DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
The amended claim set filed on 3 April 2026 is acknowledged. Claims 1-10, 12-14, 16, and 21-26 are currently pending. Of those, claims 1, 6-8, 10, 12-14, and 16 are amended. Claims 21-26 are new, and no claims are withdrawn. Claims 11, 15, and 17-20 are cancelled. Claims 1-10, 12-14, 16, and 21-26 will be examined on the merits herein.
Response to Amendment
Applicants’ arguments filed 3 April 2026 are acknowledged. For clarity, in this Action, Applicants’ arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 7 January 2026 will be referred to as “NFOA”.
Objection(s) and Rejection(s) Withdrawn
The objection to the drawings set forth in NFOA para. 8(b) is withdrawn in view of the corrected drawing sheets submitted 3 April 2026.
The objection to claim 1 is withdrawn in view of the claim amendments.
The rejection(s) of claims 11 and 15 under 35 U.S.C. 112(b), 112(a), and/or 101 are moot because the claims have been cancelled.
The rejection of claims 6-7, 10, and 14 under 35 U.S.C. 112(b) is withdrawn in view of the claim amendments.
The rejection of claims 1, 12-13, and 16 under 35 U.S.C. 112(a) is withdrawn because the amended claims 1 and 13 recite “comparing the measured levels… to a control value based on the level of anti-PA, anti-PC, and anti-PS antibodies in one or more Borrelia sp. exposure naïve subjects.” This limitation is enabled because comparing measured antibody levels to such a control value would allow one of ordinary skill in the art to determine if a subject is infected with a Borrelia sp. and addresses the concern from the previous rejection about the use of any generic “predetermined value”.
The rejection of claims 1-3, 8-9, and 13 under 35 U.S.C. 102 is withdrawn in view of the claim amendments.
The rejection of claims 1-4, 8-9, and 13 under 35 U.S.C. 103 over Thorpe in view of APL is withdrawn in view of the claim amendments.
The rejection of claims 1-10 and 13-14 under 35 U.S.C. 103 over Thorpe in view of APL, John, and Kerstholt is withdrawn in view of the claim amendments.
Objection(s)
Drawings
The drawings filed on 28 June 2023 are objected to because of the following:
In FIG. 16A, the figure shows a heat map, but the details cannot be differentiated in the black and white drawings, and
In all figures labelled “24A” and “24B”, it is difficult to differentiate which bars correspond to the group noted in the legend in the black and white drawings (see Examiner’s in NFOA). Additionally, the second set of FIG. 24A-B (i.e., the bottom figures in the Examiner’s view in NFOA) do not have a label on the y-axis (including units being measured).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
If Applicant wishes to provide color photographs and/or drawings, note that color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Response to Amendment
It is noted that a petition for color drawings has been submitted, but the objections are maintained because the petition has not been accepted. The objections will be withdrawn if/when the petition is accepted by the USPTO.
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 101
Claims 1-10, 12-14, and 16 remain rejected and claims 21-26 are newly rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The previous rejection has been amended to reflect the amendments to the claims.
Claims 1, 13, and 21 each recite steps of “detecting” the detectable binding agent or the bound antibodies, “measuring the level of antibodies”, and “comparing the measured levels…to a control value” (for claims 1 and 13) or “comparing the measured levels… to a positive control value and/or a negative control value” (for claim 21). The broadest reasonable interpretation of the term “detecting” encompasses mental processes, such as seeing or observing (see MPEP 2106.04(a)), as is evidenced by an example in the instant specification, which states, “By way of example, but not by way of limitations, a detectable binding agent may comprise an antibody linked to an enzyme, such as horseradish peroxidase (HRP). Addition of an HRP substrate, under enzymatic reaction conditions, will allow detection of the HRP-bound molecule and the target.” (para. 75) When HRP is bound by a substrate, a color change may be visible to the human eye.
Based on the above example, the step of “measuring the level of antibodies” may encompass evaluating or judging the intensity of the color change in order to determine the relative antibody levels in a sample. Thus, the full scope of “measuring” encompasses mental processes.
The action of “comparing the measured levels” involves evaluating data and falls within the category of a mental process and also is a mathematical calculation (i.e., abstract ideas).
Claims 1 and 13 also recite, “wherein if the measured level is greater than the control value for at least one of the lipids in the panel, the subject is diagnosed as positive for Lyme disease.” This step recites a mental process (i.e., an abstract idea) and also a mathematical calculation of evaluating data in order to make a diagnosis.
Claim 21 also recites, “wherein the comparing of [the measured levels…to a positive control value and/or negative control value] is indicative of the progression of the treatment for Lyme disease and/or Borrelia sp. infection.” This step recites a mental process (i.e., an abstract idea) and also a mathematical calculation of evaluating data in order to determine the progression of a disease or infection.
Claim 22 recites, “wherein the subject is undergoing treatment, and wherein the comparing of (f) is indicative of positive treatment response and/or clearance of Borrelia sp. infection when the measured level is at least 10% lower than the positive control value for at least one of the lipids in the panel.” This step recites a mental process (i.e., an abstract idea, evaluating and making a judgement) and also a mathematical calculation of evaluating data in order to make a diagnosis.
Claim 23 recites, “wherein the subject has previously been treated for Lyme disease and/or Borrelia sp. infection, and wherein the comparing of (f) is indicative of persistent Borrelia sp. infection when the measured value is greater than the negative control value for at least one of the lipids in the panel.” This step recites a mental process (i.e., an abstract idea, evaluating and making a judgement) and also a mathematical calculation of evaluating data in order to make a diagnosis.
Claims 25-26 (which depend upon claims 12 and 16, respectively) recite, “further comprising determining the level of anti-PA, anti- PC, and anti-PS antibodies in one or more additional samples obtained from the subject the during treatment, wherein the determining is indicative of positive treatment response and/or clearance of Borrelia sp. infection when the determined level is at least 10% lower than the measured levels of (d) for at least one of the lipids in the panel.” This step recites a mental process (i.e., an abstract idea, evaluating and making a judgement) and also a mathematical calculation of evaluating data in order to make a diagnosis.
Claims 12 and 16 (which are dependent upon claims 1 and 13, respectively) each recite, “further comprising treating the subject for Lyme disease and/or Borrelia sp. infection.”
This judicial exception is not integrated into a practical application because the application or use of the judicial exception does not go beyond generally linking the use of the judicial exception (i.e., “detecting” a binding agent or bound antibodies, “measuring the level of antibodies” and “comparing the measured levels”) to a particular technological environment or field of use. In this case, the recited steps of contacting an antibody-containing sample with lipids, incubating, and contacting antibodies with a detectable binding agent are performed in order to gather data for the steps of “detecting”, “measuring”, and “comparing” and are necessary precursors for all uses of these steps. Thus, steps (a)-(c) are extra-solution activity, and does not integrate the judicial exception into a practical application. See MPEP 2106.04(d)(2). An example of data gathering that the courts have found to be insignificant extra-solution activity include determining the level of a biomarker in blood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968, as well as performing clinical tests on individuals to obtain input for an equation (In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989)). See MPEP 2106.05(g). An example of limitations that the courts have described as merely indicating a field of use or technological environment in which to apply a judicial exception include, for example, language informing doctors to apply a law of nature (linkage disequilibrium) for purposes of detecting a genetic polymorphism, because this language merely informs the relevant audience that the law of nature can be used in this manner (Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1379, 118 USPQ2d 1541, 1549 (Fed. Cir. 2016)). See MPEP 2016.05(h). Furthermore, the judicial exception is not integrated into a practical application because the claim does not recite additional elements that apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition.
Claims 12 and 16 (which are dependent upon claims 1 and 13, respectively) each recite, “further comprising treating the subject for Lyme disease.” These claims do not integrate the judicial exception into a practical application because this limitation is not specific enough to effect a particular treatment or prophylaxis (MPEP 2106.04(d)(2)). In order to integrate the judicial exception(s) into a practical application, the treatment or prophylaxis limitation must be “particular,” i.e., specifically identified so that it does not encompass all application(s) of the judicial exception(s). In this case, the step of “treating the subject for Lyme disease is not particular and is merely instructions to “apply” the judicial exception(s) in a generic way. See MPEP 2106.04(d)(2). Additionally, limitations that the courts have described as merely indicating a field of use or technological environment in which to apply a judicial exception include, for example, a step of administering a drug providing 6-thioguanine to patients with an immune-mediated gastrointestinal disorder, because limiting drug administration to this patient population did no more than simply refer to the relevant pre-existing audience of doctors who used thiopurine drugs to treat patients suffering from autoimmune disorders, Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 78, 101 USPQ2d 1961, 1968 (2012). See MPEP 2106.05(h). Thus, the limitation does not integrate the judicial exception into a practical application because the application or use of the judicial exception does not go beyond generally linking the use of the judicial exception to a field of use.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional steps of contacting an antibody-containing sample with lipids, incubating, and contacting antibodies with a detectable binding agent are extra-solution activity of preparing for and gathering data for the steps of “detecting”, “measuring”, and “comparing” as discussed above. Additionally, the additional limitations only generally link the judicial exception to a particular field of use for the reasons described above. See MPEP 2106.05.
Regarding claims 2-10 (which depend upon claim 1), claim 14 (which depends upon claim 13), and 24 (which is interpreted as being dependent upon claim 23, see 112(b) rejection below) each of these claims limits the additional elements of claim 1, 13, or 23 (such as limiting the sample, subject, lipid panel, etc.) that are extra-solution activity, as described above. Thus, these claims do not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Therefore, claims 1-10, 12-14, 16, and 21-26 do not qualify as eligible subject matter (see MPEP 2106).
Response to Arguments
Applicant argues (pg. 11-12) that “claims directed to an improvement in the functioning of a computer, or an improvement to other technology or technological field are patent eligible” and that “the claimed methods provide a significant improvement in the field of Lyme disease/Borrelia sp. infection diagnosis.”
Applicant also argues (pg. 11) that in Ex Parte Desjardins, the ARP found that claims directed to training a machine learning model reflected technical improvements identified in the specification.
This argument has been fully considered but is not persuasive. As stated by the Applicant, the claims are directed towards an improvement in Lyme disease/Borrelia diagnosis, not the improvement of the immunoassay technology itself. MPEP 2106.05(a) states: “However, it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.” (emphasis added) In the instant case, making a Lyme disease/Borrelia infection diagnosis is an abstract idea in which one mathematically evaluates data gathered by the immunoassay and makes a mental judgement on whether a subject has the disease. Thus, the claimed method is an improvement of an abstract idea and not an improvement in the immunoassay technology itself.
Regarding Desjardins, this argument is not persuasive because Applicant has not explained how a machine learning case is related to the instant claimed invention in order to demonstrate that the claimed method demonstrates an improvement to other technology or technical field.
Applicant argues (pg. 11-12) that the claimed combination of lipids was not known in the art at the time the present application was filed and therefore provide significantly more than the judicial exception under Step 2B of the Alice/Mayo test and points to MPEP 2106.05 to argue that an inventive concept is “furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more that the judicial exception.
This argument has been fully considered but is not found persuasive. MPEP 2106.05(a)(II) sets forth examples that the courts have indicated may not be sufficient to show an improvement to technology, such as “Using well-known standard laboratory techniques to detect enzyme levels in a bodily sample such as blood or plasma, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1355, 1362, 123 USPQ2d 1081, 1082-83, 1088 (Fed. Cir. 2017)” The instant specification teaches that the method of determining antiphospholipid levels uses ELISA, “a common laboratory technique widely used in clinical diagnostics.” (para. 48) Thus, the claimed method constitutes using well-known standard laboratory techniques to detect antiphospholipid antibody levels in a bodily sample and does not show an improvement to immunoassay technology. Additionally, additional elements recited by the claims are not sufficient to amount to significantly more than the judicial exception for the reasons set forth in the amended rejection above.
New Rejection(s)
Claim Rejections - 35 USC § 112(b)
Claim 24 is newly 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 24 recites, “The method of claim 24….” One of ordinary shill in the art would not be able to determine the scope of the claim because it is unclear which claim the claim 24 is meant to depend upon. In the interest of compact prosecution, the claim is interpreted as being dependent upon claim 23.
Claim 24 recites, “wherein the subject has not received the treatment for at least 1 year, at least 5 years, at least 10 years, or at least 15 years.” It is unclear what reference point is used to measure “at least 1 year” (e.g., at least 1 year at the time of testing, from the time of obtaining the sample, etc.). In the interest of compact prosecution, the limitation has been interpreted to mean “at least 1 year at the time of sample collection.”
Clarification is requested.
Claim Rejections - 35 USC § 112(a)
Claim 23 is newly 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. This is a new matter rejection.
Newly added claim 23 recites “wherein the comparing of (f) is indicative of persistent Borrelia sp. infection when the measured value is greater than the negative control value for at least one of the lipids in the panel, but there does not appear to be a written description of the claim limitation “persistent Borrelia sp. infection” in the application as filed.
Applicant has pointed out para. [0003], [0008], [0060], [0090]-[0095], and [0222] (Remarks pg. 8) as supporting the new claims. However, none of the cited sections describe “persistent Borrelia sp. infection.”
Accordingly, the newly added claim constitutes new matter.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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