9Notice 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 of group I, claims 1-14 and 16-19, the combination of rs15524, rs324029, and rs2654754 and the combination of gene species CYP3A5 and DRD3 in the reply filed on 07/10/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
As addressed by applicant, claims 16-19 were erroneously omitted from group I in the restriction mailed 6/11/2026. Claims 16-19 belong in group I, however, claims 16-19 are withdrawn from the elected invention because claims 16-19 recite CYP3A5 or DRD3 and do not correspond to the combination of CYP3A5 and DRD3 as elected. Additionally, it is noted that claim 10 and 14 has been withdrawn, these claims recite non-elected combinations of SNPs.
Claims 11, 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/10/2026.
Claims 1-9, 12-13 are under examination with regard to the combination of CYP3A5 and DRD3, and rs15524, rs324029, and rs2654754.
Drawings
The drawings are acceptable.
Improper Markush
Claims 1-2, 5, 9 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping in question is any alternatively recited combination of structurally and functionally different SNPs recited in claims 1, 2, 5, 9-10, and 14. The Markush grouping is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
Each member of the set of polymorphisms set forth in claims 1, 2, 5, 9-10, and 14 are structurally unique relative to one another. There is no disclosed common substantial structural feature. The only structural similarity present is that all detected positions are part of nucleic acid molecules. The fact that the markers comprise nucleotides per se does not support a conclusion that they have a common single structural similarity because the structure of comprising a nucleotide alone is not essential to the common activity of being correlated with opioid use disorder. Accordingly, while the different SNPs are asserted to have the property of being indicative of opioid use disorder, they do not share a single structural similarity. Additionally, there is no expectation from the knowledge in the art that the members of the class will behave in the same way in the context of the opioid use disorder, in other words there is no expectation from the art that each of the claimed SNPs will be associated with opioid use disorder.
Regarding “single structural similarity”, the MPEP at 2117 IIA states that a recognized physical, chemical, or an art recognized class is a class where there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. It is specifically stated that “Thus a Markush grouping is ordinarily proper if all the members for the group belong to a recognized class (whether physical, chemical, or art recognized) and are disclosed in the specification to possess at least one property in common which is mainly responsible for their function in the claimed invention, and it is clear from their very nature or from the prior art that all members possess this property (emphasis added)”.
Therefore, in analysis of whether a claim contains an improper Markush grouping, the MPEP states: A Markush claim contains an “improper Markush grouping” if either (emphasis added): (1) the members of the Markush group do not share a ‘single structural similarity’ or (2) the members do not share a common use.”
In the instant case, the SNPs do not share any common structural element that is essential to the asserted utility of being associated with opioid use disorder. The different polymorphic position that could be detected is itself located in a separate region of the genome and has its own structure. The nature of polymorphic structures is that there are differences within a population. The flanking nucleotides surrounding each polymorphic location have a unique sequence relative to the others- they are not structurally the same when you consider the sequence required to identify one particular polymorphic position relative to another polymorphic position. The polymorphic markers recited in the instant claims, and the methods which detect them, do not share a single structural similarity since each consists of a different nucleotide alteration that occurs at a different location on human chromosome.
For example, the polymorphism of a A or G at position rs10896450 has a distinct chemical structure as compared to, for example, a polymorphism of a G or A at rs11228565 since the variant position can only be understood within the context of the surrounding nucleotides, which are structurally dissimilar (see for example SEQ ID NO: 197 and SEQ ID NO: 171 which disclose flanking sequence for these two polymorphisms). Accordingly, while the different markers are asserted to have the property of being indicative of prostate cancer, they do not share a single structural similarity.
For example, with regard to claim 1:
The SNP rs15524 is located on chromosome 7 at position 99648291 in the 3’UTR region of CYP3A5 with genotype CC, CT and TT.
The SNP rs2654754 is located on chromosome 3 as an intron variant in the gene DRD3 with a CC, CT, and TT genotypes.
Therefore, it is clear that when considering the different SNPs, even in different combinations, there does not appear to be any common structure related to the function of the SNPs individually, or any particular combination.
The only structural similarity present is that all detected positions are part of nucleic acid molecules. The fact that the markers comprise nucleotides per se does not support a conclusion that they have a common single structural similarity because the structure of comprising a nucleotide alone is not essential to the common activity of being correlated with opioid use disorder. Accordingly, while the different markers are asserted to have the property of being indicative of opioid use disorder, they do not share a single structural similarity.
Following this analysis, the claims are rejected as containing an improper Markush grouping.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 1-9, 12-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea and law of nature without significantly more.
Claim 1 recite a method of diagnosing a likelihood of opioid use disorder (OUD) in a patient with the step of diagnosing the patients likelihood of developing OUD based on the presence or absence of SNP, wherein presence of rs15524, rs324029 or rs2654754 is indicative of increased risk of developing OUD. This step is sets forth the natural correlation of the presence of rs15524, rs324029 or rs2654754 with risk of developing OUD. The recited relationship is a natural phenomenon that exists apart from any human action. This type of correlation is a consequence of a natural process and therefore a law of nature. The step further encompasses a mental process. Neither the specification or claims set forth limiting definitions and the broadest reasonably interpretation of the claim is a step that can be accomplished mentally by evaluating data and critical thinking process such that one mentally reads information on a report regarding the SNP and drawn a mental conclusion. Diagnosis may be performed mentally and this is an abstract idea.
Claim 1 recites “determining” the presence or absence of SNPs in the isolated DNA. Neither the specification nor the claims set forth limiting definition for determining. 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 in a database or report regarding presence or absence of rs15524, rs324029, and rs2654754 then draws a mental conclusion and encompasses abstract idea.
` This judicial exception is not integrated into a practical application because the claims do not recite additional steps or elements that integrate the recited 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.
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 do 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.
Claim 2 recites administering to the patient a non-opioid pain management treatment if the patient has any of rs15524, rs324029, rs2654754, however this a conditional step and only occurs if the patient has any of rs15524, rs324029, rs2654754. Furthermore the recitation of any of rs15524, rs324029, rs2654754 is not specific, this recitation encompasses any and all alleles present at position rs15524, rs324029, rs2654754. The steps of “administering to the patient a non-opioid pain management treatment if the patient has any of rs15524, rs324029, rs2654754” is 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 to any and all patients as the claim is not specific with allele present. Each patient will comprise the positions rs15524, rs324029, and rs2654754. Claim 4 recites the non-opioid pain management treatment is physical therapy, cognitive behavioral therapy or a combination thereof. This therapy is not particular and encompasses general therapy. Additionally this therapy does not encompass administration of a particular compound or therapeutic, and merely encompasses therapies such as moving, walking, or communicating.
Claim 5-8 recites administering to the patient an opioid agonist or opioid antagonist if the patient has any of rs15524, rs324029, rs2654754, however this a conditional step and only occurs if the patient has any of rs15524, rs324029, rs2654754. Furthermore the recitation of any of rs15524, rs324029, rs2654754 is not specific, this recitation encompasses any and all alleles present at position rs15524, rs324029, rs2654754. The steps 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 therapy regimens to any and all patients as the claim is not specific with allele present. Each patient will comprise the positions rs15524, rs324029, and rs2654754.
Claim 12 recites further comprising administering at treatment to the patient based on the patients diagnosed likelihood of developing OUD. However this step is 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 therapy regimens to any and all patients as the claim is not specific with allele present. Each patient will comprise the positions rs15524, rs324029, and rs2654754.
In addition to the judicial exceptions the claims recite specific SNP combination (claim 9) and further comprise asking patient diagnostic questions (claim 13). 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 significantly more so as to render the claims patent -eligible. The step of identifying obtaining a biological sample, isolating DNA from the sample, and genotyping the DNA for one or more SNPS of rs15524, rs324029, and rs2654754 merely instructs a scientist to use well-established routine and conventional nucleic acid techniques to gather samples for diagnostic analysis. As address in the instant specification methods of genotyping are well-known in the art (See para 37).
The step of genotyping a sample constitutes a data gathering step required to apply the law of nature/natural phenomenon. It is acknowledged that the claims name particular SNPs, rs15524, rs324029 and rs2654754 whose level is to be determined 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 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 Langerveld (WO20200247490A1) demonstrate genotyping rs15524, rs324029, and rs2654754. Thus the prior art and specification demonstrates it was routine, well-known and conventional in the art to determine SNPs of rs15524, rs324029, and rs2654754 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.
(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.
Claims 1, 9, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freiermuth (Clin Pharmacology and Therapeutics, May 2023, first published 2/6/2023, vol 113, no 5, pp 1089-1095).
Freiermuth teaches a method of obtaining cheek cell samples from subjects and genotyping the samples (see genotyping). Freiermuth teaches rs15524, rs324029 and rs2654754 were associated with increased odds of opioid use disorder (see pg. 1092, 1st column). Freiermuth teaches identification of genetic markers related to OUD can better inform risk and teaches in depth survey assessment with OUD (see study design) (asking patient diagnostic questions).
Claims 1-3, 4-5, 8-9, and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Langerveld (WO2020/247490A1).
Langerveld teaches a method of determining opioid use disorder risk by obtaining a biological sample from a subject, performing allelic analysis on the sample to determine the presence of alleles that comprise, determining risk score based upon predisposition to opioid addiction and administering a medical assisted treatment based on risk score (see table 7). Langerveld teaches allelic analysis includes rs15524, rs324069, and rs2740574 (see table 1). Therefore, Langerveld teaches determining the presence of rs15524, rs324069 and rs2740574. It is noted the claims do not require a specific allele to be determined only the position of the SNP to be determined, which is present in the samples analyzed by Langerveld. Langerveld teaches analysis of SNPs include evaluating risk of OUD and use of non-opioid therapies (see para 44) (claim 2-3). Langerveld teaches a medical assisted treatment procedure or patient therapy may be provided. Langerveld teaches patients determined to be high risk OUD receive increased monitoring and more frequent visits with healthcare professional (see para 53)(claim 4, cognitive behavioral therapy; claim 13 asking diagnostic questions). Langerveld teaches administering opioid based on risk of OUD (administering a treatment based on likihood of developing OUD) (see para 53) (Claim 12). Langerveld teaches reducing quantity of opioid administered (see para 142) (claim 8)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Langerveld (WO2020/247490A1) in view of Coffa (American Family Physician, 2019, 100(7): 416-425, printed pp 1-16).
Langerveld teaches a method of determining risk of opioid use disorder by genotyping rs15524, rs324029, and rs2654754. Langerveld does not teach administering a non-opioid pain management or opioid agonist or antagonists.
Coffa teaches medical treatment options for patients at risk of opioid use disorder. Coffa teaches administering methadone or naloxone to subjects with opioid use disorder (See table 2). Coffa teaches administering behavior therapy to subjects who decline medications (see pg. 8)
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to administer known medical treatment options as taught by Coffa in the method of Langerveld to treat patients identified as risk of opioid use disorder. The ordinary artisan would have had a reasonable expectation of success to administer naloxone, methadone or behavioral therapy to patients identified as risk of opioid use disorder to reduce the use of opioids, as taught by Coffa.
Conclusion
No claims are allowable.
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.
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, Fereydoun Sajjadi can be reached at 571-272-3311. 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.
/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
Prosecution Insights