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 .
Response to Election/Restriction filed on October 31, 2025 is acknowledged.
Claim 51 has been cancelled.
Claims 1-2, 4-5, 18, 22, 25-27, 32-33, 35, 40, 42, 44-45, 50 and 52-53 are pending in this application.
Information Disclosure Statement
It is noted that Applicants have not filed an information disclosure statementunder § 1.97(c). Applicant is reminded of 37 CFR § 1.56, which details Applicants dutyto disclose all information known to be material to patentability.
Restriction
6. Applicant’s election without traverse of the following species
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in the reply filed on October 31, 2025 is acknowledged. Applicant indicates that claims 1-2, 4-5, 18, 22, 25-27, 32-33, 35, 40, 42, 44-45, 50, 52 and 53 read on the elected species.
Sequence Non-Compliance
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 - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, 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.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because the application does not contain a statement that the CRF is identical to the "Sequence Listing" part of the disclosure, as described above in item 1), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Required response - Applicant must provide such statement.
Specific deficiency - This application contains a “Sequence Listing as a PDF file (37 CFR 1.821(c)(2)) or as physical sheets of paper (37 CFR 1.821(c)(3)), but fails to comply with the requirements of 37 CFR 1.821 - 1.825 because a copy of the "Sequence Listing" in computer readable form (CRF) has not been submitted as required by 37 CFR 1.821(e)(1)(i) or 1.821(e)(2)(i) as indicated in item 2) above.
Required response - Applicant must provide:
A new CRF of the “Sequence Listing” in accordance with 37 CFR 1.821(e)(1)(i) or 1.821(e)(2)(i) and
A statement that the content of the CRF is identical of the “Sequence Listing” part of the disclosure, submitted as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
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).
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.
Please see paragraphs [0004] and [0066]-[0067] of US 2023/0149333 and the objection set forth below for the sequence that need to be filed in the sequence listing.
Objections
7. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “Antimicrobial pharmaceutical compositions that contain cationic antimicrobials and methods of using them to prevent and/or treat viral infections”. This appears to be an incomplete sentence. Applicant should correct these informalities. See MPEP 608.01(b). For example, the abstract is recommended to be amended to recite, “Antimicrobial pharmaceutical compositions…are described.”
8. The specification is objected to for containing referring to sequences without also identifying them by the sequence identifier assigned to them in the sequence listing as required by 37 CFR 1.821(d). The specification discloses peptide sequences, and these are missing their respective sequence identifiers. For example, paragraphs [0004] and [0066]-[0067] of instant specification US 2023/0149333 disclose peptide sequences poly(L-lysine-HCl)55-block-poly(racemic hydrophobic amino acid)20, K55(Rac-X)20 (for X = A, I, L/F or V), but these are missing their sequence identifiers. The examiner would like to bring the applicant’s attention to the following excerpt from MPEP §2422.03:
37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application. This requirement is also intended to permit references, in both the description and claims, to sequences set forth in the "Sequence Listing" by the use of assigned sequence identifiers without repeating the sequence in the text of the description or claims. Sequence identifiers can also be used to discuss and/or claim parts or fragments of a properly presented sequence. For example, language such as "residues 14 to 243 of SEQ ID NO:23" is permissible and the fragment need not be separately presented in the "Sequence Listing." Where a sequence is embedded in the text of an application, it must be presented in a manner that complies with the requirements of the sequence rules.
The applicant is therefore required to amend the specification to comply with 37 CFR 1.821(d).
9. The specification is objected to for the following: The specification indicates "incorporation by reference" of certain documents (please see for example, paragraph [0028] of US 2023/0149333). The MPEP states the following: "An application as filed must be complete in itself in order to comply with 35 U.S.C. 112. Material nevertheless may be incorporated by reference. An application for a patent when filed may incorporate “essential material” by reference to (1) a U.S. patent, >or< (2) a U.S. patent application publication, **>which patent or patent application publication does not itself incorporate such essential material by reference…”Essential material” is defined in >37CFR1.57(c)< as that which is necessary to (1) **>provide a written description of the claimed 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 set forth the best mode contemplated by the inventor of carrying out the invention as required by the first paragraph of 35 U.S.C. 112, (2) describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by the second paragraph of 35 U.S.C. 112…” (see MPEP 608.01(p)).
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Rejections
U.S.C. 112(b)
10. The following is a quotation of the first paragraph 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.
11. Claims 4, 18, 22, 32, 40, 42, 44 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.
12. Claim 4 recites, “The method of claim 1, wherein the antimicrobial synthetic cationic polypeptide(s)…as measured by a critical aggregation concentration that is below…” The claim appears to be reciting two different method inventions: 1) a method of treating, and 2) a method of making. The metes and bounds of the claim is unclear.
13. Claim 18 recites, “ The method of claim 1, comprising administering…to tissues capable of supporting viral infection and growth…” It is unclear what is encompassed with the word “capable of”. The phrase “capable of” is not an absolute phrase. Capable does not state what actually occurs. The specification does not fully define what is meant by “capable of”.
14. Regarding claim 22, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
15. Claim 32 recites, “The method of claim 1, wherein the antimicrobial pharmaceutical composition has a low toxicity after being infused into the peritoneal cavity…as measured by a mouse survival rate of 80% or greater at 72 hours.” The claim appears to be reciting two different method inventions: 1) a method of treating, and 2) a method of making/measuring the composition. The metes and bounds of the claim is unclear.
16. Claim 40 recites, “The method of claim 1, wherein the antimicrobial pharmaceutical composition is sterilized by a sterilization technique(s) configured to achieve a sterilized antimicrobial…” The claim appears to be reciting two different method inventions: 1) a method of treating, and 2) a method of making. The metes and bounds of the claim is unclear.
17. Claim 42 recites, “The method of claim 1, wherein the antimicrobial pharmaceutical composition is sterilized by a sterilization technique(s) configured to achieve a sterilized antimicrobial…” The claim appears to be reciting two different method inventions: 1) a method of treating, and 2) a method of making. The metes and bounds of the claim is unclear.
18. Claim 44 recites, “The method of claim 1, wherein the antimicrobial pharmaceutical composition is sterilized by a sterilization technique(s) configured to achieve a sterilized antimicrobial…” The claim appears to be reciting two different method inventions: 1) a method of treating, and 2) a method of making. The metes and bounds of the claim is unclear.
Improper Markush
19. Claim 22 is rejected on the judicially created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F. 2d 716, 721-22 (CCPA 1980) and Ex parte Hazumi, 3 USPQ 2d 1059, 1060 (BPAI 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The risk factors selected from a positive test for the Coronavirus infection, obesity, diabetes, an advanced age, a cancer, a reduced respiratory function…and reduced immune response function do not share a patient population, organs or cells. There is no common core symptom among the risk factors recited.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR 41.31 (a)(1) (emphasis provided).
35 U.S.C. 112(a)
20. 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.
21. Claims 1-2, 4-5, 18, 22, 25-27, 32-33, 35, 40, 42, 44-45, 50 and 52-53 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 claimed invention.
The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
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. Eli Lilly & 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 Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to a method of treating a viral infection, comprising administering an effective amount of an antimicrobial pharmaceutical composition to a subject in need thereof, wherein the antimicrobial pharmaceutical composition comprises an aqueous carrier and an antimicrobial synthetic cationic polypeptide(s) dispersed in the aqueous carrier, wherein the antimicrobial synthetic cationic polypeptide(s) comprises at least 40 amino acid units…comprises a plurality of positively charged amino acid unit at neutral pH…comprises a plurality of hydrophobic amino acid units, and…comprises a blocky sequence arrangement of hydrophobic amino acid units and positively charged amino acid units that is configured to promote self-assembly of the antimicrobial synthetic cationic polypeptide(s) into multimeric structures in aqueous media. The generic statements antimicrobial synthetic cationic polypeptide(s) comprises at least 40 amino acid units…comprises a plurality of positively charged amino acid unit at neutral pH…comprises a plurality of hydrophobic amino acid units, and…comprises a blocky sequence arrangement of hydrophobic amino acid units and positively charged amino acid units that is configured to promote self-assembly of the antimicrobial synthetic cationic polypeptide(s) into multimeric structures in aqueous media do not provide ample written description for the compounds since the claims do not describe a single structural feature. The specification does not clearly define or provide examples of what qualify as compounds of the claimed invention.
As stated earlier, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable claim 1 is broad generics with respect all possible compounds encompassed by the claims. The possible structural variations are limitless to any class of peptide or a peptide-like molecule that can form peptide bonds. It must not be forgotten that the MPEP states that if a peptide 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. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond compounds disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus since the specification does not provide what the species of antimicrobial synthetic cationic polypeptide that comprises at least 40 amino acids encompass. The peptide must be at least 40 residues in lengths, comprises plurality of positively charged amino acids at neutral pH, comprises a plurality of hydrophobic amino acid units, and comprises a blocky sequence arrangement of hydrophobic amino acid units and positively charged amino acid units that is configured to promote self-assembly. The specification is void of organic molecules that functions as a peptide-like molecule that qualify for the functional characteristics claimed as a peptide or a peptide-like molecule or other peptidic molecules, and other synthetic peptide or peptide-like molecule that can form peptide bonds and form self-assembly.
The specification discloses the following:
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(see paragraphs [0066]-[0067]). The specification is limited to the peptide or peptide-like molecules that is described as poly(L-lysine hydrochloride)-b-poly(D,L-leucine) (Composition A) and poly(L-lysine hydrochloride)-b-poly(L-leucine) (Composition B). The working example describes the antiviral activity of Composition A and Composition B. The specification discloses that “The results summarized in Table 1 and 2 show that antimicrobial pharmaceutical compositions, containing antimicrobial synthetic cationic polypeptides that comprise a plurality of positively charged amino acid units at neutral pH, have surprising antiviral activity over a wide range of polypeptide concentrations against two very different viruses…” (see paragraph [0069]). The specification does not describe any other antimicrobial cationic peptides and the vast amount of different peptides that are encompassed within the genus. Description of poly(L-lysine hydrochloride)-b-poly(D,L-leucine) (Composition A) and poly(L-lysine hydrochloride)-b-poly(L-leucine) (Composition B) is not sufficient to encompass numerous other proteins that belong to the same genus. For example, there are varying lengths, varying amino acid compositions, and numerous distinct qualities that make up the genus. There is not sufficient amount of examples provided to encompass the numerous characteristics of the whole genus claimed.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
22. Claims 1-2, 4-5, 18, 22, 25-27, 32-33, 35, 40, 42, 44-45, 50 and 52-53 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 treating certain viruses by administering of poly(L-lysine hydrochloride)-b-poly(D,L-leucine) (Composition A) and poly(L-lysine hydrochloride)-b-poly(L-leucine) (Composition B), does not reasonably provide enablement for every peptide encompassed within antimicrobial pharmaceutical composition comprises an aqueous carrier and an antimicrobial synthetic cationic polypeptide(s) dispersed in the aqueous carrier, wherein the antimicrobial synthetic cationic polypeptide(s) comprises at least 40 amino acid units…comprises a plurality of positively charged amino acid unit at neutral pH…comprises a plurality of hydrophobic amino acid units, and…comprises a blocky sequence arrangement of hydrophobic amino acid units and positively charged amino acid units that is configured to promote self-assembly of the antimicrobial synthetic cationic polypeptide(s) into multimeric structures in aqueous media. The generic statements antimicrobial synthetic cationic polypeptide(s) comprises at least 40 amino acid units…comprises a plurality of positively charged amino acid unit at neutral pH…comprises a plurality of hydrophobic amino acid units, and…comprises a blocky sequence arrangement of hydrophobic amino acid units and positively charged amino acid units that is configured to promote self-assembly of the antimicrobial synthetic cationic polypeptide(s) into multimeric structures in aqueous media. 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/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation.
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 (5) the breadth of the claims:
The claims are drawn to a method of treating a viral infection, comprising administering an effective amount of an antimicrobial pharmaceutical composition to a subject in need thereof, wherein the antimicrobial pharmaceutical composition comprises an aqueous carrier and an antimicrobial synthetic cationic polypeptide(s) dispersed in the aqueous carrier, wherein the antimicrobial synthetic cationic polypeptide(s) comprises at least 40 amino acid units…comprises a plurality of positively charged amino acid unit at neutral pH…comprises a plurality of hydrophobic amino acid units, and…comprises a blocky sequence arrangement of hydrophobic amino acid units and positively charged amino acid units that is configured to promote self-assembly of the antimicrobial synthetic cationic polypeptide(s) into multimeric structures in aqueous media. The generic statements antimicrobial synthetic cationic polypeptide(s) comprises at least 40 amino acid units…comprises a plurality of positively charged amino acid unit at neutral pH…comprises a plurality of hydrophobic amino acid units, and…comprises a blocky sequence arrangement of hydrophobic amino acid units and positively charged amino acid units that is configured to promote self-assembly of the antimicrobial synthetic cationic polypeptide(s) into multimeric structures in aqueous media.
The claims are drawn to a largely generic peptide, limited only in a minimal length (at least 40 residues), a net cationic charge at neutral pH, comprises a plurality of hydrophobic amino acid units, and…comprises a blocky sequence arrangement of hydrophobic amino acid units and positively charged amino acid units that is configured to promote self-assembly. This is broad genus of compounds owing to the minimal definition of the peptide. The type of infection is not limited in any way, such that the claims encompass all viral infection. Overall the claims are very broad in nature.
(2) The state of the prior art and (4) the predictability or unpredictability of the art::
The prior art recognizes certain lysine and leucine containing polypeptides to have antibacterial activity and thus as useful for treatment of bacterial infections (see for example, Bevilacqua et al, US 2013/0267458). However, the art does not recognize any particular composition as providing the ability to effectively treat all viral infections.
(3) The relative skill of those in the art:
The relative skill of those in the art is high.
(4) The predictability or unpredictability of the Art
There is a general lack of predictability in the pharmaceutical art. In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970).
Whether or not a given virus will be treatable by ANY cationic charged peptide of at least 40 amino acid is not predictable.
(6) The amount of direction or guidance presented and (7) The presence or absence of working examples:
The specification is limited to the peptide or peptide-like molecules that is described as poly(L-lysine hydrochloride)-b-poly(D,L-leucine) (Composition A) and poly(L-lysine hydrochloride)-b-poly(L-leucine) (Composition B). The working example describes the antiviral activity of Composition A and Composition B. The specification discloses that “The results summarized in Table 1 and 2 show that antimicrobial pharmaceutical compositions, containing antimicrobial synthetic cationic polypeptides that comprise a plurality of positively charged amino acid units at neutral pH, have surprising antiviral activity over a wide range of polypeptide concentrations against two very different viruses…” (see paragraph [0069]). The specification does not describe any other antimicrobial cationic peptides and the vast amount of different peptides that are encompassed within the genus. Description of poly(L-lysine hydrochloride)-b-poly(D,L-leucine) (Composition A) and poly(L-lysine hydrochloride)-b-poly(L-leucine) (Composition B) is not sufficient to encompass numerous other proteins that belong to the same genus. For example, there are varying lengths (at least 40 amino acids but it can be any protein having 40 residues or more), varying amino acid compositions, and numerous distinct qualities that make up the genus. The specification however, does not provide for the myriad of oligopeptides embraced by the broad genus claimed. There is not sufficient amount of examples provided to encompass the numerous characteristics of the whole genus claimed. Since there are 20 naturally occurring amino acids, the possibilities are limitless.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by the reference above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to make oligopeptides having skin-beneficial activities.
U.S.C. 103
23. 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.
24. 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.
25. 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.
26. 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.
27. Claims 1-2, 4-5, 18, 26-27, 33,45, 50 and 52-53 is/are rejected under 35 U.S.C. 103 as being obvious over Bevilacqua et al (US 2013/0267458).
The applied reference has a common inventor (Bevilacqua) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
28. Bevilacqua et al teach cationic polypeptides, for example, poly(L-lysine-HCl)55-b-poly(rac-leucine)20 (see paragraph [0111]) and poly(L-lysine-HCl)60-co-poly(L-lysine)60 (see paragraph [0116]). Bevilacqua et al teach that natural antimicrobial peptides (AMPS) are often cationic. Natural antimicrobial peptides (AMPs) (typically, less than 50 amino acids) are widely distributed in most species…AMPS have demonstrated potent killing inhibition of bacteria, viruses, fungi and parasites. AMPs are thought to be important in preventing and controlling infections” (see paragraph [0011]). Polypeptides are taught to be antimicrobial at 100 mg/ml, which is greater than 3 logs killing (see e.g., Figures 4-6), meeting the limitation of instant claim 1, 33, 45 and 50. Bevilacqua et al teach that synthetic copolypeptides can be formulated and resulting superstructures can include multimers in solution, micelles, emulsions, sheets, vesicles, fibrils that form hydrogels. Self-assembly into different hierarchical structures (see paragraph [0026]), meeting the limitation of instant claim 2. Bevilacqua et al teach that the copolypeptides are self-assembles into multimeric structures (see for example, paragraph [0032[), meeting the limitation of instant claim 4. Bevilacqua et al teach that the preparation comprising the antimicrobial peptides can be applied to wounds, other tissues or other various surfaces (see paragraph [0034]), meeting the limitation of instant claim 18. Bevilacqua et al teach that the composition comprises a combination of immiscible phases in dispersed mixture or emulsion (see claim 16). Bevilacqua et al teach, for example, emulsion preparation where 1 w/v % polypeptide solution was added to give a final volume fraction (see for example, paragraph [0118]), meeting the limitation of instant claims 26-27. Bevilacqua et al teach that certain antimicrobial copolypeptides are effective surfactants (see paragraph [0081]), meeting the limitation of instant claim 53. Bevilacqua et al teach that synthetic copolypeptides can also be designed to form hydrogels (see paragraph [0027]), meeting the limitation of instant claim 52.
The difference between the reference and the instant claim is that the reference does not teach treating coronavirus.
29. However, it would have been obvious to one of ordinary skill in the art at the time of invention given the demonstrated antimicrobial activity of the block copolypeptides of Bevilacqua et al and their suggestion to be used in the treatment of all types of viruses, that peptides such as poly(L-lysine-HCl)55-b-poly(rac-leucine)20 (see paragraph [0111]) and poly(L-lysine-HCl)60-co-poly(L-lysine)60 could be applied to treat coronavirus. Given that the peptides are already taught to be antimicrobial and can be used to treat/inhibit bacteria, viruses, fungi and parasites, one of ordinary skill in the art would reasonably expect that the peptides would treat coronavirus.
Double Patenting
30. 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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
31. Claims 1-2, 4-5, 18, 22, 25-27, 32-33, 35, 40, 42, 44-45, 50 and 52-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 16 of U.S. Patent No. 9446090. Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve at the claimed invention of US Patent, and vice versa.
32. Instant claims are drawn to:
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33. US Patent claims are drawn to:
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34. Instant claims and US Patent claims share the same antimicrobial pharmaceutical composition comprising a synthetic cationic polypeptide. Instant invention is administering the same antimicrobial pharmaceutical composition of US Patent claims. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of US Patent claims, and vice versa.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
2/25/2026