Prosecution Insights
Last updated: April 19, 2026
Application No. 18/044,057

MODIFICATIONS OF MAMMALIAN CELLS USING ARTIFICIAL MICRO-RNA TO ALTER THEIR PROPERTIES AND THE COMPOSITIONS OF THEIR PRODUCTS

Non-Final OA §101§103§112
Filed
Mar 03, 2023
Examiner
CHONG, KIMBERLY
Art Unit
1636
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Dna Twopointo Inc.
OA Round
1 (Non-Final)
72%
Grant Probability
Favorable
1-2
OA Rounds
2y 7m
To Grant
85%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allow Rate
1066 granted / 1473 resolved
+12.4% vs TC avg
Moderate +12% lift
Without
With
+12.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
67 currently pending
Career history
1540
Total Applications
across all art units

Statute-Specific Performance

§101
3.9%
-36.1% vs TC avg
§103
26.8%
-13.2% vs TC avg
§102
20.6%
-19.4% vs TC avg
§112
29.5%
-10.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1473 resolved cases

Office Action

§101 §103 §112
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 Election/Restrictions Applicant's election without traverse of Group I and SEQ ID Nos. 570, 568, 90 and 91 in the reply filed on 10/28/2025 is acknowledged. Status of the Application Claims 48-71 are pending. Claims 48-50, 52, 53, 70 and 71 are currently under examination. Claims 51 and 54-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. SEQ ID Nos. 90, 91 and 568 are free of the prior art searched. Information Disclosure Statement The submission of the Information Disclosure Statement on 09/05/2023 is in compliance with 37 CFR 1.97. The information disclosure statement has been considered by the examiner and signed copies have been placed in the file. Claim Rejections – Improper Markush Claim 53 is rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The claims are directed to a large multitude of sequences that have no common searchable structure. Although the sequences are made up of the same four bases, they do not share any significant similarity in the order in which those bases are arranged. Thus, the structures of the sequences are different. When the Markush grouping is for alternatives of chemical compounds, they shall be regarded as being of a similar nature where the following criteria are fulfilled: (A) All alternatives have a common property or activity; and (B) (1) A common structure is present, i.e., a significant structural element is shared by all of the alternatives; or (B) (2) In cases where the common structure cannot be the unifying criteria, all alternatives belong to a recognized class of chemical compounds in the art to which the invention pertains. In paragraph (B)(1), above, the words “significant structural element is shared by all of the alternatives” refer to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity. The structural element may be a single component or a combination of individual components linked together. In paragraph (B)(2), above, the words “recognized class of chemical compounds” mean that there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved. In order for the members of the Markush group to belong to “recognized class of chemical compounds” there must be an expectation that the members of the class will behave in the same way in the context of the claimed invention. In other words, each member of the class could be substituted one for the other with the expectation that the same intended result would be achieved. In the instant case, activity of any specific nucleic acid molecule is dependent upon the specific sequence of nucleotides. The specification describes SEQ ID Nos 212-216, 567 and 569 as targeting the Neu3 mRNA and SEQ ID Nos. 217-221 and 568 as targeting Neu2 [00186-00187]. The prior art of Glanz et al. ("Sialidase activity in human pathologies." European Journal of Pharmacology 842 (2019): 345-350) teach Sialidases, or neuraminidases, are glycosidases that catalyze the hydrolysis of α-glycosidic bonds linking sialic acid residues and teach four types of sialidases were described: NEU1, NEU2, NEU3, and NEU4. The four proteins differ from each other by the expression patterns, localization and functions (see page 345). The prior art teach that even among sialidase, each has a different sequence and function. Thus there is no expectation that any one of the nucleotide sequences as claimed can be substituted for any of the other with a completely different sequence with the expectation of the same activity. In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. 134 and 37 CFR 41.31(a)(1). 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. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. 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 70 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 70 recites a “mammalian cell” thus encompasses an in vivo cell in a human organism, thereby reading on a human organism. For examination purpose, the “cell” will be interpreted as an isolated cell. 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. Claims 48, 49, 53 and 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seol (US 20120142764) in view of Zhang et al. ("Enhancing glycoprotein sialylation by targeted gene silencing in mammalian cells." Biotechnology and bioengineering 105.6 (2010): 1094-1105). Regarding claim 48, 49, 53 and 70, Seol teach multi-cistronic shRNAs for suppressing the expression of a single target gene wherein the shRNA are derived from miR-30 (see 0004-0006). Seol et al. teach the shRNA comprises a guide strand and a passenger strand and a loop strand from 15 to 30 nucleotides in length (that meets the limitations of comprising 19 nucleotides in length) and teach the stem or loop region has 5 to 30 nucleotides (see 00037). Seol et al. teach the polynucleotide is expressed in a cell (0053). Seol et al. teach pol II (CMV) promoter (0035) for expression of the polynucleotide. Seol taught that expression of multi-cistronic shRNAs for multiple silencing of different regions of a single target gene (FIG. 7A) is expected to silence the single target gene more powerfully than that of individual mono-cistronic shRNAs (paragraph 47). Seol et al. do not teach the mRNA encodes an enzyme that reduces protein sialylation or encodes a sialidase. Zhang et al. teach a strategy to slow down the sialic acid removal rate by reducing expression and activity of sialidase genes and teach sialidases (EC 3.2.1.18) are exoglycosidases catalyzing the removal of sialic acids from glycoproteins and glycolipids of which there are four (Neu1–4) characterized in human, mouse, and rat located at different locations in the cell. Zhang et al. teach Neu1 is located in the lysosome, Neu2 is a cytosolic protein, Neu3 is located in the plasma membrane and Neu4 is a second lysosomal sialidase. Zhang et al. teach these sialidases have been found to be very crucial to many biophysiological processes, such as cell differentiation regulation, tumorigenesis, neuronal differentiation and genetic defects (see page 1095 first col.). Zhang et al. teach using shRNA to reduced sialidase expression in cells (page 1102-1103). It would have been obvious to one of ordinary skill in the art at the time of the invention to use multi-cistronic amiRNAs encoding two or more amiRNAs as taught by Seol to target a sialidase mRNA in cells. It would have been obvious to try using the multi-cistronic amiRNAs for multiple silencing of different regions of a single target gene targeting this mRNA because it has been identified as associated with pancreatic ductal adenocarcinoma which is one of the most dangerous cancers. Zhang et al. teach there is a need to slow down the sialic acid removal rate and teach finite number of sialidases that have been identified in the prior art. Because Zhang et al. teach efficient reduction of expression of sialidase using shRNA and Seol et al. teach an efficient method of using very efficient multi-cistronic amiRNAs that is more powerfully than that of individual mono-cistronic amiRNAs, one would have been capable and expected to be able to design the multi-hairpin amiRNAs to target sialidase mRNA in cells. Thus the invention as a whole was prima facie obvious. Claims 48-50, 53 and 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seol (US 20120142764) in view of Glanz et al. ("Sialidase activity in human pathologies." European Journal of Pharmacology 842 (2019): 345-350). Regarding claim 48, 49, 50, 53, 70 and 71, Seol teach multi-cistronic shRNAs for suppressing the expression of a single target gene wherein the shRNA are derived from miR-30 (see 0004-0006). Seol et al. teach the shRNA comprises a guide strand and a passenger strand and a loop strand from 15 to 30 nucleotides in length (that meets the limitations of comprising 19 nucleotides in length) and teach the stem or loop region having 5 to 30 nucleotides (see 00037). Seol et al. teach the polynucleotide is expressed in a cell (0053). Seol et al. teach pol II (CMV) promoter (0035) for expression of the polynucleotide. Seol teach that expression of multi-cistronic shRNAs for multiple silencing of different regions of a single target gene (FIG. 7A) is expected to silence the single target gene more powerfully than that of individual mono-cistronic shRNAs (paragraph 47). Seol et al. do not teach the mRNA encodes an enzyme that reduces protein sialylation or encodes a sialidase and do not teach SEQ ID No. 570. Glanz et al. teach sialidases, or neuraminidases, are glycosidases that catalyze the hydrolysis of α-glycosidic bonds linking sialic acid residues to carbohydrate groups of glycoproteins and glycolipid (introduction). Glanz et al. teach cytosolic sialidase NEU2, which is almost undetectable under normal physiological conditions, was found to be involved into apoptotic events in pancreatic ductal adenocarcinoma, one of the most dangerous cancers due to poor diagnosis and prognosis (page 347). Glanz et al. teach modulation of sialidase genetic expression and enzymatic activity by specific inhibitors, antibodies and siRNAs might be effective for implementing principles of personalized medicine for managing diseases related to altered sialylation and thus solve major healthcare problems. It would have been obvious to one of ordinary skill in the art at the time of the invention to use multi-cistronic amiRNAs encoding two or more amiRNAs as taught by Seol to target a sialidase mRNA such as NEU2. It would have been obvious to try using the multi-cistronic amiRNAs for multiple silencing of different regions of a single target gene targeting this mRNA because it has been identified as associated with pancreatic ductal adenocarcinoma which is one of the most dangerous cancers. Because Glanz et al. proposes targeting NEU2 using inhibition nucleotides and Seol et al. teach an efficient method of using very efficient multi-cistronic amiRNAs that is more powerfully than that of individual mono-cistronic amiRNAs, one would have been capable and expected to be able to design the amiRNAs to target the mRNA NEU2 in efforts of finding a therapeutic to treat diseases. Regarding claim 50, the claim requires that the target mRNA comprises a sequence that is at least 98% identical to SEQ ID No. 570 (which is an mRNA encoding Neu2 as described in [00188] of the specification. The claim does not require that the recited mRNA sequence is at least 98% identical to the entire length of the recited SEQ ID N0. 570 or the nucleotides that are 98% identical consecutive. Therefore the claim embraces an mRNA comprising a sequence of any length that has nucleotides 98% identical to a SEQ ID No. 570. GenBank Accession No. NW_003615196 is a sequence of Cricetulus griseus of a sialidases Neu2 and comprises 1657 nucleotides of SEQ ID No. 570 within the entire sequence and thus would meet the limitation of the claims (see included Blast alignment of SEQ 570 and GenBank Accession No. NW_003615196). It would have been obvious to use this known sequence to design multi-cistronic amiRNAs to target the Neu2 sialidase. Thus the invention as a whole was prima facie obvious. Claim Rejections - 35 USC § 112 The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph: 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. Written Description Claims 48-50 and 70 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated: To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966; Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398. The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial Structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed structure, and v. Correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species by “…disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between functional and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Thus when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The claims are drawn to a genus of multi-hairpin amiRNA sequences of varying lengths comprising varying passenger strand complementarity to the guide strand and varying loop sequences and length and comprising any mRNA that encodes any enzyme that reduces protein sialylation or has 98% identity to SEQ ID No. 570. The specification describes multi-hairpin amiRNA sequences wherein the guide and passenger strand are each 22 nucleotides in length and the passenger strand is complementary to the guide strand. The specification describes one multi-hairpin amiRNA that is used to inhibit sialidases in [00274] wherein the mRNA encodes Neu2. The specification and claims do not indicate what distinguishing characteristics of the multi-hairpin amiRNA sequences of varying lengths and with varying passenger strand lengths comprising any mRNA or any mRNA that encodes any enzyme that reduces protein sialylation described in the specification that are concisely shared by the members of the broad genus of multi-hairpin amiRNA sequences that would convey to one of skill in the art that this multi-hairpin amiRNA represent the entire genus. A review of the specification shows that it provides no description or guidance that would allow one of skill to distinguish the functional species of the recited structural genus from the non-functional members without empirical determination. The prior art of Glanz et al. ("Sialidase activity in human pathologies." European Journal of Pharmacology 842 (2019): 345-350) teach Sialidases, or neuraminidases, are glycosidases that catalyze the hydrolysis of α-glycosidic bonds linking sialic acid residues and teach four types of sialidases were described: NEU1, NEU2, NEU3, and NEU4. The four proteins differ from each other by the expression patterns, localization and functions (see page 345). The prior art teach that even among sialidase, each has a different sequence and function. It is clear from the prior art that the specification does not describe a representative number of species to describe the entire genus. Since the disclosure and the prior art fail to describe the common attributes and characteristics concisely identifying members of the proposed genus, and because the claimed genus is highly variant comprising a vast number of different guide strand and passenger strand sequences, loop sequences and mRNA, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus claimed. "A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus" (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) (emphasis added). Further, “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618. Thus the specification and claims lack written description because it is clear that Applicant did not have possession of every multi-hairpin amiRNA sequence that encodes every mRNA encoding an enzyme that reduces protein sialylation. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521,222 USPQ 369,372-372 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the entire scope of the claimed invention. 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. Claim 53 is 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 53 recites “the polynucleotide comprises a sequence selected from SEQ ID No. 568 comprising or encoding the multi-hairpin amiRNA sequence”. SEQ ID No. 568 is defined in the specification as comprising three hairpins [00274] and claims 49 and 48 are drawn to a polynucleotide having only two hairpin amiRNA sequences. Claim 53 is broader than claims 49 and 48 and fails to further limit the claims. 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. 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 53 and 71 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. Claim 53 recites “the polynucleotide comprises a sequence selected from SEQ ID No. 568 comprising or encoding the multi-hairpin amiRNA sequence”. This limitation is unclear because it is read as SEQ ID 568, which has three amiRNA sequences, also comprises or encodes “the multi-hairpin amiRNA sequence” which would be the two amiRNA sequences of claim 48. Thus the claim is indefinite. The claim in interpreted as defined in the specification. Claim 71 is indefinite because it recites “the polynucleotide expressed to produce the amiRNA sequence” and depends from claim 48 that is drawn to a multi-amiRNA sequence. The claim lacks antecedent basis. The claim is also indefinite because the claim recites a heterologous polynucleotide encoding a secreted protein not naturally produced by the cell wherein the sialylation is compared to the sialylation of a cell that was treated with the amiRNA sequence and it is unclear what the amiRNA sequence would be. This claim will not be further examined on the merits because the meaning of the claim cannot be determined. Closest prior art The prior art of Zhang et al. ("Enhancing glycoprotein sialylation by targeted gene silencing in mammalian cells." Biotechnology and bioengineering 105.6 (2010): 1094-1105) teach siRNA sequences designed to target CHO sialidase genes as shown in Table II. Zhang et al. does not teach the claimed SEQ ID Nos. 90 and 91 as in claim 52 or SEQ ID No. 568 of claim 53. The prior art of Watts et al. ("Silencing disease genes in the laboratory and the clinic." The Journal of pathology 226.2 (2012): 365-379) designing inhibitory oligonucleotides can be challenging using different programs wherein each program results in different siRNAs that have to be further tested to determine if they can reduce the target sequence in a cell. Thus nothing in Watts et al. would lead one of skill in the art to a predictable computational tool to design siRNA sequences targeted sialidase genes. There is no motivation for one of skill in the art to identify any specific region of a sialidase gene to target, then choose any of the computational tools to design the claimed sequence to arrive at the claimed amiRNA having SEQ ID Nos. 90 and 91 or the polynucleotide of SEQ ID No. 568. Lastly there is not a finite number of identified and predictable solutions to make it obvious to try because the prior art does not teach a target region that would predictable yield oligonucleotides having SEQ ID No. 90, 91 and 568. (MPEP 2143 KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Chong at (571)272-3111. The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm. If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public. For more information about the PAIR system, see http://pair-direct.uspto.gov. For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199. /KIMBERLY CHONG/ Primary Examiner Art Unit 1636
Read full office action

Prosecution Timeline

Mar 03, 2023
Application Filed
Jan 23, 2026
Non-Final Rejection — §101, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
72%
Grant Probability
85%
With Interview (+12.5%)
2y 7m
Median Time to Grant
Low
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