DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 10, 2026 has been entered.
Status of the Claims
Claims 1 and 3-8 are pending.
It is acknowledged that claim 1 was amended in the response filed June 10, 2026 and that claims 3-8 were added.
Claims 1 and 3-8 are currently under examination.
Summary of Response to Applicant’s Arguments
This action is in response to the papers filed June 10, 2026. Applicant’s remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance.
Regarding the arguments concerning the obviousness rejections over Ko et al. in view of Colston et al. and Gene Link, the arguments have been fully considered. The rejection of claim 1 under 35 U.S.C. 103 as unpatentable over Ko et al. in view of Colston et al. and Gene Link has been withdrawn due to persuasive arguments and amendments limiting the polymers (A1) and (A2).
Modified rejections and discussion regarding arguments asserting unexpected results, as well as arguments concerning the 35 U.S.C. 103 rejections, are included below.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on applications filed in Japan on October 3, 2022. It is noted, however, that the foreign priority date is the effective filing date of the claimed invention if
the foreign application supports the claimed invention under 112(a), and
the applicant has perfected the right of priority by providing
a certified copy of the priority application, and
a translation of the priority application (if not in English).
In the instant case, the applicant has submitted a certified copy of the priority application but it is not in English and the examiner cannot determine if it supports the claimed invention. The effective filing date of the application is considered to be August 30, 2023 which is the actual filing date of instant application 18/458,354.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
In the instant case, the amendment to require “625 - 2,500” copies/mL recited in lines 3-4 of amended claim 1 filed on 06/10/2026 constitutes new matter. MPEP 2163(I)(B) states: “Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (an adequate description of a genus may not support claims to a subgenus or species within the genus).”
The instant specification provides that the range of target nucleic acid concentration in the reaction composition may be between 50 – 10,000, 100 – 5,000, 250 – 2,000, or 500 – 1,000 copies/mL (par. 35), but does not explicitly, implicitly, or inherently require a target nucleic acid concentration specifically spanning the range of “625 – 2,500 copies/mL”.
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 and 3-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suzuki et al. (published Aug 4, 2022; International Publication No. WO 2022163506; provided as Foreign Patent Document #3 in the IDS filed 11/22/23).
Regarding claim 1, Suzuki recites a nucleic acid amplification method comprising performing a nucleic acid amplification reaction (par. 95). Suzuki recites a reaction composition comprising water (par. 81), a target nucleic acid (par. 2), and polymers at a concentration of 0.001 to 1 w/v% (par. 66). This overlaps the claimed range (0.005 – 0.5 w/v%) with sufficient specificity that the limitation is considered to have been anticipated.
Regarding claims 1 and 3-7, Suzuki recites the following polymers (par. 68):
Claims 1 and 3-5: (A1) a polymer consisting of constitutional units 2-acryloyloxyethylphosphorylcholine (APC) or 2-methacryloyloxyethylphosphorylcholine (MPC), or a combination thereof (par. 38)
Claims 6 and 7: (A2) a copolymer containing (i) an APC unit, an MPC unit, or a combination thereof and (ii) an acrylic acid unit, a methacrylic acid unit, or a combination thereof (par. 50)
Suzuki recites target nucleic acid at a concentration of between 1,000 to 100,000 copies/mL (par. 96; converted from copies/µL to copies/mL). This overlaps the claimed range (625 – 2,500 copies/mL) with sufficient specificity that the limitation is considered to have been anticipated.
Regarding claim 8, Suzuki recites a combination of a polymer consisting of an APC unit and a polymer consisting of an MPC unit (par. 78).
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 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.
Claims 1, 3, 4, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Sakaki et al. (U.S. Patent 8,252,531 B2, issued August 28, 2012) in view of Gene Link 2014 (PCR Additives & Enhancers, found online at https://www.genelink.com/Literature/ps/M40-3021-PCR_Additives_Ver5.2.pdf; provided as NPL in references cited 11/12/25) and Kleiber et al. (published Aug 2000; Kleiber et al. J Mol Diagn. 2000 Aug;2(3):158-66).
Regarding claims 1, 3, 4, 6, and 7, Sakaki teaches a method of performing a nucleic acid amplification reaction (col 6, lines 65-67 – col 7, lines 1-3), using a reaction composition including an amplification target nucleic acid (col 6, lines 3-5) and the following polymers at a concentration between 0.005 to 0.5 w/v% (col 6, lines 20-25):
Claims 1, 6, and 7: a copolymer containing 2-methacryloyloxyethylphosphorylcholine (MPC) or 2-acryloyloxyethylphosphorylcholine (APC) and methacrylic acid (MA) or acrylic acid (AA) - (col 4, lines 18-24 & col 4, lines 38-42)
Claims 3 and 4: a homopolymer consisting of MPC units – (col. 8: “Synthesis Examples 2 to 5”, Table 1: “Synthesis Example 5”)
Regarding claim 1, Sakaki does not teach the presence of water in the reaction, composition.
Gene Link 2014 teaches the addition of water to ‘typical’ nucleic acid amplification reactions such as PCR (page 7, “Typical PCR Premix”).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the invention to have modified the amplification reaction of Sakaki et al. to include water to the nucleic acid amplification reaction, as suggested by Gene Link. Water is a conventional component of nucleic acid amplification reactions such as PCR, and it would have been obvious to a skilled artisan to use it to prepare the buffer, sample, or enzyme.
Regarding claim 1, the combination of Sakaki and Gene Link do not teach any particular copy number concentration of target nucleic acid.
Kleiber teaches that methods of nucleic acid detection methods possess a trade-off between sensitivity and dynamic range (pg. 158, col. 2, 2nd par.). It would have been obvious to a person with ordinary skill in the art to try optimizing the concentration of target nucleic acid in the reaction to be within a range of 625 – 2,500 copies/mL in order to avoid saturation of a quantification assay while generating sufficient product to be detected. A person with ordinary skill in the art would have a reasonable expectation of success because Kleiber demonstrates that concentration of target nucleic acid is a variable routinely optimized to affect a particular result (pg. 158, col. 2, 2nd par.)
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Sakaki et al. (U.S. Patent 8,252,531 B2, issued August 28, 2012) in view of Gene Link 2014 (PCR Additives & Enhancers, found online at https://www.genelink.com/Literature/ps/M40-3021-PCR_Additives_Ver5.2.pdf; provided as NPL in references cited 11/12/25) and Kleiber et al. (published Aug 2000; Kleiber et al. J Mol Diagn. 2000 Aug;2(3):158-66), as applied to claims 1 and 3 above, and further in view of Akkahat et al. (published Feb 24, 2012; Akkahat et al. Langmuir. 2012 Apr 3;28(13):5872-81) and Kiridoori et al. (published July 2, 2020; Japanese Patent No. 2020099875)
Sakaki, Kleiber, and Gene Link teach the limitations of claims 1 and 3, as discussed in the rejection of claims 1, 3, 4, 6, and 7 under 35 U.S.C. 103 above.
Regarding claim 5, the combination of Sakaki, Kleiber, and Gene Link does not teach a polymer consisting of a combination of an APC unit and an MPC unit.
Kiridoori teaches that APC monomer units (par. 98, 110) are useful for the purpose of preventing non-specific hybridization (par. 100). Here, the non-specific hybridization is adsorption of proteins to surfaces.
It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to substitute the MA subunit of Sakaki’s MPC-MA copolymer with APC subunits. One would have been motivated to substitute the monomers because Kiridoori teaches that APC monomer units are known for the purpose of preventing non-specific hybridization (par. 100, 110), and therefore APC and MA may be considered functional equivalents. One would have had reasonable expectation of success because Kiridoori demonstrates that copolymers containing APC can be synthesized using conventional methods (par. 128).
Regarding claim 8, the combination of Sakaki, Kleiber, and Gene Link does not teach a combination of a (homo)polymer consisting of an APC unit and a (homo)polymer consisting of an MPC unit.
However, the combination of Sakaki, Kleiber, and Gene Link does teach a polymer consisting of an MPC unit and separately (as discussed for claim 5), the combination of Sakaki, Kleiber, Gene Link, Akkahat, and Kiridoori does teach a polymer consisting of an APC unit. It would have been obvious to a person with ordinary skill in the art before the effective filing date of the instant invention to combine the elements of the MPC homopolymer and the APC homopolymer in the same reaction, using known methods. There is no evidence of unpredictability associated with using two different of the claimed polymers in a single reaction. A person with ordinary skill in the art would have recognized that the result of said combination were predictable and that the APC and MPC homopolymers would merely perform the same function as they do separately.
Response To Arguments Concerning Rejections under 35 U.S.C. 103
Arguments Concerning Unexpected Results
MPEP 716.02(b) states that the burden is on the Applicant to show that unexpected results are in fact unexpected, unobvious, and of statistical and practical significance. According to MPEP 716.02(d), the objective evidence of non-obviousness must be commensurate in scope with claims. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
The Applicant points to the results in Experimental Examples 1-2, 1-3, 1-4, 2-2, and 2-3 of the specification as an alleged demonstration of unexpected results. The Examiner found those examples in the following locations:
Experimental Examples 1-2, 1-3, 1-4 are summarized in Table 2-1 through 2-2 and Table 5-1 through 5-3.
Experimental Examples 2-2 and 2-3 are summarized in Table 6 and Tables 9-1 through 9-2.
The Applicant states that reaction compositions comprising target nucleic acids at a concentration of 625-2,500 copies/mL and polymers according to (A1) or to (A2) of the claimed invention have an increased rate of being judged as positive relative to the control. Applicant argues that this demonstrates significant improvement of the repeatability of nucleic acid amplification. In contrast, nucleic acid at a higher concentration that that of the claimed range in a reaction composition with polymers according to (A1) does not exhibit the same effect. Applicant argues that these results demonstrate a beneficial effect which could not have been reasonably expected or predicted in the absence of hindsight knowledge.
The evidence and arguments have been fully considered and are not found persuasive. While the Applicant has provided evidence which potentially supports the benefit of the polymers of the invention in nucleic acid amplification, the Applicant has not shown that such results are unexpected, and has not demonstrated that the benefit is a result of the claimed polymers (instead of polymers more generally). The lack of support in the specification is discussed more thoroughly below.
The specification provides two relevant but insufficient comparative examples of differences in amplification. The first comparative example (henceforth ‘Comparison 1’) compares the results between tests of polymers inside (polymer a1) and outside (polymer b1) the claimed range of composition. These results are shown in Tables 5-1 through 5-3. The second comparative example (henceforth ‘Comparison 2’) compares the results between concentrations of nucleic acids inside and outside the claimed range. These results are shown in Tables 6 and 9-1 through 9-2.
Comparisons between a claimed polymer and a similar but distinct polymer are among the appropriate comparisons required to demonstrate that the claimed polymers unexpectedly improve the repeatability of nucleic acid amplification. Regarding comparison 1, polymer b1 is outside the range of the polymer of the claimed instant invention (par. 79). Table 5-1 shows that claimed polymer a1 was present in the reaction at a final concentration of 0.1 w/v% while polymer b1 was present at 0.05 w/v%; both were tested at a single concentration of target nucleic acid (2,500 copies/mL). Tables 5-1 through 5-3 show a total of 10 replicants of amplification under these conditions. It is true that some of the replicants for polymer b1 demonstrate a non-detectable Ct value or a higher Ct value than polymer a1 (replicant #1, for example). However, it is also true that, in several cases, polymer b1 showed comparable or potentially more sensitive detection of the target (see replicants #2, #3, #4). Given that the comparative polymer b1 was present at a lower concentration than polymer a1, it is not clear if any differences between the two polymers are the result of the suitability of the polymer, or if polymer b1 would perform the same as polymer a1 when present at the same concentration. Additionally, the Applicant has not shown evidence of non-obviousness which is commensurate in scope with the claims, as there are many related polymers outside the claimed range which may be similar in efficacy to the claimed polymers, and many concentrations lower than 2,500 copies/mL which may affect potential improvement in amplification. Furthermore, the Applicant has not provided any analysis or evidence to demonstrate that any demonstrated differences between polymers a1 and b1 are practically or statistically significant.
Regarding Comparison 2, Tables 5-1 through 5-3 show that polymer a1 (at 0.1 w/v%) was tested in the presence of target nucleic acid at concentrations of 625 and 25,000 copies/mL. The specification provides evidence only that addition of polymer a1 provided enhanced amplification compared to no polymer at concentrations of 625 and 2,500 copies/mL of nucleic acid (Tables 5-1, 5-2). Additionally, the specification provides evidence only that addition of polymer a2 provided enhanced amplification compared to no polymer at concentrations of 2,500 and 1,250 copies/mL of nucleic acid (Tables 9-1, 9-2). In this case, the Applicant has not provided enough evidence to show that any unexpected results were the result of the presence of the specific polymers according to the claimed invention, and not merely the presence of any polymer in the reaction. The applicant has also not given a representative number of examples where amounts between 625 and 2,500 copies/mL were tested and statistical comparison was conducted to show that the results are of statistical and practical significance.
In summary, the Applicant has not provided enough evidence to show that the unexpected results are due to the claimed polymer composition and that they are in fact unexpected as well as statistically and practically significant.
Arguments Concerning Rejections under 35 U.S.C. 103
The arguments in the response filed June 10, 2026 concerning the obviousness rejections over Ko et al. in view of Colston et al. and Gene Link have been fully considered. The rejection of claim 1 under 35 U.S.C. 103 as unpatentable over Ko et al. in view of Colston et al. and Gene Link has been withdrawn because the amended claims now require that the polymer units be (meth)acrylic acid units, and not merely derivatives thereof.
The arguments in the response filed June 10, 2026 concerning the obviousness rejections over Sakaki et al. in view of Colston et al. and Gene Link have been fully considered. In the response, the Applicant argued that Sakaki does not disclose a reaction composition comprising a target nucleic acid at a concentration of between 625-2,500 copies/mL and that Sakaki does not recognize the combination of the claimed polymers and low target nucleic acid concentration unexpectedly improves the repeatability of the nucleic acid amplification. Applicant argues that Colston and Gene Link do not cure the deficiencies of Sakaki, and therefore a person with ordinary skill in the art would not have arrived at the claimed method or have recognized the unexpected benefit so the obviousness rejection should be withdrawn.
Those arguments pertaining to unexpected results are thoroughly discussed above. Applicant has not provided enough evidence to show that the unexpected results are due to the claimed polymer composition. As Sakaki claims a similar polymer at a similar concentration range for a similar purpose (inhibiting nonspecific hybridization and highly accurate nucleic acid detection), it is not clear that the polymers according to the limitations of the instant invention provide an unexpected benefit compared to the art of record.
As a result of Applicant’s amendments (filed June 10, 2026), the Colston reference was replaced with Klieber. Therefore, arguments regarding the deficiencies of the combination of Sakaki, Colston, and Gene Link and withdrawal of the obviousness rejection are considered moot. The updated rejected is detailed in ‘Claim Rejections - 35 USC § 103’ above.
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 1 and 3-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of Sakaki et al. (U.S. Patent No. 8,252,531) in view of Kleiber et al. and Gene Link 2014. Although the claims at issue are not identical, they are not patentably distinct from one another. Although the reference is not explicitly drawn to a method of nucleic acid amplification, its claim to a method of clinical analysis involving nucleic substances includes nucleic acid amplification (see reference claim 1). Both sets of claims require amplification target nucleic acids and one or more polymers including a copolymer containing a 2-(meth)acryloyloxyethylphosphorylcholine unit and a (meth)acrylic acid unit (see reference claims 1-3). Although the reference patent does not explicitly require water, it would be obvious to one with ordinary skill in the art that water is present in a nucleic acid amplification reaction (see Gene Link 2014). Although the reference patent does not explicitly require a target nucleic acid concentration between 625 – 2,500 copies/mL, it would be obvious to optimize target nucleic acid concentration to that range (see Kleiber). The instant application’s claim to a polymer with a range of concentration of 0.005 to 0.5 w/v% can be considered anticipated by the reference patent’s range for polymer of 0.0001 to 20 wt% in an aqueous solution.
Claims 1 and 3-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of Application No. 18/697,245 (copending application), in view of Sakaki et al, Kleiber et al., and Gene Link 2014. Although the claims at issue are not identical, they are not patentably distinct from one another. Both sets of claims require one or more polymers including a copolymer containing a 2-(meth)acryloyloxyethylphosphorylcholine unit and a (meth)acrylic acid unit (see reference claims 1-3). Though only claim 3 of the reference application is drawn to a method of using an agent for nucleic acid amplification, claims 1 and 2 recite polymers for use in nucleic acid amplification. It would be obvious to modify the claims to recite usage of the polymers. Although the reference patent does not explicitly require a target nucleic acid concentration between 625 – 2,500 copies/mL, it would be obvious to optimize target nucleic acid concentration to that range (see Kleiber). It would be obvious to optimize the concentration of the polymer to between 0.005 – 0.5 w/v% as a results-effective variable (see Sakaki). Although the reference application does not explicitly require water, it would be obvious to one with ordinary skill in the art that water is present in a nucleic acid amplification reaction (see Gene Link 2014). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of Application No. 18/263,416 (copending application), in view of Kleiber et al. and Sakaki et al. Although the claims at issue are not identical, they are not patentably distinct from one another. Both sets of claims require one or more polymers including a copolymer containing a 2-(meth)acryloyloxyethylphosphorylcholine unit and a (meth)acrylic acid unit and water (ref claim 6). Though the reference claim does not explicitly require nucleic acid amplification, it does recite that the polymer is for use in nucleic acid amplification. It would be obvious to modify the claims to recite usage of the polymers in a method. Although the reference patent does not explicitly require a target nucleic acid concentration between 625 – 2,500 copies/mL, it would be obvious to optimize target nucleic acid concentration to that range (see Kleiber). It would be obvious to optimize the concentration of the polymer to between 0.005 – 0.5 w/v% as a results-effective variable (see Sakaki). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of Application No. 19/470,188 (copending application), in view of Sakaki et al., Kleiber et al., and Gene Link 2014.
Although the claims at issue are not identical, they are not patentably distinct from one another. Both sets of claims amplification target nucleic acids and one or more polymers including a copolymer containing a phosphorylcholine-containing unit and a carboxy-containing unit (ref claims 1-4). Sakaki et al. demonstrates that a 2-(meth)acryloyloxyethyl phosphorylcholine and a (meth)acrylic acid unit are obvious species of those genera. Though only claims 3 and 4 of the reference application are drawn to a method of improving nucleic acid amplification, claims 1 and 2 recite polymers and compositions for use with nucleic acids. It would be obvious to modify the claims to recite usage of the polymers and/or compositions for nucleic acid amplification. Although the reference patent does not explicitly require a target nucleic acid concentration between 625 – 2,500 copies/mL, it would be obvious to optimize target nucleic acid concentration to that range (see Kleiber). Although the reference application does not explicitly require water, it would be obvious to one with ordinary skill in the art that water is present in a nucleic acid amplification reaction (see Gene Link 2014). It would be obvious to optimize the concentration of the polymer to between 0.005 – 0.5 w/v% as a results-effective variable (see Sakaki). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of Application No. 19/470,201 (copending application), in view of Sakaki et al., Kleiber et al., and Gene Link 2014.
Although the claims at issue are not identical, they are not patentably distinct from one another. Both sets of claims require amplification target nucleic acids and one or more polymers including a phosphorylcholine-containing homopolymer and/or a copolymer containing a phosphorylcholine-containing unit and a carboxy-containing unit (ref claims 1-3). Sakaki demonstrates that a 2-(meth)acryloyloxyethyl phosphorylcholine and a (meth)acrylic acid unit are obvious species of those genera. Though only claim 3 of the reference application is drawn to a method of improving nucleic acid amplification, claims 1 and 2 recite polymers and compositions for use with nucleic acids. It would be obvious to modify the claims to recite usage of the polymers and/or compositions for nucleic acid amplification. Although the reference patent does not explicitly require a target nucleic acid concentration between 625 – 2,500 copies/mL, it would be obvious to optimize target nucleic acid concentration to that range (see Kleiber). Although the reference application does not explicitly require water, it would be obvious to one with ordinary skill in the art that water is present in a nucleic acid amplification reaction (see Gene Link 2014). It would be obvious to optimize the concentration of the polymer to between 0.005 – 0.5 w/v% as a results-effective variable (see Sakaki). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of Application No. 19/130,695 (copending application) in view of Sakaki et al., Kleiber et al., and Gene Link 2014.
Although the claims at issue are not identical, they are not patentably distinct from one another. Both sets of claims require amplification target nucleic acids and one or more polymers including a phosphorylcholine-containing homopolymer and/or a copolymer containing a phosphorylcholine-containing unit and a carboxy-containing unit (ref claims 1-5). Sakaki demonstrates that a 2-(meth)acryloyloxyethyl phosphorylcholine and a (meth)acrylic acid unit are obvious species of those genera. Given that the composition is intended for nucleic acid amplification, it would be obvious to use the polymers and/or compositions for nucleic acid amplification. Although the reference patent does not explicitly require a target nucleic acid concentration between 625 – 2,500 copies/mL, it would be obvious to optimize target nucleic acid concentration to that range (see Kleiber). Although the reference application does not explicitly require water, it would be obvious to one with ordinary skill in the art that the composition be used with water in a nucleic acid amplification reaction (see Gene Link 2014). It would be obvious to optimize the concentration of the polymer to between 0.005 – 0.5 w/v% as a results-effective variable (see Sakaki). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of Application No. 19/470,881 (copending application) in view of Sakaki et al., Kleiber et al., and Gene Link 2014.
Although the claims at issue are not identical, they are not patentably distinct from one another. Both sets of claims require one or more polymers including a copolymer containing a 2-(meth)acryloyloxyethylphosphorylcholine unit and a (meth)acrylic acid unit (ref claims 1-8). Claims 7 and 8 of the reference application are drawn to a method of improving nucleic acid amplification, and claims 1-6 recite polymers and compositions for use in nucleic acid amplification. It would be obvious to modify the claims to recite usage of the polymers and/or compositions. Although the reference application does not explicitly require water, it would be obvious to one with ordinary skill in the art that the composition be used with water in a nucleic acid amplification reaction (see Gene Link 2014). Although the reference patent does not explicitly require a target nucleic acid concentration between 625 – 2,500 copies/mL, it would be obvious to optimize target nucleic acid concentration to that range (see Kleiber). It would be obvious to optimize the concentration of the polymer to between 0.005 – 0.5 w/v% as a results-effective variable (see Sakaki). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of Application No. 19/523,116 (copending application) in view of Kleiber et al. and Gene Link 2014.
Although the claims at issue are not identical, they are not patentably distinct from one another. Both sets of claims require one or more polymers including a copolymer containing a 2-(meth)acryloyloxyethylphosphorylcholine unit and a (meth)acrylic acid unit (ref claims 1-5). Claim 5 of the reference application is drawn to a method of improving nucleic acid stability, and claims 1-4 recite polymers and compositions for use in nucleic acid stabilization. It would be obvious to modify the claims to recite usage of the polymers in an amplification reaction. Although the reference application does not explicitly require water, it would be obvious to one with ordinary skill in the art that the composition be used with water in a nucleic acid amplification reaction (see Gene Link 2014). Although the reference patent does not explicitly require a target nucleic acid concentration between 625 – 2,500 copies/mL, it would be obvious to optimize target nucleic acid concentration to that range (see Kleiber). The instant application’s claim to a polymer with a range of concentration of 0.005 to 0.5 w/v% can be considered anticipated by the reference patent’s range for polymer of 0.0001 to 10 wt% in solution (claim 5). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response To Arguments Concerning Double Patenting
Rejections Based on the ‘188, ‘201, ‘695, and ‘881 Applications
In the response, the Applicants traversed the obviousness-type double patenting provisional rejections based on the ‘188, ‘201, ‘695, and ‘881 applications. In the response, the Applicants argue that MPEP 804 (I)(B)(1)(b)(i) states that: "If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent…” The Applicants argue that since they believe the remainder of the rejections have been overcome by their response (including rejections made under 35 U.S.C. 103 and Double Patenting), the instant application is in condition for allowance save for the rejections based on the ‘188, ‘201, ‘695, and ‘881 applications. Therefore, they argue that the examiner should withdraw these provisional rejections.
This argument has been fully considered but is not persuasive. The rejections based on 35 U.S.C. 103 have been maintained, and additional double patenting rejections (including non-provisional rejection) have been added. The provisional rejections based on the ‘188, ‘201, ‘695, and ‘881 applications are therefore not the only remaining rejections, and argument based on MPEP 804(I)(B)(1)(b)(i) is moot. The rejections are maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine M Jones whose telephone number is (571)272-2585. The examiner can normally be reached Monday - Friday, 8AM - 4PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.M.J./ Examiner, Art Unit 1682
/WU CHENG W SHEN/ Supervisory Patent Examiner, Art Unit 1682
Prosecution Insights