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 .
Response to Arguments
Regarding claim objections
Examiner notes that the previously set forth claim objections are withdrawn in view of the amendments to the claims.
Regarding 35 U.S.C. 112(f)
Examiner notes that the claim interpretation of acoustic coupling means is withdrawn in view of the amendments to the claims, however, new 35 U.S.C. 112(f) claim interpretation is necessitated by amendment (i.e. electronic computing units). See below rejection for more detail.
Regarding 35 U.S.C. 101
Examiner notes that while the specific limitation noted in the previous action has been amended, claim 6 remains to be rejected under 101 for the amendments to the claims which introduce an “acoustic coupling material between the probe and the breast skin”
Regarding 35 U.S.C. 112(a)
Examiner notes that claim 7 was previously recited for reciting electronic computing means which did not have sufficient structure disclosed. While claim 7 no longer recites “electronic computing means”, it is noted that claim 1 is now rejected under 112(a) for the same reasons indicated for claim 7 previously as the new limitation “electronic computing units” does have sufficient structure disclosed.
Examiner notes that the 112(a) rejections of claim 10 regarding the volume of the area, surface to volume ratio, and eccentricity, and the rejection of claim 12 (as correctly noted by applicant) is withdrawn in view of the amendments to the claims and upon further consideration.
Regarding 35 U.S.C. 112(b)
Examiner notes that while some of the 112(b) rejections are withdrawn in view of the amendments to the claims, it is noted that the claims still include 112(b) clarity issues which were not addressed by the amendments to the claims or are introduced in light of the amendments to the claims. See below rejection for further detail.
Regarding prior art
Examiner notes that the amendments to the claims overcome the prior art as best understood, however, 112(a) and 112(b) issues remain present.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 6 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 6 recites the limitation “wherein said probe comprises also acoustic coupling materials between the probe and the breast skin”, thus positively reciting the breast skin as a part of the claimed invention in its BRI, therefore is directed to or encompasses a human organism.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
The limitation “electronic computing units” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “units” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “units”) is modified by functional language (“configured to carry out a method for calculating a diagnostic parameter”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-9 and 11-17 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In this instance, claim 1 recites the limitation “electronic computing units”. Examiner notes the limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and lacks written description because the specification fails to disclose sufficient corresponding structure that performs the entire claimed functions as recited in claim 1. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim Rejections - 35 USC § 112(b)
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 1-9 and 11-17 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.
In claim 1, claim limitation “electronic computing units” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Examiner notes that due to the lack of written description it is unclear what the corresponding structure of the electronic computing means is, thus rendering the claim unclear. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 1 recites the limitation “a segment connecting said two probes” and “a straight line connecting them”. It is unclear if there is a physical segment/line connecting the probes or if the claim is intending to refer to an axis/imaginary line. In other words, it is unclear what the metes and bounds of a segment/straight line are in the context of the apparatus and if the segment/straight line are required to be physically present or not. It is further unclear if the segment and the straight line are the same or if these are different” as both appear to refer to connecting the probes or “them”. In other words, it is unclear if the segment is the same as the straight line, if the segment includes a straight line, or if these are different/distinct elements. For examination purposes, it has been interpreted that the segment and straight line are the same element and are synonymous with an axis, not a physical segment/line.
Claim 1 recites the limitation “said probes being arranged opposite each other, being configured to rotate along a circular trajectory having for center the midpoint of a segment connecting them”. The limitation is unclear for numerous reasons. For example, it is unclear what is meant by along a circular trajectory having for center the midpoint of the segment connecting them, as it is not clear what “having for center the midpoint” is intended to refer to and further unclear what “the segment connecting them” is referring to as no segment connecting any elements has been previously recited and further unclear what is meant by “them”. For examination purposes, it has been interpreted to mean that a center of the circular trajectory corresponds with or is positioned at a midpoint between the two ultrasound probes, however, clarification is required.
Claim 1 recites the limitation “said arrays comprise each a plurality of piezoelectric or CMUT transducers, any plurality positioned so that acquisitions…”. It is unclear if the limitation is referring to the previously recited piezoelectric or CMUT transducers with a first nominal frequency/second nominal frequency or if these are different plurality of piezoelectric or CMUT transducers. In other words, it is unclear if the claims is attempting to further define the piezoelectric or CMUT transducers recited previously and their positioning or if the claim is attempting to set forth new piezoelectric or CMUT transducers which are positions in a certain manner. For examination purposes, it has been interpreted to mean any plurality of piezoelectric or CMUT transducers, however, clarification is required.
Claim 10 recites the limitation “calculation of a plurality of morphological characteristics deriving from the ultrasound imaging of the jth area”. “the ultrasound imaging of the jth area” lacks sufficient antecedent basis and it is unclear which ultrasound imaging the claim is referring to and if the ultrasound imaging refers to the plurality of scans or if these are different ultrasound imaging and further unclear what the “jth” area refers to and if it corresponds with the midpoint recited previously or if this is some other area. For examination purposes, it has been interpreted to mean any ultrasound imaging from any area, however, clarification is required.
Claim 1 recites the limitation “the average acoustic attenuation coefficient relative to at least a portion of propagation line of the ultrasound signal contained inside the jth area”. There is insufficient antecedent basis for the average acoustic attenuation coefficient and the ultrasound signal contained inside the jth area making it unclear as to which ultrasound signal the claim is referring to and if it corresponds with the ultrasound imaging or the scans recited previously or if this is a different/distinct ultrasound signal. For examination purposes, it has been interpreted to mean any ultrasound signal, however, clarification is required.
Claim 1 recites the limitation “the ratio between said average acoustic attenuation coefficient and the average acoustic attenuation coefficient of the outer region of the jth area”. There is insufficient antecedent basis for the ratio and the average acoustic attenuation coefficient and the outer region making the metes and bounds of the claim unclear as to whether these elements are referring to other elements recited previously or if these are different/distinct elements. For examination purposes, it has been interpreted to mean a ratio between said average acoustic attenuation coefficient and an average acoustic attenuation coefficient of a region outside of the jth area, however, clarification is required.
Claim 1 recites the limitation “calculation of the acoustic propagation speed of the ultrasound signal relating to at least one propagation line of the ultrasound signal passing through the jth area and to at least one propagation line of the ultrasound signal not passing through any suspect area”. It is first unclear if the at least one propagation line is the same as, included in, or different from the propagation line recited previously (i.e. in step 220). Examiner notes that the limitation is unclear as to which ultrasound signal the claims is referring to and further seems to refer to the same ultrasound signal, thus it is unclear how the ultrasound signal can pass through both the jth area and not pass through any suspect area in an instance where the jth area is meant to be a suspect area.
Claim 1 recites the limitation “at least one frequency spectrum of the radiofrequency raw ultrasound signal emitted by one of said first arrays and reflected by a tissue portion contained inside the jth area”. Furthermore, it is unclear if the radiofrequency raw ultrasound signal refers to any of the previously recited ultrasound signals or if this is a different ultrasound signal. For examination purposes, it has been interpreted to mean any ultrasound signal, however, clarification is required.
Claim 1 recites the limitation “calculation of a diagnostic parameter function of the comparison of at least one of the parameters calculated in steps 210 to 270 with the same parameters calculated with respect to suspect areas for which the presence of the pathology has been subsequently confirmed; suspect areas for which the presence of a breast cancer has been subsequently exclude by means of a biopsy or other equivalent reliable technique by means of a biopsy or other equivalent reliable technique; portions of tissue not interested by suspect areas”. It is unclear if the diagnostic parameter function is the same as the diagnostic parameter recited previously or if this is merely a function used for determining the diagnostic parameter. If they are different elements it is unclear what the final diagnostic parameter that is calculated is and if it refers to the comparison or if these are different elements. It is further unclear if the “same parameters” refer to the at least one of the parameters calculated in steps 210 to 270 or if they refer to all of the parameters or if these are a different “same parameters”. It is further unclear if the comparison is made with respect to each of the suspect areas for which the presence of the pathology has been confirmed, suspect areas for which the presence of a breast cancer has been excluded, and portions of the tissue not interested by suspect areas or if the limitation refers to any one of the limitations as no “and” nor “or” is recited by the claim. It is further unclear if the suspect areas recited refer to any of the previously recited suspect areas, the jth area, or if these are different suspect areas. Furthermore, it is unclear if the pathology is the same as the breast cancer or if this is a different pathology. Substantial clarification is required of the limitation as a whole.
Claim 2 recites the limitation “in the same plane of an axis of symmetry”. It is unclear if the axis of symmetry is the same as the previously recited axis of symmetry or if this is a different axis of symmetry. For examination purposes, it has been interpreted to mean any axis of symmetry, however, clarification is required.
Claim 4 recites the limitation “carry out a B-mode ultrasound imaging starting from ultrasonic signal emitted by each of said probes and reflected by breast tissues” and “allows to carry out acoustic attenuation measures, between the signal emitted by a first probe of said two probes and the signal received by a second probe of said two probes”. The limitation is unclear as to any of the B-mode ultrasound imaging or the attenuation measures is or corresponds with the scans/ultrasound imaging recited in claim 1 or if these are different ultrasound imagings/scans. For examination purposes, it has been interpreted to mean they may be the same or different, however, clarification is required.
Claim 6 recites the limitation “each probe comprises also acoustic coupling materials configured to couple said probe with the breast skin, wherein each probe comprises a flexible membrane filled with a gel with the breast skin, comprising a flexible membrane filled with a gel”. The limitation is unclear as to whether the flexible membrane/gel is or is included in the acoustic coupling materials or if these are different elements. It appears that the flexible membrane and gel are the acoustic coupling materials, however, the claim appears to recite them as separate elements. For examination purposes, it has been interpreted that the acoustic coupling materials comprise a flexible membrane and a gel, however, clarification is required.
Claim 6 recites the limitation “wherein said probe comprises also acoustic coupling material between the probe and the breast skin, such as water, gel, or other suitable material”. The limitation is unclear as to which “said probe” the limitation is referring to and further unclear if the acoustic coupling material is the same as or different from the previously recited acoustic coupling materials or if this is a different acoustic coupling material. Furthermore, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, it has been interpreted that the acoustic coupling material is included in the acoustic coupling materials recited previously and is the gel recited previously, however, clarification is required.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation before any further processing and the claim also recites in particular before the processing for the corresponding B-mode image creation which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 7 recites the limitation “acquisition of a first B-mode ultrasound image”, “acquisition of a second B-mode ultrasound image”, “emission” and “detection”, and “repetition of step 130”. It is unclear if any of the acquisitions, emission/detections or repetition thereof are the same as or correspond to the plurality of scans relative to a plurality of planes of acquisition passing through said midpoint, the ultrasound imaging of claim 1, or if these are different/distinct elements. In other words, it is unclear if the claim is attempting to further define the plurality of scans of claim 1 or if these are different/distinct scans. For examination purposes, it ahs been interpreted to mean any acquisitions and may be the same as or different from the scans/imaging recited previously, however, clarification is required.
Claim 7 recites the limitation “said circular support”. There is insufficient antecedent basis for this limitation in the claim. It is unclear what circular support the limitation is referring to. For examination purposes, it has been interpreted to mean any circular support, however, clarification is required.
Claim 7 recites the limitation “storage of the reflected ultrasound signals, as detected by each probe”. Examiner further notes that it is unclear if the reflected ultrasound signals are or include any of the previously recited ultrasound signals from claim 1 or if these are different ultrasound signals. In other words, it is unclear if any of the ultrasound signals or claim 1 are or correspond with the acquired B-mode images or if these are different/distinct ultrasound signals. For examination purposes, it has been interpreted to mean any ultrasound signals, however, clarification is required.
Claim 8 recites the limitation “a plurality of procedures of acquisitions as set in claim 7”. It is unclear what is meant by a plurality of procedures of acquisitions as set in claim 7 means. It is unclear if the plurality of procedures of acquisitions is the same as the acquisition of the first and second B-mode images or if the claim is attempting to set forth repetition of the procedure of acquisition of claim 7 resulting a plurality of procedures. For examination purposes, it has been interpreted to mean any plurality of procedures of acquisitions of claim 7, however, clarification is required.
Claim 8 recites the limitation “raw radiofrequency reflected signals relating to all the propagation lines of the ultrasound signal emitted from each first and second array” and “raw radiofrequency transmitted ultrasound signals”. It is unclear if the raw radiofrequency reflected/transmitted ultrasound signals are the same as or correspond with the previously recited reflected ultrasound signals or transmitted ultrasound signals recited previously, are any of the previously recited ultrasound signals of claim 1, or are different/distinct raw radiofrequency reflected signals. For examination purposes, it has been interpreted to mean any raw radiofrequency reflected ultrasound signals, however, clarification is required.
Claim 9 recites the limitation “calculation of a diagnostic parameter”. It is unclear if the diagnostic parameter is the same as the diagnostic parameter recited in claim 1 or if this is a different diagnostic parameter. For examination purposes, it has been interpreted to mean any diagnostic parameter, however, clarification is required.
Claim 9 recites the limitation “morphological information”. It is unclear if this is the same morphological information recited in claim 1 or if this is a different morphological information. For examination purposes, ti ahs been interpreted to mean any morphological information, however, clarification is required.
Claim 9 recites the limitation “said suspect area”. There is insufficient antecedent basis for this limitation in the claim. It is unclear which area is considered said suspect area as multiple suspect areas and a jth area have been set forth previously. For examination purposes, it has been interpreted to mean any of the previously recited areas, however, clarification is required.
Claim 9 recites the limitation “information relating to an average acoustic attenuation coefficient”. It is unclear if this is the same average acoustic attenuation coefficient recited previously or if this is a different average acoustic attenuation coefficient. For examination purposes, it has been interpreted to mean any average acoustic attenuation coefficient, however, clarification is required.
Claim 9 recites the limitation “information relating to a frequency spectrum of the signal associated with the jth area”. It is unclear if this is included in the at least one frequency spectrum recited in claim 1 or if this is a different frequency spectrum. For examination purposes, it has been interpreted to mean any frequency spectrum, however, clarification is required.
Claim 11 recites the limitation “said suspect area”. The limitation lacks sufficient antecedent basis, as previous claims recite one or more suspect areas. It is unclear which suspect area the claim is referring to. For examination purposes, it has been interpreted to mean any suspect area, however, clarification is required.
Claim 11 recites the limitation “calculation of the correlation coefficient of the average spectrum with all the spectra used for its calculation”. There is insufficient antecedent basis for the limitation “the correlation coefficient” and “all the spectra”. It is therefore unclear what the correlation coefficient is referring to and which of the plurality of spectra “all the spectra” is referring to and further what “its calculation” is referring to. For examination purposes, it has been interpreted that the calculation of the correlation coefficient of the average spectrum of all of the plurality of spectra, however, clarification is required.
Claim 12 recites the limitation “said comparison carried out at step 280) occurs downwards of the following definition procedure of tumoral, not tumoral and healthy reference value sets, detected in ultrasound examinations carried out by means of the device according to any one of the preceding claims on patients for whom the presence of the tumoral pathology has been subsequently confirmed or excluded by means of histological examination”. It is unclear what is meant by said comparison carried out at step 280 occurs downwards. Is the claims attempting to define a time frame for when the comparison carried out at step 280 occurs (e.g. before or after) or if the claim means something else by occurring downward (e.g. a physical downward occurrence). For examination purposes, it has been interpreted to mean either before or after, however, clarification is required.
Claim 12 recites the limitation “definition of an average tumoral value and of a relative confidence interval at 75% and 95% calculated starting from the statistic distribution of the values of each parameter for all the suspect areas for whose tumoral nature has been excluded”. The limitation is unclear as to what is meant by a “not tumoral value” and how a confidence interval at 75% and 95% is calculated. Furthermore, “the statistic distribution of the values of each parameter” lacks sufficient antecedent basis. Substantial clarification of the limitation is required.
Claim 12 recites the limitation “definition of a healthy average value and of a relative confidence interval at 75% and 95% calculated starting from the statistic distribution of the values of each parameter for all the portions of the tissues belonging to said sets of portions of healthy tissue not interested by ultrasound-visible suspect areas”. The limitation is unclear as to what is meant by a “healthy average value” and how a confidence interval at 75% and 95% is calculated. Furthermore, “the statistic distribution of the values of each parameter” and “said sets of portions of healthy tissue” lack sufficient antecedent basis. Substantial clarification of the limitation is required.
Claim 12 recites the limitation “selection of a plurality of segments of propagation of the ultrasound signal which either are: - contained inside suspect areas whose tumoral nature has been subsequently confirmed by means of histological examination; contained inside suspect areas whose tumoral nature has been subsequently excluded by means of histological examination; contained inside tissue located outside of suspect areas”. Claim 1 sets forth suspect areas which have been subsequently confirmed/excluded (by means of biopsy or other equivalent), however, it is unclear if these are the same suspect areas or claim 1 or different suspect areas. In other words, the claim does not refer to the suspect areas and it is further unclear since the suspect areas are recited here as being excluded by means of histological examination but are excluded by means of biopsy or other equivalent in claim 1. For examination purposes, it has been interpreted to mean either the same or different suspect areas, however, clarification is required.
Claim 14 recites the limitation “said diagnosis parameter is a classification of said jth suspect area as ‘tumoral’ or ‘not tumoral’, obtained by: calculation of the correlation coefficient of the set of parameters relative to the jth area with the reference set relative to tumoral areas, with the reference set relative to suspect areas, resulted not tumoral in subsequent analyses; - with the reference set relative to tissue not belonging to suspect areas”. The limitations “the correlation coefficient”, “the set of parameters”, “the reference set relative to tumoral areas”, the reference set relative to suspect areas, resulted not tumoral in subsequent analyses“, and “the reference set relative to tissue not belonging to suspect areas” all lack sufficient antecedent basis in the claims making it unclear what the claims is attempting to refer back to.
Claim 15 recites the limitation said diagnosis parameter is a classification of said jth suspect area as tumoral or not tumoral, obtained by: calculation of the correlation coefficient of the average spectrum relative to the jth area with – the tumoral reference spectrum; the reference spectrum of a suspect area, subsequently resulted not tumoral; - the reference spectrum relative to the outer tissues of the suspect areas calculated at point 360”. The limitations “the correlation coefficient”, “the tumoral reference spectrum”, “the reference spectrum of a suspect area, subsequently resulted not tumoral”, and the reference spectrum relative to the outer tissues of the suspect areas calculated at point 360” lack sufficient antecedent basis in the claim.
Claim 15 recites the limitation “one of the three coefficients”. The limitation lacks sufficient antecedent basis. In this case, the claim sets forth “the correlation coefficient”, however, does not clearly set forth ‘three coefficients’ therefore making it unclear what the three coefficients refers to. For examination purposes, it has been interpreted to mean any coefficients, however, clarification is required.
Claim 15 recites the limitation “classification of the jth area as tumoral if the correlation coefficient is greater than the one of the reference set relative to tumoral areas, as not tumoral if is one of the other two”. It is unclear which correlation coefficient, which one of the reference set relative to tumoral areas the claims is referring to, and which other two the limitations are referring to.
Claim 16 recites the limitation “subdivision of the reference sets available in a training data set and a validation data set”. There is insufficient antecedent basis for the reference sets. It is unclear what the reference sets refers to.
Examiner’s Note
Examiner notes that claim 1 distinguishes over the prior art collectively, however, allowability is not determined at this time due to pending 112 issues. In this, case it is noted that Zhang and Masaki remain to the be the closest prior art, however, Zhang and Masaki fail to teach all of steps 210-280 in combination with the structure comprising two ultrasound probes having a first array and second array. Examiner notes that modifying Zhang and Masaki to include all of steps 210-280 would not have been obvious to a person having ordinary skill in the art before the effective filing date.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797