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 Preliminary Amendments filed on June 6, 2023 and December 21, 2022, have been received and entered.
Claim Disposition
3. Claims 1-16 are pending and are under examination.
Information Disclosure Statement
4. The Information Disclosure Statement filed on June 6, 2023, has been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
Drawing
5. The drawings filed on June 6, 2023, has been accepted by the examiner.
Specification Objection
6. The specification is objected to for the following informalities:
The specification is objected to because page 9 and page 8 have sections that are grayed out (in other words very pale due to a color change).
The specification is objected to because the priority information on page 1 needs to be updated because US Application No. 15753378 is now US Patent No. 11773423.
Appropriate correction is required.
Claim objection
7. Claims 1-16 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to recite “a genetically engineered microorganism” and to recite if the functional deletion is via deletion of the coding sequence/gene (i.e. ‘a recombinant organism comprising a deleted polynucleotide encoding a rmlC …..; and a recombinant polynucleotide encoding rmlA…”. The dependent claims hereto are also included.
Claim 3 is objected to for the typographical error of “TDP-fueosamine acetyitransferase”. See also claim 4.
Claim 4 is objected to for having an extraneous period (.).
For clarity it is suggested that claim 5 is amended to delete “necessary”.
For clarity the acronyms should be spelled out, such as ‘fimbrial chaperones (fcf1)”.
For clarity it is suggested that claim 7 is amended to read, “….one or more TDP-deoxysugars [[of the following,]] selected from the group consisting of:
For clarity it is suggested that claim 10 is amended to correct the typographical error of ‘glycosy’.
For clarity it is suggested that claim 12 is amended to read, “A method of producing a TDP-deoxysugar, comprising:”. See also claims 14 and 16 with similar language.
For clarity it is suggested that claim 13 is amended to read, “the functional deletion[[s]]…”.
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.
8. Claims 1-16 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 is directed to “a recombinant microorganism comprising a functional deletion of rmlC, rmlD, wecE and wecD; and a recombinant polynucleotide encoding rmlA, rmlB, pgm or combinations thereof (see claim 1 in its entirety). The claimed invention is not adequately described because the enzyme is defined by “functional deletion” and there is no mention of the genes which is likely the route of the modification. The specification on page 8 discloses that recombinant microorganisms have undergone genetic engineering, but there are no indicia as to the ‘genetic engineering the cell has undergone’. It is further disclosed that genetic engineering means that one or more nucleic acids of the microorganism have been altered by the introduction of new nucleic acids (see page 8). Thus the claimed invention is not adequately described because the gene of item (a) of claim 1 is missing. In addition, it appears from the claim language that all of claim 1 item (a) is required, however, claim 3 for example, demonstrates that the variables can be alone or in combination. The specification discloses that functional deletion is genetic engineering from the microorganism. It is further disclosed that ‘one, two, three or four of rmlC, rmlD, wecE, wecD and combinations thereof are naturally absent or naturally non-functional in the microorganism’ (see page 8). The specification also discloses that functionally deleted, functional deleted or non-functional means that sufficient amount of the gene region is removed, changed or otherwise damaged, by natural mutation, induced mutation or genetic engineering modification so that the gene region is no longer capable of producing substantial amounts of functional products of gene expression or the gene region is not able to otherwise produce products of gene expression that perform normal function. Thus, the claimed invention is not commensurate in scope with the disclosure because it’s the gene that is altered in the recombinant microorganism. Further, it is not clear from the claim language how 1(b) is altered, as the claim simply recites “a recombinant polynucleotide encoding for example rmlA”. The claimed invention lacks adequate written description also because the specification describes proteins as encoding genes (see below excerpt from specification).
“Some embodiments provide a microorganism further comprising functional deletions of one or more of ga/U, g/gC, and gaT. For example, a microorganism, such as E. coli, can have functional deletions of wecE and wecD, a functional deletion of rm/C, a functional deletion of pgi, a recombinant polypeptide that encodes rm/A, and one or more functional deletions of ga/U, g/gC, or gaT. In another embodiment a microorganism can have a function deletion of wecE and wecD, a functional deletion of rm/C, a functional deletion of pgi, a functional deletion of zwf, a recombinant polypeptide that encodes rm/A, and one or more functional deletions of ga/U, g/gC, or gaT (see page 14 of the specification)”.
No correlation is made between structure and function. The claimed invention in claim 1 does not define or identify the benefits to the modified microorganism. It is noted that claim 13 recites that production of TDP-deoxysugar is increased, however claim 1 needs to stand on its own and there’s no quantifiable way to measure the claimed increase claimed.
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, 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.
9. Claims 1-16 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 1 and the dependent claims hereto are indefinite for recitation of “functional deletion” because the language is ambiguous and could be construed as deletion of an activity of the enzyme or successful deletion process. The claim language isn’t clear also as to whether item (a) is a mixture or combination especially in view of dependent claims that recite one or more.
Claim 3 is indefinite because the language can be construed as having all the functional deletion occurring in the for example wecE as well as the recombinant polynucleotide encoding rmlA, since not separated as in claim 1. See also claim 4.
Claims 3 and 4 are indefinite because they lack clear antecedent basis for the recitation of a different TDP than what is recited in claim 1.
Claim 4 is indefinite because it has a period misplaced which renders the claimed embodiments as incomplete, thus lacking clarity and indefinite.
Claim 5 is indefinite for the recitation of “proteins necessary” because it is unclear what proteins are deemed necessary, absent reference provided.
Conclusion
10. No claims are presently allowable.
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