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
Status of Application/Amendment/Claims
Applicant's response filed 10/10/2025 has been considered. Rejections and/or objections not reiterated from the previous office action mailed 06/11/2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
With entry of the amendment filed on 10/10/2025, claims 1, 2, 7, 10, 16, 19, 22, 23, 28, 31, 33-36, 40, 43, 44, 46 and 48-50 are pending and are currently under examination
Status of the Application
Claims 1, 2, 7, 10, 16, 19, 22, 23, 28, 31, 33-36, 40, 41, 43, 44, 46 and 48 are pending and are currently under examination. Claim 36 is allowed.
Claim Objections and Rejections – necessitated by claim amendments
Claim Objections
Claims 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form.
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 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.
Claim(s) 1, 2, 19, 22, 23, 28, 34 and 35, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khvorova et al. (US Patent No. 8090542).
Regarding claims 1 and 23, Khvorova et al. teach a dsRNA that has at least 17 contiguous nucleotides with 2 mismatches with the antisense strand and the complementary sense strand and wherein the double stranded region is 19 nucleotides in length (col. 11). The sequence results below illustrate a single strand with mismatched nucleotides highlighted. The results are shown as having identical nucleotides as instant claimed SEQ ID No. 5093 in reverse and are the same as instantly claimed SEQ ID No. 4827 (sense strand).
RESULT 9 us-17-995-699-5093.szlim50.rni
US-10-714-333C-1430705
(NOTE: this sequence has 3 duplicates in the database searched)
Sequence 1430705, US/10714333C
Patent No. 8090542
GENERAL INFORMATION
APPLICANT: Dharmacon, Inc.
APPLICANT: Khvorova, Anastasia
APPLICANT: Reynolds, Angela
APPLICANT: Leake, Devin
APPLICANT: Marshall, William
APPLICANT: Scaringe, Stephen
TITLE OF INVENTION: Functional and Hyperfunctional siRNA
FILE REFERENCE: 13499US
CURRENT APPLICATION NUMBER: US/10/714,333C
CURRENT FILING DATE: 2003-11-14
PRIOR APPLICATION NUMBER: 60/502,050
PRIOR FILING DATE: 2003-09-10
PRIOR APPLICATION NUMBER: 60/426,137
PRIOR FILING DATE: 2002-11-14
NUMBER OF SEQ ID NOS: 1591911
SEQ ID NO 1430705
LENGTH: 19
TYPE: DNA
ORGANISM: Homo sapiens
Query Match 64.3%; Score 14.8; Length 19;
Best Local Similarity 77.8%;
Matches 14; Conservative 2; Mismatches 2; Indels 0; Gaps 0;
SEQ ID NO 5093 5 TAAAAGUGUACTCGACAU 22
SEQ ID NO 1430705 19 TAAAGGTGAACTCGACAT 2
Regarding claim 2, the sense strand would target nucleotides 760-780 of SEQ ID No. 4001 given claim 2 depends from claim 1 which recite the sense strand is set forth as SEQ ID No. 4827 and is taught by Khvorova et al.
Regarding claims 19 and 22, Khvorova et al. teach the dsRNA can comprise at least one modification (col. 12).
Regarding claim 34 and 35, Khvorova et al. teach the dsRNA can be introduced into cells and are in pharmaceutical compositions (col. 35).
Regarding claim 28, Khvorova et al. teach the dsRNA can be introduced into a cell using a ligand to facilitate uptake (col.35).
Thus Khvorova et al. anticipates the claims because the preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 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.
Claims 10, 16, 31 and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khvorova et al. (US Patent No. 8090542) in view of Prakash et al. (US Patent No. 11084844).
Khvorova et al. is relied upon as above but does not teach the siRNA is conjugated to a lipophilic moiety conjugated via a linker or comprises 5’ vinyl phosphonate at the 5’ end.
Prakash et al. teach siRNA for inhibiting gene expression wherein the siRNA can be conjugated to a cholesterol (a lipophilic moiety) via a linking group (col. 40) and teach the siRNA can have a 5’ vinyl phosphonate attached (col. 60). It would have been obvious to incorporate these modifications and conjugates to the siRNA taught by Khvorova et al. to enhance delivery and efficiency of inhibition.
Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed.
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 33 and 50 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 33 recites "the dsRNA of claim 1 wherein the sense strand comprises the sequence and all the modifications of SEQ ID NO: 4029, and the antisense strand comprises the sequence and all the modifications of SEQ ID NO: 4295”. The claim also recites the same limitation for SEQ ID Nos. 5800 and 5801. This claim is indefinite because claim 1 has been amended to SEQ ID Nos. 5093 and 4827 and claim 1 does not recite the sequences are modified and also are not the same sequences of claim 33 so it is unclear how these sequences of claim 33 can comprise all the modifications when there are no recited modifications.
Claim 50 is indefinite because the metes and bounds of step (a) are not defined. It is not clear what is meant by “subject”. Step (b) recites a human subject and therefore it is unclear is encompassed in “subject” in relation to step (b).
Response to Arguments and Amendments
Maintained Rejections
Enablement
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.
Claims 40, 43, 44 and 46 remain 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:
methods of inhibiting expression of SCN9A in cells or in vivo using sequences as demonstrated in Fig. 2
methods of treating chronic pain in disorders of primary erythromelalgia (PE) or paroxysmal extreme pain disorder (PEPD)
does not reasonably provide enablement for:
treating all disease and disorders associated with chronic pain as in claim 43
amelioration of at least any sign or symptom of a SCN9A associated pain disorder
administration of any additional agent or therapy suitable for treatment or prevention of an SCN9A-assocaited disorder
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.
The following factors have been considered in the analysis of enablement: (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims and nature of the invention:
The claims are drawn to methods of treating any disorder associated with SCN9A expression by administration of a dsRNA targeted to a region of the SCN9A gene such as any chronic pain and drawn to methods of amelioration of at least one sign or symptom of the disorder. The dsRNA as claimed requires at least 15 nucleotides having from 1-3 mismatches to the target gene having SEQ ID Nos.
Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.
The state of the prior art:
A thorough review of the patent and non-patent literature indicates that the state of the art demonstrating a correlation with SCN9A and any associated disorder or treatment of the vast genus of chronic pain by administration of a dsRNA targeted to specific regions of SCN9A was nascent at the time of filing.
Baker, Mark D., and Mohammed A. Nassar. "Painful and painless mutations of SCN9A and SCN11A voltage-gated sodium channels." Pflügers Archiv-European Journal of Physiology 472 (2020): 865-880. Baker et al. teach primary erythromelalgia and paroxysmal extreme pain disorder (PEDP) is caused by mutations in SCN9A (see pages 867). Baker et al. also teach in Table 6 that there are mutations that can cause painless conditions in subjects. Thus Baker et al. illustrates the unpredictability of targeting SCN9A with a dsRNA in methods of treating any SCN9A associated condition particularly wherein the condition is any type of pain.
With respect to small fiber polyneuropathy (SFN) Kelley et al. ("Association of small-fiber polyneuropathy with three previously unassociated rare missense SCN9A variants." Canadian Journal of Pain 4.1 (2020): 19-29) teach association of small fiber polyneuropathy with previous unassociated missense SCN9A variants but cautions larger studies can determine whether these are contributory or coincidental, but they associate new variants with moderate or high likelihood of pathogenicity with a new highly related phenotype (abstract and discussion pp 23-26).
A review of the prior art does not provide a correlation between administration of a dsRNA targeted to specific SCN9A regions and treatment of any SCN9A associated disorders or amelioration of any sign or symptom of the disorder.
The level of one of ordinary skill:
While the level of one of ordinary skill practicing said invention would be high, the level of predictability is considered variable as evident in the prior art discussed above and is not considered to provide sufficient enablement to practice the claimed invention.
Because the state of the prior art does not provide evidence of the degree of predictability that methods for treating any SCN9A associated disorder can occur by administration of a dsRNA targeted to specific SCN9A regions, one of ordinary skill in the art would look for guidance or direction in the instant specification.
The level of predictability in the art:
“The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.” (MPEP 2164.03). In this case, one of skill in the art cannot predict that targeted a SCN9A gene can treat any condition associated with SCN9A expression or even any condition of pain given it was shown in the art of Baker et al. that some mutations of SCN9A do not cause pain in subjects.
The amount of direction provided by the inventor:
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004).
The existence of working examples:
The working embodiment in the instant application describes using the claimed dsRNA to decrease SCN9A expression in mice. The working embodiments do not describe treating any condition associated with SCN9A expression or even any condition of pain.
The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant invention suggests administration of a dsRNA to a subject to treat any disorder, known or unknown, that is associated with SCN9A or broadly treat or ameliorate any type of chronic pain.
While the MPEP 2164.02 states the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970), the lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The prior art is undeveloped for the role SCN9A plays in all disorders as claimed and it is unpredictable that knocking out expression of SCN9A using the claimed dsRNA would provide treatment as broadly claimed. The specification does not provide sufficient guidance on using the claimed dsRNA and treat any SCN9A related disorder. For an enabling disclosure, one of skill in the art must be able to make and use the invention with a reasonable expectation of success and not to make and test if the invention actually works. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004).
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.
Response to Arguments
While the claims have been amended to include specific sequences targeted to SCN9A as shown in the specification, this does not overcome the rejection.
Applicant argues that it was generally known in the art how to design dsRNA agents for inhibiting expression of a gene in cells in vitro or in vivo and to enhance delivery, stability and half-life for in vivo application. This argument is not persuasive because the enablement rejection was not based on whether one of skill in the art can make a dsRNA to inhibit expression. The lack of enablement was based on the specification not providing sufficient guidance on using the claimed dsRNA and treating any SCN9A related pain disorder as broadly recited in claim 43. For an enabling disclosure, one of skill in the art must be able to make and use the invention with a reasonable expectation of success and not to make and test if the invention actually works. If Applicant’s arguments were true, one of skill in the art would be able to make any siRNA targeted to SCNPA and treat chronic pain associated with cancer, arthritis, diabetes, traumatic injury or any viral infection with only the guidance from the instant specification because the prior art does not show inhibition of expression SCN9A and treatment for the broad lists of disorders claimed.
Applicant further argues [t]he application as-filed provides extensive experimental evidence demonstrating the inhibition of SCN9A in vitro and in vivo with the claimed dsRNA. Moreover, in an in vivo mouse model, AD-1251284 demonstrated a high degree of knockdown of SCN9A mRNA to 14.43% remaining, which results are shown in Table 21. Accordingly, the claimed dsRNA agents are highly effective at reducing SCN9A mRNA levels. This argument is not persuasive because the lack of enablement rejection was not based on the specification providing sufficient guidance on using the claimed dsRNA and whether they can reduce expression of SCN9A in cells or mice. The rejection was given because there is no guidance provided in the specification or the prior art for inhibiting of expression SCN9A and treatment for the broad lists of disorders claimed. There is not guidance that administration to the subject, as in claim 46, would provide treatment for the disorders and further there is no guidance that the dsRNA along with any additional agent or therapy would provide treatment or prevention of a SCN9A associated disorder.
Lastly Applicant argues that [g]iven the extensive demonstration of inhibition of SCN9A in cells in vitro and in vivo, a person skilled in the art could rely on the present disclosure for guidance to predictably design and administer a dsRNA with increased stability and in vivo half-life for inhibiting SCN9A in a cell and for treating pain. In view of the above analysis, the extensive in vitro and in vivo data demonstrating SCN9A knockdown, and the guidance provided in the application disclosure for designing dsRNA for in vivo applications, one skilled in the art would be able to make and use the claimed invention without undue experimentation. As stated above, the standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant invention suggests administration of the dsRNA sequences to a subject to treat the broad list of disorders without any evidence or embodiments describing such treatment or that any additional agent or therapy in combination with the claimed dsRNA can broadly treat or ameliorate any type of chronic pain. One of skill in the art would not reasonably expect success at treating any of the broadly claimed disorders without guidance from either the specification or the prior art, of which there is none.
Closest prior art.
Claim 36 is allowed. Claim 7 is free of the prior art and SEQ ID Nos. 4029, 4295, 5800 and 5801 are free of the prior art.
The prior art of Khvorova et al. (cited above) teach a dsRNA that has at least 17 contiguous nucleotides with 2 mismatches with the antisense strand and the complementary sense strand (SEQ ID Nos. 5093 and 4827) and wherein the double stranded region is 19 nucleotides in length (col. 11) (as shown above). Khvorova et al do not teach the dsRNA comprises SEQ ID Nos. 5093 and 4827 and do not make it obvious to make these sequences because the sequences in Khvorova et al. do not target the SCN9A gene. Khvorova et al. do no teach methods of inhibiting expression of SCN9A in cells.
SCN9A has Genbank No. NM_001365536 and while the gene sequence is known and programs to design inhibitory oligonucleotides are known, 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) teach 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 dsRNA sequences targeted to SCN9A.
There is no motivation for one of skill in the art to identify any specific region of the SCN9A gene to target, then choose any of the computational tools to design the claimed sequence and then choose specific modified nucleotides, from the vast amount of known modified nucleotides and linkages, to arrive at the claimed oligonucleotide. Furthermore there is not a design need or market demand to design this specific sequence and 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 comprising SEQ ID Nos. 5093 and 4827. (MPEP 2143 KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
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).
706.07(a) Final Rejection, When Proper on Second Action [R-07.2015]
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Second or any subsequent actions on the merits shall be final, except where the examiner introduces a new ground of rejection that is neither necessitated by applicant’s amendment of the claims, nor based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p). Where information is submitted in an information disclosure statement during the period set forth in 37 CFR 1.97(c) with a fee, the examiner may use the information submitted, e.g., a printed publication or evidence of public use, and make the next Office action final whether or not the claims have been amended, provided that no other new ground of rejection which was not necessitated by amendment to the claims is introduced by the examiner. See MPEP § 609.04(b).
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 extension fee 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 date of this final action.
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 9-5 pm.
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.
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/KIMBERLY CHONG/Primary Examiner, Art Unit 1636