DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on October 10, 2025, has been received and entered.
Claim Disposition
3. Claims 1-16,18, 22-24, 26-27, 32-36, 38, 42-43 and 51 have been cancelled. Claims 17, 19-21, 25, 28-31, 37, 39-41 and 44-50 are pending and are under examination.
Claim Objection
4. Claims 17, 19-21, 25, 28-31, 37, 39-41 and 44-50 are objected to because of the following informalities:
For clarity it is suggested that claim 17 is amended to delete ‘amino acid sequence’ and insert “consists of the nucleotide sequence set forth in SEQ ID NO: 1”. The dependent claims hereto are also included.
For clarity and precision of claim language it is suggested that claim 25 is amended to read, “..the lipase enzymes have..”.
For clarity it is suggested that claim 37 is amended to read, “…[[a]] lipase enzymes…..recovering the [[two]] lipase enzymes”. The dependent claims hereto are also included.
For clarity it is suggested that claim 44 is amended to read, “…the lipase enzymes have…”.
For clarity and precision of claim language it is suggested that claim 49 is amended to read, “…yield of the lipase enzymes….[[the same strain]] a corresponding strain lacking… encoding the lipase enzymes”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
5. Claims 17, 19-21, 25, 28-31, 37, 39-41 and 44-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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 claimed invention as amended is directed to a nucleic acid construct comprising a heterologous promoter operably linked to a polynucleotide encoding a signal peptide having at least 95% sequence identity to SEQ ID NO: 2, and at least two polynucleotides encoding at least two lipase (see claim 17 in its entirety)...”. The claimed invention as set forth in claim 17 is devoid of a structure for the at least two genes, which is very broad. There are no indicia in the claimed embodiment about what specific polynucleotides encode the at least one lipase and linker polypeptide. The art generally acknowledges that several different DNA can encode the same protein. The claimed invention recites at least two polynucleotides which is not limiting. Furthermore, the claimed invention as amended recites that the gene is set forth in an amino acid sequence and genes have nucleotide sequences. Thus, the invention as claimed in claim 17 is directed to a large variable genus of polynucleotides and their expression products and not adequately described.
The specification discloses that the present invention provides means and methods for improving polypeptide expression yield by increasing the number of polypeptides that can be transferred into the ER while still using one signal peptide per translocation-dependent event, thereby increasing the number of polypeptide units that can be secreted per translocation event.... using a nucleic acid construct comprising a heterologous promoter operably linked to: a) a polynucleotide encoding a signal peptide; and b) at least two polynucleotides encoding one or more polypeptide of interest; wherein the at least two polynucleotides encoding one or more polypeptide of interest are each separated by a linker polynucleotide encoding a linker polypeptide comprising a proteolytic cleavage site; and wherein the signal peptide, the one or more polypeptide of interest and the linker polypeptide(s) comprising a proteolytic cleavage site are encoded in frame as a single polypeptide” (see page 2). It is noted that claim 21 recites the specific structure, however, it does not rectify all the deficiencies of claim 17 and claim 17 needs to stand on its own.
The instant specification fails to provide adequate description for the large genus encompassed in the claims. The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), 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 skilled artisan cannot envision the detailed chemical structure of the encompassed genus of genes, expression products and host cells and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
6. Claims 17,19-21, 25, 28-31, 37, 39-41 and 44-50 as amended 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 17 and the dependent claims hereto indefinite for the recitation of “…wherein the two polynucleotides encoding the two lipase enzymes consists of the same amino acid sequence…..”, because the gene does not have an amino acid sequence, but instead has a nucleotide sequence.
Claim 25 is indefinite for the recitation of “the lipase enzyme has an amino acid sequence….” because the independent claim recites ‘two lipase enzymes’, so which one or if both then it should be plural.
Claim 37 lacks clear antecedent basis for the recitation of “a lipase enzyme” in the preamble and “ the two lipase enzymes” in the recovery end step of the method.
Response to Arguments
7. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejections of record under 35 USC 112, first paragraph written description remains for the reasons stated above and herein. Applicant traverses the written description rejection stating that the claims have been amended, however, a new issue was created and also the issue of the missing structure for the gene remains.
The rejection remains because as stated above the claimed invention lack adequate written description because note that lead claim 17 as amended remains drawn to a genus claim with unlimited amounts of genes.
Conclusion
8. No claims are presently allowable.
9. Applicant’s amendment necessitated the new/modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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