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 .
Election/Restrictions
Applicant’s election without traverse of TERF1 antigen and systemic sclerosis in the reply filed on 04/15/2026 is acknowledged.
Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/15/2026.
Claims 1-10 and 12-20 are under examination. Claim 3 is under examination with respect to systemic sclerosis. Claim 10 is under examination with respect to TERF1.
Claim Rejections - 35 USC § 112 (b)
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 1-10 and 12-20 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 2 recite “telomerase/shelterin complex” in the step of detecting an autoantibody that targets an antigen present in a telomerase/shelterin complex in the biological sample. The recitation of telomerase/shelterin complex renders the claim indefinite. It is unclear what is encompassed by this limitation. Does the claim require detecting an antigen present in a telomerase complex, shelterin complex or some other complex that is encompassed by “telomerase/shelterin” that is not defined by the claim. The specification does nor provide a standard for ascertaining the claimed telomerase/shelterin complex and one of ordinary skill in the art would not be apprised of the scope of the claim. Because the metes and bounds of the claims are indefinite, it would not be readily apparent if one was infringing on the claimed invention and therefore the claims are indefinite.
Claim 12 recites detecting comprises detecting the presence or absence of an interaction between the autoantibody and antigen. Claim 20 recites the subject is identified to not have the disease when the autoantibody is not detected. This recitation renders the claim indefinite. Claim 12 and 20 depend from claim 2 and claim 2 recites detecting an autoantibody and identifying the disease. Claim 2 does not require detecting the presence or absence but requires detecting a autoantibody as such it is unclear the scope of claim 12 and 20 when claim 2 requires detection of an autoantibody and identifying disease. It is unclear how claim 12 limits the detection step of claim 2 because claim 2 requires detecting the autoantibody while claim 12 recites detecting the present or absence and claim 20 requires the subject is not identified to have disease when autoantibody is not detected. Each of these limitations this renders the claim indefinite. The metes and bounds of the claims are unclear and it would not be readily apparent if one was infringing on the claimed invention.
Claims 3-10 and 12-20 depend from claim 2 and are indefinite for the reasons applied to claim 2 above.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12, 19-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 recites detecting comprises detecting the presence or absence of an interaction between the autoantibody and antigen. This recitation renders the claim indefinite. Claim 12 depends from claim 2 and claim 2 recites detecting an autoantibody. It is unclear how claim 12 further limits the detection step of claim 2 because claim 2 requires detecting the autoantibody.
Claim 19 recites wherein the subject is identified to have the disease when the auto antibody is detected in the biological sample. Claim 20 recites wherein the subject is identified to not have the disease when the auto antibody is not detected in the biological sample. It is unclear how claim 19 and claim 20 further limit claim 2. Claim 2 requires detecting an autoantibody, thereby identifying the disease in the subject. It is therefore unclear how claim 19 that identifies the subject as having disease when autoantibody is detected when claim 2 already requires this limitation. It is unclear how claim 20 further limits claim 2 when claim 2 requires detecting an autoantibody and identifying a disease.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
For the purposes of examination, the recitation of antigen present in a telomerase/shelterin complex has been interpreted to encompass any antigen that interacts in any way with any gene involved in shelterin complex or telomerase complex or localization.
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 1-10, 12-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exceptions of a law of nature and an abstract idea without significantly more.
The claims recite a law of nature, specifically a natural phenomenon. Claim 1 recites identifying a disease in a subject by detecting an autoantibody that targets an antigen present in the telomeres or shelterin complex, thereby identifying a disease. Claim 2 recites detecting an autoantibody that targets an antigen present in the telomeres or shelterin complex, thereby identifying a disease. Claim 19 recites the subject is identified to have the disease when the autoantibody is detected in the biological sample from the subject. Claim 20 recites the subject is identified to not have the disease when the autoantibody is not detected in the biological sample from the subject. The recitation of detecting an autoantibody…thereby identifying a disease is a law of nature in claim 1 and 2 and the recitation of subject is identified as having or not having disease when the autoantibody is detected or not detected are natural phenomenon, the consequence of the presence of an autoantibody and antigen in a telomerase or shelterin complex with the presence of a disease. The presence of an autoantibody or antigen in a telomerase or shelterin complex with a disease or the absence of an autoantibody or antigen without a disease is a natural phenomenon that exists apart from any human action. This type of correlation is a consequence of a natural process.
The claims recite an abstract idea that is a mental process. Claim 1 and 2 recite thereby identifying a disease in the subject. Additionally claim 2 recites wherein the treatment is predicted to be beneficial to the subject based when the presence of an autoantibody is detected. Claim 19 recites the subject is identified to have the disease when the autoantibody is detected in the biological sample from the subject. Claim 20 recites the subject is identified to not have the disease when the autoantibody is not detected in the biological sample from the subject. These recitations are an abstract idea. This recitation encompasses a mental process step which could be practiced in the mind. The practitioner necessarily needs to perform a comparison in order to determine that a disease is identified. This recitation encompasses an abstract idea. Neither the specification or the claims set forth limiting definition for identifying. The claims do not set forth how each of these steps are accomplished and the broadest reasonable interpretation is a step that can be accomplished mentally be evaluating data and critical thinking process such that one mentally reads information from a report regarding detecting an autoantibody then draws a mental conclusion. Such identifying encompass process that may be performed mentally and this is an abstract idea. This recitation is a mental process. The recitation of prediction encompasses a mental process that could be practiced in the mind.
These judicial exception is not integrated into a practical application because the claims do not recite additional steps or elements that integrate the judicial exception into a practical application. For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Claim 1 does not recite any additional elements that integrates the judicial exceptions. Claim 2 recites administering a treatment to the subject, wherein the treatment is predicted to be beneficial to the subject based when the presence of the autoantibody is present. These additional elements of administering a treatment to the subject do not apply the judicial exception. The administering of treatment only occurs when it is predicted to be beneficial to a subject when the presence of autoantibody is detected. When the autoantibody is not detected, as recited in claim 12 and 20 no treatment is administered.
As mentioned above, a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. When evaluating this consideration one must the following: the particularity or generality of the treatment or prophylaxis limitation; whether the limitations have more than a nominal or insignificant relationship to exception; and whether the limitations are merely extra solution activity or field of use.
The step of “administering a treatment to the subject” is not particular i.e. specifically intended so that it does not encompass all application of the judicial exception. With regard to claim 5, the recitation of administration of the claimed therapies are not particular, i.e., specifically identified so that it does not encompass all applications of the judicial exception. In other words the claims broadly encompass any and all therapy regimens for any disease. Additionally the claims further does not require administering the therapy to the subject as the claims recite treatment is predicted to be beneficial to the subject based when the presence of the autoantibody is detected and dependent claims encompass detecting the absence of the autoantibody and therefore there appears to be an embodiment of the claim that include no detection and no treatment.
Additionally the treatment limitations do not appear to have a significant relationship to the exception. For example claim 2, requires detecting an autoantibody that targets an antigen but does not require administering a particular treatment to the subject that has the autoantibody. In addition to the judicial exceptions the claims recite type of disease (claim 3-4) type of treatment (claim 5), subject (claim 6), sample (claim 7-8, 17-18), antigen (claim 9-10), specific detection assay (claim 13-16). These additional steps/elements are not considered to integrate the judicial exception into a practical application because they merely add insignificant extra-solution activity (data gathering) to the judicial exception and further limit the judicial exception. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claims as a whole are not considered to recite any additional steps or elements that amount to significantly more than well-understood, routine, and conventional activities in the art and do not add something significantly more so as to render the claims patent -eligible. The step of autoantibody detection and telomere length merely instructs a scientist to use well-established routine and conventional immunology and nucleic acid techniques to gather samples for diagnostic analysis. As address in the instant specification methods of expression analysis are well-known in the art (See para 89-101).
The step of detecting autoantibody and telomerase length in a sample constitutes a data gathering step required to apply the law of nature/natural phenomenon. It is acknowledged that the claims name particular antigen, TERF to be detected however the claims do not require a particular, non-conventional assay consisting of or comprising a specific antibody or any other specific reagent that is used to accomplish such determining such that the claims would recite significantly more than the judicial exception. The targets to be detected are part of the judicial exception and thereby the naming of the targets does not add something “significantly more” to the recited judicial exceptions.
The additional steps and elements are recited at a high degree of generality and are all routine, well understood and conventional in the prior art. The recited steps and elements do not provide inventive concept necessary to render the claims patient eligible. There is no combination of elements in this step that distinguishes it 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. Many cited prior art references in this record demonstrate that these techniques were conventional at the time of the invention. The prior art of Villalta (Autoimmunity Reviews, 12, 2012, 114-120) teaches detection of autoantibodies of Ku by immunoblot, Chuang et al. (Exp and Therapeutic Med, 2011, 2, 63-67) teaches detection of anti-TERF1 and Adler (2021 and 2020, cited on IDS) teach detection of anti-TERF1 with telomer length in patients with SSc. Thus the prior art demonstrates it was routine, well-known and conventional in the art to detect autoantibodies to antigen TERF1 and telomere length in biological samples. The dependent claims do not provide significantly more to the claims outside of the judicial exception as they encompass conventional techniques as described in the instant specification as noted above.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adler (2020, cited on IDS).
Adler teaches obtaining patient sera and screening for autoantibodies targeting TERF1 (see methods). Adler teaches ELISA and immunoprecipitation methods were used for autoantibody detection. Adler teaches identifying scleroderma patients with multiple autoantibodies targeting TERF1 (see results).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adler (2021, cited on IDS).
Alder teaches a method of obtaining sera from patients and detecting autoantibody to antigen TERF1 (see immunoprecipitation assay). Alder teaches detection of anti-TERF1 in subjects and identifying Ssc disease (see results, pg. 914).
Claims 1-2, 6, 10, 12-13, 19-20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Chuang et al. (Exp and Therapeutic Med, 2011, 2, 63-67).
Chuang teaches detecting TRF1 in a tissue sample from patients with oral cavity squamous cell carcinoma. Chuang teaches the subjects were treated with radiotherapy, surgery and chemotherapy (see patients and tumor samples). Chuang teaches detecting autoantibody by detecting TRF1 present in the biological sample by immunoblot analysis and immunohistochemical analysis by incubating samples with anti-TRF1 polyclonal antibodies (see immunoblot analysis and immunohistochemical analysis). Chuang teaches providing a biological sample from a subject and detecting an autoantibody that targets antigen present in shelterin complex in a biological sample by detecting TRF1 by anti-TRF1 polyclonal antibodies. Chuang teaches the subjects have the disease of OSCSS (identifying a disease) and teach treating OCSCC with chemotherapy.
Claims 1-9, 12-13, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rozman (Ann Rheum Dis 2008, 67:1282-1286) as evidence by Hsu (Genes and Development, 14:2807-2812, pp 2807-2812, cited on IDS).
With regard to claim 1, Rozman teaches detection of anti-Ku is subjects with systemic sclerosis. Rozman teaches anti-Ku antibodies were found in sera of patients with SSC. Ku teaches the method detects anti-Ku that targets antigen Ku. Ku interacts with TRF1 complex and localizes to telomeric repeats by interaction with TRF1 as demonstrated by Hus (see pg. 2807). Therefore Ku is part of a telomerase and shelterin complex and detecting anti-Ku is an autoantibody that targets an antigen present in a telomerase/shelterin complex, telomerase complex and a shelterin complex.
With regard to claim 2, 5, 9 and 13, Rozman teaches detection of anti-Ku in subjects with Ssc by obtaining sera from subjects. Rozman teaches in two anti-Ku positive cases, glucocorticoids and immunosuppressive therapy were required (see pg. 1284) (anti-inflammatory medication) (claim 5). Rozman teaches detecting anti-Ku by CIE (immunoprecipitation assay) (monoclonal Ab) (claim 9, 13).
With regard to claim 3-4, Rozman teaches the disease is systemic sclerosis, a rheumatic disease (See table 2).
With regard to claim 6-8, Rozman teaches obtaining sera from human subject (see pg. 1283).
With regard to claim 19-20, Rozman teaches the subject is identified as having the disease when the autoantibody is detected (see table 2). Rozman teaches the subject is not identified as having the disease when the autoantibody is not detected (see control patients, table 1)
Claims 1-2, 6, 9-10, 12, 14-16, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aljarbou (PLoS ONE, 13(6): e01974154, pp. 1- 19).
Aljarbou teaches obtaining sample prior to medical treatment from tumor samples and blood samples of patients (see patients and samples). Aljaribou teaches treating the subject as Aljarbou teaches the analysis prior to treatment, thus teaching administering a treatment. Aljarbou teaches immunohistochemistry using anti-TERT, anti-TRF1, anti-TRF2 monoclonal antibodies (claim 9-10) to compare the difference between CRC tissues and paired mucous (see validation of gene expression using immunohistochemistry) (detecting autoantibody that targets antigen present in telomerase or shelterin complex). Aljarbou teaches measurement of telomere length was conducted by q PCR on CRC tissues.
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.
Claims 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rozman (Ann Rheum Dis 2008, 67:1282-1286) as evidence by Hsu (Genes and Development, 14:2807-2812, pp 2807-2812, cited on IDS) in view of Lakota (2019, cited on IDS).
Rozman teaches detection of anti-Ku in subjects with Ssc by obtaining sera from subjects. Rozman teaches in two anti-Ku positive cases, glucocorticoids and immunosuppressive therapy were required. Rozman teaches detecting anti-Ku by CIE in subjects with systemic scleroderma. Rozman does not teach analyzing a second sample from the subject to measure telomere length.
Lakota teaches patients with systemic sclerosis are affected with interstitial lung disease which shares features with idiopathic pulmonary fibrosis, which is associated with shortened telomere length. Lakota teaches analysis of telomere length in patients with Ssc and associated interstitial lung disease by flow-FISH (claim 16). Lakota teaches subjects telomere length was measured by flowFISH in PBMC leukocyte cells (claim 17-18).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to include analysis of telomere length by flow-FISH as taught by Lakota in the method of Rozman to allow for additional testing and diagnosis of SSc. The ordinary artisan would have been motivated to include testing of telomere length in the method of Rozman because Rozman teaches diagnosis methods of SSc and Lakota teaches analysis of telomere length to determine interstitial lung disease in patients with SSc and the ordinary artisan would have been motivated with an expectation of success to include analysis of telomere length to determine subjects with interstitial lung disease in patients with Ssc as taught by Lakota. In performing the analysis of telomere length by flow-fish as taught by Lakota, the ordinary artisan would have includes a second sample that is the same sample as the first biological sample to allow for consistent results without sample changes affecting the results.
Claims 2-10, 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Adler (2021) in view of Denton (Lancet, 2017, 390:1685-99).
Adler teaches obtaining sera samples from subjects and detecting autoantibodies that targets an antigen present in a shelterin complex in the sample and identifying systemic sclerosis (Ssc) (claim 3-4). Adler teaches performing immunoprecipitation assay for autoantibody detect (see methods) (claims 6-8). Adler teaches detecting ant-TERF1 (claim 10) by ELISA (claim 12-13) (see TERF1 ELISA). Adler teaches performing two assays to measure telomere length in peripheral leucocytes by qPCR and PBMC by flow-FISH (see telomere length measures) (claim 14-18). Adler teaches Flow-fish was done on all samples as a batch. Adler teaches detecting autoantibody to identify the disease (subjects with Ssc) and not detecting an autoantibody with not having disease (control sample) (see fig 2). Adler does not teach treating the patients with Ssc.
However it was well known in the art to treat subjects with Ssc with immune modulating therapies. Denton teaches treatment of major complications of systemic sclerosis (see figure 5). Denton teaches anti-inflammatory medication and immunosuppressive therapy (see fig 5).
It would have been obvious to one of ordinary skill at the time of the invention to include administering of anti-inflammatory or immunosuppressive therapy to manage complications of the Ssc as taught by Denton to the subjects identified as having Ssc in the method of Adler. The ordinary artisan would have had a reasonable expectation of success and been motivated to include administering a treatment to the subjects with Ssc as disclosed by Adler to allow for alleviating complications of the disease as taught by Denton.
Claims 2-10, 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Adler (2021) in view of Denton (Lancet, 2017, 390:1685-99).
Adler teaches obtaining sera samples from subjects and detecting autoantibodies that targets an antigen present in a shelterin complex in the sample and identifying systemic sclerosis (Ssc) (claim 3-4). Adler teaches performing immunoprecipitation assay for autoantibody detect (see methods) (claims 6-8). Adler teaches detecting ant-TERF1 (claim 10) by ELISA (claim 12-13) (see methods). Adler teaches performing two assays to measure telomere length in peripheral leucocytes by qPCR and PBMC by flow-FISH (see methods) (claim 14-18). Adler teaches Flow-fish was done on all samples as a batch. Adler teaches detecting autoantibody to identify the disease (subjects with Ssc) and not detecting an autoantibody with not having disease (control sample) (see fig 2). Adler does not teach treating the patients with Ssc.
However it was well known in the art to treat subjects with Ssc with immune modulating therapies. Denton teaches treatment of major complications of systemic sclerosis (see figure 5). Denton teaches anti-inflammatory medication and immunosuppressive therapy (see fig 5).
It would have been obvious to one of ordinary skill at the time of the invention to include administering of anti-inflammatory or immunosuppressive therapy to manage complications of the Ssc as taught by Denton to the subjects identified as having Ssc in the method of Adler. The ordinary artisan would have had a reasonable expectation of success and been motivated to include administering a treatment to the subjects with Ssc as disclosed by Adler to allow for alleviating complications of the disease as taught by Denton.
Conclusion
No claims are allowable.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
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