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 1-20 are pending and under consideration.
Election/Restrictions
Restriction requirement filed 8/28/2025 contained error because claim 12 of Group II has same process steps as claim 1 of Group I. Restriction requirement is vacated and all claims are rejoined.
Claim Objections
Claims 7 and 17 are objected to because of the following informalities: “wherein testing” should read “wherein the testing”. 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 11 and 13-20 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 determining the infection status of the ruminant mammal, wherein an increase in the level of mycobacterial specific marker in the sample as compared to the control level in uninfected ruminant mammal is indicative of a mycobacterial infection in the ruminant mammal. 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 determining the infection status of the ruminant mammal, wherein an increase in the level of mycobacterial specific marker in the sample as compared to the control level in uninfected ruminant mammal is indicative of a mycobacterial infection in the ruminant mammal.
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.
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.
Claims 1-20 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.
Claim 1 and 11 recite “the status of the ruminant mammal” in step (c), but does not recite what kind of status is determined. Does Applicant intend to determine infection status of the ruminant mammal (i.e. whether the ruminant mammal is infected or not)? Does Applicant intend to determine health status of the ruminant mammal (i.e. whether the ruminant mammal is healthy or not)? Because claim 1(c) does not recite the type of status, one of ordinary skill in the art would not be able to ascertain what is to be determined in step (c).
Claims 4-6 and 14-16 recite the markers by accession number. There is no clear definition in the specification of what these markers are. While they appear to be UniProt accession numbers, neither the specification or the claim unambiguously defines them. Also, these accession numbers do not necessarily refer to a single thing. For example, Q73SF4 has 80 different entries; while the sequence hasn’t changed, the fact that the records are updated indicates that any of the underlying information can change.
Claim 8 and 18 recites “the biomarker”. There is insufficient antecedent basis for this limitation in the claim. While claim 1 recites “at least one mycobacterial specific marker”, claim 1 does not recite “a biomarker”.
Claim 8 and 18 recites “ELISA assay for antibodies formed against the biomarker”. The testing step (b) of claim 1 is detecting the concentration of the at least one mycobacterial specific marker, not to detect antibodies against the at least one marker. It is unclear if Applicant intends that ELISA assay is performed with antibodies formed against the biomarker or if Applicant intends that ELISA assay is performed to detect antibodies formed against the biomarker. If Applicant intend to recite the former, it is suggested that Applicant amend “ELISA assay for antibodies formed against the biomarker” to “ELISA assay with antibodies formed against the biomarker”.
Claim 13 recites “the mycobacterium mutant vaccine”. There is insufficient antecedent basis for this limitation in the claim. Neither claim 11 nor claim 12 does not recite “a mycobacterium mutant vaccine”.
Dependent claims are also rejected because they depend from claim 1 or 11 and contain same limitation as claim 1 or 11.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 11 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seth et al (PLoS One, vol. 4, Iss. 5, e5478, May 2009; PTO-892).
Regarding claim 11 and 19, Seth teaches “We hypothesized that serum proteomes of animals in response to either M. bovis or M. paratuberculosis infection will display several commonalities and differences. Sera prospectively collected (corresponds to step (a) of claim 11) from animals experimentally infected with either M. bovis or M. paratuberculosis were analyzed using high-resolution proteomics approaches. iTRAQ, a liquid chromatography and tandem mass spectrometry approach, was used to simultaneously identify and quantify peptides (corresponds to step (b) of claim 11) from multiple infections and contemporaneous uninfected control groups. Four comparisons (corresponds to step (b) of claim 11) were performed: 1) M. bovis infection versus uninfected controls, 2) M. bovis versus M. paratuberculosis infection, 3) early, and 4) advanced M. paratuberculosis infection versus uninfected controls. One hundred and ten differentially elevated proteins (P≤0.05) were identified. Vitamin D binding protein precursor (DBP), alpha-1 acid glycoprotein, alpha-1B glycoprotein, fetuin, and serine proteinase inhibitor were identified in both infections. Transthyretin, retinol binding proteins, and cathelicidin were identified exclusively in M. paratuberculosis infection, while the serum levels of alpha-1-microglobulin/bikunin precursor (AMBP) protein, alpha-1 acid glycoprotein, fetuin, and alpha-1B glycoprotein were elevated exclusively in M. bovis infected animals (corresponds to step (c) of claim 11).” Furthermore, Figure 1 teaches “Experimental design used for four iTRAQ analyses with combinations of sera from M.bovis and/or M.paratuberculosis infection in calves” (corresponds to “a) obtaining a sample from the ruminant mammal” of instant claim 11 and serum of claim 19 because calves are ruminant mammal and M.bovis and M.paratuberculosis are mycobacterium).
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claim(s) 1, 9, 11-12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seth et al (PLoS One, vol. 4, Iss. 5, e5478, May 2009; PTO-892) in view of Fecteau et al (Vet Clin North Am Food Anim Pract., November 2011, 27(3):547-57, Treatment and chemoprophylaxis for paratuberculosis; PTO-892).
Regarding claim 1, 9, 11-12 and 19, Seth teaches “We hypothesized that serum proteomes of animals in response to either M. bovis or M. paratuberculosis infection will display several commonalities and differences. Sera prospectively collected (corresponds to step (a) of claim 1) from animals experimentally infected with either M. bovis or M. paratuberculosis were analyzed using high-resolution proteomics approaches. iTRAQ, a liquid chromatography and tandem mass spectrometry approach, was used to simultaneously identify and quantify peptides (corresponds to step (b) of claim 1) from multiple infections and contemporaneous uninfected control groups. Four comparisons (corresponds to step (b) of claim 1) were performed: 1) M. bovis infection versus uninfected controls, 2) M. bovis versus M. paratuberculosis infection, 3) early, and 4) advanced M. paratuberculosis infection versus uninfected controls. One hundred and ten differentially elevated proteins (P≤0.05) were identified. Vitamin D binding protein precursor (DBP), alpha-1 acid glycoprotein, alpha-1B glycoprotein, fetuin, and serine proteinase inhibitor were identified in both infections. Transthyretin, retinol binding proteins, and cathelicidin were identified exclusively in M. paratuberculosis infection, while the serum levels of alpha-1-microglobulin/bikunin precursor (AMBP) protein, alpha-1 acid glycoprotein, fetuin, and alpha-1B glycoprotein were elevated exclusively in M. bovis infected animals (corresponds to step (c) of claim 1).” Furthermore, Figure 1 teaches “Experimental design used for four iTRAQ analyses with combinations of sera from M.bovis and/or M.paratuberculosis infection in calves” (corresponds to “a) obtaining a sample from the ruminant mammal” of instant claim 1 and serum of claim 9 because calves are ruminant mammal and M.bovis and M.paratuberculosis are mycobacterium).
The difference between prior art and the instant invention is that Seth does not teach step (d) of 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.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because Fecteau teaches that antibiotic can be administered to ruminant mammal to treat mycobacterium infection. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 1, 7-10, 11-12 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seth et al (PLoS One, vol. 4, Iss. 5, e5478, May 2009; PTO-892) in view of Fecteau et al (Vet Clin North Am Food Anim Pract., November 2011, 27(3):547-57, Treatment and chemoprophylaxis for paratuberculosis; PTO-892) as applied to claims 1, 9, 11-12 and 19 above, and further in view of Philippe et al (US11112414; filed 6/6/2014 before EFD of instant application and therefore available as 102(a)(2) art; PTO-892).
Regarding claims 1, 9, 11-12 and 19, teachings of Seth and Fecteau were discussed above.
The difference between prior art and the instant invention is that Seth and Fecteau do not teach ELISA assay.
Regarding claims 7-10 and 17-20, Philippe teaches “A method for treating a heart failure patient who has been previously hospitalized for heart failure, comprising obtaining a blood sample said heart failure patient with diastolic dysfunction, measuring by ELISA the concentration of IGFBP2 in said blood sample obtained from said heart failure patient, comparing the concentration of IGFBP2 measured in said measuring step to a threshold value derived from the concentration of IGFBP2 in blood samples taken from a group of patients wherein each of the patients in the group has stage IV heart failure according to the New York Heart Association (NYHA) heart failure classification system, readmitting said heart failure patient for further hospitalization if said concentration of IGFBP2 measured in said measuring step exceeds the threshold value, and administering to said heart failure patient at least one treatment selected from the group consisting of an effective amount of a beta-blocker, an effective amount of an angiotensin-converting enzyme inhibitor, an effective amount of an angiotensin receptor blocker, an effective amount of an aldosterone antagonist, an implantable cardiac defibrillator, a cardiac resynchronization therapy, an implantable left ventricular assistive device and a heart transplant” (claim 7). Therefore, Philippe teaches that the concentration of specific protein in the blood sample can be determined by ELISA assay.
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to have used ELISA assay to determine the concentration of mycobacterial specific marker in blood sample because Philippe teaches that the concentration of specific protein in the blood sample can be determined by ELISA assay. Furthermore, as discussed above, Seth teaches serum sample and because serum is prepared from blood and because Philippe teaches determination of protein concentration directly from blood sample, one of ordinary skill in the art would be motivated to use blood sample without extra step of serum preparation from blood. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because Philippe teaches that the concentration of specific protein in the blood sample can be determined by ELISA assay. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
Claims 1, 7-12, and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-16 of U.S. Patent No. 10,914,739 (hereinafter patent’739; PTO-892) in view of Fecteau et al (Vet Clin North Am Food Anim Pract., November 2011, 27(3):547-57, Treatment and chemoprophylaxis for paratuberculosis; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claim 1 and 11-12, claim 1 of patent’739 claims “A method for diagnosis of mycobacterial infection in a ruminant mammal, the method comprising the steps of
a) obtaining a sample from the ruminant mammal;
b) testing the sample for a level of at least one mycobacterial-specific biomarker selected from the group consisting of NW_005125111.1:0-184, NW_005101181.1:1703-1858, NW_005101181.1:168292-168418, NC_022320.1:39973839-39974080, NC_022297.1:44037534-44043184, NC_022296.1:81262820-81263390, and antibodies specific thereto, and comparing the level of the biomarker against a control level of the biomarker detected in an uninfected ruminant mammalian sample, wherein the uninfected ruminant mammalian sample is from the same species of ruminant mammal; and
c) determining the infection status of the ruminant mammal, wherein an increase in the level of the mycobacterial-specific biomarker in the sample as compared to the control level is indicative of a mycobacterial infection in the ruminant mammal.”
Regarding claims 7-8 and 17-18, claim 3 of patent’739 claims “The method of claim 1, wherein the mycobacterial-specific biomarker is an antibody specific to NW_005125111.1:0-184, NW_005101181.1:1703-1858, NW_005101181.1:168292-168418, NC_022320.1:39973839-39974080, NC_022297.1:44037534-44043184, NC_022296.1:81262820-81263390, and wherein the testing is via ELISA assay for said antibody.”
Regarding claims 9-10 and 19-20, claim 4 of patent’739 claims that the sample is blood sample.
The difference between patent’739 and the instant invention is that patent’739 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.
Claim 1, 4-12 and 14-20 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; PTO-892) in view of Fecteau et al (Vet Clin North Am Food Anim Pract., November 2011, 27(3):547-57, Treatment and chemoprophylaxis for paratuberculosis; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 1, 4, 11-12 and 14, 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.
Conclusion
No claim is allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645