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 .
Response to Amendment
Applicant’s amendment filed 07/06/2026 is acknowledged. Claims 1, 5, 6, and 7 are amended and claims 17, 18, 22 and 25 are newly canceled. Claims 1-16 are under examination.
Objections/Rejections Withdrawn
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Specification
The objection to the disclosure for informalities is withdrawn in response to Applicant’s amendment of Table 2.
Claim Objections
The objection to claim 1 for minor informalities is withdrawn in response to Applicant’s amendment.
Claim Rejections - 35 USC § 112(b)
The rejection of claim 5 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in response to Applicant’s amendment to clarify the language of the claims.
Claim Rejections - 35 USC § 112(a)
The rejection of claims 1 and 5-16 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph for scope of enablement is withdrawn in response to Applicant’s amendment of the claims to limit the centriolar markers to tubulin, POC1B, acetylated tubulin and FAM161A, which were indicated as enabled at p. 8 of the Office action mailed 07/06/2026.
Rejection Maintained
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.
The rejection of claims 1-16 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more is maintained for reasons of record and the following.
The rejection at pages 4-7 of the Office action mailed 07/06/2026 stated:
The claims recite a method for diagnosing a likelihood of infertility in a male subject, comprising:
staining a sperm sample from said subject with at least one antibody that binds a centriolar marker at locations comprising each of a proximal centriolar (PC), atypical distal centriole (DC), and axoneme (Ax) of the sperm, wherein the antibody is configured to fluoresce upon binding to the centriolar marker;
observing fluorescence from the stained sperm sample at each of the locations;
comparing the observed fluorescence at each of the locations to a total fluorescence from the stained sperm sample at all of the locations to obtain a ratio at each of the locations (PC, DC, Ax) for the centriolar marker;
averaging the ratios by a number of samples to obtain a mean ratio for PC, DC and Ax;
comparing the mean ratios to reference mean ratios from a reference sperm sample, wherein the reference sperm sample has standard morphology; and
diagnosing a likelihood of infertility in the male subject when any one of the mean ratios falls outside of two standard deviations from the reference mean ratio at the same location.
Claims 1-16 are drawn to the statutory category of a process (see Step 1 of the Revised Guidelines).
The first step in determining whether the claims recite patent eligible subject matter is to consider whether the claims recite an abstract idea, law of nature or a natural phenomenon. See Prong One of Step 2A in the Revised Guidelines. As noted above, the claims comprise the mental steps of observing fluorescence, comparing the observed fluorescence at sperm locations PC, DC and Ax to total, averaging the ratio to obtain a mean ratio at each of the sperm locations, comparing to reference and diagnosing the likelihood of male infertility. The mental steps of observing, comparing and diagnosing are part of the judicial exception that is the natural correlation between the ratio of a centriolar marker at a particular sperm location (PC, DC or Ax) to the centriolar marker at all three locations and the likelihood of male infertility. The mental step of comparing biomarker levels is similar to comparing information regarding a sample or test subject to a control or target data (see Univ. of Utah Research Found, v. Ambry Genetics Corp., 113 USPQ2d 1241 (Fed. Cir. 2014), or diagnosing an abnormal condition by performing clinical tests and thinking about the results (see In re Grams, 12 USPQ2d 1824 (Fed. Cir. 1989). The answer to Prong One of Step 2A is yes.
The second step in determining patent eligibility of claimed subject matter is to consider whether the claims recite additional elements that integrate the judicial exception into a practical application. In addition to the mental steps of observing, comparing and diagnosing, the claims require the active step of staining the sperm. Dependent claims 5-7 recite specific centriolar markers and claim 8 recites that the reference sperm sample comprises sperm from an infertile subject with standard morphology. Claims 9 and 10 recite details about the fluorescent tag and secondary antibody in the staining procedure and claims 11-16 recite particular male subjects. The claims do not recite additional elements that integrate the judicial exception into a practical application because the active staining step is part of the necessary data gathering required in order to perform the mental steps of observing, comparing and diagnosing. Further, the dependent claims add only details about the particular markers measured (by staining), the reference to which the data are compared, how the staining is performed and the types of subjects on whom the mental steps are carried out. In summary, the answer to Prong Two of Step 2A is no.
The final step in determining whether the claims recite patent eligible subject matter is to consider whether they recite additional elements that amount to significantly more than the judicial exception. The claims do not recite any particular assay or steps that amount to significantly more than the judicial exception. For example, the claims do not recite how the centriolar markers are stained, but the specification discloses an immunofluorescence-based assay for sperm staining at paragraphs [0099]-[00101]). The art provides evidence that immunofluorescence staining is a well-established procedure that “allows for detection and localization of a wide variety of antigens in different types of tissues of various cell preparations” (see abstract of Im, K., Mareninov, S., Diaz, M.F.P., Yong, W.H. (2019). In: Yong, W. (eds) Biobanking. Methods in Molecular Biology, vol 1897. Humana Press, New York, NY. https://doi.org/10.1007/ 978-1-4939-8935-5_26). See also Azad et al. (Urology journal. (2018) 15. 10.22037/uj.v0i0.3966), which describes a sperm immunofluorescence procedure (see p. 2). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional staining step is simply appending well-understood, routine and conventional activities, previously known to the industry, and specified at a high level of generality to the judicial exception (see MPEP 2106.05(d)). In summary, the claims do not recite patent-eligible subject matter.
Response to Arguments
Applicant argues at p. 6 that claims 1-16 as a whole are not directed to an abstract idea, law of nature or natural phenomenon because they mandate staining a sperm sample from a male subject in a particular manner and observing, comparing and averaging steps that allow for diagnosis of infertility. Applicant asserts that because the claims focus on particular diagnosing procedure applied to a sperm sample using specific centriolar markers, they are not directed to a judicial exception.
This argument has been fully considered but is not found persuasive. The mental steps of observing, comparing and diagnosing are part of the judicial exception that is the natural correlation between the ratio of a centriolar marker at a particular sperm location (PC, DC or Ax) to the centriolar marker at all three locations and the likelihood of male infertility. The staining step is a routine data gathering step that allows for the mental steps of “observing, comparing and averaging” to diagnose infertility.
Applicant argues at p. 6 that each of the claims as a whole integrates any such natural correlation into a practical application under Step 2A, Prong Two. Applicant asserts that the staining step requires a specific group of centriolar markers which meaningfully limits the scope of the diagnostic technique.
This argument has been fully considered but is not found persuasive. The claims do not recite additional elements that integrate the judicial exception into a practical application because the active staining of centriolar markers is part of the necessary data gathering required in order to perform the mental steps of observing, comparing and diagnosing. The dependent claims add only details about the reference to which the data are compared, how the staining is performed and the types of subjects on whom the mental steps are carried out. The claims do not recite any new or unconventional antibodies used in the immunofluorescence assays sufficient to transform the claims.
Applicant argues at pages 6-7 that the specific staining step with at least one antibody configured to bind to a centriolar marker is not a generic instruction to obtain data. Rather, Applicant asserts it is a nonconventional and nontrivial limitation that tailors the method. Applicant argues further that neither the references by Mareninov nor Azad describe staining a sperm sample from a male subject as recited in the instant claims. Applicant also argues that the recited centriolar markers are not routine in infertility diagnositcs, which provide an inventive concept.
This argument has been fully considered but is not found persuasive. The MPEP instructs that the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See MPEP 2106.05(I), citing Mayo, 566 U.S. at 91, 101 USPQ2d at 1973.
“As made clear by the courts, the ‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) (“a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty.”). In addition, the search for an inventive concept is different from an obviousness analysis under 35 U.S.C. 103. See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016).
Although Applicant were the first to recognize tubulin, acetylated tubulin, POC1B and FAM161A might be useful in predicting infertility in bulls, The MPEP 2106.05(I) states that when evaluating eligibility under Step 2B, an inventive concept “cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself”, citing Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also MPEP 2106.04(I), which states: “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry”, citing Myriad, 569 U.S. at 591, 106 USPQ2d at 1979. This passage further states:
The Federal Circuit has also applied this principle, for example, when holding a concept of using advertising as an exchange or currency to be an abstract idea, despite the patentee’s arguments that the concept was “new”, citing Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 714-15, 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). Cf. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) (“a new abstract idea is still an abstract idea”) (emphasis in original).
Conclusion
No claim is allowed.
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 concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
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