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 .
Priority
This application was filed 05/08/2024 and is a 371 of PCT/US2022/049369 (11/09/2022) which claims PRO 63/278274 (11/11/2021). Claims 1, 6, 8, 12, 18-19, 23-24, 29, 31, 35, 41, 44-45, 50-51, 57-58 and 61 are before the Examiner.
Claim Rejections - 35 USC § 112
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.
Claims 1, 6, 8, 12, 24, 29, 31, 35, 45, 50, 51 and 61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for lipid compounds and compositions wherein the substituents on the substituted alkyls are O and C(O); R21=R22, R20=C3 (formulas III and III-A),; R17=R18=R19 and R16=C3 (formulas II-B, II-A and II); and R12=R13=R14 and R11=C3 (formulas I-C, I-B, I-A and I) does not reasonably provide enablement for lipids wherein the substituents are other than O and C(O) such as pyridine or Si or other heteroatom, R20, R16 or R11 being 1, 2, 4 or 5, and R21, R22, R17, R18, R19, R12, R13 and R14 being different from each other. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims. All the examples have each of the R20, R16 or R11 being only C3 alkyl; R21 & R22, R17 & R18 & R19 and R12& R13& R14 being the same; and the alkyls that are substituted are only substituted with either O or C(O) and nothing else.
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”. These factors include 1) the breadth of the claims, 2) the nature of the invention, 3) the state of the prior art, 4) the level of one of ordinary skill, 5) the level of predictability in the art, 6) the amount of direction provided by the inventor, 7) the existence of working examples, and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The nature of the invention: The nature of the invention is lipids that are made for the efficient delivery of mRNA using lipids of formula (I).
The state of the prior art: The state of the prior art is that it involves screening in vitro and in vivo to determine which lipid compounds exhibit the desired pharmacological activities. There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
The predictability in the art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instantly claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to the ability of lipids to be linked to drugs and then deliver those drugs to the desired areas.
The presence or absence of working examples: The compounds of the instant specification have broad definitions but very limited execution of those variables. As noted above, the only examples of substituents on the substituted alkyls are O and C(O). The only examples of R groups are R21=R22, R20=C3 (formulas III and III-A); R17=R18=R19 and R16=C3 (formulas II-B, II-A and II); and R12=R13=R14 and R11=C3 (formulas I-C, I-B, I-A and I). There are no other working examples in the instant specification.
The amount of direction or guidance present: The guidance present in the specification is that the full definitions should be able to work. However, the specific examples given show that these various moieties are actually very limited.
The breadth of the claims: The claims are drawn to the lipid compounds and compositions of claim 1.
The quantity of experimentation needed: The quantity of experimentation needed is undue. One skilled in the art would need to determine what substituents or variances of the R groups would work as mRNA lipid delivery systems. The only ones made and tested are within a small scope of the claimed formulas.
The level of the skill in the art: The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which compounds exhibit the desired pharmacological activity.
Thus, the specification fails to provide sufficient support of the broad use of the compounds of claim 1 for the treatment of disease. As a result necessitating one of ordinary skill to perform an exhaustive search for which diseases can be treated by which compound of claim 1 in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, one of ordinary skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compounds of the instant claims, with no assurance of success.
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.
Claims 1, 12, 24, 35 and 61 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2018/232120. WO teaches lipids such as #168 and other such as p181 l14, p182 l25, p241 l25, p254 l5, p282 l5, p353 l10 and p359 l1 that anticipate the instant claims.
Claims 1, 6, 8, 12, 45, 50, 51 and 61 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2021/030701. Wo teaches lipids such as table 8 p322 (for claims 1, 12 and 61), p 329 X-16, P337 XI-6, XI-18 and XI-19 (for claims 1, 45, 50, 51 and 61) and P341 XII-11 and XII-17 (for claims 1, 6, 8, 12 and 61). These anticipate the instant claims.
Claims 1, 24, 29, 31, 35, 41 and 61 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2021/050843. Wo teaches lipids such as compound 1 page 54 Fig 1 that anticipate the instant claims.
Claims 1, 12, 24, 35 and 61 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2017/112865. WO teaches lipids such as page 68 that anticipate the instant claims.
Claims 1, 6, 8, 12, 24, 29, 31, 35 and 61 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2019/027999. WO teaches lipids such as p69 B mid-page that anticipates claims 1, 6, 8, 12 and 61. Further page 71 and page 81 A scheme teaches compounds that anticipate claims 1, 24, 29, 31, 35 and 61.
Claim Objections
Claims 18, 19, 23, 44, 57 and 58 are objected to because of the following informalities: These claims depend from a rejected base claim but would be allowable if rewritten in independent form with all intervening limitations. Appropriate correction is required.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625
Prosecution Insights