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 .
Status of the Application
Claims 1, 5-7, 10, 14, 18, 22-28, 30, 34-35, 38-39, and 48 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 02/25/2026 are acknowledged. Claims under consideration in the instant office action are claims 1, 5-7, 10, 14, 18, 22-28, 30, 34-35, 38-39, and 48.
Applicants' arguments, filed 02/25/2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6, 10, 14, 18, 22-28, 30, 34-35, and 48 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vidyasagar (WO 2020/092639, as disclosed in IDS).
Vidyasagar teaches compositions comprising amino acids “useful for increasing the translocation of the cystic fibrosis transmembrane conductance (CFTR) protein from the cytoplasm to the plasma membrane, particularly in epithelial cells. Methods for increasing the concentration of CFTR in the plasma membrane, increasing chloride ion transport, and increasing water transport are also provided. These compositions and methods are useful in treating cystic fibrosis in subjects bearing one or more mutations in the CFTR protein.” (see abstract). Vidyasagar teaches such compositions can consist essentially of lysine and arginine (paragraphs 00147-00149). Vidyasagar also teaches such compositions can consist essentially of tyrosine, tryptophan, glutamine, cysteine, asparagine, and threonine (paragraphs 00147-00152). Vidyasagar teaches each amino acid present in a therapeutically effective amount and in L-amino acid form (paragraphs 0052, 0060). Vidyasagar teaches such compositions formulated for various routes of administration including pulmonary, inhalation, and intranasal (paragraph 0059). Vidyasagar teaches such therapeutic agents useful for treating lung diseases (paragraph 00129). Vidyasagar teaches that a reduction or lack of CFTR synthesis can result in impaired fluid homeostasis in airways (paragraph 0004), and as a consequence, increasing CFTR protein would ameliorate fluid homeostasis in the lungs. Vidyasagar teaches amino acids present in an amount of 0.4 to about 1.5 g/l (paragraph 00152). Vidyasagar teaches “the formulation further comprises a pharmaceutically acceptable carrier, buffer, electrolyte, adjuvant, or excipient.” (paragraph 0057). Vidyasagar teaches a device comprising such compositions for administration (paragraph 00172). Regarding the intended uses recited, including “for use in treating acute respiratory distress syndrome (ARDS), asthma, or allergic rhinitis in a subject in need thereof” and “for use in treating acute respiratory distress syndrome (ARDS), asthma, or allergic rhinitis in a subject in need thereof”, the compositions rendered obvious by Vidyasagar would not be precluded from such intended uses.
Therefore, the reference is deemed to anticipate the instant claims above.
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.
Claims 1, 5, 7, and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Vidyasagar (WO 2020/092639, as disclosed in IDS) in view of Perez-Marques et al. (Association of polymorphisms in genes of factors involved in regulation of splicing of cystic fibrosis transmembrane conductance regulator mRNA with acute respiratory distress syndrome in children with pneumonia, Critical Care, 2016, 20:281, pp. 1-10).
Vidyasagar teaches compositions comprising amino acids “useful for increasing the translocation of the cystic fibrosis transmembrane conductance (CFTR) protein from the cytoplasm to the plasma membrane, particularly in epithelial cells. Methods for increasing the concentration of CFTR in the plasma membrane, increasing chloride ion transport, and increasing water transport are also provided. These compositions and methods are useful in treating cystic fibrosis in subjects bearing one or more mutations in the CFTR protein.” (see abstract). Vidyasagar teaches such compositions can consist essentially of lysine and arginine (paragraphs 00147-00149). Vidyasagar also teaches such compositions can consist essentially of tyrosine, tryptophan, glutamine, cysteine, asparagine, and threonine (paragraphs 00147-00152). Vidyasagar teaches each amino acid present in a therapeutically effective amount and in L-amino acid form (paragraphs 0052, 0060). Vidyasagar teaches such compositions formulated for various routes of administration including pulmonary, inhalation, and intranasal (paragraph 0059). Vidyasagar teaches such therapeutic agents useful for treating lung diseases (paragraph 00129). Vidyasagar teaches that a reduction or lack of CFTR synthesis can result in impaired fluid homeostasis in airways (paragraph 0004), and as a consequence, increasing CFTR protein would ameliorate fluid homeostasis in the lungs. Vidyasagar teaches amino acids present in an amount of 0.4 to about 1.5 g/l (paragraph 00152). Vidyasagar teaches “the formulation further comprises a pharmaceutically acceptable carrier, buffer, electrolyte, adjuvant, or excipient.” (paragraph 0057). Vidyasagar teaches a device comprising such compositions for administration (paragraph 00172). Regarding the intended uses recited, including “for use in treating acute respiratory distress syndrome (ARDS), asthma, or allergic rhinitis in a subject in need thereof” and “for use in treating acute respiratory distress syndrome (ARDS), asthma, or allergic rhinitis in a subject in need thereof”, the compositions rendered obvious by Vidyasagar would not be precluded from such intended uses.
Vidyasagar does not teach arginine at a concentration of 4 mM to 10mM and 6 mM to 10 mM. Vidyasagar does not teach a method of treating acute respiratory distress syndrome (ARDS).
Perez-Marques is drawn towards the associations of polymorphisms in genes of factors involved in regulation of splicing of cystic fibrosis transmembrane conductance regulator mRNA with acute respiratory distress syndrome in children with pneumonia (see title). Perez-Marques teaches “that CFTR plays a role in ARDS in children with pneumonia and predict that genetic variants that affect the expression of functional CFTR, including variants in proteins involved in the regulation of CFTR mRNA splicing, will be associated with ARDS.” (pg. 2, left column, third paragraph).
It would have been obvious to one of ordinary skill in the art to treat ARDS by administering a therapeutically effective amount of arginine, lysine, and tyrosine, as suggested by Perez-Marques, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since lysine, arginine, and tyrosine can increase the translocation of the CFTR protein (see abstract), which would ameliorate the dysfunctional expression of CFTR in patients with ARDS as taught by Perez-Marques (pg. 2, left column, third paragraph), with a reasonable expectation of success absent evidence of criticality of the particular steps.
It would have been obvious to one of ordinary skill in the art to formulate arginine at a concentration of 4 mM to 10mM and 6 mM to 10 mM, as suggested by Vidyasagar, and produce the instant invention.
With regards to the limitation claimed in instant claims 5 and 7, which claims a concentration of 4 mM to 10mM and 6 mM to 10 mM, Vidyasagar teaches amino acids present in an amount of 0.4 to about 1.5 g/l and in therapeutically effective amounts (paragraphs 0060, 00152). Vidyasagar does not specifically teach the exact amounts claimed in instant claims 5 and 7. However, it would be within the skill of an ordinary artisan to be able to modify the concentration in order to obtain the desired therapeutic efficacy. It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding the limitation “sufficient to reduce fluid accumulation in the lungs of
the subject” when the composition recitations are met, the desired properties are met, as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope (i.e. claim 1). Additionally, when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the therapeutic profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met. 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. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). (MPEP 2111.04 I).
Response to Arguments
Applicant argues that “Because Vidyasagar neither discloses the claimed arginine-and-lysine combination in a single embodiment nor describes a composition that is the same as Applicants' "consisting essentially of' formulation, the Examiner cannot rely on inherency to read into Vidyasagar the additional requirement that the formulation is "sufficient to reduce fluid accumulation" in ARDS/asthma lungs or allergic rhinitis nasal passages. See In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (a property may be inherent only where the prior art composition is identical).” The Examiner respectfully disagrees since although the claimed invention recites “consisting essentially of” language regarding the component of free amino acids, such language does not preclude other components “that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976)” see MPEP 2111.03(III). Additionally, the claimed pharmaceutical formulation recites the transitional phrase of “comprises” which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.
Applicant also argues that “the Examiner's central technical premise that a person of ordinary skill in the art ("POSA") would understand arginine + lysine + tyrosine to increase CFTR translocation, and thus treat ARDS is not supported by a specific teaching in Vidyasagar.” The Examiner respectfully disagrees since although Vidyasagar does not explicitly teach a method of treating ARDS, Vidyasagar does teach that lysine, arginine, and tyrosine can increase the translocation of the CFTR protein (see abstract), and one of ordinary skill in the art would have been motivated to treat ARDS given that CFTR is a therapeutic target for patients with ARDS as taught by Perez-Marques.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant also argues that “Neither Vidyasagar nor Perez-Marques provides data or guidance that increasing CFTR trafficking using amino acid formulations would treat ARDS, let alone provide a basis for a reasonable expectation of success for treating ARDS by administering the particular amino-acid selections and groupings alleged by the Office Action” The Examiner respectfully disagrees since although the prior art does not provide data or explicit guidance for administering amino acid combinations for the treatment of ARDS, Vidyasagar does teach that lysine, arginine, and tyrosine can increase the translocation of the CFTR protein (see abstract), and one of ordinary skill in the art would have been motivated to treat ARDS given that CFTR is a therapeutic target for patients with ARDS as taught by Perez-Marques.
Applicant also argues that “Neither teaches that administering the asserted amino-acid formulations would reduce fluid accumulation in lungs of ARDS subjects, nor do they provide a basis to conclude that such a clinical effect would necessarily result from the proposed combination of amino acids in an ARDS patient population.” The Examiner respectfully disagrees since the prior art suggests the active steps of the claimed method of treatment, and when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the therapeutic profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met.
Conclusion
Claims 1, 5-7, 10, 14, 18, 22-28, 30, 34-35, 38-39, and 48 are rejected.
THIS ACTION IS MADE FINAL. 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 ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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