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 with traverse of the following species
PNG
media_image1.png
412
653
media_image1.png
Greyscale
in the reply filed on 13 August 2026 is acknowledged. The traversal is on the ground(s) that applicant alleges that there would be no undue burden in searching all of the species together. This is not found persuasive because Ying et al. (WO 2022/002040 A1), while being drawn to cationic lipids wherein at least one of Q1 and Q3 is an oxygen or NH group, does not appear to be drawn to the case wherein Q1 and Q3 are both carbon atoms and wherein the central phosphorus atom is bound to three carbon atoms but only one oxygen atom. See page 25 of Ying, relevant text reproduced below.
PNG
media_image2.png
600
588
media_image2.png
Greyscale
Therefore, as the entirety of the compounds are not found together in the same reference, this would appear to result in an undue burden in searching all of the species together.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Regarding claim 8, the requirement that Q3 be oxygen or NH would appear to render the structure of claim 8 different from the elected species. Regarding claim 10, in the elected species, Z4 is not the same as Z2 and Z3; as such, the subject matter of claim 10, which requires Z4 to be the same as Z2 and Z3, differs from that of the elected species. Applicant timely traversed the restriction (election) requirement in the reply filed on 13 August 2026.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 1-7, 9, 11, and 13-18 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 the recited lipid compound or a derivative thereof. The term “derivative” does not appear to have been defined by the instant specification. Consequently, it is unclear regarding what extent a compound can differ from the recited structure and remain a derivative of the recited compound. For example, claim 1 recites that Z1 is oxygen or sulfur. For example, it is unclear if a compound wherein Z1 is a nitrogen containing functional group would be a derivative of the structure of claim 1 or whether this would be outside the scope of claim 1. As such, the claim is indefinite because it is unclear how the term “derivative” further modifies the claim scope.
This rejection does not apply to claim 12 because claim 12 appears to define how the term “derivative” further modifies the claimed compound.
Claim Rejections - 35 USC § 112(d) – Failure to Limit Parent Claim
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.
Claim 11 is 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. Claim 11 appears to recite the same subject matter of claim 1, except drawn into a picture of the chemical formula. 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.
Claim Rejections - 35 USC § 102 – Anticipation
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5-7, 9, 11-15 and 18 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ying (WO 2022/002040 A1).
Ying is drawn to lipid compounds and lipid compositions for the delivery of nucleic acids, as of Ying, title and abstract. Ying teaches a large number of phosphorus containing ionizable cationic lipids, as of Ying, pages 36-42, Table 1. The examiner has reproduced below a sample of the lipids taught by Ying from page 37.
PNG
media_image3.png
364
652
media_image3.png
Greyscale
Regarding compound 8 of Ying, this lipid appears to read on the claimed invention in the following manner, as of the table composed by the examiner on the next page.
Variable
Teaching in Prior Art (i.e. Compound 8 of Ying)
Z1
Oxygen atom
Z2 and Z3
9-carbon alkyl group bound to oxygen
Q1
Oxygen
A1
C1 alkylene group
Q2
Single bond
A2
Single bond
X1
8-carbon alkyl group
Z4
-NH-CH2CH2CH2N(CH3)2
Q3
-NH
A3
Single Bond or C3 alkylene group
Q4
Single bond
A4
Single bond (if A3 is a C3 alkylene group) or C3 alkylene group (if A3 is a Single bond)
X2
-N(R7R8) wherein R7 and R8 are both methyl
As such, the subject matter of Ying is understood to be within the claim scope. The examiner notes that, although Compound 8 of Ying was analyzed in detail, this should not be construed as an admission that only Compound 8 of Ying reads on the claimed invention; other compounds taught by Ying would also appear to anticipate the claimed invention.
As to claim 3, according to the table above, Q2 is a single bond and Q1 is an oxygen atom.
As to claim 5, according to the table above, Q4 is a single bond and Q3 is NH.
As to claim 6, the prior art would appear to read on this in the case wherein A3 is a single bond and A4 is a C3 alkylene group.
As to claim 7, the prior art would appear to read on this in the case wherein A3 is a C3 alkylene group and A4 is a single bond.
As to claim 9, in the structure of Ying, Z4 and Z2 are different.
As to claim 11, the structure of Ying would appear to read on the top structure of claim 11.
As to claim 12, Ying teaches a pharmaceutically acceptable salt, as of Ying, pages 1-2, paragraph 0005.
As to claim 13, Ying teaches a pharmaceutical composition on pages 85-86, paragraph 00299. Ying teaches the following elements in the nanoparticle, as of page 118, bottom paragraph, relevant text reproduced below.
PNG
media_image4.png
146
594
media_image4.png
Greyscale
As to claim 14, Ying teaches cholesterol in the abstract.
As to claim 15, Ying teaches DSPC along with other phospholipids, as of page 4, paragraph 0016.
As to claim 18, Ying teaches mRNA on page 118, bottom paragraph.
Note Regarding Reference Date: The instant application appears to have an earliest effective filing date of 14 November 2022. Ying was published on 6 January 2022, which is less than a year earlier than the effective filing date of the instant application. Ying was also effectively filed prior to the effective filing date of the instant application. As such, Ying is understood to be prior art under AIA 35 U.S.C. 102(a)(1) and 102(a)(2). As best understood by the examiner, there does not appear to be a common inventor or assignee between Ying and the instant application.
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) 1-7, 9, and 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ying (WO 2022/002040 A1).
Ying is drawn to lipid compounds and lipid compositions for the delivery of nucleic acids, as of Ying, title and abstract. Ying teaches a large number of phosphorus containing ionizable cationic lipids, as of Ying, pages 36-42, Table 1. The examiner has reproduced below a sample of the lipids taught by Ying from page 37.
PNG
media_image3.png
364
652
media_image3.png
Greyscale
Regarding compound 8 of Ying, this lipid appears to read on the claimed invention in the following manner, as of the table composed by the examiner below.
Variable
Teaching in Prior Art (i.e. Compound 8 of Ying)
Z1
Oxygen atom
Z2 and Z3
9-carbon alkyl group bound to oxygen
Q1
Oxygen
A1
C1 alkylene group
Q2
Single bond
A2
Single bond
X1
8-carbon alkyl group
Z4
-NH-CH2CH2CH2N(CH3)2
Q3
-NH
A3
Single Bond or C3 alkylene group
Q4
Single bond
A4
Single bond (if A3 is a C3 alkylene group) or C3 alkylene group (if A3 is a Single bond)
X2
-N(R7R8) wherein R7 and R8 are both methyl
As such, the subject matter of Ying is understood to be within the claim scope. The examiner notes that, although Compound 8 of Ying was analyzed in detail, this should not be construed as an admission that only Compound 8 of Ying reads on the claimed invention
As to claim 1, purely en arguendo and for the purposes of this ground of rejection only, the examiner understands Ying to teach all of the claimed requirements, but not in the same embodiment. As such, while the prior art teaches all of the claimed components, 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 2, this claim does not appear to be anticipated by the above-reproduced structure of Compound 8 of Ying. Nevertheless, Ying teaches the following on page 25, relevant text reproduced below.
PNG
media_image2.png
600
588
media_image2.png
Greyscale
A case wherein Y is -X-G3-NR4R5, wherein X is CR10R11, wherein G3 is an alkylene group would appear to read on the claimed requirements.
As to claim 3, according to the table above, Q2 is a single bond and Q1 is an oxygen atom.
As to claim 4, this claim is rejected for essentially the same reason that claim 2 is rejected.
As to claim 5, according to the table above, Q4 is a single bond and Q3 is NH.
As to claim 6, the prior art would appear to read on this in the case wherein A3 is a single bond and A4 is a C3 alkylene group.
As to claim 7, the prior art would appear to read on this in the case wherein A3 is a C3 alkylene group and A4 is a single bond.
As to claim 9, in the structure of Ying, Z4 and Z2 are different.
As to claim 11, the structure of Ying would appear to read on the top structure of claim 11.
As to claim 12, Ying teaches a pharmaceutically acceptable salt, as of Ying, pages 1-2, paragraph 0005.
As to claim 13, Ying teaches a pharmaceutical composition on pages 85-86, paragraph 00299. Ying teaches the following elements in the nanoparticle, as of page 118, bottom paragraph, relevant text reproduced below.
PNG
media_image4.png
146
594
media_image4.png
Greyscale
As to claim 14, Ying teaches cholesterol in the abstract.
As to claim 15, Ying teaches DSPC along with other phospholipids, as of page 4, paragraph 0016.
As to claims 16-17, Ying teaches DMG-PEG as well as other PEGylated lipids on page 48, paragraph 00176.
As to claim 18, Ying teaches mRNA on page 118, bottom paragraph.
Allowable Subject Matter – Elected Specie Appears to be Allowable
Applicant elected the following specie.
PNG
media_image1.png
412
653
media_image1.png
Greyscale
The examiner takes the position that a claim narrowed to this species would appear to be in condition for allowance. As relevant prior art, the examiner cites Ying (WO 2022/002040 A1). Ying teaches the following on page 25, relevant text reproduced below.
PNG
media_image2.png
600
588
media_image2.png
Greyscale
The skilled artisan would not have been motivated to have formed the compound of the elected species in view of this teaching. This is at least because the compound of Ying comprises the central phosphorus atom bound to two oxygen atoms, whereas in the elected species, the central phosphorus atom is bound to one oxygen atom and three carbon atoms. As such, the elected species is not anticipated by Ying or obvious over Ying.
Conclusion
Although the examiner has identified the elected specie as allowable, it is nevertheless the case that no claim is currently in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
Prosecution Insights