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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/11/26 has been entered.
Election/Restrictions and Claim Status
Applicants amendments and arguments filed 3/11/26 are acknowledged. Any objection or rejection from the 9/11/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, Group 1 and the species as set forth in the reply filed on 10/17/24 were elected.
Applicants previously stated that claims 1-6 and 14 are encompassed by the elected species. Pending claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 4-13 and 15-18 have been canceled.
Claims 1-3 and 14 are being examined.
Priority
The priority information is found in the filing receipt dated 10/3/23.
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 1-3 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites ‘or a pharmaceutically acceptable salt thereof’ (4th line after formula A1). Claim 1 recites ‘or a pharmaceutically acceptable salt thereof’ (last line). The use of multiple occurrences of ‘or a pharmaceutically acceptable salt thereof’ makes the scope of the claim unclear. It is unclear if the linker itself can be a salt thereof and then formula A1 can also be a salt or if the intent is only that the final conjugate can be a salt. None of the dependent claims clarifies the claim scope.
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.
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.
Claim(s) 1-3 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Folda et al. (‘Polyreactions in oriented systems: Formation of oriented polypeptides and polyamides in monolayers and liposomes’ Macromolecular Rapid Communications v3 1982 pages 167-174; ‘Folda’ as cited with IDS of 9/22/23) in view of Heyes et al. (‘Synthesis and characterization of novel poly(ethylene glycol)-lipid conjugates suitable for use in drug delivery’ Journal of Controlled Release v112 2006 pages 280-290; ‘Heyes’).
Folda teach liposomes (title and last paragraph of page 167) and teach a goal of stabilizing liposomes (page 167 3rd paragraph). Folda teach polycondensation reactions of compounds 5 and 6 (page 168 first paragraph). In scheme 3 (page 171) Folda shows the reaction product. Folda teach that liposomes were also used (page 168 2nd paragraph and reaction scheme 4). Folda concludes that compounds were formed and the polycondensation represents a new route for stabilizing membranes (page 174). Folda teach that it is expected that the liposomes are stable but biodegradable (page 174).
Folda does not teach the inclusion of polyethylene glycol or siRNA.
Heyes teach the use of liposomal formulations to encapsulate and deliver a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph). Heyes teach the use of PEG molecules that are anchored into the liposomal bilayer (first paragraph of abstract). Heyes teach the use of SPLP (PEG-stabilized liposomal vesicles encapsulating DNA) as a model system to investigate the properties of PEG-lipids (abstract). Heyes expressly refer to nucleic acid based drugs (where ribonucleic is a type of nucleic acid) (page 280 paragraph connecting columns 1-2). In addition to DNA, Heyes recognizes the use of siRNA (page 281 first complete paragraph). Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)nNH- (figure 3 last compound page 285). Heyes reports the properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Folda because Folda expressly teach liposomes (title and last paragraph of page 167) and teach a goal of stabilizing liposomes (page 167 3rd paragraph)
and Heyes teach known applications and ways of improving liposomes (including stabilization – see 2nd paragraph of abstract). Heyes teach the use of liposomal formulations to encapsulate and deliver a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph). Heyes teach the use of PEG molecules that are anchored into the liposomal bilayer (first paragraph of abstract). Heyes teach the use of SPLP (PEG-stabilized liposomal vesicles encapsulating DNA) as a model system to investigate the properties of PEG-lipids (abstract). In addition to DNA, Heyes recognizes the use of siRNA (page 281 first complete paragraph). Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)NH- (figure 3 last compound). Thus, one would have been motivated to include the –(O-CH2CH2)nNH- group in the liposomes of Heyes. When using the configuration as shown in reaction scheme 3 of Folda (page 171) one would have been motivated to include –(O-CH2CH2)NH- (for example by replacing one of the hydrogens of the CH2 group on the bottom side as shown in reaction scheme 3). Further, since Heyes suggest known applications and the inclusion of siRNA one would have been motivated to include siRNA. One would have had a reasonable expectation of success since Heyes reports the synthesis (figure 3 on page 285) and properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes shows methods of synthesizing components (figure 3).
In relation to the fatty acid as recited in claim 1, the reaction product as shown on page 171 of Folda is such that the product comprises formula A1 where m and n are 18 and R2 and R3 are H. As recited in claim 1 formula A1 is linked to the biomolecule and consistent with the specification including previously pending claim 9 the biomolecule can be linked at any location to the fatty acid and the claim is not limited to the number of linked biomolecules. Applicants elected species includes a -C(O)N.
In relation to the conjugate as recited in claim 1, the reaction product as shown on page 171 of Folda show that the C(O) groups are conjugated to particular molecules. Further, Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)nNH- (figure 3 last compound page 285) which is an oligo ethylene glycol moiety as recited in claim 1. It is noted that claim 1 recites ‘linker comprises’ and thus is open to additional components or repeats at the terminal ends.
In relation to the biomolecule as recited in claim 1, Heyes specifically recites siRNA (page 281 first complete paragraph).
In relation to claim 2, the reaction product as shown on page 171 of Folda is such that the product comprises the last formula of claim 2 where R5 and R6 are C18alkylene.
In relation to claim 3, the reaction product as shown on page 171 of Folda is such that it comprises (CH2)12-(CH2)5-CH3 (compare the last option of instant claim 3). As recited in claim 1 formula A1 is linked to the biomolecule and consistent with the specification including claim 9 the biomolecule can be linked at any location to the fatty acid and the claim is not limited to the number of linked biomolecules. Stated another way, the instant claims are open-ended as to the point of conjugation and the number of conjugation points.
In relation to claim 14, Folda teach the mixtures as solutions thus they would have been present with a carrier (page 169 methods and page 171).
This rejection addresses additional embodiments of the claims.
Claim(s) 1-3 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Folda et al. (‘Polyreactions in oriented systems: Formation of oriented polypeptides and polyamides in monolayers and liposomes’ Macromolecular Rapid Communications v3 1982 pages 167-174; ‘Folda’ as cited with IDS of 9/22/23) in view of Bertozzi et al. (US 2009/0068738; ‘Bertozzi’) in view of Heyes et al. (‘Synthesis and characterization of novel poly(ethylene glycol)-lipid conjugates suitable for use in drug delivery’ Journal of Controlled Release v112 2006 pages 280-290; ‘Heyes’).
Folda teach liposomes (title and last paragraph of page 167) and membranes and teach a goal of stabilizing liposomes/membranes (page 167 3rd paragraph). Folda teach polycondensation reactions of compounds 5 and 6 (page 168 first paragraph). In scheme 3 (page 171) Folda shows the reaction product. Folda teach that liposomes were also used (page 168 2nd paragraph and reaction scheme 4). Folda concludes that compounds were formed and polycondensation represents a new route for stabilizing membranes (page 174). Folda teach that it is expected that the liposomes are stable but biodegradable (page 174).
Folda does not teach the inclusion of a heterocycle or siRNA.
Bertozzi teach methods of modifying compounds with specific applications for cell surfaces (abstract and sections 0008 and 0196) and specifically mention membranes and liposomes (section 0131). Bertozzi teach selectivity and compatibility with aqueous environments as advantages (abstract). In figure 1b Bertozzi shows the structure of a specific compound. Bertozzi teach synthesis of various compounds (sections 0246-0247).
Heyes teach the use of liposomal formulations to encapsulate and deliver a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph). Heyes teach the use of PEG molecules that are anchored into the liposomal bilayer (first paragraph of abstract). Heyes teach the use of SPLP (PEG-stabilized liposomal vesicles encapsulating DNA) as a model system to investigate the properties of PEG-lipids (abstract). Heyes expressly refer to nucleic acid based drugs (where ribonucleic is a type of nucleic acid) (page 280 paragraph connecting columns 1-2). In addition to DNA, Heyes recognizes the use of siRNA (page 281 first complete paragraph). Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)nNH- (figure 3 last compound page 285). Heyes reports the properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes shows methods of synthesizing components (figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Folda because Folda expressly teach liposomes (title and last paragraph of page 167) and membranes (page 167 3rd paragraph) and Bertozzi teach methods of modifying compounds with specific applications for cell surfaces and membranes (abstract and sections 0008, 0131 and 0196) and specifically mentions liposomes/membranes (section 0131). Bertozzi teach selectivity and compatibility with aqueous environments as advantages (abstract). In figure 1b Bertozzi shows the structure of a specific compound. Thus, one would have been motivated to modify the known compounds of Folda using the specific compounds taught by Bertozzi. One would have had a reasonable expectation of success since in figure 1b Bertozzi shows the structure of a specific compound and Bertozzi teach synthesis of various compounds (sections 0246-0247).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Folda because Folda expressly teach liposomes (title and last paragraph of page 167) and teach a goal of stabilizing liposomes (page 167 3rd paragraph)
and Heyes teach known applications and ways of improving liposomes (including stabilization – see 2nd paragraph of abstract). Heyes teach the use of liposomal formulations to encapsulate and deliver a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph). Heyes teach the use of PEG molecules that are anchored into the liposomal bilayer (first paragraph of abstract). Heyes teach the use of SPLP (PEG-stabilized liposomal vesicles encapsulating DNA) as a model system to investigate the properties of PEG-lipids (abstract). In addition to DNA, Heyes recognizes the use of siRNA (page 281 first complete paragraph). Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)NH- (figure 3 last compound). Thus, one would have been motivated to include the –(O-CH2CH2)nNH- group in the liposomes of Heyes. When using the configuration as shown in reaction scheme 3 of Folda (page 171) one would have been motivated to include –(O-CH2CH2)NH- (for example by replacing one of the hydrogens of the CH2 group on the bottom side as shown in reaction scheme 3). Further, since Heyes suggest known applications and the inclusion of siRNA one would have been motivated to include siRNA. One would have had a reasonable expectation of success since Heyes reports the synthesis (figure 3 on page 285) and properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract).
In relation to the fatty acid as recited in claim 1, the reaction product as shown on page 171 of Folda is such that the product comprises formula A1 where m and n are 18 and R2 and R3 are H. As recited in claim 1 formula A1 is linked to the biomolecule and consistent with the specification including claim 9 the biomolecule can be linked at any location to the fatty acid and the claim is not limited to the number of linked biomolecules. Applicants elected species includes a -C(O)N.
In relation to the conjugate as recited in claim 1, the reaction product as shown on page 171 of Folda show that the C(O) groups are conjugated to particular molecules. Further, in figure 1b Bertozzi shows the structure of a specific compound to be used for conjugation. Further, Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)nNH- (figure 3 last compound page 285) which is an oligo ethylene glycol moiety as recited in claim 1. It is noted that claim 1 recites ‘linker comprises’ and thus is open to additional components or repeats at the terminal ends.
In relation to the biomolecule as recited in claim 1, Heyes specifically recites siRNA (page 281 first complete paragraph) and Bertozzi teach applications with nucleic acids (section 0005).
In relation to claim 2, the reaction product as shown on page 171 of Folda is such that the product comprises the last formula of claim 2 where R5 and R6 are C18alkylene.
In relation to claim 3, the reaction product as shown on page 171 of Folda is such that it comprises (CH2)12-(CH2)5-CH3 (compare the last option of instant claim 3). As recited in claim 1 formula A1 is linked to the biomolecule and consistent with the specification including claim 9 the biomolecule can be linked at any location to the fatty acid and the claim is not limited to the number of linked biomolecules. Stated another way, the instant claims are open-ended as to the point of conjugation and the number of conjugation points.
In relation to claim 14, Folda teach the mixtures as solutions thus they would have been present with a carrier (page 169 methods and page 171).
Response to Arguments - 103
Applicant's arguments filed 3/11/26 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants argue that Folda alone does not teach the invention, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Although applicants argue that Heyes teach PEG with numerous repeating units, instant claim 1 recites ‘linker comprises’ and thus the terminal ends can include additional components or repeats. MPEP 2111.03 I states that the transitional phrase comprising is open-ended and does not exclude additional unrecited elements.
Although applicants argue that Heyes merely mentions siRNA, Heyes teach the use of liposomal formulations to encapsulate and deliver a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph). Heyes expressly refer to nucleic acid based drugs (where ribonucleic is a type of nucleic acid) (page 280 paragraph connecting columns 1-2).
Although applicants argue that there is no reasonable expectation of success, Heyes shows methods of synthesizing components (figure 3). Heyes reports the synthesis (figure 3 on page 285) and properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Bertozzi shows the structure of a specific compound and Bertozzi teach synthesis of various compounds (sections 0246-0247).
Although applicants argue that Bertozzi alone does not teach the invention, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Although applicants argue that there is no motivation to combine Bertozzi, Bertozzi teach methods of modifying compounds with specific applications for cell surfaces (abstract and sections 0008 and 0196) and specifically mention membranes and liposomes (section 0131). Bertozzi teach selectivity and compatibility with aqueous environments as advantages (abstract). Bertozzi teach applications with nucleic acids (section 0005).
Double Patenting
MPEP 804.01 recognizes that the protection afforded by section 121 is limited to divisional applications. The instant application is a continuation application.
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 1-3 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10588980 (‘980’) in view of Heyes et al. (‘Synthesis and characterization of novel poly(ethylene glycol)-lipid conjugates suitable for use in drug delivery’ Journal of Controlled Release v112 2006 pages 280-290; ‘Heyes’).
980 recites fatty acid conjugates (claim 1) and shows a specific formula (formula C) that includes PEG, a heterocyclic linker and a peptide biomolecule (claim 8). 980 recites compositions with a carrier (claim 18). 980 recognizes the inclusion of a coagent (claims 16 and 19 for example). 980 recites specific linkers (claim 5).
980 does not specifically recite siRNA as the biomolecule or coagent.
Heyes teach the use of liposomal formulations to encapsulate and deliver a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph). Heyes teach the use of PEG molecules that are anchored into the liposomal bilayer (first paragraph of abstract). Heyes teach the use of SPLP (PEG-stabilized liposomal vesicles encapsulating DNA) as a model system to investigate the properties of PEG-lipids (abstract). Heyes expressly refer to nucleic acid based drugs (where ribonucleic is a type of nucleic acid) (page 280 paragraph connecting columns 1-2). In addition to DNA, Heyes recognizes the use of siRNA (page 281 first complete paragraph). Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)nNH- (figure 3 last compound page 285). Heyes reports the properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes shows methods of synthesizing components (figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 980 because 980 specifically teach the inclusion of a biomolecule (claims 1 and 8) as well as a coagent (claims 16 and 19 for example). Since Heyes teach delivery of a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph) and specifically recites siRNA (page 281 first complete paragraph) one would have been motivated to use siRNA as the biomolecule. Since Heyes suggest known applications and the inclusion of siRNA one would have been motivated to include siRNA in the construct of 980. One would have had a reasonable expectation of success since Heyes reports the synthesis (figure 3 on page 285) and properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes teach applicability for a wide variety of agents (abstract).
In relation to formula I of claims 1-3, 980 recites a specific formula (formula C of claim 8) that reads on the group as claimed specifically the first options of claims 2-3. Heyes specifically recites siRNA (page 281 first complete paragraph). 980 recites specific linkers (claim 5). 980 recites a specific formula (formula C) that includes a PEG group as claimed (claim 8) specifically the first option of claim 5. 980 recites a specific formula (formula C) that includes a heterocyclic moiety (claim 8) specifically the first option of claim 6.
In relation to claim 14, 980 recites compositions with a carrier (claim 18).
Claims 1-3 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10786576 (‘576’) in view of Heyes et al. (‘Synthesis and characterization of novel poly(ethylene glycol)-lipid conjugates suitable for use in drug delivery’ Journal of Controlled Release v112 2006 pages 280-290; ‘Heyes’).
576 recites methods that require fatty acid conjugates (claim 1) and shows a specific formula (formula C) that includes PEG, a heterocyclic linker and a peptide biomolecule (claim 8). 576 recites compositions with a carrier (claim 18). 576 recites the inclusion of a coagent (claim 15 for example). 576 recites specific linkers (claim 5).
576 does not specifically recite siRNA as the biomolecule or coagent.
Heyes teach the use of liposomal formulations to encapsulate and deliver a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph). Heyes teach the use of PEG molecules that are anchored into the liposomal bilayer (first paragraph of abstract). Heyes teach the use of SPLP (PEG-stabilized liposomal vesicles encapsulating DNA) as a model system to investigate the properties of PEG-lipids (abstract). Heyes expressly refer to nucleic acid based drugs (where ribonucleic is a type of nucleic acid) (page 280 paragraph connecting columns 1-2). In addition to DNA, Heyes recognizes the use of siRNA (page 281 first complete paragraph). Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)nNH- (figure 3 last compound page 285). Heyes reports the properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes shows methods of synthesizing components (figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 576 because 576 specifically teach the inclusion of a biomolecule (claims 1 and 8) as well as a coagent (claim 15 for example). Since Heyes teach delivery of a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph) and specifically recites siRNA (page 281 first complete paragraph) one would have been motivated to use siRNA as the biomolecule. Since Heyes suggest known applications and the inclusion of siRNA one would have been motivated to include siRNA in the construct of 576. One would have had a reasonable expectation of success since Heyes reports the synthesis (figure 3 on page 285) and properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes teach applicability for a wide variety of agents (abstract).
In relation to formula I of claims 1-3, 576 recites a specific formula (formula C of claim 8) that reads on the group as claimed specifically the first options of claims 2-3. Heyes specifically recites siRNA (page 281 first complete paragraph). 576 recites specific linkers (claim 5). 576 recites a specific formula (formula C) that includes a PEG group as claimed (claim 8).
In relation to claim 14, 576 recites compositions with a carrier (claim 18).
Claims 1-3 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9931372 (as cited with IDS of 9/22/23; ‘372’) in view of Heyes et al. (‘Synthesis and characterization of novel poly(ethylene glycol)-lipid conjugates suitable for use in drug delivery’ Journal of Controlled Release v112 2006 pages 280-290; ‘Heyes’).
372 recites fatty acid conjugates (claim 1) and shows a specific formula that includes PEG and a peptide biomolecule (claim 6). 372 recites compositions with a carrier (claim 16). 372 recites the inclusion of a co-agent (claim 9 for example). 372 recites specific linkers (claim 1 and 6).
372 does not specifically recite siRNA as the biomolecule or coagent.
Heyes teach the use of liposomal formulations to encapsulate and deliver a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph). Heyes teach the use of PEG molecules that are anchored into the liposomal bilayer (first paragraph of abstract). Heyes teach the use of SPLP (PEG-stabilized liposomal vesicles encapsulating DNA) as a model system to investigate the properties of PEG-lipids (abstract). Heyes expressly refer to nucleic acid based drugs (where ribonucleic is a type of nucleic acid) (page 280 paragraph connecting columns 1-2). In addition to DNA, Heyes recognizes the use of siRNA (page 281 first complete paragraph). Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)nNH- (figure 3 last compound page 285). Heyes reports the properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes shows methods of synthesizing components (figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 372 because 372 specifically teach the inclusion of a biomolecule (claims 1 and 6) as well as a coagent (claim 9 for example). Since Heyes teach delivery of a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph) and specifically recites siRNA (page 281 first complete paragraph) one would have been motivated to use siRNA as the biomolecule. Since Heyes suggest known applications and the inclusion of siRNA one would have been motivated to include siRNA in the construct of 372. One would have had a reasonable expectation of success since Heyes reports the synthesis (figure 3 on page 285) and properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes teach applicability for a wide variety of agents (abstract).
In relation to formula I of claims 1-3, 372 recites a specific formula (claim 6) that reads on the group as claimed specifically the first options of claims 2-3. Heyes specifically recites siRNA (page 281 first complete paragraph). 372 recites specific linkers (claim 1 and 6). 372 recites a specific formula that includes a PEG group as claimed (claim 6).
In relation to claim 14, 372 recites compositions with a carrier (claim 16).
Claims 1-3 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9931372 (as cited with IDS of 9/22/23; ‘372’) in view of Bertozzi et al. (US 2009/0068738; ‘Bertozzi’) in view of Heyes et al. (‘Synthesis and characterization of novel poly(ethylene glycol)-lipid conjugates suitable for use in drug delivery’ Journal of Controlled Release v112 2006 pages 280-290; ‘Heyes’).
372 recites fatty acid conjugates (claim 1) and shows a specific formula that includes PEG and a peptide biomolecule (claim 6). 372 recites compositions with a carrier (claim 16). 372 recites the inclusion of a co-agent (claim 9 for example). 372 recites specific linkers (claim 1 and 6).
372 does not specifically recite siRNA as the biomolecule or coagent or a heterocycle.
Bertozzi teach methods of modifying compounds with specific applications in vivo and for cell surfaces (abstract and sections 0008 and 0196). Bertozzi teach selectivity and compatibility with aqueous environments as advantages (abstract). In figure 1b Bertozzi shows the structure of a specific compound. Bertozzi teach synthesis of various compounds (sections 0246-0247).
Heyes teach the use of liposomal formulations to encapsulate and deliver a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph). Heyes teach the use of PEG molecules that are anchored into the liposomal bilayer (first paragraph of abstract). Heyes teach the use of SPLP (PEG-stabilized liposomal vesicles encapsulating DNA) as a model system to investigate the properties of PEG-lipids (abstract). Heyes expressly refer to nucleic acid based drugs (where ribonucleic is a type of nucleic acid) (page 280 paragraph connecting columns 1-2). In addition to DNA, Heyes recognizes the use of siRNA (page 281 first complete paragraph). Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)nNH- (figure 3 last compound page 285). Heyes reports the properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes shows methods of synthesizing components (figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 372 because 372 expressly teach conjugates (claim 1) and method of administering (claim 7) and Bertozzi teach methods of modifying compounds with specific applications in vivo and for cell surfaces (abstract and sections 0008 and 0196). Bertozzi teach selectivity and compatibility with aqueous environments as advantages (abstract). In figure 1b Bertozzi shows the structure of a specific compound. Thus, one would have been motivated to modify the known compounds of 372 using the specific compounds taught by Bertozzi. One would have had a reasonable expectation of success since in figure 1b Bertozzi shows the structure of a specific compound and Bertozzi teach synthesis and various compounds (sections 0246-0247).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 372 because 372 specifically teach the inclusion of a biomolecule (claims 1 and 6) as well as a coagent (claim 9 for example). Since Heyes teach delivery of a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph) and specifically recites siRNA (page 281 first complete paragraph) one would have been motivated to use siRNA as the biomolecule. Since Heyes suggest known applications and the inclusion of siRNA one would have been motivated to include siRNA in the construct of 372. One would have had a reasonable expectation of success since Heyes reports the synthesis (figure 3 on page 285) and properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes teach applicability for a wide variety of agents (abstract).
In relation to formula I of claims 1-3, 372 recites a specific formula (claim 6) that reads on the group as claimed specifically the first options of claims 2-3. Heyes specifically recites siRNA (page 281 first complete paragraph). 372 recites specific linkers (claim 1 and 6).
372 recites a specific formula that includes a PEG group as claimed (claim 6).
In relation to claim 14, 372 recites compositions with a carrier (claim 16).
Claims 1-3 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-78 of copending Application No. 18281732 (reference application; ‘732’) in view of Heyes et al. (‘Synthesis and characterization of novel poly(ethylene glycol)-lipid conjugates suitable for use in drug delivery’ Journal of Controlled Release v112 2006 pages 280-290; ‘Heyes’).
This is a provisional nonstatutory double patenting rejection.
732 recites fatty acid conjugates (claim 1) and shows a specific formula that includes PEG and a biomolecule (claim 61 compound B5 on page 30 of 8/6/24 claim set). 732 recites compositions with a carrier (claim 64). 732 recites specific linkers (claim 51).
732 does not specifically recite siRNA as the biomolecule.
Heyes teach the use of liposomal formulations to encapsulate and deliver a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph). Heyes teach the use of PEG molecules that are anchored into the liposomal bilayer (first paragraph of abstract). Heyes teach the use of SPLP (PEG-stabilized liposomal vesicles encapsulating DNA) as a model system to investigate the properties of PEG-lipids (abstract). Heyes expressly refer to nucleic acid based drugs (where ribonucleic is a type of nucleic acid) (page 280 paragraph connecting columns 1-2). In addition to DNA, Heyes recognizes the use of siRNA (page 281 first complete paragraph). Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)nNH- (figure 3 last compound page 285). Heyes reports the properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes shows methods of synthesizing components (figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 732 because 732 specifically teach the inclusion of a biomolecule (claim 61 compound B5 on page 30 of 8/6/24 claim set). Since Heyes teach delivery of a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph) and specifically recites siRNA (page 281 first complete paragraph) one would have been motivated to use siRNA as the biomolecule. Since Heyes suggest known applications and the inclusion of siRNA one would have been motivated to include siRNA in the construct of 732. One would have had a reasonable expectation of success since Heyes reports the synthesis (figure 3 on page 285) and properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes teach applicability for a wide variety of agents (abstract).
In relation to formula I of claims 1-3, 732 recites a specific formula (claim 61 compound B5 on page 30) that reads on the group as claimed specifically the first options of claims 2-3. Heyes specifically recites siRNA (page 281 first complete paragraph). 732 recites specific linkers (claim 51). 732 recites a specific formula that includes a PEG group as claimed (claim 61 compound B5 on page 30).
In relation to claim 14, 732 recites compositions with a carrier (claim 64).
Claims 1-3 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-78 of copending Application No. 18281732 (reference application; ‘732’) in view of Bertozzi et al. (US 2009/0068738; ‘Bertozzi’) in view of Heyes et al. (‘Synthesis and characterization of novel poly(ethylene glycol)-lipid conjugates suitable for use in drug delivery’ Journal of Controlled Release v112 2006 pages 280-290; ‘Heyes’).
732 recites fatty acid conjugates (claim 1) and shows a specific formula that includes PEG and a biomolecule (claim 61 compound B5 on page 26). 732 recites compositions with a carrier (claim 64) and recites methods of administering (claim 69).
732 does not specifically recite siRNA as the biomolecule.
Bertozzi teach methods of modifying compounds with specific applications in vivo for cell surfaces (abstract and sections 0008 and 0196). Bertozzi teach selectivity and compatibility with aqueous environments as advantages (abstract). In figure 1b Bertozzi shows the structure of a specific compound. Bertozzi teach synthesis and various compounds (sections 0246-0247).
Heyes teach the use of liposomal formulations to encapsulate and deliver a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph). Heyes teach the use of PEG molecules that are anchored into the liposomal bilayer (first paragraph of abstract). Heyes teach the use of SPLP (PEG-stabilized liposomal vesicles encapsulating DNA) as a model system to investigate the properties of PEG-lipids (abstract). Heyes expressly refer to nucleic acid based drugs (where ribonucleic is a type of nucleic acid) (page 280 paragraph connecting columns 1-2). In addition to DNA, Heyes recognizes the use of siRNA (page 281 first complete paragraph). Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)nNH- (figure 3 last compound page 285). Heyes reports the properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes shows methods of synthesizing components (figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 732 because 732 expressly teach conjugates (claim 1) and method of administering (claim 69) and Bertozzi teach methods of modifying compounds with specific applications in vivo for cell surfaces (abstract and sections 0008 and 0196). Bertozzi teach selectivity and compatibility with aqueous environments as advantages (abstract). In figure 1b Bertozzi shows the structure of a specific compound. Thus, one would have been motivated to modify the known compounds of 732 using the specific compounds taught by Bertozzi. One would have had a reasonable expectation of success since in figure 1b Bertozzi shows the structure of a specific compound and Bertozzi teach synthesis and various compounds (sections 0246-0247).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 732 because 732 specifically teach the inclusion of a biomolecule (claim 61 compound B5 on page 30 of 8/6/24 claim set). Since Heyes teach delivery of a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph) and specifically recites siRNA (page 281 first complete paragraph) one would have been motivated to use siRNA as the biomolecule. Since Heyes suggest known applications and the inclusion of siRNA one would have been motivated to include siRNA in the construct of 732. One would have had a reasonable expectation of success since Heyes reports the synthesis (figure 3 on page 285) and properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes teach applicability for a wide variety of agents (abstract).
In relation to formula I of claims 1-3, 732 recites a specific formula (claim 61 compound B5 on page 30) that reads on the group as claimed specifically the first options of claims 2-3. Heyes specifically recites siRNA (page 281 first complete paragraph). 732 recites specific linkers (claim 51). 732 recites a specific formula that includes a PEG group as claimed (claim 61 compound B5 on page 30).
In relation to claim 14, 732 recites compositions with a carrier (claim 64).
Claims 1-3 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 18556461 (reference application; ‘461’) in view of Bertozzi et al. (US 2009/0068738; ‘Bertozzi’) in view of Heyes et al. (‘Synthesis and characterization of novel poly(ethylene glycol)-lipid conjugates suitable for use in drug delivery’ Journal of Controlled Release v112 2006 pages 280-290; ‘Heyes’).
461 recites fatty acid conjugates (claim 1) and shows specific formulas that includes PEG and a biomolecule (claim 16). 461 recites specific linkers (claim 3). 461 recites compositions with a carrier (claim 20).
461 does not specifically recite siRNA as the biomolecule or a heterocycle.
Bertozzi teach methods of modifying compounds with specific applications in vivo for cell surfaces (abstract and sections 0008 and 0196). Bertozzi teach selectivity and compatibility with aqueous environments as advantages (abstract). In figure 1b Bertozzi shows the structure of a specific compound. Bertozzi teach synthesis and various compounds (sections 0246-0247).
Heyes teach the use of liposomal formulations to encapsulate and deliver a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph). Heyes teach the use of PEG molecules that are anchored into the liposomal bilayer (first paragraph of abstract). Heyes teach the use of SPLP (PEG-stabilized liposomal vesicles encapsulating DNA) as a model system to investigate the properties of PEG-lipids (abstract). Heyes expressly refer to nucleic acid based drugs (where ribonucleic is a type of nucleic acid) (page 280 paragraph connecting columns 1-2). In addition to DNA, Heyes recognizes the use of siRNA (page 281 first complete paragraph). Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)nNH- (figure 3 last compound page 285). Heyes reports the properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes shows methods of synthesizing components (figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 461 because 461 expressly teach conjugates (claim 1) and method of administering (claim 27) and Bertozzi teach methods of modifying compounds with specific applications in vivo for cell surfaces (abstract and sections 0008 and 0196). Bertozzi teach selectivity and compatibility with aqueous environments as advantages (abstract). In figure 1b Bertozzi shows the structure of a specific compound. Thus, one would have been motivated to modify the known compounds of 461 using the specific compounds taught by Bertozzi. One would have had a reasonable expectation of success since in figure 1b Bertozzi shows the structure of a specific compound and Bertozzi teach synthesis and various compounds (sections 0246-0247).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 461 because 461 specifically teach the inclusion of an analogue (claim 1). Since Heyes teach delivery of a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph) and specifically recites siRNA (page 281 first complete paragraph) one would have been motivated to use siRNA as the biomolecule. Since Heyes suggest known applications and the inclusion of siRNA one would have been motivated to include siRNA in the construct of 461. One would have had a reasonable expectation of success since Heyes reports the synthesis (figure 3 on page 285) and properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes teach applicability for a wide variety of agents (abstract).
In relation to formula I of claims 1-3, 461 recites specific formulas (claim 16) that reads on the group as claimed specifically the first options of claims 2-3. Heyes specifically recites siRNA (page 281 first complete paragraph). 461 recites specific linkers (claim 3).
In relation to claim 14, 461 recites compositions with a carrier (claim 20).
Claims 1-3 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11752211 (‘211’) in view of Bertozzi et al. (US 2009/0068738; ‘Bertozzi’) in view of Heyes et al. (‘Synthesis and characterization of novel poly(ethylene glycol)-lipid conjugates suitable for use in drug delivery’ Journal of Controlled Release v112 2006 pages 280-290; ‘Heyes’).
211 recites fatty acid compounds (claim 1) and shows specific formulas (claim 2).
211 does not specifically recite siRNA as a biomolecule for conjugation or a heterocycle.
Bertozzi teach methods of modifying compounds with specific applications in vivo and for cell surfaces (abstract and sections 0008 and 0196). Bertozzi teach selectivity and compatibility with aqueous environments as advantages (abstract). In figure 1b Bertozzi shows the structure of a specific compound. Bertozzi teach synthesis of various compounds (sections 0246-0247).
Heyes teach the use of liposomal formulations to encapsulate and deliver a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph). Heyes teach the use of PEG molecules that are anchored into the liposomal bilayer (first paragraph of abstract). Heyes teach the use of SPLP (PEG-stabilized liposomal vesicles encapsulating DNA) as a model system to investigate the properties of PEG-lipids (abstract). Heyes expressly refer to nucleic acid based drugs (where ribonucleic is a type of nucleic acid) (page 280 paragraph connecting columns 1-2). In addition to DNA, Heyes recognizes the use of siRNA (page 281 first complete paragraph). Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)nNH- (figure 3 last compound page 285). Heyes reports the properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes shows methods of synthesizing components (figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 211 because 211 expressly teach fatty acids (claim 1) so one would have been motivated to prepare as conjugates as was known in the art. Bertozzi teach methods of modifying compounds with specific applications in vivo and for cell surfaces (abstract and sections 0008 and 0196). Bertozzi teach selectivity and compatibility with aqueous environments as advantages (abstract). In figure 1b Bertozzi shows the structure of a specific compound. Thus, one would have been motivated to modify the known compounds of 211 using the specific compounds taught by Bertozzi. One would have had a reasonable expectation of success since in figure 1b Bertozzi shows the structure of a specific compound and Bertozzi teach synthesis and various compounds (sections 0246-0247).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 211 because 211 expressly teach fatty acids (claim 1) so one would have been motivated to prepare as conjugates as use as liposomes as was known in the art. Since Heyes teach delivery of a wide variety of therapeutic agents and teach that the addition of polyethylene glycol (PEG) to the outer surface can prolong circulation and result in increased delivery, prevention of aggregation and aids in the formation of uniform particles (abstract first paragraph) and specifically recites siRNA (page 281 first complete paragraph) one would have been motivated to use siRNA as a biomolecule conjugate. Since Heyes suggest known applications and the inclusion of siRNA one would have been motivated to include siRNA in the construct of 372. One would have had a reasonable expectation of success since Heyes reports the synthesis (figure 3 on page 285) and properties of pegylated compounds (Table 1) and concludes that the novel PEG-lipids are more stable and less toxic (second paragraph of abstract). Heyes teach applicability for a wide variety of agents (abstract).
In relation to formula I of claims 1-3, 211 recites a specific formula (claim 2) that reads on the group as claimed specifically the first options of claims 2-3. Heyes specifically recites siRNA (page 281 first complete paragraph). Further, Heyes shows the structure of compound PEG-S-DSA which comprises –(O-CH2CH2)nNH- (figure 3 last compound page 285) which is an oligo ethylene glycol moiety as recited in claim 1. It is noted that claim 1 recites ‘linker comprises’ and thus is open to additional components at the terminal ends
In relation to claim 14, Heyes teach for drug delivery (title) so one would have been motivated to combine with a carrier.
Response to Arguments – Double Patenting
Applicant's arguments filed 3/11/26 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants request that the rejection be held in abeyance until the claims are allowable, there are no allowable claims. MPEP 804.02 sets forth ways to avoid a double patenting rejection. Holding a rejection in abeyance is not a way to avoid a double patenting rejection.
Although applicants argue that certain rejections are provisional, any provisional rejection is not the only rejection remaining in the instant application. MPEP 804.02 sets forth ways to avoid a double patenting rejection. Holding a rejection in abeyance is not a way to avoid a double patenting rejection.
Conclusion
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
Prosecution Insights