DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant's amendments and remarks, filed, 11/24/2025, are acknowledged. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 24, 26-29 are under examination.
Claims 1-23 are cancelled. Claims 25, 30-37 are withdrawn.
Priority
Applicant’s claim for the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) has been acknowledged. This application is a continuation of U.S. Application No. 13/039240, filed March 2, 2011, now abandoned, which is a continuation of U.S. Application No. 12/768,427, filed April 27, 2010, now abandoned, which is a continuation of U.S. Application No. 10/536,369, filed February 1, 2006, now U.S. Patent No. 7,729,863, issued June 1, 2010, which is a national stage of International Application No. PCT/US04/42267, filed December 15, 2004, which claims the benefit of U.S. Provisional Application No. 60/530,464, filed December 17, 2003. The effective filing date of this application is 12/17/2003.
Objections
The objection to the specification for embedded hyperlinks and/or other form of browser-executable code is withdrawn in view of applicant’s arguments (which cite the substitute specification filed 05/19/2023).
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 24, 26-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The United States Patent and Trademark Office published revised guidance on the application of 35 U.S.C. § 101. USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”). Under the Guidance, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (Guidance Step 2A, Prong 1); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)) (Guidance Step 2A, Prong 2).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that are not “well-understood, routine and conventional in the field” (see MPEP § 2106.05(d)); or 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50-57 (January 7, 2019).
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.(Guidance Step 2B). See Guidance, 84 Fed. Reg. at 54-56.
Step 1
The instantly claimed invention (claim 24 being representative) is directed to a method. Thus, the claim is directed to one of the statutory categories of invention. MPEP 2106.03.
A. Guidance Step 2A, Prong 1:
As discussed in the MPEP, abstract ideas include mathematical concepts (mathematical relationships, mathematical formulas or equations, mathematical calculations; see MPEP § 2106.04(a)(2), subsection I); certain methods of organizing human activity (see MPEP § 2106.04(a)(2), subsection II); and mental processes (concepts performed in the human mind including an observation, evaluation, judgment, opinion; see MPEP § 2106.04(a)(2), subsection III). In this case, the claimed steps that are part of the abstract idea are as follows:
(a) inputting the sequences of the amplicons of the at least 50 microsatellite markers and the at least 50 single nucleotide polymorphism markers into a data structure stored in the computer readable medium, wherein the data structure comprises a marker field corresponding to the at least 50 microsatellite markers and the at least 50 single nucleotide polymorphism markers and a genotyping information field comprising the allele identities of the at least 50 microsatellite markers and the at least 50 single nucleotide polymorphism markers;
(b) comparing the marker field and the genotyping information field of the data structure to a database, wherein the database comprises allele identity and allele frequency information of the at least 50 microsatellite markers and the at least 50 single nucleotide polymorphism markers of a plurality of domestic dog breeds, wherein the plurality of domestic dog breeds comprises at least five domestic dog breeds;
(c) identifying the two or more domestic dog breeds of the mixed-breed canid from the allele-identities provided in the data structure;
(d) calculating a fraction of the genome of the mixed-breed canid that is from each of the plurality of domestic dog breeds, at parent, grandparent, and great-grandparent levels using Bayesian methods…, and wherein the fraction of the genome of the mixed-breed canid from each of the two or more domestic dog breeds is at least 5%;
Mental Processes
In this case, the above steps broadly encompass collection, observation, and/or manipulation of data, as well as performing evaluations that are practically performed in the human mind. The courts are clear that an invention directed to the “collection, manipulation, and display of data” is an abstract process. See Intellectual Ventures, 850 F.3d at 1340; see generally id. at 1340-41. In addition, the specification provides sufficient evidence that the claims are directed to an abstract idea since the specific descriptions provided for accomplishing these tasks include only data analysis methods or algorithms [pages 3 and 4]. For these reasons, the above steps fall within the “mental processes” grouping of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. With regards to the recitation of a processor and database in the claims, this does not negate the mental nature of these limitations because the claims here merely use them as a tool to perform the otherwise mental processes. Therefore, the claims recite the judicial exception of a mental processes within the abstract-idea category [Step 2A, Prong 1: YES].
Mathematical Concept
In addition, step (d) is also considered a mathematical calculation since is requires “calculating a fraction” using Bayesian methods or algorithms. See MPEP § 2106.04(a)(2)(subsection I). It is noted that the grouping of “mathematical concepts” is not limited to formulas or equations, as words used in a claim operating on data to solve a problem can serve the same purpose as a formula. That is, claims are evaluated in light of the specification, and a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. Therefore, the above limitation also falls within the mathematical concepts grouping of abstract ideas. [Step 2A, Prong 1: YES].
Natural Correlation
Under the broadest reasonable interpretation, the above claims also recite a natural correlation. In particular, the instant claims require identifying a medical predisposition (i.e. disease) based on calculations associated with canid breed. Therefore, this step amounts to naturally occurring relationship between data and disease. See MPEP 2106.04(b). It is noted that even if a claim does recite a law of nature or natural phenomenon, it may still be eligible. For example, claims reciting a naturally occurring relationship between a patient’s genotype and the risk of QTc prolongation (a law of nature) were held eligible as not “directed to” that relationship because they also recited a step of treating the patient with an amount of a particular medication that was tailored to the patient’s genotype. Vanda Pharms., 887 F.3d at 1134-36, 126 USPQ2d at 1279-81. This particular treatment step applied the natural relationship in a manner that integrated it into a practical application. The court’s analysis in Vanda is equivalent to a finding of eligibility at Step 2A Prong Two (Pathway B).
B. Guidance Step 2A, Prong 2
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. In this case, the claimed steps that are not part of the abstract idea are as follows:
identifying the two or more domestic breeds that comprise….(i) contacting the genome of the mixed-breed canid with at least two primers selected from the group consisting of SEQ ID NOs: 1-200 and 244-327;
(ii) amplifying sequences of the genome of the mixed-breed canid to obtain amplicons of at least 50…
(B) managing the health care of the mixed-breed canid by identifying a medical predisposition and/or a congenital condition associated with the identified two or more domestic dog breeds by proactively acting on the identified medical predisposition and/or the identified congenital condition.
In this case, the additional contacting and amplifying steps amount to collecting data for use by the abstract idea. Therefore, these steps amount to nothing more than insignificant extra-solution activity and are not indicative of an integration into a practical application. See MPEP 2106.05(g).
With regards to the managing step, this limitation is nominally recited (without any specific acts or operations) and generically results in “proactively acting on the identified medical predisposition”. However, the “proactively acting” on information broadly encompasses providing advice and thus does not amount to a particular treatment. See MPEP 2106.04(d)(2) for examples of particular treatments. Therefore, this limitation is at best the equivalent of merely adding the words “apply it” to the judicial exception. See MPEP 2106.05(f). Accordingly, the claims as a whole do not integrate the abstract idea into a practical application.
With regard to the claimed processor, computer-readable medium, and database, these features are generically recited and used as a tool to perform the abstract idea and/or the generic function of receiving data. Moreover, applicant is reminded that “generic computer components such as a computer and database do not satisfy the inventive concept requirement.” See MPEP 2106.05(h). With regards to the claimed “data structure”, this is generically claimed at a “high level of abstraction” and encompasses a conventional database. Although this feature limits the identified judicial exception (for inputting data as recited in step a), this type of limitation merely confines the use of the abstract idea to a particular technological environment (computer readable medium) and thus fails to add an inventive concept to the claims. See MPEP 2106.05(h).
Therefore, the additionally recited steps/elements amount to insignificant extra-solution activity that does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Even when viewed in combination, these additional steps/elements do not integrate the recited judicial exception into a practical application (Step 2A, Prong Two: NO).
C. Guidance Step 2B:
Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. In this case, the claims do not include additional steps and/or elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons:
As discussed above, the non-abstract steps (including the full limitations and not just the verbs) amount to nothing more than insignificant extra-solution activity. Furthermore, with regard to step (i) and (ii), a review of the specification [pages 4, 10, 11] teaches that these steps can be performed using methods that are routine and conventional in the art, e.g. Polymerase Chain Reaction (PCR), size fractionation, DNA sequencing, DNA microarrays, high density fiber-optic arrays of beads. With regards to the particular primers being claimed, Francisco et al. (Mammalian Genome, 1996, 7,359-362) teaches a plurality of canine genetic markers and primer/probe pairs (see Table 1) which applicant’s own specification has cited and admitted as being used with the instantly claimed invention [see page 10]. With regards to the specific primers and at least 50 microsatellite markers and SNPs being claimed, the specification teaches the claimed dog breeds as being registered with the American Kennel Club [page 2] as well as exemplary markers for use in the claimed method that are associated with the various breeds and come from the cited published literature [pages 2, 3, 10, 11]. Guyon et al. (PNAS, vol. 100, no. 9, pp.5296-5301; Pub. Date: April, 29, 2003) teaches genotyping using one hundred dinucleotide microsatellite markers chosen from the 1596 microsatellites currently localized on the 3300 marker map of the dog (Table 1), which reasonably encompasses the claimed SNPs (absent any evidence to the contrary). In addition, the specification teaches health-related information that may also include potential treatments, special diets or products, diagnostic information, and insurance information (i.e. for “proactively acting on the identified medical predisposition”) [page 18]. Accordingly, there is nothing unconventional with regards to the type of primers, markers, and SNPs being used. Applicant is invited to provide
With regards to the generically recited processor and computer readable medium, as explained above, a review of the specification does not provide any evidence that these elements are anything other than generic. As such, the courts have also explained that the use of generic computer elements do not alone transform an otherwise abstract idea into patent-eligible subject matter. See DDR Holdings (Fed. Cir. 2014). Even when considered in combination, these additional steps/elements do not provide an inventive concept [Step 2B: NO].
Dependent Claims
Dependent claims 26-29 have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. Regarding claim(s) 26-27, 29 these claims further limit the specificity of the dog breeds being used and the subsequent analysis. Accordingly, these claims are still part of the judicial exception and therefore are not patent eligible for reasons discussed above (in the Step 2A and Step 2B). Regarding claim(s) 28, this claim further requires obtaining a recommendation (i.e. data collection) and generating a document (i.e. outputting data). Therefore, these steps amount to nothing more than insignificant extra-solution activity and/or generally linking the use of a judicial exception to a particular technological environment or field of use, as set forth above in the Step 2A (prong 2) and Step 2B analysis. Accordingly, these claims are not indicative of an integration into a practical application. See MPEP 2106.05(g). See MPEP § 2106.05(h).
Therefore, based on the two-part analysis, the instantly rejected claims as a whole are not drawn to eligible subject matter as they are directed to a judicial exception without significantly more.
Response to Arguments
Applicant’s arguments, filed 11/24/2025, have been fully considered but are not persuasive for the following reasons.
Applicant again argues that the amended claims provide an improvement to the technology, namely to the management of health care of a mixed breed candid. In response, the “managing” limitation is nominally recited (without any specific acts or operations) and generically results in “proactively acting on the identified medical predisposition”. However, the “proactively acting” on information broadly encompasses providing advice and thus does not amount to a particular treatment. See MPEP 2106.04(d)(2) for examples of particular treatments. Therefore, this limitation is at best the equivalent of merely adding the words “apply it” to the judicial exception. See MPEP 2106.05(f). Applicant is also reminded that the claimed invention’s use of the ineligible concept to which it is directed (i.e. the abstract idea) cannot supply the inventive concept that renders the invention ‘significantly more’ than that ineligible concept.” BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018). It is also well settled that mere computer-based efficiency does not save an otherwise abstract method. Bancorp Servs. L.L.C. v. Sun Life Assur. Co. of Canada (US.), 687 F.3d 1266, 1277-78 (Fed. Cir. 2012). As such, the examiner maintains that the claims do not integrate the recited judicial exception into a practical application and thus do not provide an improvement to the technology. For at least these reasons, the rejection is maintained.
For a list of considerations when evaluating whether additional elements integrate a judicial exception into a practical application see MPEP 2106.04(d)(1) lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
Claim rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 of carrying out his invention.
This new matter rejection is necessitated by applicant’s amendments.
Claims 24, 26-29 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 24 recites “managing the health care of the mixed-breed canid by identifying a medical predisposition and/or a congenital condition associated with the identified two or more domestic dog breeds by proactively acting on the identified medical predisposition and/or the identified congenital condition.” While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure. In this case, however, the examiner cannot find support for an ICE component that “comprises a difference array” in the original claims, drawings, or the specification as originally filed, and no basis has been pointed to for these new limitations in applicant's remarks. The specification teaches health-related information that may also include potential treatments, special diets or products, diagnostic information, and insurance information [page 18]. However, this does not provide sufficient support managing the health care of a mixed-breed candid by “proactively acting on the identified medical predisposition” [page 18]. Therefore, the teachings of the specification are not commensurate in scope with what is being claimed. In the absence of support for the newly recited limitations, these claims and claims dependent thereon are deemed to constitute new matter.
Claim rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24, 26-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 24 is/are also rejected due to said dependency.
Claim 24 recites “managing the health care of the mixed-breed canid by identifying a medical predisposition and/or a congenital condition associated with the identified two or more domestic dog breeds by proactively acting on the identified medical predisposition and/or the identified congenital condition.” This limitation is problematic for the following reasons. (1) With regards to said “managing”, this step is confusing because it relies upon two different “by” phrases (e.g. “by identifying” and “by proactively acting”) combined with “and/or” phrases. Accordingly, it is unclear what positive process limitation is minimally required to perform the claimed “managing” step. Clarification is requested via amendment, e.g. by amending the claim to recite “…by identifying….and proactively acting…”.
(2) With regards to said “identifying”, such generic functional claim language amounts to descriptions of problems to be solved and covers all means or methods of performing the claimed function. Notably, this step does not use the information from the previous “calculating” step (which generates fractional information). Moreover, a review of the specification does not describe, to any appreciable extent, any algorithms, equations, or prose equivalent that correspond to the claimed function. As a result, it is unclear what computational techniques are included or excluded by the claimed “identifying” such that one of ordinary skill in the art would know how to avoid infringement. Clarification is requested via amendment.
(3) It is unclear what limiting effect is intended by the phrase “proactively acting on the identified medical predisposition and/or the identified congenital condition.” A review of the specification does not provide any limiting definition or examples that would serve to clarify the scope. As a result, it is unclear what techniques are included or excluded by the claim language such that one of ordinary skill in the art would know how to avoid infringement. Clarification is requested via amendment.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619