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 statements (IDS) submitted on 11/17/2023 and 03/12/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The listing of references in the specification (page 25) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The Lenz et al.; Rips et al.; Comisso et al.; Hadchouel et al.; and Anonymous-2019 references cited in the IDS filed 03/12/2026 has been crossed out because these references were also cited in the IDS filed 11/17/2023.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “…increase a rate of catch-up in growth…” This limitation, as claimed, is not mentioned in the specification. The specification has support for “…increase the catch-up in growth…” (page 9, line 25), not specifically the “rate of catch-up”.
The disclosure is objected to because it contains an embedded hyperlink (see page 17, last para.) and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the term CORTECSTM UPLC, etc. which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
While the Examiner has made every attempt to check the Specification for trade mark compliance, Applicant is required to carefully check the entire Specification for any and all issues regarding trade mark use compliance.
The disclosure is objected to because of the following informalities: The Description of the Figures (starting in page 13 of the spec.) does not clearly and specifically point out what the dashed and solid lines of Figures 1A-D represent – see objection to drawings herein.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show what the dashed and solid trend lines indicate (Figures 1A-D) as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Status of the Claims
Claims 1-10 and 13-14 are pending in this application. Claims 11-12 have been cancelled by applicant.
Claim Objections
Claims 2 and 6-7 are objected to because of the following informalities:
In claim 2, text is missing the “i)” before “measuring the level…” in line 4. Also, missing semicolon “;” after “the subject” at the end of line 5. Also, an “or” is missing at the end of point “ii)” (see 112(b)).
In claim 6, “according to claims 1” should be “according to claim 1”.
Claim 6 also reads: “the method of claim 1 wherein the methionine and/or the derivative thereof is formulated for oral administration”. The language of the claim is objected to because claim 1 speaks to a method of treating comprising administration of methionine and/ or a derivative thereof, not a method of formulating methionine and/or the derivative thereof. As such, the claim should read: “The method according to claim 1, wherein the methionine and/or the derivative thereof is administered orally”.
Similarly, for claim 7, claim should read: “…wherein the methionine is administered as a tablet, a gel capsule…”
Appropriate correction is required.
Claim Interpretation
The specification defines "derivatives" as any derivative of methionine resulting from reaction at an amino group, carboxy group, side-chain functional group or from the replacement of any hydrogen by a heteroatom (page 5, lines 9-11).
The specification defines "methioninemia" as the level of amino acid methionine (page 6, line 6).
Claims 3 and 14 refer to the method of treatment wherein the subject is an adult, child, or baby (infant and neonate). The specification does not define these terms. Elsevier discloses age groups, as defined in drug monographs, are as follows (Obtained from Elsevier.support [retrieved on 02/09/2026]<URL:https://www.elsevier.support/ckpharma/answer/how-are-age-groups-defined-in-drug-monographs>):
Adults - 18 years and older.
Elderly - 65 years and older.
Adolescents - 13-18 years.
Children - 1-12 years.
Infants - 1 month - 1 year.
Neonates - Full-term newborn 0-4 weeks
Thus, for the purposes of applying art, an adult will be interpreted as a subject 18-65 years of age; a child will be a subject between 1-12 years of age; and a baby will be interpreted as encompassing neonates and infant (newborn-1 year of age). Groups between the ages of 13-18 and 65 and up are not being considered in the scope of this invention.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 13 recites a “means for measuring the level of methinoninemia in a biological sample from a subject…” followed by functional language that does not recite sufficient structure, material, or acts for performing the claimed function.
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 2, 4 and 13-14 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 2 recites the limitations “ii); iii); or iv)”. It is unclear from the claim language if points “ii)” and “iii)” are subsequent steps, or if they are meant as alternatives for the treatment. Since the points “ii)” and “iii)” seem to refer to different subject populations, the claim will be interpreted as reading: “ii); or iii); or iv)” (see claim objection).
Furthermore, in light of this interpretation, the limitation "the predetermined reference value" at the end of points “iii)” and “iv)” lacks antecedent basis since point “ii)”, which references “a predetermined value” is presented as a separate alternative of treatment in the claim and thus, the limitation “a predetermined value” of point “ii)” does not provide antecedent basis for points “iii)” or “iv)”.
Claims 4 and 13-14 are rejected being dependent upon claim 2.
Claim 13 limitation “means for measuring the level of methinoninemia in a biological sample from a subject…” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
In the present case, the disclosure is devoid of any structure that performs the function in the claim. The “means for testing” is referenced in the specification, however, no detail is provided as to what the “means for testing” comprises.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter.
Claim 10 is drawn to a composition comprising methionine (a natural product) without significantly more. The recitation of intended use: “wherein the methionine …related to MARS gene mutations”; is not further limiting, and therefore, does not integrate the exception into a practical application. MPEP 2106.04(d)(2) states: “to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering (…) to a patient" or a step of "administering a course of (…) to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration.”
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6, 8, 10, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lenz et al. (Pediatric Pulmonology. 2020; 55:3057–3066 – Cited in IDS) (“Lenz”).
Regarding claim 1, Lenz discloses oral methionine supplementation led to apparent treatment benefit in pulmonary alveolar proteinosis (PAP) with MARS1 mutation (abstract) – thus anticipating the instant method of treatment.
Regarding claim 2, Lenz discloses the treatment regimen of two children with PAP with MARS1 mutation (one < 3.5 and one <8.2 years old). Lenz discloses in cases of supplementation (administration of additional methionine), blood samples were taken before intake of methionine and found that methionine levels were in the normal range (“normal range” was disclosed to be 15‐45 µM (see Figure 5); while “target range”, or “predetermined reference value” in the instant claims, was 80 – 150 µM). Lenz discloses before supplementation (50 mg/kg/day), the methionine concentration was in the “normal range” (low – less than predetermined value). Following supplementation, Lenz discloses that plasma methionine rose to 177 µM for one of the subjects (see Section 3.2 and Figure 5) and discloses increasing dosage amount when methionine levels were below predetermined value. Thus, Lenz’s disclosure anticipates the instant method of: i) measuring level of methionemia from a biological sample; and ii) administering an increased supplementation dosage when the level of methioninemia (methionine) is less than the predetermined value.
Regarding claims 3 and 14, Lenz teaches methionine supplementation was started on a 2.5-year-old boy and another one under 8.2 years of age (reading on child – see claim interpretation) (Figure 2E; Figure 5; and abstract – results).
Regarding claim 4, Lenz discloses their target range for methionine in blood, or “predetermined reference value”, was 80 – 150 µM (see section 3.2) – thus anticipating the instant range of 45-500 µM.
Regarding claim 6, Lenz discloses oral administration of methionine (abstract – results).
Regarding claim 8, Lenz discloses administration of 50, 100, 150, and 125 mg/kg of methionine (Figure 2E, page 3061; and page 3063, col. 2, section 3.2) – thus anticipating the instantly claimed range.
Regarding claim 10, Lenz teaches methionine for oral administration (anticipating the instant pharmaceutical composition) for the treatment of PAP with MARS1 mutation in a child. Applicant is advised that a recitation of the intended use of the claimed invention, such the recitations following “wherein” in line 2 of claim 10, 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. Note: MPEP 2111.02. Applicant is further advised that 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.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Douglas Laboratories (Obtained from Amazon.com [retrieved on 02/12/2026]<URL:https://www.amazon.com/Douglas-Laboratories-L-Methionine-Neurological-Antioxidant/dp/B0014WKE4U/ref=sr_1_1_sspa?dib=eyJ2IjoiMSJ9.3XGvymVcakpL3ycSPckUxt3EG42B8dAj9MKNsPDP1jN49aFpWXE8KO4KqKtmKH_Cyo219QH9gOZPlvau13YOn7_JcfRqSuowQVxdakLfesYk2hlAmxo7VwtnXkwTJxUB37_aad2DtQC9WQCYfFcK2z0nZ6inid3Avl_XkPOoM-NT3oTdyJxQzojpZbmUdheXiaKUI6uPdtqkOT2meRbDxfpQgfjYfpJlkEVtUCQ1z1lYp11gsPSm7TT0be4pDeeTumPa1cQHh0QNUWoFfRqurpAVa7rPm5zioQm5J7l1L88.-tdUFEZx78RBbTdJuhOGZJNH5xUTqOiFpi__c5DdqfA&dib_tag=se&keywords=dl+methionine&qid=1770937320&sr=8-1-spons&sp_csd=d2lkZ2V0TmFtZT1zcF9hdGY&psc=1> – Product First Available October 2nd, 2001 (see page 3, top)) (“Douglas L”).
Regarding claim 10, Douglas L teaches their pharmaceutical composition in the form of a capsule comprising L-methionine.
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Applicant is reminded that a recitation of the intended use of the claimed invention, such the recitations following “wherein” in line 2 of claim 10, 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. Applicant is further reminded that products of identical chemical composition cannot have mutually exclusive properties." 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.
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.
Claims 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lenz et al. (Pediatric Pulmonology. 2020; 55:3057–3066 – Cited in IDS) (“Lenz”); as applied to claims 1-4, 6, 8, 10, and 14.
The teachings of Lenz are disclosed in the 102-section above and incorporated herein.
Regarding claim 5, directed to a specific therapeutically effective amount of methionine, capable of resolving the issues mentioned in the claim; Applicant is advised that where 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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05-II. Applicant is further advised that 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.
Lenz teaches that PAP related to MARS1 not only provoke interstitial lung and cholestatic liver disease, but cause a multisystemic phenotype including growth retardation, neurodevelopmental delay, anemia, and muscular hypotonia (reading on rate of catch-up) (page 3065, col. 1, last para.). Lenz teaches methionine supplementation contributed to a significant improvement in growth (rate of catch-up growth), pulmonary (reading on respiratory symptoms), and neurodevelopmental state (page 3064, lines connecting col. 1-2; and page 3060, col. 2). Lenz teaches for immediate relief of respiratory compromise therapeutic whole lung lavage (WLL) were performed, followed by oral methionine administration (page 3060, col. 2) and that no more ventilation or supplemental oxygen was needed and chest imaging improved (reading on reduced inflammation and free bronchoalveolar lavage fluid).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claim invention to administer an effective amount of methionine that would result in control of respiratory symptoms, inflammation, cholestasis, increase rate of catch-up, and free bronchoalveolar lavage fluid. One of ordinary skill would have been motivated to do so in order to ameliorate these potentially life-threatening symptoms in the afflicted subject. One of ordinary skill would have had a reasonable expectation of success in view of the teachings of Lenz.
Regarding claim 9, and administration of the therapeutically effective amount of methionine every 6 hours; Lenz discloses close monitoring of methionine levels in the plasma of two subjects suffering from PAP related to MARS1 (see Section 3.2, page 3063). Lenz teaches blood sampling 4 hours postprandially, and in case of methionine supplementation, blood sampling was done prior to the intake of methionine. Lenz discloses a target range of blood methionine to be between 80-150 µM, and discloses increasing dosage when methionine levels in blood remained in the “normal range” (lower than predetermined value). Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer methionine every six hours, or more or less frequently, in view of Lenz. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Lenz teaches close monitoring of plasma levels of methionine and administration of supplemental doses of methionine when levels were found to be under 80-150 µM. Applicant is advised that a person with ordinary skill has good reason to pursue known options within his or her technical grasp. Note: MPEP 2143(E) KSR, 550 U.S. at 421, 82 USPQ2d at 1397. Applicant is also reminded that where 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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lenz et al. (Pediatric Pulmonology. 2020; 55:3057–3066 – Cited in IDS) (“Lenz”); as applied to claims 1-6, 8-10, and 14; in view of Douglas Laboratories (Obtained from Amazon.com [retrieved on 02/12/2026]<URL:https://www.amazon.com/Douglas-Laboratories-L-Methionine-Neurological-Antioxidant/dp/B0014WKE4U/ref=sr_1_1_sspa?dib=eyJ2IjoiMSJ9.3XGvymVcakpL3ycSPckUxt3EG42B8dAj9MKNsPDP1jN49aFpWXE8KO4KqKtmKH_Cyo219QH9gOZPlvau13YOn7_JcfRqSuowQVxdakLfesYk2hlAmxo7VwtnXkwTJxUB37_aad2DtQC9WQCYfFcK2z0nZ6inid3Avl_XkPOoM-NT3oTdyJxQzojpZbmUdheXiaKUI6uPdtqkOT2meRbDxfpQgfjYfpJlkEVtUCQ1z1lYp11gsPSm7TT0be4pDeeTumPa1cQHh0QNUWoFfRqurpAVa7rPm5zioQm5J7l1L88.-tdUFEZx78RBbTdJuhOGZJNH5xUTqOiFpi__c5DdqfA&dib_tag=se&keywords=dl+methionine&qid=1770937320&sr=8-1-spons&sp_csd=d2lkZ2V0TmFtZT1zcF9hdGY&psc=1> – Product First Available October 2nd, 2001 (see page 3, top)) (“Douglas L”).
The teachings of Lenz are disclosed in the 102- and 103-sections above and incorporated herein.
While Lenz does not teach a methionine formulation in the form of a gel capsule; the teachings of Douglas L are relied upon for these disclosures.
Douglas L teaches a gelatin capsule comprising L-methionine.
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Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer L-methionine in the form of a gel capsule for the treatment of PAP related to MARS1. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Lenz teaches oral administration of methionine for the treatment of PAP related to MARS1; further because Douglas L discloses their capsule formulation of L-methionine, which is readily available for purchase to the public.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lenz et al. (Pediatric Pulmonology. 2020; 55:3057–3066 – Cited in IDS) (“Lenz”); as applied to claims 1-6, 8-10, and 14; in view of Sun et al. (Anticancer Research, 2005, 24: 59-62) (“Sun”).
The teachings of Lenz are disclosed above and incorporated herein.
While Lenz doesn’t specifically teach a kit comprising a means of measuring methioninemia in a biological sample and written instruction to adjust methionine with their supplementation dosage; the teachings of Sun are relied upon for these disclosures.
Sun teaches a rapid and sensitive method for the separation and quantification of L-methionine in plasma (abstract).
Further regarding claim 13, the preamble of this claim recites a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter. Furthermore, MPEP 2112.01 (III) reads: “where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product."). See also In re Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983) ( "Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability….[T]he critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate." ); In re Miller, 418 F.2d 1392, 1396 (CCPA 1969) (finding a new and nonobvious relationship between a measuring cup and writing showing how to "half" a recipe); In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) (matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art); In re Xiao, 462 Fed. App'x 947, 950-51 (Fed. Cir. 2011) (non-precedential) (affirming an obviousness rejection of claims directed to a tumbler lock that used letters instead of numbers and had a wild-card label instead of one of the letters); In re Bryan, 323 Fed. App'x 898, 901 (Fed. Cir. 2009) (non-precedential) (printed matter on game cards bears no new and nonobvious functional relationship to game board).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to prepare a kit comprising a “means for testing methioninemia” in a biological sample of a subject suffering from PAP with MARS gene mutations. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Lenz teaches their method of increasing the methionine levels in the plasma of a child with PAP related to MARS1 prior to administering a supplementation dose of methionine to arrive at a “predetermined concentration” of methionine in the blood. One of ordinary skill would have had a reasonable expectation of success because methods and means of measuring methionine levels in blood are known in the art, as disclosed by Sun. Regarding the inclusion of written instructions into the kit, Applicant is reminded that this recitation is not further limiting (see MPEP 2112.01 (III)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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