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
Election/Restrictions
Applicant's election without traverse of Group I in the reply filed on 11/03/2025 is acknowledged. The election of a species from claim 30 has been withdrawn.
Status of the Application
Claims 1, 4-6, 9-11, 13, 17-19, 21-23, 26, 27, 29, 30, 35, 38 and 43 are pending. Claims 1, 4-6, 9-11, 13, 18, 19, 21-23, 26, 27, 29, 30, 35 and 38 are currently under examination. Claims 17 and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The submission of the Information Disclosure Statement are in compliance with 37 CFR 1.97. The information disclosure statement has been considered by the examiner and signed copies have been placed in the file.
Claim Rejections – Improper Markush
Claims 5 and 9 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The claims are directed to an oligonucleotide conjugate comprising at least one saponin linked to a GalNAc moiety wherein the saponin comprising a saccharide chain bound to the aglycone core structure selected from a vast number of different saccharide chains in claims 5 and 9.
When the Markush grouping is for alternatives of chemical compounds, they shall be regarded as being of a similar nature where the following criteria are fulfilled:
(A) All alternatives have a common property or activity; and
(B) (1) A common structure is present, i.e., a significant structural element is shared by all of the alternatives; or
(B) (2) In cases where the common structure cannot be the unifying criteria, all alternatives belong to a recognized class of chemical compounds in the art to which the invention pertains.
In paragraph (B)(1), above, the words “significant structural element is shared by all of the alternatives” refer to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity. The structural element may be a single component or a combination of individual components linked together.
In paragraph (B)(2), above, the words “recognized class of chemical compounds” mean that there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved.
In order for the members of the Markush group to belong to “recognized class of chemical compounds” there must be an expectation that the members of the class will behave in the same way in the context of the claimed invention. In other words, each member of the class could be substituted one for the other with the expectation that the same intended result would be achieved.
In the instant case, activity of any specific saccharide chain is dependent upon the specific combination of individual monosaccharides. Table A1 in the instant specification describes the endosomal and lysosomal escape enhancing activity of differently saccharide chains. There is no expectation that any one of the nucleotide sequences as claimed can be substituted for any of the other with a completely different sequence with the expectation of the same activity.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. 134 and 37 CFR 41.31(a)(1).
Claim Objections
Claims 5, 9 and 13 are objected to because of the following informalities: The claims recite monosaccharides that are recited by their symbol and not the full name. These monosaccharides should be spelled out the first time they are used in a claim followed by their symbol. For example Galactose represents Gal, Xylose represents Xyl and D-Glucuronic acid represents GlcA. Appropriate correction is required.
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 1, 4-6, 9-11, 13, 18, 19, 21-23, 26, 27, 29 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lu, Yuping, et al. ("Antiproliferative quillaic acid and gypsogenin saponins from Saponaria officinalis L. roots." Phytochemistry 113 (2015): 108-120), Marciani et al. (US20040242502) and Sewing et al. (March 2019 cited on IDS filed 10/21/2024).
Regarding claims 1, 4, 5, 6, 9ii, 10, 13 and 26, Lu et al. teach a novel saponin with the structure below that comprises the claimed saccharide chain Gal-(1->2)-[Xyl-(1->3]-GlcA- at the A1 position, a branched oligosaccharide at the A2 position and a hydrogen at position R of the claimed Molecule 1 (see page 113 ¶ 2 and Figure 3 below).
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Regarding claim 6. The specification on page 11 lines 16-19 defines a SO1861 derivative as either comprising SO186 or SO1832 so either structure is taught by Lu et al.
Lu et al. do not teach the saponin structure comprises an oligonucleotide, a GalNAc moiety or teach a aldehyde group at position C23 of the saponin that has been derivatized.
Regarding claims 9i and 10, Marciani et al. teach the aldehyde group at position C-23 can be derivatized (see R5 structure Formula I and 0080).
Regarding claim 11, Marciani et al. teach a bidesmosidic saponin (0020).
Regarding claims 27, 30 and 38, Marciani et al. teach the use of saponin adjuvants along with nucleic acids to induce an immune response when administered to animals and humans (abstract). Marciani et al. teach the saponin derivatives can comprise hydrogen groups, branched oligosaccharide (0045-0051). Marciani et al. teach the saponin derivative can comprise a nucleic acid such as an antisense (0100) and teach pharmaceutical compositions (0030).
Regarding claims 1, 18, 19, 21, 22, 23 and 29, Sewing et al. teach tri-GalNAc conjugates for delivering oligonucleotides, such as antisense oligonucleotides (Figure 1A). Sewing et al. teach tri-GalNAc structure can comprise cleavable linkers (page 71). Sewig et al. teach use of the GalNAc conjugate had favorable properties for delivery of the antisense oligonucleotide to cells. It would have therefore been obvious to conjugate the GalNAc moiety to the antisense oligonucleotide for delivery to cells to induce immune responses given Marciani et al. Lu and Marciani et al. together provide motivation to use a saponin derivative along with an oligonucleotide for induction of an immune response in a subject.
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 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lu, Yuping, et al. ("Antiproliferative quillaic acid and gypsogenin saponins from Saponaria officinalis L. roots." Phytochemistry 113 (2015): 108-120), Marciani et al. (US20040242502) and Grijalvo, Santiago, et al. ("Covalent strategies for targeting messenger and non-coding RNAs: an updated review on siRNA, miRNA and antimiR conjugates." Genes 9.2 (2018)).
Regarding claim 35, the limitation is in the alternative either using the oligonucleotide to target an mRNA or the oligonucleotide can be used to restore miRNA function. Grijalvo et al. teach antisense oligonucleotides can target miRNA which can restore the function of the miRNA that are involved in a variety of different diseases (see page 4 last ¶). Grijalvo et al. further teach delivery of the antisense oligonucleotide using GalNAc groups (see page 21 second ¶). It would have been obvious to use the antisense linked to a GalNAc moiety to restore the function of a miRNA in a subject and further linked to a saponin derivative given Marciani et al. Lu and Marciani et al. together provide motivation to use a saponin derivative along with an oligonucleotide for treatments in a subject.
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 1, 5, 9, 10, 26 and 35 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.
Claims 1, 5 and 9 recite “derivatives thereof” and this limitation is indefinite because the metes and bounds of the derivatives have not been defined.
Claim 9 is indefinite for several reasons. Step ii lacks antecedent basis because it recites “the carbozyl group of a glucuronic acid moiety of A1” and the claim 1 or claim 9 does not recite “a carbozyl group”. The claim is further indefinite because it recites “the carbozyl group of a glucuronic acid moiety of A1” wherein A1 is defined as “a linear or branched oligosaccharide” and not “a glucuronic acid moiety”. Claim 9 is further indefinite because A1 in step ii is represented as a saccharide chain selected from group A but also stated as represented by a monosaccharide.
Claim 9 recites “and A1 comprises a glucuronic acid moiety, has been derivatized; and iii. one or more acetoxy group(s) of one saccharide moiety or of two or more saccharide moieties of A2, wherein A2 represents a saccharide chain selected from group B” and is indefinite because A1 as initially defined is a “a linear or branched oligosaccharide” and also a saccharide chain of Group A.
Further claim 9 recites in iii. A2 is has one or more acetoxy groups of one or two saccharide moieties when A2 is initially defined as a hydrogen, a monosaccharide or a linear or branched oligosaccharide. For purposes of applying prior art, claim 9 will be interpreted as A1 is the selected Gal-(1->2)-[Xyl-(1->3)]-GlcA-, A2 is a hydrogen, a monosaccharide or a linear or branched oligosaccharide and R is hydrogen in gypsogenin or hydroxyl in quillaic acid saponin.
Claim 10 recites the oligonucleotide of claim 9 and recites different moieties for A1 and A2. Because claim 9 is indefinite and it is unclear what each represents, claim 10 will be interpreted as stated above for claim 9.
Claim 26 is indefinite because it recites the “oligonucleotide conjugate of claim 1, wherein the oligonucleotide conjugate comprises 1, 2, 3, 4, 5, 6, 8, 10, 16, 32, 64, 128 or 1-100 saponin moieties, or any number of saponin moieties therein between” and is unclear because it recites overlapping ranges such as 1, 2, 3, 4, 5, 6, 8, 10, 16, 32, 64 and 1-100. Further the recitation of “any number of saponin moieties therein between” is unclear because what number represents therein between. The claim recites “64” and then “128” so does that mean the number of saponin moieties can between 64 and 128 and also 1-100? For purposes of applying prior art, the claim is interpreted as the saponin moieties can be any of 1-100 and 128.
Claim 35 is indefinite because it recites “targeting an mRNA miRNA involved in expression of any one of proteins:” and it is unclear what molecule of mRNA and miRNA can express proteins. For purposes of applying prior art, the claim is interpreted as “targeting an mRNA involved in expression of any one of proteins:”
If Applicant disagrees with the interpretation of the claims posited by the Examiner and sets forth a different interpretation, additional rejections and prior art may be applied in a subsequence Final Office Action.
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 1, 4-6, 9-11, 13, 18, 19, 21-23, 26, 27, 29, 30, 35 and 38 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 claim are drawn to a genus of oligonucleotide conjugate comprising at least one saponin that is a monodesmosidc or a bidesmosidic with an aldehyde function in position C-23 and comprising a saccharide gene with the function of targeting mRNA to reduce expression from genes such as apoB, HSP27, TTR, PCSK9, TMPRSS6, ALAS 1, AT3, GO, CC5, expression product of X gene of HBV, expression product of S gene of HBV, AAT, miR-122, hepatitis B virus HbsAg, LDHA, CEBPA and LDH, or capable of antagonizing or restoring an miRNA function or inhibiting an oncogenic miRNA (onco-miR) or suppression of expression of an onco-miR.
The specification describes a BNA nucleic acid conjugate comprising a GalNAc moiety with one saponin derivative SO1861 that comprising a saccharide chain Gal-(1->2)-[Xyl-(1->3]-GlcA- wherein the oligonucleotide conjugate was capable of reducing expression of ApoB. The genus of oligonucleotides can include RNAi, target degradation by RNase H-mediated cleavage, splicing modulation, non-coding RNA inhibition, gene activation and programmed gene editing using a CRISPR/Cas system, LNA, BNA, xeno nucleic acids, aptamers, decoy oligonucleotides, lncRNA and antisense molecules.
In analyzing 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, only the use of the conjugate comprising BNA is described. The genus encompasses a vast number of oligonucleotide and the specification does not describe all the different types with the claimed function above. The genus of oligonucleotides can include RNAi, target degradation by RNase H-mediated cleavage, splicing modulation, non-coding RNA inhibition, gene activation and programmed gene editing using a CRISPR/Cas system, LNA, BNA, xeno nucleic acids, aptamers, decoy oligonucleotides, lncRNA and antisense molecules, for example. While the genus encompasses a large number of different nucleic acids, the specification and claims do not indicate what distinguishing characteristics are concisely shared by the members of the broad genus that would convey to one of skill in the art that these oligonucleotides represent the entire genus. 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.
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 comprising a vast number of different oligonucleotides, 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 type of oligonucleotide capable of reducing expression of ApoB. The genus of oligonucleotides can include RNAi, target degradation by RNase H-mediated cleavage, splicing modulation, non-coding RNA inhibition, gene activation and programmed gene editing using a CRISPR/Cas system, LNA, BNA, xeno nucleic acids, aptamers, decoy oligonucleotides, lncRNA and antisense molecules.
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.
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 1, 4-6, 18, 19, 21-23, 26, 29, 30, 35 and 38 are provisionally rejected under the judicially created doctrine of double patenting over claims 58-71 and 75-77 of co-pending Application No. 18,012,769 (App769). This is a provisional double patenting rejection since the conflicting claims have not yet been patented. 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. Both the instant claims and App769 are drawn to a saponin derivative comprising a saccharide chain and aglycone core with an oligonucleotide conjugate and a GalNAc moiety. The instant claim 35 is drawn to the oligonucleotide targeting mRNA expression proteins identical to claims 74-76 of App769 and it would have been obvious to use the instant conjugate in methods of treatment as in claims34-37 of App599. The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008
This is a provisional obviousness-type double patenting rejection.
Claims 1, 4-6, 18, 19, 21-23, 26, 29, 30, 35 and 38 are provisionally rejected under the judicially created doctrine of double patenting over claims 1-30, 46 and 58-65 of co-pending Application No. 18,044,950 (App950). This is a provisional double patenting rejection since the conflicting claims have not yet been patented. 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. Both the instant claims and App950 are drawn to a saponin derivative comprising a saccharide chain and aglycone core with an oligonucleotide conjugate and a GalNAc moiety.
This is a provisional obviousness-type double patenting rejection.
Claims 1, 4-6, 9-11, 13, 18, 19, 21-23, 26, 27, 29, 30, 35 and 38 are provisionally rejected under the judicially created doctrine of double patenting over claims 1-37 co-pending Application No. 18,571,599 (App599). This is a provisional double patenting rejection since the conflicting claims have not yet been patented. 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. Both the instant claims and App599 are drawn to a saponin derivative comprising a saccharide chain and aglycone core with an oligonucleotide conjugate and a GalNAc moiety. The instant claim 35 is drawn to the oligonucleotide targeting mRNA expression proteins identical to claims 34-37 of App599 and it would have been obvious to use the instant conjugate in methods of treatment as in claims34-37 of App599. 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.
Claims 1, 4-6, 9-11, 13, 18, 19, 21-23, 26, 27, 29, 30, 35 and 38 are provisionally rejected under the judicially created doctrine of double patenting over claims 1-4, 9, 10 of co-pending Application No. 18,723,157 (App157). This is a provisional double patenting rejection since the conflicting claims have not yet been patented. Although the conflicting claims are not identical, they are not patentably distinct from each other. The instant claims are drawn to a saponin derivative comprising a saccharide chain and aglycone core with an oligonucleotide conjugate and a GalNAc moiety. Claims of App157 are drawn to methods of treating a muscle wasting disorder using a saponin derivative comprising a saccharide chain and aglycone core with an oligonucleotide conjugate. App157 does not teach using a GalNAc conjugate however Sewig et al. (cited above) teach use of the GalNAc conjugate had favorable properties for delivery of the antisense oligonucleotide to cells. It would have therefore been obvious to conjugate the GalNAc moiety to conjugate of App157 for delivery. It would have been further obvious to use the instant conjugate in methods of treatment as in of App157. 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.
Claims 1, 4-6, 9-11, 13, 18, 19, 21-23, 26, 27, 29, 30, 35 and 38 are provisionally rejected under the judicially created doctrine of double patenting over claims 1-3, 5, 6, and 11-12 of co-pending Application No. 18,723,096 (App096). This is a provisional double patenting rejection since the conflicting claims have not yet been patented. Although the conflicting claims are not identical, they are not patentably distinct from each other. The instant claims are drawn to a saponin derivative comprising a saccharide chain and aglycone core with an oligonucleotide conjugate and a GalNAc moiety. Claims of App096 are drawn to methods of treating a muscle wasting disorder using a saponin derivative comprising a saccharide chain and aglycone core with an oligonucleotide conjugate. App096 does not teach using a GalNAc conjugate however Sewig et al. (cited above) teach use of the GalNAc conjugate had favorable properties for delivery of the antisense oligonucleotide to cells. It would have therefore been obvious to conjugate the GalNAc moiety to conjugate of App096 for delivery. It would have been further obvious to use the instant conjugate in methods of treatment as in of App096. 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.
Conclusion
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/KIMBERLY CHONG/
Primary Examiner Art Unit 1636