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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/13/2025 has been entered.
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 9, 12-13, and 16 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.
Claim 9 recites the limitations “a presumably healthy breast”, and “a low risk” in line 10 which have improper antecedence given the recitation of the same in lines 2-3 of the same claim.
Claim 9 recites “a magnetic resonance imaging device” and “a spectroscopy mode” in line 23. This has improper antecedent basis given the recitation of the same in line 7 of the same claim.
Claim 9 recites “using a processor to correlate the level of breast density with the concentration of the selected biochemical to obtain a reference system of reference measurements which correlates the level of breast density with the concentration of the selected biochemical”; however, each and every statement that follows after this point appears to be a desiderata of what the applicant wishes the reference system to be useful for without placing any clear or examinable limitation on the structure or steps of the system. For example, these statements describe what “can be determined” from using the system without attempting to limit how the system is constructed or describing what is done to form the system. For examination purposes these statements will be treated as holding no patentable weight as they do not apply any limitation on how to perform any step or on what the structure should be.
Claim 12 is similarly affected by the foregoing issues, at least by virtue of dependency.
Regarding claim 13, it is prima facie unclear which steps are a portion of the method as the first three steps (i.e. “using a magnetic resonance imaging device to obtain … using a spectrometer to obtain … using a processor to correlate …”) appear to be preamble limitations despite being drafted as steps and despite following what may be a transitional phrase which is addressed further below. Furthermore, it is prima facie unclear whether the claim is a method or apparatus given that the claims recite “A method” but then follow with product-by-process terminology (see lines 3-10, which recite the same scope as Claim 9) the result of which is an apparatus and wherein the remaining claim limitations recite “using” structures of the apparatus so formed (see lines 11-14 which add “using” to what is otherwise the same scope as the apparatus claim as set forth in Claim 5). Furthermore, it is prima facie unclear whether or not the claim is drafted in proper format (e.g. using three part format) as it is unclear where the body begins/preamble ends which is addressed in more detail below. Furthermore and fundamentally, see MPEP 2173.05(p) and note that a product and process in the same claim, something clearly present (thought it may be, depending on the resolution portions of this this 112(b) issue, the case that the process and product are body and preamble respectively) is indefinite per se. Likewise and as best understood, the part of the claim that is presumed to be the body is also the mere function of a machine (so made by the preamble) and is therefore prima facie indefinite under MPEP 2173.05(u).Turning to the claim language itself to discuss the claim format, a first potential transitional phrase occurs in line 2, specifically “having been obtained by:”. Notably this is not one of the three standard transitional phrases and while that, on its own, is not grounds to hold the claim indefinite, it is unclear how “having been obtained by:” should limit the claim as there is no clear indication in the claims or specification whether or not this is open ended or closed claim construction. In this instance the examiner notes that proper punctuation and spacing are used and what follows after this potential transitional phrase are steps and where claim 1 of the claim recites that the claim is a “A method”. However, the examiner also notes that the steps result in an apparatus not a method of using and therefore there is at least one prima facie issue with the claim’s body and preamble not aligning in scope if “having been obtained by” is actually the transitional phrase. Alternatively, the examiner notes that beginning on page 32 of the claims there is a wherein clause which contains the term “comprises” which is understood to have the same meaning as the standard transitional phrase “comprising” but which is not formatted in a manner to render clear that would be a transitional phrase as there is not proper spacing or punctuation. If one presumes this to be the transitional phrase than it appears that the claim is a prolix claim rejectable under MPEP 2173.05(m) as the preamble is overly verbose without placing a single meaningful or intelligible limitation on the steps of the method. Moreover what follows after is clearly a method of use. As that rejection requires a separate header it is further rejected below, but would render the claim prima facie indefinite. While it is fundamentally unclear which of these two recitations should be interpreted as the transitional phrase, for examination purposes the examiner will presume hereafter that the transitional phrase is “comprises” and that the body of the claim begins on page 32 of the claims. For compact prosecution purposes the examiner will examine claim 13 below as best understood.
Claim 16 is similarly affected, at least by virtue of dependency.
Claim 13 recites the limitation “the breast density” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitations “a female subject”, “a presumably healthy breast”, and “a low risk” in lines 18-19 which have improper antecedence given the recitation of the same in lines 2-3 of the same claim.
Claim 13 recites the limitation "obtaining spectral data" in line 18. It is unclear whether this is the same or different than the obtained MRS of line 6 which calls into question what data is being used by the claim.
Claim 13 recites the limitation "a spectrometer" in line 15. This has improper antecedence given the recitation of the same in line 6 of the same claim.
Claim 13 recites the limitation "a magnetic resonance imaging device" in line 22. This has improper antecedence given the recitation of the same in line 5 of the same claim.
Regarding claim 16, the claim depends from claim 13; however, the entirety of claim 16 appears to be directed towards a preamble limitation of its parent, with no clear applicability and no clear limitation being placed on any step of the method as best understood. Therefore claim 16 is prima facie unclear and indefinite.
Claim Rejections - 35 USC § 112(b) and 35 USC § 101
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.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 13 and 16 are rejected under 35 U.S.C. 112(b) and 35 U.S.C. 101 because the claim, as best understood, recites a method of use. See MPEP 2173.05(q) which sets forth the legal and logical basis for this rejection. Note also that this applied under the current claim interpretation (specifically that the contents of claim 13 which reside on page 31 of the claims is a preamble, and the term “comprises” on page 32 line 1 is the transitional phrase). However with that established the steps are merely to use the apparatus. See the guidance provided in MPEP2173.05(q) which explains how any why the statements “A method of using … wherein the method of using comprises … using a processor” would prima facie fail to establish any meaningful step beyond mere use and therefore would dually be rejected under this title.
Claim 16 is similarly affected, at least by virtue of dependency where claim 16 appears to address a preamble limitation and thus has no clear impact on the scope of the claims as addressed above.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4-5, 8-9, 12-13, and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea, specifically a mental process, without significantly more. That is, the claim(s) recite(s) “processing the spectral data with a processor to obtain a measurement of the concentration of at least one selected biochemical whole concentration varies with breast density” [claims 1, 5, and 13] or “using a processor to correlate the breast density with the concentration of the selected biochemical to obtain a reference system of reference measurements which correlates breast density with the concentration of the selected biochemical” [claim 9]. Where this step, while nominally performed on a computer is a simple determination that could otherwise be performed in one’s head or on paper as iterated in MPEP 2106.04(a)(2)(III), and where the mere iteration that a computer should be involved is not determinative in this instance as per MPEP 2106.04(a)(2)(III)(C).
This judicial exception is not integrated into a practical application because it is one of the instances that the courts and MPEP have clearly identified an even exemplified as not having additional elements that would integrate the idea into a practical application. See in specific MPEP 2106.04(d) noting that under subsection (I) thereof the mere implementation of an otherwise abstract idea on a computer is not integration into a practical application per se. Notably the steps/processing actually stops at obtaining the concentration and does not attempt to apply this abstract idea in any way (e.g. there is not an output in any claim, there is not a diagnosis of breast cancer, etc.) which is of particular relevance because the invention is directed towards the medical field and treatment/prophylaxis are the most common way to overcome 101 rejections in this area. Likewise the examiner notes that effectively no other exception stated in the MPEP could apply (e.g. this method does not improve the function of a computer as it does not, e.g. allow for more data to be stored in the same amount of storage nor allow for faster indexing, rather it uses a general purpose computer and does not modify its core functioning – just its use). To fully compact prosecution the examiner notes that as per MPEP 2106.04(d)(2) “Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.” As such the examiner notes that even after review of the entire specification it appears that the applicant did not include, anywhere in the originally filed disclosure, any positive step that could be considered treatment or prophylaxis. As such it is exceedingly clear that the invention is specifically limited to the abstract idea unto itself and not to any practical application thereof.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because: the only other additional features are data gathering steps/structures. For instance in claims 1, 5, and (as best understood) 13 the generic recitation of a MR spectrometer used to gather data is the only other claimed step/structure. See MPEP 2106.05(g) where this sort of data gathering steps/structures are clearly discussed and clearly shown to be insignificant to the analysis. Likewise and further regarding claim 9 (or claim 13 as best understood, at least in the alternate for the preamble limitations which recite the scope of claim 9) the use of two data gathering structures (spectrometer and MRI) to perform two data gathering steps does not change the analysis and MPEP 2106.05(g) would likewise apply.
The foregoing covers the four independent claims; however, it is also pertinent to further address each dependent claim.
Likewise Claims 4, 8, 12, and 16 recite that the reference measurements are segregated by groups which merely iterates how the data is organized and does not recite a further step/structure that would need further analysis and/or materially impact the eligibility analysis conducted above.
Therefore and in light of the foregoing analysis, all claims are determined to be ineligible for a patent under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-5, 8-9, 12-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over “Optical imaging correlates with magnetic resonance imaging breast density and reveals composition changes during neoadjuvant chemotherapy” by O’Sullivan et al. (Hereafter Sullivan, previously of record) further in view of US 20160022197 A1 by Ramadan et al. (hereafter Ramadan, newly of record).
Regarding claim 1, Sullivan teaches: 1. A method for detecting the breast density of a female subject having a presumably healthy breast having a low risk of developing breast cancer according to National Institute for Health and Care Excellence (NICE) guidelines, (as best understood this holds no patentable weight but rather merely specifies the intended use/intended patient. See MPEP 2111.02(II). However and for compact prosecution purposes, see Sullivan’s Abstract and regarding the subject having “presumably healthy breasts” hereafter; the examiner notes that while the bulk of Sullivan’s disclosure focuses on patient’s who may have ‘unhealthy breasts’ that Sullivan expressly describes that, having successfully used the invention on known cancerous breasts that it should be used in the future in “perspective studies” as well as to “predict cancer risk”, i.e. on patients without known cancer as per the Conclusion section on page 13 which is the same feature the applicant describes in their specification as being “presumptively healthy” and which would fall under NICE guidelines as presumptively healthy. Lastly and for compact prosecution purposes the examiner notes that this is additionally rejected, at least in the alternative, below in the 103(a) modification), comprising:
obtaining spectral data in vivo, using a … device in a spectroscopy mode, within a voxel placed … between the nipple and chest well within a breast of the subject (see Sullivan’s Methods section on pages 3-5 and in particular the DOSI measurement subsection on page which describes the spectroscopy device and spectral data and measurement region being the breast per se noting in particular that as per Fig. 2 the measurements extend multiple cm away from the nipple and thus include (for the average woman) locations that would be approximately halfway from the nipple to chest wall), and
processing the spectral data with a processor to obtain a measurement of the concentration of at least one selected biochemical whose concentration varies with a level of breast density (see Table 2 on page 7 which clarifies that this DOSI data is processed into concentrations specifically. While the applicant well understands that these vary with breast density, for compact prosecution purposes the examiner also iterates that Statistic analysis section on pages 4-5 covers how these concentrations are correlated with breast density from the MRI data),
comparing the measurement of the concentration with known reference measurements of the concentrations of the selected biochemical of subjects having varying known levels of breast tissue density correlated with the concentration of the selected biochemical, to determine the level of breast density of the subject and the risk of breast cancer by reference to the measurement of concentration of the selected biochemical (see Sullivan’s Results section pages 5-9 noting in particular the Relation between DOSI parameters and mammographic density categories subsection and the Correlation between DOSI parameters and MRI breast density subsection which thoroughly cover how, why and to what extent the correlation exists for multiple biochemicals and how these can be used in density determinations. Regarding the new wording, this is taught in three ways. First, Sullivan expressly teaches on page 13 in the conclusion section that this is intended to be used to predict cancer risk in addition to the monitoring and detection of cancer. Second, detecting cancerous tissue itself is inherently a pass/fail detecting of risk of breast cancer (e.g. if you have detectable cancer your cancer risk is 100%) so as to teach this from a second perspective as the claims to do limit or otherwise clarify how this risk is assessed or reported. Nevertheless, for compact prosecution purposes the examiner notes that from a third perspective this feature is alternatively rejected, along with specific claimed biochemicals omitted by ellipsis, in the 103(a) analysis below), …
In the foregoing, the examiner omitted various limitations, as indicated by ellipsis, because while Sullivan teaches the majority of limitations as iterated above, Sullivan does not 1) utilize and MRI device/MRS to obtain the spectral data, does not 2) explicitly state that the voxel being imaged includes the half way point between the nipple and chest wall, and does not 3) teach the use of the specific biochemicals such as cholesterol as amended.
Regarding point 2), the examiner notes that Sullivan does teach that the voxel should be between the nipple and chest wall as he makes multiple measurements with significant penetration depth over a wide range of positions so as to at least approach or include the half way point (notably Sullivan takes multiple measurements and states both: “Because of the absorption and scattering properties of breast tissue, near-infrared light (650 to 1,000 nm) is able to penetrate several centimeters deep.” And “DOSI measurements were acquired at a minimum of 30 locations (taken in a rectangular grid pattern with 10-mm spacing between measurement points)” on pages 2 and 3 respectively) and further iterates that he takes spectral measurements from all available points so as to seemingly include this scope even if using different words (See Sullivan’s page 5 which iterates “For analysis, the average of DOSI measurement parameters (chromophore concentrations and scattering coefficients) was computed over the entire measurement region …” so as to clarify that Sullivan takes data from all obtainable regions of the breast) and as such regardless of using the exact wording of the claim Sullivan appears to at least implicitly teach the claim limitation as well as clearly and explicitly teaches an obvious variant thereof. See MPEP 2144.05 noting that this depth and location profile necessarily at least approaches or overlaps the half way point.
Therefore, it is the case that Sullivan either implicitly teaches, or prima facie obviates the use of data from half-way between the nipple and chest wall at least in light of the legal precedent set forth in MPEP 2144.05.
Regarding points 1) and 3) Ramadan in the same or related field of MR and spectroscopy-based breast imaging for cancer diagnostic purposes (see Ramadan’s Abstract), teaches that MRS/COSY can be used to obtain spectral data of breasts (see e.g. Ramadan’s [0009]). Ramadan further teaches that this sort of imaging can be conducted on specific claimed biochemicals and that these biochemicals specifically relate to breast cancer and breast cancer risk factors per se (e.g. cholesterol relates to both cancer and to BRCA1/2 and thus breast cancer risk, see Ramadan’s [0011], [0014], [0024], and [0044]). Ramadan also goes on to further teach that the use of this MRS/COSY imaging of cholesterol is advantageous as it allows to determining breast cancer/cancer risk even before any symptoms in a way not achievable with current optical imaging (see Ramadan’s [0011]-[0014], [0024], and [0046] noting that these changes to the chemistry of the breast which are detectable using MRS cannot be identified by current imaging modalities (with light microscopy given as an example) and further advantageously can be detected pre-invasive condition/pre-malignancy setting forth a clear advantage over Sullivan’s methodology).
Therefore it would have been obvious to one of ordinary skill in the art to additionally or alternatively utilize MRS to gather spectroscopic data, as taught by Ramadan, in order to advantageously allow for gathering data on specific metabolites such as cholesterol that could not be gathered by traditional optical measures and which allow for multiple advantages over optical spectroscopy such as detecting cancer and cancer risk factors before there is any observable disease.
Regarding claim 4, Sullivan further teaches: 4. The method according to claim 1, wherein the reference measurements are those of pre-menopausal women and post-menopausal women in separate groups, and the spectral data of the subject are compared to the reference measurements of the two separate groups depending on whether the subject is pre-menopausal or post-menopausal (see Sullivan’s Table 2 and note that the results are segregated by pre/post menopause per se, likewise see Sullivan’s Results section on pages 5-9 noting in particular the Baseline pre- and postmenopausal differences subsection thereof which fully describes not only that the comparison is made by menopausal status but also describes why and how this varies, etc.).
Regarding claim 5, Sullivan teaches: 5. A system for detecting the breast density of a female subject, having a presumably healthy breast and having a low risk for developing breast cancer according to National Institute for Health and Care Excellence (NICE) guidelines (as best understood this holds no patentable weight but rather merely specifies the intended use/intended patient. See MPEP 2111.02(II). However and for compact prosecution purposes, see Sullivan’s Abstract and regarding the subject having “presumably healthy breasts” hereafter; the examiner notes that while the bulk of Sullivan’s disclosure focuses on patient’s who may have ‘unhealthy breasts’ that Sullivan expressly describes that, having successfully used the invention on known cancerous breasts that it should be used in the future in “perspective studies” as well as to “predict cancer risk”, i.e. on patients without known cancer as per the Conclusion section on page 13 which is the same feature the applicant describes in their specification as being “presumptively healthy” and which would fall under NICE guidelines as presumptively healthy. Lastly and for compact prosecution purposes the examiner notes that this is additionally rejected, at least in the alternative, below in the 103(a) modification), comprising:
a … device in a spectroscopy mode for obtaining spectral data within a voxel placed at the halfway point between the nipple and chest well within a breast of the healthy subject (see Sullivan’s Methods section on pages 3-5 and in particular the DOSI measurement subsection on page 3 which describes the spectroscopy device and spectral data and measurement region being the breast and penetrating multiple cm into the tissue and being measured over a large number of distributed points and/or see Fig. 7 noting the tick marks are 1 cm. As such Sullivan’s invention is fully capable of as much. For compact prosecution purposes the examiner notes two alternative rejections. First and in the alternative, while the instant invention is an apparatus and thus only regards the capabilities, the examiner notes that actually using the half-way point per se is either implicitly taught by or an obvious variant of Sullivan’s teachings as iterated above in the rejection of claim 1 which is incorporated herein by reference. Secondly, and in the alternative the 103(a) modification below to use MRS is not depth limited and Sullivan uses all available breast data in the spectroscopic analysis as per the first paragraph of the Results section on page 5 such that in combination not only would the MRS system by fully capable of as much but it would be used to image all available portions of the breast as per Sullivan’s teachings).
a processor for processing the spectral data to obtain a measurement of the concentration of at least one selected biochemical whose concentration varies with a level of breast density (see Table 2 on page 7 which clarifies that this DOSI data is processed into concentrations specifically. While the applicant well understands that these vary with breast density, for compact prosecution purposes the examiner also iterates that Statistic analysis section on pages 4-5 covers how these concentrations are correlated with breast density from the MRI data)
to compare the measurement of the concentration with known reference measurements of the concentrations of the selected biochemical of subjects known to have varying known levels of breast tissue density correlated with the concentrations of the selected biochemical, to determine the level of breast density and the risk of breast cancer of the subject by reference to the measurement of concentration of the selected biochemical (see Sullivan’s Results section pages 5-9 noting in particular the Relation between DOSI parameters and mammographic density categories subsection and the Correlation between DOSI parameters and MRI breast density subsection which thoroughly cover how, why and to what extent the correlation exists for multiple biochemicals and how these can be used in density determinations. Regarding the new wording, this is taught in three ways. First, Sullivan expressly teaches on page 13 in the conclusion section that this is intended to be used to predict cancer risk in addition to the monitoring and detection of cancer. Second, detecting cancerous tissue itself is inherently a pass/fail detecting of risk of breast cancer (e.g. if you have detectable cancer your cancer risk is 100%) so as to teach this from a second perspective as the claims to do limit or otherwise clarify how this risk is assessed or reported. Nevertheless, for compact prosecution purposes the examiner notes that from a third perspective this feature is alternatively rejected, along with specific claimed biochemicals omitted by ellipsis, in the 103(a) analysis below) …
In the foregoing, the examiner omitted various limitations, as indicated by ellipsis, because while Sullivan teaches the majority of limitations as iterated above, Sullivan does not 1) utilize and MRI device/MRS to obtain the spectral data, does not 2) teach the use of the specific biochemicals such as cholesterol as amended.
Regarding points 1) and 2) Ramadan in the same or related field of MR and spectroscopy-based breast imaging for cancer diagnostic purposes (see Ramadan’s Abstract), teaches that MRS/COSY can be used to obtain spectral data of breasts (see e.g. Ramadan’s [0009]). Ramadan further teaches that this sort of imaging can be conducted on specific claimed biochemicals and that these biochemicals specifically relate to breast cancer and breast cancer risk factors per se (e.g. cholesterol relates to both cancer and to BRCA1/2 and thus breast cancer risk, see Ramadan’s [0011], [0014], [0024], and [0044]). Ramadan also goes on to further teach that the use of this MRS/COSY imaging of cholesterol is advantageous as it allows to determining breast cancer/cancer risk even before any symptoms in a way not achievable with current optical imaging (see Ramadan’s [0011]-[0014], [0024], and [0046] noting that these changes to the chemistry of the breast which are detectable using MRS cannot be identified by current imaging modalities (with light microscopy given as an example) and further advantageously can be detected pre-invasive condition/pre-malignancy setting forth a clear advantage over Sullivan’s methodology).
Therefore it would have been obvious to one of ordinary skill in the art to additionally or alternatively utilize MRS to gather spectroscopic data, as taught by Ramadan, in order to advantageously allow for gathering data on specific metabolites such as cholesterol that could not be gathered by traditional optical measures and which allow for multiple advantages over optical spectroscopy such as detecting cancer and cancer risk factors before there is any observable disease.
Regarding claim 8, Sullivan further teaches: 8. The system according to claim 5, wherein the reference measurements are those of pre-menopausal women and post-menopausal women in two separate groups, and the spectral data of the subject are compared to the reference measurements of the two separate groups depending on whether the subject is pre-menopausal or post-menopausal (see Sullivan’s Table 2 and note that the results are segregated by pre/post menopause per se, likewise see Sullivan’s Results section on pages 5-9 noting in particular the Baseline pre- and postmenopausal differences subsection thereof which fully describes not only that the comparison is made by menopausal status but also describes why and how this varies, etc.).
Regarding claim 9, Sullivan teaches: 9. A method of making a breast density detection system for detecting breast density of a healthy subject having a presumably healthy breast and having a low risk of developing breast cancer according to National Institute of Health and Care Excellence (NICE) guidelines, using a concentration of at least one selected biochemical in the subject's breast tissue whose concentration varies with a level of breast density (as best understood this holds no patentable weight but rather merely specifies the intended use/intended patient and the intended result. See MPEP 2111.02(II). However and for compact prosecution purposes, see Sullivan’s Abstract and regarding the subject having “presumably healthy breasts” hereafter; the examiner notes that while the bulk of Sullivan’s disclosure focuses on patient’s who may have ‘unhealthy breasts’ that Sullivan expressly describes that, having successfully used the invention on known cancerous breasts that it should be used in the future in “perspective studies” as well as to “predict cancer risk”, i.e. on patients without known cancer as per the Conclusion section on page 13 which is the same feature the applicant describes in their specification as being “presumptively healthy” and which would fall under NICE guidelines as presumptively healthy. Lastly and for compact prosecution purposes the examiner notes that this is additionally rejected, at least in the alternative, below in the 103(a) modification), comprising:
using a … imaging device in spectroscopy mode to obtain in vivo … spectra within a voxel … between the nipple and chest well within breasts from a plurality of breasts of women having a presumably healthy breast and having a low risk of developing breast cancer according to National Institute for Health and Care Excellence (NICE) guidelines (see Sullivan’s page 13 Conclusion section for this being intended to be used on healthy breasts of the sort that would read on the claimed limitations. Additionally or alternatively the examiner notes that a secondary rejection of this feature is lodged below in the 103(a) analysis), having different breast densities to obtain the concentration of at least one selected biochemical in the plurality of the breasts (see Sullivan’s Methods section on pages 3-5 and in particular the DOSI measurement subsection on page which describes the spectroscopy device and spectral data and measurement region being the breast per se noting in particular that as per Fig. 2 the measurements extend multiple cm away from the nipple and thus include (for the average woman) locations that would be approximately halfway from the nipple to chest wall);
wherein the concentration of the selected bio-chemical varies with the level of breast density; and using a processor to correlate the level of breast density with the concentration of the selected biochemical to obtain a reference system of reference measurements which correlates level of breast density with the concentration of the selected biochemical (regarding these limitations together, see Table 2 on page 7 which clarifies that this DOSI data is processed into concentrations specifically. While the applicant well understands that these vary with breast density, for compact prosecution purposes the examiner also iterates that Statistic analysis section on pages 4-5 covers how these concentrations are correlated with breast density from the MRI data as well as how they correlate to density per se),
whereby the breast density of a breast of a healthy subject having unknown breast density can be determined by obtaining spectral data in vivo from a voxel … between the nipple and chest wall (see Sullivan’s Abstract noting that the end result is a determination/assessment of an otherwise unknown breast density and see also Sullivan’s Fig. 2 noting that the measurements extend multiple cm away from the nipple and thus include (for the average woman) locations that would be approximately halfway from the nipple to chest wall) within the breast of the healthy subject using a spectrometer to determine the concentration of the selected biochemical comparing the determined concentration to reference measurements of the selected biochemical and selecting the level of breast density correlated with the selected biochemical concentration (as best understood this is inherent and/or holds no patentable weight. See the 112(b) rejections above and note that the processing steps are separate from this statement of use/result. While the foregoing is a proper and complete rejection of the current claim drafting, the examiner notes that it may compact prosecution to further reject the idea that results can be gather/applied to additional patients and thus see both Sullivan’s Discussion section on pages 9-13 and Sullivan’s Conclusion section on page 13 both of which cover that the invention is functional to detect breast density and see the 103(a) analysis below which also covers using MRS instead of or in addition to optical measures), …
In the foregoing, the examiner omitted various limitations, as indicated by ellipsis, because while Sullivan teaches the majority of limitations as iterated above, Sullivan does not 1) utilize and MRI device/MRS to obtain the spectral data, does not 2) explicitly state that the voxel being imaged includes the half way point between the nipple and chest wall, and does not 3) teach the use of the specific biochemicals such as cholesterol as amended.
Regarding point 2), the examiner notes that Sullivan does teach that the voxel should be between the nipple and chest wall as he makes multiple measurements with significant penetration depth over a wide range of positions so as to at least approach or include the half way point (notably Sullivan takes multiple measurements and states both: “Because of the absorption and scattering properties of breast tissue, near-infrared light (650 to 1,000 nm) is able to penetrate several centimeters deep.” And “DOSI measurements were acquired at a minimum of 30 locations (taken in a rectangular grid pattern with 10-mm spacing between measurement points)” on pages 2 and 3 respectively) and further iterates that he takes spectral measurements from all available points so as to seemingly include this scope even if using different words (See Sullivan’s page 5 which iterates “For analysis, the average of DOSI measurement parameters (chromophore concentrations and scattering coefficients) was computed over the entire measurement region …” so as to clarify that Sullivan takes data from all obtainable regions of the breast) and as such regardless of using the exact wording of the claim Sullivan appears to at least implicitly teach the claim limitation as well as clearly and explicitly teaches an obvious variant thereof. See MPEP 2144.05 noting that this depth and location profile necessarily at least approaches or overlaps the half way point.
Therefore, it is the case that Sullivan either implicitly teaches, or prima facie obviates the use of data from half-way between the nipple and chest wall at least in light of the legal precedent set forth in MPEP 2144.05.
Regarding points 1) and 3) Ramadan in the same or related field of MR and spectroscopy-based breast imaging for cancer diagnostic purposes (see Ramadan’s Abstract), teaches that MRS/COSY can be used to obtain spectral data of breasts (see e.g. Ramadan’s [0009]). Ramadan further teaches that this sort of imaging can be conducted on specific claimed biochemicals and that these biochemicals specifically relate to breast cancer and breast cancer risk factors per se (e.g. cholesterol relates to both cancer and to BRCA1/2 and thus breast cancer risk, see Ramadan’s [0011], [0014], [0024], and [0044]). Ramadan also goes on to further teach that the use of this MRS/COSY imaging of cholesterol is advantageous as it allows to determining breast cancer/cancer risk even before any symptoms in a way not achievable with current optical imaging (see Ramadan’s [0011]-[0014], [0024], and [0046] noting that these changes to the chemistry of the breast which are detectable using MRS cannot be identified by current imaging modalities (with light microscopy given as an example) and further advantageously can be detected pre-invasive condition/pre-malignancy setting forth a clear advantage over Sullivan’s methodology).
Therefore it would have been obvious to one of ordinary skill in the art to additionally or alternatively utilize MRS to gather spectroscopic data, as taught by Ramadan, in order to advantageously allow for gathering data on specific metabolites such as cholesterol that could not be gathered by traditional optical measures and which allow for multiple advantages over optical spectroscopy such as detecting cancer and cancer risk factors before there is any observable disease.
Regarding claim 12, Sullivan further teaches: 12. The method according to claim 9, wherein the reference measurements are those of pre-menopausal women and post-menopausal women in two separate groups, whereby the spectral data of the subject are compared to the reference measurements of the two separate groups depending on whether the subject is pre-menopausal or post-menopausal (see Sullivan’s Table 2 and note that the results are segregated by pre/post menopause per se, likewise see Sullivan’s Results section on pages 5-9 noting in particular the Baseline pre- and postmenopausal differences subsection thereof which fully describes not only that the comparison is made by menopausal status but also describes why and how this varies, etc.).
Regarding claim 13 as best understood, see the rejection of claims 1, 5, and 9 which are incorporated herein by reference as they show, respectively, the method of use, the structures used by the method, and the method of generating those structure and in each instance, these are fully obviated by Sullivan IVO Ramadan as addressed above and as incorporated herein which – as best understood fully teaches all claim limitations.
Regarding claim 16, Sullivan further teaches: 16. The method according to claim 13, wherein the reference measurements are those of pre-menopausal women and post-menopausal women in two separate groups, whereby the spectral data of the subject are compared to the reference measurements of the two separate groups depending on whether the subject is pre-menopausal or post-menopausal (see Sullivan’s Table 2 and note that the results are segregated by pre/post menopause per se, likewise see Sullivan’s Results section on pages 5-9 noting in particular the Baseline pre- and postmenopausal differences subsection thereof which fully describes not only that the comparison is made by menopausal status but also describes why and how this varies, etc.).
Response to Arguments
Applicant’s arguments, see page 9, filed 05/13/2025, with respect to the 112(a) rejections and the claim objections have been fully considered and are persuasive. The associated rejections and objections of the previous office action have been withdrawn.
Applicant’s arguments, see pages 9-10, filed 05/13/2025, with respect to the rejection(s) of claim(s) 1, 4-5, 8-9, 12-13, and 16 under Sullivan alone or IVO Sitter have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the new art of Ramadan and in view of the amendment that required such new grounds of rejection.
Additionally it may compact prosecution to iterate that while the bulk of the arguments have been rendered moot by the new reference; the examiner notes that the applicant’s characterization of deficiencies in Sullivan is not entirely correct. Specifically, Sullivan takes measurements over a wide area using fairly deeply penetrating light applied at many points. As such Sullivan certainly appears to teach the claimed midpoint despite not overtly mentioning it (note the claim does not require this to be the midpoint of the breast in all dimensions, but with the penetration and myriad points likely reaches the center in all directions anyways). Regardless, Sullivan’s teaching of gathering spectral data from the midpoint is only referred to in the alternative for this limitation as the modification to employ Ramadan would also render this point moot/obsolete as when employing MRS there is no limitation that the breast be imaged from the surface even if the applicant later claimed that this was a centerpoint in all dimensions.
Applicant's arguments filed 05/13/2025 with respect to all other issues have been fully considered but they are not persuasive with each argument being responded to in the order presented as follows:
On pages 8-9 the applicant opines that the claims are eligible because they are “substantially more than an abstract diagnostic method”. Notably the applicant does not address or respond to a single point raised by the examiner in the 101 rejection for including an abstract idea and therefore the argument is spurious because it is mere allegation that does not address the merits of the rejection, see 37 CFR 1.111(b). Additionally the statement is also seemingly false (there is no overt diagnosis step, and there is also no output whatsoever, e.g. no display). As such while the method steps determine clinically relevant data points they do not actually diagnose anything much less provide it to a doctor much less actually recite “substantially more” than a diagnosis (which is itself still merely an abstract idea as cited in the MPEP and quoted by the examiner no less). Additionally the examiner notes that at least one grounds of eligibility/101 rejection is entirely not addressed as claim 13 also is a mere use claim (i.e. the claim could be replaced by the text ‘Use the invention of claim 9’ without substantively changing the scope) which is also ineligible for reasons wholly separate from the fact that claim 9 is a mere abstract idea without significantly more and which is presumed to be understood and agreed to by the applicant as they have chosen not to respond to this rejection even with a cursory statement as was done for the other grounds of 101 rejection.
On page 9 the applicant opines that the amendment remedies the 112 issues. In this instance some rejection are removed, but the examiner notes that the applicant has again failed to clearly address any grounds of rejection raised by the examiner and that many of the issues are not addressed by any amendment including simple things like antecedent basis issues. As such the argument is unconvincing and the examiner also notes that the applicant also introduced multiple new issues under 112(b) by their amendment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael S Kellogg whose telephone number is (571)270-7278. The examiner can normally be reached M-F 9am-1pm.
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/MICHAEL S KELLOGG/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798