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 .
Claims 1-10 are the current claims hereby under examination.
Claim Interpretation - 35 USC § 112(f)
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 preAIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. 11. 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:
Claim 3:
“a device connector” uses a generic placeholder “connector” coupled with functional language “to receive the genetic information” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning (i.e. “device”) before “connector.”
“a communication unit” uses a generic placeholder “unit” coupled with functional language “to perform data communication” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning (i.e. “communication”) before “unit.”
“data storage” uses a generic placeholder “storage” coupled with functional language “for species identification” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning (i.e. “data”) before “storage.”
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. A review of the specification shows that the limitations are interpreted as follows “a device connector” (e.g. USB, Bluetooth, etc), “a communication unit” (e.g. circuit), and “data storage” (e.g. database, etc.).
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
The following is a quotation of the first paragraph of 35 U.S.C. 112(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 6 and 9 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. Claims 6 and 9 comprise a limitation directed towards predicting a subjects future health status by comparing accumulated health information over a predetermined period with current health information and applying predicted health statuses to the health information. The limitation applies to any and all future time periods and predetermined periods. The specification does not appear to support the limitation of predicting health statuses of subjects over any and all predetermined periods. As such the limitation does not appear to have support or written description.
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 6 and 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 6 and 9 comprise a limitation directed towards predicting a subjects future health status by comparing accumulated health information over a predetermined period with current health information and applying predicted health statuses to the health information. It appears unclear as to how said limitation is carried out as there does not appear to be description in the specification for how to perform the comparison of current health information to accumulated health information over any and all predetermined periods to predict a future (i.e. at any point in the future) health status. As such said limitation appears to be vague and indefinite. For examination purposes any type of comparison that compares any type of acquired health information to a current health information to determine any type of future health status will be considered to read on the limitation.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to system and method for predicting health without significantly more.
Analysis of independent claims 1:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-7 are directed to system and claims 8-10 are directed to a method caried out on a server or computer technology, which describes one or more of the four statutory categories of patentable subject matter, i.e., a process/machine. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites an abstract idea. In particular, the claim recites the following:
Generating genetic information about a microorganism according to a result of analysis;
analyzing genetic information to obtain a type and population; and
generating health information about the subject based on a result of the obtaining.
These elements recited in claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper and/or they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations.
Steps a-c involve the mental and/or mathematical step of using differences in sequencing reads and data storage to look up and compare information, which can be performed mentally or using pen and paper.
The identified abstract steps, recited at the high level of generality, do not suggest an undue level of complexity for a person with ordinary skill in the art to be practically performed in the human mind with the aid of pen and paper.
Prong Two: Claim 1 does not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea.
The additional elements merely:
a. Add insignificant pre-solution activity (e.g. using a microorganism analysis device or genome analyzer to generate sequences and computer technology to transmit them (e.g. claim 2).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. e.g., all additional elements are directed to pre-solution, which merely facilitates the abstract idea. Furthermore, the additional element is simply the addition of an element that is considered routine, conventional, and well-known (e.g. data gathering).
For example, both Apte et al. (US P/N 20190172555) and Stefan et al. (KR20090105921) teach using a genomic analyzer to generate sequence data of microorganisms from the oral cavity.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Analysis of other independent claims 39-41 and 46:
Claims 8-10 have the same analysis as above, but with the addition of the method being carried out on a computing technology such as a server. Patenting abstract ideas cannot be circumvented by attempting to limit the use [the idea] to a particular technological environment. In the instant claims, the computer and/or program/product amount to mere instruction to implement an abstract idea. The hardware recited by the system claims do not offer a meaningful limitation beyond generally linking “the use of the method to a particular technological environment,’ that is, implementation via computers.” see Alice Corp v. CLS Bank Int’l 573 U.S. (2014).
Analysis of the dependent claims:
Claims 2-7 claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely describe additional details of determining fetal fractions, estimated fractions, first and second features, or further describe the acquired type of data. However, claim 2-7 do recite some additional hardware elements, such as the gene analyzer/sequencer, server, and connection hardware, but said additions neither integrate the JE into a practical application nor add significantly to the JE as the additional elements were well known, routine, and conventional as shown by the same references described above with regards to claim 1.
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.
Claim(s) 1-4, 8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Apte et al. (US P/N 20190172555).
The claims are directed towards a system and method comprising:
at least one microorganism analysis devices analyzing a sample collected from a subject's oral cavity, performing species identification on the sample, and generating genetic information about a microorganism in the oral cavity according to a result of analysis; and
a health-care server collecting the genetic information for each subject from the microorganism analysis device, analyzing the genetic information to obtain a type and population for one or more microorganisms present in the subject's oral cavity, and generating health information about the subject based on a result of the obtaining the type and population.
With regards to limitations of claims 1 and 8: Apte et al. is directed towards a system and method for detecting oral health issues by characterizing the microbiome of an individual (see abstract and paragraph [0074]). Apte et al. describe at fig. 1a collecting a sample and identifying the taxon of it via genomic analysis. Apte et al. at fig. 1b describes using the genomic analysis to determine classification indicative of an oral health issue and determine a course of treatment. Apte et al. further describes at fig. 4 and paragraphs [0004] and [0020] doing this for a population. Similarly, Apte et al. describes the method at Fig. 2 and through the flow chart of Figs 1a -1F.
Apte et al. do not explicitly teach identifying a species on a sample. However, the instant specification does not explicitly define what is meant by the term species, but does describe being able to identify diseases and health issues, such as tooth decay. Similarly, Apte et al. describe being able to identify bacteria that cause diseases such as tooth decay (e.g. see paragraph [0014].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the instant invention that the differences between the prior art and the claimed invention were encompassed in known variations or in a principal known in the prior art.
With regards to limitations of claims 2-3 and 10: Apte et al. describe using sequencers known in the prior art such as Illumina, Roche 454, etc. at paragraph [0061]. Apte et al. at paragraphs [0068]-[0070] describe using the sequencing results to map and compare with known sequences in genomic databases. Additionally Apte et al. incorporates 14/593,424 by reference in its entirety and describes the method and system can be carried out in the cloud and/or machine (e.g. computing machine, server, etc.) at paragraph [0174] of the instant application and paragraph [0124] of the incorporated reference.
With regards to limitations of claim 4: Apte et al. teach at paragraph [0220] wherein the system generates a discrimination level to identify sequence groups, which have a predictive value. Additionally, Apte et al. describe using abundance scores (e.g. see par [0044] and table b) wherein the values are scores associated with or lack thereof a disease, which also appears to read on the broad and reasonable interpretation of a health score.
Claim(s) 5-7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Apte et al. (US P/N 20190172555) as applied to claims above and further in view of Stefan et al. (KR20090105921).
With regards to limitations of claim 5: Apte et al. teach all the limitations as described above but appears to suggest but not explicitly teach a member information manager performing a membership sign-up, login, and identification procedure.
Apte et al. suggests this as they describe the system whereby its intended to monitor the individuals/populations (see abstract and paragraphs [0086] and [0161]-[0164]. Furthermore, Apte et al. describe using additional survey information at paragraphs [0213] – [0214] wherein individuals have accounts they setup via electronic setups and storing data in databases.
Stefan et al. is analogous art as its also drawn to a genetic analysis systems and method to analyze individuals and disease. Stefan et al. describe using a subscriber system which can be accessed via online portal system where they can access their information including reports.
It would have been obvious to one of ordinary skill in the art at the time of the instant invention to have used a subscriber system as taught by Stefan et al. for use in the system taught by Apte e al. This is because the use of subscriber systems are well known in the internet age whereby the use of one would have been expected in the method and system taught by Apte et al. in order to monitor their subjects and populations over time. Additionally, the differences between the claimed invention and the prior art were encompassed in known variations or in a principal known in the prior art. It would have been obvious to pursue the known solutions of monitoring subjects, patients, and populations as taught by Stefan et al. and recognized that applying the known technique would have yielded predictable results.
With regards to limitations of claims 6-7 and 9: Apte et al. teach monitoring and predicting outcomes of treatments at paragraphs [0086], [0161], and [0250], which requires monitoring and updating health statuses and reads on a predictor predicting current and future health status.
Conclusion
No claim is allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Sims, whose telephone number is (571)-272-7540.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Jonathan Moffat can be reached via telephone (571)-272-4390.
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the Central PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central PTO Fax Center number is (571)-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791