DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In addition to the 101 rejection, a new ground(s) of rejection is made in view of the amendment to independent claim 7 and the addition of new claim 29.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 7, 10, and 23-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature or a natural phenomenon without significantly more. The claims recite the steps of (a) contacting a test compound or composition with a cell expressing PAPD5 and/or PAPD7, wherein the test compound or composition is a RNAi with a non-naturally occurring nucleotide; (b) measuring the expression and/or activity of PAPD5 and/or PAPD7 in the presence and absence of the compound or composition; (c) identifying a compound or composition that reduces the expression and/or activity of PAPD5 and/or PAPD7 as a compound that prevents, ameliorates, and/or inhibits a HBV infection and (d) generating a combined preparation comprising a nucleic acid inhibitor of PADPS inhibitor and a PAPD7 nucleic acid inhibitor that prevents, ameliorates, and/or inhibits HBV infection and combining compounds or compositions from step (c).
PAPD5 and PAPD7 play important roles in regulating cellular RNA homeostasis in human cells. See Mueller et al. (Hepatology pages 1-30, 2018,cited on an IDS). PAPD5/7 are host factors that are required for hepatitis B virus RNA stabilization.
The claims are directed to a process which is considered a statutory category. Step c) embraces a mental step. Steps c) and d) are not required when the compound does not reduce PAPD5 and/or PAPD7 expression.
The method of identifying a RNAi compound or composition that prevents/ameliorates HBV infection would be a natural characteristic of the compound or composition and the steps are just identifying the natural characteristics. Contacting a cell with a generic RNAi compound or RNAi composition and measuring expression and/or activity of PAPD5 and/or PAPD7. See MPEP 2106.04(b).l. "a correlation that is the consequence of how a certain compound is metabolized by the body, Mayo Collaborative Servs. V. Prometheus Labs., 566 U.S. 66, 75-77, 104 USPQ2d 1961, 1967-68 (2012)." The method is a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis', where the data analysis are recited at a high level of generality such that they could practically be performed in the human mind. See MPEP 2106.04(a)(2).III Step (c) of the method is directed to a mental process because it is directed to an observation or evaluation of the expression and/or activity level of the compound or composition. See MPEP 2106.04(a). This judicial exception is not integrated into a practical application because the active steps of contacting a cell with a composition or compound and performing the assay to integrate the judicial exception (here, the natural correlation between the nucleic acid or protein concentration and treating HBV infection, and the mental evaluation of the data to conclude that the compound or composition can be used to treat an HBV infection). The limitation 'generating a combined preparation comprising a nucleic acid inhibitor of PAPD5 and a nucleic acid inhibitor of PAPD7....' in amended step (d) embraces a step of telling a medical practitioner how to apply the results of step (c). Furthermore, there is no nexus between step (a)-(c) and step (d) because a nucleic acid molecule that is an inhibitor of PAPD7 and a nucleic acid molecule that is an inhibitor of PAPD5 is broader than a RNAi agent used in steps (a)-(c). The compound or composition is recited a high level of generality. The limitation 'that prevents, ameliorates and/or inhibits a hepatitis B virus (HBV) infection' in step (d) is an inherent function of the compound or composition and does not add any method steps or structural limitations. Limitation (d) in claim 7 fails to meaningfully limit the claim because it does not require any particular application of the recited observation, and is at best the equivalent of merely adding the words "apply it' to the judicial exception. Step (d) does not integrate the recited judicial exception into a practical application and the claim is therefore directed to a judicial exception.
The claim as a whole, the individual steps or combination of steps in claim 7 do not add an inventive concept to the claims. The active steps are data gathering steps, that are generally considered to be insignificant extra-solution activity under step 2a prong 2 (where integration is determined). See e.g., MPEP 2106.05), in particular subsection (3). After gathering the data, and applying the judicial exception, nothing is done with the resulting information. The information gleaned from the judicial exception is not applied in any way, and the judicial exception itself is not used to change the process. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the contacting the test RNAi agent to a cell is recited at a high level of generality that is considered well-understood, routine, conventional activity in the life science arts. See MPEP 2106.05(d)(II).
With respect to claims 25-26, this is a further limitation to step a) of the method, not to step d). The claim requires that "the test composition" is combined with the nucleic acid, not that the inhibitors of PAPD5 and PAPD7 are combined with the nucleic acid molecules. So, these claims are further limiting one of the data gathering steps to the claim. This is not sufficient to rescue a claim under step 2a prong 2 (it is still an insignificant extra-solution activity- see, MPEP 2106.05(g)). An analysis under step 2B, the limitation does not add something beyond what was routine and conventional in the art. The use of the judicial exception in this manner does not meaningfully limit the claim from going beyond generally linking the use of the judicial exception to a particular technological environment.
The 'wherein' clause in dependent claim 10 is directed to a function of the compound or composition and does not add any method steps and/or materials to distinguish the method from a judicial exception.
Claim 23 discloses what activity of PAPD5 and PAPD7 (poly A polymerase function) and is directed to a natural phenomenon being observed by the skilled artisan. Page 10 of the specification discloses that an assay for this step was considered well- understood, routine and conventional activity in the prior art. Claim 24 is a functional limitation of the compound or composition used in the assay and does not provide substantially more than the judicial exception. Claims 27-28 further define the nucleotide sequence or amino acid sequence encoded by the nucleotide sequence and are directed to sequences found in nature (see page 53). The human PAPD5 mRNA sequence is disclosed in SEQ ID NOs: 4, 5, or 10. The human PAPD7 mRNA sequence is disclosed in SEQ ID NO: 6 or 11. The specification discloses that these sequences are known and are found in nature (pages 53-55). Since the claims are process claims, the claim is not subject to the markedly different analysis for nature-based product used in the process (See MPEP 2106.04(c)(I)(C). The claims are directed to using products found in nature and studying their expression and/or activity when exposed to a compound or composition. Defining the nucleotide sequence or amino acid sequence does not add any method step(s) and/or material(s) to distinguish the method from a judicial exception.
Thus, claims 7, 10, and 23-29 are not patent eligible.
Response to Arguments
Applicant’s arguments, see pages 4-6, filed 2/6/2026, with respect to the rejection(s) of claims 7, 9, 10, 23-28 under 101 have been fully considered and are not persuasive. Therefore, the rejection has not been withdrawn.
In response to applicant’s argument that amended claim 7 cannot be considered to encompass purely mental acts because amended claim 7 requires an assay of measuring activity in a cell (amended claim 7(b)) and active steps of claim 7 are provided by Example 4 (page 83, lines 18-25), the argument(s) are not found persuasive because while the amendment removes step b) from reading on mental step, step c) of claim still reads on a mental step and step b) is considered a data gathering step based on whether or not the RNAi agent reduces expression of PAPD5 and/or PADP7 in a cell.
The amendment to claim 7 to indicate that the method is for identifying a nucleic acid molecule compound or composition that prevents, ameliorates, and/or inhibits HBV infection does not overcome the 101 rejection because the functional limitation of the nucleic acid does not add any patentable weight to the product identified in the claimed method steps. The amendment to the claim is further limiting one of the data gathering steps to the claim. This is not sufficient to rescue the claims under step 2a prong 2 since it is still an insignificant extra-solution activity. See MPEP 2106.05(g). The limitation does not add something beyond what was routine and conventional in the art, which is RNAi inhibiting expression of PAPD5 and/or PAPD7 in a cell.
The amendment to the independent claim and adding a new claim to limit the products used in step a) does not address the 101 rejection in regards to a naturally occurring product used in the claims method. The statement regarding using naturally occurring products is directed to instant claims 27 and 28. The nucleotides sequences and/or amino acid sequences read on naturally occurring PADP5 and/or PADP7 sequences known in the prior art. Since the claimed invention is directed to a method of using the sequences, the rejection does not pertain to a product found in nature. The amendment to limit the products used in step a)-c) does not address the 101 rejection based on all four steps a)-d). RNAi agents are well-known in the art prior art and can be used to collect data on whether or not a RNAi can reduced PAPD5 and PAPD7 in a cell. As stated in the rejection, there is no nexus between steps a)-c) and step d) because step d) does not require the RNAi agent identified in steps a)-c).
Suggest adding a method of using the product in a method of treating hepatitis B in a subject in need thereof to address the 101 rejection.
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.
Claims 7, 10, and 23-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of identifying an RNAi agent that reduce and/or activity of PAPD5 and/or PAPD7 comprising contacting a cell expressing PAP associated containing 5 (PAPD5) or 7 (PAPD7) with a RNAi that comprises a sequence is complementary to a nucleotide encoding PAPD5 and/or PAPD7; measuring expression and/or activity of PAPD5 and/or PAPD7 in the cell in the presence and absence of the RNAi agent; identifying a RNAi agent that reduces expression and/or activity of PAPD5 and/or PAPD7 as a compound that that prevents, ameliorates and/or inhibits HBV infection; and generating a combined preparation of an RNAi agent that inhibits PAPD5 activity and/or expression with an RNAi agent that inhibits PAPD7 activity and/or expression and using the combination of compounds to prevent, ameliorate, and/or inhibit HBV infection in a cell, does not reasonably provide enablement for identifying nucleic acid molecule compound or composition that prevents, ameliorates, and/or inhibits hepatitis B virus (HBV) infection by generating a combination of nucleic acid molecules that are inhibitors of PAPD5 and PAPD7 based on studying PAPD5 and/or PAPD7 expression in a cell exposed to RNAi agents comprising at least one non-naturally occurring nucleotide. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The claimed method broadly embraces identifying nucleic acid compounds or compositions that prevent, ameliorate, and/or inhibit a HBV infection in a cell (cell line or subject) comprising contacting a cell with any RNAi agent comprising a non-naturally occurring nucleotide; measuring the expression and/or activity of PAPD5 and/or PAPD7 in the cell in the presence and absence of the RNAi agent; identifying an agent that reduces expression and/or activity of PAPD5 and/or PAPD7 as a compound that prevents, ameliorates, and/or inhibits HBV infection; and generating a combined preparation comprising a nucleic acid molecule that is an inhibitor of PAPD5 and a nucleic acid that is an inhibitor of PAPD7.
The specification contemplates a screening assay for identifying compounds the claimed method steps. Pages 70-73 and 83-99 disclose antisense oligonucleotide agents that target PADP5 and/or PAPD7. Page 74-82 discloses studying small molecules in a screening assay.
Page 53 of the as-filed specification shows that PAPD5 and PAPD7 nucleotides and amino acid sequences are well-known in the prior art.
The claimed method embraces identifying a genus of nucleic acid molecule compounds or composition that prevent, ameliorate, and/or inhibit HBV infection based on RNAi agents that reduce expression and/or activity of PAPD5 and/or PAPD7. However, the skilled artisan cannot reasonably extrapolate from results obtained with RNAi agents to a genus of nucleic acid molecules because other than RNAi agents none of the other species of nucleic acid molecules compounds or compositions use RNAi machinery to reduce expression of PAPD5 and/or PADP7. For example, the genus of nucleic acid molecules broadly embraces antisense oligonucleotide, LNA, morpholino, aptamers, ribozymes, etc. While antisense oligonucleotide, LNA, and morpholinos comprise an a sequence that is complementary to a nucleotide sequence of PAPD5 and/or PAPD7 (similar to the antisense strand of an RNAi agent), these other species of nucleic acid do not use RNAi pathway to reduced expression of a nucleotide sequence. See also Deleavey et al. (Chemistry and Biology, 2012, pages 937-954, cited on an IDS) which teaches the different mechanism for RNAi agents compared to other nucleic acid inhibitors.
Thus, the full scope of the claimed method recited in claims 7, 10 and 23-29 is not considered enabled.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 25-26 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 25 and 26 depend on claim 7 and claim 7 limits the test compound to a RNAi agent comprising at least non-naturally occurring nucleotide. Claim 25 indicates that the test compound is a nucleic acid, which is broader than the RNAi set forth in claim 7. The siRNA and shRNA in Claim 26 limits the test compound of claim 7 because both are species of RNAi agents, however, antisense oligonucleotides are not considered RNAi agents because they use RNase degradation to reduce expression of a target sequence and not an RNAi mechanism. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 7, 10, and 23-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 11484546 in view of Deleavey et al. (Chemistry and Biology, 2012, pages 937-954, cited on an IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both set of claims embrace a method for modulating PAPD5 and PAPD7 expression in a target cell in vitro comprising contacting the cell with an oligonucleotide that reduces mRNA expression of PAPD5 and PAPD7 (see claim 33 of '546). The difference between the pending claims and the claims of ‘546 is that step a) is limited to RNAi agents and the pre-amble and step c) of the instant claim 7 is directed to identifying compounds or compositions that can be used to treat an HBV infection. Step d) of claim 7 now embraces any nucleic acid inhibitor, including the antisense oligonucleotides recited in the claims of ‘546. The method step a) and b) in instant claim 7 are recited in claim 33 of '546. Step c) in instant claim 7 is a mental step and would result when a person of ordinary skill in the art carries the method steps of claim 33 of '546 and observes a reduce expression of PAPD5 and PAPD7. Amended step d) is a step of generating compounds comprising nucleic acid molecules that are PAPD5 inhibitors and PAPD7 inhibitors. When a person of ordinary skill in the art has to look at the disclosure of the issued U.S. Patent No. '546 to determine what % of PAPD7 or PAPD5 mRNA expression is reduced with the antisense oligonucleotides they would arrive at table 20 of the '546 reference. Table 20 in columns 127-128 of '546 shows antisense oligonucleotides that reduce PAPD7 and PAPD5 mRNA expression by at least 60%. In addition, amended claims 27-28 is made obvious by the claims of '546 when a person of ordinary skill in the art has to determine what PAPD5 and PAPD7 sequences to use in the assay they would refer to the disclosure of '546 (columns 16-18) and arrive at SEQ ID NOs: in the claims 27-28 because they are human PAPD5 and PAPD7 sequences.
Deleavey et al. teach making and using chemically modified oligonucleotides (ONs) for targeted gene silencing, wherein the oligonucleotide is an antisense oligonucleotide or a siRNA molecule. ONs are under active investigation in the clinic (abstract).
It would have been prima facie obvious to a person of ordinary skill in the art before the time of the effective filing date to combine the teaching of Deleavey with the claims of ‘546 as a simple substitution to use RNAi agents instead of antisense oligonucleotides in the method of identifying nucleic acid molecules that can be used to treat HBV infection, namely to arrive at the claimed invention. A person of ordinary skill in the art would have been motivated to study RNAi agents having at least one 2’ sugar modification since these types of modification increase the bioavailability of the ON in a subject.
Therefore the invention as a whole would have been prima facie obvious to one ordinary skill in the art before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.
Claims 7, 10 and 23-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10953034 taken with Deleavey et al.(supra), both cited on an IDS. Although the claims at issue are not identical, they are not patentably distinct from each other because both set of claims embrace a method for modulating PAPD5 and PAPD7 expression in a target cell in vitro comprising contacting the cell with an oligonucleotide that reduces mRNA expression of PAPD5 and PAPD7 (see claim 11 of '034). The difference is that the pre-amble and step c) of the instant claim 7 is directed to identifying compounds or compositions comprising RNAi agents that can be used to treat an HBV infection and step d) embraces any nucleic acid that can be used to treat an HBV infection. The method step a) and b) in instant claim 7 are recited in claim 11 of '034. Step c) in instant claim 7 is a mental step and would result when a person of ordinary skill in the art carries the method steps of claim 11 of '034 and observes a reduce expression of PAPD5 and PAPD7. A person of ordinary skill in the art has to look at the reference of the issued U.S. Patent '034 to determine what % of PAPD7 or PAPD5 mRNA expression is reduced with the antisense oligonucleotides they would arrive at table 20 of '034. Table 12 in columns 149-150 of '034 shows antisense oligonucleotides that reduce PAPD7 and PAPD5 mRNA expression by at least 60%. In addition, claims 27- 28 is made obvious by the claims of '034 when a person of ordinary skill in the art has to determine what PAPD5 and PAPD7 sequences to use in the assay they would refer to the disclosure of '034 (columns 16- 20) and arrive at instant SEQ ID NOs: in claims 27-28 because they are human PAPD5 and PAPD7 sequences.
Deleavey et al. teach making and using chemically modified ONs for targeted gene silencing, wherein the oligonucleotide is an antisense oligonucleotide or a siRNA molecule. ONs are under active investigation in the clinic (abstract).
It would have been prima facie obvious to a person of ordinary skill in the art before the time of the effective filing date to combine the teaching of Deleavey with the claims of ‘034 as a simple substitution to use RNAi agents instead of antisense oligonucleotides in the method for identifying nucleic acid molecules that can be used to treat HBV infection, namely to arrive at the claimed invention. A person of ordinary skill in the art would have been motivated to study RNAi agents having at least one 2’ sugar modification since these types of modification increase the bioavailability of the ON in a subject.
Claims 7, 10 and 23-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11534452, cited on an IDS. Although the claims at issue are not identical, they are not patentably distinct from each other because both set of claims embrace a method for modulating PAPD5 and PAPD7 expression in a target cell in vivo comprising contacting the cell with an antisense oligonucleotide, siRNA molecule, or shRNA molecule that reduces mRNA expression of PAPD5 and PAPD7 (see claim 2 of '452). The only difference is that the pre-amble and step c) of the instant claim 7 is directed to identifying compounds or compositions comprising RNAi agents that can be used to treat an HBV infection. The method step a) and b) in instant claim 7 are embraced by claim 2 of '452 and the method is used for treating HBV infection in a subject. Step c) in instant claim 7 is a mental step and would result when a person of ordinary skill in the art carries the method steps of claim 2 of '452 and observes a reduce expression of PAPD5 and PAPD7. A person of ordinary skill in the art has to look at the disclosure of the issued U.S. Patent to determine what % of PAPD7 or PAPD5 mRNA expression is reduced with the antisense oligonucleotides they would arrive at table 14 of '452 reference. Table 14 in columns 85-86 of '452 shows antisense oligonucleotides that reduce PAPD7 and PAPD5 mRNA expression by at least 60%. Claim 2 of '452 recites the functional limitation in instant claim 10. In addition, instant claims 27-28 is made obvious by the claims of '452 when a person of ordinary skill in the art has to determine what PAPD5 and PAPD7 sequences to use in the assay they would refer to the disclosure of '452 (columns 44-47) and arrive at SEQ ID NOs: in the claims 27-28 because they are human PAPD5 and PAPD7 sequences. Claims 13-17 of ‘452 embrace chemically modified oligonucleotides with a 2’ sugar modification.
It would have been prima facie obvious to a person of ordinary skill in the art before the time of the effective filing date as a simple substitution to use RNAi agents instead of antisense oligonucleotides in the method of identifying nucleic acid molecules that can be used to treat HBV infection, namely to arrive at the claimed invention. A person of ordinary skill in the art would have been motivated to study RNAi agents having at least one 2’ sugar modification as recited in new claim 29 since these types of modification increase the bioavailability of the RNAi agent in a subject.
Claims 7, 10 and 23-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of US Patent No. 12303525 taken with Deleavey (supra), both of record. Although the claims at issue are not identical, they are not patentably distinct from each other because both set of claims embrace an in vitro method of modulating PAPD5 and/or PAPD7 expression in a cell comprising contacting the cell with an oligonucleotide(s) the reduce the PAPD5 and/or PAPD/7 in the cell. The claims of '525 disclose that an antisense oligonucleotide would have the functional limitations in instant claims 7 and 10. The only difference between the instant claim 7 and the claim 35 of '525 is that the claim of '525 is directed to a method of using a compound comprising a chemically modified antisense oligonucleotide that is known to reduce expression of PAPD5 and/or PAPD7. In addition, the identifying step c) in instant claim 7 is not recited in the claimed method recited in claim of '525. However, when a person of ordinary skill in the art carried out the method steps of the claims of '525 they would embrace step a) and c). In addition, it would have been obvious to measure the expression of PAPD5 and/or PAPD7 to verify that the antisense oligonucleotide works as intended. Furthermore, it would have been obvious to use the method to identify additional oligonucleotides, including RNAi agents, in the method. A person of ordinary skill in the art has to look at the disclosure of the issued patent to determine what % of PAPD7 or PAPD5 mRNA expression is reduced with the antisense oligonucleotides they would arrive at table 12 of '525 patent. Table 12 of '525 shows antisense oligonucleotides that reduce PAPD7 and PAPD5 mRNA expression by at least 60%. In addition, instant claims 27 and 28 are made obvious by the claims of '525 when a person of ordinary skill in the art has to determine what PAPD5 and PAPD7 sequences to use in the assay they would refer to the disclosure of '525 (columns 18-20) and arrive at SEQ ID NOs: in instant claims 27 and 28 because they are human PAPD5 and PAPD7 sequences.
Deleavey et al. teach making and using chemically modified ONs for targeted gene silencing, wherein the oligonucleotide is an antisense oligonucleotide or a siRNA molecule. ONs are under active investigation in the clinic (abstract).
It would have been prima facie obvious to a person of ordinary skill in the art before the time of the effective filing date to combine the teaching of Deleavey with the claims of ‘525 as a simple substitution to use RNAi agents instead of antisense oligonucleotides in the method of identifying nucleic acid molecules that can be used to treat HBV infection, namely to arrive at the claimed invention. A person of ordinary skill in the art would have been motivated to study RNAi agents having at least one 2’ sugar modification as recited in new claim 29 since these types of modification increase the bioavailability of the ON in a subject.
Response to Arguments
Applicant's arguments filed 2/9/26 have been fully considered but they are not persuasive because other than stating the applicant intends to address this rejection once the claims are otherwise in condition for allowance, the applicant does not address the merits of the double patenting rejections. The argument is the same for all of the NSDP and provisional NSDP rejections.
NOTE: the remarks to the NSDP rejection do not comply with 37 CFR 1.111(B) and MPEP 714.02; see also 707.07(a), but is still considered a bona fide attempt and accepted as a complete response in the interest of compact prosecution.
Conclusion
See attached PTO-326 for listing of claims.
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 Brian Whiteman whose telephone number is (571)272-0764. The examiner can normally be reached on Monday thru Friday; 6:00 AM to 3:00PM.
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/BRIAN WHITEMAN/ Primary Examiner, Art Unit 1636
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