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 .
Information Disclosure Statement
The information disclosure statement filed on May 6, 2024 is acknowledged and has been considered by the examiner.
Specification
The abstract of the disclosure is objected to because it is too short (22 words). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112(a)
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 20-28 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 treatment of formyl peptide receptor 1 or 2 mediated diseases or disorders using compounds containing short N-formyl modified peptides, does not reasonably provide enablement for treatment of such diseases or disorders using compounds containing any N-formyl modified polypeptide chain up to 52 amino acids in length. 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.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue.” Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. These factors include, but are not limited to:
The breadth of the claims;
The nature of the invention;
The state of the prior art;
The level of one of ordinary skill;
The level of predictability in the art;
The amount of direction provided by the inventor;
The existence of working examples; and
The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427, F.2d 833, 839, 166 USPQ 18, 24 (1970). To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, state and predictability of the art, and relative skill level
The invention of claims 20-28 relate to methods of treating diseases or disorders mediated by Formyl Peptide Receptor 1 or 2 using an N-formyl modified peptide conjugated to a poly(2-oxazoline) system. This peptide contains an N-formyl modified methionine linked to leucine via a canonical peptide bond. This is the start of a chain that can contain an additional 1-50 amino acids.
The relative skill of those in the art who would use such compounds is high, likely that of one who has obtained at a Ph.D. or M.D.
In the art, it is understood that formyl peptide receptors can bind to certain N-formyl modified short peptides, certain non-formyl short peptides, and small molecules in a sequence and structure dependent manner (see Ye, R. D.; et al., Pharmacol. Rev., 2009 – provided by applicant in IDS filed May 6, 2024). These receptors are also capable of binding to longer peptides or even proteins, though this is highly dependent on the sequences (and therefore structure) of these longer polypeptides. It is known that there are many polypeptide sequences that do not effectively bind formyl peptide receptors.
There is generally a lack of predictability in the pharmaceutical art. In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970). While predictions can be made regarding how ligands will bind receptors in silico, these are inconsistent at determining if a ligand will be able to exert a pharmacological effect in a living biological subject. Furthermore, predictions of polypeptide structures are inconsistent.
The breadth of the claims
Claim 20 is broad insofar as N-formyl modified polypeptide chain conjugated to the polymer may be 3-52 amino acids in length. It further requires at least one of the amino acids after the aforementioned leucine to contain a hydroxyl group. At this chain length, the polypeptide chain can readily fold and adopt certain tertiary structures depending on the sequence, possibly encapsulating blocking access to the formyl-modified N-terminus. Claims 26-28 narrow the structure of the poly(2-oxazoline) portion of the molecule for use in the claimed method, but none of the rejected claims limit this polypeptide chain length or sequence. Even considering the first two positions to be defined and requiring that at least one position contain a hydroxyl group (i.e., be Ser, Thr, or Tyr), there are 3 x 2049 (1.68 x 1064) possible options for the sequence of this amino acid chain when all 50 additional amino acids are present, meaning that a significantly greater number of possibilities are being claimed, as there are also many options for the sequence when an additional 49, 48, etc. amino acids are added; meaning that well over 1.68 x 1064 possible compounds are being claimed (even ignoring the variability in the poly(2-oxazoline) region of the structure). The longer forms of these polypeptides would adopt significant secondary and tertiary structures that could meaningfully change with the substitution of even a single amino acid.
The amount of direction or guidance provided and the presence or absence of working examples
The specification provides little direction or guidance for practicing the claimed invention in its “full scope.” No working examples are provided for the use of any compounds of Formula I for the treatment of any diseases or disorders. No working examples are provided for the use of any compounds of any amino acid chain composition. The guidance provided for the practice of this method of use is very broad, such that it could apply to nearly all pharmaceutical compounds.
The quantity of experimentation necessary
Experimentation to determine a therapeutically or diagnostically effective amount of material to administer to a subject can be significant. Furthermore, determining if any given compound is effective for treatment of certain diseases may span long periods of time. Additionally, determination of what 3-52 amino acid peptide sequences conjugated to the poly(2-oxazoline) system would be therapeutically effective would require significant experimentation. This would likely require testing a significant portion of the more than 1.68 x 1064 possible compounds
Because of the known state of the art, and in the absence of experimental evidence and working examples, it is apparent that the amount of experimentation required to determine which of the claimed structures could be used in the claimed methods of treatment would be efficacious is very significant and unreasonable due to the breadth of the peptide sequence being claimed.
Accordingly, the instant claims do not comply with the enablement requirement of §112(a), since to practice the claimed invention in its “full scope,” a person of ordinary skill in the art would have to engage in an unreasonable amount of experimentation, with no reasonable expectation of success.
Claim Rejections - 35 USC § 112(b)
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 4, 8, 19, 28, and 32 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 4 recites the limitation “m is an integer from 190 to 350” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 4 depends, does not provide any variable “m.”
Claim 28 recites the limitation “m is an integer from 190 to 350” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 20, from which claim 28 depends, does not provide any variable “m.”
Claims 8 and 32 define moiety X in Formula I as being selected from a list of amino acid sequences. However, the claim language in both claims is “from the group comprising of…” This phrase is unclear in meaning. Typical transition phrases include “consisting of” and “comprising.” It is unclear which of these transitional phrases is meant by the applicant. Furthermore, as “consisting of” and “comprising” language results in different scopes of a claim limitation, the lack of clarity regarding the intended transitional phrase renders the instant claims unclear in terms of metes and bounds. Therefore, these claims are considered indefinite. For the purpose of examination, the examiner will interpret the phrase to read as “consisting of,” as the list of alternatives is only proper if the list is closed. This is supported in the specification in paragraph [0044]. While claims 9-10 and 33-34 depend on claims 8 and 32, respectively, these claims narrow the scope using language that resolves the indefiniteness of claims 8 and 32 and are therefore not rejected for dependence on a claim rejected under 35 U.S.C. § 112(b).
Claim 19 requires the pharmaceutical composition further comprise an analgesic excipient. However, this is not clear language defining the invention. In the art, an excipient is understood to be an inert substance added to a drug to give it suitable consistency or form (IUPAC Gold Book E022245). An analgesic is a pharmaceutically active compound. Therefore, an analgesic compound is not an excipient. Thus, the meaning of the phrase “analgesic excipient” is unclear in scope and the claim is rendered indefinite. For the purpose of examination, this phrase will be interpreted to require an analgesic compound/agent be added to the pharmaceutical composition of claim 16. This is supported in the specification in paragraph [0063].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
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 1-9, 11-17, 21-22, 26-33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Mowycal (Houck, et al.; US 8,012,934 B2) in view of Serina (Moreadith, et al.; US 10,314,837 B2 – provided by applicant in IDS filed May 6, 2024) and Moreadith (Moreadith, R.; J.P. Morgan Biotech Showcase Presentation, 2020 – provided by applicant in IDS filed May 6, 2024), as evidenced by Ono (Terakado, et al.; US 9,771,357 B2) and Enterprise (McCarthy, et al.; US 2021/0188855 A1).
Mowycal teaches N-formyl modified small peptides and their use in treating inflammatory diseases and disorders (column 6, lines 50-66). More specifically, Mowycal discloses the following peptides: f-Met-Leu-Tyr (fMLY), f-Met-Leu-Tyr-Phe (fMLYF), f-Met-Leu-Phe-Phe (fMLFF), f-Met-Leu-Phe-Tyr (fMLFY), and f-Met-Leu-Tyr-Tyr (fMLYY) (column 6, lines 50-54; and column 11, Table 1). Mowycal teaches that these peptides may be used in pharmaceutical compositions comprising a pharmaceutically acceptable carrier (column 7, lines 29-31). Such formulations may be for inhalation (column 8, lines 63-65), injection (column 9, lines 18-21), or topical administration (column 9, lines 40-42). Mowycal teaches that such compositions prepared for inhalation may contain a mixture of trichloromonofluoromethane and dichlorodifluoromethane (column 8, line 65 to column 9, line 1). Mowycal teaches that these peptides may be used for the treatment of inflammatory diseases and disorders including asthma, eczema, psoriasis, arthritis, chronic obstructive pulmonary disease, and inflammatory bowel disease (column 6, lines 59-66).
Mowycal does not teach conjugating the N-formyl peptide to a poly(2-oxazoline) polymer.
Serina teaches poly(2-oxazoline) polymer drug conjugates (Abstract). The conjugates of Serina can be described by the following formula:
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(column 9, lines 44-60), wherein POZ is a poly(oxazoline) polymer; L is a hydrolyzable linker; A is a diagnostic or therapeutic agent; R is an initiating group that may be hydrogen, alkyl, or substituted alkyl groups (such as a C1 to C4 alkyl group or a methyl group); a is a value from 1 to 50 (column 7, lines 46-66; and column 8, lines 53-58); Z is S, O, or N; Q is a terminating group that may be inert or contain a functional group, such as a carboxylic acid (column 10, lines 10-19); and B is an optional linking group that may be an alkylene group (column 9, lines 61-63). More specifically, the above formula can be represented by the following structure further defining the POZ region wherein the variable groups are as defined above (column 11, lines 10-25):
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and wherein o is an integer from 1-50, m is an integer from 1-950, and a is ran which represents a random copolymer or block which represents a block copolymer (column 10, lines 47-50). The dotted box has been added by the examiner and indicates the A group therapeutic agent, rotigotine. Serina further describes that the conjugate may take the form of (dotted box added by examiner):
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(column 11, lines 28-56), further defining the linking group and the Z-B-Q portion of the molecule, wherein o is an integer from 1-50, m is an integer from 1-950 (column 10, lines 49-50), p is 1-16 (p represents the alkyl chain described by the variable Serina describes as R6) (column 12, lines 40-48), and the dotted box surrounds the therapeutic agent. An example of the invention of Serina is (dotted box added by examiner):
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(column 22, lines 31-58) wherein the dotted box indicates the therapeutic agent (Rotigotine). This structure could be described as a form of the broader structures above wherein o is 10, m is 190, and p is 1. Serina teaches that the agent may be any molecule having a therapeutic or diagnostic application wherein the agent is capable for forming a linkage with a functional group on a POZ polymer or the releasable, hydrolyzable linker (column 14, lines 44-54). Serina also teaches a method of treating a disease comprising administering to a subject an amount of the conjugate (column 19, lines 11-14). Serina further teaches that the compound may be prepared as a pharmaceutical composition, including compositions for injection in aqueous medium and topical formulations (column 23, lines 1-42). Serina teaches that the release of the therapeutic agent by the hydrolyzable linker can be controlled, allowing advantageous release profiles and less frequent therapeutic agent administration (column 18, line 58 to column 19, line 10).
Moreadith teaches a poly(2-oxazoline) drug conjugate system (slide 3). Moreadith teaches that candidate small molecules for such poly(2-oxazoline) conjugate systems must have a chemical handle, highlighting that hydroxyl groups are a useful chemical handle for this purpose (slide 5). Moreadith teaches that this polymer-drug conjugate system provides continuous drug delivery (slide 3) and allows for an extended circulation time (slide 4). Moreadith teaches that this prolonged release enables longer periods of detectable therapeutic agent in plasma of a subject compared to just dosing the free therapeutic agent (slide 18).
Ono teaches compounds that are agonists of ALXR (Abstract). Ono states that ALXR is also known as FPR2 (column 1, lines 25-26), which is formyl peptide receptor 2. Ono discloses that it is known in the art that ALXR/FPR2-associated diseases include asthma, arthritis, and inflammatory bowel diseases (column 19, lines 18-35).
Enterprise teaches compounds useful for the treatment of respiratory diseases and conditions (Abstract). Such respiratory diseases include chronic obstructive pulmonary disease and asthma (pg. 18, [0367]). Enterprise teaches that such compounds may be prepared as pharmaceutical compositions in the form of aerosol formulations containing propellants, stating that suitable propellants include trichloromonofluoromethane and dichlorodifluoromethane (pg. 19, [0383]).
A person of ordinary skill in the art would have recognized that Mowycal teaches N-formyl peptides containing hydroxyl groups (fMLFY and fMLYF) on tyrosine residues and their use in treating inflammatory diseases and disorders. It would also be recognized that the Serina and Moreadith references describe the same (or a similar) poly(2-oxazoline)-drug conjugate system technology as each other, as the disclosures have overlapping authors, are associated with the same company and both describe poly(2-oxazoline)-rotigotine conjugates described similarly. It would be recognized that Moreadith describes that hydroxyl-containing therapeutic agents are suitable for conjugation to the poly(2-oxazoline) system. It would be understood that the poly(2-oxazoline) conjugation system provides beneficial pharmacokinetic parameters to a therapeutic agent, improving said agents. Therefore, it would be understood by a person of ordinary skill in the art the poly(2-oxazoline) system of Serina and Moreadith could be conjugated to the fMLFY and fMLYF peptides of Mowycal to yield predictable compounds and results such as improved pharmacokinetic profile (MPEP 2143(I)(D)). Additionally, as evidenced by Ono, it would be recognized that the of inflammatory diseases and disorders that Mowycal teaches may be treated using the fMLFY and fMLYF peptides include formyl peptide receptor 2-mediated diseases such as asthma, arthritis, and inflammatory bowel disease. Furthermore, as evidenced by Enterprise, it would be understood that the trichloromonofluoromethane and dichlorodifluoromethane excipients taught by Mowycal in the inhalant formulations of the peptide pharmaceutical compositions are propellants.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the N-formyl peptides of Mowycal with the poly(2-oxazoline) conjugation system of Serina and Moreadith, conjugating the polymer system linking group hydrolyzable linker to the hydroxyl on the tyrosine positions. This would result in the predictable result of an FPR-targeting therapeutic agent with an improved release profile.
Regarding claim 1, Mowycal teaches fMLYF and fMLFY peptides (column 6, lines 50-54). Serina teaches the above reproduced poly(2-oxazoline)-pharmaceutical agent conjugate structures (formulas IIa, IIb and H-[(Acetyl-Rotigotine)10(EOZ)109]-COOH) (column 9, lines 56-53; column 11, lines 9-26; column 9, lines 30-56; and column 22, lines 31-58). Moreadith teaches that hydroxyl groups can be used to link to the hydrolyzable linker of poly(2-oxazoline) conjugate systems (slide 5). Modifying the fMLYF and fMLFY peptides of Mowycal with the poly(2-oxazoline) polymer in the same way would generate the following structures:
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wherein R is hydrogen, an alkyl group, or a substituted alkyl group (such as a C1-C4 alkyl group), o is an integer from 1-50, m is an integer from 1-950, and p is an integer from 1-16. These structures read on the claimed Formula I, as the claimed range of values for o and p lie inside the range disclosed in the prior art (MPEP § 2144.05(I)). Furthermore Formulas X-a and X-b read on claimed formula I wherein Q is poly(2-ethyl-2-oxazoline) and X is an amino acid chain 2 amino acids in length (in which tyrosine contains a hydroxyl group). Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claim 1 obvious.
Regarding claims 2 and 3, the structures produced in the rejection of claim 1 (formulas X-a and X-b) are structures wherein Q is poly(2-ethyl-2-oxazoline) and m is 1-950. The claimed range in both claims is within the taught range. Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claims 2 and 3 obvious.
Regarding claim 4, the structures produced in the rejection of claim 1 (formula X-a and X-b) are structures wherein m is 1-950; o is 1-50; p is 1-16; and R is hydrogen, alkyl, or substituted alkyl. The numerical values claimed are within each of the taught ranges. Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claim 4 obvious.
Regarding claims 5-7, the structures produced in the rejection of claim 1 (formulas X-a and X-b) are structures wherein X is 2 amino acids in length. This is within each of the claimed ranges of claims 5-7. Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claims 5-7 obvious.
Regarding claims 8 and 9, the structures produced in the rejection of claim 1 (formulas X-a and X-b are structures wherein X is either Tyr-Phe or Phe-Tyr. Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claims 8 and 9 obvious.
Regarding claim 11, the structures produced in the rejection of claim 1 (formulas X-a and X-b) read on claimed compounds I-a and I-b wherein m is 1-950, o is 1-50, and p is 1-16. R may be an alkyl group, which includes methyl. These numerical ranges include the claimed values. Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claim 11 obvious.
Regarding claim 12, Mowycal teaches that the fMLFY and fMLYF peptides may be used in pharmaceutical compositions comprising a pharmaceutically acceptable carrier (column 7, lines 29-31). Furthermore, Serina teaches that poly(2-oxazoline)-drug conjugates may be prepared as pharmaceutical compositions (column 23, lines 1-11). Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claim 12 obvious.
Regarding claim 13, Mowycal teaches that the fMLFY and fMLYF peptides may be used in pharmaceutical compositions prepared in the form of an inhalant containing a mixture of trichloromonofluoromethane and dichlorodifluoromethane (column 8, line 63 to column 9, line 5). As evidenced by Enterprise, trichloromonofluoromethane and dichlorodifluoromethane are propellant compounds (pg. 19, [0383]). Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claim 13 obvious.
Regarding claims 14 and 15, Mowycal teaches that the fMLFY and fMLYF peptides may be prepared as compositions suitable for parental administration (injection) and that such preparations are aqueous (column 9, lines 18-39). Furthermore, Serina teaches that the poly(2-oxazoline)-drug conjugate compositions may be formulated for parental use (injection) and prepared in aqueous solutions (column 23, lines 26-35). Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claims 14 and 15 obvious.
Regarding claims 16 and 17, Mowycal teaches that the fMLFY and fMLYF peptides may be prepared as compositions suitable for topical administration, including in the form of a cream or ointment (column 9, lines 40-55). Furthermore, Serina teaches that the poly(2-oxazoline)-drug conjugate compositions may be formulated for topical administration (column 23, lines 36-43). Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claims 16 and 17 obvious.
Regarding claims 20-22, for the reasons described in the above rejection of claim 1, the combined teachings of Mowycal, Serina, and Moreadith teach the following structures:
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wherein R is hydrogen, an alkyl group, or a substituted alkyl group (such as a C1-C4 alkyl group), o is an integer from 1-50, m is an integer from 1-950, and p is an integer from 1-16. These structures read on the claimed Formula I, as the claimed range of values for o and p lie inside the range disclosed in the prior art (MPEP § 2144.05(I)). Furthermore formulas X-a and X-b read on claimed Formula I wherein Q is poly(2-ethyl-2-oxazoline) and X is an amino acid chain 2 amino acids in length (in which tyrosine contains a hydroxyl group). Furthermore, Serina also teaches that poly(2-oxazoline)-drug conjugates may be used in methods of treating a disease comprising administering to a subject an amount of the conjugate (column 19, lines 11-14). Mowycal teaches that the fMLYF and fMLFY peptides may be used for the treatment of inflammatory diseases and disorders including asthma, eczema, psoriasis, arthritis, chronic obstructive pulmonary disease, and inflammatory bowel disease (column 6, lines 59-66). Such methods involved administering a therapeutically effective amount of the peptide (Abstract). As evidenced by Ono, asthma, arthritis, and inflammatory bowel diseases are ALXR (which is another name for formyl peptide receptor 2 – [column 1, lines 25-26])-associated diseases (column 19, lines 18-35). Therefore, as evidenced by Ono, Mowycal teaches methods of treating diseases or disorders mediated by Formyl Peptide Receptor 2. Thus, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claims 20-22 obvious.
Regarding claims 26 and 27, the structures of formulas X-a and X-b are structures wherein Q is poly(2-ethyl-2-oxazoline) and m is 1-950. The claimed ranges of both claims fall within the taught range. Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claims 26 and 27 obvious.
Regarding claim 28, the structures of formulas X-a and X-b are structures wherein m is 1-950; o is 1-50; p is 1-16; and R is hydrogen, alkyl, or substituted alkyl. The numerical values claimed are within each of the taught ranges. Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claim 28 obvious.
Regarding claims 29-31, the structures of formulas X-a and X-b are structures wherein X is 2 amino acids in length. This is within each of the claimed ranges of claims 29-31. Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claims 29-31 obvious.
Regarding claim 32-33, the structures of formulas X-a and X-b are structures wherein X is either Tyr-Phe or Phe-Tyr. Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claims 32 and 33 obvious.
Regarding claim 35, the structures of formulas X-a and X-b read on claimed compounds I-a and I-b wherein m is 1-950, o is 1-50, and p is 1-16. R may be an alkyl group, which includes methyl. These numerical ranges include the claimed values. Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise render claim 35 obvious.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mowycal, Serina, Moreadith, Ono, and Enterprise, as applied to claims 1-9, 11-17, 20-22, 26-33, and 35 above; further in view of Celgene (Schafer, et al.; US 2013/0116204 A1).
As described above, Mowycal, Serina, and Moreadith combine to teach compounds of formulas Xa and Xb. Furthermore, Mowycal teaches that the fMLFY and fMLYF peptides may be used in pharmaceutical compositions comprising a pharmaceutically acceptable carrier (column 7, lines 29-31). Mowycal teaches that such topical formulations may take the form of a cream or ointment (column 9, lines 40-55). Mowycal teaches that these peptides may be used for the treatment of inflammatory diseases and disorders including asthma, eczema, psoriasis, arthritis, chronic obstructive pulmonary disease, and inflammatory bowel disease (column 6, lines 59-66). Additionally, Serina teaches that poly(2-oxazoline)-drug conjugates may be prepared as pharmaceutical compositions (column 23, lines 1-11) including forms for topical formulations (column 23, lines 36-43).
The combined teachings of Mowycal, Serina, Moreadith, Ono, and Enterprise do not teach topical formulations of the N-formyl peptide containing pharmaceutical composition further comprising analgesic or non-steroidal anti-inflammatory drugs.
Celgene teaches compounds that inhibit PDE4, enabling a decrease in cAMP levels, making the compounds suitable for the treatment of inflammatory diseases (pg. 1, [0002] – [0006]). Celgene further teaches methods of treating diseases using such anti-inflammatory compounds (pg. 4, [0043]. Such inflammatory diseases include asthma, chronic obstructive pulmonary disorder, arthritis, psoriasis, dermatitis, and ulcerative colitis (pg. 4, [0044]). Celgene teaches that pharmaceutical compositions containing the anti-inflammatory compounds may be topical formulations (pg. 14, [0113]) and may include a second active ingredient (pg. 4-5, [0014]). Such second active ingredients include opioid analgesics and NSAIDs (pg. 11, [0092]). Celgene states that some combinations of the PDE4 anti-inflammatory compounds and second active agents may synergistically treat some diseases or disorders (pg. 9, [0083]).
A person of ordinary skill in the art would have recognized that the N-formyl peptides taught by Mowycal and the PDE4-inhibiting compounds of Celgene are both anti-inflammatory compounds for use in the treatment of inflammatory diseases including psoriasis, eczema, asthma, and arthritis. Furthermore, it would be recognized that Celgene describes that anti-inflammatory drugs may be combined with opioid analgesics or NSAIDs in a pharmaceutical composition. This would be recognized as a method known in the art (MPEP § 2143(I)(A) that may enable synergistic treatment of a disease or disorder. A person of ordinary skill in the art would be able to apply the second agent co-formulation technique of Celgene and apply it to the compounds of Mowycal or the compounds taught by the combination of Mowycal, Serina, and Moreadith; as co-formulation is understood in the art of pharmaceuticals.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the topical formulation of a pharmaceutical composition containing the N-formyl peptide-poly(2-oxazoline) conjugates of Mowycal, Serina, and Moreadith with the second active agent as taught by Celgene. This would result in the predictable result of a topical pharmaceutical composition comprising compounds of formulas X-a or X-b further comprising a second active compound such as an opioid analgesic or NSAID. As described in the above claim interpretation in the associated 112(b) rejection of claim 19, “opioid analgesic” reads on the limitation of “analgesic excipient.” Therefore, the combined teachings of Mowycal, Serina, Moreadith, Ono, Enterprise, and Celgene render claims 18 and 19 obvious.
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Ryu (Ryu, et al.; US 2003/0224987 A1) in view of Mowycal, Serina, and Moreadith, as evidenced by Ono.
Ryu teaches peptides that bind to formyl peptide receptor (Abstract). Ryu also teaches methods of treating diseases using these peptides, including inflammatory diseases (pg. 4, [0047]). The method comprises administering to a host in need of such treatment a therapeutically effective amount of the peptide. Ryu teaches that the disease or disorder may be ulcerative colitis, asthma, psoriasis, lung inflammation, or hyper IgE syndrome (pg. 4-5, [0056]).
Ryu does not teach methods of treating ulcerative colitis or hyper-IgE syndrome using a compound of formula I.
As described above, Mowycal, and Serina combine to teach compounds of formulas Xa and Xb. Furthermore, Serina teaches that poly(2-oxazoline)-drug conjugates may be used in methods of treating a disease comprising administering to a subject an amount of the conjugate (column 19, lines 11-14). Mowycal teaches that the fMLYF and fMLFY peptides may be used for the treatment of inflammatory diseases and disorders including asthma, eczema, psoriasis, arthritis, chronic obstructive pulmonary disease, and inflammatory bowel disease (column 6, lines 59-66). As evidenced by Ono, asthma, arthritis, and inflammatory bowel diseases are formyl peptide receptor 2-associated diseases (column 19, lines 18-35). Furthermore, Mowycal teaches that the fMLYF and fMLFY peptides can be used to block IgE activation of lymphocytes (column 5, lines 34-36).
A person of ordinary skill in the art would have recognized that both Mowycal and Ryu teach formyl peptide receptor binding peptides that can be used in the treatment of FPR-mediated diseases. It would be understood that one could substitute the peptides of Mowycal or the polymer-peptide conjugates of Mowycal, Serina, and Moreadith in place of the peptides taught by Ryu in Ryu’s methods of treating ulcerative colitis and hyper IgE syndrome, as both entities have similar pharmacological activity (MPEP § 2143(I)(B). Additionally, a person or ordinary skill in the art would understand that autosomal dominant hyper IgE syndrome is characterized by mutation to the STAT3 gene causing the disease. Therefore, a person of ordinary skill in the art would recognize that a method of treating hyper IgE syndrome in general that targets IgE activation of lymphocytes could be used for the treatment of the autosomal dominant form of the syndrome.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the FPR-targeting peptides of Ryu with the N-formyl peptide-poly(2-oxazoline) conjugates of Mowycal, Serina, and Moreadith in the method of treating ulcerative colitis or hyper-IgE syndrome. This would result in the predictable result of an alternative effective therapeutic method comprising compounds of formulas X-a or X-b.
Regarding claim 23, ulcerative colitis is a form of colitis. Therefore, the combined teachings of Ryu, Mowycal, Serina, Moreadith, and Ono render claim 23 obvious.
Regarding claim 24, Ryu teaches using anti-inflammatory peptides in a method of treating hyper-IgE syndrome 9 9pg. 4-5, [0056]). Therefore, the combined teachings of Ryu, Mowycal, Serina, Moreadith, and Ono render claim 24 obvious.
Regarding claim 25, Mowycal teaches that the fMLYF and fMLFY peptides can be used to block IgE activation of lymphocytes (column 5, lines 34-36). Ryu teaches using peptides that bind to formyl peptide receptor to treat hyper IgE syndrome (pg. 4-5, [0056]), which includes autosomal dominant hyper-IgE syndrome. Therefore, the combined teachings of Ryu Mowycal, Serina, Moreadith, and Ono render claim 25 obvious.
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 1-12, 14-16, and 20-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/224,888 in view of Serina (Moreadith, et al.; US 10,314,837 B2 – provided by applicant in IDS filed May 6, 2024) and Moreadith (Moreadith, R.; J.P. Morgan Biotech Showcase Presentation, 2020 – provided by applicant in IDS filed May 6, 2024).
The claims of copending application 18/224,888 are drawn to a method of treating a disease or disorder mediated by formyl peptide receptor 1 or 2 comprising administering a therapeutically effective amount of an N-formyl modified peptide. The peptide contains an N-formyl methionine residue linked via canonical peptide bond to a leucine residue. The leucine is connected to an amino acid chain between 1 and 50 amino acids in length. The disease or disorder to be treated is an inflammatory disease or disorder, including respiratory disease, arthritis, and autosomal dominant hyper IgE syndrome. The copending application claims provide several different embodiments of peptides that may be used for such methods of treatment. Many of these embodiments contain tyrosine.
The claims of copending application 18/224,888 do not teach N-formyl modified peptides conjugated to a poly(2-oxazoline) system.
As described above, Serina teaches poly(2-oxazoline) polymer drug conjugates (Abstract). The conjugates of Serina can be described by the following formula:
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(column 9, lines 44-60), wherein POZ is a poly(oxazoline) polymer; L is a hydrolyzable linker; A is a diagnostic or therapeutic agent; R is an initiating group that may be hydrogen, alkyl, or substituted alkyl groups (such as a C1 to C4 alkyl group or a methyl group); a is a value from 1 to 50 (column 7, lines 46-66; and column 8, lines 53-58); Z is S, O, or N; Q is a terminating group that may be inert or contain a functional group, such as a carboxylic acid (column 10, lines 10-19); and B is an optional linking group that may be an alkylene group (column 9, lines 61-63). More specifically, the above formula can be represented by the following structure further defining the POZ region wherein the variable groups are as defined above (column 11, lines 10-25):
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and wherein o is an integer from 1-50, m is an integer from 1-950, and a is ran which represents a random copolymer or block which represents a block copolymer (column 10, lines 47-50). The dotted box has been added by the examiner and indicates the A group therapeutic agent, rotigotine. Serina further describes that the conjugate may take the form of (dotted box added by examiner):
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(column 11, lines 28-56), further defining the linking group and the Z-B-Q portion of the molecule, wherein o is an integer from 1-50, m is an integer from 1-950 (column 10, lines 49-50), p is 1-16 (p represents the alkyl chain described by the variable Serina describes as R6) (column 12, lines 40-48), and the dotted box surrounds the therapeutic agent. An example of the invention of Serina is (dotted box added by examiner):
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(column 22, lines 31-58) wherein the dotted box indicates the therapeutic agent (Rotigotine). This structure could be described as a form of the broader structures above wherein o is 10, m is 190, and p is 1. Serina teaches that the agent may be any molecule having a therapeutic or diagnostic application wherein the agent is capable for forming a linkage with a functional group on a POZ polymer or the releasable, hydrolyzable linker (column 14, lines 44-54). Serina also teaches a method of treating a disease comprising administering to a subject an amount of the conjugate (column 19, lines 11-14). Serina teaches that the release of the therapeutic agent by the hydrolyzable linker can be controlled, allowing advantageous release profiles and less frequent therapeutic agent administration (column 18, line 58 to column 19, line 10).
Moreadith teaches a poly(2-oxazoline) drug conjugate system (slide 3). Moreadith teaches that candidate small molecules for such poly(2-oxazoline) conjugate systems must have a chemical handle, highlighting that hydroxyl groups are a useful chemical handle for this purpose (slide 5). Moreadith teaches that this polymer-drug conjugate system provides continuous drug delivery (slide 3) and allows for an extended circulation time (slide 4). Moreadith teaches that this prolonged release enables longer periods of detectable therapeutic agent in plasma of a subject compared to just dosing the free therapeutic agent (slide 18).
A person of ordinary skill in the art would have recognized that copending application teaches using N-formyl peptides containing hydroxyl groups on tyrosine residues for the treatment of diseases or disorders. This therefore also teaches the peptides themselves. It would also be recognized that the Serina and Moreadith references describe the same poly(2-oxazoline)-drug conjugate system technology as each other, as the disclosures have overlapping authors, are associated with the same company and both describe poly(2-oxazoline)-rotigotine conjugates. It would be recognized that Moreadith describes that hydroxyl-containing therapeutic agents are suitable for conjugation to the poly(2-oxazoline) system. It would be understood that the poly(2-oxazoline) conjugation system provides beneficial pharmacokinetic parameters to a therapeutic agent, improving said agents. Therefore, it would be understood by a person of ordinary skill in the art the poly(2-oxazoline) system of Serina and Moreadith could be conjugated to the N-formyl peptides of copending application 18/224,888 to yield predictable compounds and results.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the N-formyl peptides of copending application 18/224,888 with the poly(2-oxazoline) conjugation system of Serina and Moreadith, conjugating the polymer system linking group hydrolyzable linker to the hydroxyl on the tyrosine positions in the claimed peptides. This would result in the predictable result of an FPR-targeting therapeutic agent with an improved release profile and methods of using the conjugate for treating diseases.
Regarding instant claim 1, conflicting claim 21 of the copending application teaches peptides of sequences fMLYF, fMLFF, fMLFY, fMLYY, fMLFFY, fMLFYF, fMLYFF, and fMLYYY. These are all peptides that contain hydroxyl groups that could be conjugated to the poly(2-oxazoline) system of Serina and Moreadith (Moreadith, slide 5). Among other products, the conjugation of the polymer system would result in structures including the following:
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wherein R is hydrogen, an alkyl group, or a substituted alkyl group (such as a C1-C4 alkyl group), o is an integer from 1-50, m is an integer from 1-950, and p is an integer from 1-16. These structures read on the instantly claimed Formula I, as the claimed range of values for o and p lie inside the range disclosed in the prior art (MPEP § 2144.05(I)). Furthermore Formulas X-a and X-b read on instantly claimed formula I wherein Q is poly(2-ethyl-2-oxazoline) and X is an amino acid chain 2 amino acids in length (in which tyrosine contains a hydroxyl group). Additionally, conflicting claim 1 allows for the peptide to instead by 1-50 amino acids in length.
Regarding instant claims 2 and 3, the structures of formulas X-a and X-b are structures wherein Q is poly(2-ethyl-2-oxazoline) and m is 1-950. The claimed range in both claims is within the taught range and is therefore obvious.
Regarding instant claim 4, the structures of formulas X-a and X-b are structures wherein m is 1-950; o is 1-50; p is 1-16; and R is hydrogen, alkyl, or substituted alkyl. The numerical values claimed are within each of the taught ranges and are therefore obvious.
Regarding instant claims 5-7, the structures of formulas X-a and X-b are structures wherein X is 2 amino acids in length. This is within each of the claimed ranges of claims 5-7. Additionally, conflicting claim 1 allows for the peptide linked to f-Met-Leu to be 1-50 amino acids in length, which the claimed ranges lie within. Therefore, the claimed ranges of amino acid chain length are obvious.
Regarding instant claims 8-10, the structures of formulas X-a and X-b are structures wherein X is either Tyr-Phe or Phe-Tyr. Furthermore, conflicting claim 18 provides additional sequences for X that read on the instantly claimed sequences, all containing a hydroxyl group, which would enable conjugation to the poly(2-oxazoline) system. Additionally, conflicting claim 20 allows for X to by Tyr-Tyr-Tyr.
Regarding instant claim 11, the structures produced in the rejection of claim 1 (formulas X-a and X-b) read on claimed compounds I-a and I-b wherein m is 1-950, o is 1-50, and p is 1-16. R may be an alkyl group, which includes methyl. These numerical ranges include the claimed values. Furthermore, conflicting claim 21 also includes fMLYY and fMLYYY peptides that may similarly be conjugated to the poly(2-oxazoline) system, which would then read on instantly claimed formulas I-c and I-g.
Regarding instant claim 12, Serina teaches that poly(2-oxazoline)-drug conjugates may be prepared as pharmaceutical compositions that may comprise carriers (column 23, lines 1-11).
Regarding instant claims 14 and 15, Serina teaches that the poly(2-oxazoline)-drug conjugate compositions may be formulated for parental use (injection) and prepared in aqueous solutions (column 23, lines 26-35).
Regarding instant claim 16, Serina teaches that the poly(2-oxazoline)-drug conjugate compositions may be formulated for topical administration (column 23, lines 36-43).
Regarding instant claim 20, for the reasons described in the above non-statutory double patenting rejection of instant claim 1, the combined teachings of copending application 18/224,888, Serina, and Moreadith teach the following structures:
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wherein R is hydrogen, an alkyl group, or a substituted alkyl group (such as a C1-C4 alkyl group), o is an integer from 1-50, m is an integer from 1-950, and p is an integer from 1-16. These structures read on the claimed Formula I, as the claimed range of values for o and p lie inside the range disclosed in the prior art. Furthermore formulas X-a and X-b read on claimed Formula I wherein Q is poly(2-ethyl-2-oxazoline) and X is an amino acid chain 2 amino acids in length (in which tyrosine contains a hydroxyl group). Furthermore, Serina also teaches that poly(2-oxazoline)-drug conjugates may be used in methods of treating a disease comprising administering to a subject an amount of the conjugate (column 19, lines 11-14). Copending application (conflicting claim 1) teaches methods of using the aforementioned peptides, including the fMLYF and fMLFY peptides of formulas X-a and X-b, for the treatment of a disease or disorder mediated by Formyl Peptide Receptor 1 or 2 comprising administering to a subject in need thereof a therapeutically effective amount of the compound.
Regarding instant claim 21, conflicting claim 2 teaches the disease or disorder being an inflammatory disease or disorder.
Regarding instant claim 22, conflicting claims 3-11 teach the disease or disorder being characterized by mucosal inflammation, respiratory disease, asthma, chronic obstructive pulmonary disease, eczema, acute lung injury, arthritis, psoriasis, or an intestinal inflammatory disease or disorder.
Regarding instant claim 23, conflicting claim 12 of the copending application teaches the intestinal inflammatory disease or disorder being colitis.
Regarding instant claim 24, conflicting claim 13 of the copending application teaches the disease or disorder being a hyper-IgE syndrome.
Regarding instant claim 25, conflicting claim 14 of the copending application teaches the HIES being autosomal dominant hyper-IgE syndrome.
Regarding claims 26 and 27, the structures of formulas X-a and X-b are structures wherein Q is poly(2-ethyl-2-oxazoline) and m is 1-950. The claimed ranges of both claims fall within the taught range.
Regarding instant claim 28, the structures of formulas X-a and X-b are structures wherein m is 1-950; o is 1-50; p is 1-16; and R is hydrogen, alkyl, or substituted alkyl. The numerical values claimed are within each of the taught ranges.
Regarding instant claims 29-31, the structures of formulas X-a and X-b are structures wherein X is 2 amino acids in length. This is within each of the claimed ranges of claims 29-31. Additionally, conflicting claim 1 allows for the peptide linked to f-Met-Leu to be 1-50 amino acids in length, which the claimed ranges lie within. Therefore, the claimed ranges of amino acid chain length are obvious.
Regarding instant claim 32-34, the structures of formulas X-a and X-b are structures wherein X is either Tyr-Phe or Phe-Tyr. Furthermore, conflicting claim 18 provides additional sequences for X that read on the instantly claimed sequences, all containing a hydroxyl group, which would enable conjugation to the poly(2-oxazoline) system. Additionally, conflicting claim 20 allows for X to by Tyr-Tyr-Tyr.
Regarding instant claim 35, the structures of formulas X-a and X-b read on claimed compounds I-a and I-b wherein m is 1-950, o is 1-50, and p is 1-16. R may be an alkyl group, which includes methyl. These numerical ranges include the claimed values. Furthermore, conflicting claim 21 also includes fMLYY and fMLYYY peptides that may similarly be conjugated to the poly(2-oxazoline) system, which would then read on instantly claimed formulas I-c and I-g.
This is a provisional nonstatutory double patenting rejection.
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric P Mosher whose telephone number is (571)272-3258. The examiner can normally be reached Monday-Friday 9am-5pm.
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/E.P.M./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights