim(s) 1-19 and 22-40 (Original and canceled)
Claim(s) 84, 97-99, 114 and 127-129 (New and twice amended)
Claim(s) 79-83, 85, 86, 88-92, 94-96, 100, 101, 103-107, 109-113, 115, 116, 118-122, 124-126, 130, 131 and 133-137 (New and once amended)
Claim(s) 138-157 (New)
Claim(s) 43-78, 87, 93, 102, 108, 117, 123 and 132 (New and canceled)
Thus, the Examiner concludes that claims 20, 21, 41, 42, 79-86, 88-92, 94-101, 103-107, 109-116, 118-122, 124-131 and 133-157 are pending in the instant ‘572 Reissue Application. Claims 20, 21, 41, 42, 79-86, 88-92, 94-101, 103-107, 109-116, 118-122, 124-131 and 133-157 are examined (“Examined Claims”).
Reissue Requirements
For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which the ‘504 Patent is or was involved. These proceedings would include interferences, reissues, reexaminations, post-grant proceedings and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation.
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.
The Examiner notes that Amendment practice for Reissue Applications is NOT the same as for non-provisional applications. See MPEP §§ 1413 and 1453. Reissue application amendments must comply with 37 CFR 1.173, while non-provisional application amendments must comply with 37 CFR 1.173. Particularly,
Manner of making amendments under 37 CFR 1.173:
All markings (underlining and bracketing) are made relative to the original patent text, 37 CFR 1.173(g) (and not relative to the prior amendment).
For amendments to the abstract, specification and claims, the deleted matter must be enclosed in brackets, and the added matter must be underlined. See 37 CFR 1.173(d).
For amendments to the drawings, any changes to a patent drawing must be submitted as a replacement sheet of drawings which shall be an attachment to the amendment document. Any replacement sheet of drawings must be in compliance with § 1.84 and shall include all of the figures appearing on the original version of the sheet, even if only one figure is amended. Amended figures must be identified as "Amended," and any added figure must be identified as "New." In the event that a figure is canceled, the figure must be surrounded by brackets and identified as "Canceled." All changes to the drawing(s) shall be explained, in detail, beginning on a separate sheet accompanying the papers including the amendment to the drawings. See 37 CFR 1.173(b)(3).
The Examiner further notes that all amendments to the instant ‘572 Reissue Application must comply with 37 CFR 1.173(b)-(g).
Information Disclosure Statement(s)
Applicant's Information Disclosure Statement filed on 26 November 2025 (“Nov 2025 IDS”) has been received, considered and entered into the record.
Oath/Declaration
The Examiner finds that the Declaration filed by Applicant on 01 August 2022 (“Aug 2022 Oath/Declaration”) is currently defective because of the following:
The Examiner finds that the Aug 2022 Oath/Declaration filed by Applicant states,
New claims of the present reissue application are of different scope (e.g., broader) than claims 1-42 of U.S. Patent No. 10,517,504 (the "504 patent"). For example, at least claim 1 of the '504 patent recites "automatically processing the electronic MRI image, using one or more computer processors, to emphasize pixels associated with a border." New claim 60 of the present reissue application does not recite those limitations.
(Aug 2022 Oath/Declaration; emphasis added). Thus, Applicant asserts that new claims 60-77 are broadening claims. The Examiner finds that the Aug 2022 Oath/Declaration, in light of the originally filed preliminary Dec 2021 Claim Amendment, was compliant.
However, the Aug 2022 Oath/Declaration filed with this application is now deemed defective because the error which is relied upon to support the reissue application is not an error upon which a reissue can be based. See 37 CFR 1.175 and MPEP § 1414. The Examiner finds that the error upon which the instant reissue is based is addressed only by the non-elected Group III, claims 60-77, not Group I, claims 1-42, which is constructively elected by original presentation. Thus, the Aug 2022 Oath/Declaration is incorrect because it does not state correctly state an error upon which this instant ‘572 Reissue Application is based.
Moreover, Applicant attempted to identify and provide a statement of an error upon which the instant ‘572 Reissue Application can be based. (Aug 2024 Applicant Response at 39-40; and May 2025 Applicant Response at 34). However, while an error statement provided by Applicant in the “Remarks” section of a response is proper when the original error statement, and in return, the originally filed Oath/Declaration was deemed proper, as was set forth above, the error statement must still be compliant with 37 CFR 1.175. (See MPEP §§ 1414.03.I and 1444.III.A). Thus, the Examiner finds that Applicant must explicitly identify on the record an error being relied upon as the basis for reissue (e.g., in the remarks accompanying an amendment). (See 37 CFR 1.175(d)).
For example, and as a matter of suggestion only, the Examiner would accept the following statement of error if provided by Applicant in the “Remarks” section of a response:
Applicant believes U.S. Patent No. 10,517,504 (the “‘504 patent”) to be partly inoperative or invalid by reason of the patentee claiming more than the patentee has a right to claim. Thus, Applicant seeks to broaden claim 1. Specifically, at least claim 1 of the ‘504 patent recites “automatically processing the electronic MRI image, using one or more computer processors, to emphasize pixels associated with a border.” New claim 138 of the present reissue application does not recite this limitation and instead recites a different embodiment requiring “image fusion” instead.
Claim Interpretation
During examination, claims are given the broadest reasonable interpretation consistent with the specification and limitations in the specification are not read into the claims. See MPEP § 2111, MPEP § 2111.01 and In re Yamamoto et al., 222 USPQ 934 (Fed. Cir. 1984). Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01(I). It is further noted it is improper to import claim limitations from the specification, i.e., a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment. See MPEP § 2111.01(II). Therefore, unless one of the exceptions applies below, Examiners will interpret the limitations of the pending and examined claims using the broadest reasonable interpretation.
Lexicographic Definitions
A first exception to the prohibition of reading limitations from the specification into the claims is when the Applicant for patent has provided a lexicographic definition for the term. See MPEP § 2111.01(IV). Following an independent review of the claims in view of the specification herein, Examiners find that Applicant has not provided any lexicographic definitions related to claim terms with any reasonable clarity, deliberateness and precision.
35 U.S.C § 112 6th Paragraph
A second exception to the prohibition of reading limitations from the specification into the claims is when the claimed feature is written as a means-plus-function or a step-plus-function. See 35 U.S.C. § 112(6th ¶) and MPEP §§ 2181-2183. As noted in MPEP § 2181, a three prong test is used to determine the scope of a means-plus-function or step-plus-function limitation in a claim:
(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"
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
The Examiner finds herein that claims 20, 21, 41, 42, 79-86, 88-92, 94-101, 103-107, 109-116, 118-122, 124-131, 133-139, 142-149 and 152-1577 include one or more claim limitations that do not use the word “means,” but instead use as a generic placeholder substitute for “means.” However, the claims are not being interpreted under 35 U.S.C. §112 (6th ¶) because the claim limitations use a generic placeholder that is coupled with functional language, but recites sufficient structure to perform the recited function. Each such limitation will be discussed in turn as follows:
Functional Phrase – “Processor I”
A first means-plus-function phrase is recited in claims 20 and 21 (and included in each of dependent claims 79-86, 88-92, 109-116 and 118-122) which recites “one or more computer processors …” or hereinafter “Functional Phrase 1” or “FP1.” The Examiner determines herein that FP1 does meet the three prong test and thus will be interpreted as a means-plus-function limitation under 35 U.S.C. §112(6th ¶).
The Examiner finds that claims 20 and 21 expressly recite:
automatically processing the electronic MRI image, using one or more computer processors, to emphasize pixels associated with a border between the region of interest and structure adjacent to the region of interest; and
automatically processing the additional electronic image, using one or more computer processors, to emphasize pixels associated with a border between the region of interest and structure adjacent to the region of interest
[emphasis added].
i. 3-Prong Analysis: Prong (A)
FP1 meets invocation prong (A) because "means ... for" type language is recited. The Examiner first finds that “processor” is a generic placeholder or nonce term equivalent to “means” because the term “processor” conveys some structures, but not any specific structures related to the function.
Additionally, the Examiner has reviewed the prosecution history and the relevant prior art of record herein and find that “processor” as used in the claims does not provide an art-recognized structure to perform the claimed function.
The Examiner finds that a processor is definable as (1) a system or mechanism that accepts a program as input, prepares it for execution, and executes the process so defined with data to produce results, or (2) a computer program that includes the compiling, assembling, translating, and related functions for a specific programming language, for example, Cobol processor, Fortran processor.16 A processor is also definable as the part of a computer system that operates on data.17 Accordingly, the Examiner finds processor can be defined or interpreted as either a system or mechanism that accepts a program and executes the program process with data to acquire a result, or a computer program. Accordingly, the Examiner finds that processor implies little more than a generic processor in association with a special function. Rather more than a simple processor would be required to perform the function recited in FP1.
Accordingly, the Examiner finds nothing in the specification, prosecution history or the prior art to construe “processor…” in FP1 as the name of a sufficiently definite structure for performing the functions recited in FP1 so as to take the overall claim limitation out of the ambit of §112(6th ¶). See Williamson v. Citrix Online, L.L.C., 115 USPQ2d 1105, 1112 (Fed. Cir. 2015).
In light of the above, the Examiner concludes that the term “processor…” is a generic placeholder having no specific structure associated therewith. Because “processor …” is merely a generic placeholder having no specific structure associated therewith, the Examiner concludes that FP1 meets invocation Prong (A).
ii. 3-Prong Analysis: Prong (B)
Based upon a review of FP1, the Examiner finds the following claimed function(s) as:
[A]utomatically [P]rocessing the electronic MRI image to [E]mphasize pixels associated with a border between the region of interest and structure adjacent to the region of interest
Because FP1 recites the above recited Functions, the Examiner concludes that FP1 meets Invocation Prong (B).
iii. 3-Prong Analysis: Prong (C)
Based upon a review of the entire Functional Phrase 1, the Examiner finds that Functional Phrase 1 does not contain sufficient structure for performing the entire claimed function that is set forth within Functional Phrase 1. In fact, the Examiner finds that Functional Phrase 1 recites very little structure (if any) for performing the claimed function. Specifically, while Functional Phrase 1 cites one or more computer processors, the processors are recited generically in association with special function and thus the phrase does not recite sufficient structure for performing this special function.
Because Functional Phrase 1 does not contain sufficient structure for performing the entire claimed function, the Examiner concludes that Functional Phrase 1 meets invocation Prong (C).
Because Functional Phrase 1 meets the 3-prong analysis as set forth in MPEP § 2181 I, the Examiner concludes that Functional Phrase 1 invokes 35 U.S.C § 112 6th paragraph.
Corresponding structure for Functional Phrase 1
Once a claimed phrase invokes 35 U.S.C. § 112 6th paragraph, the next step is to determine the corresponding structure. (MPEP § 2181 II). In order to satisfy the requirements of 35 U.S.C. § 112, second paragraph, there must be identified in the applications’ disclosure a single structure and/or algorithm which performs the function of FP1.
The Examiner has carefully reviewed the original disclosure to determine the corresponding structure for FP1. In reviewing the original disclosure, the Examiner finds that the ‘504 Patent discloses:
Example embodiments relating to automated voxelation methods are provided below by reference to FIGS. 5-10B. More specifically, FIG. 5 shows a software flow diagram 200 of an automated voxelation method that can be used by an automated voxelation system, such as the system of FIG. 11 discussed below. As discussed in more detail below, the system can include an MRI/MRS system configured to acquire MRI images of a region of interest in a portion of a patient's body and/or to perform an MRS exam or procedure using the voxelation. The system can also include a computer system that can have a processor and a computer readable medium, which can be configured to execute a program that performs some or all of the method shown in FIG. 5. The method of FIG. 5 can include: image processing 210, including further detailed blocks 211-214 shown; ROI location and isolation 220, including further detailed blocks 221-224 shown; 2D voxel formation 230, including further detailed blocks 231-233 shown; and 3D voxel formation 240, including further detailed blocks 241-246 shown. Various aspects of the method are further illustrated in additional FIGS. 6-10B as follows.
(‘504 Patent at c.27, l.60 – c.28, l.13; emphasis added); and
FIG. 7A shows a flow diagram which reintroduces various detailed blocks 211-214 of image processing phase 210 of the automated voxelation approach illustrated above in FIG. 5. The modified mid-sagittal 2D planar image 250 shown in FIG. 7B illustrates the results from the image processing described.
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(Id. at c.28, ll.19-24; emphasis added). In examination of Figures 7A and 7B of the ‘504 Patent below, the Examiner finds that that the image processing 210 specifically includes consecutively executed blocks that include: locating a center image slice (i.e. 211); 3-D smoothing (i.e. 212); and top hat filtering (i.e. 213). The Examiner finds that the ‘504 Patent discloses the 3-D smoothing can be accomplished various types of image smoothing utilizing brightness values. (Id. at c.30, l.63 – c.31, l.29). In addition, the Examiner finds that the ‘504 Patent discloses many types of top-hat filtering may be utilized to deemphasize portions of the features that do not correspond to the ROI. (Id. at c.31, l.30 – c.32, l.16). Moreover, the Examiner finds that the ‘504 Patent discloses performing order statistic filtering to darken the image except for the pixels that are generally surrounded by bright pixels. (Id. at c.32, ll.17-39). The ‘504 Patent further discloses that various blocks may or may not be utilized together to perform the image processing to emphasize the pixels of the features of interest, and furthermore discloses additional image processing operations can be added with or in place of the operations disclosed in the ‘504 Patent. (Id. at c.32, ll.40-63). The Examiner finds that the structure to achieve the claim required algorithms is performed by specific hardware/software configurations. (Id. at c.42, ll. 10-30).
Thus, in light of the portions of the ‘504 Patent cited above, the Examiner concludes the corresponding structure for performing the claimed function as simply at least one or more special purpose processors/computers containing algorithms/software for automatically performing one or more of: at least one top-hat filtering operation, at least one morphological image processing operation, and an order statistic filtering operation, or its equivalent.
Functional Phrase – “Processor II”
A second means-plus-function phrase is recited in claims 20, 21 and 138 (and included in each of dependent claims 79-86, 88-92, 109-116, 118-122 and 139-147) which recites “one or more computer processors …” or hereinafter “Functional Phrase 2” or “FP2.” The Examiner determines herein that FP2 does meet the three prong test and thus will be interpreted as a means-plus-function limitation under 35 U.S.C. §112(6th ¶).
The Examiner finds that claims 20 and 21 expressly recite:
automatically identifying, using the one or more computer processors, a population of pixels in the electronic MRI image associated with the border
[emphasis added]; and,
automatically identifying, using the one or more computer processors, an additional population of pixels in the additional electronic image associated with the border between the region of interest and the structure adjacent the region of interest
[emphasis added]; and claim 138 recites,
automatically identifying, using the one or more computer processors, a population of pixels in the fused electronic MRI image associated with the border between the region of interest and the structure adjacent to the region of interest
[emphasis added].
i. 3-Prong Analysis: Prong (A)
FP2 meets invocation prong (A) because "means ... for" type language is recited. The Examiner first finds that “processor” is a generic placeholder or nonce term equivalent to “means” because the term “processor” conveys some structures, but not any specific structures related to the function.
Additionally, the Examiner has reviewed the prosecution history and the relevant prior art of record herein and find that “processor” as used in the claims does not provide an art-recognized structure to perform the claimed function. Rather more than a simple processor would be required to perform the function recited in FP2.18
Accordingly, the Examiner finds nothing in the specification, prosecution history or the prior art to construe “processor…” in FP2 as the name of a sufficiently definite structure for performing the functions recited in FP2 so as to take the overall claim limitation out of the ambit of §112(6th ¶). See Williamson v. Citrix Online, L.L.C., 115 USPQ2d 1105, 1112 (Fed. Cir. 2015).
In light of the above, the Examiner concludes that the term “processor…” is a generic placeholder having no specific structure associated therewith. Because “processor …” is merely a generic placeholder having no specific structure associated therewith, the Examiner concludes that FP2 meets invocation Prong (A).
ii. 3-Prong Analysis: Prong (B)
Based upon a review of FP2, the Examiner finds the following claimed function(s) as:
[A]utomatically [I]dentifying a population of pixels in the electronic MRI image associated with the border
[A]utomatically [I]dentifying an additional population of pixels in the additional electronic image associated with the border between the region of interest and the structure adjacent the region of interest
[A]utomatically [I]dentifying a population of pixels in the fused electronic MRI image associated with the border between the region of interest and the structure adjacent to the region of interest
Because FP2 recites the above recited Functions, the Examiner concludes that FP2 meets Invocation Prong (B).
iii. 3-Prong Analysis: Prong (C)
Based upon a review of the entire Functional Phrase 2, the Examiner finds that Functional Phrase 2 does not contain sufficient structure for performing the entire claimed function that is set forth within Functional Phrase 2. In fact, the Examiner finds that Functional Phrase 2 recites very little structure (if any) for performing the claimed function. Specifically, while Functional Phrase 2 cites one or more computer processors, the processors are recited generically in association with special function and thus the phrase does not recite sufficient structure for performing this special function.
Because Functional Phrase 2 does not contain sufficient structure for performing the entire claimed function, the Examiner concludes that Functional Phrase 2 meets invocation Prong (C).
Because Functional Phrase 2 meets the 3-prong analysis as set forth in MPEP § 2181 I, the Examiner concludes that Functional Phrase 2 invokes 35 U.S.C § 112 6th paragraph.
Corresponding structure for Functional Phrase 2
Once a claimed phrase invokes 35 U.S.C. § 112 6th paragraph, the next step is to determine the corresponding structure. (MPEP § 2181 II). In order to satisfy the requirements of 35 U.S.C. § 112, second paragraph, there must be identified in the applications’ disclosure a single structure and/or algorithm which performs the function of FP2.
The Examiner has carefully reviewed the original disclosure to determine the corresponding structure for FP2. In reviewing the original disclosure, the Examiner finds that the ‘504 Patent discloses:
Example embodiments relating to automated voxelation methods are provided below by reference to FIGS. 5-10B. More specifically, FIG. 5 shows a software flow diagram 200 of an automated voxelation method that can be used by an automated voxelation system, such as the system of FIG. 11 discussed below. As discussed in more detail below, the system can include an MRI/MRS system configured to acquire MRI images of a region of interest in a portion of a patient's body and/or to perform an MRS exam or procedure using the voxelation. The system can also include a computer system that can have a processor and a computer readable medium, which can be configured to execute a program that performs some or all of the method shown in FIG. 5. The method of FIG. 5 can include: image processing 210, including further detailed blocks 211-214 shown; ROI location and isolation 220, including further detailed blocks 221-224 shown; 2D voxel formation 230, including further detailed blocks 231-233 shown; and 3D voxel formation 240, including further detailed blocks 241-246 shown. Various aspects of the method are further illustrated in additional FIGS. 6-10B as follows.
(‘504 Patent at c.27, l.60 – c.28, l.13; emphasis added); and
FIG. 8A reintroduces the flow diagram from FIG. 5 for a ROI location and isolation phase 220 of the automated voxelation program 200, including detailed blocks 221-224. FIG. 8B shows a mid-sagittal 2D planar MRI image 250 as in prior figures for the exemplary spine, but as modified to reflect the results arrived at following completion of the location of a unique population of pixels for the ROI at block 222 shown in FIG. 8A. More specifically, FIG. 8B shows default ellipsoid search areas 260 applied to the image 250, with the unique population of pixels estimated to represent the disc ROI shown at contrast enhanced bright pseudo-ellipsoidal regions 270 within default ellipsoid search areas 260. FIG. 8C shows the same MRI image 250 as prior FIGS. 6, 7B, and 8B above, but as further modified to reflect and plot the estimated ellipsoid shapes 280 generated by the program for the respective disc nucleus regions at block 224 shown in FIG. 8A.
(Id. at c.28, ll.19-24; emphasis added). In examination of Figures 8A and 8B of the ‘504 Patent below, the Examiner finds that that the ROI location and isolation 220 specifically includes consecutively executed blocks, one of which is the locate unique population of pixels with ROI 222 block. With respect to the functionality of the locate unique population of pixels with ROI 222, the Examiner finds that the ‘504 Patent discloses,
[a]fter applying default ellipsoid search areas 260 to the image, such as at block 221 of Phase 220 of the voxel automation 200, the following can be performed. At block 222, for each or one or more of the elliptical search areas 260, all the pixels within the area which have a particular property (e.g., an intensity of at least 0.15) can be assigned to a pixel population corresponding to the ROI. The pixels can be identified by their spatial coordinates in the image (which correspond to world coordinates in the imaged object).
(Id. at c.33, ll.28-47; see Figure 8B below; emphasis added). The Examiner further finds that the default ellipsoid search areas 260 may be omitted in the identification of the population of pixels. (Id. at c.35, ll.39-46). The Examiner finds that the structure to achieve the claim required algorithms is performed by specific hardware/software configurations. (Id. at c.42, ll. 10-30).
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Thus, in light of the portions of the ‘504 Patent cited above, the Examiner concludes the corresponding structure for performing the claimed function as simply at least one or more special purpose processors/computers containing algorithms/software for automatically identifying a particular property of the pixels and assigning the identified pixels to a population of pixels, or its equivalent.
Functional Phrase – “Processor III”
A third means-plus-function phrase is recited in claims 20, 21 and 138 (and included in each of dependent claims 79-86, 88-92, 109-116, 118-122 and 139-147) which recites “one or more computer processors …” or hereinafter “Functional Phrase 3” or “FP3.” The Examiner determines herein that FP3 does meet the three prong test and thus will be interpreted as a means-plus-function limitation under 35 U.S.C. §112(6th ¶).
The Examiner finds that claims 20 and 21 expressly recite:
automatically fitting, using the one or more computer processors, a two dimensional shape inside a cross-section of the region of interest and within the border shown by the electronic MRI image based on the population of pixels
[emphasis added]; and claim 138 recites:
automatically fitting, using the one or more computer processors, a two dimensional shape inside across-section of the region of interest and within the border shown by the fused electronic MRI image based on the population of pixels
[emphasis added].
i. 3-Prong Analysis: Prong (A)
FP3 meets invocation prong (A) because "means ... for" type language is recited. The Examiner first finds that “processor” is a generic placeholder or nonce term equivalent to “means” because the term “processor” conveys some structures, but not any specific structures related to the function.
Additionally, the Examiner has reviewed the prosecution history and the relevant prior art of record herein and find that “processor” as used in the claims does not provide an art-recognized structure to perform the claimed function. Rather more than a simple processor would be required to perform the function recited in FP3.19
Accordingly, the Examiner finds nothing in the specification, prosecution history or the prior art to construe “processor…” in FP3 as the name of a sufficiently definite structure for performing the functions recited in FP3 so as to take the overall claim limitation out of the ambit of §112(6th ¶). See Williamson v. Citrix Online, L.L.C., 115 USPQ2d 1105, 1112 (Fed. Cir. 2015).
In light of the above, the Examiner concludes that the term “processor…” is a generic placeholder having no specific structure associated therewith. Because “processor …” is merely a generic placeholder having no specific structure associated therewith, the Examiner concludes that FP3 meets invocation Prong (A).
ii. 3-Prong Analysis: Prong (B)
Based upon a review of FP3, the Examiner finds the following claimed function(s) as:
[A]utomatically [F]itting a two dimensional shape inside a cross-section of the region of interest and within the border shown by the electronic MRI image based on the population of pixels
[A]utomatically [F]itting a two dimensional shape inside across-section of the region of interest and within the border shown by the fused electronic MRI image based on the population of pixels
Because FP3 recites the above recited Functions, the Examiner concludes that FP3 meets Invocation Prong (B).
iii. 3-Prong Analysis: Prong (C)
Based upon a review of the entire Functional Phrase 3, the Examiner finds that Functional Phrase 3 does not contain sufficient structure for performing the entire claimed function that is set forth within Functional Phrase 3. In fact, the Examiner finds that Functional Phrase 3 recites very little structure (if any) for performing the claimed function. Specifically, while Functional Phrase 3 cites one or more computer processors, the processors are recited generically in association with special function and thus the phrase does not recite sufficient structure for performing this special function.
Because Functional Phrase 3 does not contain sufficient structure for performing the entire claimed function, the Examiner concludes that Functional Phrase 3 meets invocation Prong (C).
Because Functional Phrase 3 meets the 3-prong analysis as set forth in MPEP § 2181 I, the Examiner concludes that Functional Phrase 3 invokes 35 U.S.C § 112 6th paragraph.
Corresponding structure for Functional Phrase 3
Once a claimed phrase invokes 35 U.S.C. § 112 6th paragraph, the next step is to determine the corresponding structure. (MPEP § 2181 II). In order to satisfy the requirements of 35 U.S.C. § 112, second paragraph, there must be identified in the applications’ disclosure a single structure and/or algorithm which performs the function of FP3.
The Examiner has carefully reviewed the original disclosure to determine the corresponding structure for FP3. In reviewing the original disclosure, the Examiner finds that the ‘504 Patent discloses:
Example embodiments relating to automated voxelation methods are provided below by reference to FIGS. 5-10B. More specifically, FIG. 5 shows a software flow diagram 200 of an automated voxelation method that can be used by an automated voxelation system, such as the system of FIG. 11 discussed below. As discussed in more detail below, the system can include an MRI/MRS system configured to acquire MRI images of a region of interest in a portion of a patient's body and/or to perform an MRS exam or procedure using the voxelation. The system can also include a computer system that can have a processor and a computer readable medium, which can be configured to execute a program that performs some or all of the method shown in FIG. 5. The method of FIG. 5 can include: image processing 210, including further detailed blocks 211-214 shown; ROI location and isolation 220, including further detailed blocks 221-224 shown; 2D voxel formation 230, including further detailed blocks 231-233 shown; and 3D voxel formation 240, including further detailed blocks 241-246 shown. Various aspects of the method are further illustrated in additional FIGS. 6-10B as follows.
(‘504 Patent at c.27, l.60 – c.28, l.13; emphasis added); and
FIG. 9A reintroduces flow diagram 200 with respect to the 2D voxel formation phase 230, including more detailed blocks 231-233 in order to prepare for 3D voxel formation phase 240. An illustrative result of this phase is shown in FIG. 9B, which shows the mid-sag[g]ital 2D planar image 250 with the 2D voxel prescriptions 290 shown within the respective discs of the 5 lumbar disc levels. FIG. 9B also shows the 2D planar image 252 for the orthogonal transverse oblique axial plane for the L4-L5 disc in this example.
(Id. at c.28, ll.42-50; emphasis added). In examination of Figures 9A and 9B of the ‘504 Patent below, the Examiner finds that that the 2D voxel formation phase 230 specifically includes consecutively executed blocks, one of which is the Scale Z dimensions for ROI thickness and Y dimension for ROI Height 233 block. With respect to the functionality of the Scale Z dimensions
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for ROI thickness and Y dimension for ROI Height 233, the Examiner finds that the ‘504 Patent discloses,
[g]iven the above ROI (disc nucleus) characteristic data provided per the operations above, it becomes possible to automatically form two dimensional (2D) shapes or voxels, at phase 230. At block 231, image coordinate data can be extracted, and at block 232, the image coordinates can be converted to world coordinates using a transformation matrix. The system can, for example, apply an experimentally determined scale factor (e.g., of 2.9 times the image to world scale factor (e.g., 0.39 from the DICOM metadata)) to the semi-minor axis to determine the voxel thickness in the z-axis (axial axis), and to the semi-minor axis to determine the voxel dimensions in the machine y-axis (coronal axis), as shown in block 233. In some embodiments, the 2D shape can be a rectilinear shape such as a rectangle, although many other 2D shapes can be used. Many variations are possible.
(Id. at c.36, ll.28-42; emphasis added). The Examiner finds that the ‘504 Patent discloses utilizing some kind of factor to ensure that the generation of the two dimensional shape includes the dimensions of the two dimensional shape being within the ROI previously determined. The Examiner further finds that the various components of the 2D voxel formation phase 230 can be omitted in the determination and fitting of the two dimensional shape inside the ROI. (Id. at c.36, ll.43-55). The Examiner finds that the structure to achieve the claim required algorithms is performed by specific hardware/software configurations. (Id. at c.42, ll. 10-30).
Thus, in light of the portions of the ‘504 Patent cited above, the Examiner concludes the corresponding structure for performing the claimed function as simply at least one or more special purpose processors/computers containing algorithms/software for automatically determining a factor to create a two dimensional shape that fits within the previously determined ROI, or its equivalent.
Functional Phrase – “Processor IV”
A fourth means-plus-function phrase is recited in claims 20 and 138 (and included in each of dependent claims 79-86, 88-92 and 139-147) which recites “one or more computer processors …” or hereinafter “Functional Phrase 4” or “FP4.” The Examiner determines herein that FP4 does meet the three prong test and thus will be interpreted as a means-plus-function limitation under 35 U.S.C. §112(6th ¶).
The Examiner finds that claims 20 and 138 expressly recites:
automatically generating, using the one or more computer processors, world coordinates that define a three dimensional selected volume comprising a voxel that fits inside of the region of interest and excludes the border based on one or more of the two dimensional shapes;
[emphasis added].
i. 3-Prong Analysis: Prong (A)
FP4 meets invocation prong (A) because "means ... for" type language is recited. The Examiner first finds that “processor” is a generic placeholder or nonce term equivalent to “means” because the term “processor” conveys some structures, but not any specific structures related to the function.
Additionally, the Examiner has reviewed the prosecution history and the relevant prior art of record herein and find that “processor” as used in the claims does not provide an art-recognized structure to perform the claimed function. Rather more than a simple processor would be required to perform the function recited in FP4.20
Accordingly, the Examiner finds nothing in the specification, prosecution history or the prior art to construe “processor…” in FP4 as the name of a sufficiently definite structure for performing the functions recited in FP4 so as to take the overall claim limitation out of the ambit of §112(6th ¶). See Williamson v. Citrix Online, L.L.C., 115 USPQ2d 1105, 1112 (Fed. Cir. 2015).
In light of the above, the Examiner concludes that the term “processor…” is a generic placeholder having no specific structure associated therewith. Because “processor …” is merely a generic placeholder having no specific structure associated therewith, the Examiner concludes that FP4 meets invocation Prong (A).
ii. 3-Prong Analysis: Prong (B)
Based upon a review of FP4, the Examiner finds the following claimed function(s) as:
[A]utomatically [G]enerating world coordinates that define a three dimensional selected volume comprising a voxel that fits inside of the region of interest and excludes the border based on one or more of the two dimensional shapes
Because FP4 recites the above recited Functions, the Examiner concludes that FP4 meets Invocation Prong (B).
iii. 3-Prong Analysis: Prong (C)
Based upon a review of the entire Functional Phrase 4, the Examiner finds that Functional Phrase 4 does not contain sufficient structure for performing the entire claimed function that is set forth within Functional Phrase 4. In fact, the Examiner finds that Functional Phrase 4 recites very little structure (if any) for performing the claimed function. Specifically, while Functional Phrase 4 cites one or more computer processors, the processors are recited generically in association with special function and thus the phrase does not recite sufficient structure for performing this special function.
Because Functional Phrase 4 does not contain sufficient structure for performing the entire claimed function, the Examiner concludes that Functional Phrase 4 meets invocation Prong (C).
Because Functional Phrase 4 meets the 3-prong analysis as set forth in MPEP § 2181 I, the Examiner concludes that Functional Phrase 4 invokes 35 U.S.C § 112 6th paragraph.
Corresponding structure for Functional Phrase 4
Once a claimed phrase invokes 35 U.S.C. § 112 6th paragraph, the next step is to determine the corresponding structure. (MPEP § 2181 II). In order to satisfy the requirements of 35 U.S.C. § 112, second paragraph, there must be identified in the applications’ disclosure a single structure and/or algorithm which performs the function of FP4.
The Examiner has carefully reviewed the original disclosure to determine the corresponding structure for FP4. In reviewing the original disclosure, the Examiner finds that the ‘504 Patent discloses:
Example embodiments relating to automated voxelation methods are provided below by reference to FIGS. 5-10B. More specifically, FIG. 5 shows a software flow diagram 200 of an automated voxelation method that can be used by an automated voxelation system, such as the system of FIG. 11 discussed below. As discussed in more detail below, the system can include an MRI/MRS system configured to acquire MRI images of a region of interest in a portion of a patient's body and/or to perform an MRS exam or procedure using the voxelation. The system can also include a computer system that can have a processor and a computer readable medium, which can be configured to execute a program that performs some or all of the method shown in FIG. 5. The method of FIG. 5 can include: image processing 210, including further detailed blocks 211-214 shown; ROI location and isolation 220, including further detailed blocks 221-224 shown; 2D voxel formation 230, including further detailed blocks 231-233 shown; and 3D voxel formation 240, including further detailed blocks 241-246 shown. Various aspects of the method are further illustrated in additional FIGS. 6-10B as follows.
(‘504 Patent at c.27, l.60 – c.28, l.13; emphasis added); and
FIGS. 10A-B illustrate the result of this process as follows. FIG. 10A reintroduces for flow diagram 200 the flow for 3D voxel formation phase 240, including more detailed blocks thereof 241-246. An illustrative 3D voxel prescription result is shown for one disc of the spine in angular perspective view relative to two transverse mid-sagittal (e.g., yz plane) and mid-coronal (e.g., xz plane) 2D MRI images.
(Id. at c.28, ll.42-50; emphasis added). In examination of Figures 10A and 10B of the ‘504 Patent, the Examiner finds that that the 3D voxel formation phase 240 specifically includes consecutively executed blocks of the Image Processing ROI Location and Isolation and 2D Voxel Formation blacks 242-244. The Examiner find that the ‘504 Patent discloses each MRI image slice can have the image processing 242, ROI location and solation 243, and 2D voxel formation 244 be performed thereon, and forming a 3D voxel formation from the combination of the 2D voxel formations of each respective MRI image slice. (Id. at c.36, l.56 – c.37, l.8). The Examiner finds that the structure to achieve the claim required algorithms is performed by specific hardware/software configurations. (Id. at c.42, ll. 10-30).
Thus, in light of the portions of the ‘504 Patent cited above, the Examiner concludes the corresponding structure for performing the claimed function as simply at least one or more special purpose processors/computers containing algorithms/software for generating a three dimensional volume from a series of images which comprises a voxel that fits inside of the region of interest and excludes the border based on one or more of the two dimensional shapes, or its equivalent.
Functional Phrase – “Processor V”
A fifth means-plus-function phrase is recited in claims 21 (and included in each of dependent claims 109-116 and 118-122) which recites “one or more computer processors …” or hereinafter “Functional Phrase 5” or “FP5.” The Examiner determines herein that FP5 does meet the three prong test and thus will be interpreted as a means-plus-function limitation under 35 U.S.C. §112(6th ¶).
The Examiner finds that claim 21 expressly recites:
automatically generating, using the one or more computer processors, world coordinates that define a three dimensional selected volume comprising a voxel that fits inside of the region of interest and excludes the border based on one or more of the two dimensional shapes by:
generating first world coordinates that define a first volume that fits inside the region of interest;
generating second world coordinates that define a second volume that fits inside the region of interest based on a different number of electronic MRI images than used for generating the first volume;
calculating a volume size of the first volume;
calculating a volume size of the second volume; and
selecting as the voxel the one of the first volume and the second volume that has the larger volume size;
[emphasis added].
i. 3-Prong Analysis: Prong (A)
FP5 meets invocation prong (A) because "means ... for" type language is recited. The Examiner first finds that “processor” is a generic placeholder or nonce term equivalent to “means” because the term “processor” conveys some structures, but not any specific structures related to the function.
Additionally, the Examiner has reviewed the prosecution history and the relevant prior art of record herein and find that “processor” as used in the claims does not provide an art-recognized structure to perform the claimed function. Rather more than a simple processor would be required to perform the function recited in FP5.21
Accordingly, the Examiner finds nothing in the specification, prosecution history or the prior art to construe “processor…” in FP5 as the name of a sufficiently definite structure for performing the functions recited in FP5 so as to take the overall claim limitation out of the ambit of §112(6th ¶). See Williamson v. Citrix Online, L.L.C., 115 USPQ2d 1105, 1112 (Fed. Cir. 2015).
In light of the above, the Examiner concludes that the term “processor…” is a generic placeholder having no specific structure associated therewith. Because “processor …” is merely a generic placeholder having no specific structure associated therewith, the Examiner concludes that FP5 meets invocation Prong (A).
ii. 3-Prong Analysis: Prong (B)
Based upon a review of FP5, the Examiner finds the following claimed function(s) as:
[A]utomatically [G]enerating world coordinates that define a three dimensional selected volume comprising a voxel that fits inside of the region of interest and excludes the border based on one or more of the two dimensional shapes by:
[G]enerating first world coordinates that define a first volume that fits inside the region of interest;
[G]enerating second world coordinates that define a second volume that fits inside the region of interest based on a different number of electronic MRI images than used for generating the first volume;
[C]alculating a volume size of the first volume;
[C]alculating a volume size of the second volume; and
[S]electing as the voxel the one of the first volume and the second volume that has the larger volume size
Because FP5 recites the above recited Functions, the Examiner concludes that FP5 meets Invocation Prong (B).
iii. 3-Prong Analysis: Prong (C)
Based upon a review of the entire Functional Phrase 5, the Examiner concludes that FP5. does contain sufficient structure for performing the entire Function of Functional Phrase 5. The Examiner finds that FP5 includes the algorithm of “generating first world coordinates that define a first volume that fits inside the region of interest; generating second world coordinates that define a second volume that fits inside the region of interest based on a different number of electronic MRI images than used for generating the first volume; calculating a volume size of the first volume; calculating a volume size of the second volume; and selecting as the voxel the one of the first volume and the second volume that has the larger volume size.” In examination of the ‘504 Patent, the Examiner finds that the ‘504 Patent discloses generating would coordinates that define a 3D selected volume several ways, one of which is using the steps as defined above. (‘504 Patent at c.37, ll.12-40). From this perspective, the Examiner finds that the further inclusion of the structure/algorithm above provides sufficient structure for performing the entire Function of Functional Phrase 5.
Because the Functional Phrase does contain sufficient structure for performing the entire claimed function, the Examiner concludes that FP5 does not meet Invocation Prong (C).
In conclusion, because FP5 does not meet the three prong analysis set forth in MPEP §2181 I, the Examiner concludes that Functional Phrase 5 does not invoke 35 U.S.C. § 112, 6th paragraph.
Functional Phrase – “Instructions I”
An eighth means-plus-function phrase is recited in claims 41 and 42 (and included in each of dependent claims 94-101, 103-107, 124-131 and 133-137) which recites “instructions …” or hereinafter “Functional Phrase 8” or “FP8.” The Examiner determines herein that FP8 does meet the three prong test and thus will be interpreted as a means-plus-function limitation under 35 U.S.C. §112(6th ¶).
The Examiner finds that claims 41 and 42 expressly recite:
the instructions configured to cause one or more computer processors to perform actions comprising:
[for each of the plurality of electronic MRI images]: processing the electronic MRI image to emphasize pixels associated with a border between the region of interest and neighboring structure
[emphasis added];
i. 3-Prong Analysis: Prong (A)
FP8 meets invocation prong (A) because "means ... for" type language is recited. The Examiner first finds that “instructions” is a generic placeholder or nonce term equivalent to “means” because the term “instructions” does nothing more than simply define a generic structure, i.e., means. The Examiner further notes that the specification of the ‘504 Patent does not specifically define “instructions” and thus the specification of the ‘504 Patent does not impart or disclose any structure for the phrase. Rather, the Examiner finds that the ‘504 Patent uses this same phrase to describe several instructions.
Furthermore, the Examiner finds there is no disclosure or suggestion from the prior art that instructions is a sufficient and definite structure to perform the functions recited in FP8. For example, U.S. Publication No. 2010/0303358 illustrates instructions for automatic analysis of image data of a structure different instructions (i.e., implemented blocks) and distinct operation from any of the instructions of the ‘504 Patent. Similarly, U.S. Patent No. 6,195,409 illustrates instructions for automatic scan prescription having different instructions (i.e., implemented blocks) and distinct operation from any of the instructions of the ‘504 Patent.
Accordingly, the Examiner finds nothing in the specification, prosecution history or the prior art to construe “instructions …” in FP8 as the name of a sufficiently definite structure for performing the functions recited in FP8 so as to take the overall claim limitation out of the ambit of §112(6th ¶). See Williamson v. Citrix Online, L.L.C., 115 USPQ2d 1105, 1112 (Fed. Cir. 2015).
In light of the above, the Examiner concludes that the term “instructions …” is a generic placeholder having no specific structure associated therewith. Because “instructions …” is merely a generic placeholder having no specific structure associated therewith, the Examiner concludes that FP8 meets invocation Prong (A).
ii. 3-Prong Analysis: Prong (B)
Based upon a review of FP8, the Examiner finds that claimed function(s) is:
[P]rocessing the electronic MRI image to emphasize pixels associated with a border between the region of interest and neighboring structure
Because FP8 recites the above recited functions, the Examiner concludes that FP8 meets Invocation Prong (B).
iii. 3-Prong Analysis: Prong (C)
Based upon a review of the entire Functional Phrase 8, the Examiner finds that Functional Phrase 8 does not contain sufficient structure for performing the entire claimed function that is set forth within Functional Phrase 8. In fact, the Examiner finds that Functional Phrase 8 recites very little structure (if any) for performing the claimed function.
Because Functional Phrase 8 does not contain sufficient structure for performing the entire claimed function, the Examiner concludes that Functional Phrase 8 meets invocation Prong (C).
Because Functional Phrase 8 meets the 3-prong analysis as set forth in MPEP § 2181 I, the Examiner concludes that Functional Phrase 8 does invokes 35 U.S.C § 112 6th paragraph.
Corresponding structure for Functional Phrase 8
Once a claimed phrase invokes 35 U.S.C. § 112 6th paragraph, the next step is to determine the corresponding structure. (MPEP § 2181 II). In order to satisfy the requirements of 35 U.S.C. § 112, second paragraph, there must be identified in the applications’ disclosure a single structure and/or algorithm which performs the function of FP8.
The Examiner has carefully reviewed the original disclosure to determine the corresponding structure for FP8. In reviewing the original disclosure, the Examiner finds that the ‘504 Patent discloses:
Example embodiments relating to automated voxelation methods are provided below by reference to FIGS. 5-10B. More specifically, FIG. 5 shows a software flow diagram 200 of an automated voxelation method that can be used by an automated voxelation system, such as the system of FIG. 11 discussed below. As discussed in more detail below, the system can include an MRI/MRS system configured to acquire MRI images of a region of interest in a portion of a patient's body and/or to perform an MRS exam or procedure using the voxelation. The system can also include a computer system that can have a processor and a computer readable medium, which can be configured to execute a program that performs some or all of the method shown in FIG. 5. The method of FIG. 5 can include: image processing 210, including further detailed blocks 211-214 shown; ROI location and isolation 220, including further detailed blocks 221-224 shown; 2D voxel formation 230, including further detailed blocks 231-233 shown; and 3D voxel formation 240, including further detailed blocks 241-246 shown. Various aspects of the method are further illustrated in additional FIGS. 6-10B as follows.
(‘504 Patent at c.27, l.60 – c.28, l.13; emphasis added); and
FIG. 7A shows a flow diagram which reintroduces various detailed blocks 211-214 of image processing phase 210 of the automated voxelation approach illustrated above in FIG. 5. The modified mid-sagittal 2D planar image 250 shown in FIG. 7B illustrates the results from the image processing described.
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(Id. at c.28, ll.19-24; emphasis added). In examination of Figures 7A and 7B of the ‘504 Patent below, the Examiner finds that that the image processing 210 specifically includes consecutively executed blocks that include: locating a center image slice (i.e. 211); 3-D smoothing (i.e. 212); and top hat filtering (i.e. 213). The Examiner finds that the ‘504 Patent discloses the 3-D smoothing can be accomplished various types of image smoothing utilizing brightness values. (Id. at c.30, l.63 – c.31, l.29). In addition, the Examiner finds that the ‘504 Patent discloses many types of top-hat filtering may be utilized to deemphasize portions of the features that do not correspond to the ROI. (Id. at c.31, l.30 – c.32, l.16). Moreover, the Examiner finds that the ‘504 Patent discloses performing order statistic filtering to darken the image except for the pixels that are generally surrounded by bright pixels. (Id. at c.32, ll.17-39). The ‘504 Patent further discloses that various blocks may or may not be utilized together to perform the image processing to emphasize the pixels of the features of interest, and furthermore discloses additional image processing operations can be added with or in place of the operations disclosed in the ‘504 Patent. (Id. at c.32, ll.40-63).
(Id. at c.32, ll.40-63).
Thus, in light of the portions of the ‘504 Patent cited above, the Examiner concludes the corresponding structure for performing the claimed function as simply algorithms/software, that can be executed by a special purpose computer/processing device, comprising performing one or more of: at least one top-hat filtering operation, at least one morphological image processing operation, and an order statistic filtering operation, or its equivalent.
Functional Phrase – “Instructions II”
A ninth means-plus-function phrase is recited in claims 41, 42 and 148 (and included in each of dependent claims 94-101, 103-107, 124-131, 133-137 and 149-157) which recites “instructions …” or hereinafter “Functional Phrase 9” or “FP9.” The Examiner determines herein that FP9 does meet the three prong test and thus will be interpreted as a means-plus-function limitation under 35 U.S.C. §112(6th ¶).
The Examiner finds that claims 41 and 42 expressly recite:
the instructions configured to cause one or more computer processors to perform actions comprising:
[for each of the plurality of electronic MRI images]: identifying a population of pixels in the electronic MRI image associated with the border;
[emphasis added]; and claim 148 expressly recites:
the instructions configured to cause one or more computer processors to perform actions comprising:
[for each of the plurality of electronic MRI images of the first imaging mode]: identifying a population of pixels in the fused MRI image associated with the border;
[emphasis added].
i. 3-Prong Analysis: Prong (A)
FP9 meets invocation prong (A) because "means ... for" type language is recited. The Examiner first finds that “instructions” is a generic placeholder or nonce term equivalent to “means” because the term “instructions” does nothing more than simply define a generic structure, i.e., means. The Examiner further notes that the specification of the ‘504 Patent does not specifically define “instructions” and thus the specification of the ‘504 Patent does not impart or disclose any structure for the phrase, for the same reasons as set forth above. (See § VIII.B.(8).i, supra).
Furthermore, the Examiner has reviewed the prosecution history and the relevant prior art of record herein and find that that “instructions” as used in the claims does not provide an art-recognized structure to perform the claimed function. Rather more than simple instructions would be required to perform the function recited in FP9.22
In light of the above, the Examiner concludes that the term “instructions …” is a generic placeholder having no specific structure associated therewith. Because “instructions …” is merely a generic placeholder having no specific structure associated therewith, the Examiner concludes that FP9 meets invocation Prong (A).
ii. 3-Prong Analysis: Prong (B)
Based upon a review of FP9, the Examiner finds that claimed function(s) is:
[I]dentifying a population of pixels in the electronic MRI image associated with the border
[I]dentifying a population of pixels in the fused MRI image associated with the border
Because FP9 recites the above recited functions, the Examiner concludes that FP9 meets Invocation Prong (B).
iii. 3-Prong Analysis: Prong (C)
Based upon a review of the entire Functional Phrase 9, the Examiner finds that Functional Phrase 9 does not contain sufficient structure for performing the entire claimed function that is set forth within Functional Phrase 9. In fact, the Examiner finds that Functional Phrase 9 recites very little structure (if any) for performing the claimed function.
Because Functional Phrase 9 does not contain sufficient structure for performing the entire claimed function, the Examiner concludes that Functional Phrase 9 meets invocation Prong (C).
Because Functional Phrase 9 meets the 3-prong analysis as set forth in MPEP § 2181 I, the Examiner concludes that Functional Phrase 9 does invokes 35 U.S.C § 112 6th paragraph.
Corresponding structure for Functional Phrase 9
Once a claimed phrase invokes 35 U.S.C. § 112 6th paragraph, the next step is to determine the corresponding structure. (MPEP § 2181 II). In order to satisfy the requirements of 35 U.S.C. § 112, second paragraph, there must be identified in the applications’ disclosure a single structure and/or algorithm which performs the function of FP9.
The Examiner has carefully reviewed the original disclosure to determine the corresponding structure for FP9. In reviewing the original disclosure, the Examiner finds that the ‘504 Patent discloses:
Example embodiments relating to automated voxelation methods are provided below by reference to FIGS. 5-10B. More specifically, FIG. 5 shows a software flow diagram 200 of an automated voxelation method that can be used by an automated voxelation system, such as the system of FIG. 11 discussed below. As discussed in more detail below, the system can include an MRI/MRS system configured to acquire MRI images of a region of interest in a portion of a patient's body and/or to perform an MRS exam or procedure using the voxelation. The system can also include a computer system that can have a processor and a computer readable medium, which can be configured to execute a program that performs some or all of the method shown in FIG. 5. The method of FIG. 5 can include: image processing 210, including further detailed blocks 211-214 shown; ROI location and isolation 220, including further detailed blocks 221-224 shown; 2D voxel formation 230, including further detailed blocks 231-233 shown; and 3D voxel formation 240, including further detailed blocks 241-246 shown. Various aspects of the method are further illustrated in additional FIGS. 6-10B as follows.
(‘504 Patent at c.27, l.60 – c.28, l.13; emphasis added); and
FIG. 8A reintroduces the flow diagram from FIG. 5 for a ROI location and isolation phase 220 of the automated voxelation program 200, including detailed blocks 221-224. FIG. 8B shows a mid-sagittal 2D planar MRI image 250 as in prior figures for the exemplary spine, but as modified to reflect the results arrived at following completion of the location of a unique population of pixels for the ROI at block 222 shown in FIG. 8A. More specifically, FIG. 8B shows default ellipsoid search areas 260 applied to the image 250, with the unique population of pixels estimated to represent the disc ROI shown at contrast enhanced bright pseudo-ellipsoidal regions 270 within default ellipsoid search areas 260. FIG. 8C shows the same MRI image 250 as prior FIGS. 6, 7B, and 8B above, but as further modified to reflect and plot the estimated ellipsoid shapes 280 generated by the program for the respective disc nucleus regions at block 224 shown in FIG. 8A.
(Id. at c.28, ll.19-24; emphasis added). In examination of Figures 8A and 8B of the ‘504 Patent below, the Examiner finds that that the ROI location and isolation 220 specifically includes consecutively executed blocks, one of which is the locate unique population of pixels with ROI 222 block. With respect to the functionality of the locate unique population of pixels with ROI 222, the Examiner finds that the ‘504 Patent discloses,
[a]fter applying default ellipsoid search areas 260 to the image, such as at block 221 of Phase 220 of the voxel automation 200, the following can be performed. At block 222, for each or one or more of the elliptical search areas 260, all the pixels within the area which have a particular property (e.g., an intensity of at least 0.15) can be assigned to a pixel population corresponding to the ROI. The pixels can be identified by their spatial coordinates in the image (which correspond to world coordinates in the imaged object).
(Id. at c.33, ll.28-47; see Figure 8B below; emphasis added). The Examiner further finds that the default ellipsoid search areas 260 may be omitted in the identification of the population of pixels. (Id. at c.35, ll.39-46).
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Thus, in light of the portions of the ‘504 Patent cited above, the Examiner concludes the corresponding structure for performing the claimed function as simply algorithms/software, that can be executed by a special purpose computer/processing device, comprising identifying a particular property of the pixels and assigning the identified pixels to a population of pixels, or its equivalent.
Functional Phrase – “Instructions III”
A tenth means-plus-function phrase is recited in claims 41, 42 and 148 (and included in each of dependent claims 94-101, 103-107, 124-131, 133-137 and 149-157) which recites “instructions …” or hereinafter “Functional Phrase 10” or “FP10.” The Examiner determines herein that FP10 does meet the three prong test and thus will be interpreted as a means-plus-function limitation under 35 U.S.C. §112(6th ¶).
The Examiner finds 41 and 42 expressly recite:
the instructions configured to cause one or more computer processors to perform actions comprising:
[for each of the plurality of electronic MRI images]: fitting a two dimensional shape inside a cross-section of the region of interest and within the border shown by the electronic MRI image based on the population of pixels;
[emphasis added]; and claim 148 expressly recites:
the instructions configured to cause one or more computer processors to perform actions comprising:
[for each of the plurality of electronic MRI images of the first imaging mode]: fitting a two dimensional shape inside across-section of the region of interest and within the border shown by the fused electronic MRI image based on the population of pixels;
[emphasis added].
i. 3-Prong Analysis: Prong (A)
FP10 meets invocation prong (A) because "means ... for" type language is recited. The Examiner first finds that “instructions” is a generic placeholder or nonce term equivalent to “means” because the term “instructions” does nothing more than simply define a generic structure, i.e., means. The Examiner further notes that the specification of the ‘504 Patent does not specifically define “instructions” and thus the specification of the ‘504 Patent does not impart or disclose any structure for the phrase, for the same reasons as set forth above. (See § VIII.B.(8).i, supra).
Furthermore, the Examiner has reviewed the prosecution history and the relevant prior art of record herein and find that that “instructions” as used in the claims does not provide an art-recognized structure to perform the claimed function. Rather more than simple instructions would be required to perform the function recited in FP10.23
In light of the above, the Examiner concludes that the term “instructions …” is a generic placeholder having no specific structure associated therewith. Because “instructions …” is merely a generic placeholder having no specific structure associated therewith, the Examiner concludes that FP10 meets invocation Prong (A).
ii. 3-Prong Analysis: Prong (B)
Based upon a review of FP10, the Examiner finds that claimed function(s) is:
[F]tting a two dimensional shape inside a cross-section of the region of interest and within the border shown by the electronic MRI image based on the population of pixels; and
[F]tting a two dimensional shape inside across-section of the region of interest and within the border shown by the fused electronic MRI image based on the population of pixels
Because FP10 recites the above recited functions, the Examiner concludes that FP10 meets Invocation Prong (B).
iii. 3-Prong Analysis: Prong (C)
Based upon a review of the entire Functional Phrase 10, the Examiner finds that Functional Phrase 10 does not contain sufficient structure for performing the entire claimed function that is set forth within Functional Phrase 10. In fact, the Examiner finds that Functional Phrase 10 recites very little structure (if any) for performing the claimed function.
Because Functional Phrase 10 does not contain sufficient structure for performing the entire claimed function, the Examiner concludes that Functional Phrase 10 meets invocation Prong (C).
Because Functional Phrase 10 meets the 3-prong analysis as set forth in MPEP § 2181 I, the Examiner concludes that Functional Phrase 10 does invokes 35 U.S.C § 112 6th paragraph.
Corresponding structure for Functional Phrase 10
Once a claimed phrase invokes 35 U.S.C. § 112 6th paragraph, the next step is to determine the corresponding structure. (MPEP § 2181 II). In order to satisfy the requirements of 35 U.S.C. § 112, second paragraph, there must be identified in the applications’ disclosure a single structure and/or algorithm which performs the function of FP10.
The Examiner has carefully reviewed the original disclosure to determine the corresponding structure for FP10. In reviewing the original disclosure, the Examiner finds that the ‘504 Patent discloses:
Example embodiments relating to automated voxelation methods are provided below by reference to FIGS. 5-10B. More specifically, FIG. 5 shows a software flow diagram 200 of an automated voxelation method that can be used by an automated voxelation system, such as the system of FIG. 11 discussed below. As discussed in more detail below, the system can include an MRI/MRS system configured to acquire MRI images of a region of interest in a portion of a patient's body and/or to perform an MRS exam or procedure using the voxelation. The system can also include a computer system that can have a processor and a computer readable medium, which can be configured to execute a program that performs some or all of the method shown in FIG. 5. The method of FIG. 5 can include: image processing 210, including further detailed blocks 211-214 shown; ROI location and isolation 220, including further detailed blocks 221-224 shown; 2D voxel formation 230, including further detailed blocks 231-233 shown; and 3D voxel formation 240, including further detailed blocks 241-246 shown. Various aspects of the method are further illustrated in additional FIGS. 6-10B as follows.
(‘504 Patent at c.27, l.60 – c.28, l.13; emphasis added); and
FIG. 9A reintroduces flow diagram 200 with respect to the 2D voxel formation phase 230, including more detailed blocks 231-233 in order to prepare for 3D voxel formation phase 240. An illustrative result of this phase is shown in FIG. 9B, which shows the mid-sag[g]ital 2D planar image 250 with the 2D voxel prescriptions 290 shown within the respective discs of the 5 lumbar disc levels. FIG. 9B also shows the 2D planar image 252 for the orthogonal transverse oblique axial plane for the L4-L5 disc in this example.
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(Id. at c.28, ll.42-50; emphasis added). In examination of Figures 9A and 9B of the ‘504 Patent below, the Examiner finds that that the 2D voxel formation phase 230 specifically includes consecutively executed blocks, one of which is the Scale Z dimensions for ROI thickness and Y dimension for ROI Height 233 block. With respect to the functionality of the Scale Z dimensions for ROI thickness and Y dimension for ROI Height 233, the Examiner finds that the ‘504 Patent discloses,
[g]iven the above ROI (disc nucleus) characteristic data provided per the operations above, it becomes possible to automatically form two dimensional (2D) shapes or voxels, at phase 230. At block 231, image coordinate data can be extracted, and at block 232, the image coordinates can be converted to world coordinates using a transformation matrix. The system can, for example, apply an experimentally determined scale factor (e.g., of 2.9 times the image to world scale factor (e.g., 0.39 from the DICOM metadata)) to the semi-minor axis to determine the voxel thickness in the z-axis (axial axis), and to the semi-minor axis to determine the voxel dimensions in the machine y-axis (coronal axis), as shown in block 233. In some embodiments, the 2D shape can be a rectilinear shape such as a rectangle, although many other 2D shapes can be used. Many variations are possible.
(Id. at c.36, ll.28-42; emphasis added). The Examiner finds that the ‘504 Patent discloses utilizing some kind of factor to ensure that the generation of the two dimensional shape includes the dimensions of the two dimensional shape being within the ROI previously determined. The Examiner further finds that the various components of the 2D voxel formation phase 230 can be omitted in the determination and fitting of the two dimensional shape inside the ROI. (Id. at c.36, ll.43-55).
Thus, in light of the portions of the ‘504 Patent cited above, the Examiner concludes the corresponding structure for performing the claimed function as simply algorithms/software, that can be executed by a special purpose computer/processing device, comprising determining a factor to create a two dimensional shape that fits within the previously determined ROI, or its equivalent.
Functional Phrase – “Instructions IV”
An eleventh means-plus-function phrase is recited in claims 41 and 148 (and included in each of dependent claims 94-101, 103-107 and 149-157) which recites “instructions …” or hereinafter “Functional Phrase 11” or “FP11.” The Examiner determines herein that FP11 does meet the three prong test and thus will be interpreted as a means-plus-function limitation under 35 U.S.C. §112(6th ¶).
The Examiner finds that 41 and 148 expressly recite:
the instructions configured to cause one or more computer processors to perform actions comprising:
[for each of the plurality of electronic MRI images]: generating world coordinates that define a voxel that fits inside of the region of interest and excludes the border based on one or more of the two dimensional shapes;
[emphasis added];
i. 3-Prong Analysis: Prong (A)
FP11 meets invocation prong (A) because "means ... for" type language is recited. The Examiner first finds that “instructions” is a generic placeholder or nonce term equivalent to “means” because the term “instructions” does nothing more than simply define a generic structure, i.e., means. The Examiner further notes that the specification of the ‘504 Patent does not specifically define “instructions” and thus the specification of the ‘504 Patent does not impart or disclose any structure for the phrase, for the same reasons as set forth above. (See § VIII.B.(8).i, supra).
Furthermore, the Examiner has reviewed the prosecution history and the relevant prior art of record herein and find that that “instructions” as used in the claims does not provide an art-recognized structure to perform the claimed function. Rather more than simple instructions would be required to perform the function recited in FP11.24
In light of the above, the Examiner concludes that the term “instructions …” is a generic placeholder having no specific structure associated therewith. Because “instructions …” is merely a generic placeholder having no specific structure associated therewith, the Examiner concludes that FP11 meets invocation Prong (A).
ii. 3-Prong Analysis: Prong (B)
Based upon a review of FP11, the Examiner finds that claimed function(s) is:
[G]enerating world coordinates that define a voxel that fits inside of the region of interest and excludes the border based on one or more of the two dimensional shapes
Because FP11 recites the above recited functions, the Examiner concludes that FP11 meets Invocation Prong (B).
iii. 3-Prong Analysis: Prong (C)
Based upon a review of the entire Functional Phrase 11, the Examiner finds that Functional Phrase 11 does not contain sufficient structure for performing the entire claimed function that is set forth within Functional Phrase 11. In fact, the Examiner finds that Functional Phrase 11 recites very little structure (if any) for performing the claimed function.
Because Functional Phrase 11 does not contain sufficient structure for performing the entire claimed function, the Examiner concludes that Functional Phrase 11 meets invocation Prong (C).
Because Functional Phrase 11 meets the 3-prong analysis as set forth in MPEP § 2181 I, the Examiner concludes that Functional Phrase 11 does invokes 35 U.S.C § 112 6th paragraph.
Corresponding structure for Functional Phrase 11
Once a claimed phrase invokes 35 U.S.C. § 112 6th paragraph, the next step is to determine the corresponding structure. (MPEP § 2181 II). In order to satisfy the requirements of 35 U.S.C. § 112, second paragraph, there must be identified in the applications’ disclosure a single structure and/or algorithm which performs the function of FP11.
The Examiner has carefully reviewed the original disclosure to determine the corresponding structure for FP11. In reviewing the original disclosure, the Examiner finds that the ‘504 Patent discloses:
Example embodiments relating to automated voxelation methods are provided below by reference to FIGS. 5-10B. More specifically, FIG. 5 shows a software flow diagram 200 of an automated voxelation method that can be used by an automated voxelation system, such as the system of FIG. 11 discussed below. As discussed in more detail below, the system can include an MRI/MRS system configured to acquire MRI images of a region of interest in a portion of a patient's body and/or to perform an MRS exam or procedure using the voxelation. The system can also include a computer system that can have a processor and a computer readable medium, which can be configured to execute a program that performs some or all of the method shown in FIG. 5. The method of FIG. 5 can include: image processing 210, including further detailed blocks 211-214 shown; ROI location and isolation 220, including further detailed blocks 221-224 shown; 2D voxel formation 230, including further detailed blocks 231-233 shown; and 3D voxel formation 240, including further detailed blocks 241-246 shown. Various aspects of the method are further illustrated in additional FIGS. 6-10B as follows.
(‘504 Patent at c.27, l.60 – c.28, l.13; emphasis added); and
FIGS. 10A-B illustrate the result of this process as follows. FIG. 10A reintroduces for flow diagram 200 the flow for 3D voxel formation phase 240, including more detailed blocks thereof 241-246. An illustrative 3D voxel prescription result is shown for one disc of the spine in angular perspective view relative to two transverse mid-sagittal (e.g., yz plane) and mid-coronal (e.g., xz plane) 2D MRI images.
(Id. at c.28, ll.42-50; emphasis added). In examination of Figures 10A and 10B of the ‘504 Patent, the Examiner finds that that the 3D voxel formation phase 240 specifically includes consecutively executed blocks of the Image Processing ROI Location and Isolation and 2D Voxel Formation blacks 242-244. The Examiner find that the ‘504 Patent discloses each MRI image slice can have the image processing 242, ROI location and solation 243, and 2D voxel formation 244 be performed thereon, and forming a 3D voxel formation from the combination of the 2D voxel formations of each respective MRI image slice. (Id. at c.36, l.56 – c.37, l.8)
Thus, in light of the portions of the ‘504 Patent cited above, the Examiner concludes the corresponding structure for performing the claimed function as simply algorithms/software, that can be executed by a special purpose computer/processing device, comprising generating a three dimensional volume from a series of images which comprises a voxel that fits inside of the region of interest and excludes the border based on one or more of the two dimensional shapes, or its equivalent.
Functional Phrase – “Instructions V”
A twelfth means-plus-function phrase is recited in claim 42 (and included in each of dependent claims 124-131 and 133-137) which recites “instructions …” or hereinafter “Functional Phrase 12” or “FP12.” The Examiner determines herein that FP12 does meet the three prong test and thus will be interpreted as a means-plus-function limitation under 35 U.S.C. §112(6th ¶).
The Examiner finds that 42 expressly recites:
the instructions configured to cause one or more computer processors to perform actions comprising:
[for each of the plurality of electronic MRI images]: generating world coordinates that define a voxel that fits inside of the region of interest and excludes the border based on one or more of the two dimensional shapes by:
generating first world coordinates that define a first volume that fits inside the region of interest;
generating second world coordinates that define a second volume that fits inside the region of interest based on a different number of electronic MRI images than used for generating the first volume;
calculating a volume size of the first volume;
calculating a volume size of the second volume; and
selecting as the voxel the one of the first volume and the second volume that has the larger volume size;
[emphasis added];
i. 3-Prong Analysis: Prong (A)
FP12 meets invocation prong (A) because "means ... for" type language is recited. The Examiner first finds that “instructions” is a generic placeholder or nonce term equivalent to “means” because the term “instructions” does nothing more than simply define a generic structure, i.e., means. The Examiner further notes that the specification of the ‘504 Patent does not specifically define “instructions” and thus the specification of the ‘504 Patent does not impart or disclose any structure for the phrase, for the same reasons as set forth above. (See § VIII.B.(8).i, supra).
Furthermore, the Examiner has reviewed the prosecution history and the relevant prior art of record herein and find that that “instructions” as used in the claims does not provide an art-recognized structure to perform the claimed function. Rather more than simple instructions would be required to perform the function recited in FP12.25
In light of the above, the Examiner concludes that the term “instructions …” is a generic placeholder having no specific structure associated therewith. Because “instructions …” is merely a generic placeholder having no specific structure associated therewith, the Examiner concludes that FP12 meets invocation Prong (A).
ii. 3-Prong Analysis: Prong (B)
Based upon a review of FP12, the Examiner finds that claimed function(s) is:
[G]enerating world coordinates that define a voxel that fits inside of the region of interest and excludes the border based on one or more of the two dimensional shapes by:
[G]enerating first world coordinates that define a first volume that fits inside the region of interest;
[G]enerating second world coordinates that define a second volume that fits inside the region of interest based on a different number of electronic MRI images than used for generating the first volume;
[C]alculating a volume size of the first volume;
[C]alculating a volume size of the second volume; and
[S]electing as the voxel the one of the first volume and the second volume that has the larger volume size
Because FP12 recites the above recited functions, the Examiner concludes that FP12 meets Invocation Prong (B).
iii. 3-Prong Analysis: Prong (C)
Based upon a review of the entire Functional Phrase 12, the Examiner concludes that FP12 does contain sufficient structure for performing the entire Function of Functional Phrase 12. The Examiner finds that FP12 includes the algorithm of “generating first world coordinates that define a first volume that fits inside the region of interest; generating second world coordinates that define a second volume that fits inside the region of interest based on a different number of electronic MRI images than used for generating the first volume; calculating a volume size of the first volume; calculating a volume size of the second volume; and selecting as the voxel the one of the first volume and the second volume that has the larger volume size.” In examination of the ‘504 Patent, the Examiner finds that the ‘504 Patent discloses generating would coordinates that define a 3D selected volume several ways, one of which is using the steps as defined above. (‘504 Patent at c.37, ll.12-40). From this perspective, the Examiner finds that the further inclusion of the structure/algorithm above provides sufficient structure for performing the entire Function of Functional Phrase 12.
Because the Functional Phrase does contain sufficient structure for performing the entire claimed function, the Examiner concludes that FP12 does not meet Invocation Prong (C).
In conclusion, because FP12 does not meet the three prong analysis set forth in MPEP §2181 I, the Examiner concludes that Functional Phrase 12 does not invoke 35 U.S.C. § 112, 6th paragraph.
Functional Phrase – “Processor VI”
A thirteenth means-plus-function phrase is recited in claim 138 (and included in each of dependent claims 139 and 142-147) which recites “instructions …” or hereinafter “Functional Phrase 13” or “FP13.” The Examiner determines herein that FP13 does meet the three prong test and thus will be interpreted as a means-plus-function limitation under 35 U.S.C. §112(6th ¶).
The Examiner finds that 138 expressly recites:
automatically processing the electronic MRI image, using one or more computer processors, to emphasize pixels associated with a border between the region of interest and structure adjacent to the region of interest; wherein the processing comprises:
accessing an additional electronic image of a second imaging mode different than the first imaging mode, the additional electronic image of the second imaging mode being of substantially the same area as the electronic MRI image of the first imaging mode; and
performing image fusion between the electronic MRI image of the first imaging mode and the additional electronic image of the second imaging mode to generate a fused electronic MRI image that provides an enhanced definition of the border;
[emphasis added].
i. 3-Prong Analysis: Prong (A)
FP13 meets invocation prong (A) because "means ... for" type language is recited. The Examiner first finds that “processor” is a generic placeholder or nonce term equivalent to “means” because the term “processor” conveys some structures, but not any specific structures related to the function.
Additionally, the Examiner has reviewed the prosecution history and the relevant prior art of record herein and find that “processor” as used in the claims does not provide an art-recognized structure to perform the claimed function. Rather more than a simple processor would be required to perform the function recited in FP13.26
Accordingly, the Examiner finds nothing in the specification, prosecution history or the prior art to construe “processor…” in FP13 as the name of a sufficiently definite structure for performing the functions recited in FP13 so as to take the overall claim limitation out of the ambit of §112(6th ¶). See Williamson v. Citrix Online, L.L.C., 115 USPQ2d 1105, 1112 (Fed. Cir. 2015).
In light of the above, the Examiner concludes that the term “processor…” is a generic placeholder having no specific structure associated therewith. Because “processor …” is merely a generic placeholder having no specific structure associated therewith, the Examiner concludes that FP2 meets invocation Prong (A).
ii. 3-Prong Analysis: Prong (B)
Based upon a review of FP13, the Examiner finds the following claimed function(s) as:
[A]utomatically [P]rocessing the electronic MRI image to [E]mphasize pixels associated with a border between the region of interest and structure adjacent to the region of interest… [comprising]
[A]ccessing an additional electronic image of a second imaging mode different than the first imaging mode, the additional electronic image of the second imaging mode being of substantially the same area as the electronic MRI image of the first imaging mode; and
[P]erforming image fusion between the electronic MRI image of the first imaging mode and the additional electronic image of the second imaging mode to generate a fused electronic MRI image that provides an enhanced definition of the border
Because FP13 recites the above recited Functions, the Examiner concludes that FP13 meets Invocation Prong (B).
iii. 3-Prong Analysis: Prong (C)
Based upon a review of the entire Functional Phrase 13, the Examiner finds that Functional Phrase 13 does not contain sufficient structure for performing the entire claimed function that is set forth within Functional Phrase 13. While one of ordinary skill in the art would recognize that “accessing an additional electronic image of a second imaging mode different than the first imaging mode” is a generic and well know function that can be performed by generic processor, the Examiner finds that Functional Phrase 13 recites very little structure (if any) for performing the claimed “performing image fusion…” function. Specifically, while Functional Phrase 13 cites one or more computer processors, the processors are recited generically in association with special function and thus the phrase does not recite sufficient structure for performing this special function.
Because Functional Phrase 13 does not contain sufficient structure for performing the entire claimed function, the Examiner concludes that Functional Phrase 13 meets invocation Prong (C).
Because Functional Phrase 13 meets the 3-prong analysis as set forth in MPEP § 2181 I, the Examiner concludes that Functional Phrase 13 invokes 35 U.S.C § 112 6th paragraph.
Corresponding structure for Functional Phrase 13
Once a claimed phrase invokes 35 U.S.C. § 112 6th paragraph, the next step is to determine the corresponding structure. (MPEP § 2181 II). In order to satisfy the requirements of 35 U.S.C. § 112, second paragraph, there must be identified in the applications’ disclosure a single structure and/or algorithm which performs the function of FP13.
The Examiner has carefully reviewed the original disclosure to determine the corresponding structure for FP13. In reviewing the original disclosure, the Examiner finds that the ‘504 Patent discloses:
One further embodiment uses two different images of the same area of tissue via two different imaging modalities, and performs an image fusion operation between them. In one embodiment, the fusion operation includes a “differencing” between the images to produce a third “differencing” image. In another embodiment, the fusion operation comprises performing a blending or merging between the images (e.g. alpha blend, for example).
(‘504 Patent at c.39, ll.39-46).
Thus, in light of the portions of the ‘504 Patent cited above, the Examiner concludes the corresponding structure for performing the claimed function as simply at least one or more special purpose processors/computers containing algorithms/software for accessing an additional electronic image of a second imaging mode different than the first imaging mode and performing an image fusion by either (1) a “differencing” between the electronic MRI image and the additional electronic image to produce a third “differencing” image; or (2) or a blending or merging between the images, or its equivalent.
Functional Phrase – “Instructions VI”
An fourteenth means-plus-function phrase is recited in claim 148 (and included in each of dependent claims 149 and 152-157) which recites “instructions …” or hereinafter “Functional Phrase 14” or “FP14.” The Examiner determines herein that FP14 does meet the three prong test and thus will be interpreted as a means-plus-function limitation under 35 U.S.C. §112(6th ¶).
The Examiner finds that claim 148 expressly recites:
the instructions configured to cause one or more computer processors to perform actions comprising:
[for each of the plurality of electronic MRI images]: processing the electronic MRI image to emphasize pixels associated with a border between the region of interest and neighboring structure wherein the processing comprises:
accessing an additional electronic image of a second imaging mode different than the first imaging mode, the additional electronic image of the second imaging mode being of substantially the same area as the electronic MRI image of the first imaging mode; and
performing image fusion between the electronic MRI image of the first imaging mode and the additional electronic image of the second imaging mode to generate a fused electronic MRI image that provides an enhanced definition of the border;
[emphasis added];
i. 3-Prong Analysis: Prong (A)
FP14 meets invocation prong (A) because "means ... for" type language is recited. The Examiner first finds that “instructions” is a generic placeholder or nonce term equivalent to “means” because the term “instructions” does nothing more than simply define a generic structure, i.e., means. The Examiner further notes that the specification of the ‘504 Patent does not specifically define “instructions” and thus the specification of the ‘504 Patent does not impart or disclose any structure for the phrase, for the same reasons as set forth above. (See § VIII.B.(8).i, supra).
Furthermore, the Examiner has reviewed the prosecution history and the relevant prior art of record herein and find that that “instructions” as used in the claims does not provide an art-recognized structure to perform the claimed function. Rather more than simple instructions would be required to perform the function recited in FP14.27
In light of the above, the Examiner concludes that the term “instructions …” is a generic placeholder having no specific structure associated therewith. Because “instructions …” is merely a generic placeholder having no specific structure associated therewith, the Examiner concludes that FP14 meets invocation Prong (A).
ii. 3-Prong Analysis: Prong (B)
Based upon a review of FP8, the Examiner finds that claimed function(s) is:
[P]rocessing the electronic MRI image to emphasize pixels associated with a border between the region of interest and neighboring structure…[comprising]
[A]ccessing an additional electronic image of a second imaging mode different than the first imaging mode, the additional electronic image of the second imaging mode being of substantially the same area as the electronic MRI image of the first imaging mode; and
[P]erforming image fusion between the electronic MRI image of the first imaging mode and the additional electronic image of the second imaging mode to generate a fused electronic MRI image that provides an enhanced definition of the border
Because FP14 recites the above recited functions, the Examiner concludes that FP14 meets Invocation Prong (B).
iii. 3-Prong Analysis: Prong (C)
Based upon a review of the entire Functional Phrase 14, the Examiner finds that Functional Phrase 13 does not contain sufficient structure for performing the entire claimed function that is set forth within Functional Phrase 14. While one of ordinary skill in the art would recognize that “accessing an additional electronic image of a second imaging mode different than the first imaging mode” is a generic and well know function that can be performed by generic instructions on a processor, the Examiner finds that Functional Phrase 14 recites very little structure (if any) for performing the claimed “performing image fusion…” function. Specifically, while Functional Phrase 14 cites instructions configured to cause one or more computer processors to perform actions, the instructions are recited generically in association with special function and thus the phrase does not recite sufficient structure for performing this special function.
Because Functional Phrase 14 does not contain sufficient structure for performing the entire claimed function, the Examiner concludes that Functional Phrase 14 meets invocation Prong (C).
Because Functional Phrase 14 meets the 3-prong analysis as set forth in MPEP § 2181 I, the Examiner concludes that Functional Phrase 14 invokes 35 U.S.C § 112 6th paragraph.
Corresponding structure for Functional Phrase 14
Once a claimed phrase invokes 35 U.S.C. § 112 6th paragraph, the next step is to determine the corresponding structure. (MPEP § 2181 II). In order to satisfy the requirements of 35 U.S.C. § 112, second paragraph, there must be identified in the applications’ disclosure a single structure and/or algorithm which performs the function of FP14.
The Examiner has carefully reviewed the original disclosure to determine the corresponding structure for FP14. In reviewing the original disclosure, the Examiner finds that the ‘504 Patent discloses:
One further embodiment uses two different images of the same area of tissue via two different imaging modalities, and performs an image fusion operation between them. In one embodiment, the fusion operation includes a “differencing” between the images to produce a third “differencing” image. In another embodiment, the fusion operation comprises performing a blending or merging between the images (e.g. alpha blend, for example).
(‘504 Patent at c.39, ll.39-46).
Thus, in light of the portions of the ‘504 Patent cited above, the Examiner concludes the corresponding structure for performing the claimed function as simply algorithms/software, that can be executed by a special purpose computer/processing device, comprising accessing an additional electronic image of a second imaging mode different than the first imaging mode and performing an image fusion by either (1) a “differencing” between the electronic MRI image and the additional electronic image to produce a third “differencing” image; or (2) or a blending or merging between the images, or its equivalent.
Claim Rejections – 35 U.S.C. § 112
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 146 and 156 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
With respect to the limitations of claims 146 and 156, the Examiner finds that claims 146 and 156 recite,
wherein at least one of the two dimensional shapes is disregarded when generating the world coordinates that define the voxel;
(Nov 2025 Claim Amendment at claims 146 and 156; emphasis added). The Examiner finds that recitation to the method and CRM having at least one of the two dimensional shapes being disregarded when generating the world coordinates that define the voxel is not sufficiently described in the ‘504 Patent. To support the Examiner’s position, the Examiner finds that the ‘504 Patent discloses one or more of the plurality of electronic MRI images being disregarded when generating the world coordinates that define the voxel. (‘504 Patent at original claim 10).
Thus, as such, the Examiner concludes that there is insufficient indication in the specification that Applicant had possession of a method and/or CRM claim comprising steps/instructions to disregard at least one of the two dimensional shapes when generating the world coordinates that define the voxel, as recited.
35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 138-147 and 150-152 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to the limitations of claim 138, the Examiner finds that claim 138 recites the limitation “wherein the processing comprises…” in lines 9-10. The claim previously recites the claim requirement “automatically processing…” in lines 7-9. It is unclear and indefinite to whether these are the same or different processing operations. Further clarification is required to either provide proper antecedent basis or further differentiate the claim requirements.
The Examiner recommends replacing “wherein the processing comprises…” with –wherein the automatic processing comprises…– similar to what is recited in claims 88 and 89.
Claims 139-147 are rejected in light of their dependency from at least independent claim 138.
With respect to the limitations of claim 140, 141, 150 and 151, the Examiner finds that claims 140, 141, 150 and 151 recite the limitation “wherein performing the image fusion comprises…” in lines 9-10. It is unclear and indefinite to whether this is the same “performing the image fusion” clam requirement that was recited in the preceding claim. Further clarification is required to either provide proper antecedent basis or further differentiate the claim requirements.
The Examiner recommends replacing “wherein performing the image fusion comprises…” with –wherein said/the performing the image fusion comprises…– .
Claims 142 and 152 recites the limitation "wherein blending the images" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 154 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01.
The omitted step is: scanning the one or more additional voxels with the MRS system. To support the Examiner’s position, the Examiner finds that the ‘504 Patent specifically discloses defining one or more additional voxels covering at least a portions of one or more additional regions of interest in order to scan the one or more additional voxels with the MRS system, not without the scanning function. (‘504 Patent at c.9, ll.31-42; also see claims 5, 6 and new claim 144)
Claim Rejections – 35 U.S.C. § 251
Oath/Declaration
Claims 20, 21, 41, 42, 79-86, 88-92, 94-101, 103-107, 109-116, 118-122, 124-131 and 133-157 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office action. (See § VII, supra).
Allowable Subject Matter
Claims 20 and 41
Claims 20 and 41 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 251 set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
As set forth in the Feb 2024 Non-Final Office Action, the prior art of record teaches the most salient features of a method for obtaining information relating to a region of interest and CRM to perform the method. Specifically, the prior art of record teaches and/or renders obvious a method accessing a plurality of MRI images and automatically processing them to define a voxel in which an MRS scan may be performed.
Allowability of independent claims 20 and 41 are indicated because none of the prior art of record teaches or fairly suggests a method for providing a magnetic resonance spectroscopy (MRS) spectrum and CRM to perform the method with all of the limitations of independent claim 20, particularly the limitation of in which an additional electronic image from: 1) a second imaging mode different than the first imaging mode; and 2) of the same corresponding area of the MRI image of the first mode, is utilized to emphasize pixels and to identify an additional population of pixels in the additional electronic image associated with the border between the region of interest and the structure adjacent to the region of interest; and automatically generating, using the one or more computer processors, world coordinates that define a three dimensional selected volume comprising a voxel that fits inside of the region of interest and excludes the border based on one or more of the two dimensional shapes, wherein the world coordinates are based at least in part on the additional population of pixels.
Claims 21 and 42
Claims 21 and 42 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 251 set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
As set forth in the Feb 2024 Non-Final Office Action, the prior art of record teaches the most salient features of a method for providing a magnetic resonance spectroscopy (MRS) spectrum and CRM to perform the method. Specifically, the prior art of record teaches and/or renders obvious a method accessing a plurality of MRI images and automatically processing them to define a voxel in which an MRS scan may be performed.
Allowability of independent claims 21 and 42 are indicated because none of the prior art of record teaches or fairly suggests a method for obtaining information relating to a region of interest and CRM to perform the method with all of the limitations of independent claim 21, particularly the limitation of in which world coordinates, that define a three dimensional selected volume comprising a voxel that fits inside of the region of interest and excludes the border based on one or more of the two dimensional shapes, being generated by the specific steps/instructions of :
generating first world coordinates that define a first volume that fits inside the region of interest;
generating second world coordinates that define a second volume that fits inside the region of interest based on a different number of electronic MRI images than used for generating the first volume;
calculating a volume size of the first volume;
calculating a volume size of the second volume; and
selecting as the voxel the one of the first volume and the second volume that has the larger volume size.
Claims 138 and 148
Claims 138 and 148 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112 and 251 set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
As set forth in the Feb 2024 Non-Final Office Action, the prior art of record teaches the most salient features of a method for providing a magnetic resonance spectroscopy (MRS) spectrum and CRM to perform the method. Specifically, the prior art of record teaches and/or renders obvious a method accessing a plurality of MRI images and automatically processing them to define a voxel in which an MRS scan may be performed.
Allowability of independent claims 138 and 148 are indicated because none of the prior art of record teaches or fairly suggests a method for obtaining information relating to a region of interest and CRM to perform the method with all of the limitations of independent claim 138, particularly the limitation of in which an additional electronic image from a second imaging mode different than the first imaging mode is accessed in order to perform an image fusion of the electronic MRI image and the additional electronic image to generate a fused electronic MRI image; so that the fused electronic MRI image is utilized to emphasize pixels and to identify a population of pixels in the fused electronic MRI image associated with the border; and automatically generating, using the one or more computer processors, world coordinates that define a three dimensional selected volume comprising a voxel that fits inside of the region of interest and excludes the border based on one or more of the two dimensional shapes, wherein the world coordinates are based at least in part on the population of pixels.
Response to Arguments
Oath/Declaration Objection(s)
With respect to the Reissue Oath/Declaration Objection, while MPEP § 1414.03.I does provide guidance and/or an avenue for Applicant to identify an error in remarks accompanying an amendment, the Examiner finds that the Nov 2025 Applicant Response did not provide a sufficient new error statement to overcome the defective oath/declaration issue. (See Mar 2025 Applicant Response at 34; and Nov 2025 Applicant Response at 37).
As asserted above, the Examiner finds that the Aug 2022 Oath/Declaration correctly identified an error, relied upon, to be corrected by the instant ‘572 Reissue Application. (See § VII, supra). However, the Aug 2022 Oath/Declaration filed with this application is now deemed defective because the error which is relied upon to support the reissue application is not an error upon which the instant ‘572 Reissue Application can be based. (Id.)
Thus, the objection and rejection based upon a defective reissue declaration under 35 U.S.C. 251 is still present and maintained in the instant ‘572 Reissue Application. (See §§ VII, X.A, supra).
Specification Objection(s)
With respect to the Specification Objections provided in the June 2025 Final Office Action, the Nov 2025 Applicant Response, including the Nov 2025 Spec Amendment and “Remarks,” has been fully considered and is persuasive. (See Nov 2025 Applicant Response at 37).
Claim Objection(s)
With respect to the Claim Objections provided in the June 2025 Final Office Action, the Nov 2025 Applicant Response, including the Nov 2025 Claim Amendment and “Remarks,” has been fully considered and is persuasive. (See Nov 2025 Applicant Response at 37).
Claim Interpretation
Owner acknowledges the Examiner’s invocation of 35 U.S.C. §112, sixth paragraph, for certain claim terms. (See Nov 2025 Applicant Response at 37). However, even though Applicant traverses the invocation of 35 U.S.C. §112, sixth paragraph, Applicant provides no arguments regarding the invocation. (Id.)
From this perspective, the Examiner finds that Applicant has not challenged any of the claim construction of terms provided in the June 2025 Final Office Action. (Id.) Thus, the Examiner finds that the outcome of the instant ‘572 Reissue Application does not rest on the proposed constructions.
35 U.S.C. § 112 for Written Description and Essential Steps
With respect to the 35 U.S.C. § 112 Written Description and Essential Step rejections provided in the June 2025 Final Office Action, the Nov 2025 Applicant Response, including the Nov 2025 Claim Amendment and “Remarks,” has been fully considered and is persuasive. (See Nov 2025 Applicant Response at 34-35). Thus, the 35 U.S.C. 35 U.S.C. § 112 (pre-AIA ), first and second paragraph rejections provided in the June 2025 Final Office Action are moot, overcome and withdrawn.
However, in light of the Nov 2025 Claim Amendment, the Examiner finds that there are outstanding 35 U.S.C. § 112 (pre-AIA ), first and second paragraph rejections issues still present. (See § IX, supra).
Original Patent Requirement
With respect to the 35 U.S.C. § 251 Original Patent Requirement rejection provided in the June 2025 Final Office Action, the Nov 2025 Applicant Response, including the Nov 2025 Claim Amendment and “Remarks,” has been fully considered and is persuasive. (See Nov 2025 Applicant Response at 34). Thus, the 35 U.S.C. § 251 Original Patent Requirement rejection provided in the June 2025 Final Office Action is moot, overcome and withdrawn.
Conclusion
Applicant is 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 Applicant decide to amend the claims, Applicant is also reminded that—like always—no new matter is allowed. The Examiner therefore leaves it up to Applicant 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, Applicant is 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 Applicant 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, Applicant is 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 Applicant choose to amend the specification, Applicant is reminded that—like always—no new matter in the specification is allowed. See 35 U.S.C. § 132(a). If Applicant has any questions on this matter, Applicant is encouraged to contact the Examiner via the telephone number listed below.
Applicant is reminded of the obligation to apprise the Office of any prior or concurrent proceedings in which the ‘504 Patent is or was involved, such as interferences or trials before the Patent Trial and Appeal Board, other reissues, reexaminations, or litigations and the results of such proceedings.
In accordance with MPEP § 1406, the Examiner has reviewed and considered the prior art cited or ‘of record’ in the original prosecution of the ‘504 Patent. Applicant is reminded that a listing of the information cited or ‘of record’ in the original prosecution of the ‘504 Patent need not be resubmitted in this reissue application unless Applicant desires the information to be printed on a patent issuing from this reissue application.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN J RALIS whose telephone number is (571)272-6227. The examiner can normally be reached on Monday-Friday 8:30am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Hetul Patel can be reached on 571-272-4184. 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.
/Stephen J. Ralis/Primary Examiner, Art Unit 3992 Conferees:
/KENNETH WHITTINGTON/Primary Examiner, Art Unit 3992 /ALEXANDER J KOSOWSKI/Supervisory Patent Examiner, Art Unit 3992
SJR
04/14/2026
1 See Feb 2024 Non-Final Office Action at § V.
2 The Examiner notes that all of the Rejected Claims stood rejected under 251; claims 1-19 and 22-40 stood rejected over 103(a); claim 42 stood rejected over 112(a); claims 7-9, 15-19, 26-28 and 35-40 stood rejected over 112(b); and claims 22, 23, 25 and 33-35 stood rejected over Double Patenting.
3 See Feb 2024 Non-Final Office Action at § XVII.
4 The Examiner notes that all of the Rejected Claims stood rejected under 251; claims 20, 41 and 78-137 stood rejected under 112(a) and 112(b); and claims 42 and 123 stood rejected under Double Patenting .
5 Claims 88-92, 97-99, 103-107, 114, 118-122, 127-129 and 133-137 amended in the instant Mar 2025 Claim Amendment.
6 Claims 78-83, 85, 86, 93-96, 100, 101, 108-113, 115, 116, 123-126, 130 and 131 newly provided in the Aug 2024 Claim Amendment.
7 Claims 1-19 and 20-40 canceled in the Aug 2024 Claim Amendment.
8 Claims 43-77 canceled in the Aug 2024 Claim Amendment; and claims 87, 102, 117 and 132 canceled in the instant Mar 2025 Claim Amendment.
9 The Examiner notes that all of the Rejected Claims stood rejected under 251; and claims 20, 41, 78-86, 88-101, 103-116, 118-131 and 133-137 stood rejected under 112(a) and 112(b).
10 Claims 20, 21 and 41 amended in the instant Nov 2025 Claim Amendment.
11 Claims 84, 97-99, 114 and 127-129 amended in the instant Nov 2025 Claim Amendment.
12 Claims 79-83, 85, 86, 94-96, 100, 101, 109-113, 115, 116, 124-126, 130 and 131 amended in the instant Nov 2025 Claim Amendment; and claims 88-92, 103-107, 118-122 and 133-137 amended in the Mar 2025 Claim Amendment.
13 Claims 138-157 newly provided in the Aug 2024 Claim Amendment.
14 Claims 1-19 and 20-40 canceled in the Aug 2024 Claim Amendment.
15 Claims 43-77 canceled in the Aug 2024 Claim Amendment; claims 87, 102, 117 and 132 canceled in the Mar 2025 Claim Amendment and claims 78, 93, 108 and 123 canceled in the instant Nov 2025 Claim Amendment.
16 IEEE 100 The Authoritative Dictionary of IEEE Standards Terms, 7th Ed. 2000 at 234
17 Merriam Webster’s Collegiate Dictionary, Tenth Edition. 1996 at 252.
18See § VIII.B.(1).i, supra).
19See § VIII.B.(1).i, supra).
20See § VIII.B.(1).i, supra).
21See § VIII.B.(1).i, supra).
22See § VIII.B.(8).i, supra).
23See § VIII.B.(8).i, supra).
24See § VIII.B.(8).i, supra).
25See § VIII.B.(8).i, supra).
26See § VIII.B.(1).i, supra).
27 See § VIII.B.(8).i, supra).
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