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 .
Status of Application/Amendment/Claims
Applicant's response filed 11/28/2025 has been considered. Rejections and/or objections not reiterated from the previous office action mailed 05/28/2025 are hereby withdrawn.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 11/28/2025, claims 16-22 and 24-36 are pending and are currently under examination.
Any rejection not reiterated in this Office Action is hereby withdrawn.
Antisense oligonucleotides comprising SEQ ID No. 22 are free of the prior art searched. The prior art did not reveal an antisense oligonucleotide having the claimed sequence and does not make it obvious to make the claimed oligonucleotide targeted to a NUMB transcript within exon 9.
New Claim Rejections – necessitated by claim amendments
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 amendment to claims 16 and 32 requiring the antisense oligonucleotide to now comprise modifications necessitated a new rejection. SEQ ID No. 22 is free of the prior art and therefore the next sequence in claim 32 is examined. The prior art did not reveal an antisense oligonucleotide having the claimed sequence and does not make it obvious to make the claimed oligonucleotide targeted to a NUMB transcript within exon 9.
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) 16, 19-22, 24-26, 28 and 30-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moeller et al. (US 2016/0145620).
Moeller et al. teach oligomers and oligonucleotides that can bind to complementary RNA and termed antisense oligonucleotides [0001-0002]. Moeller et al. teach an antisense comprising the sequence AGGCUCA (SEQ ID No. 36) having SEQ ID No. 1095 which is 17 nucleotides in length (page 206).
Moeller et al. teach the antisense oligonucleotides can be chemically modified [0028-0034].
Regarding the new limitation of claim 16, MPEP 2112.01 states that where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) and the clamed properties or functions are presumed to be inherent. Further MPEP 2112.01 states that in a composition claim, if the composition is physically the same, it must have the same properties (see discussion below).
Thus, Moeller et al. anticipates the instant claims.
Maintained Rejections
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The rejection of Claim(s) 16-22, 24-31, 33 and 36 is/are under 35 U.S.C. 102(a)(2) as being anticipated by Rossomando et al. (US 20140004565) is maintained for the reasons of record.
Applicant’s arguments are acknowledged but not found persuasive. Applicant argues Rossomando appears to disclose a very large number of sequences (over 3 million), which are entirely unconnected to the NUMB gene, and certainly not connected to exon 9 of the NUMB transcript. Further, in contrast to the present claims, none of the sequences of Rossomando, and in particular neither of the sequences cited by the Office, are provided as an antisense nucleotide. Rossomando neither describes relevant antisense oligonucleotides, nor does it disclose that any of the sequences therein would actually be suitable for reducing inclusion of NUMB exon 9 in a population of mature NUMB transcripts. In fact, Rossomando is completely silent to NUMB exon 9, or of splicing, of reducing the inclusion of NUMB exon 9.
In response, the instant specification defines an antisense oligonucleotide as: 'antisense oligonucleotide' (AON) refers to a short oligonucleotide or modified oligonucleotide which is antisense to and binds to (i.e. hybridizes to) a target region of a polynucleotide, such as a gene transcript, pre-mRNA, mRNA or RNA fragment. The oligonucleotides of Rossomando et al. are defined as RNA effector molecules and described in [0004] as a RNA effector molecule capable of modulating expression of a target gene and further describe the term ‘oligonucleotide’ as "nucleic acid molecule" encompasses not only nucleic acid molecules as expressed or found in nature, but also analogs and derivatives of nucleic acids comprising one or more ribo- or deoxyribo-nucleotide/nucleoside analogs or derivatives as described herein or as known in the art [0173] and therefore meets the limitations of the claimed antisense oligonucleotide.
Applicant is correct that Rossomando et al. does not describe antisense oligonucleotides that would be suitable for reducing inclusion of NUMB exon 9 however because the claims are drawn to an antisense oligonucleotide of at least 11 nucleotides that are complementary to at least 11 contiguous nucleotides within the target region of a NUMB transcript within exon 9, the result of reducing inclusion of NUMB exon 9 is an inherited feature of the oligonucleotide taught by Rossomando et al. MPEP 2112.01 states that where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) and the clamed properties or functions are presumed to be inherent
MPEP
2112.01 Composition, Product, and Apparatus Claims [R-3]
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I. PRODUCT AND APPARATUS CLAIMS — WHEN THE STRUCTURE RECITED IN THE REFERENCE IS SUBSTANTIALLY IDENTICAL TO THAT OF THE CLAIMS, CLAIMED PROPERTIES OR FUNCTIONS ARE PRESUMED TO BE INHERENT
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Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).
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See also In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971) (Claim 1 was directed to a parachute canopy having concentric circumferential panels radially separated from each other by radially extending tie lines. The panels were separated “such that the critical velocity of each successively larger panel will be less than the critical velocity of the previous panel, whereby said parachute will sequentially open and thus gradually decelerate.” The court found that the claim was anticipated by Menget. Menget taught a parachute having three circumferential panels separated by tie lines. The court upheld the rejection finding that applicant had failed to show that Menget did not possess the functional characteristics of the claims.); Northam Warren Corp. v. D. F. Newfield Co., 7 F. Supp. 773, 22 USPQ 313 (E.D.N.Y. 1934) (A patent to a pencil for cleaning fingernails was held invalid because a pencil of the same structure for writing was found in the prior art.).
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II. COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES
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“Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. “The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.”)
Moreover, the claim has been amended to recite wherein the antisense oligonucleotide reduces inclusion of NUMB exon 9 in a population of mature NUMB transcripts, and wherein the oligonucleotide is a chemically-modified RNA molecule, a chemically-modified DNA molecule, or a mixture of chemically-modified RNA and chemically-modified DNA and this limitation. This limitation does not change the scope of the claim. The claim is still drawn to an antisense oligonucleotide that is identical to the oligonucleotide in Rossomando et al. As stated above in MPEP 2112.01, in a composition claim, if the composition is physically the same, it must have the same properties.
Thus the rejection is maintained.
In response to Applicant stating they were not able to confirm the identity of the alleged sequences because they are not available through the Patent Center, the Examiner has provided screen shot of the sequences as available at https://seqdata.uspto.gov/. At the bottom of page 167 of the Patent Application Rossomando et al. (US 20140004565), the information is given to retrieve any sequence in the application because the sequence listing is too lengthy to print.
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Maintained Rejections
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. See 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);and, 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 16-36 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over Patent No. 11,672,816 (Patent ‘816). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter
MPEP 804 “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 determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
The instant claims are drawn to an antisense oligonucleotide for reducing inclusion of NUMB exon 9 in a population of mature NUMB transcripts, the antisense oligonucleotide comprising a sequence of at least 7 nucleotides that is complementary to a target region of a NUMB transcript within exon 9 comprising SEQ ID NO: 2. Claims of Patent ‘816 are drawn to methods of treating a proliferative disorder comprising administering an antisense oligonucleotide for reducing inclusion of NUMB exon 9 in a population of mature NUMB transcripts, the antisense oligonucleotide comprising a sequence of at least 7 nucleotides that is complementary to a target region of a NUMB transcript within exon 9 comprising SEQ ID NO: 2 and thus it would have been obvious to use the instant antisense oligonucleotide in the methods of Patent ‘816.
The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application.
Acknowledgement is made of Applicant's request that the rejection be held in abeyance until allowable matter is indicted in the instant claims, therefore the rejection is maintained.
Claim Objections/Allowable Subject Matter
Claims 34 and 35 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art does not teach antisense oligonucleotides comprising at least 21 nucleotides that are complementary to the claimed target regions of a NUMB transcript. The prior art does not teach a motivation to target a NUMB transcript to make an antisense oligonucleotide of at least 12 nucleotides in length.
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