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 03/30/2026 has been considered. Rejections and/or objections not reiterated from the previous office action mailed 12/29/2025 are hereby withdrawn.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 03/30/2025, claims 1-7, 9-11 and 13-22 are pending. Claims 13-22 are currently under examination. Claims 1-7 and 9-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The 103 rejection over Barrat et al. is withdrawn in response to Applicant’s argument.
The 103 rejection over Manoharan et al. is withdrawn in response to claim amendments limiting the oligonucleotide to ‘consisting’ of SEQ ID No. 2.
SEQ ID No. 1 is free of the prior art.
New Claim Rejection - 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 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) 13-15 and 18-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krieg et al. (Application No. 20070066554).
The claims are drawn to a pharmaceutical composition comprising an amphiphilic oligonucleotide conjugate comprising a lipophilic component comprising a cholesterol and conjugated to an oligonucleotide consisting of SEQ ID No. 2 and a poly-oligo(dT) of 10-50 (T10-T50).
Regarding claim 13-15, Krieg et al. teach an immunostimulatory oligonucleotide comprising 20 thymidine (see SEQ ID No. 226 Table A). Krieg et al. teach said oligonucleotides can comprise a phosphorothioate modification (see 0023) and can be delivered to a cell via a cholesterol conjugated on the ends (see 0285).
Regarding claims 18 and 19, Krieg et al. teach a pharmaceutical composition comprising the oligonucleotide and teach it can be administered as in claims 18 and 19 (see 0292).
Regarding claims 20 and 21, Krieg et al. teach using an antigen along with the immunostimulatory oligonucleotide (0040, 0053).
Regarding the limitation of claim 13 and claim 22 “wherein the conjugate of the lipophilic component results in a TLR stimulating compound”, the mere step of conjugation of the cholesterol to the oligonucleotide would therefore inherently make the compound a TLR stimulating compound. The compound would be TLR stimulating from the act of conjugation of the cholesterol which as described above, would be obvious to improve delivery to cells.
Thus Krieg et al. anticipates the claims.
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 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krieg et al. (Application No. 20070066554) and Irvine et al. (US 20190015522 Jan. 17 2019).
The claims are drawn to a pharmaceutical composition comprising an amphiphilic oligonucleotide conjugate comprising a lipophilic component comprising a C14 or C18 diacyl lipid or a cholesterol tail and conjugated to an oligonucleotide consisting of SEQ ID No. 2 and a poly-oligo(dT) of 10-50 (T10-T50) or (T20-25).
Regarding claim 16-17, Krieg et al. teach an immunostimulatory oligonucleotide comprising 20 thymidine (see SEQ ID No. 226 Table A). Krieg et al. teach oligonucleotides can comprise a phosphorothioate modification (0023) and can be delivered to a cell via a lipid (0285). Krieg et al. teach a pharmaceutical composition comprising the oligonucleotide and teach it can be administered as in claims 18 and 19 (see 0292).
Krieg et al. do not teach using a peg linker attached to a cholesterol tail.
Regarding claims 16 and 17, Irvine teach attaching lipid conjugates such as C14 or C18 diacyl lipid or a cholesterol tail (0033) using a peg linker (0039 and 0134) and it one of skill in the art would have been motivated to try different diacyl lipid tail lengths given it can be conjugated efficiently to oligonucleotides for delivery at the 5’ or 3’ end.
Regarding the limitation of claim 13 “wherein the conjugate of the lipophilic component results in a TLR stimulating compound”, the mere step of conjugation of the diacyl lipid to the oligonucleotide would therefore inherently make the compound a TLR stimulating compound. The compound would be TLR stimulating from the act of conjugation of the diacyl lipid which as described above, would be obvious to improve delivery to cells.
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.
Claims 13-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krieg et al. (Application No. 20070066554) and Kugimiya et al. (US 20180264105 of record cited on 892 mailed 08/18/2025).
The claims are drawn to a pharmaceutical composition comprising an amphiphilic oligonucleotide conjugate comprising a lipophilic component comprising a C14 or C18 diacyl lipid and conjugated to an oligonucleotide consisting of SEQ ID No. 2 and a poly-oligo(dT) of 10-50 (T10-T50).
Regarding claim 13, 15, 17, 18 and 19, Krieg et al. teach an immunostimulatory oligonucleotide comprising 20 thymidine (see SEQ ID No. 226 Table A). Krieg et al. teach oligonucleotides can comprise a phosphorothioate modification (0023) and can be delivered to a cell via a lipid (0285). Krieg et al. teach a pharmaceutical composition comprising the oligonucleotide and teach it can be administered as in claims 18 and 19 (see 0292).
Krieg et al. do not teach using a diacyl lipid conjugate.
Regarding the limitation of a diacyl lipid or cholesterol conjugate, claim 14 and 16, it was known in the art that using diacyl lipids or cholesterol can be efficiently conjugated to oligonucleotides for delivery to cells. Kugimiya et al. who teach diacyl lipids conjugated to immunomodulatory oligonucleotides at the 5’ or 3’ end (0022). Kugimiya et al. teach the diacyl lipid is preferably two chains and preferably C14 to C24 (0154-0155) and teach they can be attached via a linker to the oligonucleotides (0022). Kugimiya et al. also teach lipids such as cholesterol (0152).
Regarding claims 20 and 21, Kugimiya et al. teach administration of an antigen (0016 and 0175). It would have been obvious to use the oligonucleotide of Krieg et al. in combination with an antigen for treatment.
One of skill in the art would have been motivated to try different diacyl lipid tail lengths given it can be conjugated efficiently to oligonucleotides for delivery at the 5’ or 3’ end. Because Kugimiya et al. teach diacyl lipid is preferably two chains and preferably C14 to C24, this is a finite number of diacyl lipids for one of skill in the art to conjugate to the oligonucleotide, taught by Krieg et al., to find an optimal conjugate. One of skill in the art would have had good reason to want to improve the cell affinity of the immunostimulatory oligonucleotide taught by Krieg et al. for delivery of the therapeutic and capable of making the conjugates as shown in the prior art.
Regarding the limitation of claim 13 and claim 22 “wherein the conjugate of the lipophilic component results in a TLR stimulating compound”, the mere step of conjugation of the diacyl lipid to the oligonucleotide would therefore inherently make the compound a TLR stimulating compound. The compound would be TLR stimulating from the act of conjugation of the diacyl lipid which as described above, would be obvious to improve delivery to cells.
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.
Claims 13-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uchida et al. (Patent No. 6,150,092) and Kugimiya et al. (US 20180264105 of record cited on 892 mailed 08/18/2025).
The claims are drawn to a pharmaceutical composition comprising an amphiphilic oligonucleotide conjugate comprising a lipophilic component comprising a C14 or C18 diacyl lipid and conjugated to an oligonucleotide having SEQ ID No. 2 and a poly-oligo(dT) of 10-50 (T10-T50).
Regarding claim 13, 15, 17, 18 and 19, Uchida et al. teach an oligonucleotide comprising 20 thymidine which meets (see alignment below and Table 2). Uchida et al. teach oligonucleotides can comprise phosphorothioate (col. 4) and can be delivered to a cell via a lipid (col. 9). Uchida et al. teach a pharmaceutical composition comprising the oligonucleotide and teach it can be administered as in claims 18 and 19 (see col 7 and 8).
SEQ 2 1 TTTTTTTTTTTTTTTTTTTT 20
SEQ 96 1 TTTTTTTTTTTTTTTTTTTT 20
Uchida et al. teach oligonucleotides can comprise (0125).
Claims 13 and 17 recite “an immunomodulating deoxyribonucleic acid oligonucleotide” having the claimed SEQ ID No. 2 or a poly-oligonucleotide (dT). Uchida et al. does not describe the oligonucleotide as immunomodulator but because Uchida et al. teach the identical structure clamed, the oligonucleotide is inherently “an immunomodulating deoxyribonucleic acid oligonucleotide.
It is well established that the patentability of product claims depends on the structure, not function, of the product. “[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mkt. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). That is, “[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). Furthermore, note that when a rejection is based on a reference teaching a product appearing to be substantially identical to the claimed product, and when the examiner presents reasoning tending to show inherency, the burden shifts to the applicant to show an unobvious difference. See MPEP 2112: “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency under 35 U.S.C. 102, on prima facie obviousness under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].”
Uchida et al. do not teach using a diacyl lipid conjugate.
Regarding the limitation of a diacyl lipid or cholesterol conjugate, claim 14 and 16, it was known in the art that using diacyl lipids or cholesterol can be efficiently conjugated to oligonucleotides for delivery to cells. Kugimiya et al. who teach diacyl lipids conjugated to immunomodulatory oligonucleotides at the 5’ or 3’ end (0022). Kugimiya et al. teach the diacyl lipid is preferably two chains and preferably C14 to C24 (0154-0155) and teach they can be attached via a linker to the oligonucleotides (0022). Kugimiya et al. also teach lipids such as cholesterol (0152).
Regarding claims 20 and 21, Kugimiya et al. teach administration of an antigen (0016 and 0175). It would have been obvious to use the oligonucleotide of Barrat et al. in combination with an antigen for treatment.
One of skill in the art would have been motivated to try different diacyl lipid tail lengths given it can be conjugated efficiently to oligonucleotides for delivery at the 5’ or 3’ end. Because Kugimiya et al. teach diacyl lipid is preferably two chains and preferably C14 to C24, this is a finite number of diacyl lipids for one of skill in the art to conjugate to the oligonucleotide, taught by Uchida et al., to find an optimal conjugate. One of skill in the art would have had good reason to want to improve the cell affinity of the immunostimulatory oligonucleotide taught by Uchida et al. for delivery of the therapeutic and capable of making the conjugates as shown in the prior art.
Regarding the limitation of claim 13 and claim 22 “wherein the conjugate of the lipophilic component results in a TLR stimulating compound”, the mere step of conjugation of the diacyl lipid to the oligonucleotide would therefore make the compound a TLR stimulating compound. The compound would be TLR stimulating from the act of conjugation of the diacyl lipid which as described above, would be obvious to improve delivery to cells.
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(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 13-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966; Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial Structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed structure, and v. Correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art.
Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species by “…disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between functional and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Thus when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The claims are drawn to a genus of amphiphilic oligonucleotide conjugates comprising a diacyl lipid and a poly-oligo (dT) of 10-50 or 20-25 nucleotides in length with the function of any type of TLR stimulating compound.
When determining whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. In the instant case, the specification describes a lipid conjugate wherein a diacyl lipid was conjugated to a 20-mer polythymidine oligodeoxynucleotide (T-20) that resulted in TL-7 stimulation (0157)). The specification does not describe stimulation of any other TLR using a diacyl lipid conjugate comprising polythymidine oligodeoxynucleotide having as low as 10 nucleotides and up to 50 nucleotides. This example does not encompass the vast number of differently sized polythymidine oligodeoxynucleotides and different TLR.
It is then determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics (i.e. other than nucleotide sequence), specific features and functional attributes that would distinguish different members of the claimed genera. In the instant case, the only other identifying characteristics is stimulation of TL-7 with a T20 conjugated with a diacyl lipid. Such functional limitations cannot be identifying characteristics for stimulating all TLR that have structural and functional differences. The disclosure has not described all sizes of poly oligo(dT) of 10-50 nucleotides in length with the function of stimulating any TLR. A review of the specification shows that it provides no description or guidance that would allow one of skill to distinguish the functional species of the recited structural genus from the non-functional members without empirical determination.
The reference of Asami et al. ("Structural and functional understanding of the toll‐like receptors." Protein Science 30.4 (2021): 761-772) is drawn to the structure and function of toll-like receptors and describes 10 TLR that are stimulated by different compounds (see Figure 1) and have different stimulatory effects. Asami et al. describes some of the TLR are not well described, such as TLR-10 (see 1.1 page 763). Thus the state of the art does not describe all TLR that can be stimulated with a polythymidine oligodeoxynucleotide conjugated to a diacyl lipid.
Since the disclosure and the prior art fail to describe the common attributes and characteristics concisely identifying members of the proposed genus, and because the claimed genus is highly variant a vast number of sequence lengths with the function of stimulating any TLR, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus claimed.
"A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus" (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) (emphasis added).
Further, “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
Thus the specification and claims lack written description because it is clear that Applicant did not have possession of every variation of the expression construct. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521,222 USPQ 369,372-372 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the entire scope of the claimed invention.
Closest prior art
Barrat et al. (Patent 8,940,310 cited previously) is the closest prior art that teach an immunostimulatory oligonucleotide having SEQ ID No. 141 that is identical to SEQ ID No. 1 wherein the sequence further comprises two non-nucleotide hexa-(ethylene glycol) spacers attached at the 3’ end. Barrat et al. teach these spacers contribute charge and/or hydrophobicity to oligonucleotide, contribute favorable pharmacokinetic properties (e.g., improved stability, longer residence time in blood) to the IRC, and/or result in targeting of the IRC.
Barrat et al. do not teach using a diacyl lipid conjugate. There would not have been a motivation to remove the spacers in SEQ ID No. 141 and conjugate a diacyl lipid as claimed that would result in a TLR stimulating compound.
Conclusion
No claims are allowed.
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
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