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 .
FINAL ACTION
Response to Amendment
The amendment filed on 6/26/2026 has been received and claims 1-20 are pending.
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.
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: “sterilant applying module” in claim 1; “output device” in claim 16; “module” in claim 18.
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. In particular, corresponding structures for “sterilant applying module” as well as for “module” are a combination of a vaporizer and a condenser (see p. 20 [0057]). The corresponding structure for the “output device” is a printer (see claim 17).
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 § 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 19-20 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 limitation "the medical device" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the medical device" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 3-4 and 20 are rejected due to their dependence on a rejected claim.
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.
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.
Claim(s) 1-2, 5-6 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Goetz (WO2015094879) in view of Ko (20110176959).
As to Claim 1, Goetz (‘879) discloses an apparatus (100) (see Figure 1), comprising:
(a) a sterilization chamber (102), wherein the sterilization chamber (102) is configured to receive a medical device (105) (see entire document, particularly Figure 1);
(b) a vacuum source (106, 110, 112, 116, 125) in fluid communication (via 118, 114, 123) with the sterilization chamber (102) (see Figure 1);
(c) a sterilant applying module (130 - 131, 132, 134, 135, 136, 137, 138, 139, 140; 142, 144, 139, 140) in fluid communication (via 139, 140) with the sterilization chamber (102) (see entire document, particularly Figure 1, p. 10 lines 10-16);
(d) a venting valve (145; 152) in fluid communication (via 143, 147) with the sterilization chamber (102) and an atmosphere outside (via 143, 147 and a filter) of the sterilization chamber (102) (see entire document, particularly Figure 1, p. 10 lines 22-26), the venting valve (145; 152) being operable to selectively open and close a vent path (via 143, 147; ) between the sterilization chamber (102) and the atmosphere (see entire document, particularly Figure 1, p. 10 lines 22-26, p. 10 lines 20-28); and
(e) a control module (104, 155) in communication with the vacuum source (106, 110), the sterilant applying module (130, 131, 132, 135, 137, 139, 140; 142, 144, 139, 140), and the venting valve (145; 152) (see entire document, particularly Figure 1, p. 8 – lines 1-4), wherein the control module (104, 155) contains a control logic (155) configured to execute a sterilizing algorithm (see Figure 2) such that the control logic (155) is configured to:
(i) activate the vacuum source (106) to apply a vacuum to the sterilization chamber (102) (i.e. step(s) 16 and/or 26 - see Figure 2),
(ii) activate the sterilant applying module (130, 131, 132, 135, 137, 139, 140; 142, 144, 139, 140) to apply sterilant to the sterilization chamber (102) (i.e. step 22 - see Figure 2), and
(iii) selectively activating the valve (145; 152) to provide a step-wise increase in pressure within the sterilization chamber (102) (i.e. steps 28, 30 - see Figure 2).
Goetz (‘879) does not appear to specifically teach that selectively activating the venting valve to provide a step-wise incremental increase in pressure within the sterilization chamber is to drive the sterilant into the medical device by providing at least one of agitation to the medical device or convective mass transfer of the sterilant within the medical device or monitoring a venting duration and a sealing duration for the venting valve during the step-wise incremental increase in pressure to determine completion of a sterilization cycle. However, it was known in the art before the effective filing date of the claimed invention to provide a step-wise incremental increase in pressure within a sterilization chamber driving a sterilant into a medical device and monitor a venting duration and a sealing duration. Ko (‘959) discloses an apparatus and method of sterilizing an article (11) comprising a medical device (see Figures 1-7, p. 2 [0033] – lines 4-5), the apparatus comprising:
(a) a sterilization chamber (10), wherein the sterilization chamber (10) is configured to receive a medical device (11);
(b) a vacuum source (14) in fluid communication with the sterilization chamber (10);
(c) a sterilant applying module (10, 41, 42, 20, 30; 46, 47, 50) in fluid communication with the sterilization chamber (10); and
(d) a venting valve (45) in fluid communication with the sterilization chamber (10);
wherein the apparatus is controlled/configured to:
(i) activating the vacuum source (14) to apply a vacuum to the sterilization chamber (10) (i.e. prior to injection stage - see Figure 5, p. 3 [0042] – lines 4-5);
(ii) activating the sterilant applying module to apply a sterilant (42 via 43) into the sterilization chamber (10) (i.e. injection stage - see Figures 4-6);
(iii) maintaining the first pressure in the sterilization chamber (10) to the sterilization chamber (10) for a first period of time (i.e. T1 – see Figures 4-6);
(iv) selectively activating the venting valve (34) to provide a step-wise incremental increase in pressure within the sterilization chamber (10) to drive the sterilant into the medical device (11) by providing at least one of agitation to the medical device or convective mass transfer of the sterilant (i.e. due to movement of fluid driven by natural effect such as the pressure difference from venting) within the medical device (see entire document, particularly Figures 5-6, p. 2 [0019], p. 4 [0055]-[0056] and [0061], p. 5 [0064]-[0065], p. 5 [0078]); and
(v) monitor a venting duration and a sealing duration (i.e. duration of the pressure increase and duration/predetermined time period of maintaining the pressure) for the venting valve (34) during the step-wise incremental increase in pressure to determine completion of a sterilization cycle (see entire document, particularly Figures 5-6, p. 4 [0058] – last 5 lines and [0059]),
in order to facilitate the penetration of the sterilant into diffusion-limited regions, such as lumens, and thus increase the sterilization efficiency (see entire document, particularly p. 5 [0078]).
It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a control module configured to also provide a step-wise incremental increase in pressure within the sterilization chamber is to drive the sterilant into the medical device and monitor a venting duration and a sealing duration in the apparatus of Goetz as a known configuration in order to facilitate the penetration of sterilant into diffusion limited regions so as to increase sterilization efficiency as shown by Ko.
As to Claim 2, Goetz (‘879) discloses a system (see Figure 1) comprising:
the apparatus of claim 1 (see entire document, particularly Figure 1; see rejection above); and
a medical device (105) (see entire document, particularly Figure 1, p. 1 lines 12-22, p. 5 lines 13-16).
As to Claim 5, while Goetz (‘879) discloses that the apparatus (100) further comprises a door (see entire document, particularly p. 6 lines 19-21), Goetz (‘879) does not appear to specifically teach that the door opens and closes the sterilization chamber in response to actuation of a kick plate. However, as it is well known in the art before the effective filing date of the claimed invention to provide any known means to effect opening and closing a door such as by actuating a kick plate, it would have been well within the purview of one of ordinary skill in the art before the effective filing date of the claimed invention to provide a kick plate in the apparatus of Goetz in order to allow touchless door operation (i.e. opening and closure) so as enable a user to open and close a door to a sterilizer apparatus while holding item(s) to be sterilized or while wearing protection equipment on hands for loading and unloading items from the apparatus. Only the expected results would be attained.
As to Claim 6, Goetz (‘879) discloses that the sterilant applying module (130 - 131, 132, 134, 135, 136, 137, 138, 139, 140; 142, 144, 139, 140) is configured to receive replaceable sterilant cartridges (142) containing a certain amount of sterilant (see entire document, particularly p. 10 lines 10-11).
As to Claim 18, Goetz (‘879) discloses an apparatus (100) (see Figure 1), comprising:
(a) a sterilization chamber (102);
(b) a vacuum source (106, 110, 112, 116, 125) in fluid communication (via 118, 114, 123) with the sterilization chamber (102) (see Figure 1), the vacuum source (106, 110, 116) configured to apply a vacuum to the sterilization chamber (102) (see entire document, particularly Figures 1-2);
(c) a module (130 - 131, 132, 134, 135, 136, 137, 138, 139, 140; 142, 144, 139, 140) having a sterilant, the module being in fluid communication (via 139, 140) with the sterilization chamber (102) to permit application of the sterilant to the sterilization chamber (102) (see entire document, particularly Figure 1, p. 10 lines 10-16); and
(d) a venting valve (145; 152) in fluid communication (via 143, 147) with the sterilization chamber (102) and an atmosphere outside (via 143, 147 and a filter) of the sterilization chamber (102) (see entire document, particularly Figure 1, p. 10 lines 22-26), the venting valve (145; 152) being operable/capable, after application of sterilant to the sterilization chamber (102), to selectively open and close a vent path (via 143, 147) between the sterilization chamber (102) and the atmosphere to provide a step-wise incremental increase in pressure within the sterilization chamber (102) (i.e. steps 28, 30 - see entire document, particularly Figures 1-2, p. 10 lines 22-26, p. 12 lines 20-28)3 to drive the sterilant into a medical device by providing at least one of agitation to the medical device or convective mass transfer of the sterilant within the medical device,
wherein a venting duration and a sealing duration for the venting valve is capable of being monitored during the step-wise incremental increase in pressure to determine completion of a sterilization cycle.
As to Claim 19, Goetz (‘879) discloses a system (see Figure 1) comprising:
the apparatus of claim 17 (see entire document, particularly Figure 1; see rejection of claim 17 above); and
a medical device (105) (see entire document, particularly Figure 1, p. 1 lines 12-22, p. 5 lines 13-16).
Thus, Claims 1-2, 5-6 and 18-19 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Goetz (‘879) and Ko (‘959).
Claim(s) 1-5, 7-9 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Truong (20170304477) in view of Ko (20110176959).
As to Claim 1, Truong (‘477) discloses an apparatus (10) (see Figure 1), comprising:
(a) a sterilization chamber (12), wherein the sterilization chamber (12) is configured to receive a medical device (14);
(b) a vacuum source (18) in fluid communication (via 20, 22) with the sterilization chamber (12);
(c) a sterilant applying module (28) in fluid communication (via 30, 32) with the sterilization chamber (12);
(d) a venting valve (e.x. 22) in fluid communication with the sterilization chamber (12) and an atmosphere outside of the sterilization chamber (12) (see entire document, particularly p. 4 [0027] – lines 23-28), the valve (e.x. 22) being operable to selectively open and close a vent path (e.x. 20) between the sterilization chamber (12) and the atmosphere (see entire document, particularly p. 4 [0027] – lines 23-28); and
(e) a control module (38) in communication with the vacuum source (18), the sterilant applying module (28), and the valve (e.x. 22), wherein the control module (38) contains a control logic (see entire document, particularly p. 4 [0028] especially lines 10-11) configured to execute a sterilizing algorithm such that the control logic is configured to:
(i) activate the vacuum source to apply a vacuum to the sterilization chamber (12) (see entire document, particularly Figures 5-6, p. 9 [0053] and [0059] , p. 11 – Claim 1 step (f)),
(ii) activate the sterilant applying module to apply sterilant to the sterilization chamber (12) (see entire document, particularly Figures 5-6, p. 9 [0058], p. 10 [0062] , p. 11 – Claim 1 steps (h)-(i)), and
(iii) selectively activating the valve to provide a step-wise incremental increase in pressure within the sterilization chamber (12) (e.x. steps of “Open valve to…” and “Evacuate and pressurize chamber” - see entire document, particularly Figures 5-6, p. 10 [0061] – lines 8-10, p. 11 – Claim 1 step (k)).
Truong (‘477) does not appear to specifically teach that selectively activating the venting valve to provide a step-wise incremental increase in pressure within the sterilization chamber is to drive the sterilant into the medical device by providing at least one of agitation to the medical device or convective mass transfer of the sterilant within the medical device or monitoring a venting duration and a sealing duration for the venting valve during the step-wise incremental increase in pressure to determine completion of a sterilization cycle. However, it was known in the art before the effective filing date of the claimed invention to provide a step-wise incremental increase in pressure within a sterilization chamber driving a sterilant into a medical device and monitor a venting duration and a sealing duration. Ko (‘959) discloses an apparatus and method of sterilizing an article (11) comprising a medical device (see Figures 1-7, p. 2 [0033] – lines 4-5), the apparatus comprising:
(a) a sterilization chamber (10), wherein the sterilization chamber (10) is configured to receive a medical device (11);
(b) a vacuum source (14) in fluid communication with the sterilization chamber (10);
(c) a sterilant applying module (10, 41, 42, 20, 30; 46, 47, 50) in fluid communication with the sterilization chamber (10); and
(d) a venting valve (45) in fluid communication with the sterilization chamber (10);
wherein the apparatus is controlled/configured to:
(i) activating the vacuum source (14) to apply a vacuum to the sterilization chamber (10) (i.e. prior to injection stage - see Figure 5, p. 3 [0042] – lines 4-5);
(ii) activating the sterilant applying module to apply a sterilant (42 via 43) into the sterilization chamber (10) (i.e. injection stage - see Figures 4-6);
(iii) maintaining the first pressure in the sterilization chamber (10) to the sterilization chamber (10) for a first period of time (i.e. T1 – see Figures 4-6); and
(iv) selectively activating the venting valve (34) to provide a step-wise incremental increase in pressure within the sterilization chamber (10) to drive the sterilant into the medical device (11) by providing at least one of agitation to the medical device or convective mass transfer of the sterilant (i.e. due to movement of fluid driven by natural effect such as the pressure difference from venting) within the medical device (see entire document, particularly Figures 5-6, p. 2 [0019], p. 4 [0055]-[0056] and [0061], p. 5 [0064]-[0065], p. 5 [0078]); and
(v) monitor a venting duration and a sealing duration (i.e. duration of the pressure increase and duration/predetermined time period of maintaining the pressure) for the venting valve (34) during the step-wise incremental increase in pressure to determine completion of a sterilization cycle (see entire document, particularly Figures 5-6, p. 4 [0058] – last 5 lines and [0059]),
in order to facilitate the penetration of the sterilant into diffusion-limited regions, such as lumens, and thus increase the sterilization efficiency (see entire document, particularly p. 5 [0078]).
It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a control module configured to also provide a step-wise incremental increase in pressure within the sterilization chamber is to drive the sterilant into the medical device as well as to monitor a venting duration and a sealing duration in the apparatus of Truong as a known configuration in order to facilitate the penetration of sterilant into diffusion limited regions so as to increase sterilization efficiency as shown by Ko.
As to Claim 2, Truong (‘477) discloses a system (10) (see Figure 1) comprising:
the apparatus of claim 1 (see entire document, particularly Figure 1; see rejection of claim 1 above); and
a medical device (14) (see entire document, particularly Figure 1, p. 8 [0051], p. 11 – claim 1(a), p. 12 – claim 26).
As to Claim 3, Truong (‘477) discloses that the medical device (14) is an endoscope (see entire document, particularly Figure 1, p. 8 [0051] – lines 4-8, where instruments/medical devices with lumen(s) include endoscopes and thus, such instruments intrinsically comprise endoscopes).
As to Claim 4, Truong (‘477) discloses that the medical device (14) is a plurality of endoscopes (see entire document, particularly Figure 1, p. 4 [0027] – lines 3-4, p. 8 [0051] – lines 4-11, where instruments/medical devices with lumen(s) include endoscopes and thus, such instruments intrinsically comprise endoscopes).
As to Claim 5, while Truong (‘477) discloses that the apparatus (10) further comprises a door (16), Truong (‘477) does not appear to specifically teach that the door opens and closes the sterilization chamber in response to actuation of a kick plate. However, as it is well known in the art before the effective filing date of the claimed invention to provide any known means to effect opening and closing a door such as by actuating a kick plate, it would have been well within the purview of one of ordinary skill in the art before the effective filing date of the claimed invention to provide a kick plate in the apparatus of Truong in order to allow touchless door operation (i.e. opening and closure) so as enable a user to open and close a door to a sterilizer apparatus while holding item(s) to be sterilized or while wearing protection equipment on hands for loading and unloading items from the apparatus. Only the expected results would be attained.
As to Claim 7, Truong (‘477) discloses that the apparatus (10) further comprises a touch screen display (36) configured to receiver a user input (see entire document, particularly p. 4 [0027] - last 4 lines).
As to Claim 8, the touch screen display (36) of Truong (‘477) is operable to render various user interface display screens (see entire document, particularly p. 4 [0027] - last 4 lines).
As to Claim 9, Truong (‘477) discloses that the control module (38) is in communication with the sterilant applying module (28) and the touch screen display (36) and is operable/capable to execute control algorithms to drive the sterilant applying module (28) in accordance with the user input (see entire document, particularly pp. 10-11 [0065], p. 11 [0066]-[0068]).
As to Claims 16-17, Truong (‘477) discloses that the apparatus (10) further comprises an output device in the form of a printer (36) operable/capable to print information such as results associated with setup of a sterilization cycle, performance of a load conditioning cycle, and/or performance of a sterilization cycle (see entire document, particularly p. 4 [0027] - last 4 lines, p. 11 [0066]-[0068]).
As to Claim 18, Truong (‘477) discloses an apparatus (10) (see Figure 1), comprising:
(a) a sterilization chamber (12);
(b) a vacuum source (18) in fluid communication with the sterilization chamber (12), the vacuum source (18)configured to selectively apply a vacuum to the sterilization chamber (12) (see entire document, particularly p. 4 [0027] – lines 15-17 and 21-23);
(c) a module (28) having a sterilant, the module (28) being in fluid communication (via 30, 32) with the sterilization chamber (12) to permit application of the sterilant to the sterilization chamber (12); and
(d) a venting valve (e.x. 22) in fluid communication with the sterilization chamber (12) and an atmosphere outside of the sterilization chamber (12) (see entire document, particularly p. 4 [0027] – lines 23-28), the venting valve (e.x. 22) being operable to selectively open and close a vent path (e.x. 20) between the sterilization chamber (12) and the atmosphere to provide a step-wise incremental increase in pressure within the sterilization chamber (12) (e.x. steps of “Open valve to…” and “Evacuate and pressurize chamber” - see entire document, particularly Figures 5-6, p. 4 [0027] – lines 23-28, p. 10 [0061] – lines 8-10, p. 11 – Claim 1 step (k)) to drive the sterilant into a medical device by providing at least one of agitation to the medical device or convective mass transfer of the sterilant within the medical device,
wherein a venting duration and a sealing duration for the venting valve is capable of being monitored during the step-wise incremental increase in pressure to determine completion of a sterilization cycle.
As to Claim 19, Truong (‘477) discloses a system (10) (see Figure 1) comprising:
the apparatus of claim 18 (see entire document, particularly Figure 1; see rejection of claim 18 above); and
a medical device (14) (see entire document, particularly Figure 1, p. 8 [0051], p. 11 – claim 1(a), p. 12 – claim 26).
As to Claim 20, Truong (‘477) discloses that the medical device (14) is a plurality of endoscopes (see entire document, particularly Figure 1, p. 4 [0027] – lines 3-4, p. 8 [0051] – lines 4-11, where endoscopes intrinsically comprise lumens).
Thus, Claims 1-5, 7-9 and 16-20 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Truong (‘477) and Ko (‘959).
Claim(s) 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Goetz (WO2015094879) or Truong (20170304477) in view of Ko (20110176959) as applied to claim 1 above, and further in view of Thompson (20170252474).
The applied reference (i.e. Thompson) has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Goetz (‘879) or Truong (‘477) in view of Ko (‘959) are relied upon for disclosure described in the rejection of claim 1 under 35 U.S.C. 103.
While Truong (‘477) discloses that one or more biological indicator is utilized during a sterilization process (see entire document, particularly p. 1 [0004], p. 2 [0012] – lines 7-8, p. 8 [0052] – lines 2-3, p. 9 [0059]), none of Goetz (‘879) or Truong (‘477) nor Ko (‘959) appears to specifically teach that the system is further comprised of an identification tag reader operable to read an identification tag of a biological indicator.
It was known in the art before the effective filing date of the claimed invention to provide an identification tag reader in a sterilization system. Thompson (‘474) discloses a system(10) (see Figure 1), comprising:
(a) a sterilization chamber (152 within 100/150), wherein the sterilization chamber (152 within 100/150) is configured to receive a medical device (see entire document, particularly Figures 1 and 18, p. 1 [0004]-[0007]);
(b) a sterilant applying module (156) in fluid communication with the sterilization chamber (152) (see Figure 18);
(e) a control module (106, 108; 162) in communication (via 20) with the sterilant applying module (100; 156) (see entire document, particularly Figures 1 and 18); and
an identification tag reader (166) (see entire document, particularly Figures 18-19, p. 10 [0125] , p. 11 [0132]),
in order to read an identification tag of a biological indicator (see entire document, particularly p. 10 [0125], p. 11 [0132]).
It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide an identification tag reader in a sterilization system such as that of Goetz or Truong as modified by Ko as a known additional component in order to read identification tags present within the system as shown by Thompson.
As to Claims 11-12, Thompson (‘474) discloses that the identification tag reader (166) comprises an optical reader in the form of an RFID reader that is operable to read an optical identification tagin the form of an RFID identification tag of a biological indicator (see entire document, particularly p. 10 [0125], p. 11 [0132]).
As to Claim 13, the control module of Goetz (‘879) or Truong (‘477) as modified by Thompson (‘474) is capable of processing the data received through the identification tag reader.
As to Claim 14, Truong (‘477) discloses that the apparatus (10) further comprises a memory (42) operable/capable to store control logic and instructions that are executable by the control module (38, 40) to drive components such as the sterilant applying module (28) and an identification reader (166) of Thompson (‘474).
Thompson (‘474) discloses that the apparatus (see Figure 1) further comprises a memory (106 or within 108) operable/capable to store control logic and instructions that are executable by the control module (162; 106, 108) to drive components such as the sterilant applying module (156) and the identification reader (166) (see entire document, particularly p. 10 [0123], Figures 1 and 18).
As to Claim 15, the memory (42; 106 or within 108, respectively ) of Truong (‘477) and Thompson (‘474) is capable of being used to store results associated with setup of a sterilization cycle, performance of a load conditioning cycle, and/or performance of a sterilization cycle (see entire document, particularly Truong [0030] and Thompson [0077]-[0078]).
Thus, Claims 10-15 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Goetz (‘879) or Truong (‘477), Ko (‘959), and Thompson (‘474).
Claim(s) 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ricciardi (20100226821) in view of Ko (20110176959).
As to Claim 18, Ricciardi (‘821) discloses an apparatus (see entire document, particularly Figure 12), comprising:
(a) a sterilization chamber (16);
(b) a vacuum source in fluid communication (via vacuum line exhaust) with the sterilization chamber (16) (see Figure 12), the vacuum source configured to apply a vacuum to the sterilization chamber (16) to decrease pressure within the sterilization chamber to a first pressure (see entire document, particularly p. 18 [0130] – lines 1-8 and last 6 lines);
(c) a module (15, 51, 18, 04, 11, 44) having a sterilant (20), the module (15, 51, 18) being in fluid communication (i.e. via 18) with the sterilization chamber (16) to permit application of the sterilant (20) to the sterilization chamber (16); and
(d) a venting valve (35, 40) in fluid communication with the sterilization chamber (16) and an atmosphere outside of the sterilization chamber (16), the venting valve (35, 40) being operable/capable to selectively open and close (i.e. dependent on operational step/stage) a vent path (35/72, 18, 40, 54, 35/39/exhaust) between the sterilization chamber (16) and the atmosphere to provide a step-wise incremental increase in pressure within the sterilization chamber (16) (see Figure 12) to drive the sterilant into a medical device by providing at least one of agitation to the medical device or convective mass transfer of the sterilant within the medical device,
wherein a venting duration and a sealing duration for the venting valve is capable of being monitored during the step-wise incremental increase in pressure to determine completion of a sterilization cycle.
Ricciardi (‘821) does not appear to specifically teach that selectively activating the venting valve to provide a step-wise incremental increase in pressure within the sterilization chamber during the contacting time/application of the sterilant. However, it was known in the art before the effective filing date of the claimed invention to provide a step-wise incremental increase in pressure within a sterilization chamber driving a sterilant into a medical device. Ko (‘959) discloses an apparatus and method of sterilizing an article (11) comprising a medical device (see Figures 1-7, p. 2 [0033] – lines 4-5), the apparatus comprising:
(a) a sterilization chamber (10), wherein the sterilization chamber (10) is configured to receive a medical device (11);
(b) a vacuum source (14) in fluid communication with the sterilization chamber (10);
(c) a sterilant applying module (10, 41, 42, 20, 30; 46, 47, 50) in fluid communication with the sterilization chamber (10); and
(d) a venting valve (45) in fluid communication with the sterilization chamber (10);
wherein the venting valve (45)/the apparatus ss controlled/operable/configured for:
(i) activating the vacuum source (14) to apply a vacuum to the sterilization chamber (10) (i.e. prior to injection stage - see Figure 5, p. 3 [0042] – lines 4-5);
(ii) activating the sterilant applying module to apply a sterilant (42 via 43) into the sterilization chamber (10) (i.e. injection stage - see Figures 4-6);
(iii) maintaining the first pressure in the sterilization chamber (10) to the sterilization chamber (10) for a first period of time (i.e. T1 – see Figures 4-6); and
(iv) selectively activating the venting valve (34) to provide a step-wise incremental increase in pressure within the sterilization chamber (10) to drive the sterilant into the medical device (11) by providing at least one of agitation to the medical device or convective mass transfer of the sterilant (i.e. due to movement of fluid driven by natural effect such as the pressure difference from venting) within the medical device (see entire document, particularly Figures 5-6, p. 2 [0019], p. 4 [0055]-[0056] and [0061], p. 5 [0064]-[0065], p. 5 [0078]); and
(v) monitor a venting duration and a sealing duration (i.e. duration of the pressure increase and duration/predetermined time period of maintaining the pressure) for the venting valve (34) during the step-wise incremental increase in pressure to determine completion of a sterilization cycle (see entire document, particularly Figures 5-6, p. 4 [0058] – last 5 lines and [0059]),
in order to facilitate the penetration of the sterilant into diffusion-limited regions, such as lumens, and thus increase the sterilization efficiency (see entire document, particularly p. 5 [0078]).
It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a venting valve that is operable to also provide a step-wise incremental increase in pressure within the sterilization chamber during the application/contacting time of the sterilant to the sterilization chamber and operable/capable to monitor a venting duration and a sealing duration in the apparatus of Ricciardi as a known configuration in order to facilitate the penetration of sterilant into diffusion limited regions so as to increase sterilization efficiency as shown by Ko.
As to Claim 19, Ricciardi (‘821) discloses a system (see entire document, particularly Figure 12) comprising:
the apparatus of claim 18 (see entire document, particularly Figure 12; see rejection of claim 18 above); and
a medical device (01).
As to Claim 20, Ricciardi (‘821) discloses that the medical device (01) is a plurality of endoscopes (see entire document, particularly Figures 1-2, 4-5, 8-11 and 14-19, p. 8 [0079] – lines 6-7).
Thus, Claims 18-20 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Ricciardi (‘821) and Ko (‘959).
Response to Arguments
Applicant's arguments filed 6/26/2026 have been fully considered but they are not persuasive. Specifically, as to applicant’s argument on p. 8 of Remarks in regards to Ko, examiner disagrees. As to applicant’s argument in lines 5-15 on p. 8 of Remarks, examiner points out that “providing at least one of agitation to the medial device or convective mass transfer of the sterilant within the medical device” is a merely a natural result/consequence of providing a step-wise incremental increase in pressure (i.e. venting) and as Ko teaches a step-wise incremental increase in pressure Ko does intrinsically teach “providing at least one of agitation to the medial device or convective mass transfer of the sterilant within the medical device”. As to applicant’s argument in last 15 lines on p. 8 to first two lines on p. 9 of Remarks, examiner disagrees and indicates that as Ko teaches that for the step-wise incremental pressure increase via “vent & hold step[s]”/half cycle as shown in Figures 5-6 utilizes a predetermined pressure and a predetermined time for venting and sealing, Ko does teach a monitoring of the venting and sealing duration (such as “T1” shown in Figures 5-6) in order to ensure proper/desired operation of the step-wise incremental increase within the vacuum chamber in order to provide improved sterilization of the entirety of diffusion limited medical devices.
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 REGINA M YOO whose telephone number is (571)272-6690. The examiner can normally be reached Monday - Friday, 9:00 am - 5:00 pm EST.
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/REGINA M YOO/ Primary Examiner, Art Unit 1758
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