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 .
DETAILED ACTION
Election/Restrictions
Applicant's election without traverse of Group II, claims 1-13 and 15, in the reply filed on 07/13/2026 is acknowledged.
Status of the Application
Claims 1-20, 22 and 23 are pending. Claims 1-20, 22 and 23 are currently under examination. Non-elected claims 14, 17-20, 22 and 23 have been rejoined and examined because the limitations were found in the prior art.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
The Abstract filed 11/30/2022 contains statements of the alleged merits or value of the claimed invention or its speculative application because it recites the following phrases” “increase glucose production” and “reduce the abnormal accumulation of glycogen and glucose-6-phophate associated with GSD-Ia”. Appropriate corrected is required
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The claims recite "Compound I" and it is indefinite because the claim does not recite the compound structure. The specification describes, on page 36, “a compound of formula I” and describes this a terminal cap however the compound in claims 11 and 12 do not refer to this as a terminal cap. Thus it is unclear what the actual structure of Compound I encompasses. Claim 11 and the term in claim 12 will not be further examined on the merits because it cannot be ascertained, without assumption, what structure is represented by Compound I.
Claim Rejections - 35 USC § 103
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 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-10, 12-20, 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/170306 (WO306) and Martini et al. (US 2023/0009009 of record IDS filed 07/19/2023).
Regarding claims 1, 7, 8, 12 and 13, WO306 teach lipid-containing nanoparticle compositions have proven effective as transport vehicles into cells for biologically active substances such as nucleic acids (0005). WO306 teach a lipid having the claimed structure (page 97):
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WO306 teach the nanoparticle can have mRNA (00258), a phospholipid, a PEG-DMG and a structural lipid such as cholesterol (00275-00276), WO306 teach the mRNA can have 5’ and 3’ UTR sequences (00338-00359) and a poly-A region between 30 and 250 nucleotides in length (00375). WO306 does not teach the sequences of the 5’ and 3’ UTR and a 5’ terminal cap.
Regarding claim 1, Martini et al. teach mRNA therapy for treatment of glycogen storage disease type 1a (GSD-Ia) and teach the ORF comprises a polypeptide identical to SEQ ID No. 1 (see SEQ ID No. 21 page 174) and teach the nucleic acid identical to sequence of SEQ ID No. 2 (see SEQ 23 page 175-176).
Regarding claim 2, Martini et al. teach the mRNA can comprise a 5’ UTR identical to claimed SEQ ID No 55 (see SEQ ID NO. 3 page 163).
Regarding claim 3, Martini et al. teach the mRNA can comprise a 3’ UTR identical to claimed SEQ ID No 114 (see SEQ ID NO. 178 page 235).
Regarding claims 4 and 9, Martini et al. teach the mRNA can comprise modification including N1-methylpseudouracil and teach 100% of the uracils can be modified (see 0035) and it would have been obvious to incorporate this modification into the mRNA sequence of SEQ ID No 1 to arrive at SEQ ID No. 5.
Regarding claims 5, 6 and 10, Martini et al. teach the mRNA comprise a 5’ terminal cap such as a guanine cap nucleotide such as N7 methylation (see 0020, 0392) and modifications including 2’O-methyl (0391).
Regarding claims 14-20, 22 and 23, Martini et al. teach methods of expressing a glucose-6-phosphatase (G6PC) polypeptide in a human subject in need thereof, method of treating, preventing, or delaying the onset and/or progression of glycogen storage disease type la (GSD-Ia) in a human subject in need thereof, a method of increasing blood, plasma, and/or serum glucose levels in a human subject in need thereof, a method of reducing liver glycogen levels in a human subject in need thereof, a method of reducing liver glucose-6-phosphate (G6P) levels in a human subject in need thereof, a method of reducing serum and/or liver triglyceride levels in a human subject in need thereof, a method of increasing G6PC activity in a human subject in need thereof, a method of treating or preventing liver adenoma in a human subject having glycogen storage disease type la (GSD-Ia), and a method of treating or preventing liver carcinoma in a human subject having glycogen storage disease type la (GSD-Ia) comprising administering to the human subject an effective amount of the lipid nanoparticle of claim 1 ( see 0045-0056).
It would have been obvious to one of ordinary skill in the art to use the lipid carrier of WO306 as a transport vehicle for the mRNA taught by Martini et al. for expressing a glucose-6-phosphatase (G6PC) polypeptide in methods of treatment of glycogen storage disease type la (GSD-Ia) in a human subject. One of skill in the art would have been capable of making the nanoparticle given the steps of which are taught by WO306.
Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Chong at (571)272-3111. The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm.
If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY CHONG/
Primary Examiner Art Unit 1636
Prosecution Insights