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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, 7, 11-12, 15-23, 25, and 27, along with the species of an anionic first stabilizing copolymer, and the species of a lipid or combination of lipids that includes a cationic lipid in the reply filed on 31 May 2026 is acknowledged.
Claims 29-30, 32, 35, 38, 41, 45, 50, 52, 55-56, and 114 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 31 May 2026.
The examiner has decided to withdraw the species election between a cationic lipid or combination of lipids that includes a cationic lipid and a non-cationic lipid or combination of lipids that does not include a cationic lipid. This decision was made in view of the fact that, upon further consideration by the examiner, there does not appear to be a search burden in searching these together. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01. With that being said, despite this decision, the examiner has used the language “elected species” in the office action to refer to a combination of lipids that includes a cationic lipid.
Claim Interpretation
Instant claim 1, in regard to the shell, recites at least one lipid and a second stabilizing amphiphilic agent. As best understood by the examiner, lipids are amphiphilic because lipids contain a hydrophobic tail and a hydrophilic head. Nevertheless, as best understood by the examiner, the at least one lipid and the second stabilizing amphiphilic agent are separate substances. The examiner will proceed with examination with the understanding that an element in the prior art which reads on the required at least one lipid does not also read on the second stabilizing amphiphilic agent. Therefore, the examiner will search for a composition comprising all of
a first stabilizing amphiphilic copolymer;
at least one lipid, which differs from the first stabilizing amphiphilic copolymer; and
a second stabilizing amphiphilic agent, which differs from the at least one lipid and also differs from the first stabilizing amphiphilic copolymer.
The examiner also clarifies here that the term “amphiphilic” is understood to refer to a chemical compound having a hydrophilic region covalently bound to a hydrophobic region. Common amphiphilic compounds include lipids, surfactants, emulsifiers, and block copolymers comprising a hydrophobic block covalently bound to a hydrophilic block.
Claim 17, last line on page 5, recites the abbreviation “XTC2.” As best understood by the examiner, this is not a trade name and will not be subject to a rejection under 35 U.S.C. 112(b).
Multiple Numerical Ranges in Claims Are Not Indefinite
Claim 12 recites multiple numerical ranges of varying breadth in the same claim. For example, claim 12 recites a molecular weight of the poly(lactic acid), poly(lactic-co-glycolic) acid, and/or poly(caprolactone) of from about 500 to about 500,000 Daltons, from about 500 to about 50,000 Daltons, or from about 750 Daltons to about 20,000 Daltons. The inclusion of broader and narrower ranges in the same claim as alternatives does not render the claim indefinite. In support of this determination, the examiner notes that according to MPEP 2173.05(h)(I), last paragraph in section, the Markush group, "selected from the group consisting of amino, halogen, nitro, chloro and alkyl" should be acceptable even though "halogen" is generic to "chloro." In a similar vein, a Markush group reciting a broad range of from about 500 to about 500,000 Daltons and a narrower range of from about 500 to about 50,000 Daltons would appear to be acceptable even though the broader range of from about 500 to about 500,000 Daltons is generic to the narrower range of from about 500 to about 50,000 Daltons. The examiner also notes that numerical ranges in claim 12 are clearly present in the alternative; as such, the issues discussed in MPEP 2173.05(c)(I) and 2173.05(d) do not appear to be applicable in this case.
Claim Rejections - 35 USC § 103 – Obviousness
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 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.
Claim(s) 1-3, 7, 11-12, 15, 17, 20-21, 25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markwalter et al. (The AAPS Journal, Vol. 22:18, 2020, pages 1-16 and S-1 through S-27, published 2 January 2020) in view of Prud’homme et al. (WO 2019/090030 A1) and Gindy et al. (Langmuir, Vol. 30, 2014, pages 4613-4622 and 4 pages of supporting information).
Markwalter et al. (hereafter referred to as Markwalter) is drawn to a polymer nanocarrier prepared using inverse flash nanoprecipitation, as of Markwalter, page 1, title and abstract. Also see Markwalter, page 3, relevant figure reproduced below.
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Markwalter teaches polylactide-block-poly(aspartic acid) (also referred to as PLA-PAsp) and polylactide-block-polyethylene glycol in the figure reproduced above, which are the first and second amphiphilic copolymers in the above-reproduced diagram. The examiner notes that polylactide-block-poly(aspartic acid) has an anionic polyaspartic acid polar region, thereby reading on the elected specie. Markwalter teaches a water-soluble drug in the above-reproduced diagram. Elsewhere in the reference, Markwalter teaches a lipid, as of Markwalter, figure S1 on page S-2, reproduced below.
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The examiner notes that lecithin is an alternate name for phosphatidylcholine, which is a zwitterionic phospholipid.
For the purposes of this rejection, the examiner understands Markwalter to be deficient because the embodiment in which Markwalter teaches the lipid lecithin comprises PAsp-PLA-PEG; this is only a single amphiphilic copolymer rather than two separate amphiphilic copolymers, as required by the instant claims. Additionally, Markwalter does not teach a combination of lipids that includes a cationic lipid.
Prud’homme et al. (hereafter referred to as Prud’homme) is drawn to flash nanoprecipitation for preparing of controlled release particles, as of Prud’homme, title and abstract; this appears to be the same technique used in the instant application. Prud’homme teaches the following on page 15, relevant text reproduced below.
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In view of this, the examiner cites Gindy et al. (Langmuir, Vol. 30, 2014, pages 4613-4622 and 4 pages of supporting information), which is listed in the above-reproduced paragraph. Gindy et al. (hereafter referred to as Gindy) is drawn to delivery of RNA, as of Gindy, title and abstract. Gindy appears to indicate that cationic (i.e. positively charged) lipids are needed to deliver nucleic acids such as siRNA, as of Gindy, page 4614, right column, third paragraph, relevant text reproduced below.
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The examiner notes here that “cationic” and “positively charged” have the same meaning. Also see Gindy, page 4619, right column, third paragraph, relevant text reproduced below.
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It would have been prima facie obvious for one of ordinary skill in the art to have combined the cationic lipids of Prud’homme and Gindy with the non-cationic lipids of Markwalter. Markwalter is drawn to RNA in one embodiment, as of Markwalter, page 6, left column. Prud’homme and Gindy teach that cationic lipids are useful for delivery of nucleic acids such as RNA. As such, the skilled artisan would have been motivated to have combined the cationic lipids of Prud’homme and Gindy with the composition of Markwalter for predictable delivery of RNA with a reasonable expectation of success, wherein RNA is taught by Markwalter.
As to claim 1, the claim requires a water-soluble agent. Markwalter teaches a biologic in figure 3 (which is shown in green in the original figure), and this is understood to read on the requirement of a water-soluble agent.
As to claim 1, the claim requires a core containing a more polar region of a first stabilizing amphiphilic copolymer. The PAsp (polyaspartic acid or polyaspartate) in Markwalter, figure 3, is understood to read on this requirement; this is shown in light blue in the original figure.
As to claim 1, the claim requires a shell containing a less polar region of a first stabilizing amphiphilic copolymer. The PLA block of the PLA-PAsp polymer, which is shown in figure 3 of Markwalter, is understood to read on this claimed requirement.
As to claim 1, the claim requires at least one lipid in the shell. Markwalter teaches lecithin, which is phosphatidylcholine and is a phospholipid, as of figure S1 on page S-2 of Markwalter, which is reproduced above. Prud’homme and Gindy also teach a cationic lipid.
As to claim 1, the claim requires a second stabilizing amphiphilic agent in the shell. The PLA-PEG of the figure on page 3 of Markwalter is amphiphilic. This is because the PLA is the hydrophobic block and the PEG is the hydrophilic block of the polymer.
As to claim 1, the claim requires that the shell surrounds the core. This appears to be taught as of the figure on page 3 of Markwalter.
As to claim 2, the claim requires that the shell has an interior surface and exterior surface. This appears to be taught in view of the above-reproduced figure from Markwalter.
As to claim 2, the claim requires that the interior surface of the shell is in contact with the core. This appears to be taught in view of the above-reproduced figure from Markwalter.
As to claim 2, the claim requires that the second stabilizing amphiphilic agent comprises a more polar region and less polar region. This is taught by Markwalter because PEG is the more polar region and PLA is the less polar region.
As to claim 2, the claim requires that the more polar region of the second stabilizing amphiphilic agent is at the exterior surface of the shell. This is taught by Markwalter in the figure on page 3. This figure shows a PEG corona at the exterior of the shell, which is shown in a light purple color in the original figure. PEG in the PLA-PEG block copolymer is the more polar region.
As to claim 3, the figure on page 3 of Markwalter shows the water-soluble biologic agent in the core and not being in contact with the PEG which is the more polar region of the second stabilizing amphiphilic agent. Markwalter also teaches a PEG corona.
As to claim 7, Markwalter teaches RNA on page 6, left column. This reads on the required nucleic acid.
As to claim 11, Markwalter teaches PLA-PAsp, which is a block copolymer of polylactic acid and polyaspartic acid. In this case, polyaspartic acid is the hydrophilic region and polylactic acid is the hydrophobic region.
As to claim 12, Markwalter teaches a 5000 Dalton block for the polyaspartic acid and a 40,000 Dalton block for the polylactic acid, as of Markwalter, page 6, left column, paragraph entitled “Process One.” Markwalter also teaches both di-block and triblock copolymers in the above-reproduced figure from page 3 of Markwalter.
As to claim 15, Markwalter teaches lecithin, which is a phospholipid, as of figure S1 on page S-2. Prud’homme and Gindy teach cationic and/or ionizable cationic lipids.
As to claim 17, the lecithin of Markwalter is understood to read on the claim requirement of a pH sensitive lipid. This is because lecithin is phosphatidylcholine. Phosphatidylcholine has a phosphate group which becomes deprotonated at high pH and protonated at low pH, and is therefore pH sensitive.
As to claim 20, Markwalter teaches PLA-PEG, as of the figure on page 3 of Markwalter; this reads on the requirement of PEG-b-PLA.
As to claim 21, Markwalter teaches a 40,000 Dalton block for the polylactic acid, as of Markwalter, page 6, left column, paragraph entitled “Process One.” This is within the claimed range.
As to claim 25, Markwalter teaches RNA, as of page 6, left column, which reads on the requirement of part (a) of the claim.
As to claim 27, the composition of Markwalter is in an aqueous solution and is used for intracellular drug delivery, as of Markwalter, page 1, right column. This would appear to indicate that the composition of Markwalter, whether by itself or as modified by Prud’homme and Gindy, is a pharmaceutical composition.
Note Regarding Reference Date: The instant application appears to have an earliest effective filing date of 23 December 2021 in view of claiming benefit to a provisional application. Markwalter was published on 2 January 2020. As such, Markwalter was published earlier than the effective filing date of the instant application and is prior art under AIA 35 U.S.C. 102(a)(1). Because Markwalter was published over a year earlier than the earliest effective filing date of the instant application, the AIA exceptions would not appear to be applicable here.
Claim(s) 1-3, 7, 11-12, 15, 17, 20-21, 25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markwalter et al. (The AAPS Journal, Vol. 22:18, 2020, pages 1-16 and S-1 through S-27, published 2 January 2020).
As an initial matter, this rejection has been presented without regarding to applicant’s species election (which has been withdrawn by the examiner above) of a combination of lipids that includes a cationic lipid.
Markwalter et al. (hereafter referred to as Markwalter) is drawn to a polymer nanocarrier prepared using inverse flash nanoprecipitation, as of Markwalter, page 1, title and abstract. Also see Markwalter, page 3, relevant figure reproduced below.
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Markwalter teaches polylactide-block-poly(aspartic acid) and polylactide-block-polyethylene glycol in the figure reproduced above, which are the first and second amphiphilic copolymers in the above-reproduced diagram. The examiner notes that polylactide-block-poly(aspartic acid) has an anionic polyaspartic acid polar region, thereby reading on the elected specie. Markwalter teaches a water-soluble drug in the above-reproduced diagram. Elsewhere in the reference, Markwalter teaches a lipid, as of Markwalter, figure S1 on page S-2, reproduced below.
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The examiner notes that lecithin is an alternate name for phosphatidylcholine, which is a zwitterionic phospholipid.
For the purposes of this rejection, the examiner understands Markwalter to be non-anticipatory because the embodiment in which Markwalter teaches the lipid lecithin comprises PAsp-PLA-PEG; this is only a single amphiphilic copolymer rather than two separate amphiphilic copolymers, as required by the instant claims. Nevertheless, while the prior art teaches all of the claimed components (e.g. both the lipid lecithin and a combination comprising PAsp-PLA and PLA-PEG as separate polymers), the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 1, the claim requires a water-soluble agent. Markwalter teaches a biologic in figure 3 (which is shown in green in the original figure), and this is understood to read on the requirement of a water-soluble agent.
As to claim 1, the claim requires a core containing a more polar region of a first stabilizing amphiphilic copolymer. The PAsp (polyaspartic acid or polyaspartate) in Markwalter, figure 3, is understood to read on this requirement; this is shown in light blue in the original figure.
As to claim 1, the claim requires a shell containing a less polar region of a firsts stabilizing amphiphilic copolymer. The PLA block of the PLA-PAsp polymer, which is shown in figure 3 of Markwalter, is understood to read on this claimed requirement.
As to claim 1, the claim requires at least one lipid in the shell. Markwalter teaches lecithin, which is phosphatidylcholine and is a phospholipid, as of figure S1 on page S-2 of Markwalter, which is reproduced above.
As to claim 1, the claim requires a second stabilizing amphiphilic agent in the shell. The PLA-PEG of the figure on page 3 of Markwalter is amphiphilic. This is because the PLA is the hydrophobic block and the PEG is the hydrophilic block of the polymer.
As to claim 1, the claim requires that the shell surrounds the core. This appears to be taught as of the figure on page 3 of Markwalter.
As to claim 2, the claim requires that the shell has an interior surface and exterior surface. This appears to be taught in view of the above-reproduced figure from Markwalter.
As to claim 2, the claim requires that the interior surface of the shell is in contact with the core. This appears to be taught in view of the above-reproduced figure from Markwalter.
As to claim 2, the claim requires that the second stabilizing amphiphilic agent comprises a more polar region and less polar region. This is taught by Markwalter because PEG is the more polar region and PLA is the less polar region.
As to claim 2, the claim requires that the more polar region of the second stabilizing amphiphilic agent is at the exterior surface of the shell. This is taught by Markwalter in the figure on page 3. This figure shows a PEG corona at the exterior of the shell, which is shown in a light purple color in the original figure. PEG in the PLA-PEG block copolymer is the more polar region.
As to claim 3, the figure on page 3 of Markwalter shows the water-soluble biologic agent in the core and not being in contact with the PEG which is the more polar region of the second stabilizing amphiphilic agent. Markwalter also teaches a PEG corona.
As to claim 7, Markwalter teaches RNA on page 6, left column. This reads on the required nucleic acid.
As to claim 11, Markwalter teaches PLA-PAsp, which is a block copolymer of polylactic acid and polyaspartic acid. In this case, polyaspartic acid is the hydrophilic region and polylactic acid is the hydrophobic region.
As to claim 12, Markwalter teaches a 5000 Dalton block for the polyaspartic acid and a 40,000 Dalton block for the polylactic acid, as of Markwalter, page 6, left column, paragraph entitled “Process One.” Markwalter also teaches both di-block and triblock copolymers in the above-reproduced figure from page 3 of Markwalter.
As to claim 15, Markwalter teaches lecithin, which is a phospholipid, as of figure S1 on page S-2.
As to claim 17, the lecithin of Markwalter is understood to read on the claim requirement of a pH sensitive lipid. This is because lecithin is phosphatidylcholine. Phosphatidylcholine has a phosphate group which becomes deprotonated at high pH and protonated at low pH, and is therefore pH sensitive.
As to claim 20, Markwalter teaches PLA-PEG, as of the figure on page 3 of Markwalter; this reads on the requirement of PEG-b-PLA.
As to claim 21, Markwalter teaches a 40,000 Dalton block for the polylactic acid, as of Markwalter, page 6, left column, paragraph entitled “Process One.” This is within the claimed range.
As to claim 25, Markwalter teaches RNA, as of page 6, left column, which reads on the requirement of part (a) of the claim.
As to claim 27, the composition of Markwalter is in an aqueous solution and is used for intracellular drug delivery, as of Markwalter, page 1, right column. This would appear to indicate that the composition of Markwalter is a pharmaceutical composition.
Claim(s) 16-19, 22-23, 25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markwalter et al. (The AAPS Journal, Vol. 22:18, 2020, pages 1-16 and S-1 through S-27, published 2 January 2020) in view of Prud’homme et al. (WO 2019/090030 A1) and Gindy et al. (Langmuir, Vol. 30, 2014, pages 4613-4622 and 4 pages of supporting information), the combination further in view of Benenato et al. (US 2019/0016669 A1).
Markwalter is drawn to a particle for encapsulating a biologic agent, which may be RNA. Prud’homme and Gindy teach the use of cationic lipids. See the rejection above over the combination of Markwalter in view of Prud’homme and Gindy.
None of the above references teach SM-102.
Benenato et al. (hereafter referred to as Benenato) is drawn to lipid compositions for the delivery of a nucleic acid, as of Benenato, title and abstract. Benenato teaches the following lipid, as of page 17, figure reproduced below.
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Benenato does not teach the required core and shell.
It would have been prima facie obvious for one of ordinary skill in the art to have used the lipid of Benenato as the cationic lipid in the composition of Markwalter in view of Prud’homme and Gindy. The combination of Markwalter in view of Prud’homme and Gindy is useful for delivery of a nucleic acid, and Prud’homme and Gindy teach the use of a cationic lipid to achieve this. The compound of Benenato is a cationic lipid usable for the delivery of a nucleic acid. As such, the skilled artisan would have been motivated to have used the cationic lipid of Benenato for predictable delivery of the nucleic acid of Markwalter in view of Prud’homme and Gindy with a reasonable expectation of success. Generally, it is prima facie obvious to select a known material (the ionizable cationic lipid of Benenato) for incorporation into a composition (that of Markwalter in view of Prud’homme and Gindy), based on its recognized suitability for its intended use (delivery of a nucleic acid, such as the RNA in Markwalter). See MPEP 2144.07.
In the alternative, the skilled artisan would have been motivated to have substituted the cationic lipid of Benenato in place of that of Prud’homme and Gindy for predictable delivery of a nucleic acid such as that of Markwalter with a reasonable expectation of success. The simple substitution of one known element (e.g. the cationic lipid of Benenato) in place of another (the cationic lipids of Prud’homme and Gindy) in order to achieve predictable results (delivery of a nucleic acid) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
As to claim 16, the lipid of Benenato, page 17, compound 25, reads on the required SM-102.
As to claim 17, Benenato teaches DLin-KC2-DMA in paragraph 0305.
As to claim 18, Benenato teaches ionizable cationic lipid, as explained above, POPC in paragraph 0309, and cholesterol in at least paragraph 0307.
As to claim 19, Benenato teaches the following, as of paragraph 1007, reproduced below.
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The lipid according to the various formulas is a cationic or ionizable cationic lipid, DSPC and DOPE are phospholipids, and cholesterol is taught above. This is sufficient to meet the requirements of claim 19.
As to claim 20, Benenato teaches PEG-DMG in the above-reproduced paragraph. Markwalter also teaches PEG-PLA, as of page 3, figure reproduced above.
As to claim 22, Benenato teaches that alkyl/alkenyl groups may have three double bonds, as of Benenato, paragraph 0254. Said alkenyl groups may be part of the ionizable cationic lipid, as of Benenato, paragraphs 0006-0009.
As to claim 23, the compound reproduced above from Benenato is understood to read on the claimed requirements.
As to claim 25, Benenato teaches the use of pseudouridines in the nucleic acid as of at least paragraph 0319; this reads on part (b) of claim 25.
As to claim 27, Benanto teaches a pharmaceutical composition along with a carrier in paragraph 0116.
Relevant Prior Art – No Rejection
As relevant prior art, the examiner cites Shi et al. (US Patent 9,549,901). Shi et al. (hereafter referred to as Shi) is drawn to a particle with an aqueous core surrounded by a polymer, as of Shi, title and abstract. Shi teaches the following, as of figure 1, reproduced below with annotation by the examiner.
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The above-reproduced particle differs from the claimed particle because the above-reproduced particle comprises a shell made from PLGA. PLGA refers to poly(lactide-co-glycolide) or poly(lactic-co-glycolic) acid, and is hydrophobic rather than amphiphilic. This is because an amphiphilic compound or polymer comprises both a hydrophobic and a hydrophilic segment; however, the PLGA of Shi lacks a hydrophilic segment and is therefore not amphiphilic. As such, the above-reproduced figure fails to teach a single amphiphilic copolymer, let alone a second amphiphilic agent.
Also as relevant prior art, the examiner cites Nam et al. (US 2018/0250409 A1). Nam et al. (hereafter referred to as Nam) is drawn to a pharmaceutical composition for delivery of an anionic drug, as of Nam, title and abstract. Nam teaches the following embodiment, as of figure 1, reproduced below.
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The above-reproduced composition, as per instant figure 1, appears to comprise an amphiphilic block copolymer and a cationic lipid, but does not appear to comprise a second stabilizing amphiphilic agent separate from the amphiphilic block copolymer and the cationic lipid. As such, Nam is not anticipatory.
In selecting the references to be used in rejecting the claims, the examiner should carefully compare the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03. As best understood by the examiner, at best, Nam would appear to be just as good as but no better than Markwalter. As such, no additional rejection over Nam has been written by the examiner.
Relevant Patent References – No Double Patenting
US Patent 11,103,461: As a relevant reference, the examiner cites US Patent 11,103,461. This patent appears to have overlapping inventors with the instant application, and appears to be drawn to similar subject matter to that of the instant application, as the claims of the ‘461 patent are drawn to a process of making a particle. The examiner reviewed the claims of the ‘461 patent but decided not to reject the instant claims on the grounds of non-statutory double patenting over the claims of the ‘461 patent.
This is at least because the instantly claimed invention requires two separate amphiphilic copolymers which are in two separate parts of the particle. The claims of the ‘461 patent do not appear to recite this; while claims 1 and 3 of the ‘461 patent recite a single amphiphilic copolymer. Claim 4 of the ‘461 patent recites an additional lipid. Nevertheless, the claims of the ‘461 patent do not appear to recite a second stabilizing amphiphilic agent separate from the amphiphilic copolymer and the lipid.
Additionally, the instant claims require that the first stabilizing amphiphilic copolymer is in the core and the second stabilizing amphiphilic agent is in the shell. Even if, purely en arguendo, the skilled artisan would have been motivated to have modified the composition made by the method of the ‘461 patent to have included two separate amphiphilic copolymers instead of a single amphiphilic copolymer, there would have been no reasonable expectation that this would have successfully resulted in the first amphiphilic copolymer being in the core and the second amphiphilic copolymer being in the shell.
As such, for at least these reasons, the instant claims are not anticipated by the claims of the ‘461 patent nor are the instant claims obvious over the claims of the ‘461 patent.
US Patent 12,605,344: As an additional relevant reference, the examiner cites US Patent 12,605,344. The ‘344 patent has common inventors with the instant application. The examiner reviewed the claims of the ‘344 patent but decided not to reject the instant claims on the grounds of non-statutory double patenting over the claims of the ‘344 patent, and presents the following rationale in support of this decision.
The claims of the ‘344 patent are drawn to a particle comprising a core, a shell, and a coating with an inner layer and an outer layer. The core and shell of the ‘344 patent appear to be made from one amphiphilic copolymer, and the inner coating and outer coating appear to be made from a different amphiphilic copolymer.
The particle recited by the claims of the ‘344 patent appears to differ from the claimed particle because the particle recited by the claims of the ‘344 patent appears to have four layers (a core, a shell, an inner layer of the coating, and an outer layer of the coating) whereas the instantly claimed particle appears to only have two layers; namely, the core and coating.
Additionally, the instant claims require a first stabilizing amphiphilic copolymer, a second stabilizing amphiphilic agent, and a lipid which appears to be a separate ingredient from the first and second amphiphilic materials. The claims of the ‘344 patent appear to recite two amphiphilic copolymers, but do not appear to recite a lipid in addition to these two amphiphilic copolymers. In contrast, the instant claims require a first amphiphilic copolymer, at least one lipid, and a second stabilizing amphiphilic agent, wherein the examiner understands all of these to be separate elements.
The examiner notes that claim 18 of the ‘344 patent recites that the amphiphilic material of the coating polymer of the ‘344 patent is a PEG-lipid. However, that would have in the presence of an amphiphilic copolymer that forms the core and shell and a PEG-lipid that forms the coating. It would not have resulted in an amphiphilic copolymer forming the core and shell, a second amphiphilic material, and a lipid separate from the second amphiphilic material, which is what is required by the instant claims.
As such, for at least these reasons, the instant claims are not anticipated by the claims of the ‘344 patent nor are the instant claims obvious over the claims of the ‘344 patent.
US Patent 11,554,101: As an additional relevant reference, the examiner cites US Patent 11,554,101. The ‘101 patent has common inventors with the instant application. The examiner reviewed the claims of the ‘101 patent but decided not to reject the instant claims on the grounds of non-statutory double patenting over the claims of the ‘101 patent, and presents the following rationale in support of this decision.
Claim 1 of the ‘101 patent is drawn to a particle comprising a core, a shell, and a coating. As such, claim 1 of the ‘101 patent differs from the instant claims because claim 1 of the ‘101 patent appears to require three layers (i.e. the core, shell, and coating) whereas the instant claims require only two layers (i.e. the core and shell). Additionally, the claims of the ‘101 patent do not recite a lipid. As such, the claims of the ‘101 patent are insufficient to render the instantly claimed invention to be anticipated or obvious.
Conclusion
No claim is allowed.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
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