DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .2. This action is in response to the amendment filed on 06 January 2026. Applicant's arguments and amendments to the claims have been fully considered but do not place the application in condition for allowance. All rejections and objections not reiterated herein are hereby withdrawn.
Claim Status
3. Claims 14-20 and 22-26 are pending and have been examined herein.
Maintained / Modified Claim Rejections - 35 USC § 101
4. 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 14-20 and 22-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a natural phenomenon / naturally occurring product without significantly more. The judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons that follow.
Applicant’s attention is directed to MPEP 2106 “Patent Subject Matter Eligibility” and particularly 2106.04(b)II and 2106.04(c) “Examples of Products Lacking Markedly Different Characteristics.”
Regarding Step 1 of the analysis, the claims are directed to the statutory category of a product.
Regarding Step 2A, prong one, the claims recite the judicial exception of a natural phenomenon – i.e., a naturally occurring product.
Pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (June 2013), a naturally-occurring nucleic acid or fragment thereof, whether isolated or not, is not patent-eligible subject matter. Specifically, the Supreme Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”
In the present situation, the claims recite nucleic acids that are primers for amplifying a portion of exon 3 of a fAIM gene, including a fAIM exon 3 primer, a fAIM exon 5 primer, and a TERT exon 3 primer. The recited primers are naturally occurring DNA segments of the feline genome. The naturally occurring DNA segments do not have markedly different characteristics from their naturally occurring counterparts because the DNA segments convey the same genetic information.
Regarding the recitation of primers, Applicant’s attention is further directed to MPEP 2106.04(c)IIC which states:
“In Ambry Genetics, the court identified claimed DNA fragments known as "primers" as products of nature, because they lacked markedly different characteristics. University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014). The claimed primers were single-stranded pieces of DNA, each of which corresponded to a naturally occurring double-stranded DNA sequence in or near the BRCA genes. The patentee argued that these primers had markedly different structural characteristics from the natural DNA, because the primers were synthetically created and because "single-stranded DNA cannot be found in the human body". The court disagreed, concluding that the primers’ structural characteristics were not markedly different than the corresponding strands of DNA in nature, because the primers and their counterparts had the same genetic structure and nucleotide sequence.”
In response to the patentee’s position that the primers “have a fundamentally different function than when they are part of the DNA strand,” the Court rejected this position on the basis that the natural DNA performed a similar function to bind to complementary nucleotide sequences – i.e., “just as in nature, primers utilize the innate ability of DNA to bind to itself.” Thereby, the Court held that the primers did not have a different structure as compared to their full length naturally occurring nucleic acid counterparts and were therefore patent ineligible.
Additionally, the claimed kits comprise a DNA polymerase (including a thermophilic DNA polymerase and a high-fidelity-long-range DNA polymerase), dNTPs and a buffer (e.g., a phosphate buffer or a bicarbonate and carbonic acid buffer). These reagents, as broadly recited, also encompass naturally occurring products that do not have any markedly different structural properties as compared to their naturally occurring counterparts.
Regarding Step 2A, prong two, having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application.
Herein, the claims do not recite additional elements that integrate the recited judicial exceptions into a practical application of the exception(s).
Regarding Step 2B, the next question is whether the remaining elements – i.e., the non-patent-ineligible elements - either in isolation or combination, amount to significantly more than the judicial exception.
Regarding the claimed kits, the packaging of the natural products in a kit does not change their characteristics. The products may exist separately from one another and need not interact with one another in a manner which would change their characteristics from their natural counterparts.
Regarding the recitation in claim 20 that the components of the kit are provided “in a respective labeled container,” it is noted that the written material in the label is not considered to be within the statutory classes (see MPEP 706.03(a)). The presence of a labeled container does not materially alter the characteristics of the naturally occurring products in the kit. Further, the generically recited labeled containers do not add something significantly more to the recited judicial exceptions since the packaging of reagents in labeled containers was well-known, routine and conventional in the prior art.
See, for example, Mei et al (U.S. 20050042654, at para [0010]). Jones et al (U.S. 20060147962, at para [0165]) and Hong et al (U.S. 20090220943 at para [0098]).
For the reasons set forth above, the claims are not considered to recite something significantly different than a judicial exception and thereby are not directed to patent eligible subject matter.Response to Remarks:
The response argues that the claims are drawn to a kit and does not claim a DNA polymerase, dNTPs, one or more primers or buffers as separate items. It is argued that all 4 items do not occur together in nature.
These arguments have been fully considered but are not persuasive. First, it is noted that the claims do not require a single reaction mixture comprising each of the components. Rather, the components may be packaged in separate containers / tubes and need not interact with one another. Secondly, the fact that a claimed combination of reagents does not exist in nature does not necessarily result in a finding that the claimed subject matter is patent-eligible. Applicant’s attention is directed to MPEP 2106.04(c)IIA which identifies the appropriate counterpart for performing the markedly different characteristics analysis. Therein it is stated that:
“When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. For example, assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature); Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (although claimed as a pair, individual primer molecules were compared to corresponding segments of naturally occurring gene sequence); In re Bhagat, 726 Fed. Appx. 772, 778-79 (Fed. Cir. 2018) (non-precedential) (comparing claimed mixture of lipids with particular lipid profile to "naturally occurring lipid profiles of walnut oil and olive oil").”
MPEP 2106.04(c)IA also states “Where the claim is to a nature-based product in combination with non-nature based elements (e.g., a claim to "a yogurt starter kit comprising Lactobacillus in a container with instructions for culturing Lactobacillus with milk to produce yogurt"), the markedly different characteristics analysis should be applied only to the nature-based product limitation.”
Thus, in the present situation, the markedly different characteristic analysis is performed by comparing the individual products (i.e., primers, DNA polymerase, dNTPs and buffers to each of their closest naturally occurring product. As discussed in the rejection, each of the products - i.e., ., primers, DNA polymerase, dNTPs and buffers - have the same structure as their naturally occurring counterparts and do not have any markedly different characteristics as compared to their naturally occurring counterparts. Thus, the claimed kits comprising the DNA polymerase, dNTPs, one or more primers and a buffer, individually packaged as encompassed by the claims, or even when mixed in a single composition (which is not required by the claims), do not have markedly different characteristics when compared to the individual components as they occur in nature and thereby are a judicial exception. The claims do not recite any additional elements that integrate the judicial exception into a practical application. Nor do the claims recite any non-patent-ineligible elements - either in isolation or combination - that amount to significantly more than the judicial exception.
The response states:
“With reference to Example 31, "Screening for Gene Alterations", in the
USPTO May 2016 guidelines on subject matter eligibility, it is clear that
"amplification" is not something that is found in nature, and is patent eligible. Kits,
such as the claimed kit, which are constructed for "amplification" are thus patent
eligible.”
This argument has been fully considered but is not persuasive. In Example 31 of the 2016 guidance, the claims were directed to a method. The facts in Example 31 are very distinct from the facts herein since the present claims are directed to a product / kit and not to a method. Note also that the claims that were found eligible in the example were directed to methods that detected a mutation using a non-conventional method of scanning near-field optical microscopy or “Cool-Melt PCR” or were drawn to a method of amplifying nucleic acids using Cool-Melt PCR. It was determined that those claims that were patent eligible recited elements in addition to the judicial exception which were not routine, conventional or well-known in the prior art, or did not recite a judicial exception (claim 85 which recited a method of amplifying nucleic acids using “Cool-Melt PCR” and then sequencing the amplified nucleic acids. In contrast, the present claims are directed to the judicial exception of a product of nature and do not recite additional, non-patent-ineligible elements that were not well-understood, routine or conventional in the prior art.
The response asserts “At the time of the present invention, no one was routinely or conventionally amplifying a section of a nucleic acid sample obtained from a feline
subject to determine the number of copies of Exon 3 in the feline apoptosis
inhibitor of macrophages (fAIM) genes for that subject.”
However, the patent-eligibility of the claims is not determined based on the intended use of the claimed kits.
Maintained / Modified Claim Rejections - 35 USC § 112(b) - Indefiniteness
5. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 is indefinite. Claim 15 depends from claim 14 which requires “one or more primers configured to bind to the nucleic acid sample and further configured to amplify a section of the nucleic acid sample that includes all or a portion of fAIM Exon 3.” Claim 15 further recites that the “one or more primers includes at least one of…a TERT exon 3 primer. It is unclear as to how a TERT EX3 primer constitutes a primer that is configured to bind to at least a portion of Exon 3 of the fAIM gene.
Maintained / Modified Claim Rejections - 35 USC § 103
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 14-15, 18-20, and 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sugisawa et al (Scientific Reports. 2016. 6: 35251, p. 1-13 and Supplementary Information p. 1-11; cited in the Office action of 11 April 2025) in view of Miyazaki, T. (U.S. 20170172120), as evidenced by NCBI Database GenBank Accession No. LC149874.1 (National Center for Biotechnology Information, National Library of Medicine, NIH, Bethesda, MD, USA. 15 Oct 2016, available via URL: < ncbi.nlm.nih.gov/nuccore/LC149874.1?report=GenBank>).
Sugisawa et al teaches methods of performing PCR to clone feline AIM nucleic acids using primers which amplify the full length feline AIM cDNA (see p. 9 and Supplementary Table 4). Sugisawa teaches that one of the fAIM cDNAs having 3 SRCR domains was deposited as GenBank Accession No. LC149874.1 (p. 13). It is stated that:
“PCR primers were designed for SRCR1 (including ATG) and SRCR3 (including TAG) according to the sequence of 3-SRCR feline AIM (fAIM_5_f_EcoRI and fAIM_3_r_XhoI). Sequences of the oligonucleotides used are presented in Supplementary Table 4” (p. 9).
The fAIM_5_f_EcoRI and fAIM_3_r_XhoI primers set forth in Supplementary Table 4 of Sugisawa hybridize to 5’ and 3’ terminal sequences of the fAIM cDNA, as shown in the alignments below:
Alignment of fAIM_5_f_EcoRI (sbjct) and LC149874.1 (Query)
PNG
media_image1.png
214
1214
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Greyscale
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184
778
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Greyscale
Alignment of fAIM_3_r_XhoI (Sbjct) and LC149874.1 (Query)
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208
1202
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Greyscale
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180
766
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Greyscale
Note that NCBI Database GenBank Accession No. LC149874.1 is cited only to establish what is inherent to the teachings of Sugisawa.
Accordingly, with respect to claims 14 and 15, Sugisawa teaches primers configured to bind to a nucleic acid sample that includes all or at least a portion of Exon 3 with flanking sequences and thereby are “fAIM exon 3” primers - primers that amplify exon 3 of a feline AIM gene.
Since the primers of Sugisawa amplify the full length fAIM gene, including exon 3, the primers can be used to identify the total number of copies of fAIM exon 3. For example, an amplification product produced using the primers can be sequenced and the number of copies of exon 3 can be determined in the amplified product, including 2, 3 or 4 copies (claim 23). Note that the present claims do not define the primers in terms of any specific structural features or other properties that distinguish the “fAIM exon 3 primer” or “fAIM exon 5 primer” over the primers of Sugisawa.
Sugisawa does not teach packaging one or more of the primers disclosed therein in a kit, together with a DNA polymerase, dNTPs and one or more buffers.
However, Miyazaki teaches kits comprising reagents for amplifying and detecting feline / cat AIM nucleic acids, wherein the kits contain primers and other reagents for performing amplification reactions (e.g., para [0013] at “[22]”; and para [0049], [0231-0233] and [0238]). Miyazaki states “when the reaction for detecting the expression of the AIM gene is PCR, examples of such other substance include reaction buffer, dNTPs, heat-resistant DNA polymerase and the like.”
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have packaged the primers of Sugisawa into a kit, together with other reagents for performing PCR, including dNTPs, DNA polymerase and one or more buffers. One would have been motivated to have done so because Miyazaki teaches to package AIM primers and the reagents for performing PCR into a kit and this would have provided the benefits of convenience and cost-effectiveness for practioners wishing to clone, amplify or detect feline AIM nucleic acids.
Regarding the preamble of the present claims, as set forth in MPEP 2111.02 II: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” Herein, the preamble language of “for determining a total number of copies of Exon 3 in the feline apoptosis inhibitor of macrophages (fAIM) genes in a nucleic acid sample obtained from a feline subject” is a statement of purpose and intended result and does not materially affect the structural properties of the kit or its components. Thereby, the intended use of the kits does not materially distinguish the claimed kits over the kits suggested by the combined teachings of Sugisawa and Miyazaki.
Regarding claim 18, as discussed above, Miyazaki teaches including appropriate buffers in the kit. Miyazaki also teaches using washing buffers following hybridization with probes (e.g., para [0097]). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a wash buffer in the kit in those instances in which a probe was included in the kit. Such a modification would have provided the benefit of convenience and cost-effectiveness for practioners in the art wishing to detect fAIM nucleic acids using hybridization probes.
Regarding claim 19, Sugisawa teaches that AIM nucleic acids may be detected by qPCR (p. 4 final para) and that AIM cDNA was isolated by RT-PCR. Thereby, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the kit containing the primers of Sugisawa for performing qPCR or RT-PCR so that the kit could be used for these particular types of amplification assays.
Regarding claim 20, the combined reference do not specifically state that components of the kit are provided in a respective labeled container. However, it was conventional in the prior art to provide the components of the kit, including primers, buffers, dNTPs and DNA polymerase in labeled containers. One would have been motivated to have provided the components of the kit in labeled containers so that practioners would know the contents of each container / reagent in the kit.
Regarding claim 22, since the fAIM_5_f_EcoRI and fAIM_3_r_XhoI primers set forth in Supplementary Table 4 of Sugisawa hybridize to 5’ and 3’ terminal sequences of the fAIM cDNA, the primers can be used to amplify fAIM genomic DNA.
Regarding claims 24-26, it is noted that these claims are not limited to the particular fAIM exon 3, fAIM exon 5 and TERT exon 3 primers of SEQ ID NO: 10, 12, 13, 15, 16 or 18, respectively. Rather, claims 24-26 depend from claim 15 which defines the kits as comprising one of more primers including one of a fAIM exon 3, a fAIM exon 5 and a TERT exon 3 primer. Claims 24-26 further limit the kit of claim 15 by defining one of fAIM exon 3, a fAIM exon 5 and TERT exon 3 primer. But none of these claims require the particular primer. For example, claim 24 is not limited to the in vitro amplification kit of claim 15 wherein the one or more primers includes a fAIM exon 3 primer and wherein the fAIM exon 3 primers consist of SEQ ID NO: 10 and SEQ ID NO: 12.
7. Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sugisawa et al (Scientific Reports. 2016. 6: 35251, p. 1-13 and Supplementary Information p. 1-11; cited in the Office action of 11 April 2025) in view of Miyazaki, T. (U.S. 20170172120), as evidenced by NCBI Database GenBank Accession No. LC149874.1 (National Center for Biotechnology Information, National Library of Medicine, NIH, Bethesda, MD, USA. 15 Oct 2016, available via URL: < ncbi.nlm.nih.gov/nuccore/LC149874.1?report=GenBank>), and further in view of Borrebaeck (U.S. 20030148353).
The teachings of Sugisawa and Miyazaki are presented above.
Regarding claim 16, Miyazaki teaches including a heat-resistant DNA polymerase in the kit for performing PCR, but does not specify that the heat-resistant DNA polymerase is a thermophilic DNA polymerase.
However, Borrebaeck teaches methods of performing PCR and discloses that the DNA polymerase used to perform PCR can be AmpliTaq® thermostable DNA polymerase (para [0094]) - i.e., a thermophilic DNA polymerase.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included AmpliTaq® thermostable DNA polymerase in the kit comprising the primers of Sugisawa for performing PCR to amplify fAIM nucleic acids because Miyazaki teaches including a heat-resistant DNA polymerase in the kit and Borrebaeck teaches the effective use of this (heat-resistant) DNA to perform PCR.
Regarding claim 17, Miyazaki teaches including dNTPs in the kit for performing PCR but does not specify that the dNTPs are dATP, dCTP, dGTP or dTTP.
However, Borrebaeck teaches methods of performing PCR and teaches that PCR reactions contain dNTPs, including dTTP, dATP, dCTP and dGTP (para [0094]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit containing the primers of Sugisawa so as to have specifically included the dNTPs of dTTP, dATP, dCTP and dGTP because Borrebaeck teaches that these are the dNTPs that are used to perform PCR.Response to Remarks:
The response states:
“Sugisawa does not teach or suggest primers... configured to amplify a section of the nucleic acid sample that includes all or at least a portion of fAIM Exon 3... and to identify the TOTAL NUMBER of copies of fAIM Exon 3 in the nucleic acid sample (emphasis added). That is, only the applicants have shown that cats with at least three copies of Exon 3 are predisposed to kidney disorders.”
These arguments have been fully considered but are not persuasive. It is a property of the primers of Sugisawa that the primers can be used to amplify the full length fAIM cDNA, which comprises the full length sequence of exon 3. Such primers can therefore be used to detect the number of copies of exon 3. For example, the amplification product obtained using the primers of Sugisawa can be sequenced and from the sequence information, the number of copies of exon 3 can be determined. There is no requirement for Sugisawa to teach that the primers have this property. Note that the claims are drawn to a kit and not to a method of detecting the number of copies of fAIM exon 3. Further note that the claims do not recite any structural limitations for the primers which would distinguish the primers over the primers of Sugisawa. The terms of “fAIM exon 3,” “fAIM exon 5” and “TERT exon 3” are not defined in the specification or the claims and the claims do not require primers that, e.g., specifically anneal to exon 3 of the feline AIM gene or primers that specifically anneals to exon 3 of a feline TERT gene. In fact, since claim 15 defines the one or more primers configured to identify the total numbers of copies of fAIM Exon 3 as a TERT exon 3 primer, it is clear that the claims intend to encompass any primer that can be used in an amplification assay to synthesize a product which can then used to directly or indirectly determine fAIM exon 3 copy number.
The response asserts that Miyazaki and Borrebaeck do not teach detecting the total number of copies of fAIM exon 3.
However, as set forth in the rejection, Miyazaki was cited for its teachings regarding the obviousness of packaging primers and amplification reagents into a kit and Borrebaeck was cited for its teachings regarding methods of performing PCR using AmpliTaq® thermostable DNA polymerase (para [0094]) - i.e., a thermophilic DNA polymerase and the identity of dNTPs used for PCR. Further, it is again noted that the claims are not drawn to a method of determining the total number of copies of exon 3 of the feline AIM gene. Rather, the claims are drawn to kits comprising primers wherein the primers are configured to - i.e., have the property of being able to - directly or indirectly amplify a “portion” (i.e., one or two nucleotides) of a fAIM exon 3 and directly or indirectly identify the total number of copies of fAIM exon 3.
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.
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/CARLA J MYERS/Primary Examiner, Art Unit 1682