DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Currently, claims 1, 2, 5, 13-20, and 26-28 are pending in the instant application. Claims 1, 2, 5, and 20 are withdrawn from consideration as being drawn to a non-elected invention and claims 26-28 are newly added. Claims 13-19 and 26-28 are currently under examination. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are either newly applied, as necessitated by amendment, or are reiterated. They constitute the complete set being presently applied to the instant Application. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 101
Claims 13-19 and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II.
The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., , 133 S. Ct. 2107, 2116, (2013).
Claims Analysis:
As set forth in MPEP 2106, the claims have been analyzed to determine whether they are directed to one of the four statutory categories (STEP 1). The claims were then analyzed to determine if they recite a judicial exception (JE) (STEP 2A, prong 1) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)]. The claims were then analyzed to determine whether they recite an element or step that integrates the JE into a practical application (STEP 2A, prong 2) [Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)]. In the absence of a step(s) or element(s) that integrate the JE into a practical application, the additional elements/steps have been considered to determine whether they add significantly more to the JE (STEP 2B) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)]. It was found that the present claims fail to meet the elements required for patent eligibility.
The claims are directed to an “array” comprising reagents for detecting ncRNAs and as such are directed to products. Accordingly, the claims are directed to one of the four statutory categories of invention.
The claims are drawn to an “array” which comprises reagents for detecting two more more ncRNAs listed in the claims. Dependent claim 19 requires the reagent be oligonucleotide probes or primers. As such the claims are directed to a product of nature which is a judicial exception.
This judicial exception is not integrated into a practical application because the nucleic acid molecules encompassed by the claims convey the same genetic information as their naturally occurring counterparts. The Supreme Court has made clear "separating [DNA] from surrounding genetic material is not an act of invention" Myriad, 133 S. Ct. at 2117. In Myriad v. Ambry CAFC 2014-1361,1366, December 17, 2014, the CAFC further (regarding a claim directed to a pair of primers) stated “In fact, the naturally occurring genetic sequences at issue here do not perform a significantly new function. Rather, the naturally occurring material is used to form the first step in a chain reaction—a function that is performed because the primer maintains the exact same nucleotide sequence as the relevant portion of the naturally occurring sequence. One of the primary functions of DNA’s structure in nature is that complementary nucleotide sequences bind to each other. It is this same function that is exploited here—the primer binds to its complementary nucleotide sequence. Thus, just as in nature, primers utilize the innate ability of DNA to bind to itself.”
Although the claims recite “the array is attached to a solid surface” this does not add meaningful limitations to the claims because it does not appear to require a change in the structure of the claimed oligonucleotides. At page 19-20, the specification teaches that microarrays can be fabricated by a variety of technologies, including ink jet printing, for example. The specification also teaches that blots can be used to detect DNA or RNA, such as hybridization probes bound to the filter. However, neither of these embodiments require a covalent attachment to the solid support such that the structure of the claimed oligonucleotides would be distinguished from products of nature.
The array of reagents encompassed by the claims include nucleic acid sequences such as probes and primers that hybridize to, as well as fragments of the naturally occurring ncRNAs listed in the claims. None of these molecules or cells are patent eligible, whether isolated or not, pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics Inc., US (June 13, 2013). Accordingly, the claims are rejected as being directed to non-patentable subject matter.
Claim Rejections - 35 USC § 112
112-first paragraph: Written Description
Claims 13-19 and 27-28 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.
Newly added claims 27 and 28 require that the reagent oligonucleotides, that is probes or pair of amplification oligonucleotides, are fluorescently labeled as well as being comprised in an array “attached to a solid surface”. However, the specification has been thoroughly reviewed, and neither explicit nor implicit support was found for these newly claimed embodiments.
The claims have also been amended to recite “wherein the PCAT-1 comprises a nucleic acid sequence that is at least 90% identical to SEQ ID NO: 1 or SEQ ID NO: 2; and the PCAT-14 comprises a nucleic acid sequence that is at least 90% identical to any of SEQ ID NOS 3-9…”. The response references portions of the specification as well as newly added claims from a preliminary amendment as support for the amendments. However, the specification has been thoroughly reviewed but was not found to provide support for reagents which detect to two or more ncRNA prostate cancer biomarkers encoded by PCAT-1 or PCAT-14 “the PCAT-1 comprises a nucleic acid sequence that is at least 90% identical to SEQ ID NO: 1 or SEQ ID NO: 2; and the PCAT-14 comprises a nucleic acid sequence that is at least 90% identical to any of SEQ ID NOS 3-9…”. The specific SEQ ID NOS 1-9 are taught by the specification, however the specification does not teach detection of nucleic acid sequences that are at least 90% identical to SEQ ID NO: 1 or SEQ ID NO: 2 or at least 90% identical to any of SEQ ID NOS 3-9”. Additionally, the specification does not teach that PCAT 1 or PCAT 14 is encoded by nucleic acid sequences that are at least 90% identical to SEQ ID NO: 1 or SEQ ID NO: 2 or at least 90% identical to any of SEQ ID NOS 3-9 respectively, nor does it teach how to distinguish which sequences within the genus of molecules encompassed by these claim amendments would functionally “encode PCAT1 or PCAT 14”. Therefore, for these reasons and the reasons made of record in the office action dated 5/8/2025, section 12, the specification does not appear to provide an adequate written description of the broadly claimed subject matter. The response traverses the rejection. The response’s arguments have been thoroughly reviewed but were not found persuasive because the specification does not provide guidance as to how to distinguish reagents that functionally encode PCAT1 or PCAT14 other than the SEQ ID NOS 1-9, respectively, from the broad genus of possible nucleic acids encompassed by 90% identity.
112-second paragraph
Claims 13-19 and 27-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The rejection under 35 USC 112, second paragraph, is incorporated herein from the previous office action for claims 13-19 and newly added claims 27-28. The response traverses the rejection and asserts that the claims have been amended as discussed in the traversal for the 112, first paragraph rejection. This is not found persuasive because the specification does not teach the metes and bounds of reagents that functionally encode PCAT1 or PCAT14 other than the SEQ ID NOS 1-9, respectively, from the broad genus of possible nucleic acids encompassed by 90% identity.
Claim 28 lacks sufficient antecedent basis for the term “the pair of amplification oligonucleotides” because this claim is dependent on claim 18, which does not recite any amplification oligonucleotides.
Claim Rejections - 35 USC § 102
Claims 13-19 and 26 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Fodor (Fodor et al; US Patent 6,582,908).
Although the claims have been amended to recite PCAT-1 comprises a nucleic acid sequence that is at least 90% identical to SEQ ID NO: 1 or SEQ ID NO: 2; and the PCAT-14 comprises a nucleic acid sequence that is at least 90% identical to any of SEQ ID NOS 3-9, this is an intended use, that is it is directed the the target being detected, not to the array of reagents encompassed by the claims. The claims are broadly drawn to an “array” of oligonucleotides with no particular structure or nucleotide base composition. Fodor teaches arrays of all possible 10 mer nucleotide sequences (see claim 5). The array taught by Fodor necessarily comprises oligonucleotides that can function to detect the targets recited by the claims. Fodor teaches that the array was constructed by photolithography techniques which necessarily anticipates claim 17. Accordingly, the array taught by Fodor is taken anticipate the claims because the 10 mer array can be used in a method to detect the non-coding RNA sequences encompassed by the claims.
Claims 13-19 and 26 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Sultan (Sultan et al; Science, vol 321, pages 956-960, including supplementary materials; 2008).
Although the claims have been amended to recite PCAT-1 comprises a nucleic acid sequence that is at least 90% identical to SEQ ID NO: 1 or SEQ ID NO: 2; and the PCAT-14 comprises a nucleic acid sequence that is at least 90% identical to any of SEQ ID NOS 3-9, this is an intended use, that is it is directed the the target being detected, not to the array of reagents encompassed by the claims. The claims are broadly drawn to an “array” of oligonucleotides with no particular structure or nucleotide base composition. Sultan teaches analysis of the entire human transcriptome using Illumina chips for RNAseq (see abstract, supplementary materials and methods). The Illumina chips taught by Sultan inherently comprise oligonucleotides for detecting ncRNAs encompassed by the claims because the chips were used for analysis of the entire human transcriptome which includes the recitation in the claims.
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 13, 19, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,390,923 in view of Fodor.
The claims of the ‘923 patent teach detecting PCAT1 and/or PCAT14. The claims teach SEQ ID NOS for each and also teach to detect the sequences using nucleic acid hybridization. Therefore, the claims necessarily teach a set of oligonucleotides for detecting PCAT1 and/or PCAT14. Although the claims do not teach a solid support comprising bound oligonucleotide probes, Fodor teaches microarray solid supports comprising bound oligonucleotides for detecting nucleic acid molecules. Therefore it would have been prima facie obvious to the ordinary artisan to construct arrays as taught by Fodor for detecting PCAT1 and PCAT14 using hybridization probes as taught by the ‘923 claims.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner is a hoteling examiner and can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682