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 a response filed 16 June 2026, on an application filed 21 March 2025, which claims foreign priority to an application filed on 12 October 2022.
Claims 1, 7 and 8 have been amended.
Claims 3-6 and 9-12 have been canceled.
Claims 1, 2, 7 and 8 are currently pending and have been examined.
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 1, 2, 7 and 8 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 1 and 7, Applicant has claimed automatically generate a preventive health protocol by mapping a technical discrepancy between the received physical biomarker data and target health metrics of the non-patient cohort reference standard to a specific solution.
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, 2, 7 and 8 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 1 and 2 are drawn to a breast cancer risk prediction device, which is within the four statutory categories (i.e. machine). Claims 7 and 8 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 communication module configured to receive data from an external use device;
a database storing coefficients and weights set for multiple breast cancer occurrence factors;
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 is configured to:
receive physical biomarker data comprising a current height of a participant, a current weight of the participant, or a diastolic blood pressure measurement of the participant;
calculate a breast cancer occurrence rate by matching questionnaire responses and the received physical biomarker data to corresponding coefficients and weights stored in the database and applying the matched coefficients and weights to a logarithmic occurrence rate calculation model: logh(t)= logh0(t) + (β1x1+β2x2 +...+βnxn), where h(t) is the occurrence rate, h0(t) is a constant, β is a coefficient set to the questionnaire responses, and x is an assigned weight;
determine a breast cancer occurrence risk level by identifying technical correlations between the physical biomarker data and a non-patient cohort reference standard;
output a discrete breast cancer occurrence risk level stage from a plurality of discrete risk stages based on a preset range stored in the database; and
automatically generate a preventive health protocol by mapping a technical discrepancy between the received physical biomarker data and target health metrics of the non-patient cohort reference standard to a specific solution.
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 indicated by the formula) or 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 and 8 include other limitations, for example claims 2 and 8 further describe factors or calculations, 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 and 8 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claims 2and 8 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 7.
Prong 2 of Step 2A
Claims 1, 2, 7 and 8 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 and 8 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 and 8), 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, 2, 7 and 8 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 and 8 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 and 8), 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, 2, 7 and 8 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, 2, 7 and 8 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 Lewis (U.S. PG-Pub 2018/0166174 A1).
As per claims 1 and 7, Heine discloses a breast cancer risk prediction device and method executed by a processor (Heine, see Fig. 2.) comprising:
a communication module configured to receive data from an external use device (System is operative to receive data derived from imaging devices, see Fig. 2.);
a database storing coefficients and weights set for multiple breast cancer occurrence factors (Heine discloses a database storing risk factors, see Figs. 2 and 4. Heine discloses coefficients and weights for breast cancer occurrence factors to be used by a risk level prediction program, see Figs. 2B-2C, see th equations of Fig. 1 and corresponding text.);
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 is configured to (Heine, see Fig. 2 and corresponding text.):
receive physical biomarker data comprising a current height of a participant, a current weight of the participant, or a diastolic blood pressure measurement of the participant (System receives heigh and weight and other medical history of the patient, see Figs. 2 and 4.);
calculate a breast cancer occurrence rate by matching questionnaire responses and the received physical biomarker data to corresponding coefficients and weights stored in the database and applying the matched coefficients and weights to a logarithmic occurrence rate calculation model: logh(t)=logh0(t)+(β1x1+β2x2+ ... +βnxn), where h(t) is the occurrence rate, h0(t) is a constant, β is a coefficient set to the questionnaire responses, and x is an assigned weight (Heine, see equation 6 of Fig. 1. The claimed equation is the same as Equation 6 because taking the natural logarithm of both sides of the previously claimed equation h(t) =h0(t)*eβ1x1 + β1x1 + … + βnxm results in the present equation because log(AB)=log(A)+log(B) and log(eZ)=Z.);
determine a breast cancer occurrence risk level by identifying technical correlations between the physical biomarker data and a non-patient cohort reference standard (Application of equation 6 is based on analysis of biomarker data and non-patient cohort reference, which is then utilized to determine a breast cancer occurrence risk level of the patient, see Fig. 2, note the standard threshold #60, and C35L12-29.);
output a discrete breast cancer occurrence risk level stage from a plurality of discrete risk stages based on a preset range stored in the database (Heine, 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. Heine discloses discrete risk classification schemes at C3L15-44 and C10L11-52. Heine discloses storing data in Fig. 4 and corresponding text. See also Fig. 3 and corresponding text.); and
… by mapping a technical discrepancy between the received physical biomarker data and target health metrics of the non-patient cohort reference standard to a specific solution (Based on the system determining that the tissue is abnormal corresponding to the risk probability model and modified thresholds as determined from non-patient cohorts, the system initiates further examination, see Heine Fig. 4 and C35L12-29.).
Heine fails to explicitly disclose automatically generate a preventive health protocol.
Lewis teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to automatically generate a preventive health protocol (See Lewis, Figs. 1 and 48 and corresponding text.) in order to provide “continuous improvement of medical knowledge, disease, and methods of healing and treatments to improve patient outcomes”( Lewis, Abstract.).
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 automatically generate a preventive health protocol, as taught by Lewis, in order to arrive at a breast cancer risk analysis method that can provide “continuous improvement of medical knowledge, disease, and methods of healing and treatments to improve patient outcomes”( Lewis, Abstract.). 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).
Both Heine and Lewis are directed to the electronic processing of patient healthcare data.
As per claims 2-6 and 8-12, Heine/Lewis disclose claims 1 and 7, discussed above. Heine also discloses:
2,8. wherein multiple breast cancer occurrence factors are stored in a database, and 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 (See Heine, Fig. 4.).
Response to Arguments
Applicant’s arguments filed 16 June 2026 concerning the rejection of all claims under 35 U.S.C. 112 have been fully considered and they are deemed persuasive in view of the cancellation of these claims. Accordingly, these rejections have been removed.
Applicant’s arguments filed 16 June 2026 concerning the rejection of all claims under 35 U.S.C. 101 and 103(a) have been fully considered but they are not persuasive.
With regard to the rejection of the claims under 35 USC 101, Applicant argues on pages 8-10 that the claims comprise statutory material because:
A. S2AP1: the claims are not directed to a judicial exception because it utilizes hardware, and physically measured data and it does not preempt the use of the mathematical model;
B. S2AP2: the claims integrates the exception into a practical application as it provides automatic generation of a preventative health protocol; and
C. S2B: the claims provides significantly more than the abstract idea through its non-conventional combination of elements.
The Office respectfully disagrees. Please see the statutory rejection of the claims issued above, wherein the claims are shown to be directed to an abstract idea without significantly more.
Regarding A, the hardware and data elements are not part of the identified abstract idea, as they are shown to be additional elements that amount to mere instructions to apply an exception or generally link the abstract idea to a particular technological environment or field of use. The claimed data is not physically measured by the claims, it is merely received by the claims.
Further, MPEP 2106.04(1) states that questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B)." Thus, pre-emption concerns are fully addressed and made moot upon application of the two-part Alice Corp. subject matter eligibility analysis, as provided in the basis of rejection. Further, by definition, the claimed invention would preempt the identified abstract idea.
Regarding B, the recited holding of Vanda is irrelevant to the present invention. Vanda shows that a specific treatment with a specific dosage can make a claim statutory, this is unlike the present claimset that purports to automatically generate a preventive health protocol.
Regarding C, as shown above, the claims in part and in whole are shown to not amount to statutory material. Processing data corresponding to a mathematical model and outputting a treatment does not amount to a non-conventional combination of elements.
With regard to the rejection of the claims under 35 USC 103, Applicant argues on pages 13-15 that the claims overcome the applied references because:
A. “Neither Heine nor Colditz contemplates a system that operates outside the realm of medical imaging to dictate a machine-generated preventive health protocol”;
B. The references fail to disclose use of a reference standard based on a non-patient cohort; and
C. The references fail to disclose automatically generating a health protocol.
The Office respectfully disagrees.
Regarding A, in response to applicant's argument that the references fail to show certain features of applicant’s invention, it is noted that the features upon which applicant relies (i.e., see A.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here the combination of the cited references disclose the contested limitation.
Regarding B., see the standard threshold of Fig. 2#60, at least.
The remainder of Applicant's arguments (see C.) have been fully considered but are moot in view of the new ground(s) of rejection, specifically with reference to the new reference necessitated by amendment, Lewis, as detailed above, or because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
In conclusion, all of the limitations which Applicant disputes as missing in the applied references, including the features newly added by amendment, have been fully addressed by the Office as either being fully disclosed or obvious in view of the collective teachings of Heine, Lewis and Colditz, based on the logic and sound scientific reasoning of one ordinarily skilled in the art at the time of the invention, as detailed in the remarks and explanations given in the preceding sections of the present Office Action and in the prior Office Action (20 March 2026), and incorporated herein.
Conclusion
Unused but cited relevant prior art includes:
Olivier et al. (U.S. PG-Pub 2024/0233952 A1) discloses a system and method for continuous cancer treatment and prognostics.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
9 September 2026