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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-19, 24-29, and 42-44 drawn to a nucleic acid delivery construct comprising a coding RNA encoding a mitochondrial encoded NADH dehydrogenase with species election of a single domain, domain 2 (D2; SEQ ID NO:4) in the reply filed on May 26, 2026 is acknowledged. Applicant’s election filed on May 26, 2026 is non-compliant and incomplete as applicant failed to elect a single disclosed spacer sequence as set forth in the restriction/election requirement mailed on February 25, 2026. Solely in the interest of compact prosecution, the examiner will examine SEQ ID NO:35.
Status of Claims
Claims 1-44 are currently pending in the instant application. Claims 4, 9, 11-17, 20-23, and 30-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Accordingly, claims 1-3, 5-8, 10, 18-19, 24-29, and 42-44 are under examination on the merits in the instant application.
Specification
The disclosure is objected to because of the following informalities: The sequence listing filed on April 28, 2023 contains no nucleotide sequence for at least each of SEQ ID NOs:27-34. See for instance the following reproduced from the sequence listing:
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Applicant is advised to review the entire sequence listing and make appropriate corrections.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/099,151, filed on November 5, 2018.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/099,151, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The ‘151 application does not appear to disclose the claimed construct “wherein each subdomain has a higher mitochondrial targeting activity per nucleotide compared with the human cytomegalovirus b2.7 RNA.” Accordingly, claims 1-3, 5-8, 10, 24-29, and 42-44 are not entitled to earlier filing date thus the effective filing date for the claims will be the instant application’s filing date, which is April 28, 2023.
Claim Objections
Claim 2 is objected to because of the following informalities: “has” in line 2 should be “have”. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: “dehydrogenase 1” in line 3 should be “dehydrogenase 4”. Appropriate correction 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 2-3, 5-8, 10, 18-19, 24-29, and 42-44 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2-3, 5-8, 10, 18-19, 24-29, and 42-44 recite the “RNA” sequence is “SEQ ID NO: 4”. For discussion purpose, SEQ ID NO:4 as disclosed in the sequence listing is reproduced below.
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As shown above, although the molecule type is identified as “RNA”, the actual nucleotide sequence in the sequence listing is a DNA sequence. As such, the claims recite structurally conflicting limitations (RNA vs. DNA) pertaining to SEQ ID NO:4, thereby rendering the claims indefinite.
Claims 2-3 each recite the limitation "wherein the RNA sequences from human cytomegalovirus b2.7 RNA" in lines 1-2. There is insufficient antecedent basis for this limitation in the claims.
Claim 5 recites “the human cytomegalovirus above.” It is unclear what is exactly referred to by this limitation as the term “above” cannot be properly interpreted.
Claim 6 recites the limitation "the RNA sequence from human cytomegalovirus b2.7 RNA" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "wherein the at least one spacer sequence" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites “wherein a spacer sequence further comprises a stop codon.” It is unclear whether “a spacer sequence” is different from or same as “the spacer sequence” in lines 1-2 of claim 7.
Claims 42-43 each recite the limitation "wherein said cargo" in line 1. There is insufficient antecedent basis for this limitation in the claims.
Claim 44 recites the limitation "wherein said non-covalent linkage" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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 1-3, 5-8, 10, 18-19, 24-29, and 42-44 are 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.
The instant claims are drawn to a nucleic acid delivery construct, “wherein each subdomain has a higher mitochondrial targeting activity per nucleotide compared with the human cytomegalovirus b2.7 RNA.”
It is found that the instant specification, see paragraph 00142, at best describes that subdomains D1, D2, D3, D4, D1AS, and D4AS have a higher mitochondrial targeting activity per nucleotide compared with the “full length b2.7 RNA”, which is 2,512 nucleotides in length, whereas the tested subdomains are one of 117, 255, 384, and 438 nucleotides length, which are about 6-fold and up to 21-fold shorter than the 2,512-nt “full length b2.7 RNA”. Hence, the four length species having the required structure-function correlation regarding the “wherein” clause are not a representative number of structural variants within the claimed genus, which encompasses any subdomain of any length. In addition, the instant specification does not appear to describe that the subdomains D1, D2, D3, D4, D1AS, and D4AS have the required “nucleic acid delivery construct” function, in particular, pertaining to the claimed RNA encoding mitochondrial encoded NADH dehydrogenase 1 or other proteins and as such, the instant specification fails to adequately describe the required structure-function correlation for the entire genus of the claims.
In view of the foregoing, it is concluded that the instant specification fails to reasonably convey that the instant co-inventors had possession of the claimed subject matter or the entire genus as of the filing date sought or as of the filing date granted in the instant application.
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)(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.
Claims 1-3, 5-8, 10, 18-19, 24-29, and 42-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patzel et al. (US 2019/0382794 A1).
Note the priority benefit denial above.
Patzel discloses the following in claims 1-2:
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It is noted that the RNA counterpart of SEQ ID NO:4 elected by applicant is 100% identical to SEQ ID NO:4 of Patzel.
Patzel also discloses all structural limitations such as spacer sequences and including a protein (e.g., MT-ND1)-encoding RNA sequence covalently or non-covalently as claimed in the instant case. See claims 3-15, 18, and 20; Table 1A; all paragraphs including paragraph 0059.
Since all claimed structural limitations in the instant claims are fully satisfied by the nucleic acid delivery construct of Patzel, it necessarily follows that Patzel’s nucleic acid delivery would inherently possess the functional property/characteristic of having “a higher mitochondrial targeting activity per nucleotide compared with the human cytomegalovirus b2.7 RNA”, absent objective evidence to the contrary.
“[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mkt. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). That is, “[f]rom the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (CCPA 1963) (emphasis added).
Note that the Office does not have the facilities and resources to provide the factual evidence needed in order to determine and/or compare the specific activities of the instantly claimed nucleic acid delivery construct versus that of Patzel. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed construct is different from the one taught by Patzel, thereby establishing patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ2d 1922(PTO Bd.Pat. App. & Int. 1989).
In view of the foregoing, claims 1-3, 5-8, 10, 24-29, and 42-44 are described by Patzel et al.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claims recite naturally occurring RNA sequences, which function as a nucleic acid delivery construct. This judicial exception is not integrated into a practical application because the claims do not include any structural limitations that alter the naturally occurring RNA sequences into non-naturally occurring RNA sequences. That is, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Accordingly, claims 1-2 are patent ineligible under §101.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 19 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 19 recites “a recombinant cell” and “a recombinant organism”, both of which read on a human or a human having the recombinant cell in view of the fact that the “cell” encompasses a human cell as evidenced by the instant specification’s disclosure of a human cell (page 24) and in view of the plain meaning of the “cell” and “organism”, which are understood in the relevant art to include a human cell and a human being.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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