DETAILED CORRESPONDENCE
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in response to the papers filed July 1, 2026. Currently, claims 1-17 are pending. Claims 15-17 have been withdrawn as drawn to non-elected subject matter.
Election/Restrictions
Applicant's election without traverse of Group 1, claims 1-14 and Ancylostoma caninum, in the paper filed July 1, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims priority to
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Improper Markush Rejection
Claims 1-14 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
A Markush claim contains an “improper Markush grouping” if:
(1) the species of the Markush group do not share a “single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a “single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent. See MPEP § 2117.
Here each species is considered to be each of the intestinal parasites claimed. Applicant elected Ancylostoma caninum, hookworm. Trichuris vulpis is a nematode with a distinctive whip-like shape. Cystoisospora canis, previously known as Isospora canis, is a microscopic, coccidian parasite that causes an intestinal tract infection in dogs. Each of these parasites is different and does not share a common structure or function.
The recited alternative species in the groups set forth here do not share a single structural similarity, as each different parasite may be detected by DNA analysis using different primers and probes. The primers recited in the instant claims, do not share a single structural similarity since each consists of a different nucleotide sequences with different hybridization targets. The only structural similarity present is that all detected positions are part of nucleic acid molecules. The fact that the markers comprise nucleotides per se does not support a conclusion that they have a common single structural similarity because the structure of comprising a nucleotide alone is not essential to the common activity of detecting different targets.
MPEP 2117 (II)(A) provides the following guidance as to what constitutes a physical, chemical, or art recognized class:
A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein “there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved”
The recited parasites and their primers for detection do not belong to a recognized chemical class because there is no expectation from the knowledge in the art that the genes will behave in the same manner and can be substituted for one another with the same intended result achieved. In other words, there is no expectation from the knowledge in the art that each of the recited PCR primers would function in the same way in the claimed method; it is only in the context of this specification that it was disclosed that all members of this group may behave in the same way in the context of the claimed invention. Further there is no evidence of record to establish that it is clear from their very nature that each of the recited PCR primers possess the common property of detecting each other parasite. Each PCR primer pair is designed to detect different intestinal parasites that would not be expected to detect the other intestinal parasites.
MPEP 2117 (II) further states the following:
Where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the compounds do not appear to be members of a recognized physical or chemical class or members of an art-recognized class, the members are considered to share a "single structural similarity" and common use when the alternatively usable compounds share a substantial structural feature that is essential to a common use. Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
The recited alternative species do not share a substantial common structure just because they all have a sugar phosphate backbone. The sugar phosphate backbone of a nucleic acid chain is not considered to be a substantial common structural feature to the group of genes being claimed because it is shared by ALL nucleic acids. Further, the fact that the primers all have a sugar phosphate backbone does not support a conclusion that they have a common single structural similarity because the structure of comprising a sugar phosphate backbone alone is not essential to the asserted common use of detecting different intestinal parasites.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Following this analysis, the claims are rejected as containing an improper Markush grouping.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Massetti et al. (PLOS Neglected Tropical Diseases, Vol. 14 No. 6: e0008392, Jun 15, 2020) in view of GenBank Accession Number JG812694 (page 4, lines 1-2), Hu et al. (BioMed Research International Vol. 2015, Article ID 406168, 2015) and CN107937563 (April 20, 2018).
Massetti teaches high-throughput multiplex qPCRs for the surveillance of zoonotic species of canine hookworms. Massetti teaches obtaining fecal sample (page 3). The samples comprises at least one hookworm egg (page 3). Massetti further , teaches DNA concentrations and detection limits (Figure 1). Massetti teaches extracting DNA from faeces and performing multiplex qPCR (page 3). Massetti teaches sequences were aligned with GenBank sequences using Clustal Omega and primer and probes targeting highly conserved region of the ITS1 were designed and analyzed for suitability using Oligo Analyzer. Massetti teaches optimization of each assay may be performed and concentrations of primer pairs and probes were tested for select concentrations for highest efficiency and greatest sensitivity. Table 1 provides primers and probes for A. caninum. The alignment provides an alignment of the probes of Massetti and probes.
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Massetti teaches the Genbank region of A .caninum is found at GenBank Accession Number JG812694 (page 4, lines 1-2). Genbank JQ812694.1 teaches the ITS1, 5.8S rRNA and ITS2 and 28S rRNA gene partial sequence. SEQ ID NO: 1, 2 and 3 are embedded within the known ITS1 region.
Hu also teaches multiplex PCR for simultaneous detection of three zoonotic parasites including A. caninum. The primers of Hu that amplify A. caninum are 4 bp upstream of SEQ ID NO: 1. Thus Hu teaches these regions are ideal for distinguishing parasites.
Even more CN107937563 teaches primers that are 4 bp upstream of SEQ ID NO: 1 and comprise SEQ ID NO: 3 for detecting A. caninum.
It would have been prima facie obvious for one of ordinary skill in the art to conduct the A. caninum detection method of Massetti using oligonucleotide primers capable of producing an ITS1 amplicon. Massetti teaches analysis of the ITS1 region of A. caninum using primers and probes within the ITS1 region. Genbank JQ812694 is directed to the ITS1 region and comprises SEQ ID NO: 1, 2, and 3. The art is further replete with additional primer pairs that may be used to amplify and detect the ITS1 region of A. caninum. Specifically, Hu and CN107937563 flank the primers of the instant application. Massetti teaches aligning the ITS1 region to identify regions that may be used to design primers and probes and optimizing the assays. A skilled artisan at the time of filing would have designed primers and probes to known sequences (such as the sequences disclosed in Genbank JQ812694) with a high expectation of success. To design such primers constituted routine and conventional optimization at the time of filing. See In re Aller, 220 F.2d 454, at 456 (CCAP 1955) (“where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”). Numerous references describe how to design and optimize primers and probes for PCR applications including Massetti.
An ordinary artisan would have been motivatedto do so with a reasonable expectation of success, since: (i) Massetti expressly taught designing oligonucleotide primers from the known ITS1 sequence, (ii) the complete ITS1 sequence if A, caninum was known in the art at the time of the invention, and (iii) Massetti taught rules for designing amplification primers and disclosed a publicly available program that uses the disclosed rules to design primers from any known target nucleic acid sequence. The combined teachings of the cited references would have suggested a finite number of possible PCR primer pairs that could be designed from the known ITS1 sequence to the ordinary artisan, and, based on the teachings of Massetti, the ordinary artisan would have expected predictable results in obtaining and using these oligonucleotides in the A. caninum detection method to produce an amplicon with the claimed primers. Thus, absent any evidence of unexpected results with respect to particular primers, the method of claim 1 is prima facie obvious in view of the combined teachings of the cited references.
As noted in In re Aller, 105 USPQ 233 at 235, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that the primer selection performed was other than routine, that the products resulting from the optimization have any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art.
Thus, the instant sequences are clearly a functional homologues of the above similar primers based on the known ITS1 sequence. This is supported by In Re Deuel, 34 USPQ 2d 1210 (Fed. Cir. 1995), in which the Court of Appeals for the Federal Circuit stated that (emphasis added).
Normally, a prima facie case of obviousness is based upon structural similarity, i.e., an established structural relationship between a prior art compound and the claimed compound. Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.
Applicants should submit secondary evidence of non-obviousness in line with MPEP §§ 716.01-716.02 (e.g. unexpected results evidence).
Claims 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Massetti et al. (PLOS Neglected Tropical Diseases, Vol. 14 No. 6: e0008392, Jun 15, 2020) in view of GenBank Accession Number JG812694, Hu et al. (BioMed Research International Vol. 2015, Article ID 406168, 2015) and CN107937563 (April 20, 2018) as applied to Claims 1-6, 11-14 above and further in view of Muchaamba et al. (Parasitology Research, Vol. 120, pages 3451-3459, August 2021).
Massetti, Genbank, Hu nor CN107937563 teach obtaining a sample from a perianal swab prior to performing PCR analysis in field.
However, Muchaamba teaches collecting perianal swabs is a method for obtaining sample that may detect intestinal parasites. Muchaamba teaches stool samples have a high turnaround time. Muchaamba teaches parasite DNA (cells and eggs) present in the perianal region of the host can be exploited as a target for molecular diagnosis (abstract). Muchaamba teaches cotton swabs were rubbed at the perianal region and DNA was extracted. Muchaamba teaches the peri-anal cotton swabs may be used for DNA extraction in field (point of care samples). DNA was used in a multiplex PCR assay (swab-PCR). Muchaamba teaches the LAMP method may be used in field conditions and is cost-effective method for DNA extraction and analysis.
Therefore, it would have been prima facie obvious prior to the claimed invention to have modified the method of Massetti, Genbank, Hu and CN107937 to use perianal samples rather than fecal samples. Muchaamba teaches perianal samples collected using a swab allow for in field detection that relies upon less reagents and equipment. The ordinary artisan would have been motivated to have performed on the spot, point of care analysis for the expected benefits taught by Muchaamba with a reasonable expectation of success.
Conclusion
No claims allowable over the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached on (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
September 1, 2026
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