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 12/30/2025 has been received and claims 1-20 are pending.
Claim Objections
Claims 1-20 are objected to because of the following informalities:
in line 16 of Claim 1, insert --the-- before “sterilant”;
in line 11 of Claim 17, insert --the-- before “sterilant”.
Appropriate correction is required.
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; “module” in claim 17.
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.
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 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 17-20 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is no written description support for the new limitation that the step “to increase pressure within the sterilization chamber” occurs “during the application of sterilant” within the Specification as the disclosure (see, for example, Figure 5 – steps 514 and 516 vs. one or more cycles of 518 and 524, p. 15 [0044] vs pp. 15-16 [0045], p. 19 [0054] – lines 3-5 vs 6-14) appears to describe that the increase in pressure occurs after an application of the sterilant or that the sterilant may be applied during the increase in pressure in the sterilization chamber (see Specification, p. 20 [0055]).
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 17-20 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 2 recites the limitation "the medical device" in line 3. There is insufficient antecedent basis for this limitation in the claim.
In Claim 17, it is not clear whether the step “to increase pressure within the sterilization chamber” occurs “during the application of sterilant” or after the sterilant has been applied to the sterilization chamber or rather that the step of adding (additional) sterilant occurs during venting of the sterilization chamber.
Claims 3-4 and 18-20 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, 5-8 and 17-18 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 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 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 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) selectively activating the vacuum source (106) to apply a vacuum to the sterilization chamber (102) to decrease pressure within the sterilization chamber (102) to a first pressure (i.e. step(s) 16 and/or 26 - see Figure 2),
(ii) selectively activating 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 increase pressure within the sterilization chamber (102) to a second pressure (i.e. step(s) 28, 30 - see Figure 2).
Goetz (‘879) does not appear to specifically teach that selectively activating the venting valve to increase pressure within the sterilization chamber to the second pressure to drive the sterilant into the medical device. However, it was known in the art before the effective filing date of the claimed invention to selectively activate a venting valve to increase 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 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 increase the pressure to a second pressure within the sterilization chamber (10) to drive the sterilant into the medical device (11) (see entire document, particularly Figures 5-6, p. 2 [0019]);
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 selectively activating the venting valve to increase pressure within the sterilization chamber to a second pressure to drive the sterilant into the medical device 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, Goetz (‘879) discloses that the first pressure (i.e. pressure after step 16) is less than the second pressure (i.e. pressure after step(s) 28 and/or 30).
As to Claim 6, Goetz (‘879) discloses that the second pressure is atmospheric pressure (i.e. pressure after step(s) 28 and/or 30 - see entire document, particularly Figures 1-2, p. 12 lines 20-33).
As to Claim 7, Goetz (‘879) discloses that the first pressure is capable of being less than 100 torr.
As to Claim 8, Goetz (‘879) discloses that the second pressure (i.e. pressure during/after step 26) (see entire document, particularly Figure 2, p. 12 lines 14-17) is capable of being less than 100 torr.
As to Claim 17, 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 selectively apply a vacuum to the sterilization chamber (102) to decrease pressure within the sterilization chamber (102) to a first pressure (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 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 valve (145; 152) being operable to selectively open and close a vent path (via 143, 147) between the sterilization chamber (102) and the atmosphere to increase pressure within the sterilization chamber (102) to a second pressure (see entire document, particularly Figures 1-2, p. 10 lines 22-26, p. 12 lines 20-28).
Goetz (‘879) does not appear to specifically teach that increasing pressure to a second pressure within the sterilization chamber occurs 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 increase pressure within a sterilization chamber during application of sterilant to the sterilization chamber 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 increase pressure within the sterilization chamber (10) to a second pressure during the application of the sterilant to the sterilization chamber (see entire document, particularly Figures 5-6, p. 2 [0019]);
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 valve that is operable to selectively open and close to increase pressure within the sterilization chamber to a second pressure during the application of the sterilant to the sterilization chamber 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 18, Goetz (‘879) discloses a system (see Figure 1) comprising:
the apparatus of claim 17 (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).
Thus, Claims 1-2, 5-8 and 17-18 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) 1-20 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) selectively activating the vacuum source to apply a vacuum to the sterilization chamber to decrease pressure within the sterilization chamber to a first pressure (see entire document, particularly Figures 5-6, p. 9 [0053] and [0059] , p. 11 – Claim 1 step (f)),
(ii) selectively activating the sterilant applying module to apply sterilant to the sterilization chamber (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 venting valve to increase pressure within the sterilization chamber to a second pressure (i.e. ambient/atmospheric pressure) (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 increase pressure to the second pressure within the sterilization chamber is to drive the sterilant into the medical device. However, it was known in the art before the effective filing date of the claimed invention to selectively activate a venting valve to increase 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 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 increase pressure to a second pressure within the sterilization chamber (10) to drive the sterilant into the medical device (11) (see entire document, particularly Figures 5-6, p. 2 [0019]);
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 selectively activate the venting valve of Truong increasing pressure to a second pressure within the sterilization chamber to drive the sterilant into the medical device 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 endoscopes intrinsically comprise lumens and thus, instruments with lumen(s) intrinsically includes endoscope).
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 endoscopes intrinsically comprise lumens and thus, instruments with lumen(s) intrinsically includes endoscope).
As to Claim 5, Truong (‘477) discloses that the first pressure is less than second pressure (see entire document, particularly Figures 5-6, p. 4 [0027] – lines 21-25).
As to Claim 6, Truong (‘477) discloses that the second pressure is atmospheric pressure (see entire document, particularly p. 4 [0027] – lines 23-25).
As to Claim 7, Truong (‘477) discloses that the first pressure is capable of being less than 100 torr (see entire document, particularly p. 12 – claims 22-23).
As to Claim 8, Truong (‘477) discloses that the second pressure is capable of being less than 100 torr (see entire document, particularly Figures 5-6, pressure after step “Pressurize the chamber” that leads to the step of “Withdraw air from the chamber”, p. 12 – claims 22-23).
As to Claim 9, Truong (‘477) discloses that the control logic (see entire document, particularly p. 4 [0028] especially lines 10-11) is further configured to selectively activate the vacuum source (18) to apply the vacuum to the sterilization chamber (12) to reduce pressure within the sterilization chamber (12) to a third pressure (see entire document, particularly Figures 5-6 pressure after step of “pressurize the chamber” leading back to “Withdraw air from the chamber”; p. 4 [0027] – lines 21-23, p. 12 – claims 22-23).
As to Claim 10, Truong (‘477) discloses that the control logic (see entire document, particularly p. 4 [0028] especially lines 10-11) is further configured to selectively activate the valve (e.x. 22) (see entire document, particularly p. 4 [0027] – lines 23-28) to increase pressure within the sterilization chamber (12) to a fourth pressure (see entire document, particularly Figures 5-6 after step(s) “Pressurize the chamber” or “Evacuate and pressurize the chamber” and/or “Open the chamber”; for example, atmospheric pressure; p. 4 [0027] – lines 23-25).
As to Claim 11, Truong (‘477) discloses that the third pressure is less than the fourth pressure (see entire document, particularly Figures 5-6, p. 4 [0027] – lines 21-25; see rejections of claims 9-10 above).
As to Claim 12, Truong (‘477) discloses that the fourth pressure is atmospheric pressure (see entire document, particularly Figures 5-6 after step(s) “Pressurize the chamber” or “Evacuate and pressurize the chamber” and/or “Open the chamber”; for example, atmospheric pressure so as to enable opening of the chamber, p. 4 [0027] – lines 23-25).
As to Claim 13, Truong (‘477) discloses that the third pressure is capable of being less than 100 torr (see entire document, particularly Figures 5-6 pressure after step of “pressurize the chamber” leading back to “Withdraw air from the chamber”; p. 4 [0027] – lines 21-23, p. 12 – claims 22-23).
As to Claim 14, Truong (‘477) discloses that the fourth pressure is capable of being less than 100 torr (see entire document, particularly Figures 5-6, pressure after step “Pressurize the chamber” that leads to the step of “Withdraw air from the chamber”).
As to Claim 15, Truong (‘477) discloses that the fourth pressure (see entire document, particularly Figures 5-6, pressure after step “Pressurize the chamber” that leads to the step of “Withdraw air from the chamber”) is less than second pressure (see entire document, particularly Figures 5-6, pressure after step “Pressurize the chamber” or “Evacuate and pressurize the chamber” that leads to the step of “Open the chamber”, i.e., ambient/atmospheric pressure - p. 4 [0027] – lines 23-25).
As to Claim 16, Truong (‘477) discloses that the second pressure (see entire document, particularly Figures 5-6, pressure after step “Pressurize the chamber” that leads to the step of “Withdraw air from the chamber”) is less than fourth pressure (see entire document, particularly Figures 5-6, pressure after step “Pressurize the chamber” or “Evacuate and pressurize the chamber” that leads to the step of “Open the chamber”, i.e. ambient/atmospheric pressure - p. 4 [0027] – lines 23-25).
As to Claim 17, 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) to decrease pressure within the sterilization chamber (12) to a first pressure (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 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).
Truong (‘477) does not appear to specifically teach that the valve is operable to selectively open and close the vent path to increase pressure to a second pressure within the sterilization chamber during the application of the sterilant. However, it was known in the art before the effective filing date of the claimed invention to selectively open and close a vent path to increase pressure within a sterilization chamber during application of a sterilant to the sterilization chamber. 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 (i.e. opening and closing) the venting valve (34) thus a venting path to increase pressure within the sterilization chamber (10) to a second pressure during the application of the sterilant to the sterilization chamber (see entire document, particularly Figures 5-6);
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 valve that is operable to selectively open and close the vent path via the venting valve to increase pressure within the sterilization chamber to a second pressure during the application of the sterilant to the sterilization chamber 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 18, Truong (‘477) discloses a system (10) (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 (14) (see entire document, particularly Figure 1, p. 8 [0051], p. 11 – claim 1(a), p. 12 – claim 26).
As to Claim 19, Truong (‘477) discloses that the medical device (14) is an endoscope (see entire document, particularly Figure 1, p. 8 [0051] – lines 4-8, where endoscopes intrinsically comprise lumens and thus, instruments with lumen(s) intrinsically includes endoscope).
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 and thus, instruments with lumen(s) intrinsically includes endoscope).
Thus, Claims 1-20 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) 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ricciardi (20100226821) in view of Ko (20110176959).
As to Claim 17, 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 selectively 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 valve (35, 40) in fluid communication with the sterilization chamber (16) and an atmosphere outside of the sterilization chamber (16), the valve (35, 40) being operable to selectively open and close a vent path (35/72, 18, 40, 54, 35/39/exhaust) between the sterilization chamber (16) and the atmosphere to increase pressure within the sterilization chamber (16) to a second pressure (see Figures 12).
Ricciardi (‘821) does not appear to specifically teach that increasing pressure to a second pressure within the sterilization chamber is during the application of the sterilant to the sterilization chamber by selectively opening and closing a venting path. However, it was known in the art before the effective filing date of the claimed invention to selectively open and close a valve to increase pressure within a sterilization chamber to a second pressure in a sterilization chamber during application of sterilant. 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 opening and closing a vent path via the venting valve (34) to increase pressure within the sterilization chamber (10) to a second pressure during the application of the sterilant to the sterilization chamber (see entire document, particularly Figures 5-6);
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 valve operable to selectively open and close a vent path that increases pressure within the sterilization chamber to a second pressure during the application/contacting time of the sterilant to the sterilization chamber 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 18, Ricciardi (‘821) discloses a system (see entire document, particularly Figure 12) comprising:
the apparatus of claim 17 (see entire document, particularly Figure 12; see rejection of claim 17 above); and
a medical device (01).
As to Claim 19, Ricciardi (‘821) discloses that the medical device (01) is an endoscope (see entire document, particularly Figures 4-5, 8-11 and 14-19, p. 8 [0079] – line 6).
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 17-20 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Ricciardi (‘821) and Ko (‘959).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 17-18 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 18-20 of copending Application No. 18/196,133 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the limitation “activate…” in claim 1 of the reference application includes various methods to activate components such as “selectively activating…” as set forth in claim 1 of current application particularly when steps/stages with insertion/extraction of objects/instruments from the device are involved. Claims 2-4 of the current application are identical to claims 2-4 of the reference application. In addition, the limitation “to apply a vacuum” in claim 18 of the reference application encompasses various methods of application such as “to selectively apply a vacuum” as set forth in claim 17 of current application particularly when steps/stages with insertion/extraction of objects/instruments from the device are involved. Claims 18 and 20 of the current application is identical to claims 19-20 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 17 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive. Specifically, as to applicant’s argument at the bottom on p. 5 of Remarks, examiner disagrees and points out that the claims 1 and 17 do not recite the specific structures as indicated by the applicant (only in Specification as corresponding structures) but merely utilizes a generic placeholder term of a module with function of applying sterilant and thus, the limitations continues to be interpreted under 35 U.S.C. 112(f). Finally, as to applicant’s argument in first full paragraph on p. 6 of Remarks, examiner points out that a terminal disclaimer has not been filed contrary to applicant’s argument that one has been submitted with the remarks, and thus, the double patenting rejection is maintained.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REGINA M YOO/ Primary Examiner, Art Unit 1758
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