DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 22 November 2024 and 4 March 2025 are being considered by the examiner.
Specification
The attempt to incorporate subject matter into this application by reference to NPL references/websites (See paragraphs [0166] and [0167] of the application) is ineffective because 37 CFR 1.57(e) recites "An incorporation by reference by hyperlink or other form of browser executable code is not permitted.”
Claim Interpretation
Due to the claims’ repeated use of “or” limitations, there are limitations which are not positively recited in period claims that are then positively recited in claims dependent thereon. Therefore, any limitation not chosen in a previous claim due to an “or” statement is not being considered to occur in the dependent claim since it is not positively recited in the prior claim.
For example, claim 3 recites limitations four limitations separated by “or”, meaning only one needs to be chosen to occur, however, claim 4 then depends from claim 3 and recites “in a case where”, however, if those cases are not chosen in claim 3 then they are not positively recited in claim 4 and thus do not need to occur.
In the prior art rejections below, a strikethrough will be used on the limitations which are not required due to the use of “or” such that what is required in the claims can easily be ascertained.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 32 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 32 recites “computer-readable storage medium.” The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent (Paragraph [0149] makes use of “or” statements and also says things like “such as” such that non-transitory tangible media and transitory propagating signals per se are not precluded.). See MPEP 2111.01.
The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. § 101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. § 101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § I01 by adding the limitation "non-transitory" to the claim. Cf. Animals -Patentability, 1 077 0ff. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. § 101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-32 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.
The independent claims each similarly recite “perform a pullback of a catheter or probe and/or obtain one or more images or frames from the pullback of the catheter or probe” meaning that one or more images or frames DOES NOT NEED TO OCCUR due to the use of the “or” however, the claims then recites “create or construct a Carpet View Image (CVI) based on the one or more images or frames.” Thus, it is unclear whether the images need to be obtained or not. The claim should remove the “or” so as to remove the ambiguity. It is noted the claims overuses “or” language (There are 27 “or” recitations in claim 1, for example.), leading to much unclarity in the claims as to what is positively recited as noted in the claim interpretation section above. The claims should be rewritten to more clearly define what the applicant wants in the claims.
The dependent claims are rejected at least due to their dependency from the independent claims.
For examination purposes of the independent claims, it will be interpreted that the images are obtained such that the remaining limitations of the claims can occur, even though technically the only portion of the claim that is positively recited is performing a pullback (For example, if the “or” were to be considered such that the images are not obtained, then the CVI cannot be created, thus there is no CVI to be updated and no CVI to be displayed, etc.).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 16-22 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (US 2020/0226422).
Regarding claim 1, Li et al. disclose an apparatus (Figure 1) for detecting and/or characterizing one or more tissues in one or more images, the apparatus comprising:
one or more processors (Figure 1, elements 22 and 50 and Figure 4A) that operate to:
(i) perform a pullback of a or probe (Figure 1, 30 and paragraphs [0048] and [0083].) and/or obtain one or more images or frames from the pullback of the catheter or probe (Figure 1F, step 100.);
(ii) create or construct a Carpet View Image (CVI) based on the one or more images or frames from the pullback or otherwise receive or obtain the CVI (Figure 2A, paragraphs [0135] and [0137].);
(iii) detect or identify tissue type(s) of one or more tissues shown in the CVI, and/or
(iv) update the CVI by overlaying information on the CVI to indicate the detected or identified tissue type(s) and/or the determined one or more characteristics of the one or more tissues (Figure 1F, step 107 and paragraph [0122]. See also Figure 2A and paragraph [0042] and Figures 16-18.); and
(v) display the updated CVI, or the updated CVI with one or more images or frames from the pullback on a display, or
Regarding claim 2, Li et al. disclose the apparatus of claim 1, wherein the one or more processors further operate to one or more of the following:
(i) detect one or more tissue types automatically in the pullback of the catheter or the probe for one or more intravascular or Optical Coherence Tomography (OCT) images, where the one or more tissue types include the calcium type, the lipid(s) type, a fibrous tissue type, a mixed tissue type, or the another tissue type (Figure 1F, step 106 and paragraph [0121]);
(ii)
(iii)
(iv)
(v) or
(vi)
Regarding claim 3, Li et al. disclose the apparatus of claim 1, wherein the one or more processors further operate to perform one or more of the following:
display the CVI for further processing and/or display the CVI with one or more intravascular or Optical Coherence Tomography (OCT) images (Figure 1F, step 108 and paragraphs [0122]-[0123], and Figure 1, 49 is a display. See also Figure 2A and paragraph [0042] and Figures 16-18.);
or
Regarding claim 4, Li et al. disclose the apparatus of claim 3, wherein the one or more processors further operate to:
in a case where the high texture carpet view areas are detected by the one or more processors, form the high texture carpet view areas due to a presence of sharp edges in the A-line frames or images which represent calcium in the one or more intravascular or OCT images (High texture carpet view areas were not detected in claim 3 due to the or, and thus since they were not detected this limitation is not positively recited and thus not needed in the claims.); and
in a case where dark homogenous areas are detected by the one or more processors, form or associate corresponding dark homogenous areas to represent lipid(s) (Dark homogenous areas are not detected in claim 3 since lipid(s) are not detected due to the or, and thus since they were not detected this limitation is not positively recited and thus not needed in the claims.).
Regarding claim 5, Li et al. disclose the apparatus of claim 4, wherein the one or more processors further operate to use AI network(s) and Machine Learning (ML) or other AI-based features to train models to automatically detected calcium and/or lipids based on the use of the high texture carpet view areas representing calcium and based on the dark homogenous areas representing lipid(s) (See the explanation in claim 4, neither high texture or dark homogenous areas are detected, and thus this limitation also is not positively recited and does not occur in the claims.).
Regarding claim 6, Li et al. disclose the apparatus of claim 5, wherein the one or more processors further operate to use the trained models and/or trained AI network(s) on the CVI only to determine or identify and/or characterize the tissue or tissue characteristics (See the explanation of claim 5, and thus this limitation also is not positively recited and does not occur in the claims.).
Regarding claim 16, Li et al. disclose the apparatus of claim 1, further comprising one or more of the following:
a light source that operates to produce a light (Paragraph [0167].);
or
Regarding claim 17, this claim is rejected under the same rationale as claim 1.
Regarding claim 18, this claim is rejected under the same rationale as claim 2.
Regarding claim 19, this claim is rejected under the same rationale as claim 3.
Regarding claim 20, this claim is rejected under the same rationale as claim 4.
Regarding claim 21, this claim is rejected under the same rationale as claim 5.
Regarding claim 22, this claim is rejected under the same rationale as claim 6.
Regarding claim 32, this claim is rejected under the same rationale as claim 1, and also refer to paragraphs [0250] and [0256] of Li et al.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 7-10 and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 2020/0226422) in view of Hu et al. (US 2017/0076453).
Regarding claim 7, Li et al. disclose the apparatus of claim 1, wherein the one or more processors further operate to:
classify the pixel to the lipid tissue type, the calcium tissue type, or the another tissue type using artificial intelligence (Figure 1F, steps 106 and 107, and paragraphs [0121] and [0122], and Figures 16-18.), where the artificial intelligence is one of: Machine Learning (ML), random forests, support vector machines (SVM), and/or another AI-based method, network, or feature (Figure 1, 52 and paragraph [0090].); or or
Li et al. fail to explicitly teach wherein the one or more processors further operate to:
construct a patch of length L around each pixel of the CVI;
extract a set of intensity and texture features from the patch or pixel; and
point, mark, or otherwise indicate, in one or more intravascular or Optical Coherence Tomography (OCT) images, where the calcium and/or lipid starts and ends by using a column part of each corresponding area detected by the one or more processors.
Hu et al. disclose wherein one or more processors operate to:
construct a patch of length L around each pixel of the CVI (Figure 5 and paragraph [0040].);
extract a set of intensity and texture features from the patch or pixel (Figure 5 and paragraph [0040].); and
point, mark, or otherwise indicate, in one or more images, where a tissue starts and ends by using a column part of each corresponding area detected by the one or more processors (Paragraphs [0006], [0010], [0033] and [0067]).
Therefore, it would have been obvious to “one of ordinary skill” in the art before the effective filing date of the claimed invention to use the teachings of Hu et al. and apply them to the CVI in the apparatus of Li et al. The motivation to combine would have been in order to provide an improved visualization (See paragraphs [0003]-[0004] of Hu et al.).
Regarding claim 8, Li et al. and Hu et al. disclose the apparatus of claim 7, wherein the one or more processors further operate to one or more of the following:
(i)
(ii) perform construction of the patch based on the CVI (In the combination, the constructure of the patch as in Figure 5 and paragraph [0040] of Hu et a. will be based on the CVI of Li et al.);
(iii)
(iv)
(v) or
(vi)
Regarding claim 9, Li et al. and Hu et al. disclose the apparatus of claim 8, wherein the one or more processors further operate to display results of the tissue characterization completion on the display (Li et al.: Figure 1F, step 108 and paragraphs [0122]-[0123], and Figure 1, 49 is a display. See also Figure 2A and paragraph [0042] and Figures 16-18.), or
Regarding claim 10, Li et al. and Hu et al. disclose the apparatus of claim 9, wherein the trained model is one or a combination of the following:
a neural net model or neural network model (Li et al.: Figure 1, 52 and Figure 1F, step 105 and paragraph [0090].),
Regarding claim 23, this claim is rejected under the same rationale as claim 7.
Regarding claim 24, this claim is rejected under the same rationale as claim 8.
Regarding claim 25, this claim is rejected under the same rationale as claim 9.
Regarding claim 26, this claim is rejected under the same rationale as claim 10.
Claims 11 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 2020/0226422) in view of Hu et al. (US 2017/0076453) and further in view of Rajguru et al. (US 2023/0190224).
Regarding claim 11, Li et al. and Hu et al. disclose the apparatus of claim 8.
Li et al. and Hu et al. fail to teach wherein the one or more processors further operate to:
indicate a calcium pixel or patch using a solid line and/or indicate a lipid pixel or patch using a dotted or dashed line overlaid on the one or more intravascular or OCT images and/or on the CVI; and/or
perform a more detailed tissue detection by taking into consideration a spatial connection or connections of tissue in adjacent frames of the pullback.
Rajguru et al. disclose wherein one or more processors operate to:
or patch using a dotted or dashed line overlaid on the one or more intravascular or OCT images and/or on the CVI (Figure 6 shows that a patch is indicated using a dotted line.); and/or
Hence the prior art includes each element claimed although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of the actual combination of the elements in a single prior art reference. In combination, the combination of Li et al. and Hu et al. performs the same function as it does separately of displaying patches, and Rajguru et al. performs the same function as it does separately of displaying patches using a dotted line.
Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention could have combined the elements as claimed by known methods, and that in combination, each element merely performed the same function as it does separately. The results of the combination would have been predictable and resulted in displaying patches using a dotted line.
Therefore, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 27, this claim is rejected under the same rationale as claim 11.
Claims 12-15 and 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 2020/0226422) in view of So et al. (US 2005/0036667).
Regarding claim 12, Li et al. disclose the apparatus of claim 1, wherein:
the CVI has dimensions equal to a number of A-lines (A) of each A-line frame times, or by, a number of pullback cross sectional frames or images or by a number of total frames (N) (Paragraph [0135], 195 is a combination of 193.).
Li et al. fails to teach:
setting a counter i to a value of 1; and
the one or more processors further operate to:
or
(iii) in a case where i is more than N such that all of the pullback frames, N, have been processed, show, reveal, display on a display, and/or store the created or constructed CVI in the memory.
So et al. disclose an apparatus wherein:
setting a counter i to a value of 1 (Figure 5, set to 1 for the first image.); and
the one or more processors further operate to:
or
(iii) in a case where i is more than N such that all of the pullback frames, N, have been processed, show, reveal, display on a display, and/or store the created or constructed CVI in the memory (Figure 5, last section is yes at 116, where i will be more than N, then post processing at 120 occurs, where Figure 7 shows the post processing procedure, see paragraph [0068], results are displayed on a display at step 220.).
Hence the prior art includes each element claimed although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of the actual combination of the elements in a single prior art reference. In combination Li et al. performs the same function as it does separately of using pullback frames and displaying the resulting image, and So et al. performs the same function as it does separately of using a counter.
Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention could have combined the elements as claimed by known methods, and that in combination, each element merely performed the same function as it does separately. The results of the combination would have been predictable and resulted in using a counter to determine that all the images have bene processed.
Therefore, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 13, Li et al. and So et al. disclose the apparatus of claim 12, wherein the constructed or created CVI is saved in the memory and/or is sent to the one or more processors or an artificial intelligence (AI) network for use in AI evaluations or determinations (Li et al.: Figure 1F, steps 105-107.).
Regarding claim 14, Li et al. and So et al. disclose the apparatus of claim 13, wherein the one or more processors further operate to use one or more neural networks or convolutional neural networks to one or more of:
et al.: Figure 1F, step 106 and paragraph [0121].), or
Regarding claim 15, Li et al. and So et al. disclose the apparatus of claim 13, wherein the one or more processors further operate to use one or more neural networks or convolutional neural networks to one or more of:
incorporate image processing and machine learning (ML) or deep learning to automatically identify and locate calcium and lipid(s) (Li et al.: Figure 1F, steps 106 and 107, paragraphs [0121]-[0122] and Figures 16-18.); or
Regarding claim 28, this claim is rejected under the same rationale as claim 12.
Regarding claim 29, this claim is rejected under the same rationale as claim 13.
Regarding claim 30, this claim is rejected under the same rationale as claim 14.
Regarding claim 31, this claim is rejected under the same rationale as claim 15.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN G SHERMAN whose telephone number is (571)272-2941. The examiner can normally be reached Monday - Friday, 8:00am - 4pm ET.
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/STEPHEN G SHERMAN/Primary Examiner, Art Unit 2621
27 July 2026
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