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 .
Election/Restrictions
Applicant's election with traverse of Group I, and SEQ ID NO: 3 and SEQ ID NO: 7 in the reply filed on 3/16/26 is acknowledged. The traversal is on the ground(s) that there is unity of invention among the groups. This is not found persuasive because no technical feature is a special technical feature, as evidenced by the prior art rejections herein, which evidence lack of inventive step.
Claims directed to non-elected species and inventions are WITHDRAWN from prosecution.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim(s) 1, 6, 7, 10-14, 23, 26, 30, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samarasinghe in view of Wang and further in view of GenBank Records having Accessions: EU124685.1, EU124686.1, EU124687.1, EU124688.1, and EU124689.1.
Samarasinghe teaches amplifying the ITS-1 rDNA locus of Cystoisospora, including C. suis using a primer that is fully complementary to a portion of SEQ ID NO: 1 and is identical to instant SEQ ID NO: 7. ITSGF primer taught in the reference is identical to instant SEQ ID NO: 7. The primers used by Samarasinghe were single stranded nucleic acids with a length between 5 and 50 bases.
Samarasinghe teaches extraction and amplification from DNA from pig’s faecal samples (Section 2.1).
Samarasinghe teaches 45 cycles of amplification (Section 2.2).
Samarasinghe teaches restriction fragment analysis of the amplicon and identifies polymorphisms within different species tested (Figure 1). The reference teaches that sequences generated were submitted to GenBank (p. 594). Samarasinghe teaches that C. suis is clearly differentiated from other Cystoisospora based on RFLP (p. 594).
Samarasinghe does not teach amplifying a fragment of the ITS-1 rDNA locus that is less than 400 nucleotides in length, nor wherein the primer pair comprises elected SEQ ID NO: 3.
Wang teaches that ITS regions are useful targets for species specific oligonucleotides because they can vary sufficiently among several plant pathogenic species to allow the construction of unique primer sequences. The reference teaches that the ITS region had previously been used to differentiate the pathogen by RFLP. The reference demonstrates selection of species-specific primers by aligning sequence data using commercial software and selecting primers from within the ITS. The reference teaches selecting a species-specific primer from within ITS1 for each species and then pairing it with a universal primer for species-specific amplification (p. 129, Col 2; Table 1). The reference teaches advantages that because of its rapidness and ease, PCR amplification could be used for species specific detection (p. 131, 2nd col).
Therefore, it would have been obvious to have modified the method taught by Samarasinghe to have selected species-specific primer or primers from within the C. suis amplicon for the specific amplicon of the pathogenic C. suis. One would have been motivated to do so to allow for the species-specific detection of the pathogen with rapidness and ease using PCR, as exemplified by Wang. Furthermore, following the teachings of Wang, it would have been obvious to have paired one species specific primer with a universal primer, such as one of the universal Cystoisospora primers taught by Samarasinghe. Since Samarasinghe teaches polymorphic fragments within the 450bp amplicon, selection of primers to align with these polymorphic regions would have necessarily resulted in a method to produce an amplicon of less than 400bp
The teachings of Samarasinghe in view of Wang are given previously in this Office action and are fully incorporated here.
While this method teaches amplification using a primer identical to SEQ ID NO: 7, it does not teach amplification using a primer comprising instant SEQ ID NO: 3 (consonant with the election).
Samarasinghe teaches that the sequences of all of the ITS amplicons were deposited in GenBank, and Wang teaches aligning ITS sequences to select species specific primers. Instant SEQ ID NO: 3 is the complement of nucleotides 106-125 of GenBank EU124685.1, which is a portion that has many polymorphisms among the different species. A multiple alignment of all of the disclosed species is given at the end of this Office action.
It would have been obvious to have selected a primer comprising or consisting of instant SEQ ID NO: 3 from within the C. suis ITS taught by Samarasinghe and disclosed in EU124685.1, since this primer is within a region that is polymorphic among species. An ordinary artisan would have been motivated to do so with a reasonable expectation of success, since: (i) Samarasinghe expressly taught that the ITS was polymorphic among Cystoisospora species, (ii) the complete ITS sequences were disclosed by Samarasinghe and provided in the GenBank Records, and (iii) Wang demonstrated aligning ITS sequences for the express purpose of designing species specific primers, and using a species specific primer with a known universal primer as the other member of the primer pair. 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 Cystoisospora ITS sequence to the ordinary artisan, and, based on the teachings of Wang, the ordinary artisan would have expected predictable results in obtaining and using these oligonucleotides to amplify a fragment of C. suis that was less than 400 nucleotides. Thus, the claimed methods, including those using a primer pair consisting of instant SEQ ID NO: 3 and SEQ ID NO: 7 were obvious in view of the prior art.
Claim(s) 15 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samarasinghe in view of Wang as applied to claims Samarasinghe in view of Wang and further in view of GenBank Records having Accessions: EU124685.1, EU124686.1, EU124687.1, EU124688.1, and EU124689.1 above, and further in view of Garibyan et al. (J Invest Dermatol. Author manuscript; available in PMC 2014 July 17; 8 pages).
The teachings of Samarasinghe in view of Wang are given previously in this Office action and are fully incorporated here.
The combined references do not teach detecting the amplicon with a probe, here interpreted in light of the specification as being detection by hybridization to a probe.
Garibyan teaches that real time PCR can be used to detect PCR amplicons by including sequence-specific DNA probes consisting of fluorescent labeled reports in an amplification reaction that is a quantitative PCR, also known as qPCR (page 3).
It would have been obvious to have modified the method taught by Samarasinghe in view of Wang to have used probe to detect species specific amplicons as the application of a known technique to achieve a predictable result. One would have been motivated to use the probe to detect the PCR products to determine and quantify S. suis in a sample.
Response to Remarks
Any rejection that is not reiterated or updated was overcome by amendment to the claims.
Applicant argues that the claimed invention fulfills the requirements associated with unity of invention. The examiner does not agree. The prior art rejections herein evidence that the method which uses the claimed primers, and thus the claimed primers do not involve an inventive step since they are also obvious. Reconsideration will be appropriate when inventive step is established. Applicant is advised that the products, if rejoined upon a finding of unity of invention will be considered for rejections under 101 to determine whether they recite products of nature judicial exceptions.
The substitute specification has been entered.
The 326 has been marked to indicate the claim to foreign priory and that a copy of the priority document has been received.
The obviousness rejections are updated to address the amended claims but are substantively the same as those presented in the prior Office action.
The major distinction is that the final line of the main 103 rejection has been deleted since it was a typing error and did not make sense following the complete 103 analysis that preceded it.
Applicant argues that the amendments to the claims have rendered the 103 over Samarasinghe in view of Wang moot. This is agreed, since the claims now require specific primers by SEQ ID NO: that were not addressed by the combination of these two references alone.
With regard to the 103 that included the GenBank Accessions, applicant points out that the final sentence of the 103 stated that a method “using a primer pair consisting of SEQ ID NO: 3 and SEQ ID NO: 7 are free of the art.” This statement is deleted from the rejection and RETRACTED. It was a typing mistake. The rejection provides a complete analysis as to why the elected and claimed method would have been obvious. Furthermore, it is noted that most of the claims do not require a primer pair consisting of the elected primer pair. Nonetheless, even where “consisting of” language is explicitly used to define the primer pair, the prior art supports that such a method was obvious for the reasons given in the rejection.
Applicant argues that Samarasinghe does not teach a complementary primer that allows one to amplify a region specific to C. suis to discriminate this strain from other strains. But, the reference does clearly teach that there is polymorphism within the amplicon they made that would allow such a distinction. Before the effective filing date, methods for identifying species specific primers were well known, as exemplified by Wang. Thus, it would have been obvious to align the short amplicons taught by Samarasinghe and select species specific primers from the finite number of options presented.
The rejection is maintained.
The action is non-final to correct the typing error and RETRACT the statement that the claimed method is free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
Alignment of five cited GenBank sequences, SEQ ID NO: 3 complementary to the suis sequence, in the second line of the sequence towards the end, beginning with “ttcga” :
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625
528
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Prosecution Insights