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 .
This is the First Office Action on the Merits of US18/267693 filed on 06/15/2023 which is a 371 of PCT/NL2021/050776 filed on 12/17/2021, which claims foreign priority benefit of EP 20215665.9 12/18/2020. The filing receipt filed on March 1, 2024 is controlling.
Claims 1-3, 8, and 19 are cancelled.
Claims 4-7, 9-18, and 20-25 are pending and under examination.
Information Disclosure Statement
The IDS filed on 06/15/2023 has been considered by the examiner. Note that CN105753959 has been considered only the English language Abstract.
Drawings
The drawings are objected to because FIGS 5-6 have illegible text. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). See page 10, line 20; page 12, lines 14-23; page 13, para 1 & lines 8-15; page 30, lines 25-28;
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See page 34, lines 12-19. 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.
Claim Objections
Claim 4 is objected to because of the following informalities: The abbreviated term CATH2 should be written in full-length “cathelicidin 2” the first time it appears in the claims. Appropriate correction is required.
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.
Claims 10, 14, 17, 18, 20, and 24-25 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 10 recites the limitation "the treatment is treatment of Salmonella enteritidis or Candida albicans" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim because claim 10 depends from base claim 4 which does not recite a treatment.
Regarding claim 14, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 17, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 17 recites the broad recitation “wherein the subject is administered the CATH2 derivative twice”, and the claim also recites “preferably with an interval of at least 2 days” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 18 is indefinite because it depends from claim 17 and is not remedial.
Claim 20 recites the broad recitation “pathogen-specific vaccine”, and the claim also recites “preferably wherein the pathogen-specific vaccine is an (attenuated) pathogen or pathogen derived peptide or protein” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 24 and 25 are indefinite because they recite peptide structures that lack a peptide sequence identified by a SEQ ID NO. For example, it is unclear what peptide structure (amino acid sequence) is required by the terms DCATH2(1-21), CMAP4-21, etc. The designations indicate amino acid sequence positions but do not recite the amino acid to which the positions are referring.
The following is a quotation of the first paragraph of 35 U.S.C. 112(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.
Claims 4-7, 9-18, and 20-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 full-scope of the claimed invention.
Claims 4-7, 10-18, and 21-25 are drawn to a method for activating, inducing or promoting an innate immune memory in a subject in need thereof by administering an effective amount of CATH2 or a derivative thereof. The claims require the critically essential element of an effective amount of CATH2 or a derivative thereof to result in activating, inducing or promoting an innate immune memory in a subject in need thereof. Some claims specify types of these activities.
Base claim 9 is drawn to a method for improving or enhancing antimicrobial activity of an antimicrobial agent by administering an effective amount of CATH2 or a derivative thereof. Thus claim 9 requires the critically essential element of an effective amount of CATH2 or a derivative thereof to result in improving or enhancing antimicrobial activity of an antimicrobial agent in a subject in need thereof.
Base claim 20, is drawn to a method for the treatment or prevention of an infectious disease caused by a pathogen, comprising administering a pathogen-specific vaccine that is specific for said pathogen and CATH2 or a derivative thereof as an adjuvant, preferably wherein the pathogen-specific vaccine is an (attenuated) pathogen or pathogen derived peptide or protein. Thus claim 20 requires the critically essential element of an effective amount of CATH2 or a derivative thereof (as an adjuvant in combination with a vaccine) to result in treatment or prevention of an infectious disease caused by a pathogen. Claim 20 also recites the critically essential element of a pathogen-specific vaccine wherein the pathogen-specific vaccine is an (attenuated) pathogen or pathogen derived peptide or protein. Claim 22 specifies treating an inactivated or defective innate immune memory in the subject.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
To satisfy the written description requirement, MPEP §2163 states, in part “...a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.” Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species by “...disclosure of relevant, identifying characteristics, 1.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between functional and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.”
In the instant case, the claims encompass a genus of CATH2 derivatives having therapeutic properties. Also, claim 20 encompasses a pathogen-specific vaccine which is an attenuated pathogen or pathogen derived peptide or protein for prevention of an infectious disease.
It is noted that the specification discloses some examples of immune-stimulating CATH2 peptide derivatives. The specification notes that cathelicidins are host defence peptides which are part of the innate immune system. The specification states that the terms “CATH2” and “CMAP27” are used interchangeably. CMAP27 is encoded as a prepropeptide which is 154 amino acids. After processing, a C-terminal peptide is released which is the 27 amino acid sequence of this C-terminal peptide, called CMAP 27 or CATH2, and is the amino acid sequence: RFGRFLRKIRRFRPKVTITIQGSARFG. (See instant Specification page 10, line 20). Also, some preferred CATH2 derivative sequences are shown on page 12. However, the specification only correlates a few examples of a CATH2 derivative to the functions required of the present claims. Figures 1-11 show immune response of dCATH-2 in dTHP-1 cells. Peptides used are shown on page 30, lines 25-28. Specifically, CATH2, DCATH-2, and LL-37 were used. No examples using subjects are disclosed. No examples of vaccines against a pathogen are disclosed.
Further, the state of the art before the effective filing date of the presently claimed invention shows that use of CATH2 variants/derivatives for therapeutic use in a subject was unpredictable. Cuperus et al in “Immunomodulation and effects on microbiota after in ovo administration of chicken cathelicidin-2” (PLOS ONE published June 5, 2018, pages 1-19). Cuperus et al disclose that immune activity results of CATH2 derivatives were not predictable compared to expected results of wild-type. (See Abstract; pages 1-19).
The limited disclosure of the specification in view of the vast genus of CATH2 derivatives and/or variants encompassed by the claims as well as the vast number of vaccines to pathogens does not adequately describe the entire genus of molecules encompassed by the claims.
“Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly 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 the inventor(s) invented what is claimed.” (See Vas-Cath at page 1116).
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eh Lily & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) (‘In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. ..."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
In this case, the application does not identify a representative set of functional, therapeutic CATH2 derivatives or variants nor a representative set of vaccines to pathogens so that one of ordinary skill in the art would be able to envision whether a given CATH2 peptide structure variant would be encompassed by the claims and whether a given potential vaccine structure to any generic and unknown pathogen would be encompassed by the claims.
The court and the Board have repeatedly held (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,18 USPQ2d 1016 (CA FC, 1991); Fiers v. Revel, 25 USPQ2d 1601 (CA FC 1993); Fiddes v. Baird, 30 USPQ2d 1481 (BPAI 1993) and Regents of the Univ. Calif. v. Eh Lilly & Co., 43 USPQ2d 1398 (CA FC, 1997)) that an adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it, irrespective of the complexity or simplicity of the method; what is required is a description of the nucleic acid itself.
Thus, one of skill at the time of the invention could not have concluded that the inventor(s) were in possession of the genus of functional CATH2 derivatives and variants and functional/preventative vaccines.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 4-7, 9-10, 12-13, 15-16, and 21-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cuperus et al in “Immunomodulation and effects on microbiota after in ovo administration of chicken cathelicidin-2” (PLOS ONE published June 5, 2018, pages 1-19).
Claim interpretation: Note that claim 21 specifies limitations of the CATH2 derivative but does not require the CATH2 derivative. Claim 21 depends from claim 4 which recites the CATH2 derivative in the alternative. Thus prior which anticipates or renders obvious claim 4 also anticipates or renders obvious claims 21, 24, and 25.
Regarding claims 4, 21, 24, and 25, Cuperus et al discloses a method for activating, inducing or promoting an innate immune memory in a subject in need thereof, the method comprising administering to said subject an effective amount of CATH2 or a derivative thereof, thereby activating, inducing or promoting innate immune memory in said subject. Specifically, Cuperus et al teach administration of D-CATH-2 to chickens in ovo. (See Title; Abstract; page 2, “In vivo experiments”.)
Regarding claims 5-7 and 22-23, Cuperus et al discloses administration of D-CATH-2 to chickens in ovo. (See Title; Abstract; page 2, “In vivo experiments”.) Note that the intended use in the preamble of claims 5-7 and 23 generally is not afforded patentable weight for purpose of examination. The general intended use of claims 5-7 and 22-23 that the innate immune memory is innate immune memory for infectious disease, for treatment or prevention of infectious disease, and for improving or enhancing antimicrobial activity of an antimicrobial agent, in particular the CATH2 or derivative thereof are met by the reference of Cuperus et al, of administering to the subject the DCATH2. For example, note in page 1, para 1 Cuperus et al disclose that “cathelicidins are important effector molecules of the innate immune system” and that these peptides have “broad-spectrum antimicrobial” and “immunomodulatory functions”. Regarding base claim 23, Cuperus et al discloses that the antimicrobial agent is DCATH2.
Regarding claim 9, Cuperus et al discloses a method for improving or enhancing antimicrobial activity of an antimicrobial agent comprising administering to a subject in need thereof an effective amount of CATH2 or a derivative thereof, thereby improving or enhancing antimicrobial activity. For example, note in page 1, para 1 Cuperus et al disclose that “cathelicidins are important effector molecules of the innate immune system” and that these peptides have “broad-spectrum antimicrobial” and “immunomodulatory functions”. Regarding base claim 23, Cuperus et al discloses that the antimicrobial agent is DCATH2.
Regarding claim 10, Cuperus et al discloses that the treatment is of Salmonella enteritidis (See Fig5 and legend.)
Regarding claim 12, Cuperus et al discloses that the subject in need thereof is at risk of suffering from an infectious disease. Note that any general population of subjects is construed to be at risk from suffering from an infectious disease. . (See Title; Abstract; page 2, “In vivo experiments”.)
Regarding claim 13, Cuperus et al discloses administering said CATH2 or derivative thereof to subjects of a population of subjects wherein an infectious disease has been established in one or more subjects of said population. (See Title; Abstract; page 2, “In vivo experiments”.)
Regarding claim 15, Cuperus et al discloses that the subject is a chicken which reads on livestock, a farm animal, a pet, or poultry. (See Title; Abstract; page 2, “In vivo experiments”.)
Regarding claim 16, Cuperus et al discloses that the subject is poultry and the administration is performed in ovo. (See Title; Abstract; page 2, “In vivo experiments”.)
Claim(s) 4-7, 9-10, 12-13, 15-16, and 21-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haagsman et al (WO-2015/170984 published 11/12/2015; IDS ref).
See claim interpretation above.
Regarding claims 4-7, 9, 12-13, and 21-25, Haagsman et al teaches the administration of CATH2 peptides to a subject as an antimicrobial agent, preferably the DCATH2 derivative. Haagsman et al shows that CATH2 alone has antibacterial activity against S. enteritidis.
Regarding claims 10, and 15-16, in a preferred embodiment, the peptide is administered in ovo to poultry to prevent bacterial infections such as infection with Salmonella enteritidis or pathogenic E. coli.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 4-7, 9-10, 12-13, 15-16, and 20-25 are rejected under 35 U.S.C. 103 as being unpatentable over Cuperus et al in “Immunomodulation and effects on microbiota after in ovo administration of chicken cathelicidin-2” (PLOS ONE published June 5, 2018, pages 1-19), in view of Haagsman et al (WO-2015/170984 published 11/12/2015; IDS ref), in view of Bikker et al (WO-2010/093245 published 08/19/2010; IDS ref).
Claim interpretation: Note that claim 21 specifies limitations of the CATH2 derivative but does not require the CATH2 derivative. Claim 21 depends from claim 4 which recites the CATH2 derivative in the alternative. Thus prior which anticipates or renders obvious claim 4 also anticipates or renders obvious claims 21, 24, and 25.
Regarding claims 4, 21, 24, and 25, Cuperus et al discloses a method for activating, inducing or promoting an innate immune memory in a subject in need thereof, the method comprising administering to said subject an effective amount of CATH2 or a derivative thereof, thereby activating, inducing or promoting innate immune memory in said subject. Specifically, Cuperus et al teach administration of D-CATH-2 to chickens in ovo. (See Title; Abstract; page 2, “In vivo experiments”.)
Regarding claims 5-7 and 22-23, Cuperus et al discloses administration of D-CATH-2 to chickens in ovo. (See Title; Abstract; page 2, “In vivo experiments”.) Note that the intended use in the preamble of claims 5-7 and 23 generally is not afforded patentable weight for purpose of examination. The general intended use of claims 5-7 and 22-23 that the innate immune memory is innate immune memory for infectious disease, for treatment or prevention of infectious disease, and for improving or enhancing antimicrobial activity of an antimicrobial agent, in particular the CATH2 or derivative thereof are met by the reference of Cuperus et al, of administering to the subject the DCATH2. For example, note in page 1, para 1 Cuperus et al disclose that “cathelicidins are important effector molecules of the innate immune system” and that these peptides have “broad-spectrum antimicrobial” and “immunomodulatory functions”. Regarding base claim 23, Cuperus et al discloses that the antimicrobial agent is DCATH2.
Regarding claim 9, Cuperus et al discloses a method for improving or enhancing antimicrobial activity of an antimicrobial agent comprising administering to a subject in need thereof an effective amount of CATH2 or a derivative thereof, thereby improving or enhancing antimicrobial activity. For example, note in page 1, para 1 Cuperus et al disclose that “cathelicidins are important effector molecules of the innate immune system” and that these peptides have “broad-spectrum antimicrobial” and “immunomodulatory functions”. Regarding base claim 23, Cuperus et al discloses that the antimicrobial agent is DCATH2.
Regarding claim 10, Cuperus et al discloses that the treatment is of Salmonella enteritidis (See Fig5 and legend.)
Regarding claim 12, Cuperus et al discloses that the subject in need thereof is at risk of suffering from an infectious disease. Note that any general population of subjects is construed to be at risk from suffering from an infectious disease. . (See Title; Abstract; page 2, “In vivo experiments”.)
Regarding claim 13, Cuperus et al discloses administering said CATH2 or derivative thereof to subjects of a population of subjects wherein an infectious disease has been established in one or more subjects of said population. (See Title; Abstract; page 2, “In vivo experiments”.)
Regarding claim 15, Cuperus et al discloses that the subject is a chicken which reads on livestock, a farm animal, a pet, or poultry. (See Title; Abstract; page 2, “In vivo experiments”.)
Regarding claim 16, Cuperus et al discloses that the subject is poultry and the administration is performed in ovo. (See Title; Abstract; page 2, “In vivo experiments”.)
Especially regarding claims 4-7, 9, 12-13, and 21-25, Haagsman et al teaches the administration of CATH2 peptides to a subject as an antimicrobial agent, preferably the DCATH2 derivative. Regarding claims 10, and 15-16, in a preferred embodiment, Haagsman et al teaches the peptide is administered in ovo to poultry to prevent bacterial infections such as infection with Salmonella enteritidis or pathogenic E. coli. Haagsman et al shows that CATH2 alone has antibacterial activity against S. enteritidis.
However, regarding claim 20, Cuperus et al and Haagsman et al do not disclose CATH2 as a vaccine adjuvant.
Bikker et al teaches the use of CMAP27 (aka CATH2) as an antibiotic agent or a vaccine adjuvant. (See Abstract; ref claim 14).
The level of skill in the art was high before the effective filing date of the presently claimed invention.
One of ordinary skill in the art would have been motivated to use CATH2 as an antibiotic agent or a vaccine adjuvant for the rationale of boosting an immune response to protect the subject from pathogen infection.
It would have been obvious for one of ordinary skill in the art to combine the elements of the cited references to use the CATH2 as an antibiotic agent or a vaccine adjuvant because Bikker et al expressly suggests using CATH2 as an antibiotic agent or a vaccine adjuvant (see Abstract).
In view of the high skill level in the art it is considered that one of ordinary skill in the art having the cited references before the effective filing date of the presently claimed invention would have had a reasonable expectation of success to administer CATH2 or derivative to a subject for use as an antibiotic agent and a vaccine adjuvant to arrive at the presently claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 4-7, 9, 12, 14-16, and 20-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,829,524. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the present claims.
Regarding instant claims 4-7, 9, 12, and 15-16, and 21-25, patented claim 4 recites a method for activating an immune response of a chicken, the method comprising administering a CMAP27-derivative selected from the group consisting of: a C-terminally truncated CMAP27-derivative, an N-terminally truncated variant of CMAP1-21, a D-amino acid CMAP27-derivative, a cyclic CMAP27-derivative, and an inverso or retroinverso CMAP27-derivative to the chicken.
Regarding instant claim 14, patented claim 5 recites Toll-like receptor activation.
Regarding instant claim 20, patented claims 3 and 11 recite vaccinating a chicken comprising administering a CMAP27 derivative into a chicken egg or chicken.
Claims 4-7, 9, 12, 14-16, and 20-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,603,391. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the present claims.
Regarding instant claims 4-7, 9, 12, and 15-16, and 21-25, patented claims 3-4 recites a method for activating an immune response of a chicken or animal or human subject, the method comprising administering a CMAP27-derivative selected from the peptide derivative species shown in patented claim 1.
Regarding instant claim 14, patented claim 5 recites Toll-like receptor activation.
Regarding instant claim 20, patented claims 3 and 7 recites vaccinating a chicken comprising administering a CMAP27 derivative into a chicken.
Claims 4-7, 9, 12-18, and 21-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 5-14, and 16-22 of copending Application No. 18/275,155 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the present claims or are essentially the same as the present claims.
Regarding instant claims 4-7, 9, 12, 16-18, and 21-25, copending claims 1 and 12 recite a method for activating an innate immune response/treating/preventing infection of a subject, the method comprising administering a CATH2 or derivative.
Regarding instant claim 13, copending claim 8 recites a population.
Regarding instant claim 14, copending claim 22 recites Toll-like receptor activation.
Regarding instant claims 15-16, and 18, copending claim 11 recites poultry and administration in ovo and/or after hatch.
Regarding instant claim 17, copending claim 10 recites at least two days.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Related prior art which may be applied in a future office action if appropriate: US2011/0287045.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658