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 .
Claim Status
Applicant’s preliminary amendment filed on September 18, 2025, has been received and entered. Claims 2-15 have been amended and claims 16-20 have been newly added. Claims 1-20 are pending in this instant application.
Priority
Acknowledgment is made of applicant's claim for priority to the filing dates of : PCT Patent Application Serial No. PCT/EP2023/063465; filed on May 19, 2023; and European Patent Application Serial No.EP22174523.5 filed on May 20, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 13, 2025 is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1-4 are objected to because of the following informalities: In each of the claims wherein the clause limits the R3 and R4 the and conjunction is missing after several options in multiple places. For example in claim 1.
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Identical issues are found in claims 2-4.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 -Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification generically discloses vaccines can actively treat or reduce the symptoms of an ongoing disease involving a disease-associated antigen or cells expressing a disease -associated antigen, such as cancer [0223]-[0224]. Additionally, the specification generally states the invention provides a method for by administering the LNP’s, pharmaceutical compositions and vaccines according to this invention to a subject in need thereof [0225]. The figures are directed to a specific ionizable lipid nanoparticle containing 10µg mRNA, hEPO expression post injection with mRNA LNP containing 10µg, and IgG1 antibody titers against HA injected in mixed with mRNA LNP containing 10µg were determined using an in house ELISA assay However, the specification provides no examples with specific active agents to treat a diseases, types of diseases, dosage requirements to treat a disease, or specific subjects wherein the LPN has been used to actually treat or prevent any condition. The specification does not reasonably provide enablement for a method of preventing or treating or a condition in a subject in need there of.
As stated in the MPEP §2164.01(a) “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue."
In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
The nature of the invention
The state of the prior art
The predictability or lack thereof in the art
The amount of direction or guidance present
The presence or absence of working examples
The breadth of the claims
The quantity of experimentation needed, and
The level of skill in the art
It is noted that all of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The nature of the invention of independent claim 15 is a method of preventing or treating or a condition in a subject in need there of comprising administering to the subject a therapeutically effective amount of the pharmaceutical composition. And an ionizable lipid. The claim is not limited in scope of disease, condition, or active agent.
The specification generically discloses vaccines can actively treat or reduce the symptoms of an ongoing disease involving a disease-associated antigen or cells expressing a disease -associated antigen, such as cancer [0223]-[0224]. The specification never defines a condition or even mentions the term condition. Additionally, the specification generally states the invention provides a method for by administering the LNP’s, pharmaceutical compositions and vaccines according to this invention to a subject in need thereof [0225]. However, the specification provides no examples with specific active agents, types of diseases, dosage requirements, specific subjects wherein the LPN has been used to actually treat or prevent any condition, or particles encapsulating the active agent in an amount to prevent or treat a disease or condition.
In view of the lack of working examples and the most general of descriptions the specification does not enable the skilled artisan to practice a method of preventing or treating or a condition in a subject in need there of comprising administering to the subject a therapeutically effective amount of the pharmaceutical composition.
The specification provided no examples for the prevention or examples for of any disease or conditions. The generally accepted definition of the phrase “preventing a disease” is to keep the disease from occurring, or to anticipate it. Therefore, by Examiner’s broadest reasonable interpretation of the claims to the Applicant’s method for preventing a disease or condition, the “preventing” of said disease lacks enablement due to the undue amount of experimentation required by one of ordinary skill in the art to predictably practice the claimed method of preventing a disease. There are many different types of diseases and conditions with different causalities, pathways, locations, etc. The state of the art fails to provide definitive guidance in the causes (present disclosure paragraph [0002]) and subsequent prevention of neurodegenerative diseases, and the guidance that the prior art does set forth are not related to probiotic or probiotic-derived compound treatments Fratiglioni et al, (Prevention of common neurodegenerative disorders in the elderly, Exper. Gerontol., 44, 46-50, published online June 24, 2008). The route of method of administration is also critical for example the use of probiotics or probiotic-derived compounds in the prior art is generally attributed to oral or topical routes of administration. Oral administration is by far the most common method of probiotic administration. Topical administration of probiotics or probiotic-derived compounds has been disclosed for topical or skin diseases or disorders, for example to treat eczema or skin pathogen infections Lopes et al. (Topical application of probiotics in skin: adhesion, antimicrobial and antibiofilm in vitro assays. J Appl Microbiol. 2017 Feb;122(2):450-461.Published online Dec 12, 2016). Administration of probiotics or probiotic-derived compounds by injection or inhalation is not well-established in the prior art. Therefore, method of administration, such as oral, injection or inhalation administration routes are critical and as the claim specification and claim lack administration route claim 15 lacks enablement due to the undue amount of experimentation required by one of ordinary skill in the art to predictably and safely administer the present invention to a subject in need thereof.
The claims recite “administering to a subject a therapeutically effective amount”. The route of administration producing results is not predictable nor is a therapeutically effective amount predictable. Therapeutically effective amount depends upon a multitude of factors, including but not limited to, the type of disease, location of the disease, the weight of the mammalian subject, the mode of delivery, the specific targeting molecule, external factors which might be aggravating the disease, etc. The specification does not provide examples of any of the aforementioned variables. For example in the state of the art delivery of targeting RNA and plasmid DNA at the time this application was filed was unpredictable due to the fate of the vector itself, the size of siRNA sequence (it has been reported that complexes that were greater than 150nm diameter were unable to mediate gene silencing in vitro, the duration of the therapeutic effect, the cellular location of mechanistic activation, the volume of distribution, rate of tissue and target cell uptake, the target sell specificity, the rate of degradation of the siRNA and DNA plasmid, the amount and stability of the protein produced (or silenced), cytotoxicity of the delivery polymer Gary et al. (Journal of Controlled Release 121 (2007) 64-73). Further, the delivery of siRNA to mouse liver was inhibited target gene expression for a few days, which may not be sufficient time to observe a desired biological effect Wooddell et al, (Biochem Biophys Res Commun. 2005 Aug 19;334(1):117-27page 124, col. 1, para. 2). This is further evidenced in another report wherein Carmell et al. failed to produce any distinct phenotype, while siRNA, constructs directed against seven known targets that were introduced via standard trasngenesis Carmell (MA Nat Struct Biol. 2003; 10(2): 91-92).
There is no direction or guidance in the present specification with regard to preventing or treating any disease or condition. There are no embodiments or examples in the present disclosure that demonstrate or elaborate on the prevention or treatment of diseases or conditions. Due to the large quantity of experimentation necessary to identify, make and test the full scope of preventing and treating any disease and any condition as required by the claim, the lack of direction/guidance presented in the specification regarding same, lack of working examples and the teachings of the prior art and the complex nature of the invention, undue experimentation would be required of the skilled artisan to use the claimed invention.
Claim Rejections - 35 USC § 112 Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112 (ab), it is necessary to understand what Applicant is claiming and what Applicant has possession of.
The claim is genus a claim directed to methods of preventing or treating any disease or condition with an ionizable lipid and an active agent. The terms disease, condition and active agent places no limitation on the type, cause, or pathway of the disease or condition. Additionally, the claims does not limit the active agent or provide a structure on how the ionizable lipid of claim 1 and the active agent is associated. Furthermore, “administering to a subject a therapeutically effective amount” provides no guidance on the route or dosage of administration. There is nothing in the specification fails to descripe or exemplifies treating any disease with any active agent or the dosage and route in order to do so.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between structure and function, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of each genus recited in the claimed method. In the instant case, the specification fails to provide sufficient descriptive information, such as definitive structural or functional features, or critical conserved regions, of each genus. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. Thus, no identifying characteristics or properties are provided such that one of skill would be able to predictably identify the encompassed molecules as being identical to those instantly claimed. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed” (pg 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” (pg 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of each genus, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGFs were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Therefore, the method of claim 15 fails to meets the written description provision of 35 U.S.C. §112(a).. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (pg 1115).
Claim Rejections - 35 USC § 112 New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention of a method of preventing or treating a disease or condition in a subject in need thereof, comprising: administering to the subject a therapeutically effective amount of the pharmaceutical composition as defined in claim 14. This is new matter as claims never recited treating or preventing a condition nor does the specification disclose treating or preventing a condition. The specification does not define the term condition nor are there any working examples, in fact the term is not within the specification as filed. Pursuant to 37 CFR 1.118(a) states “No amendment shall introduce new matter into the disclosure of an application after the filing date of the application”
Thus, at the time the application was filed, an Artisan of skill would not recognize from the disclosure that Applicant was in possession of a method of treating a condition as claimed.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph-written description requirement”. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981) teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed…If a claim is amended to include subject matter, limitation or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. MPEP 2163.06 further notes, “When an amendment is filed in reply to an objection or rejection based on U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendment made to the disclosure”. This is a new matter rejection.
Claim Rejections - 35 USC § 102
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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-14 and 16-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by De Koker et al. (Pub. No.: WO 2022/136641; PCT filing date: Dec. 23, 2021, Effective filing date of Dec. 23 2020)
The applied reference has a common Applicant and Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1-9 and 16-18, De Koker discloses an ionizable lipid nanoparticle of formula I:
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(Claim 1).
With more specific embodiments including
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(claim 3),
And species including
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(claim 6)
Regarding claims 10-12, 14, and 19-20, De Koker discloses wherein the ionizable lipid of claim formula (I) claim 1 is in the form of a lipid nanoparticle or nanoparticle composition (claim 10) and further comprising a sterol and/or PEG lipid, and an mRNA active agent for a pharmaceutical formulation (claims 10-12, and 14).
Regarding claim 13, De Koker discloses a method of manufacturing the lipid nanoparticle composition comprising incorporating an ionizable lipid of claim 1 with one or more lipid components (page 66 lines 1-10).
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16-31 of copending Application No. 18/265,366 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant independent claim 1 is directed to an ionizable lipid of formula
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and independent claims 10 and 13-15 are directed to a lipid nanoparticle comprising an ionizable lipid of claim 1, a pharmaceutical composition comprising lipid nanoparticle(s) comprising an ionizable lipid of claim 1, and method and making and using. The reference application is also directed to an ionizable lipid of formula (I)
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Wherein many of the R groups, X group and Y and Z are identical options and therefore can form the same ionizable lipids however, some of the options for the groups may encompass more or less options. For example, the reference application discloses wherein R1 can be hydrogen but that option is not recited in the instant claims but the rest of the options for R1 are identical. The additional independent claims of the reference application are similarly directed to a nanoparticle comprising the ionizable lipid of formula I and pharmaceutical composition thereof. The dependent claims of the instant application and reference application recite identical or overlapping structures to be used in a pharmaceutical composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
the difference between claims 23-55 and claim 1-22 of patent 11,021,492 is that the instant claims are directed to a method of treating a subject with a chronic disease wherein the subject would benefit from the inhibition of the activity of mMTORC1. However, the specification and claims 23-25 of patent 11,021,492 teaches the method of treating a subject with a chronic disease wherein the subject would benefit from the inhibition of the activity of mMTORC1. Attention is directed to MPEP 804(II)(1) In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). Thus the instant claims and claims of patent 11,021,492 are obvious variants.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA R FALKOWITZ whose telephone number is (571)270-3386. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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