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 Group II, claims 38-39, 42, 46, 49, 58, 61-74 in the reply filed on 10/10/2025 is acknowledged.
Claims of Group I are cancelled.
Claim Objections
Claim 38 is objected to because of the following informalities: claim recites “the dsRNA compound” in the fourth line. This is the first mentioning of such dsRNA compound, therefore it should be changed to “a dsRNA compound”. 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 42, 61, 67-68, 72 and 73 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 42 recites exemplary language “such as” in the fourth line. It is unclear if the limitation following the language is a part of the claim or not.
Claim 61 recites exemplary language “such as” in the first line. It is unclear if the limitation following the language is a part of the claim or not.
Claim 67 recites exemplary language “such as” in the second line. It is unclear if the limitation following the language is a part of the claim or not.
Claim 68 recites exemplary language “such as” in the second line. It is unclear if the limitation following the language is a part of the claim or not.
Claim 68 recites the limitation "the coronavirus" in the first line. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination it will be considered that claim 68 depends on claim 67, but appropriate correction is required.
Claim 72 recites the term “about” in the second and third lines. Instant specification defines the term as being of deviation of at least 5 or 10% (see paragraph [0062] of instant specification). There is no upper limit of the deviation, therefore the metes and bounds of the term “about” are not defined.
Claim 73 recites exemplary language “such as” in the second and third lines. It is unclear if the limitation following the language is a part of the claim or not.
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(s) 38, 42, 46, 49, 58, 61-74 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pachuk (US 2004/0180438, September 2004, cited from IDS).
Concerning claims 38 and 72 Pachuk discloses methods of gene silencing in vertebrate cells comprising administering dsRNA having substantial sequence identity to the target nucleic acid (see Abstract, paragraph [0007]), such dsRNA can be 500, 600 or 1000 nucleotides in length (see paragraph [0031]), comprising sense (passenger) and antisense (guide) strands complementary to each other, wherein antisense strand is complementary to the target nucleic acid (see paragraph [0132, 0063]). Such dsRNA can be produced by a vector encoding dsRNA (see paragraph [0018]). Such dsRNA can be a part of pharmaceutical composition (see paragraph [0042]).
Concerning claims 42, 67 and 68 Pachuk discloses that dsRNA targets viral gene transcript sequence (see paragraphs [0015, 0119]). It is noted that claims limitations following the word “optionally” are optional and do not need to be taught in the prior art to reject the claims. Claim 68 further limits such optional limitation of claim 67, therefore it is rejected as well.
Concerning claim 46 Pachuk discloses that dsRNA can be administered topically (see paragraph [0042]), and inherently, such topical administration will be applied to the site of infection, if such exists. It is noted that claim limitations following the word “optionally” are optional and do not need to be taught in the prior art to reject the claim.
Concerning claim 49 Pachuk discloses that dsRNA can be administered intranasally, topically or subcutaneously (see paragraph [0042]).
Concerning claims 58 and 61 Pachuk discloses that the cell can be cancer (disease) cell (see paragraph [0049]).
Concerning claim 62 Pachuk discloses the dsRNA 800 nucleotides long with the guide strand fully complementary to SEAP gene (see paragraphs [0146-0148]). In this case the whole guide strand consists of nucleotides complementary to the gene, the segment of dsRNA complementary to target gene is at the 5’ end and 3’ end of the guide strand.
Concerning claim 63 Pachuk discloses the dsRNA 800 nucleotides long with the guide strand fully complementary to SEAP gene (see paragraphs [0146-0148]). It is inherent that such guide strand is complementary to the gene sequence. Instant specification defines a segment of guide strand of being as short as 20 nucleotides (see paragraphs [0070-0071] of instant specification. Therefore, the whole dsRNA of 800 nucleotides can be considered as consisting of 40 segments of 20 nucleotides long, each of those segments complementary to a different target sequence of SEAP gene.
Concerning claim 64 Pachuk discloses that dsRNA can comprise overhang (see paragraph [0063]).
Concerning claim 65 Pachuk discloses that dsRNA can comprise 2’-O-Me modified nucleotides (see paragraph [0064]).
Concerning claim 66 Pachuk discloses that dsRNA can be phosphorylated at 5’ end (see paragraph [0078]).
Concerning claim 69 Pachuk discloses that target nucleic acid (gene) can be oncogene (see paragraph [0070]). It is noted that claim limitations following the word “optionally” are optional and do not need to be taught in the prior art to reject the claim.
Concerning claim 70 Pachuk discloses that expression cassette (vector) expressing dsRNA can comprise T7 polymerase promoter (see paragraph [0027]). It is noted that claim limitations following the word “optionally” are optional and do not need to be taught in the prior art to reject the claim.
Concerning claim 71 Pachuk discloses that pharmaceutical composition comprising dsRNA can also comprise pharmaceutically acceptable carrier (see paragraph [0042]). It is noted that claim limitations following the word “optionally” are optional and do not need to be taught in the prior art to reject the claim.
Concerning claim 73 Pachuk discloses that the cell can be human cell (see paragraph [0007]).
Concerning claim 74, the claim further limits one of the options in independent claim 38, a conjugate. Other options in claims 38 and 74, dsRNA and vector, are anticipated by Pachuk, therefore a conjugate need not to be taught in the prior art to anticipate claim 74, which still comprises dsRNA and vector limitations.
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.
Claim(s) 38-39, 42, 46, 49, 58, 61-74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pachuk, above.
Teachings of Pachuk are discussed above. Pachuk further teaches determination of immune response caused by dsRNA administration (see paragraph [0108], Figure 2). Pachuk teaches that immune response needs to be reduced or prevented (see paragraph [0016]).
Pachuk do not teach administering dsRNA in an amount below predetermined IFN induction threshold.
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to administer dsRNA in the amount below predetermined IFN induction threshold as taught by Pachuk. One of the ordinary skill in the art would be motivated to do so, because Pachuk teaches determination of immune response caused by dsRNA administration and suggests reduction or prevention of such immune response, which can be achieved by administering such dsRNA at a lower concentration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637