POC
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 .
Request for Continued Examination (RCE)
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/13/2026 has been entered.
Prioritized Examination
Applicant submitted a petition for Track-1 prioritized examination request on 5/13/2026 along with an extension of time and the corresponding fees.
Notwithstanding the required extension of time, the petition was granted on 5/26/2026.
Status
Claims 1-25 are pending.
Rejections not reiterated in this office action are withdrawn.
Priority
This application is a CON of 18/455,152 (08/24/2023)
18/455,152 is a CON of 18/188,504 (03/23/2023)
18/188,504 is a CON of 17/122,321 (12/15/2020, US 11634751)
17/122,321 is a CON of 14/941,433 (11/13/2015, US 10900065)
14/941,433 has PRO 62/080,055 (11/14/2014).
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete.
The statement regarding the size of the XML file is in kilobytes, not bytes.
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings. The Figures, for example Fig. 1 includes 10 nt sequences without an identifier.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112
Claims 1-25 are rejected under 35 U.S.C. 112(a) 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 at the time the application was filed had possession of the claimed invention.
Claim 1, step (c)(i), was amended to include the following new language:
comprising complementarity to the whole transcriptome of the cell such that the plurality of nucleic acid molecules is collectively capable of annealing to the whole transcriptome of the cell
while Applicant stated the following regarding support for the amendment:
PNG
media_image1.png
100
712
media_image1.png
Greyscale
The examiner reviewed the cited paragraphs and the entire disclosure and could not locate support for such a new limitation, nor does there appear to be a written description of the limitation in the application as filed. See Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007) (holding that "[MPEP] § 2163.04 (I)(B) as written is a lawful formulation of the prima facie standard for a lack of written description rejection."). There is no literal support for the added limitation and one of skill in the art would not recognize that Applicant possessed the claim scope.
Response to Remarks - 35 USC § 112
Applicant cites new supporting paragraphs for the new claim language at paragraphs [0008], [0033], [0044]-[0046], [0053], and [0056]. Applicant explains that the cited portions “provides ample support for single-stranded nucleic acids comprising complementarity to the whole transcriptome of cells” (p. 6-7).
The cited portions were reviewed by the Examiner and found to contain the following:
[0008] refers to a random hexamer which can template the reverse transcription of substantially any transcript as well as a primer designed to target a specific transcript;
[0033] refers to sequencing RNA expression / transcriptome of a cell;
[0044]-[0046] refers to a RT primer configured to transcribe all or specific transcripts in a cell;
[0053] refers to RNA transcriptome sequencing;
[0056] refers to RNA transcriptome sequencing and a specific primer.
Nowhere in the cited portions was found explicit support for:
comprising complementarity to the whole transcriptome of the cell such that the plurality of nucleic acid molecules is collectively capable of annealing to the whole transcriptome of the cell
which, as established in the prior office action, prima facie lacked a written description (MPEP 2163.04 (I)(B)). One of skill in the art would not recognize possession of the new claim language in view of the cited portions at least because there is no explicit disclosure and the implicit support is not clear how reference to a generic and/or specific primer or random hexamer supports the new claim language. Furthermore, in response to the following prior art rejections Applicant argues the new language distinguishes the claimed invention over the cited prior art.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-9, 12-13, 16-18, 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ke et al. (Nat Methods 10, 2013-07-14, p. 857–860 and Supplemental, 35 pages).
Ke teaches in situ sequencing in cells as depicted in Fig. 1a:
PNG
media_image2.png
662
536
media_image2.png
Greyscale
through providing fixed and permeabilized cells (p. 5: “Fixation was performed in 3% (w/v) paraformaldehyde”, “The tissue was permeabilized in 2 mg/ml pepsin”), generating cDNA via RT using primers (p. 5: “In situ reverse transcription”, “cDNA primer or 5 μM of unmodified random decamers (all oligonucleotides sequences are listed in Supplementary Tables 4–6)”), tagging with barcode sequence (p. 5: “Barcode padlock probing”). Ke’s pepsin corresponds to a lysis agent. Ke teaches a ligation agent; amplification primers; and polymerase (p. 5/35). Thus, Ke teaches all elements of the claimed kit.
Claim Rejections - 35 USC § 103
Claims 1-3, 8-12, 19-23, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Nolan et al. (WO2012106385) in view of Fan et al. (US20160258012, EFD 2013-08-28) and Salathia et al. (US20160053253, EFD 2014-04-29).
Nolan teaches kits for tagging target molecules of nucleic acids from transcripts ([0069]: “kits for individually tagging cells”; [00250]-[00256]; claims 69-112; [00152]; [0063]; [00192]: “target nucleic acids may be obtained from a single cell.”; [00195]: “detect a novel transcript in order to diagnose or condition”).
Nolan teaches fixing the cells ([0006]: “In some embodiments, the invention relates to methods for identifying whether a plurality of targets are in a plurality of cells comprising: binding to the targets a plurality of tags, wherein a tag comprises a code that represents a) the target identity and b) the identity of the cell in which tag is binding. ... In some embodiments, the cell is lysed or fixed.”)
Nolan teaches permeabilizing the cells ([00116]: “Cells may be fixed prior to the addition of UBAs, ESBs or prior to COB assembly. Suitable cell permeabilization methods are known in the art and can be used to deliver components of the assay into cells and cellular components.”).
Nolan teaches single-stranded tags / UBAs ([0010]: “In some embodiments, the tag comprises a UBA.”; [0082]: “In some embodiments, the UBA is an aptamer. Aptamers include nucleic acid aptamers (i.e., single-stranded DNA molecules …”) which are configured to hybridize to the transcriptome of the cell ([00229]: “the UBAs, e.g., oligonucleotide probe, have substantially the same length so that they hybridize to target nucleotide sequences at substantially similar hybridization conditions. As a result, the process of the present invention is able to detect infectious diseases, genetic diseases, and cancer”; [0064]; [00192]: “target nucleic acids may be obtained from a single cell.”; [00195]: “detect a novel transcript in order to diagnose or condition”) and has a second sequence that is the same in each of the nucleic acid molecules ([00110]: “The COB can be attached to the UBA via a common linker (CL). The CL can also be part of an oligonucleotide”).
Nolan teaches a set of tags comprising multiple distinct barcode sequences comprising a sequence complementary to a common sequence ([00110]: “Substantially complementary or exact complementary annealing regions may be utilized for hybridization. An annealing region may be provided on both ends of an oligonucleotide ESB or APS. In some embodiments, the APSs are added in various steps of a split pool synthesis or any other suitable stepwise synthesis known in the art. An annealing region specific to each step of a stepwise synthesis maybe incorporated into the oligonucleotides”; [00111]-[00113]: “APSs can be designed to hybridize to the CL”).
Nolan teaches ligation ([0021]: “the method further comprises ligation”; [0084]; [00121]; [00170]).
Nolan teaches lysing the cell ([0006]: “In some embodiments, the cell is lysed”).
Nolan teaches PCR amplification of DNA using polymerase ([0063]: “PCR amplification”; [00115]; [00125]: “the assembled products are amplified”, “products are amplified by polymerase chain reaction (PCR).”; [00191]; [00273]: “The COBs are optionally PCR amplified for sequencing using primers targeting the amplification primer complementary regions on the CL and the last APS subunit.”; [00170]: “extended via polymerases”; [0059]).
Nolan does not teach an embodiment of a “kit” or that a first hybridization sequence comprises complementarity to the whole transcriptome.
Fan teaches “nucleic acid analysis of single cells” (Title, Abstract) and determining the whole transcriptome of the cell (Claim 132: “amplifying the whole transcriptome of said one or more cells”; [0602]: “the entire transcriptome of each single cell in the sample may also be measured”) using techniques such as RNA-seq ([0613]: “single-cell transcriptional landscape by highly multiplex RNA-seq”; [0777]: “ the target binding region comprises a sequence is adapted to hybridize to a target nucleic acid. … the target nucleic acid comprises a plurality of target nucleic acids comprising at least … 100% of the transcripts of a transcriptome of an organism”).
Salathia teaches “single cell gene expression analysis” using “unique barcodes such as unique molecular barcodes (UMI)” (Title, Abstract, claim 1) and applying RNA-Seq for whole transcriptome analysis (claim 11; [0060]: “The methods presented herein can include methods of generating tagged cDNA with sample-specific tags”; [0061]: “The double stranded cDNA can then be converted into a sequencing library using for example NEXTERA™ or TRUSEQ™ (Illumina, Inc.) for whole transcriptome RNA-Seq”). Salathia teaches whole transcriptome sequencing using random hybridization primers ([0074]-[0081]).
One of ordinary skill in the art following the teaching of Nolan would have considered known techniques for single cell analysis as taught by Fan and Salathia including the use of RNA-Seq for whole transcriptome analysis via utilizing hybridization sequences that are complementary to the whole transcriptome as taught by Fan and Salathia. One of ordinary skill in the art would have also assembled all of the elements required to perform the modified technique of Nolan thereby preparing a “kit”. One of ordinary skill in the art would have had a reasonable expectation of success because each of Nolan, Fan, and Salathia are in the same field of endeavor of single cell transcriptome analysis and they would have been motivated by the specific teaching of Nolan to perform the technique in order to identify the target molecules in a cell using the known techniques suggested by Fan and Salathia. Thus, claim 1 is prima facie obvious.
Regarding claim 2, Nolan teaches that the tags are DNA ([0010]; [0082]; [00131]: “The APS subunits or entire COBs can be detected via full sequencing of all DNA tags by any suitable methods known in the art, e.g., Illumina HiSeq 2000, including the sequencing methods described herein”).
Regarding claim 3, Nolan teaches the tags are combined in a manner to uniquely identify the target molecules with a “split pool” approach where the number of unique tags are numerically governed by the length ([00163]-[00170]). Thus, one of ordinary skill in the art would have considered optimizing the length of the barcode tag oligonucleotides among the typical lengths ([0086]: “The nucleic acid sequence is preferably at least 15 nucleotides in length, and more preferably is at least 20 nucleotides in length.”) in order to provide a sufficient number of unique tags including 8 or more nucleotides and arrive at the claimed invention.
Regarding claim 8, Nolan teaches t4 DNA ligase ([0084]: “ligation can be performed enzymatically by at least one DNA ligase or at least one RNA ligase, for example but not limited to, T4 DNA ligase”).
Regarding claims 9-11, Nolan teaches a capture region which used for isolation onto a bead ([0091]) including the use of biotin-streptavidin ([00102]) which were well-known and routinely used such that one of ordinary skill in the art would readily consider use for isolation and arrive at the claimed invention. Regarding claim 12, Nolan teaches the tags are combined in a manner to uniquely identify the target molecules with a “split pool” approach ([00163]-[00170]) and tags comprising multiple distinct barcode sequences comprising a sequence complementary to a common sequence ([00110]: “Substantially complementary or exact complementary annealing regions may be utilized for hybridization. An annealing region may be provided on both ends of an oligonucleotide ESB or APS. In some embodiments, the APSs are added in various steps of a split pool synthesis or any other suitable stepwise synthesis known in the art. An annealing region specific to each step of a stepwise synthesis maybe incorporated into the oligonucleotides”, “An annealing region specific to each step of a stepwise synthesis maybe incorporated into the oligonucleotides.”; [00111]-[00113]: “APSs can be designed to hybridize to the CL”) where the annealing regions are different ([00111]: “The annealing regions incorporated to each end of an APS can be different.”) respectively corresponding to the claim’s 3rd, 4th, and 5th sequences.
Regarding claims 19-22, Nolan teaches utilizing wells and any suitable surface known in the art ([00164]: “Cell populations can be split into wells, bead or any suitable surfaces known in the art.”) and 96-well microtiter plates ([00208]: “e.g. 96 well or greater microtiter plates”; [00212]; [00221]; claim 309) which are routinely used in the art for preparation of such nucleic acid samples, including split-pool barcoding ([00163]-[00170]) such that one of ordinary skill in the art would consider their use including a distinct barcode for each well to efficiently implement the split-pool approach and arrive at the claimed invention.
Regarding claims 23, Nolan teaches a capture region which used for isolation onto a bead ([0091]) including the use of biotin-streptavidin ([00102]) which were well-known and routinely used such that one of ordinary skill in the art would readily consider use for isolation and arrive at the claimed invention. Regarding claim 25, Nolan teaches greater than 1 million cells ([0018]-[0020]: “x is greater than 1,000,000”, x is number of cells).
With each of the above claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success before the effective filing date of the claimed invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nolan et al. (WO2012106385) in view of Fan et al. (US20160258012, EFD 2013-08-28) and Salathia et al. (US20160053253, EFD 2014-04-29) as applied to claims 1-3, 8-12, 19-23, 25 above and further in view of Nolan et al. (US20140099637)(“Nolan-2014”).
Regarding claim 4, Nolan teaches fixation but does not teach use of formaldehyde ([00300]: “The cells are immediately fixed and permeabilized by adding 50 mL cold methanol.”).
Nolan-2014 teaches use of common fixing agents including formaldehyde in a related technique of detecting nucleic acids from a cell ([0050]; Abstract; claim 1) that one of ordinary skill in the art would have considered in combination with Nolan to allow preservation of the cell.
Claims 5-7, 13-14, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Nolan et al. (WO2012106385) in view of Fan et al. (US20160258012, EFD 2013-08-28) and Salathia et al. (US20160053253, EFD 2014-04-29) as applied to claims 1-3, 8-12, 19-23, 25 above and further in view of Johnson et al. (US20140057799).
Regarding claims 5-6, Nolan teaches the cell is lysed but does not teach a specific reagent, however, Johnson teaches a related technique for studying nucleic acids in a fixed, permeabilized, single cells and performs lysis using proteinase K which is well-known and routinely used in the art ([0168]).
Regarding claim 7, Nolan teaches reverse transcription ([0059]) but not the particular enzyme reverse transcriptase, however, Johnson teaches use of reverse transcriptase ([0078]) well-known and routinely used in the art.
Regarding claims 13-14, Johnson teaches forward and reverse primers ([0014]) which comprise barcodes ([0082]; [0155]) while Nolan teaches sequencing the product using NGS systems ([00133]-[00142]) and including through the use of sequencing primers ([00270]; [00277]: “comprises a second amplification primer complimentary region for hybridization of PCR or sequencing primers.”; [00283]), such that one of ordinary skill in the art would have incorporated NGS sequencing primer sequence in the amplification primers in the course of preparing for sequencing and arrive at the claimed invention with a reasonable expectation of success.
Regarding claim 24, Nolan teaches the use of beads as per instant claim 23, but does not specifically teach SPRI beads. Johnson teaches use of SPRI beads of the same type as disclosed in the instant specification ([0147]: “Ampure bead technology (PerkinElmer)”) which one of ordinary skill in the art routinely uses in oligonucleotide purification.
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Nolan et al. (WO2012106385) in view of Fan et al. (US20160258012, EFD 2013-08-28) and Salathia et al. (US20160053253, EFD 2014-04-29) as applied to claims 1-3, 8-12, 19-23, 25 above and further in view of Islam (“From Single-Cell Transcriptomics to Single-Molecule Counting”, Thesis - Karolinska Institutet (Sweden). 2013. 59 pages).
Regarding claims 15-18, Nolan teaches using reverse transcription in preparation for sequencing ([0063], [0065]) but does not specifically teach the use of a poly(T), random hexamer, or transcript-specific sequences. However, Islam teaches that the use of these elements are part of standard sequencing library preparation in in reverse transcription (p. 15: “In standard library preparation for RNA-seq experiments, the RT reaction is primed by different types of primer and different RNA priming strategy can effect the efficiency of cDNA synthesis. Three priming strategies are available: sequence-specific primer, oligo (dT) primer and random hexamer.”) such that one of ordinary skill in the art would have reasonably considered their use and arrive at the claimed invention.
Response to Remarks - 35 USC § 103
Applicant argues “there is no suggestion whatsoever in Nolan to use nucleic acids ‘configured to hybridize to the transcriptome of the cell’ or to perform ‘single cell transcriptome analysis.’” (p. 13).
Applicant’s argument is that the new claim language added is what distinguishes the claims over the prior art. Even if there was support for the language, one of ordinary skill in the art following Nolan’s teaching would have considered using sequences that were capable of hybridizing to the transcriptome as this was Nolan’s purpose of detecting transcripts ([0195]). In addition, Nolan teaches multiplexing for “gene expression profiling” and “RNA expression analysis” in a cell ([0072]: “obtaining measurement of multiple target molecules in single cells in a complex cell population provides a better understanding of the physiological processes within each individual cell.”; [00154]: “For example but without limitation, the compositions, methods, and kits are useful for … gene expression profiling”; [00158]; [00229]: “The composition and methods of the invention can be used in gene expression analysis … Examples of genetic analyses that can be performed on nucleic acids include e-g., SNP detection, STR detection, RNA expression analysis”). Thus, one of ordinary skill in the art would have arrived at a kit comprising a nucleic acid sequence that was capable of hybridizing to the transcriptome of a cell.
Applicant argues that Nolan, Fan, or Salathia cannot be properly combined to arrive at the presently claimed kits because one of ordinary skill in the art would not have been motivated to modify the method disclosed by Nolan to analyze the whole transcriptome instead of the selected targets at the heart of Nolan's approach (p. 8). Applicant also argues that the methods described by Nolan are incompatible with those described by Fan or Salathia, and the cited references cannot be combined without fundamentally altering their operation (p. 8-11).
Regarding Applicant’s argument that Nolan is directed to a fundamentally different approach, relating instead to methods aiming to individually detect and/or quantify specific molecules of interest, the argument is not persuasive because Nolan teaches “quantifying the expression and regulation of genes and/or their products in cells” and “accurate and sensitive detection, identification and quantification of target molecules in every cell” (p. 1) for detecting 1000s of target molecules (p. 8-11) which are polynucleotides that are coding regions of DNA and mRNA (p. 17). Thus, the record establishes that Nolan is directed to techniques for detection of expression of polynucleotides in a cell and one of ordinary skill in the art would have considered Nolan as not directed to a fundamentally different approach as alleged. Furthermore, one of ordinary skill in the art would have considered the combination of the cited art as in the same field of endeavor and would have considered combining the teachings and arrive at the claimed invention with a reasonable expectation of success.
Applicant also argues that Fan and Salathia refer to methods of single-cell gene expression analysis, including RNA-seq for whole transcriptome analysis and one of ordinary skill in the art would not have combined their teachings with Nolan because they teach cell lysis or mRNA extraction.
This argument is not persuasive because one of ordinary skill in the art would have considered the teaching of Nolan regarding in tagging permeabilized cells ([00116]: “Cells may be fixed prior to the addition of UBAs, ESBs or prior to COB assembly. Suitable cell permeabilization methods are known in the art and can be used to deliver components of the assay into cells and cellular components.”) that one of ordinary skill in the art would have considered in combination with Nolan’s split-pool technique.
Applicant agues The Office Action does not explain how a method based on target molecule-binding and other steps taking place within pooled cells (Nolan) could be modified to incorporate elements taken from an approach that begins by separating the cells and then destroying the same cellular context via lysis (Fan and Salathia), e.g., without changing the respective functions of the elements or with an expectation of the combination yielding predictable results.
This argument is not persuasive because all of the prior art techniques cited are to labelling polynucleotides for identification and those of ordinary skill in the art routinely considered combining successful techniques to improve labelling – i.e., RNA-seq with barcodes, split-pool barcoding, and in-cell labelling with barcodes. Given the high level of skill in the art as evidenced by each of the cited prior art references, such a combination of nucleic acid techniques was well within their level of skill and they would have had a reasonable expectation of success in the combination.
Applicant’s arguments are not persuasive as previously established because the claims are to a “kit comprising” the elements recited and all of which are taught by the prior art in the same field of endeavor for the same purpose. Thus, one of ordinary skill in the art would have considered forming such as kit in their laboratory for studying cells in the same manner and arrived at the claimed invention with a reasonable expectation of success.
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.
In each of the following double patenting rejections, one of ordinary skill in the art practicing the claimed invention of the patent or reference application and when construing the claims therein would form a kit as in the instant claims including all of the elements therein. Thus the claimed invention is anticipated or rendered obvious.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12467076. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12428671. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12371735. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12371734. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12371733. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12305221. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12305220. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12305219. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12252735. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12252731. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12252730. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12252736. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12247247. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12247248. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12234501. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12252737. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12252736. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12252734. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12252733. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a kit for use in a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12227793. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12195786. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12180536. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12043864. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11987838. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11634751. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11555216. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11427856. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11168355. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10900065. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method that has components that anticipate the instant claims including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
Claim 1-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 18406472 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a kit used in a method that has components that anticipate the instant claims including fixation, permeabilization, ligation, and lysis agents, primers, polymerase, and nucleic acid molecules hybridizing to the same elements, including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18188504 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a method that has components that anticipate the instant claims including fixation, permeabilization, ligation, and lysis agents, primers, polymerase, and nucleic acid molecules hybridizing to the same elements, including providing permeabilized, fixed cells, generating cDNA, tagging, lysing, isolating and sequencing in the same manner to obtain the same information such that one of ordinary skill in the art would arrive at the claimed invention with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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, Kortney Klinkel can be reached at (571) 270-5293. 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 H HAVLIN/Primary Patent Examiner, Art Unit 1626
Prosecution Insights