DETAILED ACTION
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 and Claim Status
Applicant’s election without traverse of Group 2 in the reply filed on 8/3/26 is acknowledged.
Claim 1 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 8/3/26.
Applicant’s election without traverse of the species of bovine annexin A4, ampicillin and E. coli in the reply filed on 8/3/26 is acknowledged.
Since bovine annexin A4 was elected and not a portion thereof (page 19 line 30 of the specification refers to the core as having 4 repeats), claim 9 is drawn to a non-elected species. Since E. coli was elected and not necessarily a pathogenic form, claims 7 and 16 are drawn to non-elected species.
Claims 7, 9 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/3/26.
Claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 2-6, 8, 10-15 and 17-20 are being examined.
Priority
The priority information is found in the filing receipt dated 3/25/24.
Specification
The disclosure is objected to because of the following informalities:
Based on the filing date of the instant application sequence compliance is governed by ST.26 and 37 CFR 1.831-1.835.
37 CFR 1.831(a) states that amino acid sequence encompassed by the sequence rules should be disclosed in a sequence listing and 37 CFR 1.831(c) states that the corresponding sequences should be identified by sequence identifier.
In the instant case, pages 21-39 of the specification recite numerous polypeptides with 4 or more specifically identified amino acids that are encompassed by the sequence rules and also nucleic acids encompassed by the sequence rules. However, no sequence listing is of record.
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.831. However, this application fails to comply with the requirements of 37 C.F.R. §§ 1.821-1.825 for the reason(s) set forth on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. Applicant must comply with the requirements of the sequence rules (37 CFR 1.821 - 1.825). APPLICANT IS GIVEN THREE MONTHS FROM THE DATE OF THIS LETTER WITHIN WHICH TO COMPLY WITH THE SEQUENCE RULES, 37 C.F.R. §§ 1.821-1.825. Failure to comply with these requirements will result in ABANDONMENT of the application under 37 C.F.R. § 1.821(g). Extensions of time may be obtained by filing a petition accompanied by the extension fee under the provisions of 37 C.F.R. § 1.136. In no case may an applicant extend the period for response beyond the six month statutory period. Direct the response to the undersigned. Applicant is requested to return a copy of the attached Notice to Comply with the response.
Please direct all replies to the United States Patent and Trademark Office via one (1) of the following:
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2.Mailed to:
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Appropriate correction is required.
The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (numerous locations on pages 70-73). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/13/24 has been considered by the examiner.
Claim Rejections - 35 USC § 112
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 2-6, 8, 10-15 and 17-20 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.
Claims 2, 10, 13 and 18 recite ‘subunit’. The requirements of a subunit, for example the minimum length, are not clear. The specification (page 19 lines 19-20) refers to a repeat but a repeat is not necessarily the same as a subunit. None of the dependent claims clarify the claim scope.
Claims 2, 10, 13 and 18 recite ‘contacting or expressing an annexin or subunit thereof in said bacteria’ or ‘contacting or expressing an annexin or subunit thereof in bacteria’. With respect to contacting, the claim language appears to read on ‘contacting an annexin or subunit thereof in bacteria’. The specification broadly defines contacting (page 8 first paragraph), but the claim specifically refers to contacting ‘in’ bacteria. It is unclear if the use of the word ‘in’ requires more than just contacting (for example, must the contacting be in a specific location). None of the dependent claims clarifies the claim scope. Claims 14 and 19 refer to administering ‘to a subject’ but base claims 13 and 18 refer to contacting ‘in bacteria’. Claims 15 and 20 refer to administration in a vector. A vector comprises nucleic acids not amino acids so what is ‘contacted’ is not necessarily a polypeptide. The claims appear to mix and match the use of the phrases ‘contacting’ and ‘expressing’ which makes the specific required steps unclear. Administering a vector does not necessarily involve contacting with a polypeptide because a vector is made of nucleic acids.
Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification and the claims have been interpreted as being 101 compliant.
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 2-6, 8, 10-15 and 17-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for known uses of specific annexins and for A method of disrupting E. coli filaments comprising expressing bovine annexin A4 in said E. coli grown in 200 ug/ml ampicillin, does not reasonably provide enablement for the full scope of the instant claims (which broadly recites subunits and bacteria). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) The breadth of the claims:
Claims 2, 10, 13 and 18 recite ‘contacting’ which is defined as including in vitro and in vivo contacting (page 8 first paragraph).
Claims 2, 10, 13 and 18 recite ‘bacteria’ which includes any bacterial species.
Claims 2, 10, 13 and 18 recite annexin or a subunit thereof. Although unclear, subunit would appear to encompass a broad range of possibilities. The mere recitation of annexin includes annexin from any species.
Claims 2, 10, 13 and 18 recite functional properties/outcomes such as breakdown bacterial filaments, increase phagocytosis, increase the efficacy and inhibit or reduce the development.
Claims 3, 5, 10, 13 and 18 recite stress or antibiotic.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
With respect to annexins, applicants own specification states that ‘their functions are still not clearly defined’ (page 20 lines 27-28). The specification teach that certain annexins are selective and certain annexins are restrictive (page 19 first paragraph). One would not necessarily recognize any and all annexins or subunits thereof as having equivalent functions of the functional properties required by the instant claims such as breakdown bacterial filaments, increase phagocytosis, increase the efficacy and inhibit or reduce the development.
With respect to bacteria, Alberts et al (Molecular Biology of the Cell. 4th edition, New York: Garland Science; 2002; retrieved from http://www.ncbi.nlm.nih.gov/books/NBK26917/ on 3/2/15, 10 pages) teach that even within each class of pathogen that there is striking diversity (page 3 first complete paragraph) and teach that there are different classifications of bacteria including rods, spheres, spirals, etc. (‘Bacterial pathogens carry specialized virulence genes’ on page 3).
With respect to the antibiotic, Alberts et al (Molecular Biology of the Cell. 4th edition, New York: Garland Science; 2002; retrieved from http://www.ncbi.nlm.nih.gov/books/NBK26917/ on 3/2/15, 10 pages) teach that most antibiotics work by targeting specific bacterial enzymes (page 5 last complete paragraph).
(5) The relative skill of those in the art:
The level of skill in the art is high.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
Applicants data appears to relate to a single specific annexin (bovine annexin A4) and a single specific bacteria (E. coli strain BL21(DE3)).
(8) The quantity of experimentation necessary:
Experimentation and guidance is required in numerous areas particularly related to testing a wide range of annexins and subunits under a wide range of stresses/antibiotics against a wide range of bacteria. Taken together, such experimentation and guidance is necessary because the prior art cited above teach that the state of the art is unpredictable. Accordingly one would be burdened with undue experimentation to determine which subjects would be suitable. Considering the state of the art as discussed by the references above, particularly with regards to the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2-6, 8, 10-15 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson et al. (‘Comparison of the expression of native and mutant bovine annexin IV in Escherichia coli using four different expression systems’ Protein Expression and Purification v6 1995 pages 132-140; ‘Nelson’).
Nelson teach that bovine annexin IV was expressed in E. coli (abstract). Nelson teach that the vectors were transformed into E coli. (last complete paragraph on page 133). Nelson teach that transformed cultures were grown in media containing ampicillin and then induced (page 133-134 connecting paragraph).
In relation to the annexin of claims 2, 8, 10, 13 and 18, Nelson teach bovine annexin IV (abstract).
In relation to the bacteria of claims 2, 10, 13 and 18, Nelson teach E. coli (abstract).
In relation to the stress/antibiotic of claims 2-6, 10-13 and 17-18, Nelson teach ampicillin (page 133-134 connecting paragraph).
In relation to the contacting or expressing of claims 2, 10, 13-15 and 18-20, Nelson teach that the vectors were transformed into E coli. (last complete paragraph on page 133) and then induced (page 133-134 connecting paragraph).
Although unclear, the prior art is interpreted as meeting the claim limitations. In relation to any intended use, functional language or outcomes, the prior art teach the step as claimed using an agent as claimed so it would function as claimed.
Claim(s) 2-6, 8, 10-15 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harrison et al. (WO 2020/264181, 12-2020; ‘Harrison’).
Harrison teach “A method of treating a bacterial infection in a subject in need of such treatment, comprising administering to the subject a protein-drug conjugate comprising an annexin protein to which is covalently linked at least one therapeutic drug, wherein the therapeutic drug is an antibacterial antibiotic” (claim 16). Harrison defines annexin as any of annexins 1-11 and 13 (section 0081).
In relation to the annexin of claims 2, 8, 10, 13 and 18, Harrison teach annexin (claim 16) and defines annexin as any of annexins 1-11 and 13 (section 0081).
In relation to the bacteria of claims 2, 10, 13 and 18, Harrison teach a bacterial infection (claim 16).
In relation to the stress/antibiotic of claims 2-6, 10-13 and 17-18, Harrison teach an antibiotic (claim 16) and specifically recites beta-lactam (claim 8).
In relation to the contacting or expressing of claims 2, 10, 13-15 and 18-20, Harrison teach administering to a subject (claim 16).
Although unclear, the prior art is interpreted as meeting the claim limitations. In relation to any intended use, functional language or outcomes, the prior art teach the step as claimed using an agent as claimed so it would function as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
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