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 Amendment and Remarks filed January 27, 2026.
Claims 1, 5-18, 20-25 and 27-30 have been canceled. New claims 37-50 are acknowledged. Claims 31-36 have been amended.
Claims 31-50 are pending in the instant application.
Claims 31-50 have been examined on the merits as detailed below:
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112
In the previous Office Action mailed September 4, 2025, claims 25, 27-29 and 32-36 were 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. This rejection is moot against claims 25 and 27-29 in view of Applicant’s Amendment to the claims filed January 27, 2026. This rejection is withdrawn against the remaining claims in view of Applicant’s Amendment to the claims filed January 27, 2026.
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In the previous Office Action mailed September 4, 2025, claims 1, 5-18, 20-25 and 27-31 were 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. This rejection is moot against claims 1, 5-18, 20-25 and 27-30 in view of Applicant’s Amendment to the claims filed January 27, 2026. This rejection is withdrawn against the remaining claims in view of Applicant’s Amendment to the claims filed January 27, 2026.
Non-Statutory Double Patenting
In the previous Office Action mailed September 4, 2025, claim 31 was rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-45 of copending U.S. Application 17/914,307. This rejection is withdrawn in view of Applicant’s Amendment to claim 31 filed January 27, 2026.
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In the previous Office Action mailed September 4, 2025, claim 31 was rejected on the ground of nonstatutory double patenting as being unpatentable over claim 29 of copending U.S. Application 17/920,752. This rejection is withdrawn in view of Applicant’s Amendment to claim 31 filed January 27, 2026.
Applicant's amendment filed January 27, 2026 necessitated the new ground(s) of rejection presented below:
Claim Interpretation
All pending claims are ultimately dependent on claim 31 which recites in its preamble, “A synthetic bifunctional molecule”. According to the present Specification:
Bifunctional molecules are designed and synthesized to bind to two or more unique targets
The Examiner is giving the preamble of claim 31 patentable weight and will interpret the term, “bifunctional molecule” to mean a molecule which has two distinct functions of binding two unique targets. The Examiner acknowledges that the bifunctional molecule also comprises: a first domain comprising an antisense oligonucleotide (ASO), wherein the first domain specifically binds to an RNA sequence of the target ribonucleic acid (RNA); a second domain comprising a small molecule or an aptamer, wherein the second domain specifically binds to a target polypeptide; and a linker that conjugates the first domain to the second domain.
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.
Claims 31-50 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 claims are drawn to a synthetic bifunctional molecule comprising: a first domain comprising an antisense oligonucleotide (ASO), wherein the first domain specifically binds to an RNA sequence of the target ribonucleic acid (RNA); a second domain comprising a small molecule or an aptamer, wherein the second domain specifically binds to a target polypeptide; and a linker that conjugates the first domain to the second domain. Applicant is reminded of the claim interpretation of, “bifunctional molecule” supra. Written description requirement for the present claims is not met since only the first domain comprising an antisense oligonucleotide (ASO); the second domain comprises lbrutinib, or lbrutinib-MPEA, or biotin, conjugated to the ASO; the “target polypeptide” being a recruited exogenous fusion protein that is expressed or introduced in the cell; and/or the "target polypeptide" is a fusion protein that comprises either a BTK domain (that binds lbrutinib) or a monomeric streptavidin domain (that binds biotin), fused to a polypeptide comprising PIN domains, SMG6 polypeptide, SMG7 polypeptide or a CNOT7 polypeptide have been provided and detailed by the present Specification. These features are essential for the claimed synthetic bifunctional molecule to have the technical effect associated with the claimed bifunctional molecule (e.g. having two distinct functions of binding two unique targets).
Other than those bifunctional molecules described in the Examples and reported as having two distinct functions of binding two unique targets in the Figures of the present application, the Applicant provides no actual examples, just suggestions of candidate bifunctional molecules that could be synthesized to find molecules that would have the have the technical effect.
See University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424 (DC WNY 2003) and University of Rochester v. G.D. Searle & Co. et al. CAFC [(03-1304) 13 February 2004]. In University of Rochester v. G.D. Searle & Co. a patent directed to a method for inhibiting prostaglandin synthesis in a human host using an unspecified compound, in order to relieve pain without side effect of stomach irritation, did not satisfy the written description requirement of 35 U.S.C. §112, since the patent described the compound's desired function of reducing activity of the enzyme PGHS-2 without adversely affecting PGHS-1 enzyme activity, but did not identify said compound, since the invention consists of performing “assays” to screen compounds in order to discover those with the desired effect. The patent did not name even one compound that assays would identify as suitable for practice of the invention, or provide information such that one skilled in art could identify the suitable compound. And since the Specification did not indicate that the compounds are available in a public depository, the claimed treatment method cannot be practiced without the compound. Thus, the inventors cannot be said to have “possessed” the claimed invention without knowing of a compound or method certain to produce compound. Thus, said patent constituted an invitation to experiment to first identify, then characterize, and then use a therapeutic a class of compound defined only by their desired properties.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a “sufficient number” of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. In the instant case, only the first domain comprising an antisense oligonucleotide (ASO); the second domain comprises lbrutinib, or lbrutinib-MPEA, or biotin, conjugated to the ASO; the “target polypeptide” is a recruited exogenous fusion protein that is expressed or introduced in the cell; and/or the "target polypeptide" is a fusion protein that comprises either a BTK domain (that binds lbrutinib) or a monomeric streptavidin domain (that binds biotin), fused to a polypeptide comprising PIN domains, SMG6 polypeptide, SMG7 polypeptide or a CNOT7 polypeptide have been provided and detailed by the present Specification. These features are essential for the claimed molecule to have the technical effect associated with the claimed bifunctional molecule (e.g. having two distinct functions of binding two unique targets). For further explanation, see section titled, “Claim Interpretation” above. The genus encompasses a large number of molecules that have a different structure, however, the Specification does not describe the complete structure of a representative number of species of the large genus of bifunctional molecules that function as interpreted. The specification lacks written description for the claimed genus.
Further, claim 48 recites, “wherein the target RNA is degraded by non-sense-mediated mRNA decay or a CCR4-NOT complex pathway”, however, there is no description of how the bifunctional molecule of the claimed invention accomplishes this. As stated previously, the MPEP states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes. Also, see University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424 (DC WNY 2003) and University of Rochester v. G.D. Searle & Co. et al. CAFC [(03-1304) 13 February 2004].
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 as filed does not provide sufficient descriptive support for the bifunctional molecules embraced by the claims. For the reasons discussed above, the 35 USC § 112 rejection for written description is applicable.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 31, 32, 35, 37-47, 49 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20180251764 A1 to Albaeke et al. (submitted and made of record on the Information Disclosure Statement filed October 21, 2022) in view of Kapoor et al. (Cell Death and Disease 10:924, pages 1-12, December 2019).
The claims are drawn to a synthetic bifunctional molecule comprising: a first domain comprising an antisense oligonucleotide (ASO), wherein the first domain specifically binds to an RNA sequence of the target ribonucleic acid (RNA); a second domain comprising a small molecule or an aptamer, wherein the second domain specifically binds to a target polypeptide; and a linker that conjugates the first domain to the second domain. Applicant is reminded of the claim interpretation of, “bifunctional molecule” supra.
Albaeke et al. is relevant and relied upon in its entirety. Regarding claims 31, 32 and 35, Albaeke et al. teach oligonucleotide conjugates comprising a first domain comprising an ASO, wherein the first domain specifically binds to an RNA sequence of the target RNA; a second domain comprising a small molecule or an aptamer, wherein the second domain specifically binds to a target polypeptide; and a linker that conjugates the first domain to the second domain. The oligonucleotide conjugates of Albaeke et al. has two distinct functions of binding two unique targets. See Examples and Figures, such as, Fig. 16 - teaching PCSK9 LNA antisense oligonucleotides conjugated to cholesterol with different linkers silenced PCSK9 mRNA expression.
Regarding claims 37-47, 49 and 50, the ASOs of Albaeke et al. comprise locked nucleic acids (LNAs) - See Figures reporting data using LNA-antisense oligonucleotides. The ASOs of Albaeke et al. comprise a sequence comprising 30% to 60% GC content – See miR-122a (i.e. targets), such as hsa-mir-122 MI0000442 sequence, AAACGCCAUUAUCACACUAAAUAGCUACUGCUAGGC. Also, see PCSK9 Compounds comprising 30% to 60% GC content in Examples, Oligonucleotide List. The ASOs of Albaeke et al. comprise a length of 8 to 30 nucleotides and target MYC, for example. See Table 1. In some embodiments, the ASOs of Albaeke et al. target the 5’ UTR of a target, wherein the target is associated with a disease or disorder. See Table 1, for example. The conjugate may be, for example, at the 5′ end or the 3′ end of the oligomer compound.
The conjugates of Albaeke et al. may comprise cholesterol, a carbohydrate, a lipophilic moiety, a polymer, a protein or peptide, a label or dye, a small molecule, such as a small molecule therapeutic moiety, a cell surface receptor ligand and therefore comprise organic compounds having a molecule weight of 900 daltons or less. In some embodiments, the conjugate is biotin. See section titled, Lipophilic Conjugates. In other embodiments, the conjugate is an aptamer. See section titled, Aptamer.
Albaeke et al. teach non-limiting examples of therapeutic indications which may be treated by the pharmaceutical compositions of their invention include lymphoma and other types of cancers.
Albaeke et al. do not teach the small molecule conjugate is Ibrutinib.
Kapoor teaches that Ibrutinib, an FDA approved, orally administered small molecule inhibitor that binds covalently to Bruton’s tyrosine kinase (BTK), has produced remarkable responses in patients with chronic lymphocytic leukemia (CLL) and many subtypes of non-Hodgkin lymphoma (NHL), including mantle cell lymphoma, Waldenstrom macroglobulinemia, and marginal zone lymphoma. See Introduction.
Before the effective filing date of the claimed invention, a synthetic bifunctional molecule comprising a first domain comprising an ASO, wherein the first domain specifically binds to an RNA sequence of the target RNA; a second domain comprising a small molecule or an aptamer, wherein the second domain specifically binds to a target polypeptide; and a linker that conjugates the first domain to the second domain was taught and suggested in the prior art of Albaeke et al.
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 Albaeke et al. taken with Kapoor to use ASOs as the first domain and Ibrutinib as the small molecule in the second domain of a bifunctional molecule to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to combine the teachings of Albaeke et al. taken with Kapoor for beneficial and additive effects for lymphoma treatment with a reasonable expectation of success. See MPEP 2143(I)E.
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.
Non-Statutory 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 31-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-31, 33-37 and 39-47 of copending U.S. Application 17/914,307. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of copending U.S. Application 17/914,307 anticipates and/or renders obvious over the instant claims. The claims of each are drawn to overlapping subject matter. The composition recited in the claims of copending U.S. Application 17/914,307 encompasses and overlaps in scope with the composition disclosed in the claimed invention. Furthermore, the limitations of the instant claims are provided in the supporting disclosure of the copending application as certain preferred embodiments. See MPEP 804 II B 2(a).
The claims of copending U.S. Application 17/914,307 overlaps in scope and fully embraces that which is claimed in the instant invention. This is a provisional rejection because the patentably indistinct claims have not in fact been patented.
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Claims 31-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-48 of copending U.S. Application 17/920,752. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of copending U.S. Application 17/920,752 anticipates and/or renders obvious over the instant claims. The claims of each are drawn to overlapping subject matter. The composition recited in the claims of copending U.S. Application 17/920,752 encompasses and overlaps in scope with the composition disclosed in the claimed invention.
The claims of copending U.S. Application 17/920,752 overlaps in scope and fully embraces that which is claimed in the instant invention. This is a provisional rejection because the patentably indistinct claims have not in fact been patented.
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Claims 31-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22, 23, 25, 27, 29, 31, 32, 36 of copending U.S. Application 18/694,854. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of copending U.S. Application 18/694,854 anticipates and/or renders obvious over the instant claims. The claims of each are drawn to overlapping subject matter. The composition recited in the claims of copending U.S. Application 18/694,854 encompasses and overlaps in scope with the composition disclosed in the claimed invention.
The claims of copending U.S. Application 18/694,854 overlaps in scope and fully embraces that which is claimed in the instant invention. This is a provisional rejection because the patentably indistinct claims have not in fact been patented.
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 Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERRA C GIBBS/Primary Examiner, Art Unit 1635
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