FINAL ACTION
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 responsive to the Amendment and Reply filed 26 November 2025. Claims 1, 3, 6, 8, and 15 have been amended and claims 4-5 have been canceled. It is noted that all prior rejections of claims 4-5 are moot in view of the cancelation of those claims. Claims 1-3 and 6-15 are now under consideration. Applicant’s amendments and arguments have been thoroughly reviewed, and have overcome the following objections/rejections set forth in the prior Office action:
Several rejections under 35 USC 112(b)/second paragraph, in view of Applicant’s amendments and/or arguments (see in particular the Claim Interpretation below); and
The rejection of claims 1-2 and 6-15 under 35 USC 102(a)(1) in view of Applicant’s amendment of each of the independent claims to recite “the subject is a feline”.
Claims 1-3 and 6-15 remain rejected for the reasons given below, which include new grounds of rejection necessitated by Applicant’s amendments. Any rejections and/or objections not reiterated in this action have been withdrawn. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Comment Regarding Sequence Listing
Upon further consideration, the prior objection to the incorporation by reference of the sequence listing (in the specification amendment of 07/11/2023; see pages 2-4 of the Office action mailed 08/26/2025) is withdrawn (see also the Interview Summary mailed 11/20/2025; it is noted that the USPTO is in possession of the corresponding Sequence Listing having the updated file name referenced in the amendment). The examiner apologizes for any inconvenience cause to Applicant and Applicant’s representative as a result of this issue.
Claim Interpretation
Regarding the recitation in independent claim 1 of the language “providing instructions to administer arginine based on the genotype of the argininosuccinate synthase gene of the subject”, upon further consideration including consideration of Applicant’s arguments on pages 6-7 (regarding the prior rejection of this language as indefinite), it is noted that the language “administer arginine based on the genotype” is interpreted as broadly encompassing either administering or not administering arginine (although it is reiterated that the claim does not require any type of “administering”). Further, dependent claim 3 recites a requirement to provide instructions to administer arginine “when the genotype….is the minor allele or heterozygous allele” (which further supports Applicant’s argument that the claims do not actually require instructions to administer arginine in all cases, as well as interpretation of claim 1 as not necessarily requiring “instructions to administer arginine” in all cases). Thus, this language is clearly conditional/contingent in nature (such that the broadest reasonable interpretation of the claim does not require what is recited [see MPEP 2111.04(II)]); further, the claims are not limited to any specific genotypes/alleles (but rather embrace “genotyping…to determine” any major/minor/heterozygous allele of the argininosuccinate synthase gene).
Regarding each of independent claim 1 (from which claims 2-3 and 6-7 depend) and independent claim 8 (from which claims 9-15 depend), upon further consideration including consideration of Applicant’s arguments at page 7, the preamble recitation of “for identifying pets prone to disorders associated with insufficient nitrogen oxide and/or liver disorder” has been interpreted as an intended use that is not further limiting of the methods being claimed and which need not be given patentable weight when comparing the claimed invention to the prior art (as there are no actual references to any elements of the preamble in the body of the claim, as Applicant has argued that the “genotyping” of the claim achieves such an “identifying” in some but not all instances [dependent upon the outcome of the “genotyping”] [see MPEP 2111.02]).
Regarding dependent claim 3, it is noted that the limitation “the step of providing instructions…” is interpreted as referring back to the activity of “providing instructions” set forth in claim 1 (i.e., the use of the term “step of” does not render the claims indefinite, as it is clear what activity of claim 1 is being referenced).
Regarding dependent claim 15, it is noted that the limitation “the step of providing a composition comprising arginine…” is interpreted as referring back to the activity of “providing a composition comprising arginine” set forth in claim 8 (i.e., the use of the term “step of” does not render the claims indefinite, as it is clear what activity of claim 8 is being referenced).
Claim Rejections - 35 USC § 112(b)/second paragraph
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claims 3 and 15 remain 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 3 is indefinite over the recitation of the limitation “wherein the step of providing instructions to administer arginine comprising providing a pet food composition comprising….when the genotype….is the minor allele or heterozygous allele”. While Applicant’s arguments regarding the prior language of claim (Reply pages 7-8) are noted, and while it is acknowledged that the claim has been amended in an attempt to clarify the claim language, it remains unclear whether the claim requires an actual physical/manipulative step of “providing a pet food composition” or whether the claim is further limiting of the provided instructions (i.e., such that the nature of the instructions set forth in claim 3 are more specific/particular than those of claim 1). As there are different reasonable interpretations of the claim language that impart different boundaries on what is claimed, further clarification is required.
Claim 15 is indefinite over the recitation of the limitation “wherein the step of providing a composition comprising arginine to the subject when the genotype is determined to be minor allele or heterozygous allele comprises providing a composition comprising arginine based on the genotype of the argininosuccinate synthase gene of the subject”, because it is unclear how this claim language further limits what is required by claim 8, from which the claim depends. More particularly, claim 8 as written recites “providing a composition comprising arginine to the subject when the genotype” (which is determined via a previously recited “genotyping”) “is determined to be a minor allele or heterozygous allele; thus, claim 8 already requires an action/activity meeting the requirement “providing a composition comprising arginine based on the genotype of the argininosuccinate synthase gene of the subject”. Accordingly, clarification is required, particularly with regard to what the further requirement of claim 15 actually is.
Claim Rejections - 35 USC § 112(d)/fourth paragraph
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.
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claim 15 is 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. As indicated above, claim 15 is unclear with regard to how it further limits, and it is not apparent from the present claim language that claim 15 necessarily further limits claim 8. 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 Rejections - 35 USC § 103
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claim(s) 1-3 and 6-15 are rejected under 35 U.S.C. 103 as being unpatentable over Marmol-Sanchez et al (Animal Genetics 51(1):106-110 [2019]; cited in IDS) in view of Wu et al (Amino Acids 37:153-168 [2009]; cited in IDS).
Regarding independent claim 1 (from which claims 2-3 and 6-7 depend), Marmol-Sanchez et al teach determining argininosuccinate synthase 1 genotypes in pigs, particularly with regard to a nonsense mutation T944A, encoding L315X (rs81212146) (see entire reference, particularly the Abstract). More particularly, Marmol-Sanchez et al teach obtaining and genotyping biological samples (via activities including PCR and sequencing of the argininosuccinate gene)(see page 107), and report determining individuals that are AA homozygous, heterozygous (TA), and TT homozygous, such that Marmol-Sanchez et al report determining genotypes of all of a “minor allele, major allele, or heterozygous allele” (employing the terminology of claim 1); see the entire reference, particularly the Abstract and the methods described at pages 107-108). With regard to the limitation “providing instructions to administer arginine based on the genotype of the argininosuccinate synthase gene of the subject”, this claim language has been interpreted as a conditional/contingent limitation that applies only to some determined genotypes (see also the Claim Interpretation above); thus, Marmol-Sanchez et al teach all that is required by independent claim 1, other than obtaining a biological sample “wherein the subject is a feline”, and genotyping that type of biological sample as recited in the claim. Regarding the preamble recitation of “identifying pets prone to disorders associated with insufficient nitrogen oxide and/or liver disease”, it is reiterated that this claim language has not been given patentable weight (see again the Claim Interpretation above) (although it is also noted that Marmol-Sanchez et al do teach that some argininosuccinate synthase 1 genotypes are associated with conditions such as citrullinemia, thus also teaching performance of methods as claimed for purposes of “identifying pets prone to disorders associated with insufficient nitrogen oxide” [see page 106]).
With further regard to the issue of reasons/motivation for performing such genotyping on other animals (as is now required by all of the amended claims), Marmol-Sanchez et al also teach that it is known that inactivation of the ASS1 enzyme may lead to disruption of the urea cycle and citrullemia (see page 106, right column), and state that “deleterious variation segregating in domestic animals….offers an unparalleled opportunity to explore the effects of loss-of-function mutations on phenotypes….as well as to elucidate the genetic mechanisms that, on some occasions, counteract their harmful consequences” (page 109). However, Marmol-Sanchez et al do not report performing their methods on other types of domestic animals, including cats/felines.
Wu et al review the “the versatile roles of Arg in multiorgan functions, as well as the prevention and treatment of major problems related to developmental biology and nutrient metabolism”, teaching that Arg (i.e., arginine) is an essential amino acid and that arginine supplementation (including in humans and animals) – including “dietary supplementation” – may provide a variety of benefits (see entire reference, particularly page 153, including the Abstract, and page 164, right column). It is particularly noted that Wu et al teach that Arg is “classified as a nutritionally essential” amino acid for cats, and that “Appropriate use of Arg is safe for animals and human in dietary supplementation and clinical therapy” (page 164, right column). Wu et al teach that argininosuccinate synthase participates in endogenous synthesis of Arg in animals that require it (page 154, right column), such that one of ordinary skill in the art would have recognized the benefit of performing genotyping of argininosuccinate synthase, as taught by Marmol-Sanchez et al, on other animals in whom the proper functioning of this enzyme is needed for successful synthesis of endogenous Arg (which includes cats, as taught by Wu et al). Thus, in view of the teachings of Wu et al, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have practiced the genotyping taught by Marmol-Sanchez et al on biological samples from a feline subject (thereby meeting the requirements the amended claims). An ordinary artisan would have been motivated to have performed such a method for the benefit of identifying possible impairments in argininosuccinate synthase in such a subject (given Wu et al’s teachings of the importance of Arg in felines), and for the further related benefit of identifying animals (including cats) who could potentially benefit from Arg supplementation (the successful practice of which is also taught by Wu et al). It is noted that (while not considered a required element in view of the conditional/contingent nature of the ‘providing” of claim 1) the teachings of Marmol-Sanchez et al in view of Wu et al thus also provide a suggestion to “provide instructions to administer arginine based on genotype” in instances when a determined genotype is indicative of an impairment in argininosuccinate synthase function (i.e., the combined teachings of Marmol-Sanchez et al and Wu et al suggest alternative embodiments of the claims in which “instructions” as set forth in claim 1 are provided, although it is noted that the “providing” language of independent claim 1 also constitutes non-functional descriptive material that need not be given patentable weight, given the lack of any required functional relationship to the rest of the claim [see MPEP 2111.05]). Furthermore, an ordinary artisan would have had a reasonable expectation of success in performing such methods given the detailed guidance provided by Marmol-Sanchez et al regarding genotyping of the argininosuccinate synthase gene via a variety of well-known methods/techniques (e.g., PCR amplification, nucleic acid sequencing).
Regarding dependent claim 2, Marmol-Sanchez et al teach obtaining genomic DNA for genotyping from liver tissue (page 107, left column), i.e., a sample type inherently comprising a variety of different cell types, including endothelial and immune cells, and thus suggest the use of cells types embraced by the claims (and it is further noted that one of ordinary skill in the art would have also recognized that DNA for use in genotyping could have been obtained from any of a variety of cell/sample types with a reasonable expectation of success). Regarding claim 3, the claim as amended clearly only applies ‘when the genotype…is the minor allele or heterozygous allele”, such that Marmol-Sanchez et al in view of Wu et al suggest at least some embodiments embraced by the claim. Regarding claims 6-7, Marmol-Sanchez et al disclose the use of methods including PCR, hybridization, sequencing, etc. as elements of their genotype determination (see, e.g., page 107). With further regard to claim 6, it is also noted that PCR and sequencing as taught by Marmol-Sanchez et al encompass both “hybridization based” and ‘enzyme-based” methods, and that purification of amplicons based on size constitutes a type of “post-amplification method based on physical properties of DNA” (see again page 107).
With further regard to independent claim 8 (from which claims 9-15 depend), this claim recites a step of “providing a composition comprising arginine to the subject when the genotype is determined to be a minor allele or heterozygous allele”; however, the claim as written clearly does not require such an outcome of the “genotyping the biological sample”, such that Marmol-Sanchez et al in view of Wu et al also clearly suggest methods as set forth in claim 8 (and again, Wu et al do also suggests benefits of arginine supplementation when needed, as discussed above).
With further regard to claims 9-11, these claims are further limiting only of embodiments in which the activity of “providing a composition comprising arginine” is performed; thus, Marmol-Sanchez et al in view of Wu et al suggest what is claimed for the same reasons given above with regard to claim 8 (as claims 9-11 are only further limiting of one possible embodiment of the claims, which embodiment is not required due to the conditional/contingent claim language employed). Regarding claim 12, again, Marmol-Sanchez et al teach obtaining genomic DNA for genotyping from liver tissue (page 107, left column), i.e., a sample type inherently comprising a variety of different cell types, including endothelial and immune cells), as discussed above with regard to claim 2. Regarding claims 13-14, Marmol-Sanchez et al disclose the use of methods including PCR, hybridization, sequencing, etc. as elements of their genotype determination (see, e.g., page 107). Regarding the requirements of amended claim 15 – “wherein the step of providing a composition comprising arginine to the subject when the genotype is determined…comprises providing a composition comprising arginine based on the genotype…” – this language is not clearly further limiting of claim 8, and the methods of claim 15 are thus suggested for the same reasons that apply to claim 8.
It is noted that Applicant’s traversal of the prior rejections of claims under 35 USC 103 (Reply pages 10-11) has been thoroughly considered but are not persuasive with respect to the nonobviousness of the amended claims now under consideration.
Applicant summarizes the prior rejection of the claims and argues that “Marmol-Sanchez involves a mutation at codon 315 in boars and Wu is simply a review article that discusses cows, humans, and pigs” (Reply page 10). Applicant acknowledges that Wu ‘does mention the importance of arginine for felines”, but urges that Wu “provides no discussion of how arginine effects felines, how to identify disorders in felines, or any particular feline genotype”, and argues that mutations in the argininosuccinate synthase gene may vary from species to species, such that “one of ordinary skill in the art would not have expected that specific mutations in mice, boars, or humans would necessarily lead to the same results in felines” (Reply page 11). Applicant also argues that “one of ordinary skill in the art would not have expected that the mutations in Marmol-Sanchez or Wu would have been useful as a monitor of ‘disorders associated with insufficient nitrogen oxide and/or liver disorder’” (Reply page 11). Finally, the Reply urges that the cited art fails to teach genotyping of argininosuccinate synthase gene in felines (Reply page 11).
These arguments have been thoroughly considered but are not persuasive. In particular, it is noted that the claims embrace determination of any genotype of the argininosuccinate synthase gene in felines, with no particular outcome of the genotyping of the claims being required (such that the claims encompass, e.g., simply sequencing the argininosuccinate synthase gene in a biological sample from a feline, which is clear suggested by the cited art). While the examiner concurs that genotyping in a biological sample from a feline is not disclosed, such genotyping is suggested by the teachings of the prior art, and could clearly have been performed (via, e.g., PCR and/or sequencing the gene) with a reasonable expectation of success, which meets the requirements of a rejection under 35 USC 103. Again, the claims as presently written do not clearly require actual arginine supplementation in cats (at any levels), nor do the claims recite any particular mutations (and thus while the examiner agrees that different mutations may occur in differ species, have different effects, etc., the present claims do not recite/require any “specific mutations”). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Finally, with regard to the “identifying” of the claims, it is reiterated that this preamble language has not been given patentable weight (for the reasons indicated above). Thus, Applicant’s arguments are not persuasive with regard to present claims 1-3 and 6-15.
Claim Rejections - 35 USC § 101
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claims 1-3 and 6-15 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent claim 1 as amended (from which claims 2-3 and 6-7 depend) remains drawn to a method “for identifying pets prone to disorders associated with insufficient nitrogen oxide and/or liver disorder”, and includes the recitation of the activity of “providing instructions to administer arginine based on the genotype of the argininosuccinate synthase gene of the subject”. The “identifying” of the claim may be accomplished by, e.g., drawing mental conclusions regarding genotyping data/results and the implications of such data with regard to an associated “disorder”, i.e., activities that may be performed entirely in the human mind, a type of abstract idea. The “providing instructions” of the claim is only required/performed when some genotypes are determined, such that the broadest reasonable interpretation of the claim does not require this activity, and such that the claims encompasses deciding to provide instructions (or not) “based on” a determined genotype, which encompasses activity that may be performed entirely in the human mind (and further, the provision of instructions, lacking any functional relationship to other method steps – even if required - constitutes non-functional descriptive material that is not given patentable weight). The judicial exceptions are not integrated into a practical application because claim 1 at present lacks any requirement for any actions/steps that might achieve such integration. While amended claim 1 now requires “obtaining a biological sample” from a feline subject and “genotyping the biological sample to determine a genotype of an argininosuccinate synthase gene”, such testing constitutes data gathering that does not add a meaningful limitation to the method, as such step(s) is/are insignificant extra-solution activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the broad/generally recited activities of obtaining a biological sample and genotyping a known gene – whether considered individually or together/as an ordered combination - constitute types of laboratory techniques/activities that the courts have recognized as well-understood, routine, and conventional activity in the life science arts when claimed a generic manner (as they are in the instant claims); see MPEP 2106.05(d)(II) (and further, it is reiterated that genotyping of the argininosuccinate synthase gene was well-known in the art as of Applicant’s effective filing date; see again Marmol-Sanchez et al (Animal Genetics 51(1):106-110 [2019]; cited in IDS) and Perez et al (American Journal of Pathology 177(4):1958 [2010]; cited in IDS)). With further regard to dependent claim 2 this claim is further limiting only of the source for gathered data, which does not add anything amounting to an application or something “significantly more” than a JE. Regarding claim 3, the claim as written does not apply a JE, as the “providing” encompasses a more particular type of information/instruction, rather than anything “significantly more” than a JE or an application of a JE (as the claim does not clearly require the performance of any additional activities/steps). (Further, it is reiterated that providing arginine as a supplement in a pet food composition was well-known as of Applicant’s effective filing date (see, e.g., the teachings of Rutherfurd-Markwick et al [Veterinary Immunology and Immunopathology 152:333 [2013]; cited herein] regarding dietary supplementation in cats [particularly at page 335, left column], as well as the teachings of Zoran [JAVMA 221(11):1559 [2002]; cited herein [particularly page 1560, right column]). Regarding claims 6-7, these claims add only general recitations of well-known methods/techniques for genotyping, and thus are further limiting of data gathering activities – nothing amounting to an application/implementation of a JE is provided – that were also well-known as of Applicant’s effective filing date (such that nothing “significantly more” is added).
Independent claim 8 (from which claims 9-15 depend) is drawn to a method “for identifying pets prone to disorders associated with insufficient nitrogen oxide and/or liver disorder”, reciting a step “providing a composition comprising arginine to the subject when the genotype is determined to be a minor allele or heterozygous allele”. The “identifying” as recited in the claim may be accomplished by, e.g., drawing mental conclusions regarding previously obtained genotyping data/results and the implications of such data with regard to an associated “disorder”, i.e., activities that may be performed entirely in the human mind, a type of abstract idea. The “providing” of the claim is a conditional step that is performed only when some genotypes are “determined”, such that the broadest reasonable interpretation of the claim does not require this activity. The judicial exceptions are not integrated into a practical application because claim 8 at present lacks any requirement for any actions/steps that achieve such integration. As was the case with independent claim 1, the claim has been amended to recite wet/manipulative steps of “obtaining a biological sample” and “genotyping the biological sample to determine a genotype of an argininosuccinate synthase gene…”; however, such testing constitutes data gathering that does not add a meaningful limitation to the method, as such step(s) is/are insignificant extra-solution activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the broad/generally recited laboratory techniques/activities of obtaining a biological sample and genotyping a known gene therein – whether considered individually or together/as an ordered combination - constitute well-understood, routine, and conventional activity in the life science arts when claimed a generic manner (as they are in the instant claims); see MPEP 2106.05(d)(II) (and further, it is reiterated that genotyping of the argininosuccinate synthase gene was well-known in the art as of Applicant’s effective filing date; see again; see again Marmol-Sanchez et al and Perez et al). With further regard to dependent claims 9-11, these claims are further limiting of a composition that is recited within a conditional/contingent step, rather than a required element of the claims. Applicant is reminded that the broadest reasonable interpretation of a method/process having contingent limitations “requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met” (see MPEP 2111.04(II)). Regarding dependent claim 12, this claim is further limiting only of the source for gathered data, which does not add anything amounting to an application or something “significantly more” than a JE. Regarding claims 13-14, these claims add only general recitations of well-known methods/techniques for genotyping, and thus are further limiting of data gathering activities – nothing amounting to an application/implementation of a JE is provided – that were also well-known as of Applicant’s effective filing date (such that nothing “significantly more” is added). Finally, the requirements of amended claim 15 – “wherein the step of providing a composition comprising arginine to the subject when the genotype is determined…comprises providing a composition comprising arginine based on the genotype…” – are not clearly further limiting of claim 8 (and also relate to a conditional step that is performed only when some genotypes are “determined”, such that the broadest reasonable interpretation of the claim does not require this activity).
Accordingly, none of claims 1-3 and 6-15 is directed to patent eligible subject matter.
Applicant traverses the prior rejection of claims under 35 USC 101 on the following grounds. Applicant notes that the claims have been amended to recites steps of “obtaining a biological sample from a subject” and “genotyping the biological sample to determine the genotype”, and urges that the claims “cannot be performed in the human mind” and are “directed to patent eligible processes, not abstract ideas” (Reply page 9). The Reply further argues “the claims integrate determining the genotype….into a practical application, by using the determination to then optimally provide instructions or provide a composition comprising arginine to improve a feline’s health”, urging that the claims are similar to those of the Classen Immunotherapies case as outlined in MPEP 2106.05(e) (Reply page 9). Finally, Applicant also argues that “the Office has improperly characterized the providing steps as conditional”, state that claims 1 and 8 require “providing instructions” and “providing a composition”, which “will result either in the feline subject being fed an arginine rich composition, or the feline subject continuing their current diet”, such that “the feline is fed and the feline’s health is improved” (Reply page 10). Applicant urges that the “providing” of the claims “obviates any concerns about allegedly abstract ideas” (Reply page 10).
These arguments have been thoroughly considered but are not persuasive.
With regard to the addition of the activities of “obtaining a biological sample” and “genotyping the biological sample”, while the examiner concurs that these are wet/manipulative steps that cannot be conducted in the human mind, as discussed in the rejection of the amended claims above, the addition of such steps (which achieve only routine data gathering [rather than any type of application/implementation of a JE], and constitute well-understood, routine, and conventional activity) is not sufficient to render the claims patent eligible (and the claims continue to recite limitations that are considered abstract ideas, as discussed above). Regarding the argument that the claims integrate a JE in a manner similar the fact pattern in Classen, the present claims as written do not require any active/manipulative steps that clearly and necessarily implement/apply a JE (again as discussed in the revised rejection above that address the limitations of the amended claims); this is a key, critical difference as compared to Classen. Regarding the argument that the Office has improperly characterized “providing” steps as conditional, it is noted that the BRI of claim 1 does not require “providing instructions to administer arginine” in all cases (with the claim clearly encompassing a “genotyping” that may result in determining a major allele); further the providing of instructions encompasses providing information, which may or may not result in any kind of further action/manipulation (i.e., an application/implementation of a JE) being performed. Claim 8 clearly states “providing….when the genotype is determined to be a minor allele or heterozygous allele”, while the claim clearly states that the “genotyping” may result in determination of a “major allele” (i.e., the claim language itself is clearly conditional/contingent in nature, based on the language of the claim itself). Accordingly, Applicant’s arguments are not persuasive.
Conclusion
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 DIANA B JOHANNSEN whose telephone number is (571)272-0744. The examiner can normally be reached Monday-Friday, 7:30 am-3:30 pm EST.
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, Wu-Cheng Winston Shen can be reached at (571) 272-3157. 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.
/DIANA B JOHANNSEN/Primary Examiner, Art Unit 1682