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
This Office Action is a response to Applicant’s Election filed February 23, 2026.
Claims 57, 90 and 91 have been amended.
Claims 1, 12, 15, 19, 21, 37, 43, 53, 57, 60, 72, 76, 79, 83, and 90-92 are pending in the instant application.
Election/Restrictions
Applicant’s election (without traverse) of Group I in the reply filed on February 23, 2026 is acknowledged. Claims 83 and 90-92 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 23, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 1, 12, 15, 19, 21, 37, 43, 53, 57, 60, 72, 76 and 79 have been examined on the merits as detailed below:
Information Disclosure Statement
The information disclosure statement (IDS) filed on February 23, 2026 (2 pages) is acknowledged but fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement.
The IDS filed on February 23, 2026 (2 pages) does not comply with #4.
The IDS filed on February 23, 2026 (2 pages) has been placed in the application file, but the information referred to therein has been lined through to indicate that it has not been considered on the merits.
Applicant's IDS filed on February 23, 2026 (3 pages) is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Drawings
The Drawings filed on December 8, 2022 are acknowledged and have been accepted by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 12, 15, 19, 21, 37, 43, 53, 57, 60, 72, 76 and 79 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 pre-AIA the applicant regards as the invention.
Claim 43 is indefinite because the claim recites the limitation , “wherein the one or more lipophilic moieties are conjugated to one or more of the internal positions selected from the group consisting of positions 4-8 and 13-18 on the sense strand, and positions 6-10 and 15-18 on the antisense strand, counting from the 5' end of each strand”. There is insufficient antecedent basis for this limitation in the claim because claim 1, from which claim 43 depends, recites that the one or more lipophilic moieties are conjugated to one or more internal positions on the sense strand. In other words, claim 1 does not recite that the lipophilic moiety is conjugated to the sense strand and the antisense strand - only the sense strand is recited. Correction is required.
Some claims recite the phrase, “internal positions”. MPEP § 2173.02 (II) states that one of the purposes of examination under 35 USC § 112, second paragraph is to determine whether the claim apprises one of ordinary skill in the art of its scope and, therefore, serves the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent. See, e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). See also In re Larsen, No. 01-1092 (Fed. Cir. May 9, 2001) (unpublished). If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993). In this case, there is no “bright line” by which to evaluate the phrase, “internal positions” since the phrase is not defined by the claim, the specification does not provide a clear definition for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Without a definition, one in the art would not know where the metes and the bounds of the claims are. One in the art would not know what qualifies as, “internal positions”. Without a clear definition, one in the art would be required to make assumptions of the metes and bounds of the claim based on their opinion of what “internal positions” would mean in the context of the instant claims. As presented, the phrase is not clear and precise and is ambiguous, and therefore the claims are indefinite.
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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 1, 12, 15, 19, 21, 37, 43, 53, 57, 60, 72, 76 and 79 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 double stranded ribonucleic acid (dsRNA) agent for delivery by inhalation for inhibiting expression of a target gene, wherein the dsRNA agent comprises a sense strand and an antisense strand forming a double stranded region, wherein the sense strand comprises a nucleotide sequence comprising at least 15 contiguous nucleotides, with 0 or 1 mismatches, of a portion of the nucleotide sequence of the target gene, or a nucleotide sequence having at least 90% nucleotide sequence identity to a portion of the nucleotide sequence of a target gene, and the antisense strand comprises a nucleotide sequence comprising at least 15 contiguous nucleotides, with 0 or 1 mismatches, of the corresponding portion of the nucleotide sequence of a reverse complement of the target gene, or a nucleotide sequence having at least 90% nucleotide sequence identity to a portion of the nucleotide sequence of a reverse complement of the target gene, wherein a uracil base can be substituted for a thymidine base without being a mismatch, and wherein one or more lipophilic moieties are conjugated to positions 4-8 on the sense strand, counting from the 5' end, and wherein the dsRNA comprises SEQ ID NOs. 11 and 12 or SEQ ID NOs. 18 and 19, does not reasonably provide enablement for a double stranded ribonucleic acid (dsRNA) agent for delivery by inhalation for inhibiting expression of a target gene, wherein the dsRNA agent comprises a sense strand and an antisense strand forming a double stranded region, wherein the sense strand comprises a nucleotide sequence comprising at least 15 contiguous nucleotides, with 0 or 1 mismatches, of a portion of the nucleotide sequence of the target gene, or a nucleotide sequence having at least 90% nucleotide sequence identity to a portion of the nucleotide sequence of a target gene, and the antisense strand comprises a nucleotide sequence comprising at least 15 contiguous nucleotides, with 0 or 1 mismatches, of the corresponding portion of the nucleotide sequence of a reverse complement of the target gene, or a nucleotide sequence having at least 90% nucleotide sequence identity to a portion of the nucleotide sequence of a reverse complement of the target gene, wherein a uracil base can be substituted for a thymidine base without being a mismatch, and wherein one or more lipophilic moieties are conjugated to one or more internal positions on the sense strand. 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/or use the invention commensurate in scope with these claims. This is a scope enablement rejection.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988).
Wands states on page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
It should be made clear that, the enabling specification must teach those skilled in the art to make and use the full scope of the claimed invention without undue experimentation. “Although not explicitly stated in section 112, to be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without "undue experimentation." Vaeck, 947 F.2d at 495, 20 USPQ2d at 1444; Wands, 858 F.2d at 736-37, 8 USPQ2d at 1404; In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (the first paragraph of section 112 requires that the scope of protection sought in a claim bear a reasonable correlation to the scope of enablement provided by the specification).” In re Wright (CAFC) 27 USPQ2d 1510 at 1513.
The claims are drawn to a double stranded ribonucleic acid (dsRNA) agent for delivery by inhalation for inhibiting expression of a target gene, wherein the dsRNA agent comprises a sense strand and an antisense strand forming a double stranded region, wherein the sense strand comprises a nucleotide sequence comprising at least 15 contiguous nucleotides, with 0 or 1 mismatches, of a portion of the nucleotide sequence of the target gene, or a nucleotide sequence having at least 90% nucleotide sequence identity to a portion of the nucleotide sequence of a target gene, and the antisense strand comprises a nucleotide sequence comprising at least 15 contiguous nucleotides, with 0 or 1 mismatches, of the corresponding portion of the nucleotide sequence of a reverse complement of the target gene, or a nucleotide sequence having at least 90% nucleotide sequence identity to a portion of the nucleotide sequence of a reverse complement of the target gene, wherein a uracil base can be substituted for a thymidine base without being a mismatch, and wherein one or more lipophilic moieties are conjugated to one or more internal positions on the sense strand. Therefore, the invention is in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The instant Specification provides examples wherein dsRNA agents comprising positioned lipophilic moieties (e.g. C16 ligand) on the sense strand for delivery by inhalation inhibit expression of the SOD1 and CTNNB1 target genes. For example, see:
SEQ ID NOs. 11 and 12 targeted to SOD1, where a 2′-O-hexadecyl nucleoside is at position 6 of the sense strand, counting from the 5' end of the strand;
SEQ ID NOs: 18 and 19 targeted to SOD1, where a 2′-O-hexadecyl nucleoside is at position 6 of the sense strand; counting from the 5' end of the strand; and
SEQ ID NOs: 7 and 8 targeted to CTNNB1, where a 2′-O-hexadecyl nucleoside is at position 16 of the sense strand counting from the 5' end of the strand.
The present Specification teaches the knockdown of SOD1 mRNA in lung following administration by inhalation of an RNAi agent targeted to SOD1 with a C16 ligand. See Example 1 and Figures 1A-1C. Also, see Figures 2 and 3.
However, the present Specification discloses:
Modest knockdown of CTNNB1 expression was observed by qPCR; and
Knockdown of CTNNB1 was insufficient for assessment of pharmacodynamic effects by in situ hybridization
NOTE: In this context, the Examiner is interpreting “modest knockdown” of CTNNB1 to mean underwhelming, meager, or marginal.
The art teaches that gene expression inhibition after inhalation delivery is often considered challenging and, at times, unpredictable due to complex physiological and biological barriers in the lungs. See Chow et al. (Trends in Pharmacological Sciences, October 2020, Vol. 41, No. 10, pages 715-729). Also, see Rogueda P. (ONdrugDelivery, Issue 180 (Nov 2025), pages 68-72); and Oligonucleotide Therapeutics Society downloaded from https://oligotherapeutics.org/delivering-oligonucleotide-drugs-to-the-lungs-in-a-world-of-influenza-coronaviruses-asthma-and-chronic-lung-diseases/ on March 13, 2026.
The data presented in the Specification shows the unpredictability in using dsRNA agents comprising internally conjugated lipophilic moieties on the sense strand for delivery by inhalation for inhibiting expression of a target gene. For example, it appears that only SEQ ID NOs: 11/12 and 18/19, which are RNAi agents targeted to SOD1 with a C16 ligand internally positioned on the sense strand function as claimed. Applicant is reminded that the present Specification is teaches underwhelming knockdown of CTNNB1 gene expression. One of skill in the art would recognize that to make and use the dsRNA agents as claimed, there would be a low level of expectation of success (i.e., highly unpredictable) as evidenced by the data in the present Specification, Chow et al.; Rogueda P; and Oligonucleotide Therapeutics Society.
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004).
Furthermore, in In re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the Court ruled that a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was appropriate given the relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims. Such is the case here where there is a relatively incomplete understanding in the biotechnological field involved, as described above in relation to making and using dsRNA agents comprising internally positioned lipophilic moieties on the sense strand for delivery by inhalation that inhibit expression of a target gene and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims.
Thus, in view of the breadth of the claims, the lack of guidance, and the presence of very few working examples, the instant specification is not found to be enabling for the dsRNA agents as broadly claimed. Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention. Therefore, it is appropriate to reject the claims under 35 USC 112(a) for not being enabled to their full scope.
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Claims 1, 12, 15, 19, 21, 37, 43, 53, 57, 60, 72, 76 and 79 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. This is a written description rejection.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the disclosure must provide written support for the entire scope of the genus. Support for a genus is generally found where the Applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed and that applicant was in possession of the claimed genus.
The instant claims are drawn to a double stranded ribonucleic acid (dsRNA) agent for delivery by inhalation for inhibiting expression of a target gene, wherein the dsRNA agent comprises a sense strand and an antisense strand forming a double stranded region, wherein the sense strand comprises a nucleotide sequence comprising at least 15 contiguous nucleotides, with 0 or 1 mismatches, of a portion of the nucleotide sequence of the target gene, or a nucleotide sequence having at least 90% nucleotide sequence identity to a portion of the nucleotide sequence of a target gene, and the antisense strand comprises a nucleotide sequence comprising at least 15 contiguous nucleotides, with 0 or 1 mismatches, of the corresponding portion of the nucleotide sequence of a reverse complement of the target gene, or a nucleotide sequence having at least 90% nucleotide sequence identity to a portion of the nucleotide sequence of a reverse complement of the target gene, wherein a uracil base can be substituted for a thymidine base without being a mismatch, and wherein one or more lipophilic moieties are conjugated to one or more internal positions on the sense strand. As discussed below, there is insufficient written description for the dsRNA agents encompassed by the claims.
The instant Specification provides examples wherein dsRNA agents comprising positioned lipophilic moieties (e.g. C16 ligand) on the sense strand for delivery by inhalation inhibit expression of the SOD1 and CTNNB1 target genes. For example, see:
SEQ ID NOs. 11 and 12 targeted to SOD1, where a 2′-O-hexadecyl nucleoside is at position 6 of the sense strand, counting from the 5' end of the strand;
SEQ ID NOs: 18 and 19 targeted to SOD1, where a 2′-O-hexadecyl nucleoside is at position 6 of the sense strand; counting from the 5' end of the strand; and
SEQ ID NOs: 7 and 8 targeted to CTNNB1, where a 2′-O-hexadecyl nucleoside is at position 16 of the sense strand counting from the 5' end of the strand.
The present Specification teaches the knockdown of SOD1 mRNA in lung following administration by inhalation of an RNAi agent targeted to SOD1 with a C16 ligand. See Example 1 and Figures 1A-1C. Also, see Figures 2 and 3.
However, the present Specification discloses:
Modest knockdown of CTNNB1 expression was observed by qPCR; and
Knockdown of CTNNB1 was insufficient for assessment of pharmacodynamic effects by in situ hybridization
NOTE: In this context, the Examiner is interpreting “modest knockdown” of CTNNB1 to mean underwhelming, meager, or marginal.
There is insufficient written description of the dsRNA agents encompassed by the claims because there is a substantial variation within the genus of agents and the few species which carry out the functionality of the instant claims does not adequately describe or represent the entire genus of dsRNA agents.
The written description requirement for claims that recite a dsRNA agent for delivery by inhalation for inhibiting expression of a target gene, wherein one or more lipophilic moieties are conjugated to one or more internal positions on the sense strand is not met because the claims encompass a genus of dsRNA agents which are not adequately described.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
To satisfy the written description requirement an applicant must describe the invention is such a way as to convey to one skilled in the art that applicant had the invention in his possession when the application was filed. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). In cases such as the instant application where a genus is claimed, the specification must contain “either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. at 1350. However, written description requirement for claims that recite a dsRNA agent for delivery by inhalation for inhibiting expression of a target gene, wherein one or more lipophilic moieties are conjugated to one or more internal positions on the sense strand is not met.
The entire genus of inhalation delivered dsRNA agent comprising one or more lipophilic moieties conjugated to one or more internal positions on the sense strand that function as claimed does not exist in the instant application. That is, adequate written description support does not exist to practice the full scope of the invention claimed. The specification nor the art discloses neither a representative number of species agents nor any structure/function correlation that would enable one of skill to immediately envision the genus of dsRNA agents for delivery by inhalation for inhibiting expression of a target gene, wherein one or more lipophilic moieties are conjugated to one or more internal positions on the sense strand required to practice the full scope of the invention.
As stated above, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic claim. Given the breadth of the claims, the Specification lacks sufficient variety of species to reflect the variance in the genus.
In conclusion, the Specification and the prior art as filed does not provide sufficient descriptive support for the myriad of dsRNA agents embraced by the claims. For the reasons discussed above, the 35 USC § 112 rejection for written description is applicable.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 12, 15, 19, 21, 37, 43, 53, 57, 60, 72, 76 and 79 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 13, 15, 16, 20, 23, 31, 34, 44, 52-55, 71, 73, 75, 76, 78 and 98-101 of copending Application No. 17/956,882 (reference application).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the double stranded ribonucleic acid (dsRNA) agent of copending Application No. 17/956,882 overlaps in scope with the double stranded ribonucleic acid (dsRNA) agent of the instant invention. The species claim anticipates the genus claim.
The claims of copending U.S. Application 17/956,882 overlaps in scope and fully embraces that which is claimed in the present invention. This is a provisional rejection because the patentably indistinct claims have not in fact been patented.
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Claims 1, 12, 15, 19, 21, 37, 43, 53, 57, 60, 72, 76 and 79 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 11, 14, 18, 20, 32, 52, 69, 73, 74, and 76 of copending Application No. 18/136,386 (reference application).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the double stranded ribonucleic acid (dsRNA) agent of copending Application No. 18,136,386 overlaps in scope with the double stranded ribonucleic acid (dsRNA) agent of the instant invention. The species claim anticipates the genus claim.
The claims of copending U.S. Application 18/136,386 overlaps in scope and fully embraces that which is claimed in the present invention. This is a provisional rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable at this time.
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/TERRA C GIBBS/Primary Examiner, Art Unit 1635