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 objections and rejections
1. Claims 1 and 3-20 are pending. Claim 2 is cancelled. Accordingly, claims 1 and 3-20 are examined on merits in the present Office action. Applicant’s response filed April 7, 2026 is entered.
2. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
3. Rejection of claims 1 and 3-20 under 35 U.S.C. 112(b) is withdrawn in light of Applicant’s arguments and claim amendments filed in the papers of April 7, 2026, and upon further consideration.
Claim Objections
4. Claim 1 remains, claims 4-17 and 18 are objected to because of the following informalities:
In claim 1, it is suggested to delete the recitation “substantially” for the clarity of the claimed subject matter.
In claim 1, the full form of the recitation “FAME” must be recited in parenthesis.
In claims 1, 5-10, 12, and 15-17, it is suggested to insert the recitation ---mutant Chlorophyte algal--- after “the” and before “organism” for clarity of the claimed subject matter.
In claim 11, it is suggested to change the recitation “the microorganism” to ---the mutant Chlorophyte algal organism---for clarity of the claimed subject matter.
In claims 1, 4, 5, 6, 7, 8, 9, 10, 14, 15, 16, 17, 18, it is suggested to change the recitation “control organism” to ---control Chlorophyte algal organism--- for clarity of the claimed subject matter.
In claims 13, , it is suggested to change the recitation “control microorganism” to --- control Chlorophyte algal organism--- for clarity of the claimed subject matter.
Appropriate correction is required. These claim objections are also necessitated by the claim amendments filed in the papers of April 7, 2026.
Claim Rejections - 35 USC § 112
5. Claims 1 and 3-20 remain rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention for the reasons of record stated in the Office action mailed in the papers of January 15 2026.
Applicant traverses the rejection in the papers filed March 31, 2023.
Applicant primarily argues that Example 5, of the specification supports the fact that the instantly claimed invention meets the written description requirements (response, pages 5-6).
Applicant’s arguments are carefully considered but are deemed to be unpersuasive.
Contrary to Applicant’s arguments, it is maintained that claims read on any amino acid sequence from any source and of any length, and having 90% or 95% amino acid identity to identity to SEQ ID NO: 17. This will encompass sequences with unknown structure(s) and function.
The instant specification, however, only describes an SGI1 gene encoding a polypeptide of
SEQ ID NO: 17 having a conserved receiver domain and a conserved Myb domain as set forth in figures 4 and 5, respectively
Contrary to Applicant’s arguments, it is maintained that neither the specification or the claims recite any mutations outside of the gene encoding the instantly claimed SEQ ID NO: 17 that attenuate the total activity or the specific activity of the encoded SEQ ID NO: 17.
The specification does not describe structure of sequences having 90% or 95% amino acid sequence identity to SEQ ID NO: 17, and thus their function is unknown.
The only species described is the amino acid sequence of SEQ ID NO: 17.
The specification does not describe the function of instantly claimed properties for representative species as encompassed by the breadth and scope of the claimed invention.
It is therefore, maintained that one of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, SEQ ID NO: 17 is insufficient to describe the claimed genus.
It is thus maintained that one of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant as discussed above.
It is important to note that an Applicant shows possession of the claimed invention by describing distinguishing identifying characteristics (correlated to the claimed function) sufficient to show that the Applicant was in possession of the claimed invention (see MPEP 2163 § 2163[R-5]I). This has not been done in the present case.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In summary, the court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. The court goes on to say, “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
Thus, under Lilly and its progeny, the Specification does not show possession of a sufficient number of sequences falling within their potentially large genus to establish possession of their claimed genus. See Cf Enzo, 323 F.3d at 964 ("if the functional characteristic of... binding to [CD48] were coupled with a disclosed correlation between that function and a structure that is sufficiently known or disclosed," the written description requirement may be met). Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, ("definition by function ... does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is"); see also Kubin, 83 USPQ2d at 1416-17.
Applicant fails to describe a representative number of species that fall within the scope of the claimed genus. Applicant has shown structure and function relationship for only one species as discussed above. Hence, Applicant fails to meet either prong of the two-prong test set forth by Eli Lilly.
Also see in re Curtis (69 USPQ2d 1274 (Fed. Cir.2004), where the court held that there was sufficient evidence to indicate that one of ordinary skill in the art could not predict the operability of other species other that the single one disclosed in the specification. The court held that a disclosure naming a single species can support a claim to a genus that includes that species if a person of ordinary skill in the art, reading the initial disclosure, would “instantly recall” additional species of the genus already “stored” in the minds, but if other members of the genus would not “naturally occur” to a person of ordinary skill upon reading the disclosure, then unpredictability in performance of species other than specifically enumerated defeats claims to the genus.
Accordingly, there is lack of adequate description to inform a skilled artisan that applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published in Federal Register/Vol.66, No. 4/Friday, January 5, 2001/Notices; p. 1099-1111.
It is thus maintained that given the claim breadth and lack of guidance as discussed above, the specification does not provide written description of the genus broadly claimed. Accordingly, one skilled in the art would not have recognized Applicants to have been in possession of the claimed invention at the time of filing.
Conclusions
6. Claims 1 and 3-20 remain ejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vinod Kumar whose telephone number is (571) 272-4445. The examiner can normally be reached on 8.30 a.m. to 5.00 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. Abraham can be reached on (571) 270-7058 The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VINOD KUMAR/Primary Examiner, Art Unit 1663
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