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
This Office Action is a response to Applicant’s Preliminary Amendment filed October 11, 2023.
Claims 4-44, 46-67, 69, 70, 73-77, 79-82, 84, 86, 89-133, 135-156, 159-175, 177, 178, 182-185, 187, 189 and 191 have been canceled. Claims 68, 71, 72, 78, 83, 85, 134, 176, 179, 180, 181, 186, 188 and 190 have been amended.
Claims 1-3, 45, 68, 71, 72, 78, 83, 85, 87, 88, 134, 157, 158, 176, 179-181, 186, 188 and 190 are pending in the present application.
Claims 1-3, 45, 68, 71, 72, 78, 83, 85, 87, 88, 134, 157, 158, 176, 179-181, 186, 188 and 190 have been examined on the merits as detailed below:
Information Disclosure Statement
Applicant's information disclosure statement (IDS) filed December 19, 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
The listing of references in the specification at pages 138 and 139 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The Drawings filed on May 3, 2023 are acknowledged and have been accepted by the Examiner.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. Many claims recite the term, “PMS2”. According to the present Specification:
“As described herein, the term “PMS2” refers to the gene encoding for the protein PMS1 Homolog 2 (PMS2).”
The Examiner will interpret the term, “PMS2” to be the protein PMS1 Homolog 2.
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 1-3, 45, 68, 71, 72, 78, 83, 85, 87, 88, 134, 157, 158, 176, 179-181, 186, 188 and 190 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 term "substantially" in claims 1, 2, 45, 78, 87, 88, 134, 157, 186 and 188 is a relative term which renders the claims indefinite. The term "substantially" is not defined by the claim, the specification does not provide a clear definition for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, one in the art without a definition would not know where the metes and the bounds of the claims are. One in the art would not know, for example if 50% qualifies as, “substantially”. One in the art could assert that 80% is substantial and one could argue that 30% is substantial. Without a clear definition, one in the art would be required to make assumptions of the metes and bounds of the claim based on their opinion of what “substantially” would mean in the context of the instant claims.
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.
Claim Rejections - 35 USC § 102
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 3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 8090542.
The claim is drawn to a double stranded RNA (dsRNA) molecule comprising a sense strand and an antisense strand, wherein the antisense strand comprises a sequence substantially complementary to a PMS2 nucleic acid sequence of any one of SEQ ID NOs: 1-10, and comprising complementarity to at least 10, 11, 12 or 13 contiguous nucleotides of the PMS2 nucleic acid sequence of any one of SEQ ID NOs: 1-10.
U.S. Patent No. 8090542 disclose functional and hyperfunctional siRNA. U.S. Patent No. 8090542 disclose particular siRNAs, Sequence 382576 or Sequence 382539, which are dsRNA molecule comprising a sense strand and an antisense strand, wherein the antisense strand comprises a sequence substantially complementary to a PMS2 nucleic acid sequence of any one of SEQ ID NOs: 1-10 and comprising complementarity to at least 10, 11, 12 or 13 contiguous nucleotides of the PMS2 nucleic acid sequence of SEQ ID NOs. 10 and 4, respectively of the present invention. See alignments below:
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526
578
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540
576
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Therefore, claim 3 is anticipated by U.S. Patent No. 8090542.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 87 and 186 are rejected under 35 U.S.C. 103 as being unpatentable and obvious over U.S. Patent No. 10669542 B2.
Claim 87 is drawn to a branched RNA compound comprising: two or more RNA molecules comprising 15 to 35 nucleotides in length, and a sequence substantially complementary to a PMS2 mRNA, wherein the two RNA molecules are connected to one another by one or more moieties independently selected from a linker, a spacer and a branching point. Claim 186 is drawn to a method of treating or managing Huntington's Disease (HD) or a trinucleotide repeat disease or disorder, the method comprising administering to a patient in need of such treatment or management a therapeutically effective amount of an oligonucleotide comprising a sequence substantially complementary to a PMS2 nucleic acid sequence.
U.S. Patent No. 10669542 teaches oligonucleotides directed to subunits of the DNA mismatch repair system, wherein the subunit of the DNA mismatch repair system is PMS2. Specifically, U.S. Patent No. 10669542 teaches antisense compounds targeted to PMS2, wherein the antisense compounds are prepared to be circular and/or branched. NOTE: The antisense compounds of U.S. Patent No. 10669542 are siRNA, shRNA, ribozymes, external guide sequence (EGS) oligonucleotides, single- or double-stranded RNA interference (RNAi).
U.S. Patent No. 10669542 also teaches embodiments of the invention may be used to treat human DNA Repeat Expansion Disease (DRED), including Huntington's disease (HD).
Before the effective filing date of the claimed invention, it was known in the art to make and use antisense oligonucleotide compounds targeted to PMS2 as taught and suggested by the prior art of U.S. Patent No. 10669542.
It would have been obvious and one of ordinary skill in the art would have been motivated to modify the antisense oligonucleotide compounds of U.S. Patent No. 10669542 to include branched antisense for the purpose of preparing compounds to be joined.
A person of ordinary skill in the art would have been motivated to use the antisense oligonucleotide compounds of U.S. Patent No. 10669542 to treat or manage HD or a trinucleotide repeat disease or disorder as taught by the prior art reference to provide therapeutic efficacy in a human subject.
Therefore the invention as a whole would have been prima facie obvious to one ordinary skill in the art before the effective filing date of the claimed 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.
Claim 83 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claimed invention is directed to non-statutory subject matter because Section 33(a) of the America Invents Act (AIA ) reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 83 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). In the instant case, the claim is drawn to a cell comprising a vector comprising a regulatory sequence operably linked to a nucleotide sequence that encodes a double stranded RNA (dsRNA) molecule comprising a sense strand and an antisense strand, wherein the antisense strand comprises a sequence substantially complementary to a PMS2 nucleic acid sequence of any one of SEQ ID NOs: 1-10. Since the claim is not limited to “an isolated cell”, the claim is broadly interpreted to encompass stem cells which ultimately, include a human subject. Applicant is reminded that a claim directed to or including within its scope a human being will not be considered to be patentable subject matter. Section 33(a) of the AIA clearly indicates that no patent may issue on a claim encompassing a human organism, therefore, the claim is rejected under 35 U.S.C. 101.
It is noted that amending the claim such that it is limited to “an isolated cell” would obviate this rejection.
Conclusion
No claims are allowable at this time.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 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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/TERRA C GIBBS/Primary Examiner, Art Unit 1635