ETAILED ACTION
This Action is in response to the communication filed on 08/11/2025.
Claims 1-30 are pending.
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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 9-18) and the species SEQ ID NO: 2 in the reply filed on 08/11/2025 is acknowledged.
Claims 1-8, 19-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/11/2025.
Claims 9-18 are under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 10/20/2022, 06/07/2024, and 03/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 9-18 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.”
The claims are drawn to a transformant comprising the nucleic acid according to claim 1 introduced into a host, wherein the nucleic acid of claim 1 is a nucleic acid comprising a total of 20 to 60 nucleotides comprising the nucleotide sequence shown in SEQ ID NO: 1. It is noted that SEQ ID NO: 1 is the 16 nucleotide sequence cacgcgnnnncacgtg wherein each “n” is a, c, g, or t. As such, the claims encompass a nucleic acid sequence wherein only 12 of 20 to 60 nucleotides are defined. Accordingly, given the broadest possible length (60 nucleotides), the claims encompass a nucleotide sequence wherein only 20% (12 of 60) of the nucleotides are defined. The disclosure indicates that the nucleic acid enables evaluation of various endocrine disrupting action of endocrine disrupting chemicals with high sensitivity (e.g., see abstract), and further states that the object of the present invention is to provide a nucleic acid that can be used in a highly sensitive evaluation system that can detect various endocrine disrupting actions in a very small amount of endocrine disrupting chemicals (see paragraph [0016] of the published application (US20230250436)). The specification also indicates that the nucleic acid may be referred to as a “response element” and interacts with a juvenile hormone receptor (a MET protein) of Daphnia magna bound to a juvenile hormone and positively regulates the expression of a downstream gene at the transcription level (see paragraph [0028]). Accordingly, the nucleic acid must be able to interact with a juvenile hormone receptor (a MET protein) of Daphnia magna bound to a juvenile hormone and be able to positively regulate the expression of a downstream gene at the transcription level. The claims encompass a genus of structurally distinct nucleic acid sequences wherein in their broadest embodiments, only 20% (12 of 60) of the nucleotides are defined. The only specific nucleotide sequences encompassed by the claims which are shown to have the required activity are the nucleotide sequences of SEQ ID Nos: 2, 5, 8, 34, 37, 40, 43, 46, 49 and 52 (see Table 3). However, the evidence presented in the specification appears to indicate that wide range of reporter activity for the different response elements tested. For example, see Table 6 wherein yeast 4 treated with 10nM of juvenile hormone has a reporter level of 5.13 while yeast 7 treated with the same amount of juvenile hormone (10nM) has a reporter level of 0.06. Furthermore, Table 7 appears to indicate that yeast 13 and yeast 14 treated with 100nM juvenile hormone did not have any reporter level (indicated by “---“) and only have a reporter level of 0.09 when treated with 10uM juvenile hormone, while yeast 18 did not show any reporter level at 10uM (“---“) and only 0.10 at 100nM. This information appears to indicate that there is variability among the nucleic acid response elements encompassed by the claims and it is unpredictable which nucleic acid sequences encompassed by the broad claim limitations are functional and which ones are not functional without empirical determination.
Considering that vast number of different nucleic acid sequences encompassed by the claims in view of the disclosed functional variability between the different nucleic acid sequences, including the disclosure which appears to indicate a lack of function for three nucleic acid sequences (Table 7 as indicated above), the limited disclosure of approximately 10 functional nucleic acid sequences is insufficient to adequately describe the entire genus of nucleic acid 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 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 does not provide sufficient written description or guidance that would allow one of skill in the art to distinguish the functional species of the recited structural genus from the non-functional members without empirical determination. Thus, one of skill in the art at the time of invention could not have concluded that Applicant was in possession of the genus of functional nucleic acid sequences encompassed by the claims.
It is noted that limiting the genus of nucleic acid sequences encompassed by the claims to SEQ ID Nos: 2, 5, 8, 34, 37, 40, 43, 46, 49 or 52 would obviate this rejection.
Claim Rejections - 35 USC § 112(b)
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 11 and 12 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "the 3’ terminal side of a sense strand of the nucleic acid" in line 2. There is insufficient antecedent basis for this limitation in the claim because claim 9 does not recite “sense strand”; furthermore, claim 9 does not necessarily require that the nucleic acid is a double stranded nucleic acid and thus does not necessarily comprise a sense or antisense strand.
The rejection may be overcome by amending claim 11 to indicate that the nucleic acid of claim 9 is a double stranded nucleic acid comprising a sense strand and an antisense strand, wherein the double stranded nucleic acid comprises a reporter gene on the 3’ terminal end of the sense strand.
Claim 12 is recites “a nucleic acid encoding a receptor for endocrine disrupting chemicals that interacts with the nucleic acid introduced therein.” It is not clear if it is the receptor that interacts with the nucleic acid introduced therein or if it is the chemicals that interacts with the nucleic acid introduced therein. Correction is required.
Claim Objections
Claims 9-18 are objected to because of the following informalities: each of the claims refers back to a previous claim with the phrase “according to Claim…” The word “Claim” in said phrase is improperly capitalized. The objection can be obviated by changing “Claim” to “claim” (i.e., changing the capitol “C” to lower case “c”. Appropriate correction is required.
Claim 9 is also objected to because (a) claim 9 depends on withdrawn claim 1, and (b) claim 9 recites “a transformant comprising the nucleic acid according to Claim 1 introduced into a host.” The way claim 9 is currently written is awkward and not consistent with typical or standard patent claim language. A suggestion to consider is changing claim 9 to “A transformed host cell comprising a nucleic acid sequence wherein the nucleic acid sequence is 20 to 60 nucleotides in length and comprises the nucleotide sequence of SEQ ID NO: 1.” It is noted that the suggested amendment would obviate the objection but not obviate the written description rejection (under 35 USC 112(a) as indicated above). Further limiting the nucleotide to “the nucleotide sequence of any one of SEQ ID NOs: 2, 5, 8, 34, 37, 40, 43, 46, 49 or 52 is suggested to overcome the written description rejection, as indicated above. It is also noted that should claim 9 be amended to “a transformed host cell” the dependent claims should be similarly amended as well (i.e., amended from “the transformant” to “the transformed host cell”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637