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 .
Applicants’ amendment to the claims filed on 8/15/2024 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-14 are pending and examined on the merits.
Priority
Acknowledgement is made of this national stage entry of PCT/IB2022/000094 of Non-provisional Application No. 18/838,671, filed on 2/21/2022.
Drawings
The Drawings filed on 8/15/2024 are acknowledged and accepted by the Examiner.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/9/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claims 8-9 are objected to because of the following informalities: the abbreviation U and NBT needs to be spelled out. Based on claim language, it is unclear if Applicant intents on NBT to represent the abbreviation U. Additionally, the abbreviation U needs to be spelled out as ‘units.’ Clarification and/or appropriate correction is suggested.
Claim language Interpretation
In the interest of moving the prosecution forward and also in the interest of compact prosecution, Examiner has interpreted the “use claims” as claims drawn to “A method of treating…. wherein the method comprises the administering superoxide dismutase enzyme composition..”
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.
Claim 1-14 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.
Claims 1-14 are rejected as indefinite because they merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). Examiner suggests amending claim 1 for example to recite “A method for treatment and/or prevention of allergic asthma…”. Similar amendments are suggested for the remaining set of claims. Appropriate correction is required.
Regarding claim 3, the term "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. The metes and bounds of the claims are not clear. See MPEP § 2173.05(c)(I).
Claim 4 recites the limitation " …the plant-derived superoxide dismutase…" in line 2. There is insufficient antecedent basis for this limitation in the claim. There is no prior recitation of plant-derived superoxide dismutase in claim 4. Appropriate correction is suggested.
The phrase “a standardized titer” in claims 7-8 is a relative phrase which renders the claim indefinite. The phrase “a standardized titer” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The phrase " a standardized titer” is a relative phrase that renders the claim indefinite because it is unclear whether it is broad or limited. Furthermore, the support shown by the Applicant does not provide a “quantitative or measurable” definition for determining a standardized titer. The support shown lacks this essential requirement to conclude how one of skill in the art can come to a conclusion as to what is “a standardized titer” of SOD. See MPEP § 2173.05(b) III A. Appropriate correction is suggested.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to signal per se, mere information for the ‘use’ of a superoxide dismutase for the treatment and/or prevention of allergic asthmas in mammals. Note, it is not necessary for a claim to fall into only a single category, so long as it is clear that it falls into at least one category (see MPEP § 2106.03).
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
No, the claim is not drawn to a process, machine, manufacture or composition of matter, which is one of the four statutory categories. Claims are filed as “use claims”.
As such, the instant claim does not recites judicial exceptions that are not integrated into practical application, and no elements that amount to significantly more than the judicial exception as recited, the claims were found not to be drawn to eligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 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.
(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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1 is rejected under 35 U.S.C. 102a2 as being anticipated by CN111467351A (Date Published 2021-03-07, Examiner cited) {herein ‘351}.
Claim 1 is drawn to use of a superoxide dismutase for the treatment and/or prevention of allergic asthma in mammals, wherein the superoxide dismutase is administered orally alone, or optionally in combination with the administration of an aerosol preparation comprising at least one ϐ2-adrenergic receptor agonist.
With respect to claim 1, ‘351 teaches the use of an orally administered superoxide dismutase for the treatment of allergic asthma in humans (page 1, para 2; page 19, para 3; page 20, para 2).
For the reasons stated herein, the teachings of ‘351 anticipates claim 1.
Claims 1-6 are rejected under 35 U.S.C. 102a1 as being anticipated by Stephenie et al (Date Published 20 March 2020, Journal of Functional Foods, Examiner cited) {herein Stephenie}.
Claims 1-6 are drawn to use of a superoxide dismutase for the treatment and/or prevention of allergic asthma in mammals, wherein the superoxide dismutase is administered orally alone, or optionally in combination with the administration of an aerosol preparation comprising at least one ϐ2-adrenergic receptor agonist.
With respect to claims 1-6, Stephenie teaches the oral ingestion of plant derived SOD for the treatment of allergic asthma in mammals, such as humans (abstract, page 5, column 1, para 3; column 2, para 2; page 7, column 2, para 2). Commercially available wheat gliadin encapsulated melon SOD has been proven to enhance mammalian health (abstract). Since Stephenie teaches encapsuled SOD, it is the Examiner’s position that said SOD is a solid form. Additionally, since Stephanie teaches encapsulated SOD, it is the Examiner’s position that the amount of SOD would necessarily be standardized as to ensure consistency in titers. Furthermore, since the SOD is derived from plant, but administered to humans, it is the Examiner’s position that said SOD is heterologous. In addition, since prolamines are the primary storage proteins in wheat, it is the Examiner’s position that the SOD taught by Stephenie that is derived from wheat would necessarily contain prolamine. Supporting the Examiner’s position is the evidentiary reference of Mejias which demonstrates that wheat inherently contains prolamines (abstract).
For the reasons stated herein, the teachings of Stephenie anticipates claims 1-6.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Stephenie et al (Date Published 20 March 2020, Journal of Functional Foods, Examiner cited) {herein Stephenie} as evidenced by Mejias et al (Date Published: 2014, Nutrients, Examiner cited) {herein Mejias} and Allan et al (Date Published: 2026, Maltodextrin, Examiner cited) {herein Allan}.
Claims 1-14 are drawn to use of a superoxide dismutase for the treatment and/or prevention of allergic asthma in mammals, wherein the superoxide dismutase is administered orally alone, or optionally in combination with the administration of an aerosol preparation comprising at least one ϐ2-adrenergic receptor agonist.
With respect to claims 1-14, Stephenie teaches the oral ingestion of plant derived SOD for the treatment of allergic asthma in mammals, such as humans (abstract, page 5, column 1, para 3; column 2, para 2; page 7, column 2, para 2). Commercially available wheat gliadin encapsulated melon SOD has been proven to enhance mammalian health (abstract). Since Stephenie teaches encapsuled SOD, it is the Examiner’s position that said SOD is a solid form. Additionally, since Stephanie teaches encapsulated SOD, it is the Examiner’s position that the amount of SOD would necessarily be standardized as to ensure consistency in titers. Furthermore, since the SOD is derived from plant, but administered to humans, it is the Examiner’s position that said SOD is heterologous. Stephenie further teaches SOD is present in wheat with an activity of 0.5–10 U/mg protein (table 1). Since prolamines are the primary storage proteins in wheat, it is the Examiner’s position that the SOD taught by Stephenie that is derived from wheat would necessarily contain prolamine. Supporting the Examiner’s position is the evidentiary reference of Mejias which demonstrates that wheat inherently contains prolamines (abstract). It is the Examiner’s position that the wheat gliadin encapsulated melon SOD taught by Stephenie is prepared from a solid form preparation of a dried melon juice-derived extract since said encapsulated SOD is prepared utilizing melon, of which is understood by those of ordinary skill in the art to have very high water content. As such, since the structure of SOD from dried melon juice is taught by Stephenie, it is the Examiner’s position that said SOD would necessarily have an enzymatic activity of 1 to 5 U/mg since Stephenie teaches the recited SOD obtained from melon that is orally administered (abstract), which fits within the limitations of the instant application. Although Stephenie does not explicitly teach the commercially available wheat gliadin encapsulated melon SOD being comprised of qsp maltodextrin, it is well-known in the art that maltodextrin is used as a bulking agent or excipient to fill out capsules. As such, it would be obvious to one of ordinary skill in the art that the commercially available wheat gliadin encapsulated melon SOD taught by Stephenie would have a bulking agent such as qsp maltodextrin since maltodextrin is a highly utilized bulking agent and is commonly utilized as a pharmaceutical excipient in capsules. Supporting the Examiner’s position is the evidentiary reference of Allan which is cited to demonstrate that maltodextrin is routinely used as a coating or encapsulating agent in nutritional supplements to enhance dispersibility and prevent caking (page 1). Furthermore utilizing qsp maltodextrin allows for the appropriate measurements and standardization of the capsule. Therefore, the above invention would have been prima facie obvious.
Although the references of Stephanie does not explicitly teach the limitations of claims 7-10 (total weight of solid form), 11-12 (amount of SOD and number of days SOD is administered), MPEP 2144.05 states"[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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the amount of SOD and number of days SOD is administered depending on the particular application. It would be routine for one to arrive at the amount of SOD and number of days of administering the SOD for the application they intend on using the oral preparation of SOD. Therefore, the above invention would have been prima facie obvious.
It would be obvious to one of ordinary skill in the art to add albuterol (a ϐ2-adrenergic receptor agonist also known as salbutamol) as a treatment method in combination with the wheat gliadin encapsulated melon SOD, taught by Stephenie (abstract) to treat allergic asthma as it is well-known in the art that albuterol acts rapidly to open airways while the wheat gliadin encapsulated melon SOD works to address chronic oxidative stress (page 1, column 1, para 1). Thereby the combination of both the oral SOD and albuterol would both target the acute and underlying inflammatory components of respiratory conditions like allergic asthma. Additionally, by combining the two, one received the benefit of an acute rescue medication (albuterol) alongside a long-term strategy to dampen the oxidative stress and immune responses that cause asthma flare-ups, of which are predictable results. Supporting the Examiner’s rationale is MPEP 2143.A., which states “The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I] For example, the claimed invention in Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 163 USPQ 673 (1969) was a paving machine which combined several well-known elements onto a single chassis. Standard prior art paving machines typically combined equipment for spreading and shaping asphalt onto a single chassis. The patent claim included the well-known element of a radiant-heat burner attached to the side of the paver for the purpose of preventing cold joints during continuous strip paving. The prior art used radiant heat for softening the asphalt to make patches, but did not use radiant heat burners to achieve continuous strip paving. All of the component parts were known in the prior art. The only difference was the combination of the "old elements" into a single device by mounting them on a single chassis. The Court found that the operation of the heater was in no way dependent on the operation of the other equipment, and that a separate heater could also be used in conjunction with a standard paving machine to achieve the same results. The Court concluded that "[t]he convenience of putting the burner together with the other elements in one machine, though perhaps a matter of great convenience, did not produce a ‘new’ or ‘different function’" and that to those skilled in the art the use of the old elements in combination would have been obvious. Id. at 60, 163 USPQ at 674. Therefore, the above invention would have been prima facie obvious.
Conclusion
Status of Claims
Claims 1-14 are pending.
Claims 1-14 are rejected.
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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