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 the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
The instant application is a 371 of PCT/EP22/79340 filed on 10/21/2022 and claims foreign priority to application no. EP22382895.5 filed on 09/29/2022, EP22382514.2 filed on 05/30/2022, and EP21382958.3 filed on 10/22/2021. The certified copies of the foreign priority applications were filed on 04/19/2024 and are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/05/2024 and 03/21/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Claims
The preliminary claim amendments filed on 11/05/2024 is acknowledged. Claims 2, 5, 7, 9-10, 13-19, 21, 23-24, 26, 28, 30-31, and 33 are amended. Claims 3-4, 6, 8, 11-12, 22, 25, 27, and 35-46 are cancelled.
Accordingly, claims 1-2, 5, 7, 9-10, 13-21, 23-24, 26, and 28-34 are pending and being examined on the merits herein.
Drawings
The drawings are objected to because the data in FIG. 13B-13G has poor resolution and poor legibility of the axis numbers / axis label text and data label text. FIG. 13H has numbers and texts on the right legend that is not legible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112(b)
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.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites “wherein the compound is selected from Table 1”.
MPEP 2173.05(s) states that “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.”
While Table 1 discloses many compounds, it is possible to recite all of these compound structures into the claim in order to be complete in itself. Therefore, the incorporation by reference of the table is not a necessity.
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 1-2, 5, 7, 9-10, and 13-21, 23-24, 26, and 28-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/702,860 (‘860).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘860 recite a complex comprising a cationic oligosaccharide and an RNA, wherein the cationic oligosaccharides comprise a plurality of cationic moieties bonded to trehalose, a sucrose, or a gluco-n-oligosaccharide moiety, where n is 2-6, and a molar ratio of N/P in the complex is less than 20:1 (claim 1). The claims of ’860 recite the RNA is modRNA and others (claim 2), has a diameter of 30-300nm (claim 5), further comprises a suitable surfactant such as a polysorbate (claims 26-27), a molar ratio of oligosaccharide to surfactant of 1:0.00075 to about 1:3 (claim 28), and the same method of increasing expression of RNA in a target such as the lungs as well as a method of treating a disease such as an infection disease comprising administering the complex (claims 30-33).
Furthermore, the claims of ’860 recite all of the same structural limitations and excluded provisos of the recited cationic oligosaccharide as the instant compound (claims 6-8, 11, 15-16, and 19-25), and further recites the oligosaccharide is selected from Table 1 (claim 29), which includes the same compounds such as JLF19 (page 62 in the specification of ‘860). This JLF19 compound meets the structural limitation of the recited compound in the instant claims and is not an excluded proviso compound.
Therefore, all of the limitations of the instant application for the instant complex are recited in the claims of ‘860 such that the ordinary skilled artisan would have readily envisaged the instant compound and complex.
In regards to instant claims 1-2, 5, 7, 9-10, and 13-20, even though the claims of ‘860 do not recite claims directed toward the instant compound itself, the instant compound includes Z1 and Z2 groups that are cationic or ionizable groups, which indicates that additional counterpart components will complex with the instant compound. Therefore, the complex comprising the instant compound recited in the claims of ‘860 meets the limitations of the instant compound.
This reference application has the same patent term filing date as the instant application (10/21/2022). See MPEP 804 I.B.1.(b)(iii).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 5, 7, 9-10, 13-21, 23-24, 26, and 31-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/702,857 (‘857).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘857 recite a complex comprising one of more compounds of claim 1 and an RNA (claim 25). The claims of 857 recite the RNA is modRNA and others (claim 27), a ratio of N/P in the complex is less than 20:1 (claim 28). has a diameter of 30-150nm (claim 30), the same method of treating a disease such as an infection disease comprising administering the complex (claims 33-34), and a method of delivery of the composition to a target such as the liver (claims 31-32)
Furthermore, the claims of ‘857 recite the same structural limitations as the instant compound (claims 1-2, 5, 7, 9-10, 14-17, and 23) but does not recite the excluded proviso.
However, the claims of ‘857 further recite the compound is selected from Table 1 (claim 24), which includes the compounds such as PRX047 (page 62 in the specification of ‘857). This PRX047 compound meets the structural limitation of the recited compound in the instant claims and is not an excluded proviso compound.
Therefore, all of the limitations of the instant application for the instant compound and complex are recited in the claims of ‘857 such that the ordinary skilled artisan would have readily envisaged the instant compound and complex.
In regards to instant claims 31-32, even though the claims of ‘857 do not explicitly recite a method of increasing or causing increased expression of RNA in a target such as the liver in a subject, this increased RNA expression would flow naturally from the methods of ‘857 because the method of ‘857 (claims 33-34) recites the same active step of delivering the same compound-RNA complex to the same target such as the liver in a subject.
MPEP 2145 II states that “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
This reference application has the same patent term filing date as the instant application (10/21/2022). See MPEP 804 I.B.1.(b)(iii).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 21, and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/702,857 (‘857) in view of Thomas (WO2021000041A1 in PTO-892).
The claims of ‘857 recite the instant compound and complex as described above.
The only difference between ‘857 and the instant claims is ‘857 does not recite further comprising a surfactant such as polysorbate in the recited molar ratio.
Thomas discloses a similar sugar- ionizable lipid-based compounds that are useful for the delivery of nucleic acids (Abstract, claim 1, and paragraph 00105). Thomas further discloses that these compounds can be mixed with a stabilizing agent and other lipid components such that the compound is present at about 10-90 mol% and the stabilizing agent is present at about 0-10 mol% (paragraph 00112). Thomas discloses that the stabilizing agent can be polysorbate 80 and others (paragraph 00117).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included into the complex of ‘857 the polysorbate 80 in the mol% amounts as disclosed in Thomas to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because Thomas provides guidance of including polysorbate as a stabilizing agent with a similar sugar- ionizable lipid-based compound that has the same purpose of gene delivery. Furthermore, the modified complex would have mol% amounts that overlap in molar ratios, rendering the recited molar ratio in the instant claims obvious. See MPEP 2144.05 I.
This reference application has the same patent term filing date as the instant application (10/21/2022). See MPEP 804 I.B.1.(b)(iii).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 5, 7, 9-10, and 13-21, 23-24, 26, and 28-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/702,858 (‘858).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘858 recite a complex comprising a cationic oligosaccharide comprising one or more cationic moieties bonded to trehalose, a sucrose, or a gluco-n-oligosaccharide moiety, where n is 2-6, surfactant, and one or more additives (claim 1). The claims of ‘858 recite that the surfactant can be a polysorbate and others (claim 2) and in a molar ratio of 1:0.0075 to 1:3 (claim 4). The claims of ‘858 recite that the complex further comprises a nucleic acid such as modRNA (claims 7 and 10), has an N/P ratio of less than 20:1 (claim 11), and a diameter of 50-150 nm (claim 14). The claims of ‘858 recite the same method of increasing expression of RNA in a target such as the lungs as well as a method of treating a disease such as an infection disease comprising administering the complex (claims 72-75).
Furthermore, the claims of ‘858 recite all of the same structural limitations of the recited cationic oligosaccharide as the instant compound (claim 54, 57, 61-62, 66-67, and 69) but does not recite the excluded provisos.
However, the claims of ‘858 further recites the oligosaccharide is selected from Table 1 (claim 70), which includes the same compounds such as JLF19 (page 60 in the specification of ‘858). This JLF19 compound meets the structural limitation of the recited compound in the instant claims and is not an excluded proviso compound.
Therefore, all of the limitations of the instant application for the instant complex are recited in the claims of ‘858 such that the ordinary skilled artisan would have readily envisaged the instant complex.
In regards to instant claims 1-2, 5, 7, 9-10, and 13-20, even though the claims of ‘858 do not recite claims directed toward the instant compound itself, the instant compound includes Z1 and Z2 groups that are cationic or ionizable groups, which indicates that additional counterpart components will complex with the instant compound. Therefore, the complex comprising the instant compound recited in the claims of ‘858 meets the limitations of the instant compound.
This reference application has the same patent term filing date as the instant application (10/21/2022). See MPEP 804 I.B.1.(b)(iii).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 5, 7, 9-10, 13-21, 23-24, 26, and 31-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/702,855 (‘855) in view of Carbajo-Gordillo (in IDS filed 11/05/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘855 recite a complex comprising the compound of claim 1 and an RNA (claim 18). The claims of ‘855 recite the RNA is modRNA and others (claim 20), a ratio of N/P in the complex is less than 20:1 (claim 21), has a diameter of 30-150nm (claim 23), the same method of treating a disease such as an infection disease comprising administering the complex (claims 26-27), and a method of delivery of the composition to a target such as the liver (claims 24-25).
Furthermore, the claims of ‘855 recite all of the same structural limitations as the instant compound (claims 1-2, 5, 7, 9, and 12-16) except the ‘855 compound recites a disulfide linkage instead of a single sulfide linkage and also does not recite the excluded provisos. Furthermore, the claims of ‘855 recite the compound is selected from Table 1 (claim 17), which includes the compounds such as PRX017 (page 53 in the specification of ‘855). This PRX017 compound also meets the structural limitation of the recited compound in the instant claims with the only difference also being the disulfide linkage instead of the single sulfide linkage and not reciting the excluded provisos.
Carbajo-Gordillo teaches trehalose-based Siamese twin amphiphiles with tuneable self-assembling, DNA nanocomplexing and gene delivery properties (Abstract).
Carbajo-Gordillo teaches their amphiphile compounds having the following structure shown in Scheme 1:
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It would have been prima facie obvious before the effective filing date of the claimed invention to substituted the disulfide linkage recited in the claims of ‘855 with the single sulfide linkage as disclosed in Carbajo-Gordillo to arrive at the claimed invention.
One of ordinary skill in the art would have substituted one known element (disulfide linkage) for another (single sulfide linkage) to obtain predictable results and would have a reasonable expectation of success in doing so because both the claims of ‘855 and Carbajo-Gordillo recite nearly identical structures of trehalose-based siamese twin amphiphile compounds that are useful for the same purpose of gene delivery. Furthermore, this modified compound is not an excluded proviso compound.
In regards to instant claims 31-32, even though the combination of claims of ‘855 and Carbajo-Gordillo do not explicitly recite a method of increasing or causing increased expression of RNA in a target such as the liver in a subject, this increased RNA expression would flow naturally from the combined references because the combined references recite the same active step of delivering the same compound-RNA complex to the same target such as the liver in a subject.
MPEP 2145 II states that “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
This reference application has the same patent term filing date as the instant application (10/21/2022). See MPEP 804 I.B.1.(b)(iii).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 21, and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/702,855 (‘855) in view of Carbajo-Gordillo (in IDS filed 11/05/2024) and Thomas (WO2021000041A1 in PTO-892).
The combination of claims of ‘855 and Carbajo-Gordillo recite the instant compound and complex as described above.
The only difference between the combined refences and the instant claims is the combined references do not recite further comprising a surfactant such as polysorbate in the recited molar ratio.
The teachings of Thomas are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included into the complex as recited by the combination of claims of ‘855 and Carbajo-Gordillo described above the polysorbate 80 as disclosed in Thomas to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because Thomas provides guidance of including polysorbate as a stabilizing agent with a similar sugar- ionizable lipid-based compound that has the same purpose of gene delivery. Furthermore, the modified complex would have mol% amounts that overlap in molar ratios, rendering the recited molar ratio in the instant claims obvious. See MPEP 2144.05 I.
This reference application has the same patent term filing date as the instant application (10/21/2022). See MPEP 804 I.B.1.(b)(iii).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 1-2, 5, 7, 9-10, 13-21, 23-24, 26, and 28-34 are rejected, but may be allowable if the 35 USC 112(b) rejection and provisional non-statutory double patenting rejections are overcome.
The closest prior art is Carbajo-Gordillo (in IDS filed 11/05/2024).
Carbajo-Gordillo teaches trehalose-based Siamese twin amphiphiles with tuneable self-assembling, DNA nanocomplexing and gene delivery properties (Abstract).
Carbajo-Gordillo teaches their amphiphile compounds having the following structure shown in Scheme 1:
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Compounds 6-10 meet the limitation of formula I compound in the instant claims when A is A1.
However, instant claim 1 specifically excludes out these compounds in the recited exclusion provisos when A is A1.
Carbajo-Gordillo further discloses that specific arrangements of flexible spacers (cysteaminyl, ethylene segments), pH buffering groups (triazole heterocycles, tertiary amines), hydrogen bonding modules (thiourea motifs) and peripheral primary amines can translate into distinct self-assembling properties, plasmid DNA (pDNA) complexing abilities and vector/pDNA nanocomplex topologies, thereby impacting transfection capabilities and providing information on the molecular determinants of efficient gene delivery (first paragraph left column page 8228).
Reineke (in IDS filed 11/05/2024) discloses carbohydrate polycations that are tetrahalose or cyclodextrin based with amidine-based polycation modifications (Figure 2 page 252) that are useful for similar gene delivery applications (Abstract), but does not disclose the recited combination of modified groups on the sugar units (the X1-Y1-Z1 groups). Furthermore, Reineke does not disclose the tetrahalose-based compound having lipid modified groups on both sugar units of the tetrahalose based compound.
WO’916 (in IDS filed 11/05/2024) and KR’461 (in IDS filed 11/05/2024) teach similar dithiolsaccharide compound structures (see compound structures in claim 1 of both WO’916 and KR’461 (page 2)), but do not teach their compounds being useful for similar applications. WO’916 teaches that their compounds are useful as mucolytic agents (Abstract), and KR’461 teaches that their compounds are useful as dispersing agents (Abstract). Furthermore, both WO’916 and KR’461 do not teach a recited Z1 or Z2 group (cationic or ionizable groups).
Therefore, it would not have been prima facie obvious before the effective filing date of the claimed invention to modify the structures disclosed in Carbajo-Gordillo and arrive at the claimed compounds with a reasonable expectation of success because the prior art does not provide reasonable guidance to modify the Carbajo-Gordillo compounds with a recited combination of substituents (the X1-Y1-Z1 groups) and further retain the disclosed properties/functions of gene delivery that are based on specific structural arrangements within the compound. While Reineke discloses similar sugar-lipid type compounds for similar gene delivery application, Reineke does not disclose the specific modification groups as recited in the instant claims and does not disclose the same structural arrangements of the lipid modification groups on the disaccharide units. Furthermore, while WO’916 and KR’461 teach similar dithiolsaccharide structures, both of these references do not disclose their compounds being useful for similar gene delivery applications and also do not teach a recited Z1 or Z2 group.
Therefore, the ordinary skilled artisan would have to rely on hindsight reasoning and/or undue experimentation to arrive at the claimed invention. Furthermore, the claimed compounds when A is A2 or A3 are not disclosed in the prior art.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
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