DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed June 18, 2026. Currently, claims 1, 3, 5, 7, 9-10, 12-13, 15, 17, 21, 25-26, 28-29, 31, 33-35, 42, 45, 46, 49-58 are pending. Claims 1, 3, 5, 7, 9-10, 12-13, 15, 17, 21, 45, 50-58 have been withdrawn as drawn to non-elected subject matter.
Election/Restrictions
Applicant's election without traverse of Group II and CYP2B6, Claims 25-26, 28-29, 31, 33-35, 42, 46, 49 in the paper filed June 18, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims priority to
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Drawings
MPEP 608.02, part VIII states:
Color drawings and color photographs are not accepted in utility applications filed under 35 U.S.C. 111 unless a petition filed under 37 CFR 1.84(a)(2) or (b)(2) is granted. Color drawings and color photographs are not permitted in international applications (see PCT Rule 11.13 ).
Unless a petition is filed and granted, color drawings or color photographs will not be accepted in a utility patent application filed under 35 U.S.C. 111. The examiner must object to the color drawings or color photographs as being improper and require applicant either to cancel the drawings or to provide substitute black and white drawings.
The drawings filed are presented in color. No petition for color drawings has been filed; therefore, the color drawings or color photographs are being objected to as being improper. The specification is also objected to for not reciting the requisite color petition language as the first paragraph of the brief description of the drawings.
Improper Markush Rejection
Claim 42 is 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.
A Markush claim contains an “improper Markush grouping” if:
(1) the species of the Markush group do not share a “single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a “single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent. See MPEP § 2117.
Here each species is considered to each of the genes.
The recited alternative species in the groups set forth here do not share a single structural similarity, as each different gene that could be detected is itself located in a separate region of the genome and has its own structure. The genes recited in the instant claims, do not share a single structural similarity since each consists of a different nucleotide sequences with different expression patterns. 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 colorectal cancer. Accordingly, while the different markers are asserted to have the property of being associated with different responses to therapy, they do not share a single structural similarity.
MPEP 2117 (II)(A) provides the following guidance as to what constitutes a physical, chemical, or art recognized class:
A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein “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. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved”
The recited genes do not belong to a recognized chemical class because there is no expectation from the knowledge in the art that the genes will behave in the same manner and can be substituted for one another with the same intended result achieved. In other words, there is no expectation from the knowledge in the art that each of the recited genes would function in the same way in the claimed method; it is only in the context of this specification that it was disclosed that all members of this group may behave in the same way in the context of the claimed invention. Further there is no evidence of record to establish that it is clear from their very nature that each of the recited genes possess the common property of being associated with different responses to therapy.
MPEP 2117 (II) further states the following:
Where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the compounds do not appear to be members of a recognized physical or chemical class or members of an art-recognized class, the members are considered to share a "single structural similarity" and common use when the alternatively usable compounds share a substantial structural feature that is essential to a common use. Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
The recited alternative species do not share a substantial common structure just because they all have a sugar phosphate backbone. The sugar phosphate backbone of a nucleic acid chain is not considered to be a substantial common structural feature to the group of genes being claimed because it is shared by ALL nucleic acids. Further, the fact that the genes all have a sugar phosphate backbone does not support a conclusion that they have a common single structural similarity because the structure of comprising a sugar phosphate backbone alone is not essential to the asserted common use of being associated with different responses to therapy.
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.
Following this analysis, the claims are rejected as containing an improper Markush grouping.
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 25-26, 28-29, 31, 33-35, 42, 46 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II.
Based upon consideration of the claims as a whole, as well as consideration of elements/steps recited in addition to the judicial exception, the present claims fail to meet the elements required for patent eligibility.
Question 1
The claimed invention is directed to a process that involves a natural principle and a judicial exception.
Question 2A Prong I
The claims are taken to be directed to an abstract idea, a law of nature and a natural phenomenon.
Claim 25 is directed to “a method for providing personalized analgesic therapy to a surgical patient to improve post surgical outcomes”.
Claim 25 is directed to a process that involves the judicial exceptions of an abstract idea (i.e. the abstract steps of “directing preoperative genotyping, producing a prediction and making a determination”) and a law of nature/natural phenomenon (i.e. the natural correlation between the alleles and predicting a patient’s response to perioperative methadone).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons that follow.
Herein, claim 25 involves the patent-ineligible concept of an abstract process. Claim 25 requires performing the step of “directing perioperative genotyping”. It is unclear what directing genotyping encompasses. If the limitation merely requires someone to verbally tell someone to do genotyping or send written instructions, this is merely instructions and abstract ideas. The claim further requires producing a prediction and making a determination. Neither the specification nor the claims set forth a limiting definition for "producing a prediction” or making a determination and the claims do not set forth how "producing a prediction” or making a determination is accomplished. As broadly recited the determining step may be accomplished mentally by thinking about a subject’s genotype and assessing whether the subject has endometrial carcinoma. Thus, the "producing a prediction” or making a determination steps constitute an abstract process idea.
A correlation that preexists in the human is an unpatentable phenomenon. The association between genotypes of a loci, including CYP2B6 and response to perioperative methadone administration is a law of nature/natural phenomenon. The "making a determination" step which tells users of the process to predict methadone response in the sample, amounts to no more than an "instruction to apply the natural law". This prediction and determination step is no more than a mental step. Even if the step requires something more such as to verbalize the discovery of the natural law, this mere verbalization is not an application of the law of nature to a new and useful end. The making a determination step does not require the process user to do anything in light of the correlation. The "making a determination” step fails to provide the “practical assurance” sought by the Prometheus Court that the “process is more than a drafting effort designed to monopolize the law of nature itself.”
Question 2A Prong II
The exception is not integrated into a practical application of the exception. The claims do not recite any additional elements that integrate the exception into a practical application of the exception. Even if the claim required genotyping and no merely directing genotyping, this is not an integration of the exception into a practical application. Instead, these elements are data gathering required to perform the method. Thus, the claim is “directed to” the exception.
The making of a determination or directing administration of methadone is not an active administration or treatment step. The mere telling someone they should do something or take a medication is not the same as actual treatment or administration.
Accordingly, the claims are directed to judicial exceptions.
Question 2B
The second step of Alice involves determining whether the remaining elements, either in isolation or combination with the other non patent ineligible elements, are sufficient to “’transform the nature of the claim’ into a patent eligible application” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
The claims are not sufficiently defined to provide a method which is significantly more from a statement of a natural principle for at least these reasons:
The claims do not include applying the judicial exception, or by use of, a particular machine. The claims do not tie the steps to a “particular machine" and therefore do not meet the machine or transformation test on these grounds. The use of machines generally does not impose a meaningful limit on claim scope.
The claims also do not add a specific limitation other than what is well-understood, routine and conventional in the field. The genotyping of a known loci is a mere data gathering step that amounts to extra solution activity to the judicial exception. It merely tells the users of the method to determine the genotype of a sample without further specification as to how the sample should be analyzed. The claim does not recite a new, innovative method for such determination. The determining step essentially tells users to determine the markers through whatever known processes they wish to use. The steps are recited at a high level of generality. The claim merely instructs a scientist to use any mutation analysis to determine the mutation/allele status. The claim does not require the use of any particular non-conventional reagents. When recited at this high level of generality, there is no meaningful limitation that distinguishes this step from well understood, routine and conventional activities engaged in by scientists prior to applicant’s invention and at the time the application was filed.
Additionally, the teachings in the specification demonstrate the well understood, routine, conventional nature of additional elements because it teaches that the additional elements were well known.
Further it is noted that the courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014)
For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112-Description
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 25-26, 28-29, 31, 33-35, 42, 46 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are broadly drawn to methods which comprise genotyping a patient to determining what allele is present at a gene loci, including elected CYP2B6. which possess the functionality of being associated with response to perioperative methadone administration.
Relevant to the lack of particular structural limitations in the rejected claims drawn to nucleic acids, MPEP 2163 states:
The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.
Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ 2d 1161 (Fed. Cir. 2010) recently re-affirmed the written description requirement. Ariad reiterates that “the hallmark of written description is disclosure" and “possession as shown in the disclosure” is a more complete formulation of the test for written description. Ariad considers situations of genus claims and states that the written description requirement ensure that "when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function."
Vas-Cath Inc. V. Mahurkar, 19 USPQ2b 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed”. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision. In The Regents of the University of California v. Eli Lilly (43 USPQ2b 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of DNA molecules, usually defined by a nucleotide sequence, falling within the scope of the claimed genus. At section B(1), the court states that “An adequate written description of a DNA…’ required a precise definition, such as by structure, formula, chemical name, or physical properties’, not a mere wish or plan for obtaining the claimed chemical invention”.
In the case of the instant claims, the functionality of predicting a patient’s response to perioperative methadone administration is a critical feature of the claimed methods.
The specification teaches identifying several variants and polymorphisms in the however does not provide a representative number of loci/alleles. With respect to the elected CYP2B6 loci, the specification teaches only particular loci are associated with predicting perioperative methadone administration. The specification does not provide providing personalize analgesic therapy. However, it is not clear that all of these loci in CYP2B6 are associated with response to perioperative methadone administration, as some were found in both rapid and intermediate metabolizers (see Figure 19) other alleles are found in both normal and poor metabolizers (see Figure 19). There is not description of which alleles are within the scope of the claims. Further, the specification does not provide any differences in doses that response to different loci. Given the guidance in the specification and what was taught in the art prior to the invention, the skilled artisan would be unable to predictably correlate structural changes in CYP2B6 let lone any enzyme, receptor or other protein associated with methadone metabolism or response with response to methadone, simply based on their existence.
In analyzing whether the written description requirement is met for a genus claim, it is first determined whether a representative number of species have been described by their complete structure. With respect to claims which encompass variants, no common structural attributes identify the members of the genus. The current claims encompass a large genus of nucleic acids which comprise variants in any region of any any enzyme, receptor or other protein associated with methadone metabolism or response with response to methadone nucleic acid. The genus includes an enormous number of variants, polymorphisms and mutations for which no written description is provided in the specification. This large genus is represented in the specification by only a few polymorphisms for which data is provided. No structural limitations or requirements which provide guidance on the identification of sequences which meet the functional limitations of diagnosing LE is provided. The specification provides no correlation between the structure of the recited polymorphisms and the claimed function of such polymorphisms. Therefore, the polymorphisms are not representative of the genus of any polymorphism associated with response to methadone because it is not clear which polymorphisms would have the same affect. Therefore, the specification fails to teach how to distinguish members of the claimed genus of polymorphisms and variants which possess the claimed functionality from non members.
With respect to Claim 46, the specification does not describe which loci will predict if the patient administered methadone will experience an acceptable analgesic effect, nausea, vomiting, excessive sedation.
The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general guidance is what is needed. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, variants of Caymans ataxia gene alone is insufficient to describe the genus. There is no description of the mutational sites that exist in nature and there is no description of how the structure of Caymans ataxia gene relates to the structure of any strictly neutral alleles. The general knowledge in the art concerning variants does not provide any indication of how the structure of one allele is representative of unknown alleles. The nature of alleles is such that they are variant structures, and in the present state of the art the structure of one does not provide guidance to the structure of others. The common attributes are not described. The specification provides no correlation between structure of polymorphisms and the function of such polymorphisms. The polymorphisms shown are not representative of the genus of any polymorphism associated with Caymans ataxia because it is not clear which polymorphisms within the gene (coding or non-coding) region of Cayman ataxia nucleic acid would have the same effect. One of skill in the art would conclude that applicant was not in possession of the claimed genus because a description of only one member of this genus is not representative of the variants of the genus and is insufficient to support the claim.
Thus, considering the breadth of the polynucleotides required by the claimed methods, their specific required functionalities, and the teachings of the instant specification, it is the conclusion that the specification does not provide an adequate written description of the broadly claimed subject matter.
Claim Rejections - 35 USC § 112- Second Paragraph
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.
Claims 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 pre-AIA the applicant regards as the invention.
A) Claim 25 is indefinite because it is unclear what “directing preoperative genotyping of a patient encompasses. It is unclear whether the claim merely tells someone to do the genotyping or requires performing genotyping. Clarification is required to understand the metes and bounds of the claimed limitations.
B) Claim 46 uses relative terms that do not have clear metes and bounds. The claim requires loci will predict if the patient administered methadone will experience an acceptable analgesic effect, nausea, vomiting, excessive sedation. It is unclear what acceptable and excessive encompass. These are relative terms that have not been defined in the specification or the art.
C) Claim 49 is indefinite as being both incomplete, by its dependence on a cancelled claim; and for lack of antecedent basis for its limitation (“The composition …”) which is not present in cancelled base claim 43. Amending claim 49 to refer to a claim which recites the reactant in the composition, or deleting the claim, would obviate the rejection.
Claim Rejections - 35 USC § 103
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 25-26, 28-29, 31, 33-35, 42, 46 are rejected under 35 U.S.C. 103 as being unpatentable over Kharasch et al. (Anesthesiology, Vol. 123, No. 5, pages 1142-1153, November 2015).
Kharasch et al. teaches genotyping CYP2B6 polymorphisms to determine plasma concentrations, clearance and metabolism of methadone (abstract). Kharasch teaches CYP2B6 polymorphisms influence methadone plasma concentrations, due to altered methadone metabolism and thus clearance. Kharasch teaches CYP2B6 polymorphisms have greater consequence for oral then intravenous. Kharasch teaches methadone is a long-duration opioid for acute, chronic, perioperative neuropathic and cancer pain (page 2, para 1). Kharasch teaches intravenous and oral methadone plasma concentrations in carriers differed in different variants (see Figure 3).
Kharasch does not teach genotyping a patient in need of surgery. However, Kharasch teaches methadone is a long-duration opioid for acute, chronic, perioperative neuropathic and cancer pain (page 2, para 1).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention to have analyzed patients prior to surgery for their genotype to provide information about methadone administration. Kharasch teaches different variants had different influences for oral and intravenous administrations. Kharasch predicts the patient’s response to methadone administration for the different variants. It would have been prima facie obvious to have genotypes patients in need of surgery to determine what allele is present at their CYP2B6 loci to determine and predict the response to perioperative methadone administration. The ordinary artisan would have been motivated to determine the response to methadone to determine what concentrations and frequency of methadone should be administered to achieve optimal results and minimize side effects.
With respect to Claims 29, 31, 33-35 the claim does not require an actual administration of methadone and is merely instructions for the administration. However, if the claim were amended to require actual administration, it would have bene obvious to have administered doses compatible with the genotypes.
Claims 25-26, 28-29, 31, 33-35, 42, 46 are rejected under 35 U.S.C. 103 as being unpatentable over Packiasabapathy et al. (Pharmacogenomics, pages 2020-0040, July 24, 2020).
Packiasabapathy teaches methadone is a synthetic opioid with longer duration of action and lower abuse potential than morphine and manages chronic and acute surgical pain (abstract). Packiasabapathy teaches genetic variants should be considered in conjunction to improve predictive ability. Table 1 provides an extensive list of loci and genetic polymorphisms with significant in vivo effect on methadone pharmacokinetics, including CYP2B6. Further, the executive summary provides combinations of genetic variants strongly influence response to methadone and dose requirements. Packiasabapathy further provides numerous variants that predict therapy and response to methadone.
Packiasabapathy does not teach genotyping a patient in need of surgery. However, Packiasabapathy teaches methadone is a synthetic opioid with longer duration of action and lower abuse potential than morphine and manages chronic and acute surgical pain (abstract).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention to have analyzed patients prior to surgery for their genotype to provide information about methadone administration. Packiasabapathy teaches different variants had different influences for oral and intravenous administrations. Packiasabapathy predicts the patient’s response to methadone administration for the different variants. It would have been prima facie obvious to have genotypes patients in need of surgery to determine what allele is present at their CYP2B6 loci to determine and predict the response to perioperative methadone administration. The ordinary artisan would have been motivated to determine the response to methadone to determine what concentrations and frequency of methadone should be administered to achieve optimal results and minimize side effects.
With respect to Claims 29, 31, 33-35 the claim does not require an actual administration of methadone and is merely instructions for the administration. However, if the claim were amended to require actual administration, it would have bene obvious to have administered doses compatible with the genotypes.
Conclusion
No claims allowable over the art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Packiasabapathy et al. (Pharmacogenomics, Vol. 22, No. 10, pages 591-602, Jun 8, 2021) is applicant’s own work about associations between Cyp2B6 polymorphisms, perioperative methadone metabolism and clinical outcomes in children.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached on (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
July 28, 2026
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