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 .
Response to Amendment
This is an office action in response to Applicant's arguments and remarks filed on 6/23/2026. Claims 1-2, 4-7, 9-11, and 13-20 are pending in the application. Claims 10-11 and 18-20 have been withdrawn and claims 1-2, 4-7, 9, 13-17 are being examined herein.
Status of Objections and Rejections
The rejections of claims 3 and 8 are obviated by Applicant's cancellation.
All rejections from the previous office action are withdrawn in view of Applicant's amendment.
New grounds of objection have been raised.
New grounds of rejection under 35 U.S.C. 112 are necessitated by the amendments.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Claim Objections
Claim 15 is objected to because of the following informalities:
Claim 15, please amend the term “contaminant” to “decontaminant” in line 2.
Appropriate correction is required.
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 9 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. Specifically, claim 1 recites “wherein the first filter and the second filter are fluidically arranged in series with each other” and claim 9 recites “wherein the first filter and the second filter are arranged fluidically parallel to each other.” It is unclear how the first filter and second filter can simultaneously fluidically arranged in series and parallel to each other, as these are mutually exclusive arrangements. Because claim 9 fails to provide structure that is compatible with and further limits the claimed structure recited in claim 1, prior art will not be applied.
Claim Interpretation
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 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “switching device, wherein the switching device is configured to direct air from the working space…” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Specifically, the switching device will be understood to be at least one valve as described in the specification (page 9, lines 19-25) and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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(s) 1-2, 4-7, 9, 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mikio (JP 4529593 B2) (references herein made with respect to English Machine Translation).
Regarding claim 1, Mikio teaches a pharmaceutical unit (Fig. 1, aseptic isolator system 1, page 2, para 7) comprising:
a working space that is sealed off from its environment (Fig. 1, isolator 2) ,
a filter system comprising a first flow path and a first filter (Fig. 1, first filter 36 is disposed within a first flow path 31),
wherein the first filter is disposed in the first flow path and is configured to filter air that is directed from the working space via the first flow path (Fig. 1, filter 36 is functionally capable of filtering air directed from the working space via three-way solenoid valve 41),
wherein the filter system comprises a second flow path and a switching device (Fig. 1, three-way solenoid valves 34 and 38 constitute a switching device coupled to second flow path 23),
wherein the switching device is configured to direct air from the working space via the first flow path and thus via the first filter during an operating phase of the pharmaceutical unit (valves 34 and 38 functionally capable of directing air from working space via first flow path 41), and to direct the air from the working space exclusively via the second flow path during a decontamination phase of the pharmaceutical unit, so that the first filter is not exposed to a decontaminant during the decontamination phase in which the decontaminant is supplied to the working space (Fig. 1, valves 34 and 38 are functionally capable of directing air containing a sterilant to and from working space such as to bypass filter 36, page 6, para 9),
wherein the filter system comprises a second filter arranged in the second flow path and configured to filter air from the working space that is directed via the second flow path (Fig. 1, second filter 32 arranged in second flow path 23),
wherein the first filter and the second filter are fluidically arranged in series with each other, wherein the second filter is arranged downstream of the first filter (Fig. 1, second filter 32 downstream of first filter 36, both are arranged in series),
wherein the second flow path directs the air from the working space in parallel around the first filter and through the second filter (Fig. 1, second flow path 23 functionally capable of directing air from working space through the second filter and around the first filter).
Regarding claim 2, Mikio teaches the pharmaceutical unit according to claim 1, wherein the decontamination phase is a bio-decontamination phase in which hydrogen peroxide is introduced into the working space (page 5, paras 4-6; page 6, para 1).
Regarding claim 4, Mikio teaches the pharmaceutical unit according to claim 1, wherein the switching device comprises at least one valve the at least one valve being configured to fluidically couple and/or decouple the first and second flow path to the working space (Fig. 1, valves 34 and 38 couple first and second flow paths [31 and 23] to working space 2).
Regarding claim 5, Mikio teaches the pharmaceutical unit according to claim 3, wherein the first filter is arranged within the pharmaceutical unit (Fig. 1, first filter 36 arranged within pharmaceutical unit 1).
Regarding claim 6, Mikio teaches the pharmaceutical unit according to claim 3, wherein the first filter is arranged outside the working space (Fig. 1, first filter 36 is outside working space 2).
Regarding claim 7, Mikio teaches the pharmaceutical unit according claim 3, wherein the switching device is configured to direct air from the working space, via the first filter and the second filter during the operating phase of the pharmaceutical unit (Fig. 1, switching device comprises valves 34 and 38 which are functionally capable of directing air from working space 2 through both first filter 36 and second filter 32).
Regarding claim 9, claim 9 is rejected due to its dependency on claim 1 in addition to the 112 issues described above.
Regarding claim 13, Mikio teaches the pharmaceutical unit according to claim 1, wherein the pharmaceutical unit is a clean room (page 1, para 1).
Regarding claim 14, Mikio teaches the pharmaceutical unit according to claim 1, wherein the decontaminant is air from the working space (Fig. 1, decontaminant is capable of being air from working space 2).
Regarding claim 15, Mikio teaches the pharmaceutical unit according to claim 1, wherein the decontaminant is a gaseous contaminant (decontaminant can be gaseous hydrogen peroxide, page 4, para 1).
Regarding claim 16, Mikio teaches the pharmaceutical unit according to claim 4, wherein the at least one valve includes two valves (Fig. 1, valves 34 and 38).
Regarding claim 17, Mikio teaches the pharmaceutical unit according to claim 1, wherein the second filter is a police filter (Fig. 1, filter 32 understood to be police filter).
Response to Arguments
In the arguments presented on pages 6-7 of the amendment, filed 6/23/2026, the Applicant argues that one having ordinary skill in the art would not be motivated to modify the system of Bissell with the bypass lines as taught by Frieters as doing so would exposure the sterile interior chamber of Bissell to contamination and render it unsatisfactory for its intended purpose with respect to the rejection(s) of claim(s) 1 (the scope of which was previously presented in claim 8, now cancelled) under 35 U.S.C. 103.
This argument has been fully considered and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the art Mikio (JP 4529593 B2). See rejection above.
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.
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/N.S.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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