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 and Claim Status
Applicant’s election without traverse of Group 4 in the reply filed on 6/18/26 is acknowledged.
Claims 6-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/18/26.
Applicant’s election of the species of PML-1 encoded by SEQ ID NO:15 and pneumonia in the reply filed on 6/18/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 1-5 are being examined.
Priority
The priority information is found in the filing receipt dated 3/5/24.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/21/25 has been considered by the examiner.
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 1-5 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.
As set forth in MPEP 2173.05(q) “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness”.
MPEP 2173.05(q) expressly states: “a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).”
In the instant case, claim 1 recites ‘using’ (claim 1 line 1 as well as each of 1-5 of claim 1) but does not recite any steps involved in the process. It is unclear what step or steps are required to carry out the ‘using’. None of claims 2-5 clarify the claim scope.
Claim 1 recites 1-5 where the last line of 4 recites ‘and’. It is unclear if each of 1-5 is intended to be met. As noted above, the scope of 1-5 is unclear and it is unclear if each of 1-5 is intended to be met.
Claim 1 option 3 refers to ‘main pathological feature’. The term “main” in claim 1 is a relative term which renders the claim indefinite. The term “main” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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 1-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because MPEP 2173.05(q) recognizes that use claims that do not purport to claim a process, machine, manufacture or composition of matter fail to comply with 35 USC 101.
MPEP 2173.05(q) states: “ “Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 ").”
In the instant case, claim 1 recites ‘using’ (claim 1 line 1 as well as each of 1-5 of claim 1) but does not recite any steps involved in the process. It is unclear what step or steps are required to carry out the ‘using’. None of claims 2-5 clarify the claim scope. Further, SEQ ID NO:3 is from Homo sapiens (see sequence listing) and corresponds to a natural product (see MPEP 2106.04b).
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (US 2018/0163202; ‘Yang’).
Yang teach that TRIM19 is also known as PML (section 0009). Yang teach that the amino acid sequence for TRIM19 is SEQ ID NO:38 and the nucleotide sequence is SEQ ID NO:37 (Table 1 on page 14 and sequence listing). Yang teach that each TRIM protein (except TRIM12 and TRIM30) was expressed in HeLa cells (section 0398). Yang teach the data related to TRIM19 expression is provided in figure 19 (section 0400). Yang teach that the plasmid used for expression in mammalian cells were made in pRK5 (section 0268). Yang teach that in the experiments described above (which include section 0398) that the proteins were cloned into the pRK5 plasmid (section 0401). Yang teach PML for protection from neurodegeneration (section 0372 and claims 9 and 13). Yang teach PML as having an antiviral response (section 0265).
In relation to the protein as recited in claim 1, Yang teach that TRIM19 is also known as PML (section 0009). Yang teach that the amino acid sequence for TRIM19 is SEQ ID NO:38 (Table 1 and sequence listing) which is the same as instant SEQ ID NO:3.
In relation the method of claims 1-5, as noted above the claims are unclear. Yang teach that each TRIM protein (except TRIM12 and TRIM30) was expressed in HeLa cells (section 0398). Yang teach the data related to TRIM19 expression is provided in figure 19 (section 0400). Thus, Yang used the TRIM19 (i.e. PML) protein. In relation to any functional properties, since the same protein was used such protein would function as claimed. Since the use claim is unclear it is interpreted as including any use including in vitro and preventative uses.
In relation to the nucleotide sequence of claim 3, Yang teach that TRIM19 is also known as PML (section 0009). Yang teach that the nucleotide sequence is SEQ ID NO:37 (Table 1 and sequence listing) which is the same as instant SEQ ID NO:1.
In relation to claims 4-5, Yang teach that the plasmid used for expression in mammalian cells were made in pRK5 (section 0268). Yang teach that in the experiments described above (which include section 0398) that the proteins were cloned into the pRK5 plasmid (section 0401).
Claim Rejections - 35 USC § 103
The rejection below addresses additional embodiments of the claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2018/0163202; ‘Yang’).
Yang teach that TRIM19 is also known as PML (section 0009). Yang teach that the amino acid sequence for TRIM19 is SEQ ID NO:38 and the nucleotide sequence is SEQ ID NO:37 (Table 1 on page 14 and sequence listing). Yang teach that each TRIM protein (except TRIM12 and TRIM30) was expressed in HeLa cells (section 0398). Yang teach the data related to TRIM19 expression is provided in figure 19 (section 0400). Yang teach that the plasmid used for expression in mammalian cells were made in pRK5 (section 0268). Yang teach that in the experiments described above (which include section 0398) that the proteins were cloned into the pRK5 plasmid (section 0401). Yang teach PML for protection from neurodegeneration (section 0372 and claim 9). Yang teach PML as having an antiviral response (section 0265). Yang teach a composition that comprises one of the peptides and specifically recites TRIM19 (section 0128). Yang teach treating and preventing disease (claim 13) and recites diseases including neurodegenerative disease and cancer (claim 9). Yang teach administration to a subject (section 0202). Yang teach protection against neurodegeneration (example 1 and section 0264). Yang teach that alternative nucleotide sequences are possible due to reductant codons (section 0159).
Yang does not administer to a subject with a viral disease such as pneumonia.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Yang based on the express teachings a suggestions of Yang. Yang teach PML for protection from neurodegeneration (section 0372 and claim 9). Yang teach PML as having an antiviral response (section 0265). Yang teach a composition that comprises one of the peptides and specifically recites TRIM19 (section 0128). Yang teach treating and preventing disease (claim 13) and recites diseases including neurodegenerative disease and cancer (claim 9). Yang teach administration to a subject (section 0202). Yang teach protection against neurodegeneration (example 1 and section 0264). Thus, one would have been motivated to administer to the subjects suggested by Yang. Yang teach that the plasmid used for expression in mammalian cells were made in pRK5 (section 0268) and that the proteins were cloned into the pRK5 plasmid (section 0401) so one would have been motivated to use known expression vectors. One would have had a reasonable expectation of success since Yang teach PML for protection from neurodegeneration (section 0372 and claim 9). Yang teach PML as having an antiviral response (section 0265).
In relation to the protein as recited in claim 1, Yang teach that TRIM19 is also known as PML (section 0009). Yang teach that the amino acid sequence for TRIM19 is SEQ ID NO:38 (Table 1 and sequence listing) which is the same as instant SEQ ID NO:3.
In relation the method of claims 1-5, as noted above the claims are unclear. Yang teach that each TRIM protein (except TRIM12 and TRIM30) was expressed in HeLa cells (section 0398). Yang teach the data related to TRIM19 expression is provided in figure 19 (section 0400). Thus, Yang used the TRIM19 (i.e. PML) protein. In relation to any functional properties, since the same protein was used such protein would function as claimed. Since the use claim is unclear it is interpreted as including any use including in vitro and preventative uses. In addition, Yang teach PML for protection from neurodegeneration (section 0372 and claim 9). Yang teach PML as having an antiviral response (section 0265). Yang teach a composition that comprises one of the peptides and specifically recites TRIM19 (section 0128). Yang teach treating and preventing disease (claim 13) and recites diseases including neurodegenerative disease and cancer (claim 9).
In relation to the nucleotide sequence of claim 3, Yang teach that TRIM19 is also known as PML (section 0009). Yang teach that the nucleotide sequence is SEQ ID NO:37 (Table 1 and sequence listing) which is the same as instant SEQ ID NO:1.
In relation to claims 4-5, Yang teach that the plasmid used for expression in mammalian cells were made in pRK5 (section 0268). Yang teach that in the experiments described above (which include section 0398) that the proteins were cloned into the pRK5 plasmid (section 0401).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
Prosecution Insights