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 .
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites the extracting height data, determining whether there is a decreasing section and determining an error in the height data.
The limitation of extracting height data, determining whether there is a decreasing section and determining an error in the height data, as drafted, are processes that, under their broadest reasonable interpretation, cover performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “by a computing device” the claims are direct to concepts relating to organizing information in a way that can be performed mentally or analogous to human mental work and nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the computing device language, “extracting” and “determining” in the context of this claim encompasses the user manually selecting data or parameters and making a visual assessment of the data. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of receiving time-series bio-component data of a subject. This involves mere data gathering and amounts to insignificant extra-solutional activity, specifically pre-solutional activity. Additionally, the computing device and various units are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Similarly the dependent claims do not include additional elements that amount to significantly more. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept and well-understood, routine and conventional activity is not sufficient to amount to significantly more than the abstract idea itself. The claim is not patent eligible.
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: “a first input unit”; “a second input unit”; “a height data extraction unit”; “a decreasing section determination unit”; “a growth stage classification unit” and “an error detecting unit” in claim 13. “a connecting unit” in claim 14. “an error detection unit” in claim 15
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 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to a computer program which is not one of the four statutory categories.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to a computer-readable recording media which could be a signal which is not one of the four statutory categories.
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.
Claim limitations “a first input unit”, “a second input unit”, “a height data extraction unit”, “a decreasing section determination unit”, “a growth stage classification unit”, “an error detecting unit”, “a connecting unit” and “an error detection unit” have been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because there does not appear to be any structure disclose in the specification other than the block diagrams for what the various units are composed of. The boundaries of this claim limitation are ambiguous; 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.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claims 1-12 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 1 recites a decreasing section within a section and later “wherein there is the section” and it is unclear what sections are being referred. It is presumed that the first section mentioned is a section of the height data as a time series.
Claims 2 and 3 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. It is unclear what the first data is. The specification does not clarify what it is other than some combination of the bio-component data and the identification data.
Claims 4-10 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. It is unclear if the growth period is actually determined as part of the method or if growth period is just inherent in the age of the subject. Additionally, claim 4 recites is classified based on a monthly age of the identification data but it is not clear if this is referring to the age of the data itself or the age of the subject.
Claims 6-9 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. Claims 7-9 recite comparing the difference value calculated at the first point with the difference at the second point but claim 6 recites calculating a difference between height data at any first point and height data at any second point so it is unclear if the difference is between the first point and the second point or between each of those points and some other point. The specification at ¶184 discloses several different differences that can be determined and it is unclear which is being claimed.
Claim 10 is 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. It is unclear what is meant by “based on a period of the decreasing section and a degree of decrease in height”. It is unclear what the period is referring to or what a degree of decrease is, it could be an rate of change or an absolute difference.
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.
Claim(s) 1-3 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Daymont et al. “Automated identification of implausible values in growth data from pediatric electronic health records”
Regarding claim 1, Daymont discloses a method of preprocessing height measurement data for growth prediction performed by computing device, comprising:
receiving time-series bio-component data of a subject ([pg. 1081, col 2] the data received is electronic health record datasets);
receiving identification data of the subject ([pg. 1081] age and other identifying information is included);
extracting height data from the bio-component data ([pg. 1081, col 2] height and weight data are extracted from the datasets);
determining whether there is a decreasing section within a section where the height data is input ([pg. 1083, col 1] drops in height data over a certain threshold were flagged); and
when there is the section where the height data decreases, determining an error in the height data based on a growth stage in which the decreasing section is included ([FIG.3][pg. 1081] the flagged implausible measurements are removed based on median data and patient age. As growth stage is not defined age can be considered a growth stage as it is known growth rates vary by age).
Regarding claim 2, Daymont discloses generating first data by concatenating the time-series bio-component data of the subject and the identification data of the subject ([pg. 1085] the height and weight data is compared against the age data, the growth curve in figure 2-3, so they are linked or concatenated).
Regarding claim 3, Daymont discloses after generating the first data, deleting the bio-component data when a preset value is included in the bio-component data ([figure.2] the data is cleaned by removing height values exceeding a threshold).
Regarding claim 11, Daymont discloses a program stored in a computer-readable recording medium including a program code for executing the method of preprocessing height measurement data for growth prediction according to claim 1 ([pg. 1081, software] the analysis is performed on computer software).
Regarding claim 12, Daymont discloses a computer-readable recording medium on which a program for executing the method of preprocessing height measurement data for growth prediction according claim 1 ([pg. 1083, col 1] when any two measurements of height, which are z-scores and differences from the average population values, exceed a change threshold they are flagged and removed or corrected. The larger difference is removed).
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.
Claim(s) 4-10 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daymont in view of Miller et al. “Development of Tanner Stage–Age Adjusted CDC Height Curves for Research and Clinical Applications”
Regarding claim 4, Daymont discloses the growth stage in that it shows the height data in relation to age which is indicative of growth stage. Daymont does not specifically disclose that the stage includes a normal growth period, a rapid growth period, a decelerated growth period, and a non-growth period, and is classified based on a monthly age of the identification data. Miller teaches a similar growth chart analysis that separates the growth chart data into distinct periods ([pg. 5, results] Tanner stages 1-V correspond with the normal, rapid, decelerated and non-growth periods and are determined by age). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the method of Daymont with the teachings of Miller in order to account for pubertal maturation in growth chart data ([pg. 7, discussion]).
Regarding claim 5, Daymont discloses in the determining of the error, when the decreasing section is included in the rapid growth period, the height data of the decreasing section is deleted ([FIG.3][pg. 1081] the flagged implausible measurements are removed based on median data and patient age. As growth stage is not defined age can be considered a growth stage as it is known growth rates vary by age).
Regarding claim 6, Daymont discloses the determining of the error includes calculating a difference between height data at any first point and height data at a second point, respectively, forming the decreasing section and an average data value of the corresponding monthly age of a plurality of sample subjects, when the decreasing section is included in the normal growth period ([pg. 1081, description of methods] the height is evaluated in terms of z-score which is a comparison against the average population data and differences between points is determined based on this).
Regarding claim 7, Daymont discloses the determining of the error further includes comparing the difference value calculated at the first point with the difference value calculated at the second point ([FIG.3][pg. 1081] the flagged implausible measurements are removed based on median data and patient age. As growth stage is not defined age can be considered a growth stage as it is known growth rates vary by age).
Regarding claim 8, Daymont discloses in the determining of the error, when the difference value calculated at the first point is smaller than the difference value calculated at the second point, the height data at the second point is deleted ([pg. 1083, col 1] when any two measurements of height, which are differences from the average population values, exceed a change threshold they are flagged and removed or corrected. The larger difference is removed).
Regarding claim 9, Daymont discloses in the determining of the error, when the difference value calculated at the first point is greater than or equal to the difference value calculated at the second point, the height data at the first point is deleted ([pg. 1083, col 1] when any two measurements of height, which are differences from the average population values, exceed a change threshold they are flagged and removed or corrected. The larger difference is removed).
Regarding claim 10, Daymont discloses in the determining of the error, when the decreasing section is included in the decelerated growth period or the non-growth period, the data of the decreasing section is deleted based on a period of the decreasing section and a degree of decrease in height (pg. 1082, col 2 to pg. 1083, col 1] when any two measurements of height, which are z-scores and differences from the average population values, exceed a change threshold they are flagged and removed or corrected. The larger difference is removed).
Regarding claim 13, Daymont discloses an apparatus for preprocessing height measurement data for growth prediction, comprising:
a first input unit that receives time-series bio-component data of a subject ([pg. 1081, col 2] growth chart data is received from electronic health records. It is noted that the units do not have any explicit structure in the specification and as such are considered to be software functions or modules);
a second input unit that receives identification data of the subject ([pg. 1081] age and other identifying information is included);
a height data extraction unit that extracts height data from the bio-component data ([pg. 1081, col 2] height and weight data are extracted from the datasets);
a decreasing section determination unit that determines whether there is a decreasing section within a section where the height data is input ([pg. 1083, col 1] drops in height data over a certain threshold were flagged);
an error determination unit that determines an error in the height data based on the growth stage including the decreasing section ([FIG.3][pg. 1081] the flagged implausible measurements are removed based on median data and patient age. As growth stage is not defined age can be considered a growth stage as it is known growth rates vary by age).
Daymont does not specifically disclose a growth stage classification unit that classifies a growth stage including the decreasing section when there is the section where the height data decreases. Miller teaches a similar growth chart analysis that separates the growth chart data into distinct periods ([pg. 5, results] Tanner stages 1-V correspond with the normal, rapid, decelerated and non-growth periods and are determined by age). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the method of Daymont with the teachings of Miller in order to account for pubertal maturation in growth chart data ([pg. 7, discussion]).
Regarding claim 14, Daymont discloses a connection unit that connects data input through the first input unit and the second input unit to generate first data ([pg. 1085] the height and weight data is compared against the age data, see the growth curve in figure 2-3).
Regarding claim 15, Daymont discloses an error detection unit that deletes the bio-component data when a preset value is measured in the bio-component data among the first data ([figure.2] the data is cleaned by removing height values exceeding a threshold).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights