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 accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Claims 1-3, 5-6, 8, 10, 14, 17, 40-42, 45 and 48-50 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more, wherein the abstract idea is a mental process of determining oximetry based on an individual’s personalized physiology for calibration.
For independent claims 1 and 40, the claim(s) recite(s) a process of receiving pregnant abdomen optical characteristics and determining a personalized light transmission calibration to be applied to a fetal oximetry measurement.
As broadly as claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a medical professional, particularly a routinely skilled obstetrician, capturing data, printing it out, and using the data to mentally extract, classify or learn from data features to determine a personalized oximetry calibration for the mother and fetus based on calibration ascertained from skin color, geometry, and visible physiology. Stated another way, an obstetrician performing a routine fetal oximetry analysis may perform the calibration method mentally while viewing oximetry results in lieu of observed patient characteristics.
This judicial exception is not integrated into a practical application because the process steps as broadly as claimed are not tied to nor required to be performed, executed, or programmed on a special purpose computer. Although the judicial exception is performed on or tied to a mere generic processing device, controller, or the like, it is not so programmed to be a practical application surpassing the mental processing of a routinely skilled obstetrician.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the preliminary steps of receiving optical characteristics and light transmission data for oximetry are well-known, routine and conventional amounting to insignificant data gathering as pre-solution activity.
Depending claims 2-3, 5-6, 8, 10, 14, 17, 41-42, 45 and 48-50 inherit and do not remedy the non-statutory deficiency noted above, despite further specifying steps relating to reception of physiological data, using images or models, or providing output of oximetry determinations, these steps do not integrate into a practical application nor include additional elements amounting to significantly more than the mental process and/or could merely be provided verbally by the routinely skilled obstetrician.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 6, 8, 10, 14, 17, 40-42, 45, and 48-50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ray et al. (WO 2021/016641, hereinafter Ray).
For claim 1, Ray discloses a method (Figs 13-15B) ([0168-0222]), comprising inter alia:
receiving, by a processor, an optical characteristic of a pregnant mammal's abdomen (1305) (Figs 13-15B) ([0168-0222]);
determining, by the processor, a personalized calibration formula for the pregnant mammal's abdomen using the optical characteristic (1340) (Figs 13-15B) ([0168-0222]);
receiving, by the processor, light transmission data, the light transmission data corresponding to an optical signal that is detected by a photodetector and converted into the light transmission data, the optical signal being a composite of light that was incident on the pregnant mammal's abdomen and a fetus disposed within the pregnant mammal's abdomen (1345) (Figs 13-15B) ([0168-0222]); and
determining, by the processor, an oximetry value for the fetus using the personalized calibration formula and the received light transmission data (1350) (Figs 13-15B) ([0168-0222]).
For claim 2, Ray discloses the method of claim 1, further comprising: receiving a geometrical characteristic of the pregnant mammal's abdomen (Figs 13-15B) ([0168-0222]), wherein the personalized calibration formula is further determined using the geometrical characteristic (Figs 13-15B) ([0168-0222]).
For claim 3, Ray discloses the method of claim 1, further comprising: receiving a physiological characteristic of at least one of the pregnant mammal and the fetus (Figs 13-15B) ([0168-0222]), wherein the personalized calibration formula is further determined using the physiological characteristic (Figs 13-15B) ([0168-0222]).
For claim 5, Ray discloses the method of claim 1, wherein the oximetry value is at least one of a level of fetal hemoglobin oxygen saturation and a level of fetal tissue oxygen saturation (Figs 13-15B) ([0168-0222]).
For claim 6, Ray discloses the method of claim 1, further comprising: receiving, by the processor, an image of the pregnant mammal's abdomen (Figs 13-15B) ([0168-0222]); and analyzing, by the processor, the image to determine the optical characteristic (Figs 13-15B) ([0168-0222]).
For claim 8, Ray discloses the method of claim 1, further comprising: determining, by the processor, an indication of fetal distress using the fetal oximetry value (Figs 13-15B) ([0168-0222]); and providing, by the processor, the indication of fetal distress a to a display device (Figs 13-15B) ([0168-0222]).
For claim 10, Ray discloses the method of claim 1, wherein determining the personalized calibration formula for the pregnant mammal's abdomen further comprises: generating, by the processor, a tissue model of the pregnant mammal's abdomen (Figs 13-15B) ([0168-0222]), wherein the tissue model is used by the processor to determine the personalized calibration formula (Figs 13-15B) ([0168-0222]).
For claim 14, Ray discloses the method of claim 1, wherein the optical characteristic is at least one of a light scattering coefficient specific to the mammal, a light absorption coefficient specific to the mammal, and a skin color of the mammal (Figs 13-15B) ([0168-0222]).
For claim 17, Ray discloses the method of claim 1, further comprising: determining whether the fetus has fetal hypoxia or fetal hypoxemia using the oximetry value for the fetus (Figs 13-15B) ([0168-0222]); and providing an indication of a determination that the fetus has fetal hypoxia or fetal hypoxemia to a display device (Figs 13-15B) ([0168-0222]).
For claim 40, Ray discloses a method (Figs 13-15B) ([0168-0222]), comprising inter alia:
receiving, by a processor, an optical characteristic of a mammal (1305) (Figs 13-15B) ([0168-0222]);
determining, by the processor, a personalized calibration formula for the mammal using the optical characteristic (1340) (Figs 13-15B) ([0168-0222]);
receiving, by the processor, light transmission data, the light transmission data corresponding to an optical signal that is detected by a photodetector and converted into the light transmission data, the optical signal being a composite of light that was incident on the mammal (1345) (Figs 13-15B) ([0168-0222]); and
determining, by the processor, an oximetry value for the mammal using the personalized calibration formula and the received light transmission data (1350) (Figs 13-15B) ([0168-0222]).
For claim 41, Ray discloses the method of claim 40, further comprising: receiving a geometrical characteristic of the mammal (Figs 13-15B) ([0168-0222]), wherein the personalized calibration formula is further determined using the geometrical characteristic (Figs 13-15B) ([0168-0222]).
For claim 42, Ray discloses the method of claim 40, further comprising: receiving a physiological characteristic of the mammal (Figs 13-15B) ([0168-0222]), wherein the personalized calibration formula is further determined using the physiological characteristic (Figs 13-15B) ([0168-0222]).
For claim 45, Ray discloses the method of claim 40, further comprising: receiving, by the processor, an image of the mammal (Figs 13-15B) ([0168-0222]); and analyzing, by the processor, the image to determine the optical characteristic (Figs 13-15B) ([0168-0222]).
For claim 48, Ray discloses the method of claim 40, further comprising: comparing, by the processor, the oximetry value to a threshold oximetry value (Figs 13-15B) ([0168-0222]); and providing, by the processor, an indication of the comparison to a display device (Figs 13-15B) ([0168-0222]).
For claim 49, Ray discloses the method of claim 40, wherein determining the personalized calibration formula for the mammal further comprises: generating, by the processor, a tissue model of the mammal (Figs 13-15B) ([0168-0222]), wherein the tissue model is used by the processor to determine the personalized calibration formula (Figs 13-15B) ([0168-0222]).
For claim 50, Ray discloses the method of claim 49, wherein determining the oximetry value for the mammal further includes inputting the received light transmission data into the tissue model (Figs 13-15B) ([0168-0222]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to methods for processing fetal oximetry.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
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