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
Currently, claims 1-11 are pending in the instant application. Claims 1-3 have been amended and claims 2-11 are withdrawn. This action is written in response to applicant' s correspondence submitted 10/29/2025. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant' s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is Final.
Election/Restrictions
Newly amended claims 2-3 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claims 2 and 3 recite additional SNPs that were non-elected in the species requirement mailed 04/11/2025. Each of the SNPs are structurally and functionally distinct and each combination of SNPs are structurally and functionally distinct. Applicant in response to the restriction mailed 04/11/2025 elected the specific combination of rs73520681 and rs61094339. Claims 2 and 3 recite non-elected combinations of SNPs and recite more than the elected combination.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 2-3 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1 is under examination with respect to rs73520681 and rs61094339.
Withdrawn Rejections
The improper Markush rejection for claims 2-3 is withdrawn in view of the amendment to the claims.
The rejection of claims 1-3 under 35 USC 102(a)(1) as anticipated by Shiota is withdrawn in view of the affidavit filed 10/29/2025 that Shiota is less than a year and not prior art as the prior art was conceived by the joint inventors and are an exception under USC 102(b)(1).
New Grounds of Rejection
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.
Claim 1 is 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 detecting an absence of two or more SNPs in the subject, wherein the two or more SNPs comprise rs73520681 and rs61094339 wherein the presence of rs73520681 and rs61094339 indicates the subject has resistance or possibly has resistance to BCG intravesical infusion therapy and treating the subject wherein the two or more SNPs are not detected with BCG intravesical infusion therapy. The recitation of absence of rs73520681 and rs61094339 is unclear. rs73520681 and rs61094339 represent a position within genomic DNA, refSNP identify the position and do not specify specific alleles. rs73520681 and rs61094339 comprise different alleles at the specific identified locations. It is unclear if the claim is requiring detecting no nucleotide at position rs73520681 and rs61094339 or the absence of an unstated allele. If the claim is intended to recite an absence of a specific allele, it is unclear which allele is absent. It is unclear when treating occurs because treating occurs in subject wherein the rs73520681 and rs61094339 are not detect but this could encompass detecting the absence of any A, T, C, or G and treating the subject. This interpretation would encompasses any subject being treated because absence of rs73520681 and rs61094339 can be interpreted as any one allele is not present and not a specific allele or the absence of the nucleotide not present. Additionally it is unclear if detecting the presence of any allele at rs73520681 and rs61094339 is required because the wherein clause requires the presence of rs73520681 and rs61094339 but there are no active process steps related to the presence of rs73520681 and rs61094339. Additionally the claim does not specific which allele is present. It is unclear what is being detected to determine treatment. The metes and bounds of the claim are indefinite and one of ordinary skill in the art would not be apprised of infringing on the claimed invention.
Claim 1 recites the limitation "the presence of rs73520681 and rs61094339" in line 7. The claim does not require detecting a presence of rs73520681 and rs61094339 or recite any specific alleles at position rs73520681 and rs61094339 and it is unclear if this limitation is required to be detected to determine resistance or treatment and if this limitation is part of the process or a characterization of the process. It is unclear how the presence is related to the step of treating. There is insufficient antecedent basis for this limitation in the claim.
Maintained Rejections
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 is rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims recite a law of nature and include an abstract idea comprising mental processes. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. This rejection was previously presented and has been rewritten to address the amendment to the claims.
The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? Yes, all of the claims are directed to a process.
Step 2A. Is the claim directed to a law of nature, a natural phenomenon or an abstract idea (judicially recognized exception) and does the claim recite additional elements that integrate the judicial exception into a practical application?
Yes, the claims are directed to law of nature/natural phenomenon. Claim 1 recites predicting a therapeutic effect of BCG intravesical infusion therapy in treating bladder cancer comprising a step of detecting absence of rs73520681 and rs61094339 wherein the presence of rs73520681 and rs61094339 indicates resistance of resistant to BCG therapy in treating bladder cancer. This type of correlation is a consequence of natural processes.
The claims also recite the judicial exception of an abstract idea and particularly mental processes. Claim 1 recites the abstract idea of a mental process. Claim 1 recites the step of “detecting” an absence of rs73520681 and rs61094339. Neither the specification or the claims set forth limiting definition for detecting the presence or absence and the claims do not set forth how detecting is accomplished. The broadest reasonable interpretation of the detecting step that can be accomplished mentally by evaluating data and critical thinking process wherein one mentally reads information in a database or report regarding expression levels then draws a mental conclusion. Such detecting thereby encompasses process that may be performed mentally and this is an abstract idea.
Additionally the recitation of predicting resistance to BCG therapy and/or predicting possibility of relapse after BCG is a mental process that is accomplished mentally by evaluating data and critical thinking to determine the mental conclusion for resistance to BCG therapy and predicting possibility of relapse after BCG.
Having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application.
The claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). 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.
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:
(i) the particularity or generality of the treatment or prophylaxis limitation;
(ii) whether the limitations have more than a nominal or insignificant relationship to the exception; and
(iii) whether the limitations are merely extra solution activity or field of use.
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. While the claim recites the step of treating the subject wherein the two or more SNPs are not detect with BCG intravesical infusion therapy (absence of SNPs) the claim encompasses detecting the presence rs73520681 and rs61094339 and therefore the step of treating the subject with SNPs not detected has been considered to be a conditional step (see rejection under 35 USC 112(b)). The treating step encompasses treating any subject with the absence of any A, C, G, or T allele at position rs73520681 and rs61094339, which does not limit the treating step and integrate the judicial exception.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? No.
Herein 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 detecting the absence of rs73520681 and rs61094339 and predicting resistance to BCG therapy in treating bladder cancer merely instructs a scientist to use well established, routine and conventional nucleic acid techniques to gather samples for diagnostic analysis.
The step of detecting the presence or absence of a SNP constitutes a data gathering step required to apply the law of nature/natural phenomenon. The step further encompasses an abstract idea as it encompasses reading data from previously recorded information. It is acknowledged that the claims name particular SNPs, rs73520681 and rs61094339, that are detected, however the claims do not require a particular, non-conventional primer or probe consisting of or comprising a specific nucleotide sequence or any other specific reagent that is used to accomplish such detecting 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 detecting SNPs and these techniques were conventional at the time of the invention. Thus the prior art and specification demonstrates it was routine, well-known and conventional in the art to detect rs73520681 and rs61094339. Dependent claims 2-3 further limit the recited judicial exception. 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.
Response to Arguments
The rejection traverses the rejection on page 7 of the remarks mailed 10/29/2025. The response asserts the claims have been amended to be directed to a method of treatment that includes a specific treatment step. This response has been reviewed but not found persuasive. While the claims recite a step of treating bladder cancer in a subject by predicting a therapeutic effect of BCG therapy by detecting an absence of rs73520681 and rs61094339 and treating the subject wherein the two or more SNPs are not detected with BCG therapy, this is not a limiting step that integrates the judicial exception. Detecting the absence of rs73520681 and rs61094339 encompasses detecting the absence of any allele at position rs73520681 and rs61094339 and treating the subject and therefore does not integrate the judicial exception. For these reasons and reasons of record this rejection is maintained.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grotenhuis (Bladder Cancer, 2016, 2:77-89). This rejection was previously presented and has been rewritten to address the amendment to the claims.
Grotenhuis teaches detecting the presence or absence of SNPs for association of prognostic and therapeutic response to BCG in bladder cancer (see materials and methods and fig 1). Grotenhuis teaches SNPs were assessed for treatment with BCG and recurrence (See pg.79) (claim 2 and 3). Grotenhuis teaches genotyping was done using genome wide associate study including Illumina beadchip and 1000 genome (see genotyping and imputation). In the process of evaluating genotyping this will include detecting the presence or absence of rs73520681 and rs61094339. It is noted the claim encompasses absence and does not require a specific allele, as such any method that analyzes a whole genome approach will include analysis of absence of any unspecified allele at the positions of rs73520681 and rs61094339. Grotenhuis further teaches patients were treated with BCG (See fig 1 and pg. 79). Because the claims do not require detecting a specific allele and administering BCG to the subject with the specific allele and only require treating a patient with an absence of rs73520681 and rs61094339, which encompasses any allele at position rs73520681 and rs61094339, Grotenhus anticipates the claimed invention.
Response to Arguments
The response traverses the rejection on page 8 and asserts the claims have been amended to include a specific treatment step. The response asserts Grotenhuis does not disclose determining the absence or present of the specific SNPs of amended claim 1 nor treating a subject based on the presence or absence of the recited SNPs. This response has been reviewed but not found persuasive. Grotenhuis does teach treating a subject with BCG therapy (see fig 1). Grotenhuis further teaches detecting SNPs, including absence of rs73520681 and rs61094339 as the claims do not require any specific allele at rs73520681 and rs61094339. Additionally it is noted the claim only requires detecting the absence of rs73520681 and rs61094339, which as addressed in the rejection under 35 USC 112(b) is indefinite as it is unclear if the claim requires no nucleotide at the positions of rs73520681 and rs61094339 or if it requires detecting the absence of a specific allele at position rs73520681 and rs61094339, which is not stated. Additionally the step of treating recites treating the subject wherein the two or more SNPs are not detected with BCG intravesical infusion therapy. This step does not require detecting a specific allele at position rs73520681 and rs61094339 and then treating the subject that was detected to have a specific allele with BCG therapy. The step of treating encompasses determining the two or more SNPs at any time, which is anticipated by Grotenhuis. For these reasons and reasons of record this rejection is maintained.
Conclusion
No claims are 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 SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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/SARAE L BAUSCH/ Primary Examiner, Art Unit 1699