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 .
DETAILED ACTION
Election/Restrictions
1. Applicant's election of Group II, claims 12-25 and 29-34, without traverse, filed November 23, 2025 is acknowledged and has been entered. Claims 1-11 and 26-28 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being claims drawn to a non-elected invention. Accordingly, claims 1-34 are pending. Claims 12-25 and 29-34 are under examination.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Based on the Filing Receipt, the present application claims the benefit of Provisional Application Number 63/297,184 filed 01/06/2022. Accordingly, the effective filing date of the instant application is January 6, 2022 which is the filing date of Provisional Application Number 63/297,184 from which the benefit of domestic priority is claimed.
Claim Objections
3. Claim “19” is objected to because of a typographic error. The claim set filed on January 6, 2023 includes claims 1-34 with two “claim 9” occurrences. The second occurrence of “claim 9” after claim 18 should be --claim 19.-- Appropriate correction is required.
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.
4. Claims 12-25 and 29-34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 is indefinite in appearing to recite a mental step in reciting, “determining” in all occurrences in the claim because it fails to clearly define what active positive laboratory method steps are intended. Perhaps, Applicant intends “detecting” or “measuring.” See also claim 29.
Claim 12, step b) is indefinite in reciting “administering an effective amount of treatment” because “effective” and “treatment” are subjective terms lacking a comparative basis for defining their metes and bounds.
Claim 18 is indefinite in appearing to recite a mental step in reciting, “determining” in all occurrences in the claim because it fails to clearly define what active positive laboratory method steps are intended. Perhaps, Applicant intends “detecting” or “measuring.”
Claim 19 is indefinite in appearing to recite a mental step in reciting, “determining” in all occurrences in the claim because it fails to clearly define what active positive laboratory method steps are intended. Perhaps, Applicant intends “detecting” or “measuring.” See also claim 32.
Claim 19, step b) is indefinite in reciting “administering an effective amount of treatment” because “effective” and “treatment” are subjective terms lacking a comparative basis for defining their metes and bounds.
Claim 25 is indefinite in appearing to recite a mental step in reciting, “determining” in all occurrences in the claim because it fails to clearly define what active positive laboratory method steps are intended. Perhaps, Applicant intends “detecting” or “measuring.”
Claim 29 is vague and indefinite in reciting “the percentage … is high/elevated” in all occurrences in the claim because “high/elevated” are relative and subjective terms lacking a comparative basis for defining their metes and bounds.”
Claim 30 is vague and indefinite in reciting “the percentage … is high/elevated” and “the percentage … is low/reduced” in all occurrences in the claim because “high/elevated” and “low/reduced” are relative and subjective terms lacking a comparative basis for defining their metes and bounds.”
Claim 32 is vague and indefinite in reciting “the percentage … is high/elevated” in all occurrences in the claim because “high/elevated” are relative and subjective terms lacking a comparative basis for defining their metes and bounds.”
Claim 33 is vague and indefinite in reciting “the percentage … is high/elevated” and “the percentage … is low/reduced” because “high/elevated” and “low/reduced” are relative and subjective terms lacking a comparative basis for defining their metes and bounds.”
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.
5. Claims 18 and 25 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. Based upon an analysis with respect to each of these claims as a whole, these claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 18 and 25 recite a correlation between the level of CD4+CD8+ double positive T (DPT) cells relative to the level of CD45RO+ T cells in peripheral blood mononuclear cells (PBMC: biological sample) isolated from a subject and prediction of acute graft-versus-host disease (aGVHD) and/or hematologic malignancy relapse in the subject; wherein the level of CD4+CD8+ DPT cells that is between 4-6% of all CD45RO+ T cells in the sample predicts aGVHD in the subject and wherein the level of CD4+CD8+ DPT cells that is <=1% of all CD45RO+ T cells in the sample predicts hematologic malignancy relapse in the subject. This judicial exception is not integrated into a practical application because the claimed invention is limited to a correlation being categorized as a law of nature/natural phenomenon or existence in nature apart from any human action without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more because the judicial exception is not integrated i0nto a significant practical application in a manner that imposes a meaningful limit on the judicial exception. This new consideration is based on case law including Vanda, for evaluation of particular treatment or prophylaxis limitations.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A Prong One
Claim 18 recites predicting aGVHD and claim 25 recites predicting aGVHD and/or hematologic malignancy relapse in a subject receiving HSCT by measuring the level of CD4+CD8+ DPT cells relative to the level of CD45RO+ T cells in the PBMC isolated from a subject, wherein a level of CD4+CD8+ DPT cells that is between 4-6% of all CD45RO+ T cells in the sample provides a prediction of aGVHD in the subject and wherein a level of CD4+CD8+ DPT cells that is of <=1% all CD45RO+ T cells in the sample provides a prediction of hematologic malignancy relapse in the subject.
The claimed steps of determining CD4+CD8+ DPT and CD45RO+ T cell levels in the blood sample from the subject receiving HSCT and determining the percentage of CD4+CD8+ DPT cells relative to CD45RO+ T cells that provide indication of aGVHD and/or hematologic malignancy relapse in the subject, read on mental processes, such as a physician obtaining data result from a patient, evaluating, and forming an observation/evaluation/judgment/opinion regarding the subject’s likely prognosis of the disease. See the 2019 Revised Patent Subject Matter Eligibility Guidance (“2019 PEG”), issued on 1/7/2019 and available at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf.
Such steps of evaluating biomarker levels relative to other biomarker levels read on mental processes insofar as such statistical calculation and evaluation comparison of information could take place wholly in the human mind, or by a human using pen and paper. Similar mental processes have been held by the courts to be abstract ideas, e.g., collecting and comparing known information in Classen, or comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC. Such concepts as assessing abnormal proportions and results, and analyzing the results have also been characterized by the courts as abstract ideas. Additionally, the measured proportion between CD4+CD8+ DPT cells and CD45RO+ cells and presence aGVHD or hematologic malignancy relapse is also categorized as a law of nature/natural phenomenon; and this is a judicial exception as the correlation exists in nature apart from any human action (July 2015 Update, Quick Reference Sheet; see also Univ. of Utah Research Found. v. Ambry Genetics Corp., 774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and In re Grams, 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)).
The claimed step of calculating percentage of double positivity cell biomarkers against related positive cell biomarker also recite mathematical processes encompassed in “mathematical concepts” in order to obtain a number or a variable or index that is deemed to be representative of specific biomarker relationship that exists in the presence of disease. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number such as in this case a percentage of two separate associated biomarker levels that provides further mathematical data representative of correlation to a disease. Such step of calculating in order to determine a percentage ratio using mathematical calculation methods or similar mathematical concepts and processes have also been held by the courts to be abstract ideas or mental steps (i.e. performing a resampled statistical analysis to generate a resampled distribution, SAP Am., Inc. v. InvestPic, LLC,20; calculating a number representing an alarm limit value using the mathematical formula ‘‘B1=B0 (1.0–F) + PVL(F),’’ Parker v. Flook;21 and using a formula to convert geospatial coordinates into natural numbers, Burnett v. Panasonic Corp.22). As set forth supra, the judicial exception recited is not integrated into a practical application because steps corresponding to mental activity, which could be performed in a practitioner’s head, are insufficient to constitute a practical application.
Step 2A Prong Two
“Integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception; evaluating whether any additional element is recited beyond the judicial exception; and determining whether the additional element(s) integrate the exception into a practical application of the exception. This new consideration is based on case law including Vanda, for evaluation of particular treatment or prophylaxis limitations.
With respect to claims 18 and 25, this judicial exception is not integrated into a practical application because steps corresponding to mental activity, which could be performed in a practitioner’s head, are insufficient to constitute a practical application. In this case, prognosing and predicting aGVHD and hematologic malignancy relapse, without significantly more, is a judicial exception and not a practical application thereof.
There are no subsequent steps in claims 18 and 25 recited that would be performed depending on the results of the assay. As in Mayo, there is no requirement that a physician act on the results of the method. Rather, the claims merely inform a relevant audience about the judicial exception, at most amounting to a suggestion that a physician should take those laws into account when treating the patient, such as recited in claims 12 and 19. There are no subsequent steps recited that would practically apply the method depending on the results of the method, i.e. process steps that integrate the natural principle into the method and assure that it is applied in some practical manner.
It is also noted that the claims do not clearly recite or require any physical or wet steps to be performed, such as performing immunological assays to measure the CD4+CD8+ and CD45RO+ expression levels in T cells. Steps of “determining the level of CD4+CD8+ and CD45RO+ expression levels in T cells” when given their broadest reasonable interpretation, could read on reading numbers off of a chart, which would also constitute mental activity. The determining steps are recited at a high level of generality and are not tied, for example, to a particular machine or apparatus. Accordingly, even if the claims are interpreted as requiring a wet assay step to detect or measure the biomarkers of claims 12 and 19, such steps are insufficient because the purpose is merely to obtain data. This does not go beyond insignificant presolution activity, i.e., a mere data gathering step necessary to use the correlation, similar to the fact pattern in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) and Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015). As above, there are no subsequent steps recited in claims 19 and 25 that would practically apply the methods depending on the results of the method, i.e. process steps that integrate the natural principle into the method and assure that it is applied in some practical manner.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As noted above, the recited data gathering steps are recited at a high level of generality and are not limited, for example, to any specific or unconventional testing technique. Limitations that are necessary for all practical applications of a judicial exception, such that everyone practicing the judicial exception would be required to perform those steps or every product embodying that judicial exception would be required to include those features, would not be sufficient to confer patent eligibility.
Therefore, prior to the effective filing date of the claimed invention, it was well-understood, routine and conventional to determine cell surface antigen expression positivity in PBMCs.
See also Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015):
Where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine and well understood applications in the art.
When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or a transformation of a particular article, in such steps that distinguishes them from well-understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant’s invention, and at the time the application was filed, e.g., the routine and conventional techniques of detecting a protein using an antibody to that protein. See also MPEP 2106.05(g). Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)).
The combination of steps recited in these process claims taken as a whole, including the well-understood, routine, and conventional steps of data acquisition recited with a high level of generality which would substantially foreclose others from using the naturally occurring correlation, or limitations of the use to a particular technological environment (field-of-use) (“Guidance”, I.B.1), are not sufficient to qualify as a patent-eligible practical application of a law of nature or of a naturally occurring correlation, i.e. of a natural principle, as the claims do not amount to significantly more than a statement of the natural principle with generalized directions to apply it to the relevant population. See Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289, 101 USPQ2d 1961 (2012).
Based upon this analysis of the claims as a whole, the claims do not recite something significantly different than a judicial exception and fail to include additional elements that are sufficient to amount to significantly more than the judicial exception(s).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
6. Claims 12-25, 29, 30, 32, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2009/011456 A1) in view of Hillhouse et al. (Double Negative T Cell Levels Correlate with Chronic Graft-versus-Host Disease Severity. Biol Blood and Marrow Transplant 25:19-25 (2019)).
Miller et al. disclose a method of predicting (prognosis) and treating a subject at risk of acute graft-versus-host disease (aGVHD) in need of treatment for aGVHD ([0010, 0011, 0024-0024, 0041-0045]; Figure 1A, Figure 1B). The method comprises: (1) measuring a level of CD4+CD8+ double positive T cells (DPT, CD4+CD8β+ T cells) in a biosample isolated from the subject using flow cytometry (Table 3; [0010, 0017-0020, 0022, 0026, 0042, 0044, 0056; 0073, 0076]; Figure 1A, Figure 1B; Figure 2; Figure 3A; Figure 3C; Figure 5); (2) measuring a level of CD45RO+ (cellular activation marker) T cells (memory T cells) in the biosample isolated from the subject ([0037, 0045, 0056, 0076]; Table 2); (3) identifying and selecting the subject as at risk of aGVHD when the level of CD4+CD8+ DPT cells is high/elevated in percentage, proportion data, or cell population abundance in the biosample of the subject relative to control values (Table 3; [0010, 0026, 0031, 0037, 0041, 0042, 0045, 0049-0051, 0053, 0056, 0073, 0076]; Table 2); and (4) administering to the subject an amount of treatment effective to treat aGVHD in the subject ([0010, 0023, 0026, 0031, 0038]; Figure 1B; Figure 6). Smith et al. teach using the method to predict (prognosis) aGVHD in the subject (Abstract; Table 3; [0023, 0074]).
The biosample is bone marrow tissue or autologous whole blood obtained from the subject 7-21 days (encompassed within 5-22 days) after HSC transplant (post transplantation) ([0017-0020]; Figure 3B; Figure 3C). The biosample may be a bone marrow tissue or autologous whole blood obtained from the subject at least 22 days (encompassed within 22-90 days) after HSC transplant [0027]; so that the method can be used to predict aGVHD in the subject [0024, 0027, 0028]. Smith et al. teach that the subject has undergone hematopoietic stem cell (HSC) transplantation (bone marrow transplant) [0017, 0027]. Smith et al. also teach measuring the percentage of Treg cells (CD3, CD4, CD25 expression) in total T cells, CD8β+ T cells in total T cells, and DPT cells; wherein the subject is treated for aGVHD when the Treg cell % in total T cells is high/elevated, the CD8β+ T cell % in total T cells is high/elevated, and/or the DPT cell % is high/elevated in the blood sample of aGVHD subjects [0031, 0037, 0045, 0049, 0050, 0053, 0056, 0073]; Table 2). The treatment as taught by Smith et al. comprises methylprednisolone [0038].
Smith et al. is silent in explicitly relating the percentage level of CD4+CD8+ DPT cells to all CD45RO+ T cells in samples of GVHD subjects.
Hillhouse et al. specifically teach a) measuring a level of CD4+CD8+ DPT cells in biosample isolated from GVHD subjects using flow cytometry (p. 22, right column; Figure 2B); and b) then measuring a level of CD45RO+ T cells in the biosample isolated from the subjects (p. 22, right col.; Figure 2C); and, c) identifying and selecting the subject as at risk of GVHD based on the level of CD4+CD8+ DPT cells relative to all CD45RO+ T cells in the biosample (Figure 2B; Figure 2C). Hillhouse et al. also teach specifically using CD4, CD25, and FoxP3 cell surface expression to determine the level of CD4+CD25+FoxP3 T regulatory cells (Tregs) in the biosample of GVHD subjects who show low/reduced levels of Treg cell frequency (p. 20, left col. 2nd full ¶). Hillhouse et al. show using flow cytometry to detect percentages of T cell blasts (cancer cells) in acute lymphocytic leukemia (ALL) subjects (Table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have incorporated the teaching of Hillhouse in directly correlating the percentage of CD4+CD8+ DCT cells relative to the total of CD45RO+ T cells because Hillhouse shows that such combination of biomarker parameters provides additional advantage in correlating T cell population biomarker expressions in the diagnosis, prediction, and treatment regimen of GVHD. One of ordinary skill would have had reasonable expectation of success in incorporating the teaching of Hillhouse into the method of Smith because both of Smith and Hillhouse teach analogous art in diagnosis and treatment of aGVHD.
With respect to the range of 4-6% CD4+CD8+ DPT cell percentage relative to all CD45RO+ T cells that is used as a predictive value that is also used as a basis for administering treatment of aGVHD; generally, differences in concentration percentages will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific percentage limitation recited in instant claims 12, 18, 19, and 25 are for any particular purpose or solve any stated problem and the prior art references teach that concentrations often vary according to the cell subpopulations and samples being analyzed; and various matrices, solutions and parameters appear to work equally as well; absent evidence to the contrary, it would have been obvious for one of ordinary skill to have discovered the optimum workable range of the methods disclosed by the prior art by normal optimization procedures.
Allowable Subject Matter
7. Claims 31 and 34 are free of the prior art of record. Claims 31 and 34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
8. No claims are allowed.
Remarks
9. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure:
Soiffer et al. (Randomized Trial of CD8+ T-Cell Depletion in the Prevention of Graft-versus-Host Disease Associated with Donor Lymphocyte Infusion. Biology of Blood and Marrow Transplantation 8: 625-632 (2002)) teach T-cell recovery of both CD4+CD45RO+ and CD8+CD45RO+ displayed alongside TCR scores in a representative patient before and after infusion of CD8-depleted donor lymphocyte infusion (DLI).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
December 11, 2025