Status of the Claims
Claims 2-21 are pending and examined herein.
Claim 1 is cancelled.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim 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.
Claim 14 recites that the linker between the analyte-binding moiety and the first oligonucleotide is a “cleavable linker, wherein the cleavable linker is a photocleavable linker, UV-cleavable linker, or an enzyme-cleavable linker” (emphasis added). However, in the specification there is no mention of photocleavable nor UV-cleavable linkers. The references in the specification to the linker between the analyte-binding moiety and first oligonucleotide include:
p. 31, ¶[00125]: “Oligonucleotides may be coupled to the probes or proteins by conjugation, chemical or photo-crosslinking via suitable groups and the like.”
p. 4, ¶[00164]: “a protein-based probe can be conjugated or otherwise linked to an oligonucleotide address tag.”
p. 50, ¶[00173]: “Additional details of the polynucleotide-protein conjugates used in the present disclosure are disclosed in United States Provisional Patent Application Serial No. 61/902,105.” This provisional application similarly makes no mention of photocleavable nor UV-cleavable linkers used to conjugate an analyte-binding moiety with a first oligonucleotide.
As the instant specification does not contain adequate written description of photocleavable and UV-cleavable linkers, these limitations of claim 14 constitute new matter.
Claim Interpretation
Claim 3 recites limitations of first and second “ligation regions”. There is no limiting definition of “ligation regions” provided in the disclosure, so the broadest reasonable interpretation is taken to mean a region of an oligonucleotide that is intended for ligation. This constitutes an intended use and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, as per MPEP § 2115, “[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)), and that the manner or method in which a machine is to be utilized is not germane to the issue of patentability of the machine itself.
See also MPEP § 2111.02, citing In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus), and MPEP § 2112.01 citing In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) stating that “discovery of an unobvious property and use does not overcome the statutory restraint of section 102 when the claimed composition is known”.
Therefore, if a region of an oligonucleotide of the prior art has sufficient structure to achieve the intended use of “ligation”, it will meet the limitation of the claim.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Application 19/021,456
Claim 2 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of copending Application No. 19021456 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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.
US Pat No. 9,868,979
Claims 2, 7-12, and 18-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-14, 16, 18-19, and 28-32 of U.S. Patent No. 9868979 in view of Huang et al. (WO 2011/062933).
Regarding claims 2 and 3, claims 1, 12-14, 16, and 28-32 of the ‘979 patent disclose: attaching a biological sample to first and second microfluidic devices that have multiple first and second addressing channels, wherein the addressing channels identify specific areas of the sample; delivering two probes to intersecting regions of the sample; delivering first and second addressing tags through the first and second addressing channels where the addressing tags are associated with the probes; and coupling the first and second addressing tags. The ‘979 patent does not disclose the configuration of the probes recited in the instant claim, nor using the probes to analyze the interaction between a protein and nucleic acid.
Huang discloses a proximity ligation assay that utilizes two barcoded probes to bind distinct sites of a target analyte (p. 14, lines 13-28), where the oligonucleotide tags are coupled (p. 15, lines 1-10). Additionally, Huang suggests that these types of methods are useful for the analysis of nucleic acid-polypeptide interactions (p. 16, lines 4-6, 25-29). Therefore, it would have been obvious to one of ordinary skill in the art by the effective filing date to incorporate coupling of the addressing tags of the polynucleotide and protein targets of the instant claim.
Furthermore, the configuration of the probes constitutes a design choice and would therefore have been obvious over the claims of the ‘979 patent.
Claims 2-3 and 8-11 of the ‘979 patent recite the limitations of claims 7-12 of the instant application.
Additionally, claims 1, 4, and 18-19 of the ‘979 patent recite the limitations of claims 18-21 of the instant application.
US Pat No. 10,774,372
Claims 2-4, 13, 15, 17-18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17 and 21 of U.S. Patent No. 10774372 in view of Huang et al.
Regarding claim 2, claim 15 of the ‘372 patent discloses: attaching a biological sample to first and second microfluidic devices that have multiple first and second addressing channels, wherein the addressing channels identify specific areas of the sample; delivering an analyte-binding moiety with a barcode and a targeting oligonucleotide to intersecting regions of the sample; delivering first and second addressing tags through the first and second addressing channels where the addressing tags are associated with the analyte-binding moiety and the targeting oligonucleotide; and that the first and second address tags are coupled at the intersecting area. The ‘372 patent does not disclose the configuration of the probes recited in the instant claim, nor using the probes to analyze the interaction between a protein and nucleic acid. These limitations would be rendered obvious by the same reasoning described previously.
The disclosures of claims 15 and 16 of the ‘372 patent in view of Huang also render obvious claims 3-4 and 13-16 of the instant application.
Additionally, claims 15, 17, and 21 of the ‘372 patent recite the limitations of claims 17, 18, and 20 of the instant application
US Pat No. 10,927,403
Claims 2-5 and 7-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 19, 23, 25, 35-40, and 42-44 of U.S. Patent No. 10927403 in view of Huang et al.
Regarding claim 2, claim 2 of the ‘403 patent discloses: attaching a biological sample to first and second microfluidic devices that have multiple first and second addressing channels, wherein the addressing channels identify specific areas of the sample; delivering an analyte-binding moiety with a barcode and a targeting oligonucleotide to intersecting regions of the sample; delivering first and second addressing tags through the first and second addressing channels where the addressing tags are associated with the analyte-binding moiety and the targeting oligonucleotide; and that the first and second address tags are coupled at the intersecting area. The ‘403 patent does not disclose the configuration of the probes recited in the instant claim, nor using the probes to analyze the interaction between a protein and nucleic acid. These limitations would be rendered obvious by the same reasoning described previously.
The disclosures of claims 2, 19, and 42 of the ‘403 patent in view of Huang also render obvious claims 3-5 and 13-16 of the instant application.
Claims 35-40 of the ‘403 patent recite the limitations of claims 7-12 of the instant application.
Additionally, claims 2, 23, 25, and 43-44 of the ‘403 patent recite the limitations of claims 17-21 of the instant application.
US Pat No. 11,046,996
Claims 2-16 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-12, and 14-15 of U.S. Patent No. 11046996 in view of Huang et al.
Regarding claims 2, claims 1 and 14 of the ‘996 patent disclose: attaching a biological sample to first and second microfluidic devices that have multiple first and second addressing channels, wherein the addressing channels identify specific areas of the sample; delivering an analyte-binding moiety with a barcode and a targeting oligonucleotide to intersecting regions of the sample; delivering first and second addressing tags through the first and second addressing channels where the addressing tags are associated with the analyte-binding moiety and the targeting oligonucleotide; and that the first and second address tags are coupled at the intersecting area. The ‘996 patent does not disclose the configuration of the probes recited in the instant claim, nor using the probes to analyze the interaction between a protein and nucleic acid. These limitations would be rendered obvious by the same reasoning described previously.
The disclosures of claims 1, 9, 12, and 15 of the ‘996 patent in view of Huang also render obvious claims 3-6 and 13-16 of the instant application.
Claims 2-7 of the ‘996 patent recite the limitations of claims 7-12 of the instant application.
Additionally, claims 10 and 11 of the ‘996 patent recite the limitations of claims 18 and 19 of the instant application.
Conclusion
No claims are allowed.
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/ALEXANDRA OLSON/Examiner, Art Unit 1684
/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
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