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 2-4, 6-12, 17, 19, 23-28, 33-44, and 46-48 drawn to a tsRNA molecule that triggers 3’ ER with species election of ganciclovir in the reply filed on May 20, 2026 is acknowledged.
Status of Claims
Claims 1-4 and 6-48 are pending in the instant application. Claims 13-16, 20-22, 29-32, and 45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 1-4, 6-12, 17-19, 23-28, 33-44, and 46-48 are under examination on the merits in the instant application.
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. 16/090,226, filed on September 29, 2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 10, 2022 has been considered by the examiner. Note that foreign patent document numbers 2 and 7 are not considered as they are in non-English language and an English language translation has not been submitted.
Specification
1. The abstract of the disclosure is objected to because it contains legal phraseology “said”, which should be avoided. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
2. The specification is objected to as it does not contain proper section headings as provided in 37 CFR 1.77(b). For instance, “Statements of the Invention” and “Methods and Materials” are improper, and the specification does not contain the required section “DETAILED DESCRIPTION OF THE INVENTION”. Appropriate correction is required.
3. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See page 22. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
4. The disclosure is objected to for containing sequence rule non-compliant subject matter. See page 15, line 32. Appropriate correction is required as instructed below.
Drawings
1. The drawings are objected to because the description of the drawings as provided in the specification is not reflected in the actual drawings. That is, the specification explicitly states that the instant application “contains at least one drawings executed in color.” However, there is no color drawing and furthermore, there is no petition to accept color drawings in the instant application. Appropriate correction and/or clear explanation is required.
2. The drawings are objected to because Figures 1C, 7a-7e, and 8a-8e contain sequence rule non-compliant subject matter. Appropriate correction is required as instructed below.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide sequences appearing in the drawings, see Figures 1C, 7a-7e, and 8a-8e, are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency – Nucleotide sequences appearing in the specification, see page 15, are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claim 9 is objected to because of the following informalities: “adjacent” in line 2 should be “adjacent to”. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: “vectors” in line 2 should be “vector”. Appropriate correction is required.
Claim 41 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 11. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 39-40 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites that the binding site of claim 1 comprises nucleotides of “25, 26, 27, 28, 29,…299, 300 or more nucleotides.” This limitation fails to further limit the number of nucleotides for the binding site of claim 1 because claim 1 already requires that the minimum number of nucleotides is “at least 25”, wherein the numbers recited in claim 2 do not further limit the “at least 25” nucleotides as evidenced by the fact that the minimum number recited in claim 2 is “25” without any maximum number as evidenced by “or more nucleotides.” As such, the limitations recited in claim 2 do nothing to change the scope of the number of nucleotides recited for the binding site of claim 1.
Claim 39 recites limitations that are already recited in claim 1 thus fails to further limit the subject matter of claim 1.
Claim 40 recites that the “binding domain is complementary to a part of a gene”. This limitation is inherently required by claim 1, which recites and the binding domain should be “specific” for a part of a gene. Hence, claim 40 fails to further limit the subject matter of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 1-4, 6-12, 17-19, 23-28, 33-44, and 46-48 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.
Claim 1 and dependent claims thereof recite “within or outside said binding site…has one or more mismatch nucleotides with respect to said gene.” It is unclear which nucleotide positions are meant to read on being “outside said binding site”. That is, the claims fail to particularly point out and distinctly claim how distant the “outside” should be for introducing the one or more mismatch nucleotides in relation to the binding site sequence, thereby rendering the claimed structure indefinite.
Claim 3 recites that the binding domain of claim 1 “comprises a sequence of nucleotides that is at least 50%, 55%,… complementary to said part of a gene”.
It is noted that the binding domain of claim 1 is required to be “specific for at least a part of a gene”. It is unclear how a nucleotide sequence that is merely 50% complementary to the part of a gene can possibly deemed “specific” for the part of the gene. As such, claim 3 recites structurally and functionally conflicting limitations regarding the binding domain, thereby rendering the claim indefinite.
Claim 4 recites the limitation "the mismatches" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 10 and 11 each recite the limitation "said binding domains". There is insufficient antecedent basis for this limitation in the claims.
Claim 12 recites “outside the binding domain”. It is unclear which nucleotide positions are meant to read on being “outside the binding domain”. That is, the claims fail to particularly point out and distinctly claim how distant the “outside” should be for introducing the one or more mismatch nucleotides in relation to the binding domain sequence, thereby rendering the claimed structure indefinite.
Claim 19 recites multiple broad limitations (e.g., “skin cancers”, “leukemia”) and also simultaneously recites multiple narrower limitations (e.g., “melanoma including malignant melanoma”, “ALL”, “AML”, “CML”) within the broad limitations. The claim is deemed indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
Claim 20 recites “any other integrating virus.” It is unclear what is meant by this limitation and which “other integrating virus” is deemed “viral infection”.
Claims 21-22 each recite “or others.” The claims fails to particularly point out and distinctly claim what is meant by “others.”
Claim 33-34 each recite the limitation "said cell". There is insufficient antecedent basis for this limitation in the claims.
Claims 35-36 each recite “one further component of said suicide system”. It is unclear what is meant by “one further component”. That is, it is unclear whether the “one further component” is same as the “component of a suicide system” thus having two of the same components or whether the “further component” is something entirely different from what is recited in claim 1. As such, the clear metes and bounds of the structure of claims 35-36 cannot be ascertained.
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 1-4, 6-12, 17-19, 23-28, 33-44, and 46-48 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 encompass and read on a 3’ exon replacement (3’ ER) tsRNA molecule composition comprising an unstructured BD having at least 25 and up to “300 or more nucleotides” in length, wherein for the BD that is at least 44 nucleotides in length, the BD is required to comprise “one or more mismatch nucleotides” “outside said binding site”.
The instant specification does not appear to provide a representative number of structurally variant species within the claimed genus of 3’ ER tsRNA having the length range of 25 nucleotides up to an unlimited, infinite number of nucleotides for the claimed BD. That is, the instant specification at best appears to disclose a 50-mer 3’ ER BD sequence, wherein the single 50-mer length of the BD is not reflective of the substantial structural variations encompassed by the claimed BD lengths. In fact, a post-filing reference by Poddar et al. (Molecular Therapy: Nucleic Acids, 2018, 11:41-56) reports that the 3’ER is provided by “unstructured BDs of 50 to 100 nt in length” such that the tsRNA “should comprise unstructured BDs of 50 to 100 nt in length imperfectly binding to 3’ or 5’ proximal introns of one or multiple biomarker pre-mRNA for 3’ or 5’ ER, respectively.” See page 52. Note that the post-filing reference reflects the absence of relevant prior art pertaining to the lengths of 25 nucleotides to an infinite number of nucleotides for the instantly claimed unstructured BD for 3’ ER.
Regarding the “mismatched nucleotides” required to be present “outside said binding site” of a BD of 44 nucleotides or longer, the instant specification does not appear to provide any BD satisfying the claimed structural limitations. Indeed, the post-filing reference by Poddar also discloses that two mismatches are present in the “central” position (specifically positions 18-19) of the 50-mer BD. See Figure 2A. The two mismatch nucleotide positions 18-19 within the 50-mer BD sequence are far from representing any number of mismatches “within” or “outside” of the binding site when the BD is at least 40 nucleotides in length.
Claim 12 requires that “said tsRNA, outside the binding domain, comprises at least one cis-binding or self-binding domain.” As already noted above in the §112(b) rejection, the limitation “outside the binding domain” is indeterminable and indefinite. Now, the “cis-binding or self-binding domain” that is required to be present “outside the binding domain” is not clearly defined/described in the specification, which at best appears to disclose “self-binding domain BD-D which was positioned directedly upstream of BD-opt to shield the PPT of acceptor splice site A of the trans-splicing RNA”. See page 26. As such, the instant specification appears to describe a single position (upstream from the BD) for the genus of “outside the binding domain” and a single nucleotide sequence species (a sequence binding to the PPT of the tsRNA) within the claimed genus of any “at least one cis-binding or self-binding domain.” The single species disclosed in the instant specification is not a representative number of species within the claimed genus because the tsRNA function for providing 3’ER was deemed to highly depend on the actual structure/sequence of the tsRNA, which is expressly acknowledged on the record that the claimed tsRNA molecule comprises “novel optimized RNA sequences”. See page 23. That is, the specification expressly acknowledges on the record that the claimed tsRNA or the tsRNA that the instant co-inventors completed and had possession of as of the filing date has “novel” and “optimized” RNA sequences, thereby suggesting a lack of relevant prior art knowledge pertaining to the claimed genus, let alone the disclosed species. As such, the instant specification must describe a sufficient number of structural variants within the claimed genus in order to comply with the written description requirement because the specificity of the disclosure is inversely correlated with the state of the prior art knowledge and the level of predictability. See MPEP §2163.
It is also noted that claim 38 requires “at least one expressible protein comprises two A/G-rich exonic splice enhancers (ESE)”. The instant specification discloses that the tsRNA molecule comprises “an optimized HSVtk gene harbouring a novel strengthened exonic splice enhancer (ESE) as well as the a-globin mini intron.” (emphasis added). See page 23. The instant specification does not appear to disclose the crucial “novel strengthened exonic splice enhancer (ESE)” sequence, which appears to correspond to what is claimed in claim 38. Further, even if such sequence is expressly disclosed in the instant specification, the single species, which is “novel”, cannot represent the entire genus of any ESE sequences “generated by using degenerative alternative codons” because neither the instant specification nor the prior art teaches which ESE sequence included in the claimed tsRNA has the function of triggering 3’ER as required by the claims.
In view of the foregoing, it is clear that the instant specification is deficient and insufficient to adequately describe the entire genus of the claimed subject matter in the manner to reasonably convey that the instant co-inventors completed and had possession of the entire genus of tsRNA molecules as of the filing date sought 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, 6, 8-9, 17-19, 23-28, 33-37, 39-41, 44, and 46-48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bauer et al. (US 2015/0250901 A1, applicant’s citation).
Bauer discloses a “pre-mRNA trans-splicing molecule (RTM)” comprising “a binding domain (DB)” of “at least 10 to 30” nucleotides in length and is complementary to an intron sequence of a target pre-mRNA that is associated with a cancerous disease such as skin cancer, a “spacer region”, “a splicing domain” comprising “a polypyrimidine tract (PPT), a 3’ acceptor splice site” and/or 5’ splice donor site”, and “a complete coding sequence of a suicide gene” such as “herpes simplex type 1 thymidine kinase (HSV-TK)”, wherein the RTM is formulated in a vector (e.g., “liposomes”, “adeno-associated virus”, and “plasmids”) or as a pharmaceutical composition with a physiologically/pharmaceutically acceptable carrier that can be used with an anti-cancer prodrug such as “ganciclovir, which is converted in vivo to a toxic compound by HSV-tk”, wherein the RTM is expressed in a mammalian including human cell. See paragraphs 0010-0011, 0016-0020, 0034-0036, 0038, and 0040-0052.
Since Bauer does not expressly teach that the DB sequence comprises a self-complementary sequence, Bauer’s DB is deemed to be free of a self-complementary sequence, absent objective evidence to the contrary.
Since Bauer’s RTM fully satisfies all structural limitations set forth in claim 1, it necessarily follows that Bauer’s RTM would have an inherent property that “triggers 3’ER” as recited in claims 8 and 17, absent objective evidence to the contrary.
Accordingly, 1-3, 6, 8-9, 17-19, 23-28, 33-37, 39-41, 44, and 46-48 are described by Bauer et al.
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 (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 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.
Claims 1-3, 6-11, 17-28, 33-37, 39-41, 44, and 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over Bauer et al. (US 2015/0250901 A1, applicant’s citation) in view of Bunnell et al. (Clinical Microbiology Reviews, 1998, 11:42-56).
Bauer discloses a “pre-mRNA trans-splicing molecule (RTM)” comprising “a binding domain (DB)” of “at least 10 to 30” nucleotides in length and is complementary to an intron sequence of a target pre-mRNA that is associated with a cancerous disease such as skin cancer, a “spacer region”, “a splicing domain” comprising “a polypyrimidine tract (PPT), and a 3’ acceptor splice site”, and “a complete coding sequence of a suicide gene” such as “herpes simplex type 1 thymidine kinase (HSV-TK)”, wherein the RTM is formulated in a vector (e.g., “liposomes”, “adeno-associated virus”, and “plasmids”) or as a pharmaceutical composition with a physiologically/pharmaceutically acceptable carrier that can be used with an anti-cancer prodrug such as “ganciclovir, which is converted in vivo to a toxic compound by HSV-tk”, wherein the RTM is expressed in a mammalian including human cell. See paragraphs 0010-0011, 0016-0020, 0034-0036, 0038, and 0040-0052.
Since Bauer does not expressly teach that the DB sequence comprises a self-complementary sequence, Bauer’s DB is deemed to be free of a self-complementary sequence, absent objective evidence to the contrary.
Bauer does not teach targeting genes associated with viral infection or bacterial infection or a genetic disease, nor does Bauer teach targeting two different parts of a gene or two different genes.
Bunnell teaches that treatment of “hereditary genetic disorders and infectious diseases” via “nucleic acid moieties” including “suicide genes” such as HSV tk is an art-recognized goal”, wherein the infectious diseases are associated with “bacterial, viral, or parasitic pathogens” and include HIV-1 infection. See the entire reference including pages 42-45.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the RTM of Bauer by additionally including another target-specific BD sequence, each BD sequence targeting different positions of the same disease-associated gene or two different positions of two different disease-associated genes. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to make a tsRNA molecule having a greater level of efficacy by targeting two regions of the same gene because one of ordinary skill in the art would have reasonably deemed that targeting two regions of the same gene would provide a greater level of target binding as compared to a tsRNA molecule targeting only one region of a gene, thereby providing a higher or greater level of RTM activity. Similarly, one of ordinary skill in the art would have been motivated to make a bi-funcitonal tsRNA molecule simultaneously targeting two genes because one of ordinary skill in the art would have reasonably deemed that targeting two different genes associated with a disease would be more effective in providing the intended therapeutic effect than targeting a single gene. It would also have been obvious to one of ordinary skill in the art to design the BD to target any of the art-recognized genes associated with a genetic disorder, a viral infection, or a bacterial infection because making a nucleic acid-based therapeutic agent for the purpose of treating a genetic disorder, a viral infection, or a bacterial infection was an art-recognized goal as evidenced by Bunnell.
Accordingly, claims 1-3, 6-11, 17-28, 33-37, 39-41, 44, and 46-48 taken as a whole would have been prima facie obvious before the effective filing date.
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 23 is rejected under 35 U.S.C. 101 because 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 23 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).
The instant claims as written reads on a human organism comprising a human cell that contains the claimed tsRNA in light of the fact that the “cell” is defined as being “most typically human.” See page 8 of the specification.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6-12, 17-19, 23-28, 33-44, and 46-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,517,583 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘583 patent claims drawn to and that require a tsRNA molecule comprising the instantly claimed structural limitations including a disease-associated gene binding domain, a nucleotide encoding a suicide protein such as HSVtk, and a splice signal.
Claims 1-4, 6-12, 17-19, 23-28, 33-44, and 46-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8-9, 13, 18, 20, 24-25, 30, 33-34, 36-37, 40, 46, and 48 of copending Application No. 18/730,291.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘291 claims drawn to and that require a tsRNA molecule comprising the instantly claimed structural limitations including a disease-associated gene binding domain, a nucleotide encoding a suicide protein, and a splice signal.
Conclusion
No claim is allowed.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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