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
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 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.
Response to Restriction/Election
Applicant’s election of with traverse of Group I, claims 1-2, in response to restriction requirement is acknowledged. Applicant’s traversal is on the ground that there is no burden on searching both groups as set forth by examiner.
The above arguments have fully been considered but are not found persuasive for the reason of record set forth in items 3 of the restriction/election mailed on 5/18/2026. The invention of Group I is directed to a method of diagnosing and the invention of Group II is directed to a product (rTPO) and the condition for patentability is different in each case. A patentability determination for Invention I would require an assessment of the novelty and unobviousness of the method steps recited in claim 1 while a patentability determination for invention II would require an assessment of the novelty and unobviousness of the product rTPO. In addition, the search for each of the distinct inventions of Groups I-II is not co-extensive particularly with regard to the literature search. Further, a reference that would anticipate the invention of one group would not necessarily anticipate or even make obvious another group. Thus, it will be an undue burden to examine both the inventive Groups in one application.
Therefore, claims 3-19 are withdrawn from further consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Applicants preserve their right to file a divisional on the non-elected subject matter.
Status of the claims
Claims 1-2 are examined on merits in this office action.
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 1-2 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 recites “wherein, in the presence of anti-thyroid peroxidase antibody in the biological sample, a complex comprising the labeled cynomolgus monkey rTPO, the unlabeled cynomolgus monkey rTPO, and solid support is formed”. Claims 2 recites “wherein, in the presence of anti-thyroid peroxidase antibody in the biological sample, a complex comprising the solid support, the cynomolgus monkey rTPO, and the anti-human secondary antibody is formed”.
The process of formation of complex with the solid support is vague and indefinite because the solid support as recited does not contain any immobilized reactive or specific binding molecules that are capable of forming any complex with the labeled or unlabeled rTPOs. Without a clear binding affinity of the rTPO with the different components and without a clear binding property of the solid support, the formation of the complex by the recitation “the complex is formed” is vague and indefinite. Is the complex is due to hydrophobic interaction and if it is due to hydrophobic interaction, the solid support has not been recited to have any hydrophobic components to provide the complex.
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.
Claim 1-2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. an abstract idea) without significantly more.
Step 1: The instantly claimed invention is directed to a method for detection of thyroid disease comprising determining the presence of anti-thyroid peroxidase antibody using recombinant cynomolgus monkey thyroid peroxidase (rTPO) to form a complex. The claim thus recites series of steps and, therefore, the instantly claimed invention falls into one of the four statutory categories. (Step 1: YES).
ELIGIBILITY STEP 2A; WHETHER A CALIM IS DIRECTED TO A JUDICIAL EXCEPTION. First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Step 2A Prong 1
Claim 1 recites the following steps which fall under the mathematical concepts and/or mental processes groupings of abstract ideas and law of nature or natural phenomena:
Claim 1 is drawn to a method of diagnosis a thyroid disease by detecting complex of anti-thyroid peroxidase antibody (i.e. a biomarker) in a biological sample with rTPO.
First, these limitations are abstract ideas of mental processes for the following reasons. In particular, the steps of detecting can be practically performed in the practitioner’s mind by detection color of the complex. Therefore, these limitations recite a mental process.
Second, the claims are drawn to detection of thyroid disease by detecting anti-thyroid antibody in the sample and associating/correlating of the detected biomarker of anti-thyroid peroxidase antibody with a thyroid disease. The claim thereby recites laws of nature/ natural phenomena. The natural relationship to which the claims are directed (i.e., the naturally occurring correlation between the presence of anti-thyroid antibody and the thyroid disease) exists in principle apart from any human action. Similar concepts have been held by the courts to constitute laws of nature/ natural phenomena, as in the identification of a correlation between the presence of a marker in a bodily sample (such as blood or plasma) and cardiovascular disease risk in Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017); 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)). (Step 2A, Prong 1: YES).
Step 2A: Prong 2:
The Step 2A, Prong 2 analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the judicial exception. A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Besides the abstract ideas and law of nature/natural phenomena, claims 1 and 2 recites detecting of the anti-thyroid biomarker comprises incubating sample with labeled and unlabeled rTPO to form a complex and detecting the complex.
When so evaluated, The additional elements claim 1 and 2 of performing immunoassays by forming complex with antibodies and labeled antigen do not integrate the judicial exception into a practical application because these steps constitute as insignificant extra solution activity of data gathering. These additional elements only interact with the judicial exception by providing data to be processed by the judicial exception.
Thus, none of the additional elements recited in the claims would integrate a judicial exception into a practical application, and the claims are directed the judicial exceptions (Step 2A, Prong 2: NO).
Step 2B:
In the second step it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. See MPEP 2106.05. The claims do not include any additional steps appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception.
The additional elements are well-understood, routine, and conventional. This position is supported by Burne et al et al. (Thyroid 2005). Burne teaches detecting the presence or absence of autoantibodies to thyroid peroxidase in a subject, comprising the steps of: contacting biological sample from said subject with an rTPO and detecting complex formed with antibody present in the sample.
Therefore, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself. (Step 2B: NO)
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. For additional guidance, applicant is directed generally to applicant is directed generally to the MPEP § 2106.
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 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11835518 in view of Rho et al (Endocrine 2012).
Claims 1-18 of US patent ‘518 discloses method of detection of anti-thyroid peroxidase antibody in a biological sample utilizing labeled and unlabeled cynomolgus monkey thyroid peroxidase (rTPO) to form complex with anti-human secondary antibody and anti-thyroid peroxidase antibody in the sample and detecting the complex. Therefore, claims 1-18 of US patent teaches the method processes disclosed in claims 1 and 2.
Claims of US patent ‘518 however, do not teach diagnosis of thyroid disease in the subject by detecting of antithyroid peroxidase antibody in the subject.
Rho teaches that detection of antithyroid peroxidase antibody is widely used in the diagnosis of autoimmune thyroiditis (i.e. a thyroid disease) (Abstract).
Therefore, from the teaching of Rho, it would be obvious to one of ordinary skilled in the art to easily envisage detection of thyroid disease from the detection of anti-thyroid peroxidase antibody in a biological sample by the method as described in US patent ‘518 with a reasonable expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rapaport (WO9102061) discloses recombinant human thyroid peroxidase and discloses detection of anti-thyroid peroxidase antibody in a sample utilizing the recombinant human thyroid peroxidase. Rapaport discloses detecting an antibody to human thyroid peroxidase in a sample, comprising contacting a sample suspected of having an antibody to human thyroid peroxidase with the recombinant human thyroid peroxidase, wherein said recombinant human thyroid peroxidase is detectably labeled, so as to form a complex between said antibody to human thyroid peroxidase present in said sample and said detectably labeled recombinant human thyroid peroxidase, and detecting the complexed or uncomplexed detectably labeled recombinant human thyroid peroxidase (claim 9). Rapaport however, does not teach recombinant cynomolgus monkey thyroid peroxidase and does not teach solid support based detection by complex formation utilizing the recombinant cynomolgus monkey thyroid peroxidase.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAFIQUL HAQ whose telephone number is (571)272-6103. The examiner can normally be reached on Mon-Fri 8-4:30.
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, Gregory S. Emch can be reached on 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
Prosecution Insights