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
Acknowledgment is made of applicant’s claim for priority. The certified copy has been filed in parent Application No. 63/271,960, filed on 10/26/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/01/2024 is being considered by the examiner.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
The use of the term GFP SimpleStep ELISA® Kit (page 39), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Drawings
Figure 14 is objected to because of the poor image resolution making the image difficult to understand.
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.
Claim 28 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.
While the specification provides narrowed subcategories of lipid nanoparticles of formula (I) and lists specific examples such as compounds 1-5 (see table 1, pages 36-42) and eGFP mRNA, hEPO or Luciferase mRNA(page 39), the disclosure does not demonstrate possession of the full scope of the claimed subject matter. The use of a method of treating any diseases or disorder with modified mRNA delivered by the instant nanoparticles encompasses additional, undefined methods beyond those described. However, the specification does not provide sufficient details, representative examples, or common principles to support the breadth of such an open-ended genus. For example, details such as what mRNA to treat which diseases, what compounds of the instant formula can form lipid nanoparticles suitable for treating which diseases, dosage regimes and schedules are necessary details for treating diseases and disorders and these details are not included in the instant application. For example, there are several biological barriers that are challenging to overcome when treating disease such as neurological diseases, pregnancy-related diseases, retinal diseases that require specific nanoparticle development[Han et al., Predictive High-Throughput Platform for Dual Screening of mRNA Lipid Nanoparticle Blood–Brain Barrier Transfection and Crossing, Nano Lett. 2024 February 07; 24(5): 1477–1486]. As such, a persona of ordinary skill in the art would not reasonably conclude that Applicant was in possession of the entire scope of claim 28.
Allowable Subject Matter
Claims 1-17, 23, 25, 27 are allowed.
Conclusion
Claim 28 is rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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