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 Amendment filed on October 22, 2024, has been received and entered.
3. Applicant’s election without traverse of Group II on July 27, 2026 is acknowldeged.
Claim Disposition
4. Claims 1-20 are pending. Claims 8-20 are under examination. Claims 1-7 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
5. The Information Disclosure Statement filed on October 14, 2024, 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. Note that a reference has been lined through based on an improper citation of the date.
Drawing
6. The Drawings filed on July 29, 2024, are accepted by the examiner.
Specification Objection
7. The specification is objected to for the following informalities:
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following is suggested: "System for engineering outer membrane vesicles".
Appropriate correction is required.
Abstract Objection
8. The Abstract is objected to for the following informalities:
The acronym “OMV” should be spelled out.
Appropriate correction is required.
Claim objection
9. Claims 8-20 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 8 is amended to delete all the extraneous ‘and’ between the ‘wherein’ clause except for the one that appears between the last two ‘wherein’ clause. The dependent claims hereto are also included.
For clarity it is suggested that claims 9-20 are amended to insert a comma (,) after the claim 1 number and before ‘wherein’, for example (The system of claim 8, wherein….).
For clarity it is suggested that the acronym is spelled out in claims 17 and 18.
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.
10. Claims 8-20 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 system for the production and isolation of a compound of interest comprising at least one deletion of an endogenous gene….resulting in an increase in the production of outer membrane vesicles OMV)….. and the modified organism Pseudomonas further comprises at least one or more exogenous gene encoding an enzyme….( see claim 8 in its entirety). The claim language is devoid of any structural limitations, thus not adequately described. The claimed invention is directed to a large variable genus of genes, enzymes, linkers, substrate, compound of interest and modifications that are not defined or described. It is noted that dependent claims provide structures, however, the independent claim needs to stand on its own.
The claimed invention encompasses a large variable genus of structures. The claimed invention is overly broad and not commensurate in scope with the disclosure in the specification. The claimed invention does not inform the ordinary skilled worker of the specific product, as no correlation is made between structure and function.
The claimed invention encompasses a large variable genus of structures for the protein and nucleic acid, that is not adequately described. The art recognizes that a single change in the protein structure can be detrimental for functioning, which would produce a different structure and which makes the instant claim language overly broad. The structural difference could render the protein as non-functional. The claimed invention is not adequately described because the claims far exceed the scope of the disclosure in the specification and the art. The claimed invention also encompasses additional domains with no assertion of where they are positioned in the fusion protein.
Thus the claimed invention is not adequately described because there is no demonstration of applicant being in possession of the vast 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, 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
11. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
12. Claim(s) 8, 10-13 and 15- 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over by BIOMVIS S.R.L. et al., (WO 2020/212524) in view of Jung et al. (1998, of record in the application) and Ayalon et al. (US Patent No. 9732148, 2017).
The claimed invention is directed to a system for the production and isolation of a compound of interest comprising a genetically modified Pseudomonas sp. (see claim 8 in its entirety) and the language in the claim is very broad, thus the art is applied to reflect that scope.
The primary reference teaches a recombinant system and a gram-negative bacteria carrying a gene mutation that cause deletions of proteins belonging to OMV (see abstract and Disclosure of Invention). The gram-negative bacteria is specifically designed to optimize the production and therapeutic use of OMVs in Pseudomonas (see page 1). The primary reference discloses the importance of OMVs (see pages 2-3). The primary reference does not teach exogenous gene encoding an enzyme with a deleted endogenous gene. However, the secondary reference teaches heterologous proteins to the outer membrane vesicles with the accompanying genes (see abstract), a modified bacteria is disclosed such as Pseudomonas, linker and production of a compound. The reference teaches endogenous genes modified with insertion of exogenous genes in organism such as Pseudomonas and tag/label ( see abstract, FIGs and entire reference). The primary references do not teach that the outer membrane protein is OmpA, however, the secondary reference discloses OmpA. The secondary reference teaches ice-nucleation protein (Inp) is a glycosyl phosphatidylinositol-anchored outer membrane protein found in some gram-negative bacteria. It is further disclosed that using Pseudomonas syringae Inp as an anchoring motif, they investigated the functional display of a foreign protein, Zymomonas mobills levansucrase (LevU), on the surface of Escherichia coli. The cells expressing Inp-LevU were found to retain both the ice-nucleation and whole-cell levansucrase enzyme activities, indicating the functional expression of Inp-LevU hybrid protein on the cell surface. The surface localization was further verified by immunofluorescence microscopy, fluorescence-activated cell sorting flow cytometry and immunogold electron microscopical examination. No growth inhibition or changes in the outer membrane integrity were observed upon the induction of fusion protein synthesis. Viability of the cells was also maintained over 48 hours in the stationary phase. Surface-displayed levansucrases were found to be resistant to the externally added proteases unless the cells were treated with EDTA. When the levansucrase-displayed cells were used as the enzyme source, levan (44 g/L) was efficiently synthesized from sucrose (130 g/L) with 34% (wt/wt) conversion yield, generating glucose (65 g/L) as a by-product. The secondary reference also teaches OmpA among others as the outer membrane protein (see abstract and pages 576-77, and the entire reference). In addition, the structures in claim 20 are not novel and SEQ ID NO: 5 presented in the alignment below is well established in the art (see US Patent 9732148).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because the combined teaching of the references render the claimed invention as obvious. Motivation exists to combine the references because they are analogous art.
Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Alignment
RESULT 1
US-14-884-542-19
Sequence 19, US/14884542
Patent No. 9732148
GENERAL INFORMATION
APPLICANT: AYALON, GAI
APPLICANT: MAURER, TILL
TITLE OF INVENTION: ANTI-ALPHA-SYNUCLEIN ANTIBODIES AND METHODS OF USE
FILE REFERENCE: P32300-US-1
CURRENT APPLICATION NUMBER: US/14/884,542
CURRENT FILING DATE: 2015-10-15
PRIOR APPLICATION NUMBER: 62/064,867
PRIOR FILING DATE: 2014-10-16
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 19
LENGTH: 43
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 100.0%; Score 182; Length 43;
Best Local Similarity 100.0%;
Matches 38; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MDVFMKGLSKAKEGVVAAAEKTKQGVAEAAGKTKEGVL 38
||||||||||||||||||||||||||||||||||||||
Db 1 MDVFMKGLSKAKEGVVAAAEKTKQGVAEAAGKTKEGVL 38
Conclusion
13. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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