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.
Nucleotide and/or Amino Acid Sequence Disclosures
The sequence information in the instant application has been entered.
Information Disclosure Statement
An information disclosure statement (IDS) was filed on 3 May 2024. This IDS includes reference BA, which is KR-10-201900067621-A. The copy of this reference appears to have been printed in errant text that is not readable. As such, this reference has been crossed out and has not been considered. Similarly, all foreign patent documents provided as of the 09/30/2024 IDS with the exception of JP 2003501363 A have been crossed out because they have been printed in errant text.
Claim Interpretation
Claim 10 recites the N:P ratio. This is understood to refer to the ratio of cationic nitrogen in the cationic lipids of the liposome to anionic phosphate in the mRNA.
Claim 11 recites that the composition further comprises an immune booster. For the purposes of examination under prior art, the examiner will examine the claims with the understanding that the immune booster is a separate element as compared with the mRNA and is a separate element as compared with the liposome. This is particularly relevant because mRNA (especially naked or underivatized mRNA) can act as an immune booster, as can liposomes. Nevertheless, for the purposes of examination under prior art, the examiner will proceed with the understanding that the immune booster is a separate ingredient as compared with these elements.
As to claim 12, the abbreviation “PAMP” refers to a pathogen associated molecular pattern. The abbreviation “3D-MPL” refers to 3-O-deacylated monophosphoryl lipid. The term “CpG DNA” refers to deoxyribonucleic acid containing motifs comprising cytosine followed by guanine. The term “poly I:C” refers to polyinosinic:polycytidylic acid. All of these compounds were well-known vaccine immunostimulants (i.e. adjuvants) at the time of filing, frequently used in vaccines that require an adjuvant, such as protein/peptide vaccines.
Claim 13 recites a method of treating a disease. The instant specification, in page 11, paragraph 0055, discloses the following.
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For the purposes of examination under prior art, the examiner understands that vaccination of a patient against an infectious disease would read on the required “treating” step of claim 13. This is the case even if the patient being vaccinated is healthy at the time of vaccination. This is because, were the patient to come in contact with the disease being vaccinated against following an immune response to the vaccination process, the symptoms of said disease would be less severe than what said symptoms would have been in the absence of vaccination.
Claim 15 recites a functional cosmetic. For the purposes of examination under prior art, a composition capable of improving the appearance of skin anywhere on the body is understood to be a functional cosmetic. This is the case even if (a) the composition is not directly applied to the area of the skin that needs to be improved; and (b) the improvement to the appearance of the skin does not occur immediately upon administration. Additionally, the examiner notes that the term “functional cosmetic” is recited in the preamble of the claim. See MPEP 2111.02 regarding interpretation of words in the preamble of the claim. For the purposes of examination, a prior art composition comprising all of the required elements of the claim but not referring to its composition as a functional cosmetic is understood to meet the claim requirements.
Claim Rejections - 35 USC § 102(a)(1) – 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.
Claim(s) 1-3, 5, 9, 13-14, and 16-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brito et al. (US 2016/0311759 A1).
Brito et al. (hereafter referred to as Brito) is drawn to a lipid composition for the delivery of active agents, as of Brito, title and abstract. Brito teaches the following formulation, as of page 97, paragraph 1055, relevant text reproduced below.
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As to claim 1, the above-reproduced text describes a liposome formulation comprising a cationic lipid for mRNA delivery.
As to claim 2, Brito teaches DSPC, as of the above-reproduced text from paragraph 1055, which reads on the required neutral lipid.
As to claim 3, Brito teaches cholesterol, as of paragraph 1055, reproduced above.
As to claim 5, Brito teaches DSPC, as of the above-reproduced paragraph.
As to claim 9, Brito teaches mRNA encoding the fusion (F) protein from the respiratory syncytial virus (RSV), as of Brito, paragraph 1059.
As to claim 13, the composition of Brito appears to be an RSV vaccine, thereby read on the claimed subject matter.
As to claim 14, the composition of Brito appears to be an RSV vaccine.
As to claims 16-17, Brito teaches the following, as of paragraph 1057, reproduced below.
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This is understood to read on the required mixing step of claim 16 and the required sequential mixing step of claim 17.
Examiner Note Regarding Claims Not Rejected as Anticipated: Claims 6-8 are drawn to amounts of ingredients and ratios of amounts to ingredients. The examiner notes that the claims recite amounts and ratios according to weight. In contrast, Brito teaches amounts as mole ratios as of paragraph 1055. In view of this, as well as the fact that the cationic lipid in Brito is not specified in paragraph 1055, the examiner is unable to calculate mole ratios from the teachings of Brito. As such, the examiner has taken the position that claims 6-8 of Brito are not anticipated by Brito. The examiner notes that this determination applies to a finding on anticipation only, and does not apply to a rejection over Brito based upon obviousness.
Claim(s) 1-3, 5-9, and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ciaramella et al. (US 2019/0008938 A1).
Ciaramella et al. (hereafter referred to as Ciaramella) is drawn to mRNA for cancer vaccines, as of Ciaramella, title and abstract. Ciaramella teaches the following, as of paragraph 0291, reproduced below.
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As such, Ciaramella teaches a cationic liposome formulation comprising mRNA, as of the above-reproduced paragraph. Also see Ciaramella, paragraph 0320, which is reproduced below.
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As to claim 2, Ciaramella teaches dipalmitoyl phosphatidylcholine, as of the above-reproduced paragraph, and distearoyl phosphatidylcholine (DSPC), as of paragraph 0320. These are neutral lipids.
As to claim 3, Ciaramella teaches cholesterol, as of the above-reproduced paragraph.
As to claim 5, Ciaramella teaches dipalmitoyl phosphatidylcholine, as of the above-reproduced paragraph, and distearoyl phosphatidylcholine (DSPC), as of paragraph 0320. These are neutral lipids.
As to claim 6, the examiner notes that the percentages in paragraph 0291 do not appear to be taught as being molar ratios; as such, the examiner has proceeded with the understanding that these are weight ratios. Ciaramella teaches a ratio of 57.1:7.1 of cationic lipid to neutral lipid. This is a ratio of about 8.04:1 or about 4.02:0.5. This ratio is within the claimed range.
As to claim 7, Ciaramella teaches 57.1:34.3 cationic lipid to cholesterol. This is a ratio of 1.66:1, which is within the claimed range.
As to claim 8, Ciaramella teaches a ratio of cationic lipid to neutral lipid to cholesterol of 57.1:7.1:34.3. This is a ratio of 4.02:0.5:2.40, which is within the claimed range.
As to claim 9, Ciaramella teaches a cancer vaccine, as of the title. As such, the skilled artisan would have understood that the mRNA encodes a protein or peptide that would have acted as an immunogen.
As to claim 13, Ciaramella teaches cancer vaccination, as of the abstract.
As to claim 14, Ciaramella teaches cancer vaccination, as of the abstract. As such, the skilled artisan would have understood the composition of Ciaramella to have been a vaccine.
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) 1-9 and 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brito et al. (US 2016/0311759 A1).
Brito et al. (hereafter referred to as Brito) is drawn to a lipid composition for the delivery of active agents, as of Brito, title and abstract. Brito teaches the following formulation, as of page 97, paragraph 1055, relevant text reproduced below.
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As to claim 1, the above-reproduced text describes a liposome formulation comprising a cationic lipid for mRNA delivery.
As to claim 1, purely en arguendo and for the purposes of this ground of rejection only, the examiner understands that Brito teaches all of the claimed requirements, but not necessarily in the same embodiment. As such, for the purposes of this ground of rejection only, the examiner understands that 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, Brito teaches DSPC, as of the above-reproduced text from paragraph 1055, which reads on the required neutral lipid.
As to claim 3, Brito teaches cholesterol, as of paragraph 1055, reproduced above.
As to claim 4, Brito teaches DOTAP as of paragraphs 1056 and 0208.
As to claim 5, Brito teaches DSPC, as of the above-reproduced paragraph.
As to claims 6-8, Brito teaches 40 mol% cationic lipid, 10 mol% DSPC, 48 mol% cholesterol, and 2 mol% PEGylated lipid, as of paragraph 0055; mole ratios of these ingredients are apparent from this teaching. Generally, differences in concentration between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, there is no evidence of criticality. As such, differences between the concentration (or ratio of concentrations) of the above-indicated ingredients between the prior art and claimed invention is not sufficient to support the patentability of the claimed subject matter. Additionally, 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, a liposome comprising cationic lipid, DSPC, cholesterol, and PEG-lipid has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of these concentrations (or these ratios of concentrations) via routine experimentation.
As to claim 9, Brito teaches mRNA encoding the fusion (F) protein from the respiratory syncytial virus (RSV), as of Brito, paragraph 1059.
As to claim 11, Brito teaches aluminum hydroxide as an adjuvant on paragraph 0317.
As to claim 12, Brito teaches lipoprotein in paragraph 0380.
As to claim 13, the composition of Brito appears to be an RSV vaccine, thereby read on the claimed subject matter. With that being said, Brito also teaches administering antigens against cancer in paragraph 0438.
As to claim 14, the composition of Brito, paragraph 1055, appears to be an RSV vaccine.
As to claim 15, Brito teaches treating skin cancer, as of paragraph 0263, and dermatological diseases as of paragraph 0271. The examiner takes the position that a composition capable of treating these conditions would have read on the required functional cosmetic. This is because the term “cosmetic” is used for an agent that improves appearance, often of skin. The skilled artisan would have expected that a composition that treats skin cancer would have improved the appearance of the skin by reducing the disfiguring of the visible cancer or tumor, thereby reading on the required cosmetic.
As to claims 16-17, Brito teaches the following, as of paragraph 1057, reproduced below.
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This is understood to read on the required mixing step of claim 16 and the required sequential mixing step of claim 17.
As to claim 18, Brito teaches aluminum hydroxide as an adjuvant (i.e. immune booster) as of Brito, paragraph 0317. While Brito is silent as to how this is added, the skilled artisan would have been motivated to have added the aluminum hydroxide of Brito as Brito suggests this elsewhere in the reference.
As to claim 19, Brito teaches aluminum hydroxide in a list of elements. Brito appears to be silent as to the order in which this ingredient is added to the composition. Nevertheless, this is insufficient to overcome the applied rejection. The selection of any order of mixing ingredients is prima facie obvious. See MPEP 2144.04(IV)(C).
Claim(s) 1-11 and 13-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ciaramella et al. (US 2019/0008938 A1).
Ciaramella et al. (hereafter referred to as Ciaramella) is drawn to mRNA for cancer vaccines, as of Ciaramella, title and abstract. Ciaramella teaches the following, as of paragraph 0291, reproduced below.
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As such, Ciaramella teaches a cationic liposome formulation comprising mRNA, as of the above-reproduced paragraph. Also see Ciaramella, paragraph 0320, which is reproduced below.
As to claim 1, purely en arguendo, and for the purposes of this ground of rejection, the examiner understands that Ciaramella is not anticipatory, at least because the subject matter of paragraph 0291 of Ciaramella appears applicable to siRNA rather than mRNA. 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, Ciaramella teaches dipalmitoyl phosphatidylcholine, as of the above-reproduced paragraph, and distearoyl phosphatidylcholine (DSPC), as of paragraph 0320. These are neutral lipids.
As to claim 3, Ciaramella teaches cholesterol, as of the above-reproduced paragraph.
As to claim 4, Ciaramella teaches DOTAP in a list of cationic lipids, as of paragraph 0374.
As to claim 5, Ciaramella teaches dipalmitoyl phosphatidylcholine, as of the above-reproduced paragraph, and distearoyl phosphatidylcholine (DSPC), as of paragraph 0320. These are neutral lipids.
As to claim 6, the examiner notes that the percentages in paragraph 0291 do not appear to be taught as being molar ratios; as such, the examiner has proceeded with the understanding that these are weight ratios. Ciaramella teaches a ratio of 57.1:7.1 of cationic lipid to neutral lipid. This is a ratio of about 8.04:1 or about 4.02:0.5. This ratio is within the claimed range.
As to claim 7, Ciaramella teaches 57.1:34.3 cationic lipid to cholesterol. This is a ratio of 1.66:1, which is within the claimed range.
As to claim 8, Ciaramella teaches a ratio of cationic lipid to neutral lipid to cholesterol of 57.1:7.1:34.3. This is a ratio of 4.02:0.5:2.40, which is within the claimed range.
As to claim 6-8, in the alternative, the examiner takes the position that, purely en arguendo, and in regard to this ground of rejection only, Ciaramella is silent to the required ranges of liposome elements because Ciaramella does not specify that the ratios in paragraph 0291 are weight ratios. Nevertheless, generally, differences in concentration between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, there is no evidence of criticality. As such, differences between the concentration (or ratio of concentrations) of the above-indicated ingredients between the prior art and claimed invention is not sufficient to support the patentability of the claimed subject matter. Additionally, 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, a liposome comprising cationic lipid, DSPC, cholesterol, and PEG-lipid has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of these concentrations (or these ratios of concentrations) via routine experimentation.
As to claim 9, Ciaramella teaches a cancer vaccine, as of the title. As such, the skilled artisan would have understood that the mRNA encodes a protein or peptide that would have acted as an immunogen.
As to claim 10, the range of between 1:1 to 20:1, as of Ciaramella, overlaps with the claimed range of 0.233:1 to 1.39:1 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 11, Ciaramella teaches an adjuvant, as of paragraph 0237. This is understood to read on the required immunostimulant, as the term “adjuvant” is generally used in the art to refer to an immunostimulant, and an immunostimulant is an immune booster. Ciaramella also teaches an additional immunostimulatory agent, as of paragraph 0430.
As to claim 13, Ciaramella teaches administration of an mRNA cancer vaccine, as of paragraph 0040.
As to claim 14, Ciaramella teaches cancer vaccination, as of the abstract. As such, the skilled artisan would have understood the composition of Ciaramella to have been a vaccine.
As to claim 15, Ciaramella teaches treating skin cancer, as of paragraph 0263, and dermatological diseases as of paragraph 0242. The examiner takes the position that a composition capable of treating these conditions would have read on the required functional cosmetic. This is because the term “cosmetic” is used for an agent that improves appearance, often of skin. The skilled artisan would have expected that a composition that treats skin cancer would have improved the appearance of the skin by reducing the disfiguring of the visible cancer or tumor, thereby reading on the required cosmetic.
As to claims 16-17, Ciaramella teaches mixing the elements using microfluidic mixers, as of Ciaramella, paragraphs 0443-0446. While some of the subject matter in this paragraph is drawn to siRNA formulations rather than mRNA formulations, it is nevertheless the case that the skilled artisan would have been motivated to have used the methods taught by Ciaramella for making siRNA liposomes in order to have predictably made a mRNA liposome with a reasonable expectation of success.
As to claim 18, because Ciaramella teaches an adjuvant, immunostimulant, or immune booster as of paragraphs 0237 and 0430. As such, the skilled artisan would have been motivated to have added the step of mixing the adjuvant or immunostimulant to the method taught by Ciaramella, paragraphs 0443-0446 in order to have predictably mixed the adjuvant or immunostimulant with the liposome+RNA of Ciaramella in order to have predictably formulated a liposome comprising RNA capable of stimulating an increased immune response as compared with what would have been the case in the absence of the adjuvant or immunostimulant with a reasonable expectation of success.
As to claim 19, Ciaramella teaches an adjuvant or immunostimulant in paragraphs 0237 and 0440. Ciaramella appears to be silent as to the order in which this ingredient is added to the composition. Nevertheless, this is insufficient to overcome the applied rejection. The selection of any order of mixing ingredients is prima facie obvious. See MPEP 2144.04(IV)(C).
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brito et al. (US 2016/0311759 A1) in view of Ciaramella et al. (US 2019/0008938 A1).
Brito is drawn to a cationic liposome for delivering mRNA that may act as an immunogen. See the rejections above over Brito by itself.
Brito differs from the claimed invention because, while Brito teaches N:P ratios, the N:P ratios taught by Brito are not as high as what is required by the instant claims.
Ciaramella et al. (hereafter referred to as Ciaramella) is drawn to mRNA cancer vaccines, as of Ciaramella, title and abstract. The composition of Ciaramella may be in the form of a liposome, as of Ciaramella, paragraph 0315. Ciaramella teaches a N:P ratio of between 1:1 and 20:1, as of paragraph 0330. See the rejections above over Ciaramella by itself.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the composition of Brito to have had a N:P ratio in the range taught by Ciaramella. Both Brito and Ciaramella are drawn to liposome particles for delivery of mRNA. Ciaramella teaches that the N:P of these particles may be in the range of 1:1 to 20:1. As such, the skilled artisan would have been motivated to have optimized the particles of Brito to have achieved a N:P of between 1:1 to 20:1 for predictable delivery of mRNA for the purpose of vaccination with a reasonable expectation of success.
As to claim 10, the range of between 1:1 to 20:1, as of Ciaramella, overlaps with the claimed range of 0.233:1 to 1.39:1 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).
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brito et al. (US 2016/0311759 A1) in view of Nelson et al. (Science Advances, Vol. 6, 2020, pages 1-13 and 13 pages of supplemental information).
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ciaramella et al. (US 2019/0008938 A1) in view of Nelson et al. (Science Advances, Vol. 6, 2020, pages 1-13 and 13 pages of supplemental information).
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brito et al. (US 2016/0311759 A1) in view of Ciaramella et al. (US 2019/0008938 A1), the combination further in view of Nelson et al. (Science Advances, Vol. 6, 2020, pages 1-13 and 13 pages of supplemental information).
Brito is drawn to a liposomal mRNA vaccine. Ciaramella is drawn to a liposomal mRNA vaccine with a N:P of 1:1. See the above rejections over Brito by itself, Ciaramella by itself, and Brito in view of Ciaramella.
For the purposes of this rejection, the examiner understands that both Brito and Ciaramella are deficient because they fail to teach poly(I:C), which is recited by claim 12.
Nelson et al. (hereafter referred to as Nelson) is drawn to messenger RNA, as of Nelson, page 1, title and abstract. Said messenger RNA may be administered in a lipid nanoparticle, as of Nelson, page 1, left column, wherein the abbreviation “LNP” refers to a lipid nanoparticle. Nelson teaches the use of poly(I:C) to simulate interferon response to mRNA administration, as of Nelson, page 5, left column, end of first full paragraph and end of last full paragraph. This appears to lead to an improved B-cell response, as of Nelson, page 5, end of last full paragraph.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the compositions of Brito and Ciaramella to have further included poly(I:C). Brito and Ciaramella are both drawn to mRNA vaccines in liposome and/or lipid nanoparticles. Nelson indicates that the inclusion of poly(I:C) ultimately improves the B-cell response to the administered mRNA vaccine. As such, the skilled artisan would have been motivated to have added the poly(I:C) of Nelson to the compositions of Brito, Ciaramella, and/or their combination in order to have predictably improved the B-cell response to said vaccine with a reasonable expectation of success.
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 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/548,080 (reference application). 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 liposome comprising mRNA and a cationic lipid.
Copending claim 4 is drawn to a liposome or lipid nanoparticle comprising a cationic lipid and mRNA encoding the SARS-CoV-2 spike protein antigen.
The instant and copending claims differ because the copending claims require that the mRNA encode an antigen of SARS-CoV-2, whereas the instant claims do not limit the mRNA. Nevertheless, the subject matter of the copending claims is within the scope of that of the instant claims. As such, the subject matter of the copending claims effectively anticipates that of the instant claims, resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/566,654 (reference application). 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 liposome comprising mRNA and a cationic lipid.
Copending claim 1 is drawn to a liposome or lipid nanoparticle comprising a cationic lipid and mRNA, wherein the mRNA is modified, including with pseudouridine and methylpseudouridine, as of copending claim 2.
The instant and copending claims differ because the copending claims require modified mRNA, whereas this feature is not required by the instant claims. Nevertheless, the subject matter of the copending claims is within the scope of that of the instant claims. As such, the subject matter of the copending claims effectively anticipates that of the instant claims, resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 13 Appears Properly Enabled
The examiner has decided not to reject claim 13 on the grounds of lack of enablement. The examiner’s reason for this is that (a) the term “treating” has been defined in the instant specification as anything that alleviates symptoms from a particular disease, and does not appear to have been defined to include prevention or complete cure, and (b) mRNA, delivered via lipid nanoparticles were known to have treated the recited disease prior to the effective filing date.
In support of that position, the examiner notes the following:
Regarding treatment of cancer and tumors, Ciaramella is drawn to cancer vaccines, as of Ciaramella, title and abstract. These may be therapeutic vaccines administered to a person with cancer to treat said cancer or strengthen the body’s natural defenses against said cancer, as of paragraph 0002 of Ciaramella.
Regarding treatment of autoimmune diseases, Brito teaches this as of paragraphs 0255 and 0264.
Regarding treatment of genetic diseases, the use of lipid nanoparticles encoding mRNA for this purpose has been taught by Bancel et al. (US 2014/0148502 A1). Use of mRNA to encode a protein in a genetic disease characterize by a dysfunctional or aberrant protein such as cystic fibrosis is taught by Bancel, paragraph 0813. The examiner has not rejected the instant claims over Bancel as it would appear to be duplicative of the rejections already presented. See MPEP 904.03.
Regarding treatment of inflammatory disease, Brito teaches this as of paragraph 0255. Additionally, the skilled artisan would have recognized various viral conditions such as influenza or COVID-19 to be inflammatory diseases as an inflammatory response is part of the natural immune response to said disease. The skilled artisan would have expected that a vaccine against influenza or COVID-19 would have decreased the severity of these diseases when the patient encountered the virus causing said diseases. As the severity of these diseases includes a dangerous inflammatory response (especially in influenza, such as in the 1918 “Spanish Flu” pandemic), the skilled artisan would have understood that a vaccine against such diseases would have reduced the symptoms of inflammatory diseases.
As to the recited viral and bacterial infections, Brito teaches vaccination against a virus or bacterium, as of paragraph 0176.
As such, in view of these prior art teachings, the examiner has not rejected claim 13 for lacking enablement.
Conclusion
No claim is allowed.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612