Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Application
Claims 1-19 and 21 are pending and are currently under examination.
Claim Rejections – Improper Markush
Claims 15 and 18 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: claim 15 is directed to a large multitude of different proteins and claim 18 is directed to a large multitude of different inhibitors.
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, the protein amino acid structures do not share a structural similarity or common property or activity. Likewise, the inhibitors of DNMT do not share a common structure and a common activity given some are small molecules, chemical compound or nucleic acids. There is no expectation that any one of the proteins or inhibitors as claimed can be substituted for any of the other 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 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.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 21 recites “preferably and it is unclear whether the limitations following the phrase are part of the claimed invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krieg et al. (US 20150141320).
Regarding claim 1, Krieg et al. teach a single stranded oligonucleotide having 15 consecutive nucleotides identical to instantly claimed SEQ ID No. 2 (see alignment below). This meets the limitation of an antisense oligonucleotide comprising 12-50 nucleotides of SEQ ID No. 2.
Regarding claims 2-5, Krieg et al. teach the oligonucleotide comprises modifications such as LNA and 2’-O-methyl (0022-0025).
Regarding claims 6-8, the oligonucleotide can consist of LNA at either the 5’ or 3’ end and deoxyribonucleotides in the center or gapmers (163-167).
Regarding claim 9, Krieg et al. teach one or more 2’O-methoxy ethyl (0153, 0191).
Regarding claim 11, Krieg et al. teach the locked nucleic acid comprising a methylene bridge (0153).
Regarding claim 12, Krieg et al. teach phosphorothioate linkages between one or all nucleotides (0025).
Regarding claim 13, Krieg et al. teach pharmaceutical compositions (0027).
RESULT 14
US-14-401-248-1657017
Sequence 1657017, US/14401248
Publication No. US20150141320A1
GENERAL INFORMATION
APPLICANT: RaNA Therapeutics, Inc.
APPLICANT: The General Hospital Corporation d/b/a Massachusetts General Hospital
TITLE OF INVENTION: COMPOSITIONS AND METHODS FOR MODULATING GENE EXPRESSION
FILE REFERENCE: R0693.70015WO00
CURRENT APPLICATION NUMBER: US/14/401,248
CURRENT FILING DATE: 2014-11-14
PRIOR APPLICATION NUMBER: US 61/648,077
PRIOR FILING DATE: 2012-05-16
NUMBER OF SEQ ID NOS: 2142811
SEQ ID NO 1657017
LENGTH: 15
TYPE: DNA
ORGANISM: Homo sapiens
Query Match 75.0%; Score 15; Length 15;
Best Local Similarity 100.0%;
Matches 15; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
SEQ 2 5 TCATGCAATGCACAT 19
SEQ ID 1657017 1 TCATGCAATGCACAT 15
Thus Krieg et al. anticipates the instant 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.
Claim(s) 1-19 and 21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee et al (WO 2016/164463 of record IDS filed 08/11/2023) .
Regarding claim 1, Lee et al disclose compositions comprising a XIST RNA inhibitor (see lines 26-28 on page 2), wherein the inhibitor can be nucleic acids (see lines 14-19 on page 2).
Regarding claims 2-13, Lee et al disclose that such inhibitory nucleic acids can be 8-30 nucleotides in length (see lines 22-23 on page 4), can comprise nucleotide analogues (see lines 24-25 on page 4), can comprise 2’-O-methyl (see lines 26-27 on page 4), can comprise at least one ribonucleotide or bridged nucleotide (see lines 29-30 on page 4 and page 40-41), such bridged nucleotide can be LNA (see lines 1-2 on page 5) and each nucleotide can be LNA or multiple LNA (see lines 4-5 on page 5), one or more of the nucleotides of the inhibitory nucleic acid can comprise 2’-fluoro-deoxyribonucleotides and/or 2’-O-methyl nucleotides (see lines 6-8 on page 5), one or more of the nucleotides of the inhibitory nucleic acid can comprise one of both of ENA nucleotide analogues or LNA nucleotides (see lines 9-11 on page 5), the nucleotides of the inhibitory nucleic acid can comprise phosphorothioate internucleotide linkages between at least two nucleotides, or between all nucleotides (see lines 12-15 on page 5), such inhibitory nucleic acid can be gapmer or mixmer (see lines 16-17 on page 5) and teach pharmaceutical compositions (see page 45).
Regarding claims 14-18, Lee et al. teach the composition can comprise an inhibitor of an XIST protein such as DNMT (see lines 26-28 on page 2 and claims 1, 2 and 5).
Regarding claim 19, Lee et al. teach administering one or more inhibitors of an XIST interacting protein (see lines 1-7 page 4).
Regarding claim 21, Lee et al. teach methods of activating an inactive X-linked allele in a cell using a nucleic acid inhibitor of XIST and DNMT (see lines 10-20 page 2).
Lee et al. does not specifically teach oligonucleotides comprising 12-50 consecutive nucleotides SEQ ID Nos. 1-45 or teach oligonucleotides comprising 12-50 consecutive nucleotides at or with 100 nts of the binding sites for the antisense sense having SEQ ID Nos, 1-45. The specification describes the sequences as targeted to exons 1-6 of XIST (Genbank NR_001564) (Fig. 7 in the spec).
Lee et al. teach the full XIST sequence is available in the ensemble database at ENSG00000229807; it is present on Chromosome X at 73,820,651-73,852,753 reverse strand (Human GRCh38.p2). The full sequence is shown in SEQ ID NO:66; XIST exons correspond to 601-11972 (exon l); 15851-15914 (exon 2); 19593-20116 (exon 3); 21957-21984 (exon 4); 22080-22288 (exon 5); and 23887-33304 (exon 6). Alternatively, see NCBI Reference Sequence: NR_001564.2, Homo sapiens X inactive specific transcript (non-protein coding) (XIST), long non-coding RNA, wherein the exons correspond to 1-11372, 11373-11436, 11437-11573, 11574-11782, 11783-11946, and 11947-19280. The inhibitory nucleic acid targeting XIST RNA can be any inhibitory nucleic acid as described herein, and can include modifications described herein or known in the art. In some embodiments, the inhibitory nucleic acid is an antisense oligonucleotide (ASO) that targets a sequence in XIST RNA, e.g., a sequence within an XIST exon as shown in SEQ ID NO:66 or within the RNA sequence as set forth in NR_001564.2. (see page 23).
Lee et al. teach routine methods can be used to design an inhibitory nucleic acid that binds the target sequence with sufficient specificity using bioinformatic methods known in the art to identify regions of secondary structures and descries gene walk as a method to optimize inhibitory activity of the nucleic acid and further suggest local alignment tools such as BLAST programs to identify binding areas to design antisense oligonucleotides (see page m27, lines 22-34).
It would have been obvious for one of skill in the art to make the claimed sequences given Lee et al. teach the full XIST sequence and known exon regions and teach well known routine methods that can be used to design and test oligonucleotides to the target region. One of skill in the art would have been motivated to use this method to design therapeutics for treating X-linked diseases.
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 1-19 and 21 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 antisense oligonucleotides comprising 12-50 nucleotides of SEQ ID Nos. 1-45 or any oligonucleotide 12-50 nucleotides in length that binds within 100 nucleotides of the binding site for ASO’s comprising SEQ ID Nos. 1-45 in XIST and Claims 14, 15 and 18 are drawn to an inhibitor of an XIST interacting protein with the function of increasing expression of an inactive X-linked allele in a cell.
The specification describes sequences having SEQ ID Nos. 1-45 that bind XIST
and antisense and siRNA sequences that target DNMT as well as an inhibitor of DNMT such as decitabine. The specification and claims do not indicate what distinguishing characteristics of these sequences that that would convey to one of skill in the art that these sequences represent the entire genus of any oligonucleotide 12-50 nucleotides comprising SEQ ID Nos. 1-45 or any oligonucleotide 12-50 nucleotides in length that binds within 100 nucleotides of the binding site for ASO’s or the sequences targeted to DNMT represents the entire genus targeted to any XIST interacting protein. 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 antisense sequences to different regions of XIST and comprising any type if inhibitor to a vast number of XIST interaction proteins, 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 sequence 12-50 nucleotides comprising SEQ ID Nos. 1-45 and every sequence of 12-50 nucleotides within 100 nt of the target region of XIST ASO’s and every inhibitor of XIST interaction protein.
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.
Enablement
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of upregulating CDKL5 in human patient cells using a composition comprising an XIST antisense oligonucleotide and a DNMT inhibitor decitabine, does not reasonably provide enablement for methods of increasing expression of any inactive X-linked allele in a cell using the claimed antisense oligonucleotides. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The following factors have been considered in the analysis of enablement: (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims and the nature of the invention:
The claims are drawn to methods of increasing expression of any inactive X-linked allele in a cell comprising administering the claimed antisense oligonucleotides targeted to XIST and any inhibitor of a XIST interacting protein. Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.
The state of the prior art:
A thorough review of the patent and non-patent literature indicates that the state of the art demonstrating methods of increasing expression of any inactive X-linked allele in a cell by administering the claimed antisense oligonucleotides targeted to XIST and any inhibitor of any XIST interacting protein was nascent at the time of filing.
The level of one of ordinary skill:
While the level of one of ordinary skill practicing said invention would be high, the level of predictability is considered variable as evident in the prior art discussed above and is not considered to provide sufficient enablement to practice the claimed invention.
Because the state of the prior art does not provide evidence of the degree of predictability that methods for increasing expression of any inactive X-linked allele in a cell can occur by administering the claimed antisense oligonucleotides targeted to XIST and any inhibitor of any XIST interacting protein, one of ordinary skill in the art would look for guidance or direction in the instant specification.
The level of predictability in the art:
“The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.” (MPEP 2164.03).
The amount of direction provided by the inventor:
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004).
The existence of working examples:
The working embodiment in the instant application describes methods of upregulating CDKL5 in human patient cells using a composition comprising an XIST antisense oligonucleotide and a DNMT inhibitor decitabine. The working embodiments do not describe increasing expression of any inactive X-linked allele using the claimed antisense composition comprising any inhibitor of XIST-interacting protein.
The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant invention suggests administration, of the claimed antisense oligonucleotides and any inhibitor of XIST-interacting protein to a subject increasing expression of any inactive X-linked allele in a cell without an enabling disclosure or guidance in the prior art.
While the MPEP 2164.02 states the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970), the lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The prior art is undeveloped for the role inhibitors of XIST and inhibitors of any XIST-interacting protein plays in the ability to increase expression of any inactive X-linked allele in a cell. The specification does not provide sufficient guidance such that one of skill in the art must be able to make and use the invention with a reasonable expectation of success and not to make and test if the invention actually works. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004).
Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
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 1-19 and 21 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-5, 8-10 and 14-24 of Applicant No. 18,417,527. 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. The instant claims and claims of App’527 are drawn to compositions comprising antisense oligonucleotides targeted to XIST and an inhibitor of a XIST-interacting protein such as DNMT and to methods of increasing an inactive X-linked allele in a cell.
Claims 1-19 and 21 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-7, 13-16, 18-20, 22-23, 26-27, 33-34 and 36-27 of Applicant No. 18,032,643. 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. The instant claims and claims of App’643 are drawn to compositions comprising antisense oligonucleotides having SEQ ID Nos. 1-45 targeted to XIST and an inhibitor of a XIST-interacting protein and to methods of increasing an inactive X-linked allele in a cell.
Claims 1-19 and 21 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-18 of Patent No. 10,961,532. 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. The instant claims are drawn to compositions comprising antisense oligonucleotides targeted to XIST and an inhibitor of a XIST-interacting protein and it would have been obvious to use this composition in the methods of Patent ‘532.
Claims 1-19 and 21 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-15 of Patent No. 11,912,994. 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. The instant claims and claims of Patent ‘994 are drawn to compositions comprising antisense oligonucleotides having SEQ ID Nos. 1-45 targeted to XIST and an inhibitor of a XIST-interacting protein.
Conclusion
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 between M-F 8:00am-4:30pm.
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.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public. For more information about the PAIR system, see http://pair-direct.uspto.gov.
For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199.
/KIMBERLY CHONG/
Primary Examiner Art Unit 1636