DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in reply to an application filed 21 March 2025, which claims foreign priority to an application filed on 12 October 2022.
Claims 1-12 are currently pending and have been examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 21 March 2025 has been considered by the Office to the extent indicated.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 12 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention.
“While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed, In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) en banc. The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).” (MPEP 2163.03).
In the instant case, some of the original claims are disclosed “ipsis verbis” in the originally filled specification; however the specification does not provide a written description support because while the functions claimed are disclosed in the specification, the specification does not disclose how the functions are performed by the system. How specifically the Applicant intended the system to operate as claimed is not disclosed in the originally filled specification.
Regarding claims 6 and 12, Applicant has claimed wherein the risk level prediction program provides a solution corresponding to the breast cancer occurrence risk level.
In regards to these functions of the system, the originally filed specification discloses:
[0033] Additionally, the risk level prediction program may also provide a solution corresponding to the breast cancer occurrence risk level, or may also provide a solution according to the questionnaire response.
[0034] For example, a solution, which recommends to eat vegetables twice a day, fruits once, soybeans once, and mixed grain rice twice a day, may be provided to a participant who answers that the participant does not have healthy eating habits, and a solution, which recommends to adjust a weight through appropriate eating habits and regular exercise according to the weight, may be provided.
As shown, the originally filed specification provides a vague disclosure, and one simple example, as to what is being done as far as the end result but fails to provide a clear disclosure as to how the claimed invention perform the features claimed. The disclosure is informing the reader of what happens as far as end results is concerned but fails to disclose the process that results in the claimed function. The disclosure fails to show how the system provides a solution corresponding to the breast cancer occurrence risk level.
The broad disclosure of the result that is desired is not providing an adequate written description of the invention, because this is not actually showing that applicant had developed any specific method, calculation, or algorithm to do what is claimed.
This is different from the enablement issue, which is a separate part of 112,1st paragraph. For the examiner to be able to search this aspect of the invention, the examiner must ascertain how applicant is accomplishing the disclosed result of the method steps being claimed. All that the examiner has to work from is the broad disclosure of one simple solution. The examiner takes the position that with respect to these limitations or features of the claims, the specification fails to provide an adequate written description of the invention to an extent that would sufficiently show that applicant was in possession of an invention that could operate as claimed. Simply disclosing a vague description, without actually explaining how the system perform the functions claimed, results in a written description problem under 112,1st paragraph. The examiner has no idea how applicant actually contemplated doing these steps because nothing is disclosed other than the broad disclosure of the specification. This does not satisfy the written description part of 112,1st paragraph in the opinion of the examiner. Moreover, the examiner is left guessing as to how this is accomplished.
Appropriate correction is required.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1-12 are within the four statutory categories. Claims 8-14 are drawn to a breast cancer risk prediction device, which is within the four statutory categories (i.e. machine). Claims 1-7 are drawn to a breast cancer risk prediction method, which is within the four statutory categories (i.e. process).
Prong 1 of Step 2A
Claim 1 recites: A breast cancer risk prediction device comprising:
a memory storing a risk level prediction program; and a
processor configured to execute the risk level prediction program,
wherein the risk level prediction program calculates a breast cancer occurrence rate by applying questionnaire responses on multiple breast cancer occurrence factors to an occurrence rate calculation model, and outputs a breast cancer occurrence risk level according to the breast cancer occurrence rate, and
the occurrence rate calculation model calculates the breast cancer occurrence rate by using an equation for calculating a correlation between the multiple breast cancer occurrence factors and breast cancer occurrence by using the multiple breast cancer occurrence factors for a non-patient cohort who does not have a certain disease.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract ideas of “mathematical concepts” and/or the abstract idea of a mental process because they recite a process that is composed of mathematical concepts (as underlined could be practically performed in the human mind (i.e. observations, evaluations, judgments, and/or opinions) or using a pen and paper, but for the recitation of generic computer components (i.e. program and the structural components of the computer), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea(s) are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for claim 7 is identical as the abstract idea for claim 1, because the only difference between claims 1 and 7 is that claim 1 recites a device, whereas claim 7 recites a method.
Dependent claims 2-6 and 8-12 include other limitations, for example claims 2-4, 3 and 8-10 further describe factors or calculations and claims 5, 6, 11 and 12 further describe the risk level, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Additionally, any limitations in dependent claims 2-6 and 8-12 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claims 2-6 and 8-12 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 7.
Prong 2 of Step 2A
Claims 1-12 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the program and the structural components of the computer, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraph 37 of the present Specification, see MPEP 2106.05(f); and/or
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language limiting the data to healthcare data, which amounts to limiting the abstract idea to the field of healthcare, see MPEP 2106.05(h); and/or
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application (e.g. see MPEP 2106.05(g)).
Additionally, dependent claims 2-6 and 8-12 include other limitations, but these limitations also amount to no more than mere instructions to generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in dependent claims 2-6 and 8-12), and/or do not include any additional elements beyond those already recited in independent claims 1 and 7, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claims 1-12 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the program and the structural components of the computer), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the insignificant extra-solution activity comprises limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
Paragraph 37 of the Specification discloses that the additional elements (i.e. the program and the structural components of the computer) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receive and process data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
iii. Electronic recordkeeping, Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log); and
iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Dependent claims 2-6 and 8-12 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1 and 7, and/or the additional elements recited in the aforementioned dependent claims similarly amount to generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in dependent claims 2-6 and 8-12), and hence do not amount to “significantly more” than the abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-12 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being obvious over Heine et al. (U.S. Patent 7,664,604 B1), hereinafter Heine, further in view of Colditz et al. (U.S. PG-Pub 2024/0020842 A1), hereinafter Colditz.
As per claims 1 and 7, Heine discloses a breast cancer risk prediction method and device (Heine, see Fig. 2.) comprising:
a memory storing a risk level prediction program (Heine, see the algorithm operative to be ran by a computer disclosed in Fig. 2 and corresponding text.); and
a processor configured to execute the risk level prediction program, wherein the risk level prediction program calculates a breast cancer occurrence rate by applying questionnaire responses on multiple breast cancer occurrence factors to an occurrence rate calculation model, and outputs a breast cancer occurrence risk level according to the breast cancer occurrence rate (Heine, computer algorithm takes breast cancer risk factors in view of patient history to determine a breast cancer risk level of the patient, see Fig. 2 and corresponding text. It is old and well known to acquire patient history through use of a questionnaire.), and
the occurrence rate calculation model calculates the breast cancer occurrence rate by using an equation for calculating a correlation between the multiple breast cancer occurrence factors and breast cancer occurrence by using the multiple breast cancer occurrence factors for a non-patient cohort (Heine discloses use of an occurrence rate calculation model, see the Cox proportional hazard model of Fig. 1 equation 6.).
As shown above, Heine discloses use of patient history. Heine fails to explicitly disclose:
questionnaire responses; and
A non-patient cohort who does not have a certain disease.
Colditz teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to utilize questionnaire responses to calculate a breast cancer risk, based on risk factors for a non-patient cohort (See Colditz, Fig. 2b and paragraphs 108-109 and 146.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the breast cancer risk analysis method of Heine to include utilizing questionnaire responses and considering a cohort of non-patients who do not have a certain disease, as taught by Colditz, in order to arrive at a breast cancer risk analysis method that had access to data directly provided by a subject and also excluded cohort members that would skew results, in order to provide an improved cancer risk analysis.
Both Martin and Rao are directed to the electronic processing of patient healthcare data. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
As per claims 2-6 and 8-12, Heine/Colditz disclose claims 1 and 7, discussed above. Heine also discloses:
2,8. wherein the multiple breast cancer occurrence factors include at least one of a female history factor, a lifestyle factor, a disease history factor, a family history factor, a weight factor, a body measurement index factor, and a biomarker factor I (See Heine, Fig. 4.);
3,9. wherein the occurrence rate calculation model calculates the breast cancer occurrence rate by matching coefficients respectively corresponding to the questionnaire responses for the multiple breast cancer occurrence factors, assigning weights set to the coefficients, and calculating the coefficients to which the weights are assigned (See the use of the proportional hazards model of Fig. 1 Equation 6, and C34L48-C25L5.);
4,10. wherein the equation uses Equation 1 below,
Equation 1 h(t) =h0(t)*eβ1x1 + β1x1 + … + βnxm
where, h(t) is the breast cancer occurrence rate, h0(t) is a constant, β is a coefficient set to the questionnaire responses, and x is a weight set to the coefficients (See the use of the proportional hazards model of Fig. 1 Equation 6, and C34L48-C25L5.);
5,10. wherein the breast cancer occurrence risk level is classified into a plurality of risk stages based on a preset range, and the risk level prediction program outputs one of the plurality of risk stages corresponding to the breast cancer occurrence rate (Heien, risk probability model of Fig. 2 #10 outputs a probability, which inherently consists of a plurality of stages. Also see the modified threshold output of normal/abnormal of Fig. 2 #s 70-90.); and
6,11. wherein the risk level prediction program provides a solution corresponding to the breast cancer occurrence risk level (Corresponding to an abnormal stage determination, the system outputs an indication that the patient data should be subject to further examination, see Fig. 2 #100.).
Conclusion
The following uncited prior art is considered relevant to the present claimset:
Morin (U.S. PG-Pub 2024/0233952 A1) discloses a system for calculating cancer risks;
Louro. “Developing and Validating an Individualized Breast Cancer Risk Prediction Model for Women Attending Breast Cancer Screening.” PloS one. 16.3 (2021): n. pag. Web discloses the use of the Cox Proportional Hazard model to predict the risk of cancer.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
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/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
13 March 2026