DETAILED ACTION
Formal Matters
Claims 16-22 are cancelled. Claims 1-15 and 23-26 are pending and under examination.
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/US2023/067206 filed on 5/19/2023, which claims priority to US provisional applications 63/380,214 filed on 10/19/2022 and 63/344,162 filed on 5/20/2022.
Information Disclosure Statements
The information disclosure statements (IDS) filed on 11/19/2024 and 3/4/2025 have been considered by the examiner.
Claim Objections
Claim 15 is objected to for using capitalized “A” rather than “a” within the body of the claim to start the different options of items within the body of the claim. The first “A” at the start of the claim is the one that is acceptable. Appropriate correction is required.
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 1-15 and 23-26 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.
Claims 1, 3, 5, 7, 9, and 10 are indefinite for the phrase “R3 is optionally substituted C3-C22 alkyl…” as it is unclear if applicant means that R3 is “an optionally substituted C3-C22 alkyl” or if the proposed definition of R3 “is optional”. Thus, in one reading R3 is allowed not to have a definition in one option due to “is optionally”. If applicant only means to refer to it as being “an optionally substituted…” group, then applicant may amend the claim to “R3 is an optionally substituted C3-C22 alkyl….” for claim 1 or as according to the claim in question. For the purpose of compact prosecution, the examiner will consider the group as being optional but will additionally search the groups as if they were necessary since the species of compounds provided in the disclosure have such groups at R3.
Claims 2, 4, 6, 8, 12 and 13 are rejected as being dependent on indefinite claims without repairing the issue of indefiniteness.
Claims 2-13 are indefinite for the recitation of “pharmaceutical composition of claim “#”, or salt or isomer thereof” as it is unclear how the composition would have a salt or isomer thereof. In claim 1, it appears the “or salt or isomer thereof” is supposed to refer to the lipid of formula I rather than the “composition comprising” it. It is suggested that applicant delete this recitation of “or salt or isomer thereof” in the preambles of claim 2-13.
Claim 12 is indefinite for the addition of “an alkenyl group comprising two or more double bonds for two reasons. One is the use of “comprising” within the closed Markush group “selected from the group consisting of” and the other is it is unclear if these alkenyl groups are limited by the same carbon chain limitation found in claim 1 or if it now opens the claim to other alkenyl groups. It is suggested that applicant amend the limitation to “a C7-C22 alkenyl group with two or more double bonds.”
Claim 13 is indefinite for the addition of “an alkynyl group comprising two or more double bonds for two reasons. One is the use of “comprising” within the closed Markush group “selected from the group consisting of” and the other is it is unclear if these alkynyl groups are limited by the same carbon chain limitation found in claim 1 or if it now opens the claim to other alkynyl groups. It is suggested that applicant amend the limitation to “a C7-C22 alkynyl group with two or more double bonds.”
Claims 14 and 15 are indefinite for use of “and salts and isomers thereof” (multiple recitations of it in claim 15) as in this composition claim it is unclear if applicant means these to optional salts or isomers or if the composition should also contain both some salts and isomers of the lipids in addition to the lipids. It is suggested applicant use “or salts or isomers thereof” if the intention is optional. For the purpose of compact prosecution, the examiner will consider these as options.
Claims 23-26 are rejected as being dependent on an indefinite claim.
Claim 15 is indefinite for the recitation of “A reversible zwitterionic lipid selected from among:” as one of the options as claim 15 is supposed to be toward a group of compositions (A composition selected from among the following). It is unclear if applicant is allowing the group to now contain lipid/compounds without being compositions or if it should still just be toward options of compositions as introduced. It is suggested that applicant remain consistent with “composition comprising a reversible zwitterionic lipid…” unless they want to convert the claim toward being options of the lipid compound.
Claims 23-26 are rejected as being dependent on an indefinite claim.
Claim 23 is indefinite for referring to “a reversible zwitterionic lipid of claim 15” because although there are such compounds within claim 15 for its compositions, claim 15 is toward “A composition”. Thus, it is unclear if applicant intends the lipid particle to just include the lipid or the composition with the lipid. Applicant may say “comprising the composition of claim 15”
Claims 24-26 are rejected as being dependent on an indefinite claim.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-2 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Perrissoud US 20070167408.
Perrissoud teaches “novel alkyl phospholipid derivatives with reduced cytotoxicity that are useful for treating various diseases and/or pathophysiological conditions in mammals, preferably humans, that are caused by microorganisms, in particular bacteria, fungi, protozoa and/or viruses. Such alkyl phospholipids can be employed as single drugs or in the course of combination therapies and can also be used for the treatment of tumors.” (abstract). Perrissoud teaches compounds such as
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189
634
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(found in claim 7 of Perrissoud).
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123
600
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Greyscale
is another compound taught in Perrissoud. As applicant’s claim 1 allows for R1 and R2 to be joined to form an optionally substituted heterocycle. Compound 2 and Compound 69 in Perrissoud (shown above) allow for a form that meets that limitations for R1 and R2. The R3 in compound 69 is C18. Since R1 and R2 are fused to the same group, they are the same.
A difference between such compounds and claim 1 is that n is 2 in this compound, however, Perrissoud does disclose compounds that have a group with n of 3 at the position between the oxygen off the phosphorous and a nitrogen atom with 3 alkyl groups (e.g. compound of formula 281 in the claims of Perrissoud), and thus, having these extensions in that carbon chain is possible in teachings of Perrissoud. Note that Perrissoud also provides for a broader formula in its claim 1 where applicant can utilize different size groups. Perrissoud also allows for tertiary amine groups that are sufficiently basic (paragraph 138) that they can help the compound be converted with organic or inorganic acids into salts.
One of ordinary skill in the art before the time of filing would have been able to work within the teachings of the prior art to provide a compound where the group between the P-O and the N in the compound was more than 2 (e.g. 3) and to provide the N as a tertiary amine rather than having to be quaternary. Thus, the teachings of Perrissoud allow such modifications to its compounds. Disclosed compounds of Perrissoud are considered sufficiently similar with compounds of applicant’s claims while also being safe for pharmaceutical use that Perrissoud’s teachings obviate a portion of applicant’s compounds in claims 1 and 2 (see MPEP 2144.09).
Advisory Notice of Possible Allowable Subject Matter
Claims 3-15 and 23-26 are not rejected over prior art as there was no prior art found to teach or obviate the lipid compounds in these claims. However, the claims are rejected under USC 112(b). If applicant amends independent claim 1 to overcome the prior art via a limitation to further differentiate the lipid from the prior art, then applicant can overcome the prior art of record. There may be multiple options for applicant to consider. Applicant would also have to correct for issues under USC 112(b) and objections noted above. It is noted that in context of claims 14 and 15, these are in independent form, but would need issues corrected under 112b and/or objection.
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 on M-F 9:00 am to 6:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached on (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/
Examiner, Art Unit 1613
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