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
Claims 4 and 14 are canceled.
Claims 1-3, 5-13 and 15-20 are pending and under consideration.
Withdrawn Rejections
Objection of claims 7 and 17 is withdrawn. Applicant amended the claims 7 and 17, thereby obviating this rejection/objection.
Rejection of Claims 1-20 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn. Applicant amended the claims and provided a persuasive argument, thereby obviating this rejection/objection.
Rejection of Claim(s) 11 and 19 under 35 U.S.C. 102(a)(1) as being anticipated by Seth et al (PLoS One, vol. 4, Iss. 5, e5478, May 2009) is withdrawn. Applicant amended the claim 11 to recite specific markers, thereby obviating this rejection/objection.
Rejection of Claim(s) 1, 9, 11-12 and 19 under 35 U.S.C. 103 as being unpatentable over Seth et al (PLoS One, vol. 4, Iss. 5, e5478, May 2009) in view of Fecteau et al (Vet Clin North Am Food Anim Pract., November 2011, 27(3):547-57) is withdrawn.
Rejection of Claim(s) 1, 7-10, 11-12 and 17-20 under 35 U.S.C. 103 as being unpatentable over Seth et al in view of Fecteau et al as applied to claims 1, 9, 11-12 and 19 above, and further in view of Philippe et al (US11112414) is withdrawn.
Applicant amended the independent claims 1 and 11 to recite specific markers, thereby obviating these rejections.
Rejection of Claims 1, 7-12, and 17-20 on the ground of nonstatutory double patenting as being unpatentable over claim 1-16 of U.S. Patent No. 10,914,739 in view of Fecteau et al (Vet Clin North Am Food Anim Pract., November 2011, 27(3):547-57) is withdrawn. Applicant amended the independent claims 1 and 11 to recite specific markers, thereby obviating this rejection.
NEW - Claim Rejections - 35 USC § 112
(necessitated by amendments)
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.
Claims 1-3, 5-13 and 15-20 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.
Step (b) of claims 1 and 11 recites testing a level of mycobacterial marker but does not recite testing for antibody before wherein-clause. However, wherein-clause recites that testing comprises detecting both mycobacterial marker and antibody against mycobacterial marker. Because claims 1 and 11 define that testing is only for mycobacterial marker, not for antibody against the marker before wherein-clause, it is not clear if the testing step includes testing for antibody or not.
Dependent claims do not remedy this deficiency.
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.
Claims 11, 13 and 15-20 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. The claims are directed to a judicial exception (natural phenomenon), specifically, the claims are drawn to detecting a level of mycobacterial specific marker. Furthermore, the claims do not integrate said judicial exception into practical application, and the claims do not recite additional elements that amount to significantly more than said judicial exception.
The MPEP Section 2103 through 2106 provides a means of determining whether a particular claim is patent eligible under 35 U.S.C. 101.
Step 1 - Following a determination of the broadest reasonable interpretation of a claim, is the claim drawn to a process, machine, manufacture, or composition of matter? If the answer to this inquiry is “Yes,” the analysis moves on to step 2A.
Step 2A - A two-prong analysis. For prong one, does the claim recite an abstract idea, law of nature, or natural phenomenon? If “Yes,” the analysis proceeds to prong two, which asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If “No,” the analysis moves on to step 2B.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? If “No,” the claim is not eligible subject matter under 35 U.S.C. 101.
In the instant case, the claims are drawn to a process, so the answer to Step 1 is “Yes.”
With respect to prong one of Step 2A, the answer is “Yes,” because as indicated above, the claims are drawn to a natural phenomenon, specifically, the claims are drawn to detecting a level of mycobacterial specific marker. The recited mycobacterial specific markers are natural products which exist in nature.
With respect to prong two of Step 2A, the claim does not recite additional elements that integrate the judicial exception into a practical application. In addition to the recited judicial exception, the claims recite testing via ELISA assay (claim 17-18). However, this limitation relates to general method of measuring the level of mycobacterial specific marker in a sample and does not integrate the judicial exception into a practical application. Said limitation does not integrate the recited judicial exception, for example, by applying or using said judicial exception to effect a particular treatment for a disease or medical condition. Therefore, the answer to prong two of the Step 2A analysis is “No.”
With respect to Step 2B, using ELISA assay to determine the level of natural protein in the sample is well-understood, routine, and conventional data gathering step that were practiced by investigators prior to Applicant’s invention. These steps do not amount to additional elements that amount to significantly more than the recited judicial exception. Accordingly, the answer to the Step 2B analysis is “No,” and therefore the claims are not eligible subject matter under 35 U.S.C. 101.
A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Recited elements such as “detecting” and "comparing", based on the natural principle impose no meaningful limit on the performance of the claimed invention. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas). Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the recited natural principle. The claims do not "practically apply" the natural principle; rather, the claims "simply inform" the natural principle to one performing routine active method steps and do not amount to significantly more than the natural principle itself. Thus, the technology used by the instant claims is well-known in the art and does not contribute significantly more to the judicial exception.
Response to Arguments
In the response filed on 8/7/2026, Applicant argued at page 7 “Amended claim 11 does not recite a judicial exception”.
Applicant's arguments have been fully considered but they are not persuasive. Amended claim 11 now recites “at least one mycobacterial specific marker selected from the group consisting of Q73SF4, Q73Y73, Q73ZE6, Q73SL7, Q73VK6, Q73XZ0, Q740D1, Q73UE0, Q73VL6, Q73YW9, Q741L4, Q744E5, Q73YP5, Q73WE5, Q73U21, Q73UH9, Q741M5, Q742F4,and 073SU6”. Because these markers are natural proteins which exist in nature, these proteins are product of nature and therefore are judicial exceptions.
Applicant argued at page 8, “The claimed markers were selected because they are expressed by wild-type M. ap during infection but lower or absent in mycobacterial vaccine strains. Specification, paragraph [0107] and Table 1. Thus, claim 11 applies the marker detection in a specific veterinary vaccination context to address a problem in the field of detecting vaccinated versus infected animals, rather than merely reciting a natural correlation. Thus, any judicial exception that may be recited in claim 11 is integrated into a practical application and claim 11 is patent eligible under Step 2A, Prong 2 of the Alice/Mayo test.”
Applicant's arguments have been fully considered but they are not persuasive. Applicant’s argument is not commensurate with claim scope of instant claim 11. Unlike instant claim 1, claim 11 does not recite any step of administering antibiotic like claim 1(d), nor any step of diagnosing specific disease. Claim 11 only recites step of detecting mycobacterial proteins which are products of nature. Therefore, claim 11 does not recite additional elements that integrate the judicial exception into a practical application.
Applicant argued at page 8, “Amended claim 11 recites significantly more than any judicial exception that may be recited in the claim.”
Applicant's arguments have been fully considered but they are not persuasive. As discussed above, in order to satisfy Step 2B, the claim must recite additional elements that amount to significantly more than the judicial exception. These elements are additional elements in addition to the judicial exception itself. The mycobacterial specific marker selected from the group consisting of Q73SF4, Q73Y73, Q73ZE6, Q73SL7, Q73VK6, Q73XZ0, Q740D1, Q73UE0, Q73VL6, Q73YW9, Q741L4, Q744E5, Q73YP5, Q73WE5, Q73U21, Q73UH9, Q741M5, Q742F4,and 073SU6 is product of nature and is the judicial exception itself, not additional elements that amount to significantly more than the judicial exception.
MAINTAINED - Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1, 5-12 and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-10 of U.S. Patent No. 10,054,586 (hereinafter patent’586) in view of Fecteau et al (Vet Clin North Am Food Anim Pract., November 2011, 27(3):547-57, Treatment and chemoprophylaxis for paratuberculosis). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 1 and 11-12, claim 1 of patent’586 claims “A method for diagnosis of mycobacterial infection in a mammal, the method comprising the steps of
a) obtaining a sample from the mammal, wherein the sample is of a first type;
b) testing the sample for the concentration level of at least one mycobacterial-specific biomarker selected from the group consisting of Q73SF4, Q73Y73, Q73ZE6, Q73SL7, Q73VK6, Q73XZ0, Q740D1, Q73UE0, Q73VL6, Q73YW9, Q741L4, Q744E5, Q73YP5, Q73WE5, Q73U21, Q73UH9, Q741M5, Q742F4, Q73SU6, and antibodies specific thereto and comparing the level of the mycobacterial-specific biomarker against the level detected in an uninfected mammalian sample, wherein the uninfected mammalian sample is of the first type and is from the same species of mammal; and
c) determining the infection status of the mammal, wherein an increase in the concentration level of the mycobacterial-specific biomarker is indicative of a mycobacterial infection in the mammal.”
Regarding claim 5 and 15, claim 9 of patent’586 claims “The method of claim 1, wherein the mycobacterial-specific biomarker comprises at least one member selected from the group consisting of Q73SF4, Q73Y73, Q73ZE6, Q73SL7, Q73VK6, Q73XZ0, Q740D1 and Q73UE0.”
Regarding claim 6 and 16, claim 10 of patent’586 claims “The method of claim 1, wherein the mycobacterial-specific biomarker comprises at least one member selected from the group consisting of Q73VL6, Q73YW9, Q741L4, Q744E5, Q73YP5, Q73WE5, Q73U21, Q73UH9, Q741M5, Q742F4, and Q73 SU6.”
Regarding claims 7-8 and 17-18, claim 3 of patent’586 claims “The method of claim 1, wherein the mycobacterial-specific biomarker is an antibody and the testing is via ELISA assay.”
Regarding claims 9-10 and 19-20, claim 4 of patent’586 claims that the sample is blood sample.
The difference between patent’586 and the instant invention is that patent’586 does not claim administering antibiotic of step (d) of instant claim 1.
Fecteau teaches “There are no definitive cures for Mycobacterium avium subsp. paratuberculosis (MAP) infections, but several therapeutic agents may be employed to reduce or alleviate the clinical signs (mainly weight loss and diarrhea) associated with MAP infections and help prolong the life of the animal. Treatment typically must be maintained for the life of the animal and treated animals usually continue to shed MAP organisms, but often in reduced numbers. In addition, there are currently no drugs approved for paratuberculosis treatment in food producing animals in the United States. However, therapeutic options do exist for cattle and other ruminants that are of significant economic, genetic or sentimental value” (page 547). Fecteau further teaches “Isoniazid, one of the earliest drugs used to treat cattle with JD, has been used for several decades to treat human tuberculosis” (page 549). Isoniazid is antibiotic. Therefore, Fecteau teaches administering antibiotic to ruminant mammal to treat mycobacterium infection.
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to have administered antibiotic to the ruminant mammal which was diagnosed to be infected with mycobacterium in order to treat the mycobacterial infection by antibiotic because Fecteau teaches that antibiotic can be administered to ruminant mammal to treat mycobacterium infection. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
Response to Arguments
In the response filed on 8/7/2026, Applicant argued at page 12 “Without acquiescing to the rejection, Applicant will file a terminal disclaimer over the '586 patent. Therefore, reconsideration and withdrawal of the rejection is requested.”
Because Terminal Disclaimer has not been filed, this rejection is maintained.
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 CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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