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 Claims
The amendments and arguments filed 2 June 2026 are acknowledged and have been fully considered. Claims 1-33 are currently pending. Claims 1 and 12 are amended; claims 34-60 are cancelled; no claims are withdrawn; no claims are new.
Claims 1-33 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. In particular, the rejection of claims under 35 U.S.C. 112(d) is withdrawn in view of Applicant’s amendment to claim 12 and persuasive arguments. Further, the rejection of claims under 35 U.S.C. 112(b) as being indefinite for not defining the percentage is withdrawn in view of Applicant’s persuasive arguments. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? The factors to be considered when determining whether any necessary experimentation is undue have been set forth by the courts in the Wands factors (see MPEP 2164.01(a)) and In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
These factors are:
(1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of working examples; and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
(1) Breadth of the claims:
Claim 1 is drawn to a method for decontaminating a chamber interior using a vapor phase hydrogen peroxide decontamination cycle, wherein the decontamination cycles a dose of gas for a dwell time. Claim 1 further recites the dose of gas is a least amount of the gas that maintains full saturation of the chamber interior over the dwell time; and the dwell time is a least amount of time in which the population of viable spores is exposed to the dose of gas to reduce the population of viable spores to an allowable remaining amount, wherein the least amount of gas and the least amount of time are experimentally derived by performing a plurality of experiments testing a plurality of doses of gas comprising hydrogen peroxide and a plurality of amounts of time.
As such, instant claim 1 is drawn to a very broad method as there are no limits set for the dose of gas, dwell time, allowable remaining amount of viable spores, and concentration of hydrogen peroxide in the gas; additionally the shape, size, and material of the chamber interior to be decontaminated as well as the species of viable spores are not defined. Further, as none of the dependent claims define more than two of these variables, the dependent claims are similarly broad in scope to independent claim 1.
(2) Nature of the invention; (3) State of the prior art; and (5) Level of predictability in the art:
It is evidenced by Bounoure et al. (Am J Health-Syst Pharm, 2006, Vol 63, 451-455; of record) that the dwell time for decontamination of an isolator is dependent on hydrogen peroxide concentration, isolator type, and sterilization criteria (Pg. 454 right column). It is further evidenced by Castro et al. (Rev Cienc Farm Basica Apl, 2011, Vol. 32, 335-339; of record) that the D value, and therefore required time for decontamination, is dependent on the material of the surface to be decontaminated and the species of microorganism present (Tables 3-4 on pg. 337). And as evidenced by the instant specification, the dwell time is dependent on a number of factors, such as the size, geometry, temperature, and humidity of the chamber being decontaminated (Par. [0045]); and the dose of gas is dependent on factors including the dwell time (Par. [0032]) and the chamber being decontaminated (Par. [0035]).
Further, the instant specification discloses that the preferred amount of gas is only the preferred amount among those tested (Par. [0034]) and the least time is only the least time among the amounts of time tested (Par. [0042]), indicating that one of ordinary skill in the art would not have any certainty whether they have determined the absolute least amount of gas and absolute least time or merely the least amongst the values tested.
Based on the large number of variables that are inter-dependent, the variance in the chambers being decontaminated, and the uncertainty in the results obtained from the experiments, the level of predictability in the art is low.
(4) Level of one of ordinary skill:
The level of skill to practice the art of the instantly claimed invention is high and requires a variety of skills usually found in institutions and companies that employ highly trained and skilled scientists to carry out these tasks.
(6) Amount of direction provided by the inventor; (7) Existence of working examples:
The amount of direction provided by the inventor is limited to a singular method of experiment to determine the lowest dose of gas and lowest dwell time as outlined in Fig. 4. Further, no working examples have been provided, only a set of hypothetical data depicted in Figs. 2-3.
(8) Quantity of experimentation needed to use the invention:
As disclosed in the instant specification, each experiment may be performed in triplicate to verify accuracy of results, and experiments may be performed using different locations or D values of biological indicators (Par. [0044]).
Based on the low level of predictability in the art, the large number of variables to be tested, the inter-dependency of dwell time and gas dose, and the need for duplicate experimentation to verify accuracy, a prohibitively large number of experiments would be required to determine the least amount of gas and least amount of time in order to practice the method of the instant claims.
As such, claims 1-33 are rejected as being non-enabled.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-33 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 1 recites a dose of gas, wherein the dose of gas is a least amount of the gas that maintains full saturation of the chamber interior over the dwell time; further reciting the dwell time is a least amount of time in which the population of viable spores is exposed to the dose of gas to reduce the population of viable spores to an allowable remaining amount. Claim 1 further recites the least amount of gas and the least amount of time are experimentally derived by a plurality of experiments.
According to the general knowledge in the technical field of the invention:
the necessary dwell time for effective decontamination depends on the hydrogen peroxide dose in the chamber; and
the necessary hydrogen peroxide dose for maintaining the chamber saturation depends on the dwell time.
Based on the double dependency of the hydrogen peroxide dose and dwell time, one of ordinary skill in the art would not be able to simultaneously determine the necessary hydrogen peroxide dose and the necessary dwell time. While one of ordinary skill in the art would understand that the recited experiments could provide a hydrogen peroxide dose and dwell time, this only provides possibilities as to what the limits are for the scope of the claimed hydrogen peroxide dose and dwell time.
Further, as the allowable remaining amount of viable spores is an additional undefined variable that influences the dwell time and hydrogen peroxide dose. While one of ordinary skill in the art would understand what is considered an allowable remaining amount of viable spores in the art, that would merely provide possibilities as to what the limit is for an amount of viable spores.
As such, one of ordinary skill in the art would not be able to determine what the metes and bounds of the claims are, only possibilities as to what the metes and bounds might be, which does not meet the standard of particularly pointing out and distinctly claiming the subject matter set forth in 35 U.S.C. 112(b).
As such, claim 1 is rejected as indefinite.
As none of the dependent claims define the variables of the method in such a way as to clearly and precisely define the metes and bounds of the claimed invention, claims 2-33 are also rejected as indefinite.
Response to Arguments
Applicant's arguments filed 2 June 2026 have been fully considered but they are not persuasive.
Applicant argues on pg. 8 of the remarks that the amendment to claim 1 provides a means by which the double dependency of the hydrogen peroxide dose and dwell time, further arguing that one of ordinary skill in the art would understand how to select a suitable allowable remaining amount of viable spores and apply the claimed method accordingly.
These arguments are not persuasive. As discussed in MPEP 2173, “The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent.” In the instant case, as the hydrogen peroxide dose, dwell time, and allowable remaining amount of viable spores are not defined, neither the scope of the claims nor the boundaries of what constitutes infringement are clear. While one of ordinary skill in the art would understand that the plurality of experiments recited in claim 1 could provide a dose and dwell time, these would be merely exemplary of possible boundaries of the claim. Further, while one of ordinary skill in the art would be able to select a suitable allowable remaining amount of viable spores, this would be an amount defined by the artisan and does not set a boundary to the scope of the claims.
As such, a person having ordinary skill in the art would, at best, be able to determine possibilities of the scope of the claims, which would not inform the public of what constitutes infringement. As such, the claims do not meet the standard of particularly pointing out and distinctly claiming set forth in 35 U.S.C. 112(b).
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 Paul Hoerner whose telephone number is (571)270-0259. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm eastern.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/PAUL HOERNER/Examiner, Art Unit 1611
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