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 .
Applicant’s election without traverse of age-related macular degeneration, siRNA, cGAS, cGAS siRNA, and IL-18 neutralizing antibody, in the reply filed on 11/4/24 is acknowledged.
Claims 5, 6, 11-13, 20, and 55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/4/24.
Markush Rejection
Claims 1, 3, and 14-19 are 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 various types of inhibitory compounds including antisense oligonucleotides, shRNA, siRNA, and antibodies, each of which has a different structure and acts via a different mechanism/is processed differently in the cell. siRNAs and shRNAs have different structures and act via different mechanisms, but are structurally similar and act via similar mechanism. Therefore, shRNAs will be considered as a separate species that will be rejoined upon allowability of siRNA. However, antisense oligonucleotides and antibodies have a different structure and act via a different mechanism. Antisense oligonucleotides will be considered as a separate species that will be rejoined upon allowability of siRNA because it has similar considerations and is a nucleic acid therapeutic. However, the antibodies have different structural and functional considerations and are not in the same field of study. Antibodies act on amino acids and have different structures and functions.
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).
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 inhibitory compound is dependent upon the specific sequence of nucleotides of the target. There is no expectation that any one of the compounds as claimed can be substituted for any of the other with the expectation of the same activity.
Response to Arguments
Applicant argues that although antibodies bind to amino acids, one or ordinary skill in the art would understand that they act on products of translation. Contrary to applicant’s arguments, all agents that act on transcription or translation would not be considered in the same application. Antibodies have different structures and act via a different mechanism than the recited nucleic acid inhibitors. Antibodies would not be expected to have identical activity to the nucleic acid inhibitors.
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, 3, and 14-19 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 claims have been amended to recite “cGAS-directed small interfering RNA”, which is a genus that has not been adequately described in the specification. The specification does not adequately describe the structure required for a siRNA to be “directed” to cGAS. It is noted that the previous claims recited “cGAS siRNA”, which is not identical in scope to “cGAS-directed small interfering RNA”. The specification does not describe the structure required for the siRNA to be directed by cGAS.
The single species of the specification is a single sequence (SEQ ID NO: 2) that is disclosed in the specification as being a human cGAS siRNA. It is unclear how the 48-mer single stranded sequence is a siRNA.
The specification does not disclose species representative of the entire claimed genus of any “cGAS-directed small interfering RNA”. Without further description, one would not be able to recognize which siRNAs would have the structure to meet the recited function.
The MPEP states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. See 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 species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. Additionally, in Carnegie Mellon University v. Hoffman-La Roche Inc., Nos. 07-1266, -1267 (Fed. Cir. Sept. 8, 2008), the Federal Circuit affirmed that a claim to a genus described in functional terms was not supported by the specification’s disclosure of species that were not representative of the entire genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The claims are rejected under the written description requirement for failing to disclose adequate species to represent the claimed genus, the genus being siRNAs that are directed by cGAS.
The Guidelines for Examination of Patent Applications under the 35 USC § 112, first paragraph, “Written Description” Requirement”, published at Federal Register, Vol. 66, No. 4, pp. 1099-1111 outline the method of analysis of claims to determine whether adequate written description is present. The first step is to determine what the claim as a whole covers, i.e., discussion of the full scope of the claim. Second, the application should be fully reviewed to understand how applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim with the scope of the description. Third, determine whether the applicant was in possession of the claimed invention as a whole at the time of filing.
To achieve the desired function, it appears that the siRNA is required to have a strand that is fully complementary to the target. For example, Elbashir et al. (The EMBO Journal, Vol. 20, No. 23, pages 6877-6888, 2001) teaches that duplexes of 21-23 nt RNAs are the sequence specific mediators of RNAi and that even single mismatches between the siRNA duplex and the target mRNA abolish interference (abstract and page 6888).
Thus, having analyzed the claims with regard to the Written Description guidelines, it is clear that the specification does not disclose a representative number of species for siRNAs that are directed by cGAS. Thus, one skilled in the art would be led to conclude that Applicant was not in possession of the claimed invention at the time the application was filed.
Additionally, the specification does not disclose the newly recited term “cGAS-directed small interfering RNA”. This portion of the rejection is a new matter rejection.
MPEP §2163.06 notes:
If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).
MPEP §2163.02 teaches that:
Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application.
A review of the specification does not reveal support for where the claim amendments are found. Should applicant disagree, applicants are encouraged to point out with particularity by page and line number where such support might exist for each claim limitation added in the amended claims filed on 8/14/25.
There is no support for this claim limitation in the claimed priority documents. Therefore, the effective filing date of the instant claims is considered, for purposes of prior art, to be 5/12/23, which is the filing date of the instant application.
Claims 1, 3, 7, and 14-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of inhibiting cGAS with a cGAS siRNA, does not reasonably provide enablement for preventing or treating age-related macular degeneration in a subject in need thereof via delivery of the cGAS siRNA. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in a determination of lack of enablement include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
The claims are directed to a method of preventing or treating age-related macular degeneration in a subject in need thereof comprising administering to the subject a pharmaceutical composition comprising a cGAS-directed siRNA.
The specification teaches that Caspase-4 is activated in AMD; and that Caspase-4 and Gasdermin D are required for Alu RNA-induced RPE degeneration and inflammasome activation. (pages 89-92).
The specification discloses an increased abundance of cGAS protein in the RPE of human geographic atrophy eyes compared to unaffected aged eyes (page 95). The specification does not demonstrate inhibition of cGAS and the outcome of treating or preventing age-related macular degeneration.
The specification does not draw an adequate nexus between inhibition of cGAS alone and the predictable outcome of treatment or absolute prevention of AMD.
There is no guidance in the specification as filed that teaches how to deliver any cGAS-directed siRNA via any means and predictably result in treatment of age-related macular degeneration in vivo.
The single species of the specification for a cGAS siRNA is a single sequence (SEQ ID NO: 2) that is disclosed in the specification as being a human cGAS siRNA. It is unclear how the 48-mer single stranded sequence is a siRNA.
The specification does not demonstrate even a single species of cGAS-directed siRNA or cGAS siRNA delivery via any means and does not demonstrate successful treatment or absolute prevention of age-related macular degeneration.
The instant claims are directed to broad naked delivery (i.e. oral) with any siRNA directed to cGAS and the predicable outcome of absolute prevention or of treatment of AMD. The instant specification is not enabling for delivery via any means of any siRNA directed to cGAS of any sequence and the predictable recited outcomes. The specification in fact does not disclose even a single species of sequence of a cGAS-directed siRNA with effective action.
The scope of the claims in view of the specification as filed together do not reconcile the unpredictability in the art to enable one of skill in the art to make and/or use the claimed invention, namely a broad method of treating age-related macular degeneration with an enormous possible genus of agents encompassing in vivo effects.
MPEP 2164.01
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.
Also, MPEP 2164.01(a)
A conclusion of lack of enablement means that, based on the evidence regarding each of
the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed
invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27
USPQ2d 1510, 1513 (Fed. Cir. 1993).
Given the teachings of the specification as discussed above, one skilled in the art could not predict a priori whether introduction of any cGAS siRNA in vivo by the broadly disclosed methodologies of the instantly claimed invention, would result in successful treatment or absolute prevention of age-related macular degeneration. To practice the claimed invention, one of skill in the art would have to de novo determine; the sequence of the siRNA, the stability of each agent in vivo, delivery of the agent to the whole organism, specificity to the target tissue in vivo, dosage and toxicity in vivo, and entry of the molecule into the cell in vivo and the effective action therein. Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation (see MPEP 2164.01(a)).
Response to Arguments
Applicant’s arguments are with regards to the non-elected inhibitors, whereas the instant rejection is specific to the elected inhibitor, cGAS siRNAs.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 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, 7, and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ndubaku et al. (US 10,738,056 B2), in view of Shapiro et al. (US 10,517,890 B2), Bertrand et al. (Biochemical and Biophysical Research Communications, 296, 2002, 1000-1004), Ijima et al. (IOVS, 2014, 55, 10, 6673-6678), and Nguyen et al. (Eye (2012) 26, 1099–1105).
Ndubaku et al. teach that a compound of the invention inhibits the cGAS/STING pathway, and can be useful in treating a disease including age-related macular degeneration. (For priority, this is also disclosed at paragraph [0075] of 62/559,482, filed on 9/15/17).
Ndubaku et al. teach that thus there is a need for inhibitors of the cGAS/STING pathway for the treatment of a variety of diseases.
Ndubaku et al. teach that the present invention provides a pharmaceutical composition comprising a compound as disclosed herein, including any pharmaceutically acceptable salt, pharmaceutically acceptable solvate or pharmaceutically acceptable hydrate thereof together with a pharmaceutically acceptable diluent or carrier.
Ndubaku et al. teach that the present invention provides novel pyrazolopyrimidinone or triazolopyrimidinone compounds, synthetic methods for making the compounds, pharmaceutical compositions containing them and various uses of the compounds.
Ndubaku et al. teach that cGAS inhibitory activity can be determined.
Ndubaku et al. teach that compounds of the present invention can inhibit the cGAS/STING pathway and, accordingly, in one aspect of the invention, certain compounds disclosed herein are candidates for treating, or preventing certain conditions and diseases. The present invention provides methods for treating conditions and diseases wherein the course of the condition or disease can be influenced by the cGAS/STING pathway. The method includes administering to a subject in need of such treatment, a therapeutically effective amount of a compound of the present invention, or a pharmaceutically acceptable salt, metabolite, solvate, hydrate, or stereoisomer thereof.
Therefore, Ndubaku et al. teach a method of treating age-related macular degeneration comprising administering a cGAS-STING pathway inhibitor (instant claims 1, 15, and 16).
It is noted that claims 14 and 18 recite outcomes that would necessarily flow from the method rather than recitation of a method step.
Ndubaku et al. does not teach that the inhibitor is a cGAS-directed siRNA.
However, Shapiro et al. teach siRNAs targeted to cGAS. Bertrand et al. teach a comparison of antisense oligonucleotides and siRNAs and teach that siRNAs appear to be quantitatively more efficient and its effect longer lasting in cell culture and that in mice, siRNA activity was observed but no antisense activity was observed (see abstract). Bertrand et al. teach that since intracellular delivery of ODNs and siRNAs is very similar, results already obtained with ODNs over the last 20 years could now be improved using siRNAs in the same conditions of delivery into cells (see page 1003, 1st column). Bertand et al. specifically states “Finally, we suggest that siRNAs are very promising tools for gene inhibition in vivo (page 1000).”
It would have been obvious to utilize a cGAS siRNA as the inhibitory compound of the method of Ndubaku et al. because cGAS siRNAs were known, as evidenced by Shapiro et al., and the benefits of siRNAs were known, as evidenced by Bertrand et al. (instant claims 1 and 7).
Additionally, Nguyen et al. teach a phase 1 dose escalation study of a siRNA targeting the RTP801 gene in age-related macular degeneration patients (title). Therefore, it was known to deliver siRNAs to treat age-related macular degeneration. Although the specification does not adequately describe the genus of siRNAs that are directed in any manner by cGAS, it was known to utilize siRNAs to treat AMD, cGAS siRNAs were known, and there was motivation to inhibit cGAS in AMD (instant claims 1 and 7).
Additionally, it was known to inhibit cGAS to treat age related macular degeneration and therefore selection of the age related macular degeneration being a geographic atrophy is a matter of design choice and is a species of the known target genus (instant claim 3).
Delivery of two of the same inhibitor is considered to be a matter of design choice and a routine design parameter. It is routine to deliver an inhibitory agent more than once. For example, Ndubaku et al. teach dosage and administration are adjusted to provide sufficient levels of the active agent(s) or to maintain the desired effect. Factors which may be taken into account include the severity of the disease state, general health of the subject, age, weight, and gender of the subject, diet, time and frequency of administration, drug combination(s), reaction sensitivities, and tolerance/response to therapy. Long-acting pharmaceutical compositions may be administered every 3 to 4 days, every week, or once every two weeks depending on half-life and clearance rate of the particular formulation (instant claim 17).
With regards to an additional agent comprising an IL-18 neutralizing antibody, Ijima et al. teach that IL-18 induces retinal pigment epithelium degeneration in mice (title) and that serum IL-18 levels in AMD patient were higher than those of the control (Results, page 6673). Therefore, it would have been obvious to include a IL-18 antibody into the formulation of the method of Ndubaku et al. with the expectation of inhibiting the negative effect of IL-18 in AMD (instant claim 19).
Response to Arguments
Applicant argues that Bertrand does not provide sufficient evidence that siRNAs could be successfully employed in vivo to treat any condition with a reasonable expectation of success. More particularly, applicant respectfully submits that the data provided by Bertrand show that in vivo, siRNAs may have some activity, but that that activity would not have been expected to one of ordinary skill in the art to be sufficient to prevent or treat age-related macular degeneration (claim 1) or inhibit non- canonical inflammasome signaling (claim 37) because the level to which the cGAS siRNA reduced expression of its target in vivo would be unlikely to be therapeutic.
Contrary to applicant’s argument, it was well known many years prior to filing of the instant application that siRNAs can be used therapeutically in vivo for treatment and are commonly accepted target specific nucleic acid inhibitory compounds. The examiner could cite a plethora of articles to support siRNA therapeutic usage prior to the filing date. For example, Nguyen et al. (Eye (2012) 26, 1099–1105) teach a phase 1 dose escalation study of a siRNA targeting the RTP801 gene in age-related macular degeneration patients (title).
However, Bertrand et al. alone is certainly sufficient motivation to select a siRNA as an inhibitory compound as a matter of design choice, particularly given that cGAS siRNAs were known, as evidenced by Ndubaku et al. Bertand et al. teaches that siRNA activity was observed in mice but not with antisense oligonucleotides (abstract). Bertand et al. specifically states “Finally, we suggest that siRNAs are very promising tools for gene inhibition in vivo (page 1000). It is noted that the instant specification does not demonstrate delivery of a cGAS-directed siRNA and the treatment of AMD.
Applicant argues that Ndubaku teaches pyrazolopyrimidinone compounds that inhibit cGAS, but in no example are any data provided that any disclosed compound provides sufficient inhibitory activity to provide reasonable predictability that any disclosed compound would prevent or treat age-related macular degeneration as in claim 1 or inhibit non-canonical inflammasome signaling as in claim 37 of the instant application. It is noted that the instant specification does not demonstrate this either. Ndubaku offers motivation to inhibit cGAS for treatment of AMD, wherein cGAS siRNAs were known and siRNAs were known to treat AMD. Applicant is arguing the agent of Ndubaku et al. would not treat AMD, but Ndubaku et al. is not relied upon for treatment of AMD. Ndubaku et al. is relied upon for motivation to inhibit cGAS for treatment of AMD.
Ndubaku et al. teach: The present invention provides a method of treating a cGAS/STING pathway-mediated condition, comprising administering to a subject in need thereof an effective amount of one or more compounds or compositions of the present invention, including any pharmaceutically acceptable salt, pharmaceutically acceptable solvate or pharmaceutically acceptable hydrate thereof (column 22), wherein the condition is age-related macular degeneration (column 22). Therefore, there was clear motivation to inhibit cGAS/STING to treat AMD.
Applicant argues that even assuming merely for the sake of argument that Shapiro teaches siRNAs that are targeted to cGAS, Shapiro provides no data or support for the assertion that cGAS siRNAs can deplete cGAS in vivo in a therapeutically significant way. Importantly, the instant specification does not demonstrate this either. There was motivation in the art to inhibit cGAS/STING pathway to treat AMD (Ndubaku et al.); siRNAs were known inhibitory compounds with motivation to use in vivo (Bertand et al. and Nguyen et al.) and cGAS siRNAs were known (Shapiro). The instant specification does not demonstrate any unexpected result for any specific siRNA and does not in fact demonstrate even a single species of cGAS-directed siRNA delivery with the treatment of AMD.
With regards to applicant’s arguments regarding Bertrand, Bertand acknowledges delivery challenges with siRNAs and antisense oligonucleotides but specifically teaches that siRNAs are very promising tools for gene inhibition in vivo. However, applicant’s argument highlights the fact that the instant claims are directed to broad naked delivery via any means of any cGAS-directed siRNA with the recited outcome of treatment of prevention of AMD, which is not enabled as set forth above. This is different from obviousness. It was known in the art that delivery vehicles are necessary for in vivo therapeutics with siRNAs.
With regards to Ijima et al., applicant argues that this reference fails to suggest that cGAS siRNAs would have therapeutic value, which is not a teaching that Ijima et al. was relied upon for.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy R Hudson whose telephone number is (571)272-0755. The examiner can normally be reached M-F 8:00am-6:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached on 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636