FINAL 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 .
Amendments and Status of the Claims
2. This action is in response to papers filed 16 April 2026 in which the specification and claims 12, 15, 17, 24, 32, and 37 were amended, claims 21, 41, and 113 were canceled, and new claims 114-119 were added. All of the amendments have been thoroughly reviewed and entered.
Any previous rejections not reiterated below are withdrawn in view of the amendments.
Applicant’s arguments have been thoroughly reviewed and are addressed following the rejections necessitated by the amendments.
3. Claims 1-2,5-6, 12, 14-17, 22, 24-25, 32, 37, and 114-119 are under prosecution.
4. This Office Action includes new rejections necessitated by the amendments.
Information Disclosure Statement
5. The Information Disclosure Statement filed 16 April 2026 is acknowledged and has been considered.
Claim Rejections - 35 USC § 112 and Claim Interpretation
6. 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.
7. Claim 37 is 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 necessitated by the amendments.
Claim 37 is amended to recite CNVK and CNVD phosphoramidites and to recite the full names of the acronyms. While review of the specification yields a recitation of phosphoramidates, the specification does not discuss phosphoramidites.
In addition, the specification does not include the names associated with the acronyms CNVK or CNVD. Therefore, the amendments constitute new matter.
For the purposes of examination, the names associated with the claimed acronyms are interpreted as being correct, based on the teachings of Fujimoto et al (Org. Lett., vol. 17, pages 936-939, published 5 February 2015).
8. 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.
9. Claim 32 is 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.
The term “small” in claim 32 is a relative term which renders the claim indefinite. The term “small” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 103
10. 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.
11. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
12. Claims 1-2, 5, 17, 22, 24-25, 32, 37, 40, and 119 are rejected under 35 U.S.C. 103 as being unpatentable over Gaublomme et al. (U.S. Patent Application Publication No. US 2018/0320224 A1, published 8 November 2018) and Gelman et al. (U.S. Patent Application Publication No. US 2014/0005253 A1, published 2 January 2014).
Regarding claim 1, Gaublomme et al. teach a barcode composition in the form of Figure 2H, which comprises a first strand (i.e., the top strand of Figure 2H) comprising, starting from the 5’ end, a first targeting domain, in the form of an aptamer, followed by a first hybridization domain comprising a spacer and NXT2*, wherein the spacer is a photocleavable linker (paragraph 0085). Figure 2H further comprises a second (i.e., the bottom) strand having from the 5’ end a barcode domain and a second hybridization domain hybridized to the first hybridization domain (e.g., NXT2*). Gaublomme et al. also teach the compositions have the added advantage of allowing mRNA detection in single cells (Abstract). Thus, Gaublomme et al. teach the known techniques discussed above.
While Gaublomme et al. teach the use of aptamers and the detection of mRNA molecules (Abstract). Gaublomme et al. do not teach the aptamer itself binds the mRNA molecule.
However, Gelman et al. teach compositions wherein nucleic acid aptamer molecules are designed to bind target mRNA molecule, which has the added advantage of allowing detection to target molecules that do not naturally bind to nucleic acids (i.e., probes; paragraph 0437). Thus, Gelman et al. teach the known techniques discussed above.
In addition, it is noted that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). See MPEP §2144.04. Thus, any arrangement of the claimed domains and sequences is an obvious variant of the cited prior art.
MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, counsel’s mere arguments cannot take the place of evidence in the record.
It is noted that the Response above should not be construed as an invitation to file an after final declaration. See MPEP 715.09.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Gaublomme et al. and Gelman et al. to arrive at the instantly claimed composition with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a composition having the added advantage of allowing mRNA detection in single cells as explicitly taught by Gaublomme et al. (Abstract) as well as the added advantage of allowing detection of target molecules that do not naturally bind nucleic acids as explicitly taught by Gelman et al. (paragraph 0437). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in compositions useful for detecting mRNA molecules.
Regarding claim 2, the composition of claim 1 is discussed above. Gaublomme et al. teach the second nucleic acid comprises a primer sequence (e.g., NXT1*; paragraph 0039) at the 5’ end (e.g., Figure 2H).
Regarding claim 5, the composition of claim 1 is discussed above. Gaublomme et al. teach a third nucleic acid which also comprises a barcode domain (e.g., the molecule comprising aptamer 2 of Figure 2I).
Gaublomme et al. also teach sets of molecules have identical barcodes (paragraph 0065). Thus, in the embodiment wherein the barcode of the third nucleic acid is identical to the barcode of the first nucleic acid of Figure 2I, they both would be complementary to the clamed first barcode, which is in the second nucleic acid of Figure 2I.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Regarding claim 17, the composition of claim 1 is discussed above. Gaublomme et al. teach each of the domains is independently 1-1000 nucleotides in length (paragraphs 0007, 0052, and 0065-0066).
It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Regarding claim 22, the composition of claim 1 is discussed above. Gaublomme et al. teach at least one nucleic acid comprises and additional photocleavable spacer (e.g., Figure 2H).
Regarding claims 24-25, the composition of claim 1 is discussed above. Gaublomme et al. teach the composition comprises a detectable labeled (i.e., a labeled target; paragraph 0073). In addition, Gelman et al. teach labeled target elements comprising fluorescent molecules (e.g., Cy3; paragraph 0617).
Regarding claim 32, the composition of claim 24 is discussed above. Gaublomme et al. teach the target element is a nucleic acid (i.e. an mRNA molecule; Abstract), as do Gelman et al. (paragraph 0437).
Regarding claim 37, the composition of claim 1 is discussed above. Gaublomme et al. teach the spacer is a sequence and comprises a photocleavable linker (paragraph 0085), and the use of 5-iododeoxyruidine as a photoreactive group (paragraph 0194). Thus, would have been obvious to use the photoreactive nucleotide 5-iododeoxyruidine as the photoreactive group in the spacer.
Regarding claim 40, the composition of claim 1 is discussed above. Gaublomme et al. teach kits (paragraph 0059), as do Gelman et al. (Abstract)
In addition, the specification does not define the term “kit,”, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
Regarding claim 119, the composition of claim 1 is discussed above. The claimed third domain is relevant only to the third alternative version of the second nucleic acid described in claim 1. Therefore, in the embodiments of claim 1 where the first version of the second nucleic acid is considered (as is the case in the instant rejection), the instant claim is not further limiting.
13. Claims 6, 12, and 114-115 are rejected under 35 U.S.C. 103 as being unpatentable over Gaublomme et al. (U.S. Patent Application Publication No. US 2018/0320224 A1, published 8 November 2018) and Gelman et al. (U.S. Patent Application Publication No. US 2014/0005253 A1, published 2 January 2014) as applied to claims 1 and 5 above, alternatively further in combination with Tsuji et al. (U.S. Patent Application Publication No. US 2012/0129720 A1, published 24 May 2012).
Regarding claims 6 and 115, the compositions of claims 1 and 5 are discussed above in Section 12.
Gaublomme et al. teach oligonucleotides comprise two (i.e., one or more) primer sequences (paragraph 0085).
It is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device. Thus, any arrangement of the claimed primers (i.e., at the 5’ end upstream of the first binding domain (i.e., aptamer; claim 6)) or at the 5’ end (i.e., claim 115) of the cited prior art is an obvious variant.
In addition, placement of the primer NXT3* (paragraph 0039) of the third nucleic acid upstream of aptamer 2 of Figure 2I, or the placement of a UMI in the third nucleic acid at the 5’ end, is an obvious variant (i.e., claim 6).
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Alternatively, Tsuji et al teach binding domains (i.e., aptamers) having a 5’ (i.e., upstream) primer sequence, which has the added advantage of allowing amplification of the aptamer (paragraph 0110). Thus, Tsuji et al. teach the known techniques discussed above.
It would therefore have alternatively been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Tsuji et al. with Gaublomme et al. and Gelman et al. to arrive at the instantly claimed compositions with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in compositions having the added advantage of allowing amplification of the aptamer (and thus the entire first nucleic acid) as explicitly taught by Tsuji et al. (paragraph 0110). In addition, it would have been obvious to the ordinary artisan that the known techniques of Tsuji et al. could have been combined with the cited prior art with predictable results because the known techniques of Tsuji et al. predictably result in compositions useful for amplifying nucleic acids.
Regarding claim 12, the composition of claim 1 is discussed above in Section 12.
Gaublomme et al. teach the aptamer is RNA (paragraph 0052) and the barcode is RNA (paragraph 0060) and the UMI is RNA (paragraph 0066). Thus, it would have been obvious that the entire first nucleic acids is RNA.
Alternatively, Tsuji et al. teach entire molecule is an RNA; namely, the molecules, including the aptamer, primer, and other portions are RNA and are amplified by RNA polymerase (paragraph 0110) are part of an RNA pool (e.g., paragraph 0138), and therefore are interpreted as being entirely RNA. Thus, the primer and the aptamer are RNA. Tsuji et al. also teach the added advantage of being synthesized using an automated synthesis device (paragraph 0121). Thus, Tsuji et al. teach the known techniques discussed above.
It would therefore have alternatively been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Tsuji et al. with Gaublomme et al. and Gelman et al. to arrive at the instantly claimed composition with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a composition having the added advantage of allowing use of an automated synthesis device as explicitly taught by Tsuji et al. (paragraph 0121). In addition, it would have been obvious to the ordinary artisan that the known techniques of Tsuji et al. could have been combined with the cited prior art with predictable results because the known techniques of Tsuji et al. predictably result in easily synthesized compositions.
Regarding claim 114, the composition of claim 12 is discussed above.
Gaublomme et al. teach poly(A) (paragraph 0085).
It is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device. Thus, any arrangement of the claimed poly(A) of the cited prior art is an obvious variant.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
Alternatively, Tsuji et al. teach poly(A) attached to the 3’ end of the aptamer (paragraph 0179), Therefore, the poly(A) would be on the 5’ end of binding domain NXT2* of Gaublomme et al. and is reasonably interpreted as being part of the hybridization domain. Tsuji et al. also teach the added advantage of allowing capture on a chip (i.e., immobilization; paragraph 0179), which is a stated desire of Gaublomme et al. (paragraph 0078). Thus, Tsuji et al. teach the known techniques discussed above. Thus, Tsuji et al. teach the known techniques discussed above.
It would therefore have alternatively been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Tsuji et al. with Gaublomme et al. and Gelman et al. to arrive at the instantly claimed composition with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a composition having the added advantage of allowing capture on a chip as explicitly taught by Tsuji et al. (paragraph 0179), which is a stated desire of Gaublomme et al. (paragraph 0078). In addition, it would have been obvious to the ordinary artisan that the known techniques of Tsuji et al. could have been combined with the cited prior art with predictable results because the known techniques of Tsuji et al. predictably result in useful domains for nucleic acid capture.
14. Claims 14-16 and 116 are rejected under 35 U.S.C. 103 as being unpatentable over Gaublomme et al. (U.S. Patent Application Publication No. US 2018/0320224 A1, published 8 November 2018) and Gelman et al. (U.S. Patent Application Publication No. US 2014/0005253 A1, published 2 January 2014) as applied to claim 1 above, alternatively further in view of Karube et al. (U.S. Patent Application Publication No. US 2003/0170650 A1, published 11 September 2003).
The courts have stated “[A] prior art reference must be considered in its entirety, i.e., as a whole” W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983) (see MPEP 2141.02 VI).
Thus, while the rejections listed below present a modified interpretation of the teachings of the cited prior art solely for the purpose of clarity, the rejections of the claims are maintained over the prior art of record.
Regarding claims 14-16 and 116, the composition of claim 1 is discussed above in Section 12.
It is reiterated that the courts have found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the providing a first targeting domain that is “substantially complementary” to a target nucleic acid (i.e., claim 14) merely represent routine optimization of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
With respect to claims 15-16 and 116, the limitations are directed to the targe nucleic acid, which is not actually part of the claimed composition.
Alternatively, Karube et al. teach compositions wherein aptamers are formed by having a (i.e., the claimed first) nucleic acid comprise a nucleic acid sequence (i.e., the claimed first targeting domain) that hybridizes to a target nucleotide sequence (paragraph 0011). Because the first targeting domain hybridizes to the target nucleic acid, they are substantially complementary (i.e., claim 14; see also paragraph 0036). Karube et al. further teach the compositions have the added advantage of detecting SNPs and low molecular weight compounds (Abstract and paragraph 0024). Thus, Karube et al. teach the known techniques discussed above.
It would therefore have alternatively been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Karube et al. with Gaublomme et al. and Gelman et al. to arrive at the instantly claimed compositions with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a composition having the added advantage of detecting SNPs and low molecular weight compounds as explicitly taught by Karube et al. (Abstract and paragraph 0024). In addition, it would have been obvious to the ordinary artisan that the known techniques of Karube et al. could have been combined with the cited prior art with predictable results because the known techniques of Karube et al. predictably result in compositions useful for detecting various molecules.
15. Claims 117-118 are rejected under 35 U.S.C. 103 as being unpatentable over Gaublomme et al. (U.S. Patent Application Publication No. US 2018/0320224 A1, published 8 November 2018) and Gelman et al. (U.S. Patent Application Publication No. US 2014/0005253 A1, published 2 January 2014) as applied to claim 1 above, and further in combination with Mellem et al. (U.S. Patent Application Publication No. US 2016/0167054 A1, published 16 June 2016).
Regarding claims 117-118, the composition of claim 1 is discussed above in Section 12.
Gaublomme et al. also teach devices (i.e., claim 117; paragraph 0003) and UV treatment (paragraph 0014), as well as PCR (paragraph 0007). Gelman et al. teach light sources, in the form of lasers (i.e., claim 118), as well as PCR (paragraph 0619).
Neither reference teaches a sample holder.
However, Mellem et al. teach PCR devices comprising a sample holder and a light source (paragraph 0020), and that the devices have the added advantage of allowing uniform and simultaneous temperature cycling of multiple PCR samples (paragraph 0003). Thus, Mellem et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Mellem et al. with Gaublomme et al. and Gelman et al. to arrive at the instantly claimed device with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a device having the added advantage of allowing uniform and simultaneous temperature cycling of multiple PCR samples as explicitly taught by Mellem et al. (paragraph 0003). In addition, it would have been obvious to the ordinary artisan that the known techniques of Mellem et al. could have been combined with the cited prior art with predictable results because the known techniques of Mellem et al. predictably result in device useful for detecting PCR reactions.
Response to Arguments
16. Applicant’s arguments filed 16 April 2026 (hereafter the “Remarks”) have been considered but are unpersuasive for the reasons discussed below.
A. Pages 10-11 of the Remarks discuss the amendments and the previous indefiniteness rejections, which are withdrawn in view of the amendments.
However, with respect to claim 37, while Applicant has provided a single reference discussing small molecules as non-peptide molecules o less than about 1000 Daltons, Applicant has provided no evidence that this definition is a universally accepted art-recognized definition. The rejection is therefore maintained.
B. Pages 11-12 of the Remarks discuss the previous rejections under 35 U.S.C 112(d), which are withdrawn in view of the amendments
C. Applicant argues on pages 13-15 of the Remarks, Applicant argues that paragraph 0085 of Gaublomme et al. clearly refers t to the spacer of the second oligonucleotide of Figure 2H, based on paragraph 0011 of Gaublomme et al. Applicant also cites paragraphs 0189-0190 of Gaublomme et al. as teach the spacer that function to block polymerase extension.
However, paragraph 0011 of Gaublomme et al. begins with the phrase “[i]n another aspect,” and repeatedly discusses what “may” be included in the oligonucleotides described therein. Paragraphs 0189-0190 are also replete with statements regarding what “may” or “can” be included in the oligonucleotides, and the specific arrangement cited from paragraph 0189 is described as “one embodiment.” Thus, none of Applicant’s citations are limiting.
Further, paragraph 0085 of Gaublomme et al (cited in the rejections above) specifically says the “oligonucleotide may also contain…one or more cleavable spacers, e.g., a photocleavable liker.” Thus, paragraph 0085 clearly suggests photocleavable linkers are part of a spacer.
In addition, paragraph 0039, which describes the various embodiments of Figure 2, specifically describes a “photo-cleavable spacer.”
Inclusion of the photocleavable linker as part of the spacer is therefore clearly obvious.
In addition, as noted many times in the rejections above, the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device. Thus, any arrangement of the claimed domains and sequences is an obvious variant of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
D. In response to Applicant's argument on page 14 of the Remarks that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., a photoreactive element in the second hybridization domain) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Specifically, claim 1 states that “at least one of the first or second hybridization domains comprises a photoreactive element.” This instant rejection relies upon the combination of the spacer and NXT2* of the first oligonucleotide as having the photocleavable element. Because the claim requires the second hybridization domain to be “substantially complementary” to the first hybridization binding domain, the first hybridization binding domain is reasonable interpreted as including both NXT2* and the spacer.
E. With respect to claim 5, Applicant argues on 15 of the Remarks that the Office Action does not explain why the skilled artisan would make the two barcodes complementary, and that such a change would affecting binding of the aptamers to the proteins.
However, in this instance, no motivation is required, as both alternatives are taught as viable embodiments in a single reference.
In addition, the fact that the inventor has allegedly recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Specifically, as noted above, the embodiments of Gaublomme et al. where the barcodes are the same merely results in the claimed complementarity.
Whis respect to allegedly affecting aptamer binding, Applicant has presented no evidence to support this assertion. The argument is therefore not convincing.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
F. With respect to claim 37, Applicant argues on pages 15-16 of the Remarks that the photoreactive group is part of the aptamer, as discussed in paragraphs 0007 and 0194 of Gaublomme et al.
However, paragraph 0007 of Gaublomme et al. begins with the phrase “[i]n another aspect,” and repeatedly discusses “one embodiment” and “certain embodiments.”. Paragraphs 0194 is specific to Example 2, which is prefaced in paragraph 0175, which stated “the following examples…are given for illustration purposes only and are not intended to limit the invention is any way.” Thus, none of Applicant’s citations are limiting.
Further, paragraph 0085 of Gaublomme et al (cited in the rejections above) specifically says the “oligonucleotide may also contain…one or more cleavable spacers, e.g., a photocleavable liker.” Thus, paragraph 0085 clearly suggests photocleavable linkers are part of a spacer. The use of 5-iododeoxyruidine as a photoreactive group (paragraph 0194). Thus, would have been obvious to use the photoreactive nucleotide 5-iododeoxyruidine as the photoreactive group in the spacer.
In addition, as noted many times in the rejections above, the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device. Thus, any arrangement of the claimed domains and sequences is an obvious variant of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
G. Applicant’s arguments on pages 16-17 regarding the spacer, linker, polymerase extension, etc. are addressed above.
With respect to the alleged modification of operation, Applicant has merely posed hypothetical uses without any citations of Gaublomme et al. as to how the modification would conflict with the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
H. Applicant argues on page 17 that Gelman et al. teach aptamer binding to ligand binding domains of a protein, not nucleic acids. Thus, Applicant agues Gelman et al. individually.
However, paragraph 0437 of Gelman et al. explicitly states that aptamers can ben nucleic acids that bind to a target molecule such as mRNA. Thus, it would have been obvious to have aptamers that bind to RNA.
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Specifically, paragraph 0052 of Gaublomme et al. discussed how to make aptamers that bind nucleic acids.
I. On pages 16-20, Applicant cites paragraph 0190 of Gaublomme et al. to indicate improper combination with Karube et al.
However, as noted above, providing a first targeting domain that is “substantially complementary” to a target nucleic acid (i.e., claim 14) merely represent routine optimization of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
With respect to claims 15-16 and 116, the limitations are directed to the targe nucleic acid, which is not actually part of the claimed composition.
Alternatively, Karube et al. teach compositions wherein aptamers are formed by having a (i.e., the claimed first) nucleic acid comprise a nucleic acid sequence (i.e., the claimed first targeting domain) that hybridizes to a target nucleotide sequence (paragraph 0011). Because the first targeting domain hybridizes to the target nucleic acid, they are substantially complementary (i.e., claim 14; see also paragraph 0036). Karube et al. further teach the compositions have the added advantage of detecting SNPs and low molecular weight compounds (Abstract and paragraph 0024). Thus, the modification is obvious.
In addition, paragraph 0036 of Karube et al. specifically discusses complete complementarity between two strands (see also paragraphs 0002-0003 and 0005). Thus, complete complementarity is well known in the art..
J. Applicant argues on pages 20-21 of the Remarks that the proposed rearrangement results in polymerase extension into aptamer 2 and interferes with protein binding.
Applicant has presented no evidence to support this assertion. The argument is therefore not convincing.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
In addition, a review of the recitations of DNA polymerase in Gaublomme et al. repeatedly refer to “one aspect (e.g., paragraph 0007),” “another aspect (e.g., paragraphs 0023-0024 and 0029) “certain embodiments(e.g., paragraph 0084),” etc., and thus are non-limiting.
K. Applicant’s remaining arguments rely on alleged deficiencies previously addressed, which are unpersuasive for the reasons discussed above. Therefore, the claims remained rejected based on the prior art citations presented in the rejections.
Conclusion
17, No claim is allowed.
18. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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, Anne Gussow can be reached at 571-272-6047. 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.
Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
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