*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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 27, 2026 has been entered.
Priority
This application is a 371 of PCT/KR2022/00894 l filed on 06/23/2022, and claims
foreign priority in Republic of Korea application KRl0-2021-0082361 filed on 06/24/2021 and
KRl0-2022-0076212 filed on 06/22/2022.
Claim Status
Claims 1 and 4-36 are pending and examined. Previously withdrawn claims 4, 6, 7, 8, and 18-36 are rejoined. Claims 2 and 3 were canceled. Claim 1 was amended.
Withdrawn Claim Rejections - 35 USC § 112
Rejections of claims 1, 5, and 9-17 are withdrawn because amendment of claim 1 obviated the rejection.
Withdrawn Claim Rejections - 35 USC § 103
Rejections of claims 1 and 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Rajeev (US 9,999,673 B2 Date of Patent June 19, 2018 – of record in IDS dated 12/17/2023) and Viger Gravel (The Journal of Physical Chemistry B, 2018, 122, 2073-2081, Supporting Information appended thereto) are withdrawn because claim 1 was amended to exclude the compounds that are obvious over Rajeev.
Election/Restriction
Claims 1, 5, and 9-17 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 18-36, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on October 28, 2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. 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.
Claims 1, 5, and 9-17 are allowable. Claims 4 and 6-8, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among inventions of species of lipid nanoparticles, as set forth in the Office action mailed on October 28, 2025, is hereby withdrawn and claims 4 and 4-8 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. 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.
Claim Objections
Claim 18 is objected to because “a lipid formulations” is not grammatical and should be amended to “a lipid formulation” singular.
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 4, 6-8, 18, 19-36 are rejected under 35 U.S.C. 1 12(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 4 is indefinite because it depends from a canceled claim 3. For the purpose of searching, the claim is interpreted as a dependent of claim 1. This is the broadest reasonable interpretation of the claim in view of the specification.
Claim 4 is further indefinite because it recites an improper Markush group and the alternatives from which the variables are selected are not clear. Ground of rejection may be obviated by replacing “fragments or antibody” in line 5 with “fragments, antibody”; and by adding a comma before “and aptamers”.
Claims 6 and 24 are indefinite because the chemical structure of Formula 4 is not clear. It is recommended to replace the structure with a structure having clear solid lines, where every element and symbol is clear. Currently, the resolution is poor to the extent that lines are broken and letters are not clear.
Claim 7 is indefinite because it depends from a canceled claim 2. For the purpose of searching, the claim is interpreted as a dependent of claim 1. This is the broadest reasonable interpretation of the claim in view of the specification.
Claim 8 is indefinite because it depends from an indefinite base claim.
Claim 18 is indefinite because end of step (a) recites “and adjusting pH” without stating the pH of what is being adjusted. Step (a) requires mixing an organic solution with a buffer solution without stating what is produced by the mixing. According to Example 2 in the specification, a resultant solution that is produced by mixing an organic lipid solution with a buffer solution, was further mixed with a buffer to adjust the pH of the resultant solution.
Grounds of rejection may be obviated by amending step (a) to state what is formed by the mixing of the organic solution and the buffer solution and by adding a step that accounts for adjusting the pH of the solution that is formed in the mixing step. For example, replace “thereof and adjusting pH” with “thereof, to form a first buffered organic solution, and adding a buffer to the first buffered organic solution to adjust the pH of the first buffered organic solution and form a second buffered organic solution”.
Claim 18 is indefinite because step (b) recites removing a solvent from the solution without indicating from which solution the solvent is being removed. If applicant accepts the suggestion above, ground of rejection may be obviated by replacing step (b) with “removing a solvent from the second buffered organic solution”.
Claims 19-21 and 23 are indefinite because the claims depend from an indefinite base claim.
Claim 22 is indefinite because it recites an improper Markush group and the alternatives from which the variables are selected are not clear. Ground of rejection may be obviated by replacing “fragments or antibody” in line 5 with “fragments, antibody”; and by adding a comma before “and aptamers”. It is further recommended to amend the claim dependency from claim 21 to claim 18, in the event that applicant accepts the recommendation to cancel claim 21 made below.
Claims 25-29 are indefinite because the claims depend from an indefinite base claim. It is further recommended to amend claim 25 dependency from claim 20 to claim 18, in the event that applicant accepts the recommendation to cancel claim 20 made below.
Claim 30 is indefinite because it recites “further comprising sterol lipid and neutral lipid” without indicating what further comprises said components. According to Example 2 of the specification, a sterol lipid and a neutral lipid are a part of the organic solution. It is recommended to amend the claim to recite “wherein the organic solution further comprises a sterol lipid and a neutral lipid”.
Claims 31-33 and 36 are indefinite because the claims depend from an indefinite base claim.
Claim 34 recites "protein-nucleic acid structures". The phrase is indefinite because the specification does not define the phrase nor provide any examples said structures. The phrase was searched, and it appears in patent literature, however none of the recovered references explain its meaning. Ground of rejection may be obviated by deleting the phrase.
Claim 35 depends from claim 34 and further defines the nucleic acid. The claim is indefinite because it does not clarify the meaning of protein-nucleic acid structures. The claim is further indefinite because it is not clear if "the nucleic acid" is only intended to further limit "protein-nucleic acid structures" or other listed drugs. Claim 34 recites peptides, protein drugs, and anionic biopolymer-drug conjugates in the list of drugs. It is unclear which drugs are intended to be further defined by "the nucleic acid" in claim 35. Ground of rejection may be obviated by changing the dependency of claim 35 from claim 34 to claim 18.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 20 and 21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 20 and 21 recite the same limitations that are already recited in claim 1, therefore the claims do not further limit the method of claim 18 which refers to claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Reasons for Allowance
Claims 1, 5, and 9-17 are allowed. The closest prior art of record is Rajeev and Viger Gravel and their teachings are summarized in the previous office actions. The claimed invention is not obvious over the cited references because Rajeev does not teach a compound of Formula 1 as claimed and it would not have been obvious to the skilled artisan to modify Rajeev’s compound of Formula I as described in columns 24 and 25 by replacing L with a moiety that corresponds to the instantly claimed L6 variable.
Conclusion
Claims 1, 5, 9-17 are allowed. Claims 4, 6-8, 18, 19-36 are rejected.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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