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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The abstract of the disclosure is objected to because said abstract exceeds the maximum allowable length of 150 words and one paragraph. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 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.
The claim limitation “a compressed-gas generating means” as stated in claim 1 invokes interpretation under 35 U.S.C. 112(f). However, the structure of the functional limitation is not further defined by the application specification, drawings, or subsequent claims. For the purpose of this examination, “a compressed-gas generating means” is interpreted to mean any structure capable of supplying compressed gas to the chamber.
The claim limitation “a decontamination-agent supplying means” as stated in claim 1 invokes interpretation under 35 U.S.C. 112(f). However. The structure of the function limitation is not further defined by the application specification, drawings, or subsequent claims. For the purpose of this examination, “a decontamination-agent supplying means” is interpreted to mean any structure of supplying a decontamination agent into the box main body.
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 limitations 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 limitations are: a carrying apparatus configured to carry, a decontamination-agent applying device configured to apply, a clean-air applying device configured to apply clean air in claim 1, a first exhaust device configured to exhaust air and a second exhaust device configured to exhaust air in claim 7.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recites 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.
The claim limitation “a carrying apparatus configured to carry” as stated in claim 1 invokes interpretation under 35 U.S.C. 112(f). However, the structure of the functional limitation is not further defined by the application specification, drawings, or subsequent claims. For the purpose of this examination, “a carrying apparatus configured to carry” is interpreted to mean any structure capable of supporting an article through the pass box.
The claim limitation “a decontamination-agent applying device configured to apply” as stated in claim 1 invokes interpretation under 35 U.S.C. 112(f). The structure of this limitation is further specified in claim 1 as a device containing a compressed-gas generating means, a decontamination-agent supplying means, a mixed-gas regulator, and a heater. Claim interpretation of limitations “a compressed-gas generating means” and “a decontamination-agent supplying means” are provided above.
The claim limitation “a clean-air applying device configured to apply clean air” as stated in claim 1 invokes interpretation under 35 U.S.C. 112(f). However, the structure of the functional limitation is not further defined by the application specification, drawings, or subsequent claims. For the purpose of this examination, “a clean-air applying device” is interpreted to mean any structure capable of supplying clean air to the chamber.
The claim limitation “a first exhaust device configured to exhaust air” as stated in claim 7 invokes interpretation under 35 U.S.C. 112(f). However, the structure of the functional limitation is not further defined by the application specification, drawings, or subsequent claims. For the purpose of this examination, “a first exhaust device” is interpreted to mean any structure capable of removing air from the chambers.
The claim limitation “a second exhaust device configured to exhaust air” as stated in claim 7 invokes interpretation under 35 U.S.C. 112(f). However, the structure of the functional limitation is not further defined by the application specification, drawings, or subsequent claims. For the purpose of this examination, “a second exhaust device” is interpreted to mean any structure capable of removing air from the chambers.
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 1 and 3-11 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 limitations “a compressed-gas generating means”, “a decontamination-agent supplying means”, “a carrying apparatus configured to carry”, “a clean-air applying device configured to apply clean air” in claim 1 and “a first exhaust device configured to exhaust air” and “a second exhaust device configured to exhaust air” in claim 7 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. There is no description in the application specification, drawings, or subsequent claims to further define the structures of the compressed air generator or the decontamination agent supplier. 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 5 recites the limitation "said carrying apparatus" in line one of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 3-11 are rejected based on their dependence on claim 1.
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 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, 3, and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Funazuka (US 20160184814 A1) in view of Kawasaki (JP 2018191546 A).
Regarding claim 1, teaches a pass box configured for transfer of an article into a work room maintaining a sterile environment therein (aseptic manipulation chamber to transfer object between chambers, abstract), the pass box comprising: a pass box main-body (Figure 1 aseptic manipulation system “100”) having (1) a carrying-in zone dimensioned to receive said article from an outside environment (Figure 3 (1) inlet portion “36”), (2) a decontamination zone configured to have an outer surface of the article decontaminated therein by a decontamination agent (decontamination chamber provided to remove microbes adhering to an object, paragraph [0008]), (3) an aeration zone configured to have a remainder of decontamination agent remaining on said outer surface of the article that has been treated in the decontamination zone removed (second ventilation mechanism ventilates the inside of the second operation chamber, paragraph [0007], and residual decontaminants removed by ventilation, paragraph [0062]), and (4) a carrying-out zone from which said article that has passed the aeration zone is carried out into said work room (Figure 1 connecting portion “21” to transfer object between aseptic manipulation system “100” and incubator “20”), and a carrying apparatus configured to carry the article inside said pass box main-body (gloves provided on the wall of the chambers to perform treatments on an object laced in the chambers, paragraph [0018]), wherein: said carrying-in zone includes an airtightly sealable carrying-in port dimensioned to pass said article therethrough from outside environment (closing member set to locking mechanism so that chamber is hermetically isolated from the outside, paragraph [0047], and Figure 1 closing member “37” on pass box “110”), said decontamination zone includes a decontamination-agent applying device configured to apply a decontamination agent mist to said outer surface of the article that has been delivered from the carrying-in zone by the carrying apparatus (Figure 2 decontamination vapor supplied to decontamination chamber “31” from decontamination vapor supply chamber “42”), said aeration zone includes a clean-air applying device configured to apply clean air to a surface of said article delivered by the carrying apparatus from the decontamination zone (Figure 2 air supply blower “81” supplies air into aseptic manipulation chamber “10”), said carrying-out zone includes a carrying-out port dimensioned to pass the article carried out by said carrying apparatus to an inside of said work room (closing member set to locking mechanism so that chamber is hermetically isolated from the outside, paragraph [0047], and Figure 1 closing member “22” between aseptic manipulation system “100” and incubator “20”), said decontamination-agent applying device includes a compressed-gas generating means configured to generate compressed gas (Figure 2 air supply fan “51” and second gas supply line “84” provides air supply to chamber “31”, a decontamination-agent supplying means configured to supply the decontamination agent (Figure 2 hydrogen peroxide solution supplied from bottle “60”), a mixed gas-liquid regulator configured to mix said compressed gas and said decontamination agent to form a mixed gas-liquid and to regulate said mixed gas-liquid (Figure 2 air supply and decontamination agent supplied to vapor supply chamber “42” and circulation is controlled by circulation blower “70”), and a heater configured to heat said mixed gas-liquid and to obtain said decontamination agent mist (hydrogen peroxide solution is supplied to evaporator and heated to form hydrogen peroxide vapor, paragraph [0023]), wherein: the pass box is configured to control an amount of said compressed gas supplied from said compressed-gas generating means (Figure 2 air volume regulator valve “85”), an amount of said decontamination agent supplied from said decontamination-agent supply means (hydrogen peroxide provided from bottle to evaporator in predetermined amount by pump, paragraph [0023]), a heating temperature of said heater, and a temperature of said decontamination agent mist applied to said outer surface of said article, and wherein: the carrying apparatus is configured to perform a first carrying process, a second carrying process, and a third carrying process (Figures 3 and 4 object “M” is transferred between chambers “31”, “32”, and “10” in steps (1)-(7) such that: in said first carrying process, a first part of the article that has been carried into the carrying-in zone and has not been decontaminated yet is supported and carried from the carrying-in zone to the decontamination zone, and a second part of the article is decontaminated (supported by user’s hands inserted into gloves the object is placed in the first chamber and decontaminated, paragraphs [0046]-[0048]), in said second carrying process, in a state in which the second part of the article is switched to be supported, the article is carried from the decontamination zone to the aeration zone, a part of the article other than the second part is decontaminated (in step (4) user’s hands are inserted in second set of gloves and object is transferred to second chamber, paragraph [0050], and object is decontaminated a second time, paragraph [0054]), and a third part of the article is aerated in the aeration zone, and in said third carrying process, in a state in which the third part of the article is switched to be supported, the article is carried from the aeration zone to the carrying-out zone, and a part of the article other than the third part is aerated (in step (7) user’s hands are inserted in third set of gloves and object is transferred from second chamber to aseptic manipulation chamber, paragraph [0056], and aeration carried out in which residual decontaminants remaining on object are removed, paragraph [0062]), but does not teach wherein the pass box is configured to control a heating temperature of said heater, and a temperature of said decontamination agent mist applied to said outer surface of said article. However, Kawasaki teaches wherein the pass box is configured to control a heating temperature of said heater, and a temperature of said decontamination agent mist applied to said outer surface of said article (temperature control means for adjusting temperature of air, paragraph [0011], and temperature of water vapor discharged controlled , paragraph [0053]).
Funazuka and Kawasaki are considered analogous to the current invention because all are in the field of sterilizing pass boxes. Therefore it would have been obvious to one of ordinary skill in the art to combine the sterilizing pass box taught by Funazuka with the temperature control taught by Kawasaki because Kawasaki teaches adding temperature control advantageously maintains a uniform temperature in the chamber and does not cause condensation inside of the chamber (paragraph [0009]).
Regarding claim 3, the combination of Funazuka and Kawasaki teaches said carrying apparatus includes a first carrying device configured to perform the first carrying process (Figure 1 gloves “34” in chamber “31”, Funazuka), a second carrying device configured to perform the second carrying process (Figure 1 gloves “35” in chamber “32”, Funazuka), and a third carrying device configured to perform the third carrying process (Figure 1 gloves “13” in chamber “10, Funazuka).
Regarding claim 5, the combination of Funazuka and Kawasaki teaches wherein said carrying apparatus is configured to operate continuously or semi-continuously (Figures 3 and 4 show a semi-continuous process through steps (1)-(7), Funazuka). While the combination of Funazuka does not explicitly teach a total of operation times of said first carrying process, second carrying process, and third carrying process is within 10 minutes, an apparatus claim defines what a devis is and not what a device does. Because the combination of Funazuka and Kawasaki teaches all structural limitations of the current invention, said combination would have been capable of performing the carrying processes within 10 minutes and a prima facie case of obviousness is established (See MPEP 2114 I-II).
Regarding claim 6, the combination of Funazuka and Kawasaki teaches the pass box configured to control a temperature of said decontamination agent mist within a range from 30°C to 60°C (temperature inside the chamber is maintained at 37°C, paragraph [0059], and temperature of vapor is constantly regulated and not significantly change the temperature of the air circulating, paragraph [0057], Kawasaki).
Regarding claim 7, the combination of Funazuka and Kawasaki teaches the pass box further comprising: a first exhaust device configured to exhaust air in said carrying-in zone and said decontamination zone (Figure 2 discharge fan “53” for first chamber “31”, Funazuka) and a second exhaust device configured to exhaust air in said aeration zone and said carrying-out zone (Figure 2 discharge air blower “91” for chamber “10”, Funazuka), wherein: a first exhaust amount of said first exhaust device is set larger than a second exhaust amount of said second exhaust device, wherein the air in said carrying-in zone and said decontamination zone does not mix in said aeration zone and said carrying-out zone (air pressure in the aseptic manipulation chamber “10” is higher than that of the first operation chamber “31” so that air is prevented from flowing between the first operation chamber and the aseptic manipulation chamber, paragraph [0021], Funazuka), and an air pressure in said pass box main-body is set to a more negative pressure than an air pressure inside said work room, wherein the air in said pass box main-body does not mix inside said work room (air pressure in isolator/culture chamber must be maintained higher than the external environment to prevent contamination from the outside environment, paragraph [0021], Kawasaki).
Regarding claim 8, the combination of Funazuka and Kawasaki teaches wherein said heater includes (see Figure 4 of Kawasaki below): an introduction port configured to introduce said mixed gas-liquid (“65a”), a cylindrical outer cylinder tube (“61”), a heat generating body incorporated inside said outer cylinder tube in parallel to a longitudinal direction of said outer cylinder tube (“63”), and an ejection port configured to eject therethrough the decontamination agent mist (65b”), and wherein said pass box is configured: to heat said mixed gas-liquid while the mixed gas-liquid passes between said outer cylinder tube and said heat generating body, to convert the whole or a part of said mixed gas-liquid into a decontamination agent gas, and to transform said decontamination agent into the decontamination agent mist with the use of said compressed gas (paragraph [0053], Kawasaki).
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It would have been obvious to one of ordinary skill in the art to further modify the sterilizing pass box as taught by Funazuka and Kawasaki with the above heater configuration taught by Kawasaki because Kawasaki teaches this configuration directly sterilizes the vapor mixture before application so that it does not adversely affect the internal sterile environment (paragraph [0020]).
Regarding claim 9, the combination of Funazuka and Kawasaki teaches wherein said heater includes (see Figure 5 of Kawasaki below): an introduction port configured to introduce said mixed gas-liquid (“75a”), a cylindrical outer cylinder tube (“71”), a heat generating body incorporated inside said outer cylinder tube in parallel to a longitudinal direction of said outer cylinder tube (“72”), and an ejection port configured to eject therethrough the decontamination agent mist (“75b”), wherein said heat generating body includes a rod-shaped heater disposed in a longitudinal direction thereof (“73”) and an evaporation tube wound in a spiral that extends in the longitudinal direction along an outer periphery of said heater (“74”), and wherein said pass box is configured: to heat said mixed gas-liquid while the mixed gas-liquid passes between said outer cylinder tube and said heat generating body, to convert the while or a part of said mixed gas-liquid into a decontamination agent gas, and to transform said decontamination agent into the decontamination agent mist with the use of said compressed gas (paragraphs [0054]-[0055], Kawasaki).
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It would have been obvious to one of ordinary skill in the art to further modify the sterilizing pass box as taught by Funazuka and Kawasaki with the above heater configuration taught by Kawasaki because Kawasaki teaches this configuration has an effective thermal efficiency for providing decontamination agent (paragraph [0056]).
Regarding claim 10, the combination of Funazuka and Kawasaki teaches wherein said heater includes a mixed gas regulator configured to mix said decontamination agent gas and said compressed gas between said heat generating body and said ejection port (gas-liquid mixture is generated in the gas-liquid regulator is heated while passing between outer tube and heating element, paragraph [0026], Kawasaki), and wherein the pass box is configured to control an amount of said compressed gas introduced into said mixed gas regulator (gas-liquid regulator adjusts the gas-liquid mixture obtained by mixing the compressed air, paragraph [0011], Kawasaki).
Regarding claim 11, the combination of Funazuka and Kawasaki teaches wherein said heater includes a mixed gas regulator configured to mix said decontamination agent gas and said compressed gas between said heat generating body and said ejection port (gas-liquid mixture is generated in the gas-liquid regulator is heated while passing between outer tube and heating element, paragraph [0026], Kawasaki), and wherein the pass box is configured to control an amount of said compressed gas introduced into said mixed gas regulator (gas-liquid regulator adjusts the gas-liquid mixture obtained by mixing the compressed air, paragraph [0011], Kawasaki).
Allowable Subject Matter
Claims 4 would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for indicating allowable subject matter:
Regarding claim 4, the closest prior art is Funazuka in view of Kawasaki as identified above. However, a combination of Funazuka and Kawasaki fails to teach a first carrying device to perform the first and third carrying processes and a second carrying device to perform the second carrying device.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
The prior art as a whole does not teach the claimed invention within the claim environment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA ROSE SARANTAKOS whose telephone number is (703)756-5524. The examiner can normally be reached Mon-Fri 7:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.R.S./Examiner, Art Unit 1799
/DONALD R SPAMER/Primary Examiner, Art Unit 1799