Notice of Pre-AIA or AIA Status
DETAILED ACTION
Status of the Claims
Claims 1-12 are pending and under examination.
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 .
Priority
This application is a national stage entry of PCT/EP2022/081525 filed on 11/10/2022, which claims priority from European application EP21306582.4 filed on 11/15/2021.
Information Disclosure Statement
The information disclosure statement filed on 05/13/2024 has been considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to products of nature. The lipid compounds are natural as provided on page 3 of applicant’s specification (natural TA lipids) and by Rowland US 20100297217 which teaches they are naturally occurring in crude oil and “A particularly preferred method for the isolation of compounds of the present invention from crude oil is disclosed by Lutnaes, B. F., et al., ‘Archael C80 isoprenoid tetraacids responsible for naphthenate deposition in crude oil processing’” (Rowland paragraphs 40-41). Example 1 of Rowland provides for methylated tetraacids isolated from samples of crude oil (paragraph 66). Also, see Lutnaes et al (J Org Biomol Chem 2006, volume 4, pages 616-620), which provides for such tetraacids that are responsible for naphthenate deposition in crude oil (abstract and figure 2 structures) As the compounds are lipids, their molecules will naturally form liposomes when in contact with water as this is the nature of lipids. To this point, it is noted that tetra-acidosomes are found to be liposomes of these lipid compounds (page 8). In regards to encapsulating a molecule of interest, this could include water molecules, other lipids or other natural compounds of natural crude oil. Claims 9 and 10 are Use claims (MPEP 2173.05(q)) and will be read as to compositions, and thus, remain natural products that can have such uses. This is similar for claim 11, although not a use claim, it is toward an intended use. Claims 6 and 7 are toward the liposome size and polydispersity properties. As such lipid compounds occur naturally, they are naturally capable of these sizes and polydispersity values when placed in water/aqueous environment. Additionally, note that to the vague nature of probes and targeting agents, natural derivatives of such lipids with natural modifications at these ends could constitute such groups. Although these compounds are isolated from natural crude oil, they still are naturally occurring compounds with natural structure themselves.
Claims 9 and 10 are “Use” Claims and are rejected under USC 101 for walking the line between being a product and method of use. A claim needs to be toward one category of invention (in this case, composition or method of use). See MPEP 2173.05(q) – Use claims.
Claim Rejections - 35 USC § 112(a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1, 2, 4 and 5 provide for targeting agent and probe, which are compounds defined by function and not their structure. The specification on page 6 provides that targeting agent could be, for example, peptide, antibody, or vitamin, but does not provide for other types of targeting agents outside of these or various sequences/structures of the peptides or antibodies that could be utilized. The specification on page 6 provides that probe can be a fluorescent probe with examples of Nile Red and fluorescein as such probes. However, these targeting agents and probes are only a possible subset of compounds that could be used for targeting or probing and are not defined by a particular structure in the claims or in the specification. Thus, the applicant has description for more particular subgenre or species that are mentioned in the specification where structure would be envisioned for some of the functional compounds under these genre, but does not have written description for the entire genre of targeting agents or probes based on functions with no definitive structure that would encompass all types of probing or targeting of numerous and varying molecules that exist.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claims 1 and 4 recite the broad recitation “RA, RB, RC, and RD independently represent a linear or branched, aliphatic or alicyclic, saturated, hydrocarbon group comprising 2 to 8 carbon atoms”, and the claim also recites “preferably RA, RB, RC and RD independently represent
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”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the present instance, claims 1 and 4 recite the broad recitation “COOR¹, with R¹ which represents an aliphatic linear or branched, saturated or - unsaturated alkyl chain with a number of carbon atoms between 1 to 22”, and the claim also recites “especially 4 carbon atoms”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-3 and 5-12 are rejected as being dependent on an indefinite claim.
Claims 1, 2, 4 and 5 are indefinite for the recitation of “A2 or A3 possibly being identical or different…” as it is unclear if what follows “possibly” must be part of the claimed invention or just a limitation that is a possibility among others.
Claims 3 and 6-12 are rejected as being dependent on an indefinite claim.
Claims 1, 2, 4 and 5 are indefinite for recitations of “probe” and “targeting agent” that are allowed as groups for the compound. As these do not provide a structural component to the compound or a particular chemical structure, it is unclear what is allowed to be a group or what is excluded as a group based on these limitations. Thus, the metes and bounds cannot be properly determined. For the purpose of compact prosecution, if a group is present at such positions, it will read on the claim. Applicant does provide for subgenre groups of compounds or compounds that could be imported into these claims that would provide enough structure when limited to such.
Claims 3 and 6-12 are rejected for being dependent on an indefinite claim.
Claims 9-10 are indefinite for being “use” claims where no method step is recited making it unclear if these are to a method of use or to a composition with an intended use limitation. See MPEP 2173.05(q) – Use claims.
Claim 10 recites the limitation "the gastrointestinal environment" in the claim without a previous recitation of “gastrointestinal environment” or a subject that may have a gastrointestinal environment. There is insufficient antecedent basis for this limitation in the claim.
Claims 12 is indefinite as the claim provides for potentially a large number of tetrameric acid lipids to react with broad genre of reducing agent, an alcohol, an amine or an ester that would potentially cover numerous, different types of reactions with varying reactant compounds of those genre that could make the lipid compounds as in claim 1. Applicant only shows in the examples of the specification taking particular lipid compounds (having the core as the compound in claim 1) and then functionalizing them with compounds that would provide groups as recited for P1, P2, P3 and P4 in claim 1. By the applicant’s examples, it appears there would be certain tetrameric acid lipids reacting with certain reducing agents, alcohols, amines or esters that could be used to manufacture the compounds as in claim 1. Thus, it is unclear what the metes and bounds of the number and types of reactions that would be covered by the claim in order to formulation compounds as in claim 1. If the prior art teaches reactant compounds that can be construed as such tetrameric acid lipid with reducing agent, alcohol, amine or ester in a reaction to make a compound encompassed by claim 1, then it will read on the claim regardless the type of reaction used. Applicant may provide for structures or more particular compounds that would be to the intended reactants for reactions of applicant.
Claim Rejections – 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rowland US 20100297217.
Rowland teaches isoprenoids for the preparation of liposomes that can be used for delivery of pharmaceutically active compounds to a subject (abstract). Rowland teaches
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(abstract, also note compounds in paragraphs 28, 80 and 83 that have methoxy groups in the P positions).
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Example 1 of Rowland provides for methylated tetraacids isolated from samples of crude oil (paragraph 66). Rowland teaches “An isoprenoid according to claim 16, wherein both R7 present in the groups of general formula (II) are groups of the general formula CO—R9 in which R9 is H, OH, methyl or methoxy” (claim 17 of Rowland). Example 3 of Rowland provides for adding the compound to water and that active ingredient can be in the finished liposome (paragraphs 90-91). Rowland provides typical vesicles of 50 to 100 nm (paragraph 91). Rowland provides for using isoprenoid tetracids for liposomes for enhanced delivery of pharmaceuticals (paragraph 44). In regards to claim 12, Rowland provides that “The compounds of the present invention are extracted from the aforementioned crude oils in the form of acids and/or esters, typically tetraacids and tetra-esters. Compounds of the present invention in which one or more of R7 and R8 are hydrogen may be prepared from the corresponding acid or ester by methods well known in the art. One suitable method is to react the acid or ester with a suitable reducing agent. Reducing agents active in such reactions are well known in the art and include lithium aluminum hydride (LiAlH4) and sodium borohydride (NaBH4).” (paragraph 43). Rowland teaches “in particular in the enhanced delivery of such agents to target cells within the human or animal body” (paragraph 44). In regards to the polydispersity index of less than 0.3 in claim 7, since Rowland provides for a liposome in example 3 made of tetraacids of the applicant’s claims, it will have such a polydispersity index of the claims (see MPEP 2112).
Claim Rejections - 35 USC § 103
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 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.
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.
Claim 7 in addition to 1-6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Rowland US 20100297217 in view of Danaei et al (Pharmaceutics, 2018, volume 10, pages 1-17).
In regards to claim 7, if applicant can show that the polydispersity index of Rowland is not less than 0.3, then this rejection also applies to the adjustment of polydispersity of a liposome.
Rowland teaches the claims as discussed above.
Rowland is silent to the polydispersity index of its liposomal formulations.
Danaei provides that “The suitability of nanocarrier formulations for a particular route of drug administration depends on their average diameter, PDI and size stability, among other parameters. Controlling and validating these parameters are of key importance for the effective clinical applications of nanocarrier formulations.” (abstract). Danaei also provides that suitable liposomes for carrying drugs have PDI of 0.3 or less (last paragraph on page 8), which are considered acceptable. Danaei also provides different size particle size ranges such as 10-50nm and 50-200 nm depending on the route of administration (table 1).
Thus, one of ordinary skill in the prior art would be motivated to formulate the liposomes of Rowland with polydispersity index of 0.3 or less by the teachings of Danaei, which provides that this is most acceptable for drug carrying liposomes. There would be a reasonable expectation of combining the teachings of the prior art to provide such liposomes of Rowland with PDI of less than 0.3 for best performance as a drug delivery system.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613