DETAILED ACTION
Claims 1-8 are pending and are addressed herein.
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 .
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 1-8 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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.
To satisfy the written description requirement, MPEP §2163 states, in part “…a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.” 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.”
In their broadest embodiments, the claims are drawn to an aptamer that binds to chymase and comprises a common sequence represented by UAACR1-[loop]-R 2GGGG (represented by the stem-loop structure of formula (1) in the claims), wherein R1 and R2 are each any one base and the base length of the aptamer is not less than 28 and the structure of (1’) has a length of 3 to 21 and at least two bases at the 5’-end of the UAAC sequence and at least two bases at the 3’-end of the GGGG sequence form base pairs, and wherein the aptamer comprises a nucleotide sequence selected from any of SEQ ID NOs: 1-11, 14-33, and 42-84, wherein uracil is optionally thymine, and wherein one to several nucleotides are substituted, deleted, inserted or added in the nucleotide sequence other than the sequence UAAC and GGGG in the formula (1) (see claim 1).
As such, the claims encompass a genus of aptamers which bind to chymase and which must have the generic nucleic acid sequence/structure as set forth in claim 1 which includes sequences similar to any of the indicated SEQ ID NOs, but includes “one to several” nucleotide substitutions, deletions, insertions or additions. Considering that the claims explicitly encompass variant aptamer sequences that include aptamers “one to several” nucleotide substitutions, deletions, insertions or additions, the claims encompass an enormous number of different nucleic acid sequences.
The application discloses 63 different sequences identified as aptamers which bind chymase and have the required structure: SEQ ID Nos: 1-11 and 14-33, 42-84 which range in size from 22 to 77 nucleotides in length. The application indicates that many different chymase binding aptamers were produced using the SELEX method and a “common sequence” having the sequence UAACR1N1R2GGGG as indicated above, was identified in a number of the aptamers. Although all of the aptamers of SEQ ID Nos: 1-11, 14-33, 42-84 comprise the required common sequence, there is no evidence of a structure-function relationship between the “common sequence” and chymase-binding aptamer function such that all sequence encompassed by the claims, which and includes the sequence of the indicated SEQ ID NOs with “one to several” nucleotide substitutions, deletions, insertions or additions, would have the required function. That is, there is no indication indicating where nucleotides can be substituted, deleted, inserted, or added and result in functional aptamer that binds chymase. The limited disclosure of the specification in view of the vast genus of molecules encompassed by the claims does not adequately describe the entire genus of molecules encompassed by the claims.
“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).
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without a 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.
The court and the Board have repeatedly held (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,18 USPQ2d 1016 (CA FC, 1991); Fiers v. Revel, 25 USPQ2d 1601 (CA FC 1993); Fiddes v. Baird, 30 USPQ2d 1481 (BPAI 1993) and Regents of the Univ. Calif. v. Eli Lilly & Co., 43 USPQ2d 1398 (CA FC, 1997)) that an adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it, irrespective of the complexity or simplicity of the method; what is required is a description of the nucleic acid itself.
The specification lacks 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. Thus one of skill at the time of the invention could not have concluded that Applicant was in possession of the genus of functional inhibitory oligonucleotides that is required to practice any of the claimed methods.
It is noted that limiting the claims to the aptamers of SEQ ID Nos: 1-11, 14-33, 42-84 would obviate this rejection.
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 4 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the functional substance according to claim 1" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not recite any “functional substance.”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,639,503 (of record- IDS citation). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 1 and claim 1 of the ‘503 patent are very similar and overlap in scope such as each is drawn to an aptamer that binds to chymase and comprises a potential secondary structure represented by the same formula (1) wherein (1’) is a stem-loop and R1 and R2 are each any 1 base, wherein the aptamers are of the same length and include specific nucleotide sequences, however instant claim 1 further indicates, “and wherein one to several nucleotides are substituted, deleted, inserted or added in the nucleotide sequence other than the sequence UAAC and GGGG in the formula (1).” Thus although the claims overlap, instant claim 1 is broader in scope as it allows for substitution, deletion, insertion or addition of one to several nucleotides in the sequence other than the UAAC and GGGG in formula (1). Since instant claim 1 is broader in scope than claim 1 of the issued patent, instant claim 1 is anticipated by claim 1 of the issued patent. It is also noted that instant claims 2-8 correspond to claims 2-8 of the issued patent. Therefore, the instant claims are not patentably distinct from the claims of the ‘058 patent and the double patenting rejection is appropriate.
Conclusion
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637