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 .
DETAILED ACTION
Responsive to communication entered 08/04/2025.
Priority
This application, Pub. No. US 2023/0056532 A1, published 02/23/2023, is a § 371 National Stage of International Patent Application No. PCT/US2021/012220, filed 01/05/2021, Pub. No. WO 2021/141922 A1, which claims priority to US Provisional application No. 62/958,202, filed·01/07/2020.
Status of Claims
Claims 1-7, 9-14, 25 and 26 are currently pending. Claims 1-24 have been originally filed. Claims 5, 7, 10 and 20 have been amended; and Claims 8, 15, 16 and 24 have been canceled, as set forth in Applicant’s Preliminary amendment filed 07/05/2022. Claims 1-7, 9-14 and 17-23 have been subject to election/restriction requirement mailed 06/04/2025. Claims 1, 5, 11 and 14 have been amended; Claims 17-23 have been canceled; and Claims 25 and 26 have been added, as set forth in Applicant’s amendment filed 07/05/2022. Claims 1-7, 9-14, 25 and 26 are examined.
Election/Restrictions
Applicant's election, without traverse, of Group I, Claims 1-7, 9-14, 25 and 26, drawn to a method for analyzing a macromolecule, and without traverse, of the species:
a polypeptide as a macromolecule;
a nucleic acid molecule as a recording tag, a coding tag and an adaptor molecule;
a bead as a support;
a polypeptide as a binding agent; and
information transfer from the secondary tag to the recording tag is mediated by a DNA ligase and the extended recording tag is analyzed by a nucleic acid sequencing method using a sequencing primer,
in the reply filed on 08/04/2025 is acknowledged.
Applicant identified Claims 1-7, 9-14, 25 and 26 as the claims encompassing the elected species.
Election was made without traverse in the reply filed on 08/04/2025.
Information Disclosure Statement
The information disclosure statement, submitted on 02/14/2023, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Specification
The use of the term(s) Nanobody®, Alexa®, BODIPY®, Texas Red®, HaloTag®, which is a trade name or a mark used in commerce, has been noted in this application. See, for example, paragraphs [0148], [0156] and [0180] of US 2023/0056532 A1. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks,
service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Appropriate correction is required.
Claim Rejection - 35 USC § 112
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 112 that form the basis for the rejections under this section made in this Office action:
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7, 9-14, 25 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention (“new matter”).
The claims, as recited in the amended independent Claim 1, are drawn to:
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At page 6 of the Remarks filed 08/04/2025, Applicant argues that:
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Emphasis added.
The Examiner respectfully disagrees for the following reasons.
First, as to concern the amended independent Claim 1, the only appearance of the term “encoder sequence” in the application as filed appears to be found in the following context:
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Emphasis added.
As such, contrary to Applicant’s allegation, the recitation “wherein the first hybridization sequence is substantially complementary to the encoder sequence of coding tag” is not supported by the originally filed disclosure.
Second, as to concern the newly added Claim 25, there is no support for the generic recitation “wherein the adaptor molecule comprises a cleavable linker between the first hybridization sequence and the secondary tag” because the disclosure of paragraphs [0030] and [0085] is limited to the following:
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Emphasis added.
According to MPEP 2163.06, “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application.” Emphasis added.
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-5, 7, 10-13, 25 and 26 are rejected under 35 U.S.C. 103 as obvious over Chee et al., WO 2017/192633, published 11/09/2017, US counterpart of which Chee et al., US 2019/0145982 A1, published 05/16/2019 (IDS submitted 02/14/2023), in view of Frank, “BARCRAWL and BARTAB: software tools for the design and implementation of barcoded primers for highly multiplexed DNA sequencing,” BMC Bioinformatics, 2009, 10: 362, pp. 1-13 (IDS submitted 02/14/2023).
For Applicant’s convenience, the citations are made to the paragraphs of Chee et al., US 2019/0145982 A1.
Regarding Claim 1, Chee et al., teach a method for analyzing a macromolecule (paragraph [0025) a method for analyzing a plurality of macromolecules), comprising the steps of: (a) providing a macromolecule and an associated recording tag joined to a support (paragraph [0026) (a) providing a macromolecule, an associated first recording tag and an associated second recording tag joined to a solid support); (b) contacting the macromolecule with a binding agent capable of binding to the macromolecule, wherein the binding agent comprises a coding tag comprising … an encoder sequence (paragraph [0095] wherein the coding tag comprises an encoder sequence), to allow binding between the macromolecule and the binding agent (paragraph [0027) (b) contacting the macromolecule with a first binding agent capable of binding to the macromolecule, wherein the first binding agent comprises a first coding tag with identifying information regarding the first binding agent); (c) providing an adaptor molecule comprising a first hybridization sequence, wherein the first hybridization sequence is substantially complementary to the encoder sequence of the coding tag, to allow hybridization between the first hybridization sequence and the encoder sequence, wherein step (c) is performed before, after or simultaneously with step (b) (paragraph [0323) the term "spacer" (Sp) refers to a nucleic acid molecule of about 1 base to about 20 bases ... in length that is present on a terminus of a recording tag or coding tag ... Sp' refers to spacer sequence complementary to Sp; paragraph [0532] In an example illustrated in FIG. 11B, the recording tag is comprised of ... a common spacer sequence (Sp1) ... the coding tag is comprised of a common spacer sequence (Sp2'), ... Prior to the introduction of the coding tag-labeled binding agent, ... an adaptor sequence, Sp1 '-Sp2, is annealed to the recording tag Sp1 . This adapter sequence also capable of interacting with the Sp2' sequence on the coding tag);
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and (e) analyzing the extended recording tag (paragraph [0031) (F) analyzing the first ... extended recording tags).
Chee et al. fail to explicitly disclose a secondary tag in the step (c); and the step (d) transferring information of the secondary tag to the recording tag to generate an extended recording tag, wherein the information of the secondary tag is transferred from the adaptor molecule to the recording tag after the coding tag associated with the binding agent hybridizes with the first hybridization sequence on the adaptor molecule.
Frank teaches a composite oligonucleotide containing a unique tag (page 2, right column, 2nd paragraph, The primary structures of forward and reverse PCR primers used to barcode amplicons are schematized in Fig. 1 ... At a minimum, the barcode must lie upstream of the specificity region of the oligonucleotide; wherein, as shown at page 3, Fig. 1 A, a composite forward primer contains Sequencing-Barcode-Template-specificity:
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It would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have modified the adaptor of Chee et al. to include a secondary tag, since the general conditions of the claim are disclosed in the prior art (Chee et al., paragraph [0532] FIG. 11 B ... an adapter sequence, Sp1'-Sp2; Frank, at page 3, Fig. 1A, shows a composite forward primer containing Sequencing-Barcode-Template-specificity), and developing a composite adaptor containing a barcode tag between Sp1' and Sp2 [Sp1'-barcode-Sp2] involves only routine skill in the art. The motivation of doing so would be to develop a broad application of methods for analyzing a macromolecule using various adaptor molecules including an adaptor molecule containing a secondary tag, i.e. a barcode, between a first and a second hybridization sequence.
Further, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have modified the method of Chee et al. to include transferring information of the secondary tag to the recording tag to generate an extended recording tag, wherein the information of the secondary tag is transferred from the adaptor molecule to the recording tag after the coding tag associated with the binding agent hybridizes with the first hybridization sequence on the adaptor molecule, since the general conditions of the claim are disclosed in the prior art (Chee et al., paragraph [0532] FIG. 11 B ... In an example illustrated in FIG. 11 B, the recording tag is comprised of ... a common spacer sequence (Sp1) ... the coding tag is comprised of a common spacer sequence (Sp2'), ... an adapter sequence, Sp1'-Sp2, is annealed to the recording tag Sp1. This adapter sequence also capable of interacting with the Sp2' sequence on the coding tag, bringing the recording tag and coding tag in proximity to each other; wherein Fig. 11 B of Chee et al. shows extended recording tag after transfer of the information of the coding tag to the recording tag upon binding of the adaptor to the recording tag and the coding tag; Frank, at page 3, Fig. 1A, shows a composite forward primer containing Sequencing-Barcode-Template-specificity), transferring the barcode information of the modified adaptor (Sp1'-barcode-Sp2) to the recording tag to generate extended recording tag involves only routine skill in the art. The motivation of doing so would be to develop a broad application of methods for analyzing a macromolecule using various adaptor molecules including an adaptor molecule containing a secondary tag, i.e. a barcode, between a first and a second hybridization sequence.
Regarding Claim 2, combination of Chee et al. and Frank teaches the method of Claim 1. Chee et al. further teach wherein step (b) comprises contacting a plurality of macromolecules with a plurality of binding agents (paragraphs [0027] and [0029] (b) contacting the macromolecule with a first binding agent capable of binding to the macromolecule ... (d) contacting the macromolecule with a second binding agent capable of binding to the macromolecule). Chee et al. fail to explicitly disclose wherein step (c) comprises providing a plurality of adaptor molecules, wherein the plurality of adaptor molecules comprises at least one adaptor molecule capable of hybridizing to at least one coding tag associated with the binding agent. However, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have modified the method of Chee et al. to include step (c) comprises providing a plurality of adaptor molecules, wherein the plurality of adaptor molecules comprises at least one adaptor molecule capable of hybridizing to at least one coding tag associated with the binding agent, since the general conditions of the claim are disclosed in the prior art (Chee et al., paragraph [0532] FIG. 11 B ... In an example illustrated in FIG. 11 B, the recording tag is comprised of ... a common spacer sequence (Sp1) ... the coding tag is comprised of a common spacer sequence (Sp2'), Prior to the introduction of the coding tag-labeled binding agent, .. . an adapter sequence, Sp1'-Sp2, is annealed to the recording tag Sp1. This adapter sequence also capable of interacting with the Sp2' sequence on the coding tag; paragraph [0323] Sp' refers to spacer sequence complementary to Sp), using a plurality of adaptor molecules involves only routine skill in the art. The motivation of doing so would be to develop a broad application of methods for analyzing a macromolecule using a plurality of adaptor molecules.
Regarding Claim 3, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have modified the method, taught by combination of Chee et al. and Frank, wherein multiple coding tags associated with the binding agent are configured to hybridize to adaptor molecules comprising the same secondary tag, since the general conditions of the claim are disclosed in the prior art, and configuring multiple coding tags containing Sp2' to hybridize to adaptor molecules comprising the same secondary tag, i.e., barcode, between Sp1' and Sp2 involves only routine skill in the art. The motivation of doing so would be to develop a broad application of methods for analyzing a macromolecule using various design of adaptor molecules, including an adaptor molecule containing the same barcode for the multiple coding tags associated with a specific binding molecule.
Regarding Claim 4, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have modified the method, taught by combination of Chee et al. and Frank, to include a second hybridization sequence substantially complementary to a sequence at the 3' terminus of the recording tag, since the general conditions of the claim are disclosed in the prior art (Chee et al., paragraph [0085] wherein the recording tag comprises a spacer at its 3'-terminus; paragraph [0532] In an example illustrated in FIG. 11 B, the recording tag is comprised of ... a common spacer sequence (Sp1) ...an adapter sequence, Sp1 '-Sp2, is annealed to the recording tag Sp1; paragraph [0323] Sp' refers to spacer sequence complementary to Sp), because using an adaptor molecule having a second hybridization sequence substantially complementary to a sequence at the 3' terminus of the recording tag involves only routine skill in the art. The motivation of doing so would be to develop a broad application of methods for analyzing a macromolecule using various adaptor molecules, including an adaptor molecule containing a second hybridization sequence substantially complementary to a sequence at the 3' terminus of the recording tag.
Further, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have modified the method, taught by combination of Chee et al. and Frank, to include information transfer of the secondary tag from the adaptor molecule to the recording tag occurs after: the first hybridization sequence on the adaptor molecule hybridizes to the coding tag of the binding agent; and the second hybridization sequence of the adaptor molecule hybridizes to a portion of the recording tag, since the general conditions of the claim are disclosed in the prior art (Chee et al., paragraph [0532] FIG. 11 B ... In an example illustrated in FIG. 11 B, the recording tag is comprised of ... a common spacer sequence (Sp1) ... the coding tag is comprised of a common spacer sequence (Sp2'), ... an adapter sequence, Sp1'-Sp2, is annealed to the recording tag Sp1. This adapter sequence also capable of interacting with the Sp2' sequence on the coding tag, bringing the recording tag and coding tag in proximity to each other; wherein Fig. 11 B of Chee et al. shows extended recording tag after transfer of the information of the coding tag to the recording tag upon binding of the adaptor to the recording tag and the coding tag; Frank, at page 3, Fig. 1A, shows a composite forward primer containing Sequencing-Barcode-Template-specificity), and transferring the barcode information of the modified adaptor (Sp1'-barcode-Sp2] to the recording tag upon binding of the modified adaptor to both recording tag and coding tag involves only routine skill in the art. The motivation of doing so would be to develop a broad application of methods for analyzing a macromolecule using various adaptor molecules including an adaptor molecule containing a secondary tag, i.e. a barcode, between a first and a second hybridization sequence.
Regarding Claim 5, combination of Chee et al. and Frank teaches the method of Claim 1. Chee et al. further teach wherein the macromolecule is a polypeptide (the elected species (1)), analyzing the macromolecule comprises determining at least a portion of an amino acid sequence of the polypeptide (paragraph [0076] wherein the macromolecule is a protein, polypeptide or peptide; paragraph [0258] FIGS. 3A-D illustrate a process for a degradation-based peptide sequencing assay by construction of a DNA extended recording tag representing the peptide sequence), and recording tag, the coding tag and the adaptor molecule comprise a nucleic acid molecule (the elected species (2)) (paragraph [0532] In an example illustrated in FIG. 11B, the recording tag is comprised of ... a common spacer sequence (Sp1) ... the coding tag is comprised of a common spacer sequence {Sp2'), ... an adapter sequence, Sp1 '-Sp2, is annealed to the recording tag Sp1. This adapter sequence also capable of interacting with the Sp2' sequence on the coding tag; paragraph [0323] the term "spacer" (Sp) refers to a nucleic acid molecule of about 1 base to about 20 bases ... in length that is present on a terminus of a recording tag or coding tag .. . Sp' refers to spacer sequence complementary to Sp).
Regarding Claim 7, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used in the method, taught by combination of Chee et al. and Frank, information transfer from the secondary tag to the recording tag mediated by a DNA ligase (the elected species (5)) or DNA polymerase, since the general conditions of the claim are disclosed in the prior art (Chee et al., paragraph [0532] In certain embodiments, the information transfer from the recording tag to the coding tag can be accomplished using a primer extension step ... In an example illustrated in FIG. 11B, the recording tag is comprised of ... a common spacer sequence (Sp1) ... the coding tag is comprised of a common spacer sequence (Sp2'), ... an adapter sequence, Sp1 '-Sp2, is annealed to the recording tag Sp1. This adapter sequence also capable of interacting with the Sp2' sequence on the coding tag; paragraphs [0099]-[0100) wherein transferring the information of the coding tag to the recording tag is mediated by a DNA ligase ... wherein transferring the information of the coding tag to the recording tag is mediated by a DNA polymerase), and generating an extended recording tag by transferring information from the secondary tag to the recording tag via a DNA ligase or DNA polymerase involves only routine skill in the art.
Regarding Claim 10, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used in the method, taught by combination of Chee et al. and Frank, a secondary tag comprising a binding cycle specific sequence, since the general conditions of the claim are disclosed in the prior art ((Chee et al., paragraph [0322] the term "binding cycle specific tag" .. . refers to a unique sequence used to identify a library of binding agents used within a particular binding cycle. A binding cycle specific tag may comprise about 2 bases to about 8 bases (e.g., 2, 3, 4, 5, 6, 7, or 8 bases) in length; Frank, page 3, Fig. 1A of Frank shows a composite forward primer containing Sequencing-Barcode-Template-specificity), and using a binding cycle specific sequence as a secondary tag involves only routine skill in the art. The motivation of doing so would be to develop a broad application of methods for analyzing a macromolecule using various adaptor molecules including an adaptor molecule containing a binding cycle specific sequence.
Regarding Claim 11, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used in the method, taught by combination of Chee et al. and Frank, an adaptor molecule comprising from 5' to 3' direction: a first hybridization sequence, a secondary tag, and a second hybridization sequence, and a secondary tag comprising identifying information regarding the binding agent, a binding cycle-specific barcode, a unique molecular identifier, or a combination thereof, since the general conditions of the claim are disclosed in the prior art (Chee et al., paragraph [0532] FIG. 11 B ... In an example illustrated in FIG. 11 B, the recording tag is comprised of ... a common spacer sequence (Sp1) ... the coding tag is comprised of a common spacer sequence (Sp2'), ... an adapter sequence, Sp1'-Sp2, is annealed to the recording tag Sp1. This adapter sequence also capable of interacting with the Sp2' sequence on the coding tag, bringing the recording tag and coding tag in proximity to each other; wherein Fig. 11 B of Chee et al. shows extended recording tag after transfer of the information of the coding tag to the recording tag upon binding of the adaptor to the recording tag and the coding tag; Frank, at page 3, Fig. 1A, shows a composite forward primer containing Sequencing-Barcode-Template-specificity), and developing an adaptor molecule containing 5'-first hybridization sequence- unique molecular identifier -second hybridization sequence-3' involves only routine skill in the art. The motivation of doing so would be to develop a broad application of methods for analyzing a macromolecule using various adaptor molecules including an adaptor molecule containing a unique molecular identifier.
Regarding Claim 12, combination of Chee et al. and Frank teaches the method of Claim 5. Chee et al. further teach wherein the binding agent is configured to bind to an N-terminal amino acid (NTAA) residue of the polypeptide (paragraph [0053] a first binding agent capable of binding to the modified NTAA).
Regarding Claim 13, combination of Chee et al. and Frank teaches the method of
Claim 5. Chee et al. further teach wherein the method further comprises the following step: (a') modifying an N-terminal amino acid (NTAA) residue of the polypeptide, thereby producing a modified NTAA residue, and the binding agent is configured to bind to the modified NTAA residue of the polypeptide (paragraph [0076] wherein the macromolecule is a protein, polypeptide or peptide; paragraphs [0052]-[0053] (b) modifying the N-terminal amino acid (NTAA) of the peptide with a chemical agent to yield a modified NTAA; (c) contacting the peptide with a first binding agent capable of binding to the modified NTAA).
Regarding Claim 25, combination of Chee et al. and Frank teaches the method of Claim 1. Chee et al. further teach the use of a cleavable linker and its cleavage after information transfer from the coding tag to the recording tag (paragraph [0287] (E) After information transfer from the coding tag to the recording tag, the coding tag is nicked (cleaved) at its uracil site using a uracil-specific excision reagent (e.g., USER™) enzyme mix.).
Regarding Claim 26, combination of Chee et al. and Frank teaches the method of Claim 1. Chee et al. further teach wherein analyzing the extended recording tag comprises performing one of the following nucleic acid sequencing method (paragraphs [0102]-[0103] wherein analyzing the extended recording tag comprises a nucleic acid sequencing method ... wherein the nucleic acid sequencing method is sequencing by synthesis, sequencing by ligation, sequencing by hybridization, polony sequencing, ion semiconductor sequencing, or pyrosequencing).
Regarding the elected species (3), Chee et al., throughout the publication and, for example, in paragraph [0185], teach a polystyrene bead, a polymer bead, an agarose bead, an acrylamide bead, a solid core bead, a porous bead, a paramagnetic bead, glass bead, or a controlled pore bead as a solid support.
Regarding the elected species (4), Chee et al., throughout the publication and, for example, in paragraph [0186], teach a polypeptide as a binding agent.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 7, 10-13, 25 and 26 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over Claims 1-29 of US Patent No. 12,123,878 B2, issued 10/22/2024, which prior publication is Chee et al., US 2019/0145982 A1, published 05/16/2019 (IDS submitted 02/14/2023), in view of Frank, “BARCRAWL and BARTAB: software tools for the design and implementation of barcoded primers for highly multiplexed DNA sequencing,” BMC Bioinformatics, 2009, 10: 362, pp. 1-13 (IDS submitted 02/14/2023).
US Patent 12,123,878 B2 claims:
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For the reasons set forth in the 103 rejection above, the instantly claimed method would have been prima facie obvious for one of ordinary skill in the art over the method claimed by US Patent No. 12,123,878 B2.
Claims 1-5, 7, 10-13, 25 and 26 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over Claims 1-16 of US Patent No. 12,019,077 B2, issued 06/25/2024 from application No. 17/197,796, which is continuation of 16/098,436, which publication is Chee et al., US 2019/0145982 A1, published 05/16/2019 (IDS submitted 02/14/2023), in view of Frank, “BARCRAWL and BARTAB: software tools for the design and implementation of barcoded primers for highly multiplexed DNA sequencing,” BMC Bioinformatics, 2009, 10: 362, pp. 1-13 (IDS submitted 02/14/2023).
US Patent 12,019,077 B2 claims a method for analyzing the immobilized barcoded peptides on the beads comprising the following steps:
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For the reasons set forth in the 103 rejection above, the instantly claimed method would have been prima facie obvious for one of ordinary skill in the art over the method claimed by US Patent No. 12,019,077 B2.
Claims 1-5, 7, 10-13, 25 and 26 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over Claims 1-23 of US Patent No. 11,513,126 B2, issued 11/29/2022 (IDS submitted 02/14/2023), in view of Chee et al., WO 2017/192633, published 11/09/2017, US counterpart of which Chee et al., US 2019/0145982 A1, published 05/16/2019 (IDS submitted 02/14/2023), and Frank, “BARCRAWL and BARTAB: software tools for the design and implementation of barcoded primers for highly multiplexed DNA sequencing,” BMC Bioinformatics, 2009, 10: 362, pp. 1-13 (IDS submitted 02/14/2023).
The teachings of Chee et al. and Frank are discussed in the 103 rejection above and incorporated herein in its entirety.
The US Patent 11,513,126 B2 claims:
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It would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used a kit claimed US Patent 11,513,126 B2, in the method, taught by combination of Chee et al. and Frank.
Claims 1-7, 9-14, 25 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-21 of U.S. Patent No. 11,169,157 B2, issued 11/09/2021. Although the claims at issue are not identical, they are not patentably distinct from each other because US 11,169,157 B2 claims:
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230
596
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142
614
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398
606
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382
604
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58
602
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Conclusion
No claims are allowed.
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/GALINA M. YAKOVLEVA/Primary Examiner, Art Unit 1678