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 .
Claim Status
Currently, claims 1, 5, 8, 11, 13, 15, 17-20 are pending in the instant application. Claims 2-4, 6-7, 9-10, 12, 14, and 16 have been canceled and claims 5, 8, 13, 15, 18-20 are withdrawn as being drawn to a non-elected invention. This action is written in response to applicant' s correspondence submitted 03/05/2026. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant' s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is Final.
The amendment to the specification has been entered.
Withdrawn Rejections
The objection to claim 1 has been withdrawn in view of the amendment to the claims.
Maintained Rejections
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 1, 11, and 17 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. This rejection was previously presented and has been rewritten to address the amendment to the claims.
Claim 1 recites said microsatellite marker consisting of a DNA sequence loci that is differentially expressed with a highest expression level at a specific base pairs with one or more primers selected from the group consisting of Dims19…or combination thereof. This recitation renders the claim indefinite. The claims are directed to products and not a method and the recitation of “differentially expressed with a highest expression” are process steps. It is not clear what the features of the microsatellite marker encompass and what limitations are required for differentiation. For example does the claim require a marker that has a specific number of base pairs, a nucleotide at a specific loci, or does the claim require a specific primer? Microsatellite markers are tandemly repeating DNA sequence motifs that range in length from 1 to 8 nucleotides. Primers are used to amplify microsatellite regions. The result is analysis of the microsatellite loci with allele size and repeat type. The claim recites a marker consists of a DNA sequence however then requires one or more primers, consisting of language is closed and does not allow for additional sequences, it is unclear if the claim requires a DNA sequence or single nucleotide that is capable of expression or if the claim is requiring that the DNA sequence is one of the primers recited in the claim. If it is the later the claim is indefinite because it recites closed language followed by open language. Additionally it is unclear if the claim is requiring only one nucleotide as the claim recites a DNA sequence loci, which can consist of only one nucleotide. Expression level has to do with amount of DNA that is measured, for example for an entire sequence and not a level of a specific base pair. The claims are vague and indefinite and it is unclear what the features of the marker comprise. Thus it is unclear what is encompassed by the claimed microsatellite marker and what the structural limitations of the claimed marker encompass given the recitation of a marker consisting of a DNA sequence loci that is differentially expression with one or more primers.. Combining two statutory classes of invention in a single product claim raises questions of what the structural requirement of the claimed marker encompasses. One of ordinary skill in the art would not know the metes and bounds of the claimed marker and an evaluation of the possibility of infringement would not be able to be ascertained with a reasonable degree of certainty. The specification does not provide a standard for ascertaining the request degree of the claimed molecular marker and one of ordinary skill in the would not be reasonably apprised of the scope of the invention.
Claims 11 and 17 depend from claim 1 and are indefinite for the reasons applied to claim 1.
Response to Arguments
The response traverses the rejection on page 5 of the remarks mailed 03/05/2026 and assert claim 1 has been amended to particularly define the claimed microsatellite marker consisting of a DNA sequence loci that is differentially expressed with a highest expression level at a specific base pair with one or more primers. This response has been reviewed but not found persuasive. For the reasons addressed in the rejection above, this rejection is maintained. The amendment to the claim does not clarify the scope of the claimed microsatellite marker. The claims require the marker consists of a DNA sequence loci but does not define the DNA sequence loci and recites method steps to characterize the sequence, however there are no structural requirements for the DNA sequence loci. Additionally the claim recites primers, however the claim limits the language to consisting a DNA sequence loci, which is only one position but then requires primers, it is unclear what is encompassed by the claimed marker and what the structural limitations of the claim encompass.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 11, and 17 rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. This rejection was previously presented and has been rewritten to address the amendment to the claims. The claims recite a law of nature.
The claims are directed to a law of nature. The claims are drawn to a composition of matter and encompass a natural phenomenon. Specifically the claims are drawn to a composition that comprises a microsatellite locus of D. immitis. Because the claims are drawn to markers that comprise nucleic acid sequences to known naturally occurring nucleic acids of Dirofilari immitis the claims encompass a law of nature. Such isolated nucleic acid molecules that are identical to naturally occurring nucleic acid are naturally occurring sequences.
The specification does not define a microsatellite marker. There is no recitation within the claims that indicate that the marker claimed have any structural or functional characteristics that differ from the naturally occurring nucleic acids. While the claims recite microsatellite marker consisting of a DNA sequence loci that is differentially expressed with a highest expression level at a specific base pair with one or more primers, there is no requirement that there any structural difference between the claimed microsatellite marker and the loci in strains of D. immitis, as such this recitation does not structurally change the naturally occurring sequence of the marker. There is no indication in the specification that the microsatellite marker claimed here have any structural or functional characteristics that differ from the naturally occurring nucleic acids. Additionally the claims reciting a corresponding primer that differentiates JYD-34 heartworm, GAIII heartworm, shows a peak at 168 base pairs or 162 base pairs does not result in a structure that is markedly different than the naturally occurring nucleic acid sequence because the recitation is intended use and does not impart any structural requirements on the marker than what is encompassed by the naturally occurring sequence.
There is no indication that the marker results in changing the structure, function or other properties of the naturally occurring nucleic acid. According the microsatellite marker is a product of nature exception and the claim is directed to at least one exception. This judicial exception is not integrated into a practical application because the claims recite corresponding primers and strains that are naturally occurring and the primers detect naturally occurring sequences. The recitation of marker is nothing more than an attempt to generally link the product of nature to a technological environment and is a nominal extra solution component of the claim and does not structurally change the nucleic acid sequence. Sanchez (2020) cited in this record demonstrate the microsatellite marker and primer are naturally occurring sequences.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims as a whole are not considered to recite any additional elements that amount to significantly more than the naturally occurring nucleotide sequences. Besides the nucleic acids, the claims recite a intended use with respect to the primer and marker. Additional claims recite a marker that differentiates JYD-34 and GAIII heartworm strains and is differentially expressed with a highest expression level at a specific base. As addressed above, this is considered functional language that does not impart any structural requirement on the microsatellite marker and it is not considered to be significantly more than the judicial exception. At the time the invention was made, microsatellite markers was well-established, routine and conventional. Additionally where a marker is recited at such a high level of generality it does not meaningfully limit the claim. The recitation of intended use and functional language do not structurally change the nucleic acid sequence and is not significantly more than the naturally occurring sequence. Thus the claims as a whole does not amount to significantly more than each “product of nature” by itself and the claims do not qualify as eligible subject matter.
Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter.
Response to Arguments
The response traverses the rejection on page 6 of the remarks mailed 03/05/2026. The response asserts that the claim has been amended to a microsatellite marker consisting of a specific DNA sequence loci that is different expression with highest expression level at a specific base pairs with one or more particular corresponding primers. The response asserts that the claimed microsatellite marker of the specific loci containing a specific number of base pairs within the marker showing peak, highest expression level at the specific base pairs with one or more particular corresponding primers for differentiation three different isolates of heartworm is significantly more than each product of nature. This response has been reviewed but not found persuasive. The claims do not require or recite any specific structural requirements other than a DNA sequence and even arguendo the claim is requiring primers for Dim19, the primers for Dim19 are naturally occurring sequences. There is nothing recited within the claim that is significantly more than the product of nature. For these reasons and reasons of record is maintained.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 11, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanchez (Veterinary Parasitology, 2020, 283, 109125, pp 1-10). This rejection was previously presented and has been rewritten to address the amendment to the claims.
With regard to claim 1-2 and 17, Sanchez teaches microsatellite locus Dims19 and allele sizes of 159-171 for D. immitis (see table 3). Sanchez teaches primers for the locus Dims19. Because Sanchez teaches the microsatellite locus, Dims19 of D. immitis, Sanchez anticipates the claimed invention. The claim has been interpreted to require a DNA sequence that includes the microsatellite locus Dims19 or primers for Dims19. While the claim recites a marker consisting of a DNA sequence the claim further requires one or more primers. The claim does not comprise any structural requirements other than a microsatellite maker. The claim has been interpreted to require a marker that is capable of differentiating one or more isolates of D. immitis and is capable of having a DNA sequence loci that is differentially expression with one or more corresponding primers. As such the Dims19 locus and allelic sizes disclosed by Sanchez encompass a microsatellite marker that meets the limitations of the claims.
With regard to claims 11, Sanchez teaches JYD.A(34).2t isolate (JYD-34) and GA2.At.a2 t (GA III isolates)(see table 1). While the claim is directed to a microsatellite marker without any structural limitations as addressed above, the marker disclosed by Sanchez is capable of differentiating JYD-34 and GA III heartworms. Sanchez teaches the allele sizes of the marker comprise 159-171 base pairs, which is encompassed by claims 11, 168 base pairs (see table 3).
Response to Arguments
The response traverses the rejection on page 6-7 of the remarks mailed 03/05/2026. The response asserts the claim has been amended to recite markers for differentiating JYD34 heartworm from GA III heartworm and/or SC-20 with a microsatellite marker consisting of a DNA Sequence loci that is differentially expressed with highest expression level at a specific base pair with one or more primers, Dim19. The response asserts that Sanchez discloses a panel of microsatellite markers but does not disclose a microsatellite marker consisting of the DNA Sequence loci that is differentially expressed with the highest expression level at the specific base pair with one or more recited primers, alone or in combination. As addressed in the rejection under 35 USC 112(b) the claims do not clearly recite the structural requirements of the markers. Additionally it is unclear if the marker consists of only one loci or if the claim comprise a loci and primers, which is what is recited within the claim. Additionally the recitation of differentiation and differentiated expressed are intended use and functional language that does not result in any structural limitation requirements of the marker. The claims have been interpreted to require a primer, Dim19, which is anticipated by Sanchez. For these reasons and reasons of record the rejection is maintained.
Conclusion
No claims are allowable.
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 SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
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