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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 2, 2026 has been entered.
Status of Claims/Rejections
Claims 1-5, 8-9, 11, and 17-29 are currently pending in the instant application. Claims 21-26 and 28-29 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b). Claims 17-18 are currently amended to recite a “method”, which is a non-elected invention. Hence, claims 17-18, 21-26, and 28-29 are withdrawn from further consideration as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Accordingly, claims 1-5, 8-9, 11, 19-20, and 27 are under examination on the merits in the instant application.
Any rejections not repeated in this Office action are withdrawn. The following objections/rejections are the only rejections applied in this application.
Claim Objections
Claim 2 is objected to because of the following informalities: “are” line 2 should be “is”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: the comma (,) in line 2 should be deleted. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 8-9, 11, 19-20, and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3-4 recite the limitation "wherein the time interval" in lines 1-2. There is insufficient antecedent basis for this limitation in the claims.
Claims 1-5, 8-9, 11, and 19-20 recite “wherein the composition is configured to be administered to the mammal such that seizure suppression lasts for at least 50 days after administration.” Claim 27 recites “wherein the oligonucleotide is configured to be administered as a single injection wherein seizure suppression lasts for at least 50 days or at least 70, 90 or 120 days after administration.”
Claims 1-5, 8-9, 11, 19-20, and 27 do not particularly point out and distinctly claim the structural features/limitations that are required to be “configured to be administered to the mammal such that seizure suppression lasts for at least 50 days after administration” or “configured to be administered as a single injection wherein seizure suppression lasts for at least 50 days or at least 70, 90 or 120 days after administration.” That is, the only structural limitation recited for the claimed composition is the “anti miR-134 oligonucleotide” comprising SEQ ID NO:8, and there is no structural limitation as to the compositions’ structural configuration for satisfying the “wherein” clause. As such, the structural limitation required for the “wherein” clause cannot be clearly ascertained, thereby rendering the structural of the claimed composition indefinite.
Solely in the interest of compact prosecution, the “wherein” clause’s configuration limitation will be fully satisfied by the structure of SEQ ID NO:8.
Response to Arguments
Applicant's arguments filed on June 2, 2026 have been fully considered but they are not persuasive. Applicant argues that the claim amendments filed on June 2, 2026 are sufficient to overcome the rejection regarding the “wherein” clause. Contrary to applicant’s argument, the “wherein” clause is not amended to recite any structural limitation for being specifically “configured” to satisfy the clause. Accordingly, the rejection is hereby reiterated.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 9, 11, and 19-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 9 recites that “the anti miR-134 oligonucleotide, contains at least one ENA nucleotide.” It is noted that claim 1 as currently amended expressly requires that the anti miR-134 oligonucleotide should be SEQ ID NO:8 comprising LNA. Hence, the requirement for “at least one ENA nucleotide” recited in claim 9 fails to further limit the subject matter of claim 1.
Claim 11 recites “the anti miR-134 oligonucleotide is a mixmer.” It is noted that claim 1 as currently amended expressly requires that the anti miR-134 oligonucleotide should be SEQ ID NO:8, which comprises a mixture of DNA and LNA, thereby being a mixmer. Hence, claim 11 fails to further limit the subject matter of claim 1.
Claim 19 recites that the composition of claim 1 comprises at least one of 2’-O-alkyl-RNA monomers, beta-D-oxy-LNA, 6’methyl beta-D-oxy LNA and ENA.” It is noted that claim 1 as currently amended expressly requires that the anti miR-134 oligonucleotide should be SEQ ID NO:8 comprising LNA. Hence, the modifications recited in claim 19 fail to further limit the subject matter of claim 1.
Claim 20 recites that the anti miR-134 contains an LNA. It is noted that claim 1 as currently amended already requires that the anti miR-134 oligonucleotide should comprise an LNA. Hence, claim 20 fails to further limit the subject matter of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 8, 11, 19-20, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elmen et al. (US 2010/0004320 A1, of record).
Elmen teaches making a mixmer anti-miR-134 oligonucleotide of SEQ ID NO:121 in Table 2 at page 41 as copied below, wherein the uppercase letters (e.g., “T”) represent LNA and the lowercase letters (e.g., “g”) represent DNA
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It is noted that the above nucleotide sequence and mixmer modification pattern are 100% identical to those in SEQ ID NO:8 claimed in the instant case.
Elment teaches that the LNA can be an “oxy-LNA” in “beta-D-form”. See paragraphs 0281-0283.
Elmen teaches that the disclosed oligonucleotide can comprise 5-methylcytosine and phosphorothioate linkages and is formulated as a pharmaceutical composition for treating a disease, wherein the oligonucleotide is administered “monthly or yearly, or even once every 2 to 10 years”. See paragraphs 0188, 0201, 0284, and 0326-0328.
Elmen discloses “fully thiolated backbone” is a “preferable” internucleotide linkage backbone for the “enhanced” LNA-antimiR oligonucleotide targeting miR-21 for glioblastoma treatment. See paragraphs 0615-0616.
Indeed, Elmen exemplifies full “PS backbone” LNA-antimiR oligonucleotides in Table 1, wherein the LNA-antimiR oligonucleotides include the new, enhanced modification design of 5’-XxXxXXxxXxXxXX-3’, wherein X is LNA and x is DNA. See the following portion reproduced from Table 1:
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It is noted that “for administration to a mammal suffering from a disease wherein lowering of an activity of miR-134 is beneficial” recited in claims 1-5, 8-9, 11, and 19-20 and “for use in the treatment of a neurological disorder” recited in claim 27 are mere intended use of the claimed anti miR-134 oligonucleotide, wherein intended use is not a claim limitation, unless there is objective evidence that Elmen’s oligonucleotide formulated as a pharmaceutical composition is incapable of the intended use.
In addition, since all structural limitations of the instantly rejected claims are met by Elmen’s composition taught to have all of the instantly claimed structural features, it necessarily follows that the prior art’s composition is inherently configured as recited in the “wherein” clause, thereby fully inherently fully satisfying the “wherein” clause, absent objective evidence to the contrary. Note that “[f]rom the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (CCPA 1963).
Note that the Office does not have the facilities and resources to provide the factual evidence needed in order to determine and/or compare the specific activities of the instantly claimed oligonucleotide of SEQ ID NO:8 versus Elmen’s SEQ ID NO:121 comprising full PS backbone and 5-methylcytosine LNA. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed oligonucleotide is different from the one taught by Elmen, thereby establishing that Elmen’s oligonucleotide cannot possess the function/intended use recited in the instant claims, hence establishing patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ2d 1922(PTO Bd.Pat. App. & Int. 1989).
Accordingly, claims 1-5, 8, 11, 19-20, and 27 are described by Elmen et al.
Response to Arguments
Applicant's arguments filed on June 2, 2026 have been fully considered but they are not persuasive. Applicant argues that Elmen does not teach the claimed composition/oligonucleotide as currently amended. Contrary to applicant’s argument, Elmen’s disclosure teaches all structural limitations set forth in the instant claims as currently amended as described in the rejection above, wherein any and all functional limitations/intended use are mere inherent properties of SEQ ID NO:8 that is a DNA/LNA mixmer with “full” PS backbone and 5-methylcytosine LNA, absent objective evidence to the contrary.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 8, 11, 19-20, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Elmen et al. (US 2010/0004320 A1, of record) in view of Kauppinen et al. (US 2011/0077288 A1, of record) and Henshall et al. (US 2014/0235696 A1, of record).
Elmen teaches making a mixmer anti-miR-134 oligonucleotide of SEQ ID NO:121 in Table 2 at page 41 as copied below, wherein the uppercase letters (e.g., “T”) represent LNA and the lowercase letters (e.g., “g”) represent DNA
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It is noted that the above nucleotide sequence and mixmer modification pattern are 100% identical to those in SEQ ID NO:8 claimed in the instant case.
Elment teaches that the LNA can be an “oxy-LNA” in “beta-D-form”. See paragraphs 0281-0283.
Elmen teaches that the disclosed oligonucleotide can comprise 5-methylcytosine and phosphorothioate linkages and is formulated as a pharmaceutical composition for treating a disease, wherein the oligonucleotide is administered “monthly or yearly, or even once every 2 to 10 years”. See paragraphs 0188, 0201, 0284, and 0326-0328.
Elmen discloses “fully thiolated backbone” is a “preferable” internucleotide linkage backbone for the “enhanced” LNA-antimiR oligonucleotide targeting miR-21 for glioblastoma treatment. See paragraphs 0615-0616.
Indeed, Elmen exemplifies full “PS backbone” LNA-antimiR oligonucleotides in Table 1, wherein the LNA-antimiR oligonucleotides include the new, enhanced modification design of 5’-XxXxXXxxXxXxXX-3’, wherein X is LNA and x is DNA. See the following portion reproduced from Table 1:
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Consistent with Elmen, Kauppinen teaches that an oligonucleotide that inhibits miRNA activity (e.g., “high-affinity LNA-antimiR” having “CcAttGTcaCaCtCC”) has “a complete phosphorothioate backbone (PS)” thus is “fully thiolated”. See paragraphs 0004 and 0251; Table 4.
Kauppinen teaches that “combining the high-affinity LNA-antimiR with phosphorothioate (PS) modifications could enable in vivo delivery” and can provide “potent” target miRNA silencing in vivo “at a considerably lower dose” “without additional conjugation chemistries.” See paragraphs 0259-0260.
Kauppinen teaches that each dose/dosage of the high-affinity LNA-antimiR is “a single administration” and wherein “the dosage interval” between each administration is at least “50” days, “70” days, “90” days, and “120” days. See paragraphs 0010, 0012, 0031, and 0078.
Henshall teaches that an antagomir of miR-134 modified with LNA is useful for treating “seizure-related disorders and neurologic injuries” as evidenced by the finding that in vivo blocking of miR-134 in the brain “strongly inhibits seizures occurring”. See paragraphs 0006-0007, 0017-0018, 0022-0023, 0027, 0050, and 0061.
It would have been obvious to one of ordinary skill in the art before the effective filing date to design Elmen’s mixmer of SEQ ID NO:121 with full PS backbone as already taught by Elmen and to reasonably expect such mixmer to be useful in preventing seizures from occurring after a single administration at is at least 120 days apart from the next administration dose in view of the teachings of Kauppinen pertaining to the benefits of Elmen’s 15-mer mixmer design combined with full PS backbone such that the benefits include “potent” in vivo target miRNA silencing “at a considerably lower dose” “without additional conjugation chemistries” thus such “high-affinity” antimiR mixmer, which would thus allow less frequent dosing such as the dosing interval of at least 120 days, and further in view of the art-recognized scientific finding that miR-134 inhibition “strongly inhibits seizures occurring” thus is useful for treating “seizure-related disorders and neurologic injuries” as evidenced by the teachings of Henshall.
In addition, since all structural limitations of the instantly rejected claims are met by Elmen’s composition taught to have all of the instantly claimed structural features, it necessarily follows that the prior art’s composition is inherently configured as recited in the “wherein” clause, thereby fully inherently fully satisfying the “wherein” clause, absent objective evidence to the contrary. Note that “[f]rom the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (CCPA 1963).
Note that the Office does not have the facilities and resources to provide the factual evidence needed in order to determine and/or compare the specific activities of the instantly claimed oligonucleotide of SEQ ID NO:8 versus Elmen’s SEQ ID NO:121 comprising full PS backbone and 5-methylcytosine LNA. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed oligonucleotide is different from the one taught by Elmen, thereby establishing that Elmen’s oligonucleotide cannot possess the function/intended use recited in the instant claims, hence establishing patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ2d 1922(PTO Bd.Pat. App. & Int. 1989).
Accordingly, claims 1-5, 8, 11, 19-20, and 27 taken as a whole would have been prima facie obvious before the effective filing date.
Response to Arguments
Applicant's arguments filed on June 2, 2026 have been fully considered but they are not persuasive. Applicant argues that none of Elmen, Kauppinen, and Henshall teaches the instantly claimed structure. Contrary to applicant’s argument, all structural features recited in the rejected claims are taught by Elmen, further corroborated by Kauppinen’s teachings pertaining to the combination of the art-recognized 5’-XxXxXXxxXxXxXX-3’ mixmer and full PS backbone.
Applicant argues that the claims are not obvious because the examiner improperly relied on improper hindsight, wherein Elmen discloses many antagomir sequences, not particularly focusing on the instantly claimed antagomir. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
It is noted that Elmen expressly disclosed and taught the instantly claimed oligonucleotide sequence/modification. That is, the mere fact that Elmen discloses non-miR-134 antigomir sequences is not sufficient to rebut the objective fact that the instantly claimed oligonucleotide sequence/modification is not the inventive, novel work of the instant co-inventors. Furthermore, making a pharmaceutically or therapeutically useful LNA-modified miR-134 antagomir for treating of seizures/neurological conditions was an art-recognized goal as evidenced by Henshall. As such, there is no reason for one of ordinary skill in the art to purposefully exclude or disregard Elmen’s SEQ ID NO:121 regardless of the number of antimiR sequences listed in Table 2.
Applicant argues that the claims are not obvious because of “unexpected and superior” or “unexpected and surprising” results and “discovery by the present inventors” such that “a single injection could produce near-complete cessation of seizures lasting at least 50 days – and possibly indefinitely” with “seizure suppression reaching as high as 97%” with “reduced mortality rates in treated animals”. In response, applicant’s attention is directed to the fact that unexpected results must be compared to the closest prior art, which is Elmen in the instant case. Applicant did not provide any objective, factual evidence demonstrating that the results or “discovery” summarized by applicant are “really unexpected” when compared to Elmen’s SEQ ID NO:121 taught to have full PS modification.
“To be particularly probative, evidence of unexpected results must establish that there is a difference between the results obtained and those of the closest prior art, and that the difference would not have been expected by one of ordinary skill in the art at the time of the invention.” (emphasis added). Bristol-Myers Squibb Co. Teva Pharm. USA, Inc., 725 F.3d 967, 977 (Fed. Cir. 2014).
“When unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” (emphasis added). In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
“Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected.” (emphasis added). See MPEP §716.02.
In view of the foregoing, this rejection is hereby reiterated.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8, 11, 19-20, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-14 of U.S. Patent No. 9,803,200 B2 in view of Elmen et al. (US 2010/0004320 A1, of record) and Kauppinen et al. (US 2011/0077288 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been anticipated by and/or obvious over the ‘200 patent claims, which are drawn to using “a miR-134 antagomir” that is an “LNA”-modified oligonucleotide. Now, in order to use the “agent for inhibiting the activity of miR-134” or the “miR-134 antagomir” in the “method for treating epilepsy” as claimed in the ‘200 patent, the instantly claimed composition and the manufacturing method of the claimed composition are necessary, wherein it would have been obvious to make the DNA/LNA mixmer antagomir of SEQ ID NO:8 with full PS backbone claimed in the instant case in view of the teachings of Elmen and Kauppinen. Since all structural limitations of the instantly rejected claims are met by the agent comprising SEQ ID NO:5 claimed in the ‘200 patent claims, it necessarily follows that the agent of the ‘200 patent claims is inherently configured as recited in the “wherein” clause in the instant claims and also inherently possess the property to provide the intended use recited in the instant claims, absent objective evidence to the contrary.
Claims 1-5, 8, 11, 19-20, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,066,664 B2 in view of Elmen et al. (US 2010/0004320 A1, of record) and Kauppinen et al. (US 2011/0077288 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been anticipated by and/or obvious over the ‘664 patent claims. That is, in order to use the “agent for inhibiting the activity of miR-134” in the “method of treating a neurological condition” that is “an epilepsy syndrome” as claimed in the ‘664 patent, the instantly claimed composition and the manufacturing method of the claimed composition are necessary, wherein it would have been obvious to make the DNA/LNA mixmer antagomir of SEQ ID NO:8 with full PS backbone claimed in the instant case in view of the teachings of Elmen and Kauppinen. Since all structural limitations of the instantly rejected claims are met by the agent comprising SEQ ID NO:5 as encompassed by the ‘664 patent claims, it necessarily follows that the agent of the ‘664 patent claims is inherently configured as recited in the “wherein” clause in the instant claims and also inherently possess the property to provide the intended use recited in the instant claims, absent objective evidence to the contrary.
Response to Arguments
Applicant's arguments filed on June 2, 2026 have been fully considered but they are not persuasive. Applicant argues that the NSDP rejections are moot in view of the claim amendments. In response, it is noted that the instant NSDP rejections set forth hereinabove are now rejected over the reference patent claims in view of both Elmen and Kauppinen.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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