DETAILED ACTION
This action is in reference to the communication filed on 29 JAN 2025.
Claims 1-36 are present and have been examined.
Claim Interpretation
Claim(s) 14 is a product-by-process claim(s). Regarding product-by-process claims, MPEP § 2113 states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."
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 14 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 14 recites the limitation “The disease map produced by the method of claim 1” in the claim. There is insufficient antecedent basis for this limitation in the claim. It is unclear what disease map the claim is referring to, as no previous disease map exists in claim 1 – instead claim 1 recites a process without the actual map itself being claimed. Examiner as noted is interpreting claim 14 as a product by process claim. Examiner presumes that the intent is for the claim to recite “A disease map produced by the method of claim 1” – as this would remove the issue with antecedent basis.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
MPEP 608 recites: “On the other hand, if claim 1 recites a method of making a specified product, a claim to the product set forth in claim 1 would not be a proper dependent claim if the product can be made by a method other than that recited in the base method claim, and thus, does not include the limitations of the base claim.” Examiner notes the interpretation above with regard to antecedent basis, and notes that Claim 14 explicitly recites a claim to a product, and as such categorically does not further limit claim 1 per the cited portion of the MPEP. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-36 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claim(s) 1-36 the independent claim(s) 1, 15, 26 recite(s) a method, a system, and a computer readable media, each of which is a statutory category of invention.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claim(s) 1-36, the independent claim(s) (claims 1, 15, 26 ) is/are directed, in part, to:
A
These claim elements are considered to be abstract ideas because they are directed to mathematical concepts including relationships, formulas, equations or calculations. Applying a “clustering algorithm” to weights and bias values from an existing trained neural network, is categorically an example of such mathematical concepts. Examiner finds that the limitations regarding the prior training of the algorithm are descriptive of the data in general.
Examiner also finds that the claims recite examples of mental processes, such as concepts performed in the human mind including observation, evaluation, judgement, and opinion. Examiner notes that while the limitations read “clustering algorithm,” to be applied to a set of data about disease and/or populations, to create a risk map, no specific algorithm is explicitly disclosed. As such, Examiner find that considering the relationships between a set of data about disease and population(s) to create a risk map is, to be broadly at least, an example of observations of data, evaluating the data, and presenting the opinion in the form of the risk map.
If a claim limitation, under its broadest reasonable interpretation, covers mathematical relationships, formulas, equations, and/or calculations, then it falls within the “mathematical concepts” grouping of abstract ideas. If a claim limitation falls into concepts performed in the human mind, then I falls within the “mental processes” category of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
This judicial exception is not integrated into a practical application. In particular, the claim(s) recite(s) additional elements: Claim 1 recites that the method is “computer implemented,” claim 15 – “a system comprising a processor, a memory communicatively coupled ” and claim 26 recites “ a computer readable media comprising non- transitory computer executable instructions, executed by at least one processor” to perform the claim steps. Examiner finds that the processors and memory/media in claims 15, 26, and by extension/BRI, the computer in claim 1, are all recited at a high level of generality and as such amount to no more than adding the words “apply it” to the judicial exception, or mere instructions to implement the abstract idea on a computer, or merely uses the computer as a tool to perform the abstract idea (see MPEP 2106.05f), or generally links the use of the judicial exception to a particular technological field of use/computing environment (see MPEP 2106.05h). Examiner finds no improvement to the functioning of the computer or any other technology or technical field in the elements identified above as claimed (see MPEP 2106.05a), nor any other application or use of the judicial exception in some meaningful way beyond a general like between the use of the judicial exception to a particular technological environment (see MPEP 2106.05e).
Accordingly, this/these additional element(s) do(es) 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.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
The independent claim(s) is/are additionally directed to claim element: Claim 1 recites that the method is “computer implemented,” claim 15 – “a system comprising a processor, a memory communicatively coupled ” and claim 26 recites “ a computer readable media comprising non- transitory computer executable instructions, executed by at least one processor.” When considered individually, the identified claim elements only contribute generic recitations of technical elements to the claims. It is readily apparent, for example, that the claim is not directed to any specific improvements of these elements. Examiner looks to Applicant’s specification in:
[0050] Computer 201 may be implemented as any of a desktop computer, a laptop computer, can be incorporated in one or more servers, clusters, or other computers or hardware resources, or can be implemented using cloud-based resources. Computer 201 includes volatile memory 214 and persistent memory 212, the latter of which can store computer-readable instructions, that, when executed by electronic processor 210, configure computer 201 to perform any of the methods disclosed herein, including method 100, and/or form or store any electronic neural network, and/or perform any classification technique as described herein. Computer 201 further includes network interface 208, which communicatively couples computer 201 to training corpus source 202 via network 204. Other configurations of system 200, associated network connections and other hardware, software, and service resources are possible.
[0051] The computer programs can exist in a variety of forms both active and inactive. For example, the computer programs can exist as software program(s) comprised of program instructions in source code, object code, executable code or other formats; firmware program(s), or hardware description language (HDL) files. Any of the above can be embodied on a transitory or non-transitory computer readable medium, which include storage devices and signals, in compressed or uncompressed form. Exemplary computer readable storage devices include conventional computer system RAM (random access memory), ROM (read-only memory), EPROM (erasable, programmable ROM), EEPROM (electrically erasable, programmable ROM), and magnetic or optical disks or tap
These passages, as well as others, makes it clear that the invention is not directed to a technical improvement. When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense – i.e. a generic computer receives information from another generic computer, processes the information and then sends information back. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
As per dependent claims 2-14, 16-26, 27-36:
Dependent claims 6, 20 recite specific clustering algorithms. Examiner finds that the algorithms themselves are a further recitation of the mathematical concepts as identified above with respect to claims 1, 15, 26. In the interest of compact prosecution, Examiner notes that these algorithms do not provide a practical application nor significantly more than the abstract idea(s) identified above. No improvement to the functioning of the computer or anything pertaining to the algorithms themselves is noted. Instead, the specification appears to rely on the known existence of said algorithms as clustering algorithms, and further relies on their known capabilities and application therein. As such these claims are not found to recite significantly more.
Dependent claims 2-5, 7-14, 16-19, 21-25, 27-30, 32- 36 are not directed any additional abstract ideas and are also not directed to any additional non-abstract claim elements. Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above – such as the calculations, the weights, the outcomes, and the variables, as well as generating a therapy and different elements regarding the map itself as created per the clustering. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
Claims 14 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 14 recites “A disease map produced by the method of claim 1.” The claim is recited to comprise a system having various features that, under the broadest reasonable interpretation, may be entirely embodied in software/data per se. According to MPEP 2106 (I), there are four categories of invention: process, machine, article of manufacture, and composition of matter. Therefore, as "software" or “data” is neither a category of invention nor a subset of one of the categories it does not represent patent eligible subject matter. See In re Nuijten, Docket No. 2006-1371 (Fed. Cir. Sept. 20, 2007). As such, the system is directed to data per se and is not directed to a statutory category of invention. The claim only recites the map itself, rather than any structure therein. The specification does not reveal any additional structure to be imparted into the claim language. As such, the claim is interpreted as data per se.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fink et al (US20170103172, hereinafter Fink).
In reference to claim 14:
Fink teaches all the structural limitations of the disease map claimed by the applicant (see [Fig 7 and related text] “FIG. 7 shows the generated Cellular Automaton to model fourteen town/cities in Sierra Leone. Each node 70-83 represents one town or city. The edges (arrows) connecting nodes (inter-node connections) represent propagation pathways. Propagation paths may include any pathway in which a propagation event or spreading pattern to be monitored may progress, travel or be plotted. Different thickness of edges denotes variations in the throughputs: the thicker the edge, the higher the throughput (e.g., traffic volume).”) Examiner notes that any map would read on the claim as presented – including the “Treasure Map” held by young Master Hawkins in the 1996 masterpiece “Muppet Treasure Island,” or the map of a completely fictional “Middle Earth” in the 2001 cinematic endurance test known as “Lord of the Rings.” As stated above, regarding product-by-process claims, because Fink as cited teaches the claimed product, the claimed process does not provide patentable distinction over the prior art of record. See MPEP 2113.
Non-Obvious Subject Matter
Claims 1-36 are believed to be free from the prior art.
The closest prior art is believed to be:
US20170103172, to Fink et al: discloses a means of generating a disease map using a differential equation means of modeling in order to determine the risk of a disease spreading over a given population. The modeling is specifically executed using a neural network model in order to provide temporal mapping and development of the map over a plurality of levels of granularity and scale.
US20200294680, to Gupta et al: discloses a means of mapping and predicting the spread of an infectious disease, using a model and applying it to a given population. Using machine learning and AI, the reference can use the disease mapping to predict and create an appropriate response to the threat of spread using the actual magnitude of the risk to a given location/population.
US10573003, to Sethi: discloses a pre-trained machine learning model such as a penalized logistic regression model which is used to classify infectious diseases locally and as compared to a point of interest. The pre-trained model is trained to reduce the difference between the classifier output and the “known” or actual rate of infection/spread in a given area. This information is used the quantify the extent of the risk of the spread for future modeling. Sethi further teaches the use of a clustering algorithm for the purposes of mapping.
US20140087963 to Johnston et al: discloses a means of using a peptide sequencing/binding values process to train a regressor, and wherein the peptide sequence/binding data and values are used to represent a plurality of conditions.
US20040153249, to Zhang et al, also teaches a means of using peptide sequencing to train a modeling process to be used in disease prediction methods.
US 10140835, to Padhye: uses vector mapping and a predictive algorithm in order to determine the risk of spread of the vectors transporting the disease itself, thereby mapping the risk of the spread by mapping vectors over a given area rather than the specific spread of the disease itself. Historical machine learning techniques are used to make these predictions of vector movement.
US20210319847, to Min: discloses a neural network trained on data comprising peptide binding property predictors, using the positive bonding sequences only as this allows for optimized training. A discriminator is used to update the training data to represent the sampled positive peptide sequences. An encoding vector may be used to represent the training sequences themselves. Min further teaches that the inputs to the training process may be weighed based on the connection between pairs.
However, the cited references when taken separately or in any combination, does not specifically teach applying a clustering algorithm to the weights and bias values of the neural network, and specifically does not teach the specific training of the neural network as claimed, wherein the sequence and the binding value pair data comprise sequence/binding values of one or more antibodies to the peptides, from a reference subject with antibodies. Simplified, Examiner finds that the means through which the neural network is trained for the predictive clustering is not fairly taught in the references, particularly in view of the specific peptide sequence information and peptide binding values as applied to the one or more antibodies.
The Examiner hereby asserts that the totality of the evidence neither anticipates nor renders obvious the particular combination of elements as claimed. That is, the Examiner emphasizes the claims as a whole and hereby asserts that the totality of the evidence fails to set forth, either explicitly or implicitly, an appropriate rationale for combining or otherwise modifying the available prior art to arrive at the claimed invention. The combination of features as claimed would not be obvious to one of ordinary skill in the art because any combination of the evidence at hand to reach the combination of features as claimed would require a substantial reconstruction of Applicant’s claimed invention relying on improper hindsight bias.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE KOLOSOWSKI-GAGER whose telephone number is (571)270-5920. The examiner can normally be reached Monday - Friday.
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, Mamon Obeid can be reached at 571-270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687