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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 15 May 2026 has been entered.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because:
The lettering is not of proper size, uniform density, and well-defined in Figure(s) 1 and 5. See 37 CFR 1.84(p)(1) – (5). (“Numbers, letters, and reference characters must measure at least .32 cm (1/8 inch) in height.”)
The margins are not of proper size in Figure(s) 1 and 5. See 37 CFR 1.84(g).
In Figure(s) 1 and 5 the reference characters, sheet numbers, and view numbers are not all oriented in the same direction so as to avoid having to rotate the sheet. See 37 CFR 1.84(p)(1).
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
INFORMATION ON HOW TO EFFECT DRAWING CHANGES
Replacement Drawing Sheets
Drawing changes must be made by presenting replacement sheets which incorporate the desired changes and which comply with 37 CFR 1.84. An explanation of the changes made must be presented either in the drawing amendments section, or remarks, section of the amendment paper. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). A replacement sheet must include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of the amended drawing(s) must not be labeled as “amended.” If the changes to the drawing figure(s) are not accepted by the examiner, applicant will be notified of any required corrective action in the next Office action. No further drawing submission will be required, unless applicant is notified.
Identifying indicia, if provided, should include the title of the invention, inventor’s name, and application number, or docket number (if any) if an application number has not been assigned to the application. If this information is provided, it must be placed on the front of each sheet and within the top margin.
Annotated Drawing Sheets
A marked-up copy of any amended drawing figure, including annotations indicating the changes made, are required by the examiner. The annotated drawing sheet(s) must be clearly labeled as “Annotated Sheet” and must be presented in the amendment or remarks section that explains the change(s) to the drawings.
Timing of Corrections
Applicant is required to submit acceptable corrected drawings within the time period set in the Office action. See 37 CFR 1.85(a). Failure to take corrective action within the set period will result in ABANDONMENT of the application.
If corrected drawings are required in a Notice of Allowability (PTOL-37), the new drawings MUST be filed within the THREE MONTH shortened statutory period set for reply in the “Notice of Allowability.” Extensions of time may NOT be obtained under the provisions of 37 CFR 1.136 for filing the corrected drawings after the mailing of a Notice of Allowability.
Claim Interpretation
Attention is directed to MPEP 904.01 [R-08.2012].
The breadth of the claims in the application should always be carefully noted; that is, the examiner should be fully aware of what the claims do not call for, as well as what they do require. During patent examination, the claims are given the broadest reasonable interpretation consistent with the specification. See In re Morris, 127 F.3d 1048, 44 USPQ2d 1023 (Fed. Cir. 1997). See MPEP § 2111 - § 2116.01 for case law pertinent to claim analysis.
It is noted with particularity that narrowing limitations found in the specification cannot be inferred in the claims where the elements not set forth in the claims are linchpin of patentability. In re Philips Industries v. State Stove & Mfg. Co, Inc., 186 USPQ 458 (CA6 1975). While the claims are to be interpreted in light of the specification, it does not follow that limitations from the specification may be read into the claims. On the contrary, claims must be interpreted as broadly as their terms reasonably allow. See Ex parte Oetiker, 23 USPQ2d 1641 (BPAI, 1992). In added support of this position, attention is directed to MPEP 2111 [R-11.2013], where, citing In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA 1969), is stated:
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.
Additionally, attention is directed to MPEP 2111.01 [R-01.2024], wherein is stated:
II. IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE SPECIFICATION
“Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.” Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004).
Attention is also directed to MPEP 2111.02 II [R-07.2022]. As stated herein:
II. PREAMBLE STATEMENTS RECITING PURPOSE OR INTENDED USE
PNG
media_image1.png
18
19
media_image1.png
Greyscale
The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "'extraneous' limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation")… (Emphasis added)
Attention is directed to MPEP 2111 [R-10.2019]. As stated therein:
During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard:
The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1). (Emphasis added).
Attention is directed to MPEP 2173.04 [R-10.2019]. As stated therein:
Breadth of a claim is not to be equated with indefiniteness. In re Miller, 441 F.2d 689, 169 USPQ 597 (CCPA 1971); In re Gardner, 427 F.2d 786, 788, 166 USPQ 138, 140 (CCPA 1970) ("Breadth is not indefiniteness."). A broad claim is not indefinite merely because it encompasses a wide scope of subject matter provided the scope is clearly defined. But a claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear. For example, a genus claim that covers multiple species is broad, but is not indefinite because of its breadth, which is otherwise clear. But a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim). (Emphasis added)
Claim Rejections - 35 USC § 112, Second Paragraph / (b)
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.
Standard for Definiteness.
Attention is directed to MPEP 2171 [R-11.2013]:
Two separate requirements are set forth in 35 U.S.C. 112(b) and pre-AIA 35 U.S.C. 112, second paragraph, namely that:
(A) the claims must set forth the subject matter that the inventor or a joint inventor regards as the invention; and
(B) the claims must particularly point out and distinctly define the metes and bounds of the subject matter to be protected by the patent grant.
The first requirement is a subjective one because it is dependent on what the inventor or a joint inventor for a patent regards as his or her invention. Note that although pre-AIA 35 U.S.C. 112, second paragraph, uses the phrase "which applicant regards as his invention," pre-AIA 37 CFR 1.41(a) provides that a patent is applied for in the name or names of the actual inventor or inventors.
The second requirement is an objective one because it is not dependent on the views of the inventor or any particular individual, but is evaluated in the context of whether the claim is definite — i.e., whether the scope of the claim is clear to a hypothetical person possessing the ordinary level of skill in the pertinent art.
Attention is directed to MPEP 2173.02 I [R-01.2024]:
During prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc). As the Federal Circuit stated in Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008):
“We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.”
***
During examination, after applying the broadest reasonable interpretation to the claim, if the metes and bounds of the claimed invention are not clear, the claim is indefinite and should be rejected. Packard, 751 F.3d at 1310 (“[W]hen the USPTO has initially issued a well-grounded rejection that identifies ways in which language in a claim is ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention, and thereafter the applicant fails to provide a satisfactory response, the USPTO can properly reject the claim as failing to meet the statutory requirements of § 112(b).”); Zletz, 893 F.2d at 322, 13 USPQ2d at 1322.
Attention is also directed to MPEP 2173.02 III B [R-01-2024], which states in part:
To comply with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, applicants are required to make the terms that are used to define the invention clear and precise, so that the metes and bounds of the subject matter that will be protected by the patent grant can be ascertained. See MPEP § 2173.05(a), subsection I. It is important that a person of ordinary skill in the art be able to interpret the metes and bounds of the claims so as to understand how to avoid infringement of the patent that ultimately issues from the application being examined. See MPEP § 2173.02, subsection II (citing Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470 (Fed. Cir. 1993)); see also Halliburton Energy Servs., 514 F.3d at 1249, 85 USPQ2d at 1658 (“Otherwise, competitors cannot avoid infringement, defeating the public notice function of patent claims.”). Examiners should bear in mind that “[a]n essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.” Zletz, 893 F.2d at 322, 13 USPQ2d at 1322 [Fed. Cir. 1989]. (Emphasis added)
Attention is also directed to MPEP 2173.04 [R-10-2019], which states in part:
A broad claim is not indefinite merely because it encompasses a wide scope of subject matter provided the scope is clearly defined. But a claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear. For example, a genus claim that covers multiple species is broad, but is not indefinite because of its breadth, which is otherwise clear. But a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim).
Holding and Rationale
Claims 1, 4, 19, 21, 22, 32, 36, 39, and 57-66 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.
The term “associates” in claims 1 and 39 is a relative term which renders the claims indefinite. The term “associates” is not defined by the claims, 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. Claims 4, 19, 21, 22, 32, 36, and 57-66, which depend from claim 1, fail to overcome this issue and are similarly rejected.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims 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.
Holding and Rationale
Claim(s) 1, 4, 36, 39 and 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/029163 A1 (Aikawa et al.), in view of US 5,217,905 (Marchand et al.), US 2019/0203269 A1 (Zingg et al.), US 2009/0105082 A1 (Chetverin et al.), Re. 35,716 (Stapleton et al.), US 2020/0354774 A1 (Church et al.) and US 2016/0115473 A1 (Kim).
Aikawa et al., teach of combining different assays. At paragraph [0220], Aikawa et al., teach:
[0220] 47. The assay of paragraph 46, wherein said at least one analysis is selected from the group consisting of western blot, enzyme linked absorbance assay, mass spectrometry, immunoassay, flow cytometry, immunohistochemical analysis, probe hybridization, primer extension, amplification, sequencing, 5′ nuclease digestion, molecular beacon assay, DNA chip analysis, oligonucleotide ligation assay, size analysis, single-stranded conformation polymorphism, polymerase chain reaction (PCR), real-time quantitative PCR, and any combinations thereof. (Emphasis added)
Marchand et al., at column 2, third paragraph, teach of matrix materials that can be used in different assays. As disclosed therein:
The device proposed comprises a matrix formed of a strip of nitrocellulose or diazobenzyloxymethyl (DBM) paper in a porous gel, such as polyacrylamide, agarose or collagen, it being possible for the antigen to be trapped in the pores of the gel or to be crosslinked with the gel via the amine groups of the ligand and the carboxyl groups carried by the matrix, or formed of a strip of cellulose or plastic fibers, inside which particles or beads containing the ligand are trapped. (Emphasis added)
Zingg et al., at paragraph [0004], teach:
The single-stranded RCA products are usually separated as high molecular weight polynucleotides with low migration in matrices, such as agarose or polyacrylamide gels or paper, and detected by using a labeled start primer or by hybridization of labeled oligonucleotide detection probes (e.g., fluorescent, biotinylated, digoxigeninated, or radiolabeled) and by enzymatic amplification in vitro as well as in situ (e.g., in paraffin-embedded tissue slides or fixed cells).
Chetverin et al., at paragraph [0047], teach:
[0047] FIG. 11 demonstrates images of molecular colonies generated by the indicated number of E. coli cells embedded and lysed within a polyacrylamide gel, obtained during in-gel PCR in the presence of adjacently hybridizing FRET probes. (Emphasis added)
Stapleton et al., at column 15, last paragraph, bridging to column 16, teach:
Detection systems utilizing biotin, digoxgenin, fluorescence, antibodies or enzymes or combinations of these produce unambiguous signals within cells embedded in an agarose matrix. If primers or nucleotides are not labeled during amplification; labeled oligonucleotides may be hybridized to amplification products for a 30-minute incubation, followed by rinsing twice at minute intervals and once with slide at stringent temperature without zone spreading of signal from target cells. (Emphasis added)
Church et al., at paragraph [0081], teach:
[0081] According to one aspect, the matrix is porous thereby allowing the introduction of reagents into the matrix at the site of a nucleic acid for amplification of the nucleic acid. A porous matrix may be made according to methods known to those of skill in the art. In one example, a polyacrylamide gel matrix is co-polymerized with acrydite-modified streptavidin monomers and biotinylated DNA molecules, using a suitable acrylamide:bis-acrylamide ratio to control the cross-linking density. Additional control over the molecular sieve size and density is achieved by adding additional cross-linkers such as functionalized polyethylene glycols. (Emphasis added)
As evidenced above, it was well known in the art that cells and/or tissues could be embedded in a matrix, and that the embedded cells or tissue can then be subjected to a combination of assays, including nucleic acid and immunoassay analysis. It was also well known in the art which materials make for a good matrix, and that the density of the matrix could be controlled via the use of cross-linking chemicals, e.g., acrydite.
Neither Aikawa et al., Marchand et al., Zingg et al., Chetverin et al., Stapleton et al., nor Church et al., have been found to teach use of hairpin probes.
Kim, at paragraphs [0163] and [0237], teach:
[0163] In some embodiments related to hairpin oligonucleotides comprising a PEG linker, the polymerase (e.g., a high-fidelity polymerase) comprises a proof-reading activity, a 3′ exonuclease activity, and/or a strand displacement activity, but lacks a 5′ exonuclease activity, and the PEG-DNA junction blocks the polymerase to provide a defined end to amplicons. (Emphasis added)
[0237] During the development of the technology provided herein, hairpin oligonucleotides comprising polyethylene glycol (PEG) linkers were designed (FIG. 12) and tested (FIG. 13). It was contemplated that hairpin oligonucleotides comprising PEG linkers would be useful for amplification reactions (e.g., as described herein) using a polymerase (e.g., a high-fidelity polymerase) that comprises a proof-reading activity, a 3′ exonuclease activity, and/or a strand displacement activity, but that lacks a 5′ exonuclease activity. (Emphasis added)
As evidenced above, the use of hairpin oligonucleotide probes was not only known in the art, but their use in combination of a matrix material (PEG) and that the polymerase had strand displacement activity (limitations of independent claims 1 and 39).
In view of the above presentation and in he absence of convincing evidence to the contrary, claims 1, 4, 36, 39 and 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/029163 A1 (Aikawa et al.), in view of US 5,217,905 (Marchand et al.), US 2019/0203269 A1 (Zingg et al.), US 2009/0105082 A1 (Chetverin et al.), Re. 35,716 (Stapleton et al.), US 2020/0354774 A1 (Church et al.) and US 2016/0115473 A1 (Kim).
Claim(s) 59 and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/029163 A1 (Aikawa et al.), in view of US 5,217,905 (Marchand et al.), US 2019/0203269 A1 (Zingg et al.), US 2009/0105082 A1 (Chetverin et al.), Re. 35,716 (Stapleton et al.), US 2020/0354774 A1 (Church et al.) and US 2016/0115473 A1 (Kim) as applied to claims 1, 4, 36, 39 and 58 above, and further in view of US 5,567,627 (Lehnen).
See above for the basis of the reaction as it relates to the disclosure of Aikawa et al., Marchand et al., Zingg et al., Chetverin et al., Stapleton et al., Church et al., and Kim.
Neither Aikawa et al., Marchand et al., Zingg et al., Chetverin et al., Stapleton et al., Church et al., nor Kim have been found to clarity the range of analytes that can be detected.
Lehnen, at column 3, last paragraph, teach:
In accordance with the subject invention compositions and methods and an apparatus are provided for the performance of simultaneous discrete assays of multiple analytes of interest in a sample, particularly a biological sample. The analytes may be polypeptides such as antigens, antibodies, nucleic acids, haptens, carbohydrates or combinations thereof. (Emphasis added)
The above showing is deemed to fairly suggest limitations of claims 59 and 60.
In view of the above presentation, it would have been quite obvious to one of ordinary skill in the art at the time of the inventio to have designed the method/assay whereby analytes such as polypeptides and carbohydrates would be detected. In view of the well-developed state of the art, said artisan would have been amply motivated and would have had a most reasonable expectation of success.
In view of the above presentation and din the absence of convincing evidence to the contrary, claims 59 and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/029163 A1 (Aikawa et al.), in view of US 5,217,905 (Marchand et al.), US 2019/0203269 A1 (Zingg et al.), US 2009/0105082 A1 (Chetverin et al.), Re. 35,716 (Stapleton et al.), US 2020/0354774 A1 (Church et al.) and US 2016/0115473 A1 (Kim) as applied to claims 1, 4, 36, 39 and 58 above, and further in view of US 5,567,627 (Lehnen).
Claim(s) 61-63 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/029163 A1 (Aikawa et al.), in view of US 5,217,905 (Marchand et al.), US 2019/0203269 A1 (Zingg et al.), US 2009/0105082 A1 (Chetverin et al.), Re. 35,716 (Stapleton et al.), US 2020/0354774 A1 (Church et al.) and US 2016/0115473 A1 (Kim) as applied to claims 1, 4, 36, 39 and 58 above, and further in view of US 2017/0314066 A1 (Mao et al.).
See above for the basis of the reaction as it relates to the disclosure of Aikawa et al., Marchand et al., Zingg et al., Chetverin et al., Stapleton et al., Church et al., and Kim.
Neither Aikawa et al., Marchand et al., Zingg et al., Chetverin et al., Stapleton et al., Church et al., nor Kim have been found to teach incorporating a spacer region into the hairpin probes.
Mao, at paragraph [0033], teach:
To effectively probe towards the bottom of the 50T trawl, the two hairpins had a total of 88 nucleotides with a 10-nt spacer (loop) in between. (Emphasis added)
In view of the above presentation, it would have been quite obvious to include a spacer region which comprises a nucleotide sequence. It is noted that the nucleotides comprise carbon and that such would constitute “a carbon spacer”.
The placement of the spacer in/between region(s) of the hairpin probe is deemed to be an obvious design choice.
In view of the above presentation and in the absence of convincing evidence to the contrary, claims 61-63 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/029163 A1 (Aikawa et al.), in view of US 5,217,905 (Marchand et al.), US 2019/0203269 A1 (Zingg et al.), US 2009/0105082 A1 (Chetverin et al.), Re. 35,716 (Stapleton et al.), US 2020/0354774 A1 (Church et al.) and US 2016/0115473 A1 (Kim) as applied to claims 1, 4, 36, 39 and 58 above, and further in view of US 2017/0314066 A1 (Mao et al.).
Conclusion
Objections and/or rejections which appeared in the prior Office action and which have not been repeated hereinabove have been withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradley L. Sisson whose telephone number is (571)272-0751. The examiner can normally be reached Monday to Thursday, from 6:30 AM to 5 PM..
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 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.
/Bradley L. Sisson/Primary Examiner, Art Unit 1682
Prosecution Insights