DETAILED ACTION
Applicants’ arguments, filed 18 November 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Priority
The instant application ultimately claims foreign priority to application PCTEP1201319, filed on 26 March 2012. This foreign priority claim appears improper or incorrect for the following reason.
The examiner notes that the instant application is a continuation of application 16/578,601, which issued as US Patent 11,559,587. A portion of the front page of this patent has been reproduced below, with annotation by the examiner.
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The front page of the ‘587 patent appears to indicate that the ‘587 patent is a continuation-in-part of application No. PCT/EP2012/001319. This is different from a foreign priority claim to application No. PCT/EP2012/001319.
Application 16/578,601 is a divisional of application 14/388,192, which matured into US Patent 10,485,884. This patent is also a continuation-in-part of application PCT/EP2012/001319, and does not include a foreign priority claim.
As such, the foreign priority claim in the instant application appears improper or incorrect.
Response to Arguments Regarding Priority Issues
In applicant’s response on 18 November 2025 (hereafter referred to as applicant’s response), applicant makes the following argument on page 8 of applicant’s response.
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This is not persuasive. The domestic continuity cannot be captured because the benefit claim is beyond the 4/16-month timeframe. See MPEP 211, specifically 211.03, second paragraph in section, regarding the 4/16 month timeframe. Applicant must submit a petition to accept their domestic benefit claims. See MPEP 211.04 regarding such petitions.
Note Regarding “N:P Ratio”
The examiner makes the following note regarding the terms “N:P ratio” or “N/P ratio.”
The examiner notes that the terms “N/P ratio”, also written as “n/p ratio”, “N:P ratio”, or “n:p ratio” were common terms in the art area of cationic liposomes or lipid nanoparticles for the delivery of nucleic acids, as of the date of the instant invention. These terms refer to the ratio of positive to negative charges, which is a concept recited by instant claim 54.
The examiner notes that the phrase “N/P ratio” can be defined as either
Negative to positive ratio, with “N” referring to negative, and “P” referring to positive; or
Nitrogen to Phosphorus ratio, with “N” referring to nitrogen, and “P” referring to phosphorus.
The examiner notes that these definitions are opposite to each other. This is because nitrogen is found in cationic lipids and is positively charged, whereas phosphorus is found in nucleic acids and is negatively charged. As such, when evaluating the phrase “N/P ratio” in the prior art, the examiner has clarified how the particular phrase is defined by each reference.
Applicant does not appear to dispute this in applicant’s response.
Note Regarding Abbreviations and Acronyms in Claims
The examiner notes that claims 58 and 73 recite a large number of abbreviations and acronyms. These acronyms are disclosed in the original application but not defined by the original application; see e.g. page 18, first full paragraph of the instant specification. Nevertheless, the instant claims indicate that these abbreviations refer to tumor antigens encoded by the administered RNA. These tumor antigens appear to have been known in the art prior to the date at which the invention was made. In support of this position, the examiner cites Dubensky Jr. et al. (US 2004/0228877 A1), paragraph 0164, Hoerr et al. (US 2010/0189729 A1), paragraph 0035, Tureci et al. (US 2010/0111993 A1), Aburatani et al. (US 2011/0059469 A1) which teaches Claudin-6, and Sahin et al. (Clinical Cancer Research, Vol. 14(23), 2008, pages 7624-7634), which teaches Claudin 18.2.
Therefore, the examiner takes the position that because the abbreviations and acronyms recited in claims 58 and 73 are drawn to well-known tumor antigens, it is therefore the claims that claims 58 and 73 are not indefinite.
Applicant does not appear to dispute this in applicant’s response.
Claim Rejections - 35 USC § 103 – Obviousness
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 negated by the manner in which the invention was made.
The factual inquiries 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 54, 58-65, 69, and 73-80 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Geall et al. (WO 2012/030901 A1) in view of Manoharan et al. (WO 2011/071860 A2).
Geall et al. (hereafter referred to as Geall) is drawn to the administration of small liposomes for the delivery of immunogen encoding RNA, as of Geall, title and abstract. This method entails delivering RNA in a liposome sized from about 80-160 nm, as of Geall, page 1, lines 15-20, which is a sufficiently small size to be a lipid nanoparticle. The RNA encodes a polypeptide against which an immune response will be elicited after administration, as of Geall, page 8 lines 6-17, wherein said immunogen may be for a bacterial, viral, fungal, or parasite disease, as well as a tumor antigen. Geall teaches a cationic lipid which may be DOTMA, as of Geall, page 2 line 10.
Geall does not teach the required ratio of positive to negative charges.
Manoharan et al. (hereafter referred to as Manoharan) is drawn to a method for delivery of a nucleic acid, as of Manoharan, title and abstract. Delivery utilizes a lipid particle, which comprises a charged which may be a quaternary nitrogen containing cationic lipid, as of Manoharan, second half of page 67, with relevant text reproduced below.
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Manoharan also teaches N to P ratios of about 5:1 to about 1:1 on page 68, lines 1-2.
Manoharan differs from the claimed invention because Manoharan does not appear to teach RNA molecules that encode at least one antigen. In contrast, the nucleic acid molecules of Manoharan appear to be non-coding RNAs like siRNA. While Manoharan teaches immunostimulatory nucleic acids on pages 79-80, these appear to be immunostimulatory non-coding nucleic acid adjuvants such as CpG oligodinucleotides, and do not appear to operate by encoding at least one antigen.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the positive:negative charge ratio in Geall to have been in the range taught by Manoharan. Geall teaches a method of delivery of a nucleic acid encoding an antigen with a liposomal lipid nanoparticle comprising a cationic lipid, but is silent as to the positive:negative charge ratio. Manoharan teaches that a specific range of ratios of positive to negative charge is useful for delivery of a nucleic acid via a cationic lipid nanoparticle. As such, the skilled artisan would have been motivated to have modified the lipid nanoparticle of Geall to have had the positive to negative charge ratio of Manoharan for predictable delivery of the nucleic acid of Geall with a reasonable expectation of success.
As to claim 54, the claim requires a method for inducing an immune response. This is taught by Geall, title, abstract, and page 8 lines 6-17, which is reproduced below.
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As to claim 54, the claim requires nanoparticles. The particles of Geall are sized from 80-160 nm, as of Geall, page 3 line 15, and are thereby nanoparticles.
As to claim 54 part (i), the claim requires at least one cationic lipid. Geall teaches the following, as of page 2, relevant text reproduced below.
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As to claim 54, part (ii), the claim requires that the RNA molecule encodes at least one antigen. This is taught as of Geall, page 8, lines 6-17, reproduced above.
As to claim 54, the claim requires a ratio of positive to negative charges between 1:1.2 and 1:2. Manoharan teaches N to P ratios (e.g. of positive nitrogen to negative phosphorus) of about 5:1 to about 1:1 on page 68, lines 1-2. This is not the same as what is required by the instant claims. Nevertheless, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a liposomal lipid nanoparticle comprising positively charged cationic lipid and negatively charged nucleic acid has been taught by the prior art, as has the concept of a ratio between these components. As such, it would not have been inventive to have discovered the optimum or workable ranges of these components via routine experimentation.
As to claim 54, the last three lines of the claim require a tumor-associated antigen. Geall teaches a tumor antigen, as of Geall, page 14, paragraph starting at line 5.
As to claim 58, Geall teaches the “BAGE” antigen on page 14 line 6.
As to claim 59, Geall teaches a tumor antigen response against cancer, as of Geall, page 14 line 25.
As to claim 60, Geall teaches tumor responses against breast, ovarian, and colon cancer, as of page 14 lines 25-26.
As to claim 61, Geall teaches a melanoma antigen on page 14 line 8.
As to claim 62, Geall teaches pancreatic cancer on page 14 line 11.
As to claim 63, Geall teaches self-replicating RNA, as of at least Geall, page 1 line 19. The examiner understands the self-replicating RNA of Geall to be a form of mRNA.
As to claim 64, Geall teaches DOTMA as of at least page 2, line 10, Manoharan also teaches DOTMA on page 63 line 22. (The examiner notes that Manoharan incorrectly identifies DOTMA as a protonatable lipid; in contrast, DOTMA is permanently cationic but not protonatable).
As to claim 65, Manoharan teaches neutral lipids such as DOPE, DSPC, POPC, and DPPC on page 63 line 11; these are understood to read on the required helper lipids. Geall also teaches zwitterionic lipids such as DPPC, DOPC, DSPC, and DOPE on page 2 lines 13-14; these are understood to read on the required helper lipids.
As to claim 69, this claim is an independent claim having essentially the same limitations as claim 54; however, the recited method is for stimulating, priming, and/or expanding T-cells in a subject. This claim is rejected for essentially the same reason that claim 54 is rejected. Geall teaches this as of page 34, relevant text reproduced below.
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As to claim 69, the claim requires a tumor antigen. Geall teaches a tumor antigen, as of Geall, page 14, paragraph starting at line 5.
As to claim 73, Geall teaches the “BAGE” antigen on page 14 line 6.
As to claim 74, Geall teaches a tumor antigen response against cancer, as of Geall, page 14 line 25.
As to claim 75, Geall teaches tumor responses against breast, ovarian, and colon cancer, as of page 14 lines 25-26.
As to claim 76, Geall teaches a melanoma antigen on page 14 line 8.
As to claim 77, Geall teaches pancreatic cancer on page 14 line 11.
As to claim 78, Geall teaches self-replicating RNA, as of at least Geall, page 1 line 19. The examiner understands the self-replicating RNA of Geall to be a form of mRNA.
As to claim 79, Geall teaches DOTMA as of at least page 2, line 10, Manoharan also teaches DOTMA on page 63 line 22. (The examiner notes that Manoharan incorrectly identifies DOTMA as a protonatable lipid; in contrast, DOTMA is permanently cationic but not protonatable).
As to claim 80, Manoharan teaches neutral lipids such as DOPE, DSPC, POPC, and DPPC on page 63 line 11; these are understood to read on the required helper lipids. Geall also teaches zwitterionic lipids such as DPPC, DOPC, DSPC, and DOPE on page 2 lines 13-14; these are understood to read on the required helper lipids.
Note Regarding Reference Date: Geall is a publication of the World Intellectual Property Office that was published in English after November 29, 2000 and designates the United States, and was effectively filed prior to the effective filing date of the instant application. As such, Geall is prior art under pre-AIA 35 U.S.C. 102(e).
Claims 66-68 and 81-83 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Geall et al. (WO 2012/030901 A1) in view of Manoharan et al. (WO 2011/071860 A2), the combination further in view of Mahato et al. (Human Gene Therapy, Vol. 9, 1998, pages 2083-2099).
Geall is drawn to administration of RNA encoding an antigen with a liposomal lipid nanoparticle comprising a cationic lipid, as of Geall, title and abstract. Manoharan is drawn to administration of a nucleic acid with a liposomal lipid nanoparticle comprising a cationic lipid and a neutral lipid. See the rejection above over Geall in view of Maonharan. While Geall and Manoharan are drawn primarily to delivery of RNA, both references teach delivery of DNA, as of Geall, page 25 lines 10-15 and Manoharan, page 70, lines 18-20.
Neither Geall nor Manoharan teach the required ratio of cationic lipid to helper lipid.
Mahato et al. (hereafter referred to as Mahato) is drawn to a lipid complex for delivery of plasmid DNA, as of Mahato, page 2083, title and abstract. In one embodiment, Mahato teaches a 2:1 Ratio of DOTMA to DOPE, as of Mahato, page 2083, left column, last full paragraph, reproduced below.
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Also see Mahato, page 2083, right column, bottom paragraph. Mahato also teaches a mean particle size from 200 nm to 328 nm, as of page 2086, right column, first paragraph in “results” section, and sizes from 248-458 nm as of page 2087, right column. Mahato also teaches sizes ranging from 100 nm to 800 nm, as of page 2088, figure 4.
Mahato differs from the claimed invention because Mahato is drawn to delivery of DNA rather than RNA.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the liposome and/or lipid nanoparticle of Geall in view of Manoharan in the manner taught by Mahato. Both Geall and Manoharan are drawn to lipid nanoparticles comprising a cationic lipid for delivery of a nucleic acid, which may be DNA or RNA. As such, the skilled artisan would have been motivated to have modified the lipid nanoparticle of Geall in view of the teachings of Manoharan in view of the teachings of Mahato for predictable delivery of the nucleic acid of Geall in view of Manoharan with a reasonable expectation of success. The examiner notes that although Geall and Manoharan are primarily drawn to RNA delivery (but also teach DNA delivery) whereas Mahato is drawn to DNA delivery, the strategy used to deliver these nucleic acids is the same in Geall and Manoharan as said strategy involves using a cationic lipid particle.
As to claim 66, the claim requires a ratio of positive to negative charges of about 1.3:2. Manoharan teaches N to P ratios (e.g. of positive nitrogen to negative phosphorus) of about 5:1 to about 1:1 on page 68, lines 1-2. This is not the same as what is required by the instant claims. Nevertheless, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a liposomal lipid nanoparticle comprising positively charged cationic lipid and negatively charged nucleic acid has been taught by the prior art, as has the concept of a ratio between these components. As such, it would not have been inventive to have discovered the optimum or workable ranges of these components via routine experimentation.
As to claim 66, the claim requires a molar ratio of DOTMA to DOPE of about 2:1. Mahato teaches this as of page 2083, left column, last full paragraph.
As to claim 67, this claim appears to have mostly the same requirements as claim 66. The only additional requirement of claim 67 that is not required by claim 66 is the particle size range of from 300 nm to 500 nm. Mahato also teaches a mean particle size from 200 nm to 328 nm, as of page 2086, right column, first paragraph in “results” section, and sizes from 248-458 nm as of page 2087, right column. Mahato also teaches sizes ranging from 100 nm to 800 nm, as of page 2088, figure 4. These particle sizes overlap with the claimed size range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 68, this claim is rejected for essentially the same reason that claim 67 is rejected. The examiner notes that claim 68 further limits the DOTMA/DOPE ratio and the particle size, but is broader than claim 67. As such, the rationale applied by the examiner regarding claim 67 also applies to claim 68.
As to claim 81, this claim is rejected for essentially the same reason that claim 66 is rejected.
As to claim 82, this claim is rejected for essentially the same reason that claim 67 is rejected.
As to claim 83, this claim is rejected for essentially the same reason that claim 68 is rejected.
Claims 54, 58-65, 69, and 73-80 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Geall et al. (WO 2012/030901 A1) in view of Manoharan et al. (WO 2011/071860 A2), the combination further in view of Fotin-Mleczek et al. (US 2011/0250225 A1).
Claims 66-68 and 81-83 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Geall et al. (WO 2012/030901 A1) in view of Manoharan et al. (WO 2011/071860 A2) and Mahato et al. (Human Gene Therapy, Vol. 9, 1998, pages 2083-2099), the combination further in view of Fotin-Mleczek et al. (US 2011/0250225 A1).
Geall is drawn to administration of RNA encoding an antigen with a liposomal lipid nanoparticle comprising a cationic lipid, as of Geall, title and abstract. Manoharan is drawn to administration of a nucleic acid with a liposomal lipid nanoparticle comprising a cationic lipid and a neutral lipid. See the rejection above over Geall in view of Manoharan. Mahato is drawn to DOTMA/DOPE at a 2:1 ratio. See the above rejection over Geall in view of Manoharan and Mahato.
For the purposes of this rejection, the examiner takes the position that none of the above references teach the required ratio of positive to negative charges (i.e. N/P ratio).
Fotin-Mleczek et al. (hereafter referred to as Fotin) is drawn to an immnostimulatory composition comprising mRNA for use in a vaccine, as of Fotin, title and abstract. Fotin teaches the following as of paragraph 0230, reproduced below.
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As such, the lowest N/P value in Fotin’s most preferable range is 0.5:1, which is the same as 1:2.
Fotin differs from the claimed invention because Fotin does not appear to exemplify a lipid nanoparticle.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the N:P ratio of the combination of Geall in view of Manoharan to have been in the range taught by Fotin. The combination of Geall in view of Manoharan is drawn to a lipid nanoparticle for administering RNA having a particular ratio of positive to negative charges. Fotin is also drawn to a composition for administering RNA, which has a positive to negative charge ratio as low as 0.5:1 (i.e. 1:2) but also up to 2:1. As such, the skilled artisan would have been motivated to have modified the combination of Geall in view of Manoharan to have achieved the positive to negative charge ratios taught by Fotin for predictable administration of RNA with a reasonable expectation of success.
As to all of the pending claims, the positive to negative ratios of 0.5:1 to 2:1 taught by paragraph 0230 of Fotin overlap with the claimed range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
Response to Arguments Regarding Obviousness Rejections
Applicant has presented arguments regarding the previously applied obviousness rejections, as of applicant’s response on 18 November 2025 (hereafter referred to as applicant’s response). The examiner has addressed these arguments below.
Applicant argues that the claimed invention exhibited effective targeting or accumulation in tumor antigen presenting cells, as of applicant’s response, page 9, relevant text reproduced below. Applicant also argued that clearance by the liver and lung has been avoided, as of page 9, relevant text reproduced below.
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Regarding the issue of liver and/or lung clearance, the examiner takes the position that while the issue of clearance by the lung and liver is not explicitly discussed by Geall, it is evident from Geall that clearance of the active agent from the lung and liver is not so strong as to prevent the method of Geall from being successful. In support of this position, the examiner notes Geall, page 35, relevant table reproduced below, wherein the abbreviation “2wp1” and “2wp2” refer to two weeks post the first and second doses respectively, and the number in the table refers to an antibody titer.
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As such, the examiner takes the position that Geall does not suffer from liver or lung clearance to such an extent that such clearance prevents the method of Geall from being operable to achieve an immune response to the encoded antigen. As such, nothing in applicant’s response shows that the claimed method has superior resistance to liver and lung clearance compared with the method of Geall. As such, applicant’s arguments regarding issues relating to liver and lung clearance have not been found to be persuasive.
Applicant argues that the claimed method results in targeting or accumulation of the nanoparticles in tumor antigen presenting cells, as of applicant’s response, page 9, relevant text reproduced above. The examiner understands applicant’s use of the phrase “tumor antigen presenting cells” as opposed to “antigen presenting cells” as an argument that there is something significantly different between tumor vaccination and infectious disease vaccination. Applicant makes additional arguments regarding alleged differences between tumor vaccination and infectious disease vaccination on page 11, in which applicant makes the following arguments.
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The examiner generally disputes applicant’s position that the process of tumor vaccination differs from the process of infectious disease vaccination to such an extent that Geall’s teachings are inapplicable to tumor vaccination despite the fact that Geall teaches a long list of antitumor antigens on page 14 of Geall.
Briefly, applicant has not shown that tumor antigen presenting cells differ from “regular” antigen presenting cells. Applicant has also not shown that the antigen presenting cells used in antitumor vaccination must necessarily be the same type of antigen presenting cells that are used in natural immune responses against a tumor. Applicant has also not provided support for the unsupported assertion that particles that encode a tumor antigen for antitumor vaccination must have target selectivity in a manner not necessary or less relevant for infectious disease vaccination. These issues are explained in greater detail below.
As best understood by the examiner, the process of vaccination entails administering the antigen or nucleic acid encoding the antigen. Upon vaccination, the body raises an innate immune response at the site of administration of the vaccine. This is followed by the activity of antigen presenting cells, which present the antigen to B-cells for antibody production as well as to T-cells. The T-cells and antibodies produced by the B-cells, which have been trained to recognize the antigen, then become capable of eliminating the antigen in the body where it appears. This general idea is taught by Geall because Geall teaches measuring antibody titers on page 35, middle of page, and measuring T-cell activity on page 34 at the bottom of the page. Nothing in applicant’s response explains how this process differs for anti-tumor vaccination as compared with infectious disease vaccination.
The examiner notes here that anti-tumor vaccination (albeit not mRNA vaccination) was in widespread use prior to the effective filing date. Specifically, the vaccine against human papilloma virus (HPV) had been approved in June 2006 for prevention of certain types of cancers as well as genital warts; the examiner admits that this vaccine is an anti-viral vaccine, but it is also an antitumor vaccine. See e.g. Braaten et al. (Reviews in Obstetrics and Gynecology, Vol. 1, No. 1, 2008, pages 2-10), specifically as of page 3, left column, top of page. The examiner clarifies that even if, purely en arguendo, genital warts are not cancer, they are still tumors; with that being said, as best understood by the examiner, HPV vaccines are designed to prevent certain cancers. The examiner additionally cites Stanley (Gynecologic Oncology, Vol. 109, 2008, pages S15-S21) which discusses the types of antigen-presenting dendritic cells used by the HPV vaccine on page S15, abstract and page S17, top left paragraph. Interestingly, Stanley, page S17, top left paragraph appears to indicate that actual HPV infection is detected by the intraepithelial dendritic cells, whereas HPV vaccines are detected by the stromal dendritic cells; the skilled artisan would have understood that dendritic cells are antigen presenting cells. Nevertheless, this difference between the type of antigen presenting cells used in response to natural infection and the type of antigen presenting cells used in vaccination does not appear to cause the HPV vaccine to be ineffective. This would appear to indicate that there is significant flexibility in which types of antigen presenting cells respond to a particular antigen, and that an antitumor vaccine need not make use of the same type of antigen presenting cells as the natural immune pathway.
Therefore, applicant’s argument that a tumor vaccine necessitates the use of different antigen presenting cells as compared with an infectious disease vaccine is not persuasive and appears to be contradicted by the knowledge in the art surrounding HPV vaccines. Additionally, nothing in applicant’s response explains why tumor vaccines require more “target selectivity” than infectious disease vaccines. Vaccines are designed to be effective at the site of administration, which is often in the arm and is nowhere near the site most relevant for the disease. (For example, an influenza vaccine is given in the arm despite the fact that influenza affects the lungs to a greater extent than it affects the arm). As best understood by the examiner, this would appear to be the case regarding both tumor vaccines and infectious disease vaccines.
The examiner notes that the Braaten and Stanley references are not part of the statement of rejection, and are cited by the examiner to rebut various statements made in applicant’s response regarding tumor vaccination.
The examiner further notes that applicant has underlined “self-replicating RNA” on page 11 of applicant’s response. Applicant also argues on page 12, first full paragraph item (ii), that in order to obtain the claimed invention from Geall, the skilled artisan must forgo the self-replicating RNA. This argument is not persuasive. Nothing in the claims excludes self-replicating RNA. Applicant appears to be arguing a limitation that is not claimed. See MPEP 2145(IV). Nothing in the claims excludes a self-replicating RNA comprising both the self-replicating machinery and the antitumor antigen on the same RNA. The skilled artisan would have been motivated to have made this RNA by substituting RNA encoding the antitumor antigen in place of RNA encoding the RSV antigen in Geall, thereby resulting in a self-replicating antitumor RNA. Nothing in the claims excludes a self-replicating RNA.
Regarding the Manoharan reference, applicant makes the following argument, as of applicant’s response, page 11, relevant text reproduced below.
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The examiner disputes the idea that in the applied rejection, the examiner previously took the position that there is overlap between Manoharan and the instant claims. Looking to the prior office action mailed on 18 July 2025, page 10, second paragraph, the examiner appeared to take the position that although Manoharan’s N:P ratios differ from that of the claimed invention, this difference is still not sufficient to overcome the prima facie case of obviousness. The examiner did not erroneously assert that there was overlap of ranges in the prior art that was not actually present in the prior art.
Applicant then argues that Manoharan favors an inverse ratio of positive to negative charges that differs from the claimed ratio, as of applicant’s response, paragraph bridging pages 11-12.
In response, the examiner notes that a prima facie case of obviousness based upon routine optimization may be rebutted by showing that the prior art teaches away from the claimed range. See MPEP 2144.05(III)(B). Nevertheless, the examiner disagrees that applicant has established that Manoharan teaches away from the claimed invention. This is because nothing in applicant’s arguments shows that Manoharan explains why a N:P ratio in the claimed range is believed to be undesirable by Manoharan. The examiner notes MPEP 2144.05(III)(B), second paragraph in section, in which the MPEP discusses a case in which teaching away was not established.
Regarding the Mahato reference, applicant argues that nothing in Mahato cures the alleged deficiencies of Geall and Manoharan, as of applicant’s response, page 12 and the top of page 13. This is not persuasive. Geall and Manoharan are not deficient for the reasons set forth above. Additionally, applicant argues that the examiner has pointed to no passage in Mahato that suggests that the substitution of DNA in place of RNA would have yielded particles with suitable activity. This is not persuasive, as it addresses a point that was not actually made by the examiner. The examiner did not rely upon Mahato to provide a reason to substitute DNA in place of RNA. In contrast, the examiner relied upon Mahato to provide a particular ratio of cationic lipid to helper lipid; see page 14 of the prior office action on 18 July 2025. As such, applicant’s arguments are not persuasive as they appear to address a point not actually made by the examiner.
Regarding the Fotin reference, applicant makes the following argument on page 13, relevant text reproduced below.
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This is not persuasive. As an initial matter, Fotin does teach cationic lipids as of paragraph 0020, in which Fotin teaches DOTAM and DOPE. Also see claim 27 of Fotin.
With that being said, the examiner does not dispute that although Fotin teaches cationic lipids in the broad disclosure of Fotin, the main focus of the Fotin reference does appear to be using polypeptides to deliver nucleic acids. For example, Example 1 as of paragraph 0351 of Fotin appears to deliver nucleic acid with polyarginine. Nevertheless, the polypeptides used by Fotin are cationic polypeptides. For example, polyarginine has multiple arginine units that comprise amine containing side chains which are protonated at neutral pH resulting in a polycationic charge. These cationic polypeptides and the cationic lipids of Geall, Manoharan, and the instantly claimed invention have a similar purpose; namely, to deliver nucleic acid intracellularly. As such, the teachings of Fotin regarding cationic polypeptides can be applicable to teachings in other prior art references related to cationic lipids because the cationic polypeptides of Fotin and the cationic lipids of other references have essentially the same function in the art.
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 54, 58-69, and 73-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-39 of U.S. Patent No. 10,485,884. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a method of inducing an immune response against a tumor antigen. This method entails administering a composition comprising a cationic lipid and an RNA molecule encoding at least one antigen. The claims require a particular ratio of positive to negative charges. Dependent claims limit the presented lipid to DOTMA/DOPE.
The conflicting claims are drawn to a method of administering an RNA molecule encoding an antigen in combination with a cationic lipid for delivery to the spleen. The claims recite a particular ratio of positive to negative charges. Conflicting claim 30 recites a DOTMA/DOPE lipid particle. Conflicting claim 37 recites a nucleic acid encoding an antigen for eliciting an immune response.
The instant and conflicting claims differ because the conflicting claims recite targeting the spleen, which is not recited by the instant claims. Nevertheless, the skilled artisan would have expected that had the method of the conflicting claims taken place, the resultant method would have induced an immune response (e.g. as required by claim 54). This method also would have stimulated T-cells (e.g. as required by claim 69) because the stimulation of T-cells is part of the natural immune response. As such, the subject matter of the conflicting claims appears to effectively anticipate that of the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
The examiner notes that the instant claims recite a tumor antigen. In contrast, conflicting claim 37 recites a disease-associated antigen. Nevertheless, the specification of the ‘884 patent defines the phrase “disease-associated antigen” as including a tumor antigen. See the ‘884 patent, column 11, relevant text reproduced below.
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As such, conflicting claim 37 is understood to be drawn to tumor antigens.
Note Regarding the Examiner’s Citation of the Specification of the ‘884 Patent: The examiner notes that ordinarily, the specification of the conflicting patent cannot be considered in the determination of double patenting. Nevertheless, MPEP 804(II)(B)(1), second paragraph in section, states that the specification [i.e. of the conflicting patent] can be used as a dictionary to learn the meaning of a term in the claim. As such, it is the examiner’s position that citation to the specification is proper in this case.
Claims 54, 58-69, and 73-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of U.S. Patent No. 11,559,587. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a method of inducing an immune response against a tumor antigen. This method entails administering a composition comprising a cationic lipid and an RNA molecule encoding at least one antigen. The claims require a particular ratio of positive to negative charges. Dependent claims limit the presented lipid to DOTMA/DOPE.
The conflicting claims are drawn to a composition comprising nanoparticles. These nanoparticles comprise a cationic lipid, an RNA molecule encoding an antigen, and a specific ratio of positive to negative charges, as of conflicting claim 1. Conflicting claim 26 recites a combination of DOTMA and DOPE. Conflicting claims 32-33 recite a disease-associated antigen or a tumor antigen.
The instant and conflicting claims differ because the instant claims are drawn to a method of inducing an immune response, whereas the conflicting claims are drawn to a pharmaceutical composition. Nevertheless, the conflicting claims recite an antigen, e.g. as of conflicting claims 32-33. The skilled artisan would have expected the composition of the conflicting claims, during ordinary use, would have induced an immune response in a subject because the composition of the conflicting claims is intended to deliver an antigen. As such, the subject matter of the conflicting claims is understood to effectively anticipate that of the instant claims, thereby leading to a prima facie case of anticipatory-type non-statutory double patenting. The composition of the conflicting claims anticipates the claimed method as it carries out the claimed process during normal operation; see MPEP 2112.02(I).
Claims 54, 58-69, and 73-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,059,498 in view of Geall et al. (WO 2012/030901 A1).
Claims 54, 58-69, and 73-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,059,498 in view of Fotin-Mleczek et al. (US 2011/0250225 A1).
The instant claims are drawn to a method of inducing an immune response. This method entails administering a composition comprising a cationic lipid and an RNA molecule encoding at least one tumor antigen. The claims require a particular ratio of positive to negative charges. Dependent claims limit the presented lipid to DOTMA/DOPE.
The conflicting claims are drawn to a composition comprising RNA lipoplex particles. The conflicting claims recite a cationic lipid and an additional lipid, and recite a ratio of positive to negative charges of from about 1:2 to 1.9:2. Dependent claims such as claim 14 limit the lipids to DOTMA and DOPE.
The conflicting claims do not recite a method of inducing an immune response.
Geall et al. (hereafter referred to as Geall) is drawn to the administration of small liposomes for the delivery of immunogen encoding RNA, as of Geall, title and abstract. This method entails delivering RNA in a liposome sized from about 80-160 nm, as of Geall, page 1, lines 15-20, which is a sufficiently small size to be a lipid nanoparticle. The RNA encodes a polypeptide against which an immune response will be elicited after administration, as of Geall, page 8 lines 6-17, wherein said immunogen may be a tumor antigen. See the rejection above in which Geall is discussed in more detail.
Fotin-Mleczek et al. (hereafter referred to as Fotin) is drawn to an immnostimulatory composition comprising mRNA for use in a vaccine, as of Fotin, title and abstract. See the rejection above in which Fotin was discussed in more detail.
It would have been prima facie obvious for one of ordinary skill in the art to have used mRNA encoding an antigen and inducing an immune response in the composition of the conflicting claims. The conflicting claims are drawn to a composition comprising RNA, but are silent as to the use of the RNA or to what the RNA encodes. However, Geall and Fotin teach that RNA can be used to encode an antigen against which an immune response is desired. As such, the skilled artisan would have been motivated to have used an RNA that encodes an antigen against which an immune response is desired in the composition of the conflicting claims in order to have predictably achieved a pharmaceutical or therapeutic effect with a reasonable expectation of success.
Claims 54, 58-69, and 73-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11,395,799 in view of Geall et al. (WO 2012/030901 A1).
Claims 54, 58-69, and 73-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,395,799 in view of Fotin-Mleczek et al. (US 2011/0250225 A1).
The instant claims are drawn to a method of inducing an immune response. This method entails administering a composition comprising a cationic lipid and an RNA molecule encoding at least one antigen. The claims require a particular ratio of positive to negative charges. Dependent claims limit the presented lipid to DOTMA/DOPE.
The conflicting claims are drawn to a method of making a composition comprising RNA lipoplex particles comprising DOTMA and DOPE. The conflicting claims recite a cationic lipid and an additional lipid, and recite a ratio of positive to negative charges of from about 1:2 to 1.9:2, as of conflicting claim 21.
The conflicting claims do not recite a method of inducing an immune response.
Geall et al. (hereafter referred to as Geall) is drawn to the administration of small liposomes for the delivery of immunogen encoding RNA, as of Geall, title and abstract. This method entails delivering RNA in a liposome sized from about 80-160 nm, as of Geall, page 1, lines 15-20, which is a sufficiently small size to be a lipid nanoparticle. The RNA encodes a polypeptide against which an immune response will be elicited after administration, as of Geall, page 8 lines 6-17, wherein said immunogen may be a tumor antigen. See the rejection above in which Geall is discussed in more detail.
Fotin-Mleczek et al. (hereafter referred to as Fotin) is drawn to an immnostimulatory composition comprising mRNA for use in a vaccine, as of Fotin, title and abstract. See the rejection above in which Fotin was discussed in more detail.
It would have been prima facie obvious for one of ordinary skill in the art to have used mRNA encoding an antigen and inducing an immune response in the composition made by the method of the conflicting claims. The conflicting claims are drawn to a method of making a composition comprising RNA, but are silent as to the use of the RNA or to what the RNA encodes. However, Geall and Fotin teach that RNA can be used to encode an antigen against which an immune response is desired. As such, the skilled artisan would have been motivated to have used an RNA that encodes an antigen against which an immune response is desired in the composition made by the method of the conflicting claims in order to have predictably achieved a pharmaceutical or therapeutic effect with a reasonable expectation of success.
Claims 54, 58-69, and 73-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7-18, 20-21, 28, 46, 68, and 80 of copending Application No. 18/762,297 in view of Geall et al. (WO 2012/030901 A1).
Claims 54-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7-18, 20-21, 28, 46, 68, and 80 of copending Application No. 18/762,297 in view of Fotin-Mleczek et al. (US 2011/0250225 A1).
The instant claims are drawn to a method of inducing an immune response. This method entails administering a composition comprising a cationic lipid and an RNA molecule encoding at least one tumor antigen. The claims require a particular ratio of positive to negative charges. Dependent claims limit the presented lipid to DOTMA/DOPE.
The copending claims are drawn to a composition comprising a composition of RNA lipoplex particles comprising a particular ratio of positive charges to negative charges, as of copending claim 68. The conflicting claims recite a cationic lipid and an additional lipid, and recite a ratio of positive to negative charges of from about 1:2 to 1.9:2, as of copending claim 68. Other claims such as copending claim 17 limit the lipids to DOTMA and DOPE.
The copending claims do not recite a method of inducing an immune response.
Geall et al. (hereafter referred to as Geall) is drawn to the administration of small liposomes for the delivery of immunogen encoding RNA, as of Geall, title and abstract. This method entails delivering RNA in a liposome sized from about 80-160 nm, as of Geall, page 1, lines 15-20, which is a sufficiently small size to be a lipid nanoparticle. The RNA encodes a polypeptide against which an immune response will be elicited after administration, as of Geall, page 8 lines 6-17, wherein said immunogen may be for a bacterial, viral, fungal, or parasite disease, as well as a tumor antigen. See the rejection above in which Geall is discussed in more detail.
Fotin-Mleczek et al. (hereafter referred to as Fotin) is drawn to an immnostimulatory composition comprising mRNA for use in a vaccine, as of Fotin, title and abstract. See the rejection above in which Fotin was discussed in more detail.
It would have been prima facie obvious for one of ordinary skill in the art to have used mRNA encoding an antigen and inducing an immune response in the composition of the copending claims. The copending claims are drawn to a composition comprising RNA, but are silent as to the use of the RNA or to what the RNA encodes. However, Geall and Fotin teach that RNA can be used to encode an antigen against which an immune response is desired. As such, the skilled artisan would have been motivated to have used an RNA that encodes an antigen against which an immune response is desired in the composition of the copending claims in order to have predictably achieved a pharmaceutical or therapeutic effect with a reasonable expectation of success.
These are provisional nonstatutory double patenting rejections.
Response to Arguments Regarding Double Patenting Rejections
Applicant has presented arguments regarding the previously applied double patenting rejections, as of pages 14-20 of applicant’s response.
As an initial matter, applicant has made the following argument on page 14, as well as elsewhere in applicant’s response.
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The examiner disagrees with this position as it applies to the currently pending case. As best understood by the examiner, this would appear to be the appropriate standard in the case in which the two-way test for double patenting is to be used. In contrast, in the case where the one-way test for double patenting is to be used, it is only needed that the conflicting claims effectively anticipate the instant claims, not that the instant claims effectively anticipate the conflicting claims. See MPEP 804(II)(B)(4 and 5) for information about the one-way test and the two-way test for distinctness. As best understood by the examiner, the one-way test for distinctness is applicable here. This is because the two-way test is only applicable when applicant could not have filed the claims in a single application and the Office is solely responsible for any delays; see MPEP 804(II)(B)(5). There is no evidence of this being the case here; as such, the one-way test is applicable. As such, the position taken in the above-reproduced paragraph is not applicable because it applies to the two-way test whereas the one-way test would appear to be applicable here.
Regarding the ‘884 patent, applicant argues that the conflicting claims target the spleen, whereas the instant claims do not specifically target the spleen, as of applicant’s response, page 14. This is not persuasive because the instant claims do not exclude particles targeting the spleen. As such, that the conflicting claims present a limitation not recited by the instant claims is not sufficient to overcome the applied rejection.
Regarding the ‘587 patent, applicant argues that the conflicting claims require specific polydispersity indices and diameters not required by the instant claims, as of the top paragraph of page 15. This is not persuasive because the instant claims do not exclude particle populations with a particular polydispersity index or diameter. As such, that the conflicting claims present a limitation not recited by the instant claims is not sufficient to overcome the applied rejection.
Regarding the ‘498 patent, the examiner notes applicant’s comparison of claim 1 from the ‘498 patent with instant claim 1. Applicant then argues the following as of pages 16-17, relevant text reproduced below.
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This is not persuasive. That RNA was used to encode antigens was well-known at the time of filing of the instant application, as taught by Geall.
Applicant then makes the following argument, as of page 17, relevant text reproduced below.
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This is not persuasive. The teachings of Geall at the bottom of page 34 appear to be specifically drawn to T-cell activity. While these teachings relate to infectious disease antigens rather than tumor antigens, Geall teaches tumor antigens elsewhere in the document. For example, page 14 of Geall, starting at line 5, teaches tumor antigens which can be encoded by the RNA of Geall. There would have been a reasonable expectation that had the self-replicating RNA of Geall been modified to have encoded the tumor antigens on page 14 of Geall that the resultant RNA would have successfully elicited a T-cell response against the encoded antigen. Prior art is presumed to be operable/enabling; see MPEP 2121.
Applicant appears to make similar arguments regarding the ‘799 patent on pages 17-19 of applicant’s response. These arguments are not persuasive for essentially the same reason that the arguments related to the ‘498 patent are not persuasive.
Regarding copending application 18/762,297, applicant argued that the examiner should withdraw this rejection as the only remaining rejection in an application having an earlier filing date, as of applicant’s response, pages 19-20. This is not persuasive. The provisional non-statutory double patenting rejection over the ‘297 application is not the only remaining rejection. As applicant has not provided additional arguments regarding the ‘297 application, this rejection has been maintained.
Additional Relevant Prior Art
As additional relevant prior art, the examiner cites Brito et al. (WO 2013/006834 A1), which appears to have been effectively filed prior to the effective filing date of the instant application. Brito et al. (hereafter referred to as Brito) is drawn to oil in water emulsions comprising a cationic lipid for delivery of a nucleic acid molecule, as of Brito, title and abstract. The nucleic acid may encode a tumor antigen and/or tumor immunogen, as of Brito, pages 58-59, though other antigen types are taught as of Brito, pages 53-58.
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. It is the examiner’s position that Brito is no better than the above-cited references because Brito teaches a N/P ratio of at least 1.1:1, as of the abstract of Brito. Teachings elsewhere in the reference indicate that the phrase “at least 1.1:1” means includes N/P ratios such as 2:1, 4:1, 8:1, and 12:1, but not N/P ratios wherein the value of P exceeds the value of N; see Brito, page 78, bottom paragraph. As such, for this reason, the instant claims are not anticipated by Brito.
Brito is also not anticipatory because the actual embodied examples do not appear to encode an anticancer antigen. Brito appears to use RNA encoding the “SEAP” protein, which is easily detectable by an assay, rather than a protein intended to act as an antitumor antigen; see Brito, page 75, paragraph 00268, as well as the respiratory syncytial virus fusion protein (RSV F) antigen on page 78, paragraph 0028. With that being said, it is the examiner’s position that the teachings of Brito, like the teachings of Geall, generally support the idea that mRNA encoding one type of antigen may be readily substituted with mRNA encoding a different type of antigen. This would appear to rebut the arguments presented on page 11, second full paragraph of applicant’s response in which applicant appears to argue that there are substantially different concerns related to delivery of mRNA encoding an antitumor antigen as compared with mRNA encoding an infectious disease antigen.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
Prosecution Insights