DETAILED ACTION
Claims 1-19 are currently pending in the instant application. Claims 1-19 are rejected.
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 Amendment and Arguments
Applicant's amendment and arguments filed 13 July 2026 have been fully and entered into the instant application. Applicant’s amendment to the specification has overcome the objection to the abstract and the objections to the specification. Applicant’s amendment has overcome the objections to claims 3, 4, 7, 13, and 15. Applicant’s amendment has overcome the 35 USC 112(b) rejection of claims 7, 8, 12, and 13 as the term “substantially” has been deleted from claims 7 and 12; the phrase “use at least substantially” has been deleted from claims 7 and 12, and the term “the” has been deleted from claims 8, 12, and 13. Applicant’s amendment to claims 1 and 10 to insert
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(claim 1) and
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(claim 10) has overcome the 35 USC 102(a)(1) rejection. However, claims 1-12, 14-16, and 18 are now rejected under 35 USC 103. In regards to the 35 USC 103 rejection of claims 13 and 17, Applicant argues that the disclosure of Prince, which discloses daily dosages of calpain inhibitors for administration by inhalation (0.001 to 30mg/kg) (para. [00232]) and discloses that effective concentration needed to ameliorate the disease being treated can be empirically determine (para. [00319], differs from a solvent suitable for administration by inhalation through a nebulizer, wherein a concentration of the active ingredient within the suitable solvent is between 0.34mg/mg and 34 mg/ml. This argument is not persuasive, as Prince discloses that the calpain inhibitor can be administered into the airway of the subject through a use of a nebulizer (para. [0014]), paragraph [0019] on page 4 provides wherein the calpain inhibitor can be E64D, page 5 provides that the calpain inhibitor can be administered by inhalation, examples of pharmaceutical devices for aerosol delivery include metered dose inhalers, dry powder inhalers, and air-jet nebulizers, page 63 provides aerosol formulations of the calpain inhibitor with solvents such as ethanol, page 64 provides wherein nebulized formulation can contain ethanol as a solvent and provides the calpain inhibitor in inhalable form and wherein the composition can be particle sizes between 1 um to about 20, such as 1 to 10, such as 2 to 7, such as 3 to 5um, discloses daily dosages of calpain inhibitors for administration by inhalation (0.001 to 30mg/kg) (para. [00232]), and discloses that effective concentration needed to ameliorate the disease being treated can be empirically determine (para. [00319]. Additionally, in regards to the 0.34mg/ml and 34mg/ml concentration of the active ingredient in the nebulizer in comparison to the 0.001 to 30mg/kg dose in the prior art. According to Enderle et al., the average weight of an adult human could be considered 76.9kg for example, see Table 1, page 647. According to the RXWellz article, a typical fill volume for a standard nebulizer is approximately 2 to 4 ml. Therefore, a hypothetical dose range of the instant claims would be administering .34mg/ml in 2ml for a low range dose 0.68mg and administering a dose of 34mg/ml in 4ml would be a high range dose of 136mg. Compared to the prior art of 0.001 to 30mg/kg in an average adult human at 76.9kg would be a range of 0.0769mg to 2307mg. Therefore, the claimed range of between 0.34mg/ml and 34mg/ml is a range within the prior art range. See MPEP 2144.05, in the case where the clime ranges lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. Additionally, see wherein the concentration of the calpain inhibitor in the ‘956 WO is described in paragraph [0319] and [0329]:
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While applicant has stated that:
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, it is noted that the claims are not limited to administration of E64d by inhalation as the pharmaceutical composition claims are product claims and require a solvent suitable for inhalation, but do not require an active inhalation step. A solvent suitable for inhalation does not require inhalation. Additionally, the instant method claims just require administration, the administration is not limited to inhalation. Lastly, applicant has not provided a showing that the claimed range is critical by showing that the claimed range achieves unexpected results relative to the prior art range. The 35 USC 103 rejection is therefore maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 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. Specifically claims 1 and 10 state that the active ingredient is comprising one or more of a compound “comprising” cathepsin inhibitor aloxistatin. It is unclear how a compound can comprise another compound as E64d is a complete compound in and of itself so it is therefore unclear what parts of E64d can change to be comprised by a compound. In the abovementioned phrase, the term, “comprising”, is open-ended and thus, does not exclude additional, unrecited elements, according to MPEP 2111.03(I). Subsequently, it is unclear to the Examiner whether the abovementioned compound could have other elements or functional groups present besides what is in E64d.. Accordingly, the metes and bounds of this claim is unclear, which rendered this claim indefinite. The term “comprising” or forms of the term are considered open-ended language and therefore include additional subject matter that is not described in the instant specification and is not particularly pointed out or distinctly claimed. The identity of the additional atoms or groups is unknown and how to determine the identity of the additional atoms or groups is not pointed out or distinctly claimed. The term “compound” contradicts the open language "comprising." A "compound" is defined as a substance whose molecules consist of unlike elements and whose constituents cannot be separated by physical means. Grant & Hackh's Chemical Dictionary (5th Ed. 1987) at page 148. By contrast, a composition is defined as elements or compounds forming a material or produced from it by analysis. Id. In other words, a compound is a molecule with more than one element, and a composition is a mixture of two or more compounds or molecules. The transitional term "comprising" is synonymous with "including", "containing", and "characterized by". "Comprising" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). Thus, a contradiction arises within the definition of the compound in the active ingredient in claims 1 and 10 and their dependent claims because a "compound" requires a definite chemical formula, and the open-ended term "comprising" does not exclude unrecited elements. Furthermore, "comprising", used in conjunction with "compound" fails to articulate exactly what subject matter is excluded from the claimed scope of compounds, thereby rendering the scope of claims 1-19 indefinite. It is suggested that claim 1 language be amended to: A pharmaceutical composition comprising: an active ingredient comprising one or more of a cathepsin inhibitor aloxistatin (E64d) according to Formula (I),
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, a physiologically acceptable salt of the compound according to Formula (I), a solvate of the compound according to Formula (I), and a hydrate of the compound according to Formula (I); and a solvent suitable for administration…..
Claim 7 is 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 7 is recites the limitation "the inhalation” in reference to claim 1. There is insufficient antecedent basis for this limitation in the claim as claim 1 is a pharmaceutical composition claim. There is no active inhalation step in the pharmaceutical composition claim. Additionally, while the word “inhalation” is found in claim 1, it is found in the definition of the solvent, not as an active step, but as a descriptor limiting what solvent can be found in the pharmaceutical composition, i.e. it must be one that is suitable for inhalation. There is on “inhalation of the pharmaceutical composition” found in claim 1.
As seen by applicant’s instant specification, paragraph [0006], E64D is the formula:
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which is the formula of instant claims 1-12, 14-16, 18 and 19. Applicant’s instant claims 1-9 and 18 are drawn to a pharmaceutical composition comprising one or more of a compound according to Formula (I):
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, a physiologically acceptable salt of the compound according to Formula 9I), a solvate of the compound according to Formula (I), and a hydrate of the compound according to Formula (I), wherein the pharmaceutical composition further comprises a suitable solvent as a carrier. Instant claim 5 has the limitation wherein the suitable solvent comprises alcohol. Instant claim 9 has the further limitation wherein the compound is attached or conjugated to a suitable solid carrier comprising a suitable porous particle. Instant claim 18 has the further limitation wherein the alcohol comprises ethanol. As seen above, the ‘956 WO provides pharmaceutical compositions comprising a calpain inhibitor, specifically E64D, as seen on page 2 wherein methods of reducing inflammation by administering at least one calpain inhibitor to the respiratory epithelial cells in the airway of the subject is provided and as seen in paragraph [0019] on page 4 wherein the calpain inhibitor can be E64D. Additionally, page 59 of the ‘956 WO provides the pharmaceutical compositions comprising the calpain inhibitor in free or pharmaceutically acceptable salt form, together with a diluent or carrier with page 63 providing aerosol formulations of the calpain inhibitor with solvents such as ethanol. Lastly, page 64 provides wherein nebulized formulation can contain ethanol as a solvent and provides the calpain inhibitor in inhalable form. In regards to instant claim 9, paragraph [00240] on page 66 provides powder compositions containing the calpain inhibitor which has a mixture of the compound and a suitable powder base such as lactose or starch. As evidenced by Pilcer et al., lactose is a porous particle, see abstract wherein the drug particles are mixed with larger carrier particles, which are commonly lactose. Figure 1, page 235 of Pilcer et al. provides an illustration of the porous surface of lactose carrier particles.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2009/145956.
WO2009/145956 discloses methods of reducing inflammation by administering at least one calpain inhibitor to the respiratory epithelial cells in the airway of the subject, page 2. Page 3 provides for reducing inflammation. Page 3 provides wherein the subject can suffer from diseases and disorders such as asthma and cystic fibrosis. Paragraph [0019] on page 4 provides wherein the calpain inhibitor can be E64D. Page 5 provides that the calpain inhibitor can be administered by inhalation. Page 5 provides additional therapeutic agents, such as corticosteroids. Page 11 provides that the disclosure provides compositions and methods that reduce calpain activity in a subject having, or at risk of having an airway inflammation-related disorder. Page 12 provides administration into the airway of the subject by inhalation with the use of a nebulizer. Page 13 provides methods for reducing inflammation in a mammal. Page 18 provides that the specific compositions and methods can be useful for treating or preventing the occurrence of an airway inflammation-related disease or disorder in a subject. Page 32 provides methods for the treatment, prevention, inhibition or reduction of inflammation in a subject suffering, or at risk of suffering from a variety of inflammatory or obstructive airway diseases and conditions such as cystic fibrosis and COPD. Page 45 provides that administration by inhalation may be oral and/or nasal. Examples of pharmaceutical devices for aerosol delivery include metered dose inhalers, dry powder inhalers, and air-jet nebulizers. Page 47 provides the calpain inhibitor E64D in paragraph [00175]. Page 59 provides the pharmaceutical compositions comprising the calpain inhibitor in free or pharmaceutically acceptable salt form, together with a diluent or carrier. Page 63 provides aerosol formulations of the calpain inhibitor with solvents such as ethanol. Page 64 provides wherein nebulized formulation can contain ethanol as a solvent and provides the calpain inhibitor in inhalable form and wherein the composition can be particle sizes between 1 um to about 20, such as 1 to 10, such as 2 to 7, such as 3 to 5um. Page 65 provides pulmonary delivery of therapeutic agents in subjects suffering from or at risk of suffering from an inflammation-related disease or disorder with discussion of the pulmonary epithelium cells. Paragraph [00240] on page 66 provides powder compositions containing the calpain inhibitor which has a mixture of the compound and a suitable powder base such as lactose or starch. Co-administration with other compositions are provided on page 80 where the other composition can be co-administered via orally, intranasally, inhalation, etc. Claim 1 of the ‘956 WO is drawn to a method for reducing inflammation in a subject, the method comprising administering at least one calpain inhibitor to the respiratory epithelial cells in the airway of the subject. Claim 5 of the ‘956 WO provides wherein the subject suffers from diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. Claim 12 of the ‘956 WO provides wherein the calpain inhibitor is E64D. Claim 18 of the ‘956 WO provides where there is an additional therapeutic agent. Claim 24 of the ‘956 WO provides wherein the calpain inhibitor is administered by inhalation. Claim 25 of the ‘956 WO provides wherein the calpain inhibitor is linked to a targeting moiety that specifically binds to the surface of a cell in the pulmonary epithelium.
The difference between the instant claims 1-19 and the ‘956 WO is that the instant claims require a concentration of the active ingredient within the suitable solvent between 0.34mg/ml and 34mg/ml. However, the ‘956 WO discloses daily dosages of calpain inhibitors for administration by inhalation (0.001 to 30mg/kg) (para. [00232]) and discloses that effective concentration needed to ameliorate the disease being treated can be empirically determine (para. [00319]). Therefore, the claimed range of between 0.34mg/ml and 34mg/ml is a range within the prior art range. See MPEP 2144.05, in the case where the clime ranges lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. Additionally, see wherein the concentration of the calpain inhibitor in the ‘956 WO is described in paragraph [0319] and [0329]:
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As seen by applicant’s instant specification, paragraph [0006], E64D is the formula:
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which is the formula of instant claims 1-12, 14-16, 18 and 19. Applicant’s instant claims 1-9 and 18 are drawn to a pharmaceutical composition comprising and active ingredient comprising one or more of a compound according to Formula (I):
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, a physiologically acceptable salt of the compound according to Formula (I), a solvate of the compound according to Formula (I), and a hydrate of the compound according to Formula (I), wherein the pharmaceutical composition further comprises a solvent suitable for administration by inhalation through a nebulizer wherein a concentration of the active ingredient within the suitable solvent is between 0.34mg/ml and 34 mg/ml. Instant claim 5 has the limitation wherein the suitable solvent comprises alcohol. Instant claim 9 has the further limitation wherein the compound is attached or conjugated to a suitable solid carrier comprising a suitable porous particle. Instant claim 18 has the further limitation wherein the alcohol comprises ethanol. As seen above, the ‘956 WO provides pharmaceutical compositions comprising a calpain inhibitor, specifically E64D, as seen on page 2 wherein methods of reducing inflammation by administering at least one calpain inhibitor to the respiratory epithelial cells in the airway of the subject is provided and as seen in paragraph [0019] on page 4 wherein the calpain inhibitor can be E64D. Additionally, page 59 of the ‘956 WO provides the pharmaceutical compositions comprising the calpain inhibitor in free or pharmaceutically acceptable salt form, together with a diluent or carrier with page 63 providing aerosol formulations of the calpain inhibitor with solvents such as ethanol. Lastly, page 64 provides wherein nebulized formulation can contain ethanol as a solvent and provides the calpain inhibitor in inhalable form. In regards to instant claim 9, paragraph [00240] on page 66 provides powder compositions containing the calpain inhibitor which has a mixture of the compound and a suitable powder base such as lactose or starch. As evidenced by Pilcer et al., lactose is a porous particle, see abstract wherein the drug particles are mixed with larger carrier particles, which are commonly lactose. Figure 1, page 235 of Pilcer et al. provides an illustration of the porous surface of lactose carrier particles.
Please note, claims 1-9 and 18 are pharmaceutical composition claims with intended use limitations of “prevention and treatment of a disease…” and “administered by inhalation”. Claim 4 additionally has the intended use limitation of in combination with another therapy. Claim 6 additionally has the limitation to the intended “inhalation” use is “through a breath-triggered nebulizer”. Claim 7 has the additional limitation to the intended use wherein the use at least substantially avoids a conversion of cathepsin inhibitor aloxistatin. Claim 8 has the additional limitation to the intended use wherein a cumulative E64D deposition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. None of the intended uses found in claims result in a structural difference between the claimed invention and the prior art. The prior art pharmaceutical compositions are capable of performing the intended use and therefore meet the claims.
In regards to Applicant’s instant method claims 10-12, 14-16 and 19 as seen above, provides for the method of preventing or treating at least one of an inflammatory disease by administering to a mammalian subject a pharmaceutical composition comprising E64D administered in a solvent suitable for administration by inhalation through a nebulizer wherein a concentration of the active ingredient within the suitable solvent is between 0.34mg/ml and 34 mg/ml, with a nebulizer for example, with a suitable solvent which is an alcohol, such as ethanol, wherein the inflammation can be due to COPD, asthma, or cystic fibrosis among other inflammatory diseases, with additional therapy, such as corticosteroids. The prior art of the ‘956 WO provides methods of reducing inflammation by administering at least one calpain inhibitor to the respiratory epithelial cells in the airway of the subject, page 2. Page 3 provides for reducing inflammation. Page 3 provides wherein the subject can suffer from diseases and disorders such as asthma and cystic fibrosis. Page 5 provides additional therapeutic agents, such as corticosteroids. Page 12 provides administration into the airway of the subject by inhalation with the use of a nebulizer. Page 13 provides methods for reducing inflammation in a mammal. Page 47 provides the calpain inhibitor E64D in paragraph [00175]. Page 64 provides wherein nebulized formulation can contain ethanol as a solvent and provides the calpain inhibitor in inhalable form and wherein the composition can be particle sizes between 1 um to about 20, such as 1 to 10, such as 2 to 7, such as 3 to 5um. Paragraph [00240] on page 66 provides powder compositions containing the calpain inhibitor which has a mixture of the compound and a suitable powder base such as lactose or starch. . As evidenced by Pilcer et al., lactose is a porous particle, see abstract wherein the drug particles are mixed with larger carrier particles, which are commonly lactose. Figure 1, page 235 of Pilcer et al. provides an illustration of the porous surface of lactose carrier particles.
In regards to claim 12, , avoiding the conversion of E64D to E54C before entry into targeted pulmonary epithelial cells is considered a property of the composition. See the instant specification which provides: that in order to avoid the early conversion of E64D to E64C before entry into the targeted pulmonary epithelial cells, a solution for inhalation was developed. The administration of E64D by inhalation ensures that sufficient E64D is available. The avoidance of conversion is considered to be a characteristic inherent to the composition, even if this characteristic was not known in the prior art. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Additionally, see also In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) ("From the standpoint of patent law, a compound and all its properties are inseparable.").
The difference between instant claim 13 and the ‘956 WO is that the particle size distribution of about 0.5 to 3um of instant claim 13 overlaps with the particle size distribution in the ‘956 WO which can be 1 to 10um, see page 64 wherein the nebulized form particle sizes are between 1um to about 20, such as 1 to 10, such as 2 to 7, such as 3 to 5um. See MPEP 2144.05, in the case where the claim ranges overlap, a prima facie case of obviousness exists. Additionally, see wherein the concentration of the calpain inhibitor in the ‘956 WO is described in paragraph [0319] and [0329]:
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In regards to instant claim 17, the ‘956 WO does not provide the monitoring steps of claim 17, however, these monitoring steps are routine monitoring steps known to those of skill in the art to assess the treatment of disease or assess the toxicity of a drug after administration. Additionally, see paragraph [00243] of the ‘956 WO which provides pulmonary function tests, as well as diagnostic tests for the clinical progression of an inflammatory condition, are known to those individuals with skill in the art. With paragraph [00242] providing the efficacy of the dosing regime can be determined by assessing for improved lung function in the patient.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 15 September 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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