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 .
Election/Restrictions
2. Applicant’s election without traverse of Group I (claims 1-5, 12, and 30) in the reply filed on September 18, 2025 is acknowledged.
Applicant’s election without traverse of “Species (A) and SEQ ID NO: 1” for examination in the reply of September 18, 2025 is also acknowledged.
As noted by Applicant, claims 1-5, 12, and 30 read on the elected invention and species.
Claims 6-11, 13-18, 22, 24, and 26-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 18, 2025.
Specification
3. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see pages 6-7, paras. 26 and 29). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
4. The claims present two issues that merit discussion: (a) the presence of variable nucleotides in the elected oligonucleotide (i.e., SEQ ID NO: 1), and (b) the use of “having” as a transitional phrase.
(a) the presence of variable nucleotides in SEQ ID NO: 1
The elected oligonucleotide, SEQ ID NO: 1, contains two variable positions: (i) R, which may be A or G, at position 9; and (ii) Y, which may be C or T, at position 17. Since independent claims 1, 2, 12, and 30 recite “an oligonucleotide” or “a primer,” they are considered to encompass oligonucleotides in which one of the options for each variable position is satisfied. In other words, the claims are not interpreted as requiring a mixture of all four possible oligonucleotides encompassed by SEQ ID NO: 1, and are interpreted as encompassing single oligonucleotides that contain one of the permitted options at each variable position.
(b) the use of “having” as a transitional phrase
Claims 2, 4, 12, and 30 use the transitional phrase “having.” More specifically, claims 2 and 4 recite “having the sequence,” and claims 12 and 30 recite “having a sequence.”
As discussed in MPEP 2111.03 IV, the transitional phrase “having” “must be interpreted in light of the specification to determine whether open or closed claim language in intended.”
In this case, the specification does not explicitly define the transitional phrase “having” as being open or closed, nor does it contain other teachings that would clarify the issue of whether “having” is open or closed. As can be seen in, e.g., paras. 7, 8, and 14, the specification simply uses “having” as a transitional phrase without elaboration as to whether open or closed language is intended. As a result, it is not clear whether the language is intended to be open or closed. This is also discussed in the indefiniteness rejection set forth below. For prior art purposes, “having” has been treated as equivalent to “comprising.”
Claim Objections
5. Claim 1 is objected to because both instances of “SEQ ID NO: 1-29” should be replaced with “SEQ ID NOs: 1-29” to be more accurate and also to be consistent with the dependent claims.
Claim 1 is also objected to because of the following minor informality: deleting the “a sequence” language in parts (i) and (ii) is suggested to make the claim more concise. To illustrate, the claim could be amended as follows: An isolated oligonucleotide selected from the group consisting of: (i) an oligonucleotide consisting of any one of SEQ ID NOs: 1-29, having 1-5 nucleotides added or removed from the 5’ and/or 3’ ends; and (ii) an oligonucleotide consisting of any one of SEQ ID NOs: 1-29.
Claim 3 is objected to because of the following minor informality. Replacing “at least two or more” with “at least two” or “two or more” is suggested.
Claim 4 is objected to because of the following minor informality. Replacing “SEQ ID NOs: 1-7, 8,” in line 3 with “SEQ ID NOs: 1-8” is suggested to improve conciseness.
Claim 12 is objected to because “SEQ ID NO: 1-29” in each claim should be replaced with “SEQ ID NOs: 1-29” to be more accurate.
Claim Rejections - 35 USC § 101
6. 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 1-5, 12, and 30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception—specifically, a product of nature—without significantly more.
Claim 1
Claim 1 is drawn to an isolated oligonucleotide “selected from the group consisting of: (i) a sequence of any one of SEQ ID NOs: 1-29, having 1-5 nucleotides added or removed from the 5’ and/or 3’ ends; and (ii) a sequence consisting of any one of SEQ ID NOs: 1-29.” As noted above, Applicant has elected SEQ ID NO: 1 for examination.
As discussed in MPEP 2106.04(b)(II), products of nature include naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. In this case, it is not clear that the oligonucleotides encompassed by claim 1 in view of the species election are found in nature, but said oligonucleotides need not possess any sequence differences or additional structural elements (e.g., a non-naturally occurring detectable label) relative to their naturally occurring counterparts, which are bacterial 16S rRNA sequences (see para. 13 and Table 1 on page 23 of the specification; see also Figure 1A and paras. 27 and 126 of Hunter et al. (US 2004/0072242 A1), where the instant SEQ ID NO: 1 is contained in at least the naturally occurring sequences identified as SEQ ID NOs: 12 and 13 in the figure). See also MPEP 2106.04(c)(II)(A), which discusses how to select the naturally occurring counterpart for a short, single-stranded nucleic acid fragment (e.g., a primer or probe) and states that the appropriate counterpart for such a nucleic acid is the corresponding sense or antisense strand of the naturally occurring sequence. The claimed oligonucleotides also do not have any functional differences relative to the naturally occurring counterpart because both nucleic acids perform the same function of hybridization to a complementary nucleic acid sequence. See also MPEP 2106.04(c)(II)(C)(2), which discusses why primers lack markedly different characteristics. The same reasoning set forth there applies here. Thus, claim 1 is directed to a judicial exception.
This judicial exception is not integrated into a practical application because there are no other limitations in the claim besides the judicial exception. As well, since the claim only recites the judicial exception, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Thus, the isolated oligonucleotide of claim 1 is rejected under 35 U.S.C. 101 as being directed to ineligible subject matter.
Claim 2
Claim 2 is drawn to a composition comprising at least one oligonucleotide “having the sequence set forth in SEQ ID NOs: 1-29.” SEQ ID NO: 1 was elected for examination.
Claim 2 is directed to a judicial exception for the reasons set forth above with respect to claim 1. As with claim 1, it is not clear that the oligonucleotides encompassed by claim 2 in view of the species election are found in nature, but said oligonucleotides need not possess any sequence differences or additional structural elements (e.g., a non-naturally occurring detectable label) relative to their naturally occurring counterparts (i.e., bacterial 16S rRNA sequences). As well, there is no functional difference between the claimed oligonucleotides and their naturally occurring counterparts because both nucleic acids perform the same function of hybridization to a complementary nucleic acid sequence. Thus, claim 2 is directed to a judicial exception.
This judicial exception is not integrated into a practical application because there are no other limitations in the claim besides the judicial exception. As well, since the claim only recites the judicial exception, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Thus, the composition of claim 2 is rejected under 35 U.S.C. 101 as being directed to ineligible subject matter.
Claims 3-5
Claims 3-5 each depend from claim 2 and recite further limitations concerning the composition. More specifically, claim 3 requires the composition to contain at least two oligonucleotides. Claim 4 further limits the sequences of the oligonucleotide, and claim 5 recites an intended use for the oligonucleotides. These claims are also directed to a judicial exception without significantly more for the same reasons set forth above with respect to claims 1 and 2. Briefly, the compositions need not contain any components other than an oligonucleotide(s), which is/are not markedly different, structurally or functionally, relative to its/their naturally occurring counterpart(s). The judicial exception(s) is/are not integrated into a practical application because there are no other limitations in the claims other than an intended use recitation in claim 5, which does not impose any additional structural requirements on the judicial exception. And, since the claims only recite the judicial exception or a judicial exception in combination with an intended use recitation, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 12
Claim 12 is drawn to a composition comprising “at least one primer having a sequence selected from the group consisting of SEQ ID NOs: 1-29 and any combination thereof.” SEQ ID NO: 1 was elected for examination.
Claim 12 is directed to a judicial exception for the reasons set forth above with respect to claim 1. As with claim 1, it is not clear that the oligonucleotides encompassed by claim 12 in view of the species election are found in nature, but said oligonucleotides need not possess any sequence differences or additional structural elements (e.g., a non-naturally occurring detectable label) relative to their naturally occurring counterparts (i.e., bacterial 16S rRNA sequences). As well, there is no functional difference between the claimed oligonucleotides and their naturally occurring counterparts because both nucleic acids perform the same function of hybridization to a complementary nucleic acid sequence. Thus, claim 12 is directed to a judicial exception.
This judicial exception is not integrated into a practical application because there are no other limitations in the claim besides the judicial exception. As well, since the claim only recites the judicial exception, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Thus, the composition of claim 12 is rejected under 35 U.S.C. 101 as being directed to ineligible subject matter.
Claim 30
Claim 30 is drawn to a kit comprising “a compartment adapted to contain one or more primers having a sequence selected from SEQ ID NOs: 1-29, and any combination thereof.” SEQ ID NO: 1 was elected for examination.
Claim 30 is directed to a judicial exception for the reasons set forth above with respect to claim 1. As with claim 1, it is not clear that the oligonucleotides encompassed by claim 30 in view of the species election are found in nature, but said oligonucleotides need not possess any sequence differences or additional structural elements (e.g., a non-naturally occurring detectable label) relative to their naturally occurring counterparts (i.e., bacterial 16S rRNA sequences). As well, there is no functional difference between the claimed oligonucleotides and their naturally occurring counterparts because both nucleic acids perform the same function of hybridization to a complementary nucleic acid sequence. Thus, claim 30 is directed to a judicial exception.
This judicial exception is not integrated into a practical application because there are no other limitations in the claim besides the judicial exception other than the requirement for the primer(s) to be provided in a kit. This does not result in integration of the judicial exception into a practical application because a kit is an insignificant extra-solution element that attempts to limit the judicial exception to a particular technological environment. See MPEP 2106.05(g) for further discussion. As well, since the claim only recites the judicial exception and the presence of an insignificant extra-solution element that is also routine and conventional, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Thus, the kit of claim 30 is rejected under 35 U.S.C. 101 as being directed to ineligible subject matter.
Claim Rejections - 35 USC § 112
7. 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 2-5, 12, and 30 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.
Claim 2
Claim 2 uses the transitional phrase “having” in line 2, where “having the sequence” is recited.
As discussed in MPEP 2111.03 IV, the transitional phrase “having” “must be interpreted in light of the specification to determine whether open or closed claim language in intended.”
In this case, the specification does not explicitly define the transitional phrase “having” as being open or closed, nor does it contain other teachings that would clarify the issue of whether “having” is open or closed. As can be seen in, e.g., paras. 7, 8, and 14, the specification simply uses “having” as a transitional phrase without elaboration as to whether open or closed language is intended. As a result, it is not clear whether the language is intended to be open or closed, and claim 2 is indefinite for this reason. In other words, the scope of claim 2 is not clear because it cannot be determined from the specification whether “having” is open or closed language. For prior art purposes, “having” has been treated as equivalent to “comprising.”
Claim 3
Claim 3 is indefinite for two reasons. First, the claim depends from claim 2 and does not correct its indefiniteness issue. Second, the structural requirements of the oligonucleotides in the composition are not clear. More specifically as to the second issue, it is not clear whether each of the oligonucleotides in the composition must be selected from SEQ ID NOs: 1-29 or if only one of the oligonucleotides in the composition must be so selected. Put another way, the language in claim 3 is ambiguous such that it is not clear what, if any, sequence limitations are imposed on the additional oligonucleotide(s) required by claim 3. Since the requirements of the claim are not clear, it is indefinite.
Claim 4
Claim 4 is indefinite for three reasons. First, the claim depends from claim 2 and does not correct its indefiniteness issue. Second, the claim recites the transitional phrase “having” in line 2, which renders the claim indefinite for the reasons set forth above with respect to claim 2. Third, the requirements imposed by “at least one oligonucleotide [is] selected from oligonucleotides having the sequence of SEQ ID NOs: 1-7, 8, or any two or more of SEQ ID NOs: 1-8” are unclear. More specifically, it is not clear as to which interpretation of the portion in bold is correct: (a) the composition requires two or more oligonucleotides, each of which must be selected from SEQ ID NOs: 1-8, or (b) the composition requires one oligonucleotide which is a fusion of any two of SEQ ID NOs: 1-8 (e.g., an oligonucleotide resulting from the fusion of SEQ ID NOs: 1 and 3).
Claim 5
Claim 5 is indefinite for two reasons. First, the claim depends from claim 2 and does not correct its indefiniteness issues. Second, the claim recites an intended use limitation with active language (i.e., “is used to detect bacteria”), which creates uncertainty as to whether the claim is still intended to be drawn to a product. Amending the claim to replace the active language with language such as “is capable of being used” or “can be used” would address the issue.
Claim 12
Claim 12 is indefinite for several reasons. First, the claim uses the transitional phrase “having” in line 3, which renders the claim indefinite for the reasons set forth above with respect to claim 2. Second, it is unclear how a microbe can be any combination of bacteria, mycobacteria, babesia, and/or fungi as recited in lines 1-2 since a microbe (singular) would necessarily fall into just one of the aforementioned categories, with the exception of mycobacteria, which are a particular type of bacteria. Applicant could address the issue by amending the claim to recite, for example, “A composition for detecting bacteria, mycobacteria, babesia, fungi, or any combination thereof.” Third, the use of “and any combination thereof” in the last line of the claim creates uncertainty as to the primer sequences encompassed by the claim. Similar to claim 4, the use of “and any combination thereof” in the last line encompasses primers resulting from fusing two or more of SEQ ID NOs: 1-29 (e.g., SEQ ID NOs: 1, 3, and 5) to form a single oligonucleotide, which does not appear to be Applicant’s intention. If Applicant intends to require all primers in the composition to be selected from SEQ ID NOs: 1-29, the claim should be amended to clearly state as much.
Claim 30
Claim 30 is indefinite for three reasons. First, the claim uses “having” as a transitional phrase in line 2, which renders the claim indefinite for the reasons set forth above with respect to claim 2. Second, the “and any combination thereof” language in line 3 renders the claim indefinite for the reasons set forth above with respect to claims 4 and 12. Briefly, the “and any combination thereof” language indicates that the primers in the kit may be formed by fusing two or more of SEQ ID NOs: 1-29, but this does not appear to be Applicant’s intention. As with claim 12, if Applicant intends to require all primers in the kit to be selected from SEQ ID NOs: 1-29, the claim should be amended to clearly state as much. Third, the metes and bounds of “associated with 16S rDNA or 16S rRNA” are not clear. More specifically, it is not clear what types of nucleic acids would be considered “associated with 16S rRNA and 16S rDNA,” and the specification does not clarify the issue because it simply uses the claim language without elaboration (see, e.g., para. 14). For example, are nucleic acids “associated with 16S rRNA and 16S rDNA” nucleic acids that bind to these nucleic acids, nucleic acids that have a similar function (e.g., 23S nucleic acids), nucleic acids with a certain degree of sequence similarity to 16S rRNA and 16S rDNA, or some other type of nucleic acids? This question cannot be resolved, so the claim is indefinite for this additional reason.
Claim Rejections - 35 USC § 102
8. 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.
9. Claims 1-5 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ohba et al. (Journal of Veterinary Medical Science 2007; 69(4): 449-453).
Regarding claim 1, Ohba discloses an isolated oligonucleotide primer that is identical in sequence and length to the instant SEQ ID NO: 1 (see p. 450, col. 1, where the Pag313 primer is taught). As noted above, claim 1 does not require a mixture of all four oligonucleotides encompassed by the variable positions and encompasses a single oligonucleotide, provided that the single oligonucleotide contains one of the two possible options at each variable position. In this case, the Pag313 primer meets this requirement. Thus, the isolated oligonucleotide of claim 1 is anticipated by Ohba.
Regarding claims 2, 4, and 12, the Pag313 primer of Ohba was used to conduct PCR (p. 450, col. 1). Therefore, it is present in a composition as required by claims 2, 4, and 12. As well, as with claim 1, claims 2, 4, and 12 do not require a mixture of all four oligonucleotides encompassed by the variable positions and embrace a single oligonucleotide, provided that the single oligonucleotide contains one of the two possible options at each variable position. As noted above, the Pag313 primer of Ohba meets this requirement.
Regarding claim 3, as noted above, the requirements of this claim are unclear, but one possibility, in view of the species election, is that the claim requires the composition to contain two or more oligonucleotides, wherein the each of the two or more oligonucleotides is suitable for microbial detection and wherein at least one of the two or more oligonucleotides contains SEQ ID NO: 1. In this case, the PCR of Ohba is conducted using the Pag313 primer, which as noted above, is identical in sequence and length to the instant SEQ ID NO: 1, and also a second primer (Pag1128 - see p. 450, col. 1). Thus, Ohba anticipates the composition of claim 3.
Regarding claim 5, the composition of Ohba is used to detect bacterial nucleic acids (p. 450, col. 1).
10. Claims 1-5, 12, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Azzazy et al. (US 2014/0356859 A1).
Regarding claims 1, 2, and 4, Azzazy discloses an isolated oligonucleotide, SEQ ID NO: 196, that comprises the instant SEQ ID NO: 1 plus three additional nucleotides at the 5’ end and five additional nucleotides at the 3’ end (p. 48, para. 402). Azzazy further teaches that SEQ ID NO: 196 may be provided in a composition for detection of mycobacteria (paras. 97-100 and 125-129). As noted above, the claims do not require a mixture of all four oligonucleotides encompassed by the variable positions and embrace a single oligonucleotide, provided that the single oligonucleotide contains one of the two possible options at each variable position. In this case, SEQ ID NO: 196 of Azzazy meets this requirement. Thus, Azzazy anticipates the isolated oligonucleotide of claim 1 and the compositions of claims 2 and 4.
Regarding claim 3, as noted above, the requirements of this claim are unclear, but one possibility, in view of the species election, is that the claim requires the composition to contain two or more oligonucleotides, wherein the each of the two or more oligonucleotides is suitable for microbial detection and wherein at least one of the two or more oligonucleotides contains the instant SEQ ID NO: 1. In this case, Azzazy discloses SEQ ID NO: 196, which comprises the instant SEQ ID NO: 1. Azzazy also teaches that the composition may be conducted using more than one mycobacteria-specific oligonucleotide (para. 100). Thus, Azzazy also anticipates the composition of claim 3.
Regarding claim 5, the composition of Azzazy is used to detect bacterial nucleic acids (see, e.g., para. 402 and also paras. 99-100).
Regarding claim 12, as discussed above, SEQ ID NO: 196 of Azzazy comprises the instant SEQ ID NO: 1. Azzazy does not teach that this oligonucleotide is a primer, but as can be seen in para. 402, the oligonucleotide of SEQ ID NO: 196 is not blocked at the 3’ end nor is it too long to function as a primer. Therefore, Azzazy also anticipates the primer of claim 12.
Regarding claim 30, Azzazy teaches that the disclosed SEQ ID NO: 196 may be provided in a kit (paras. 125-129). The kit of Azzazy may also include reaction containers (para. 204). These containers meet the requirement in claim 30 for the kit to contain “a compartment adapted to contain one or more primers having a sequence selected from SEQ ID NOs: 1-29.”
Double Patenting
11. 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.
12. Claims 1-5, 12, and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-38 of copending Application No. 17/920,571 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘571 application overlap in scope with the claims of the instant application and recite all of their features.
More specifically, SEQ ID NO: 1 recited in part (A) of claim 36 of the ‘571 application is identical to the instant SEQ ID NO: 1. Therefore, the kit recited in claim 36 of the ‘571 application, which includes SEQ ID NO: 1 as a primer (see claim 36), contains an isolated oligonucleotide encompassed by the instant claim 1. The kit recited in claim 36 of the ‘571 application also contains all of the elements required by the instant claim 30. Since claim 36 of the ‘571 application also recites additional elements (e.g., a type V CRISPR/Cas effector protein) not required by the instant claims 1 and 30, it constitutes a species of the more broadly recited claims 1 and 30. As discussed in MPEP 804 II.B.2, a species claim anticipates a more generic claim.
Part (A) of the kit recited in claim 36 of the ‘571 application is also a composition as recited in the instant claims 2, 4, and 12. Thus, these instant claims are also not patentably distinct from the claims of the ‘571 application.
Further regarding the instant claim 3, the primer pairs recited in part (A) of claim 36 of the ‘571 application also include an oligonucleotide, SEQ ID NO: 2, that is identical to the instant SEQ ID NO: 2. Thus, the instant claim 3 is also not patentably distinct from the claims of the ‘571 application.
Further regarding the instant claim 5, SEQ ID NO: 1 recited in part (A) of claim 36 of the ‘571 application is described in the specification of the ‘571 application as being useful for detecting bacteria (see, e.g., Table 1 on page 28 of the specification of the ‘571 application). Thus, the instant claim 5 is not patentably distinct from the claims of the ‘571 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
13. No claims are currently allowable.
The following prior art references not applied are cited as references of interest:
(i) Sampath et al. (US 2012/0122098 A1) discloses SEQ ID NO: 48 in Table 2 on page 37. This oligonucleotide comprises the instant SEQ ID NO: 1 with three nucleotides removed at the 5’ end.
(ii) Wang et al. (PLoS ONE 2009; 4: e7401) discloses conserved 16S rDNA fragments (Table 1 on p. 2). The second fragment shown in this table comprises the instant SEQ ID NO: 1 with two nucleotides removed at the 5’ end.
(iii) Baker et al. (Journal of Microbiological Methods 2003; 55: 541-555) identifies conserved regions in bacterial 16S rRNA sequences (Fig. 1). The instant SEQ ID NO: 1 is contained in this sequence (nucleotides 312-332), and many of these nucleotides are identified by Baker as conserved.
(iv) Hogan et al. (US 2019/0085414 A1) discloses an oligonucleotide primer, SEQ ID NO: 141, that comprises the instant SEQ ID NO: 1 (Table 18 on p. 33). The oligonucleotide is used as a primer in primer pair (para. 88).
(v) Amano et al. (US 2016/0244812 A1) discloses an oligonucleotide, SEQ ID NO: 36, that comprises the instant SEQ ID NO: 1 minus the last four nucleotides (para. 66 and the Sequence Listing).
(vi) Lee et al. (US 2015/0087540 A1) discloses an oligonucleotide, SEQ ID NO: 53, that comprises the instant SEQ ID NO: 1 (see, e.g., Table 12 on page 13).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Angela Bertagna whose telephone number is (571)272-8291. The examiner can normally be reached 8-5, M-F.
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/ANGELA M. BERTAGNA/Primary Examiner, Art Unit 1681