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 arguments and amendments have been thoroughly reviewed and considered. Claims 22, 26-27, and 30-31 remain withdrawn. Claims 21, 28, and 32-39 are pending and are examined on the merits herein.
Response to Applicant’s Amendments
Claim Objections
Claims 33, 36-37, and 39 were objected to for minor informalities. In light of Applicant’s amendments to the claims submitted 4/15/2026, the objections for claims 33, 36, and 39 have been withdrawn. Claim 37 has not been amended, and so this objection has been maintained. See also new grounds of objection below.
35 USC 112(b) Rejections
Claims 21, 28, and 32-39 were rejected for various indefiniteness issues. In light of Applicant’s amendments to the claims submitted 4/15/2026, these rejections have been withdrawn.
35 USC 112(d) Rejections
Claims 32 and 38 were rejected for being improper dependent claims. In light of Applicant’s amendments to the claims submitted 4/15/2026, these rejections have been withdrawn.
35 USC 103 Rejections
Claims 21, 28, and 34-37 were rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee et al. (WO 2008/089193 A2) in view of Yu et al. (Bioinformatics, 2011).
Claims 32 and 38 were rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee et al. (WO 2008/089193 A2), in view of Yu et al. (Bioinformatics, 2011), and further in view of Brentano et al. (US 2008/0274449 A1).
Claims 33 and 39 were rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee et al. (WO 2008/089193 A2), in view of Yu et al. (Bioinformatics, 2011), and further in view of Carlson et al. (U.S. Patent Application Publication No. 2006/0014142 A1) in view of Pichuantes et al. (U.S. Patent No. 6,942,965 B2), and in view of Zhang et al. (Chinese Patent Application No. 101875942 A).
Applicant’s arguments and amendments have been thoroughly reviewed and considered. The rejections for claims 32 and 38 have been withdrawn. The rejections for claims 21, 28, 33-37, and 39 are maintained. See “Response to Applicant’s Arguments” below.
Double Patenting
Claims 21, 28, 33, 36, and 38 were rejected on the ground of nonstatutory double patenting over claims 1, 9, and 23-26 of US 9,752,201 B2.
Instant claim 21 has been amended to specify that “the amplifying and detecting is multiplex amplifying and detecting,” but this amendment is in regard to a use for the oligomer combination, and does not affect the actual structure of the claimed oligomer combination. Additionally, the amendment to clarify the promoter sequence in the second parvovirus amplification oligomer still reads on the second parvovirus amplification oligomer in (b) of claim 1 of the ‘201 patent. Thus, the currently claimed oligomer combination of instant claim 21, along with the inventions of current dependent claims 28, 33, 36, and 38, are still patentably indistinct from claims 1, 9, and 23-26 of the ‘201 patent, and so these rejections are maintained.
Response to Applicant’s Arguments
Regarding the 35 USC 103 Rejections, Applicant argues that though the promotor sequences of claim 21 with regard to the second parvovirus amplification oligomer are broad in nature, and do not require a specific sequence, that these promotor sequences are “only relevant for the choice of RNA polymerase to include in the reaction mixture,” and provides support in the instant specification for the general inclusion of promotors in promotor-primers, as well as support for primers that do not require promotors (Remarks, pages 8-9). Applicant also states that in light of this, the unexpectedly low cycle times and performance in their provided data are thus commensurate in scope with the invention of claim 21.
Regarding the 5’ promoter sequences recited in claim 21 with the second target-hybridizing region, Applicant provides general support in their Remarks and instant specification for including such a promoter in the instant claims. The Examiner notes that support for such a promoter is present. However, in the instant specification, para. 221 states that a “promoter” is “a specific nucleic acid sequence that is recognized by a DNA-dependent RNA polymerase ("transcriptase") as a signal to bind to the nucleic acid and begin the transcription of RNA at a specific site.” While this provides a clear function for the promoter, it does not specify a particular length or nucleotide make-up for the promoter, aspects which both can affect how a given oligomer may behave (e.g. melting temperature and hybridization efficacy). Thus, for a specific promoter sequence encompassed by (b) of claim 21 that is not considered in the instant specification and data provided, there is no indication that an oligomer with that promoter will behave similarly to the oligomers described by Applicant’s examples and other data.
In the Examiner’s previous response that considered Applicant’s data submitted to this point, paras. 13-14 of the Non-Final Rejection noted potentially unexpected results associated with the use of SEQ ID NOs: 78, 79, 80, and 83 with each of instant SEQ ID NOs: 88, 89, 91, and 92. Applicant has limited the first parvovirus amplification oligomer of (a) of claim 21 to exclude SEQ ID NO: 81, but as the second parvovirus amplification oligomer of (b) of claim 21 is not limited to one of SEQ ID NOs: 88, 89, 91, and 92, the claims are not commensurate in scope with the unexpected results shown in Applicant’s data.
Thus, the Examiner maintains their position with regard to instant claim 21 and its dependents, with the exception of claim 38.
Regarding claim 38, this claim does specify the particular promoter sequences that must be used in (b). The second parvovirus amplification oligomers of this claim are those noted to, in combination with the first parvovirus amplification primers described in (a), produce unexpected results in the Non-Final Rejection (see para. 13). As these unexpected results were shown with clear comparisons to a variety of other primer pairs, the strength of the data provided is considered sufficient over the scope/range encompassed by the claim. This is the basis for the withdrawal of the prior art rejection concerning this claim.
Regarding claim 32, the claim has now been amended to be an independent claim. This claim also recites the four three primer combinations that were noted to show superior results compared to other three primer combinations in the Non-Final Rejection mailed 1/16/2026 (see paras. 11-12 of the rejection). The strength of the data provided – namely that these combinations can detect targets at 100% efficiency down to 50 copies per reaction, and can detect as few as 5 copies per reaction, is considered sufficient over the scope/range encompassed by the claim. This is the basis for the withdrawal of the prior art rejection concerning this claim.
Regarding claim 33, Applicant argues that Example 7 of the instant specification does describe the use of hepatitis A virus nucleic acids and parvovirus nucleic acids together. While this may be true, it is unclear what particular sequences are used together in the example, as para. 280 simply states, “Target capture oligomers were used singly and in combinations (meaning two or more target capture oligomers targeting hepatitis A virus or two or more target capture oligomers targeting parvovirus) in a target capture reaction,” with no indication as to which of the sequences recited earlier in the paragraph were actually used together. Additionally, no specific data is provided for how particular sequences performed, as the section simply ends with, “The single and combinations of specific target capture oligomers demonstrated improved sensitivity and capture efficiency compared to the non-specific target capture methods.” It is not clear that this description indicates that the use of the oligomers produces unexpected results, as there appears to be a comparison of two distinctly different methods (specific target capture and non-specific target capture), and the ordinary artisan would generally expect different methods to have different sensitivity or efficiency results. Applicant points to additional paragraphs in their Remarks that discuss the use of hepatitis A and parvovirus oligomers together, but these are general teachings, and do not remedy the deficiencies described here.
Therefore, Applicant’s arguments concerning this claim are not persuasive.
Thus, for those claims for which Applicant has not provided persuasive arguments or amendments, the prior art rejections have been maintained and are reiterated below.
Claim Objections
Claim 35 is objected to because of the following informality: it is recommended that in the final line, “and ribonucleoside” read “and/or ribonucleoside,” as one or more of the listed items may be used. Appropriate correction is required.
Claim 37 is objected to because of the following informalities: it is recommended that in lines 1-2, the wherein clause read “wherein the detection of the human parvovirus amplification product” to better match the language of the detecting step of claim 36, from which this claim depends. Appropriate correction is required.
Claim Interpretation
In claim 21, it is stated that the first and second amplification oligomers are used in combination for multiplex amplification and detection. However, the claim is directed to a product. As these recited uses do not impart any structure to the oligomer combination, they are considered intended use, and therefore the prior art does not need to teach said uses of the oligomers in combination in order to read on the instant claims. See MPEP 2111.02 II.
For each of the claimed amplification oligomers that comprises a target-hybridizing sequence that either comprises or consists of a particular sequence, it is noted that the amplification oligomer itself can still contain additional sequences outside of the target-hybridizing sequence.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 21, 28, and 34-37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee et al. (WO 2008/089193 A2) in view of Yu et al. (Bioinformatics, 2011).
Lee teaches nucleic acid molecules derived from parvovirus B19 (Abstract). These molecules include primers and probes (e.g. page 15, para. 3 and page 16, para. 2). Two such molecules are SEQ ID NOs: 34 and 36, which are capable of amplifying parvovirus B19 nucleic acid in a sample (pages 10-11, under step (a)(i)). SEQ ID NO: 36 contains the sequences of instant SEQ ID NOs: 108 and 111. Lee also teaches SEQ ID NO: 128, which is a partial parvovirus B19 genomic sequence (page 13, para. 1). This sequence contains instant SEQ ID NOs: 78-80, 83, 108-109, 111-112, and 119. Lee also teaches the use of kits containing the primers of their invention, where primers may be designed from SEQ ID NO: 128 (page 21, para. 2), or from other disclosed sequences (page 32, para. 3; instant claim 34). This reference also teaches real-time PCR and notes that this may be performed quantitatively. In this PCR method, samples with viral nucleic acids are used and combined with amplification reagents (which include dNTPs) in a tube or plate, and detection of amplicons occurs during the various amplification cycles (Example 2, pages 34-35; instant claims 36-37). Lee also teaches the use of multiplex assays (page 23, para. 2), and notes that the kit contains at least one primer and probe, indicating that multiple primers (and multiple primer pairs) may be used (page 21, para. 3). It is noted that Lee also teaches in other examples that viral RNA may be reverse transcribed into cDNA via the use of a reverse transcriptase before PCR is performed (page 36, paras. 1-2).
Furthermore, Lee also teaches the use of promoters for isolated nucleic acids. These promoters can be artificially attached to the nucleic acid molecules (pages 25-26, joining para.). Isolated nucleic acids of their invention may be sequences short enough to be used as primers (see pages 5 and 8), can hybridize to a parvovirus genomic sequence (page 9, paras. 1-4), and can be obtained by PCR (page 25, para. 2) or used in amplification (page 27, para. 5 and page 28, para. 2). Lee teaches that promoters may be T7 promoters (page 27, para. 5). Figure 8 of the reference also shows a promoter on the 5’ end of a sequence. The promoter sequence may be used as a polymerase recognition site (page 26, para. 1).
Yu teaches a method using PriSM software where panels of primer pairs can be designed from known sequences, and particularly from known viral genomes (page 267, column 1, para. 4). These primer pairs can be used for amplification, and specifically PCR (page 267, column 1, paras. 3-4).
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to use the sequences described by Lee as amplification oligomers to arrive at the inventions of claims 21, 28, and 35. The teachings of Yu indicate that software for PCR primer design is available and can be used by the ordinary artisan to obtain multiple primers suitable for amplifying a known sequence (page 267, column 1, paras. 3-4). In view of this, the ordinary artisan would have been motivated to use the commercially available software disclosed in Yu and the known human parvovirus sequences and primers disclosed by Lee to design additional primers for use in the method, kit, and reaction mixture of Lee, and in the absence of unexpected results, the claimed primers (instant SEQ ID NOs: 78-80, 83, 108-109, 111-112, and 119) simply represent the result of an obvious series of steps. Lee already teaches the use of primers that include the sequences of SEQ ID NOs: 108 and 111, and teaches that their SEQ ID NO: 128 can be used to develop further primers, which would allow the ordinary artisan to arrive at SEQ ID NOs: 78-80, 83, 109, 112, and 119. Additionally, as Lee does not put a limit on the number of primers that may be provided in their kit, the ordinary artisan would be motivated to include multiple primers, as using multiple primer sequences would increase the chance that a target viral nucleic acid could be detected, which would be important in diagnostic and other medical contexts. As Lee teaches means of amplification and detection using their primer sequences, there would be a reasonable expectation of success in using these sequences to perform the method of Lee and in arriving at the amplification oligomers of the claimed invention.
Furthermore, in view of the promoter teachings of Lee described above, it would be prima facie obvious to combine any of the primer sequences described above by Lee in view of Yu with a promoter sequence – namely because said addition may lead to increased polymerase binding and therefore greater amplification yield, which would be motivating to the ordinary artisan. Lee teaches that the addition of promoters to nucleic acids related to viral genomes and amplification/detection is well-known, thus providing a reasonable expectation of success.
Therefore, claims 21, 28, and 34-37 are prima facie obvious over Lee in view of Yu.
Claims 33 and 39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee et al. (WO 2008/089193 A2), in view of Yu et al. (Bioinformatics, 2011), and further in view of Carlson et al. (U.S. Patent Application Publication No. 2006/0014142 A1) in view of Pichuantes et al. (U.S. Patent No. 6,942,965 B2), and in view of Zhang et al. (Chinese Patent Application No. 101875942 A).
Regarding claims 33 and 39, Lee in view of Yu teaches the oligomer combination of claim 21. However, neither of these references teach measuring parvovirus and HAV nucleic acids.
Carlson teaches in vitro methods for amplifying and detecting HAV sequences (Abstract). This reference specifically teaches an embodiment in which HAV and human parvovirus B19 are simultaneously detected in human samples (para. 68). This involves the use of amplification oligomers and detection probes, and both viruses are amplified and detected in the same reaction mixture (para. 68). Carlson concludes that “These results show that HAV nucleic acid is specifically detected when the sample includes HAV and another virus, human parvovirus B19, which is also specifically detected,” (para. 68).
However, Carlson does not teach the recited sequences in claim 33.
Pichuantes teaches primers and probes for HAV (Abstract). This reference specifically teaches SEQ ID NO: 29, which is an insert encoding the full length HAV open reading frame (Figure 3 and column 3, para. 5). SEQ ID NO: 29 includes instant SEQ ID NOs: 173 and 174. In addition, Pichuantes teaches that, “Sequence [sic] of polynucleotides that encode HAV proteins are also useful for designing primers for polymerase chain reaction (PCR),” (column 14, para. 3), and that PCR products can be detected using quantitative methods, such as by measuring fluorescence (column 17, para. 3).
However, this reference does not teach instant SEQ ID NOs: 175 and 177.
Zhang teaches the complete HAV genome (English Translation para. 1). This genome can be found in SEQ ID NO: 1, and it contains instant SEQ ID NOs: 175 and 177. Zhang also teaches that primers can be made from SEQ ID NO: 1 for use in detecting HAV, and that these primers can be between 15-100 nucleotides in length (English Translation paras. 16-17). These primers can then be used for PCR (English Translation para. 27).
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to use the teachings of Carlson, Pichuantes, and Zhang to add to the method of Lee in view of Yu and arrive at the methods of instant claims 33 and 39. This would involve including primers for HAV in the amplification methods described by Lee in order to detect parvovirus and HAV in a single sample. Carlson provides evidence that these viruses can specifically be detected separately in a single mixture, and by developing such a multiplex assay, it would allow for more efficient diagnostic tools and would save on diagnostic reagents and equipment. Carlson also provides a reasonable expectation of success, as they accomplished a successful multiplex assay with these two viruses. As for the primer sequences, as stated above, Yu teaches designing multiple primers from known sequences, and so this would motivate one of ordinary skill in the art to design HAV primer sequences for use in the method of Lee, in view of Yu, and in view of Carlson. Thus, the ordinary artisan would have been motivated to use the commercially available software disclosed in Yu and the known HAV sequences disclosed by Pichuantes and Zhang to design additional primers for use in the method and oligonucleotide combination of Lee, in view of Yu, and in view of Carlson, and in the absence of unexpected results, the claimed primers (instant SEQ ID NOs: 173-175 and 177) simply represent the result of an obvious series of steps.
Therefore, claims 33 and 39 are prima facie obvious over Lee, in view of Yu, and further in view of Carlson, in view of Pichuantes, and in view of Zhang.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21, 28, 33, 36, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, and 23-26 of U.S. Patent No. 9,752,201 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘201 patent recites a method for detecting human parvovirus involving two amplification oligomers, one of SEQ ID NO: 80 (which is identical to instant SEQ ID NO: 80), and one of SEQ ID NO: 111 or 112 with a 5’ promoter attached (which are identical to instant SEQ ID NOs: 111 and 112, also with a 5’ promoter attached). Thus, this claim teaches the oligomer combination of instant claim 21. It is noted that instant claim 21 states that “the amplifying and detecting is multiplex amplifying and detecting,” but this amendment is in regard to a use for the oligomer combination, and does not affect the actual structure of the claimed oligomer combination or how it relates to the claims of the ‘201 patent. The method of claim 1 also reads on instant claim 36, as a sample is contacted with the oligomers, in vitro amplification is performed, and the presence/absence of parvovirus is detected. Claim 1 of the ‘201 patent also reads on the oligomer combination of instant claim 38, as in instant claim 38, SEQ ID NO: 80 can be used, as well as SEQ ID NOS: 91 or 92, which are equivalent to SEQ ID NOs: 111 and 112 with the addition of 5’ promoters.
Claim 9 of the ‘201 patent combines the parvovirus detection with HAV detection, where the same first and second amplification oligomers for HAV presented in instant claim 33 are used. This claim also reads on instant claim 39, as in vitro amplification and detection steps are also recited.
Claim 23 of the ‘201 patent recites the additional use of SEQ ID NO: 119, and so reads on instant claim 28.
Claim 24 of the ‘201 patent recites the use of a T7 promoter sequence for the second amplification oligomer. As this type of promoter is the one used in the instant claims (see Table 3 of the instant specification), this claim also reads on instant claims 21, 36, and 38.
Claim 25 recites the use of a particular promoter sequence (5’-aatttaatac gactcactat agggaga-3’). This corresponds to the same promoter used in the sequences of the instant claims that contain a promoter sequence, and so this claim also reads on instant claims 21, 36, and 38.
Claim 26 requires the specific use of SEQ ID NOs: 91 and 92 as the second amplification oligomer, and so even more explicitly reads on the limitations of instant claims 21, 36, and 38.
Conclusion
Claim 32 is allowable. All other instantly examined claims have pending objections and/or rejections.
THIS ACTION IS MADE FINAL. 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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/F.F.G./Examiner, Art Unit 1681
/ANGELA M. BERTAGNA/Primary Examiner, Art Unit 1681
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