FINAL OFFICE ACTION
This Final office action addresses U.S. Application No. 18/053,587, which is a broadening reissue of U.S. Application No. 17/065,607 (hereinafter the “607 Application"), entitled SYSTEM AND METHOD FOR ALTERNATING-DIRECT HIGH VOLTAGE LEAK DETECTION, which issued as U.S. Patent No. 11/300,476 (hereinafter the “476 Patent").
The status of the claims is as follows:
Claims 24-37 are pending.
Claims 24-37 are rejected.
I. STATUS OF CLAIMS
Applicant filed an amendment on September 2, 2025 (hereinafter the “2025 Amendment”) in response to the non-final Office action mailed April 1, 2025 (hereinafter the “2025 NF Action”). In the 2025 Amendment, patent claims 1-12 were cancelled, previously added claims 13-23 were cancelled and new claims 24-37 were added. Therefore, claims 24-37 are pending and are examined.
II. PRIORITY
Examiners acknowledge the Applicant’s claim that present application is a reissue application of the 607 Application, filed October 8, 2020. Examiners further acknowledge that the 607 Application was filed as a divisional application of U.S. Application No. 16/074,146, filed as PCT/US2016/056976 on October 14, 2016, which claims priority to U.S. Provisional Application No. 62/317,873, filed April 4, 2016 and U.S. Provisional Application No. 62/289,579, filed February 1, 2016 (hereinafter the “579 Provisional Application”). Therefore, Examiners find the earliest possible filing date for the claims is the date of the 579 Provisional Application.
III. REISSUE OATH/DECLARATION
37 C.F.R. §1.175 Reissue oath or declaration (in part).
(a) The inventor’s oath or declaration for a reissue application, in addition to complying with the requirements of § 1.63, § 1.64, or § 1.67, must also specifically identify at least one error pursuant to 35 U.S.C. 251 being relied upon as the basis for reissue and state that the applicant believes the original patent to be wholly or partly inoperative or invalid by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than the patentee had the right to claim in the patent.
(b) If the reissue application seeks to enlarge the scope of the claims of the patent (a basis for the reissue is the patentee claiming less than the patentee had the right to claim in the patent), the inventor's oath or declaration for a reissue application must identify a claim that the application seeks to broaden. A claim is a broadened claim if the claim is broadened in any respect.
The reissue declaration filed November 8, 2022, along with the filing of the present application (hereinafter the “2022 Reissue Declaration”) is acknowledged. However, Examiners continue to object to the 2022 Reissue Declaration on the basis that Examiners find that it fails to state a proper basis on which to base a reissue application. As noted in the 2022 Reissue Declarations, Applicant states the error as:
Claim 13 recites: [a] method for detecting leaks in a package, comprising: positioning a package between an inspection electrode and a detection electrode: applying an AC voltage with a OC high voltage offset through the inspection electrode to the package; detecting using the detection electrode an electrical current flow through the package induced by the applied AC voltage with the DC high voltage offset: and determining whether there is a leak in the package based on the detected electrical current.” Claim 13 does
not include the limitation of “wherein 0.004ppm of ozone is produced when -18.5 KVP is applied over 5 minutes" in claim 1.
However, Examiners find that claim 13 has been cancelled via the 2025 Amendment and do not find a claim corresponding to cancelled claim 13 in the claims after the 2025 Amendment. Thus, Applicant is required to provide a new declaration with a statement of error with respect to 476 Patent identifying “a single word, phrase, or expression” from the 476 Patent that was not included therein that rendered the 476 Patent invalid or inoperative and how this error is being corrected in the reissue application. Furthermore, if Applicant believes the patent claims of the 476 Patent are still being broadened in this reissue, Applicant is also required to specifically identify a patent claim Applicant seeks to broaden.
IV. CLAIM OBJECTIONS
Claim 31 is objected to because while the preamble recites the method for testing a “package,” the body of the claim recites testing a “vial.” Thus, the claim is internally inconsistent by testing different objects. Appropriate correction is required.
V. CLAIM REJECTIONS – 35 U.S.C. §112
The following is a quotation 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 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.
A. New Matter Rejections “hermetically sealing the package”
Claims 24-30 are rejected under 35 U.S.C. §112(a) 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, at the time the application was filed, had possession of the claimed invention. Claims 24-30 recite that “the amount of ozone is measurable by hermetically sealing the package.” However, Examiners are unable to find a disclosure in the 476 Patent written description support for this feature, particularly the hermetically sealing of the “package.”
Examiners find the only disclosure of hermetically sealing from the 476 Patent is:
An experiment was performed to determine how much ozone the conventional HVLD systems produce during an inspection in comparison to the HVLD technology based on an ADHV. A calibrated Aeroqual 200 Series ozone detector with 0.00 lppm resolution was placed inside the test chamber of both systems. Both systems were hermetically sealed.
Examiners find this portion of the 476 Patent provides support for hermetically sealing the chambers for the ADHV and HVLD systems, but does not provide support for hermetically sealing any package. Accordingly, Examiners conclude claims 24-30 lack written description support in the 476 Patent and thus contain new matter.
B. Indefiniteness Rejections – “an AC voltage…”
Claims 24-37 are rejected under 35 U.S.C. §112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Line 3 of claims 24 and 31 recite applying an AC voltage with a DC high voltage. Furthermore, line 13 of claims 24 and 31 recite applying only an AC voltage. However, Examiners do not find it clear from the claim language if this AC voltage is a different or the same AC voltage, especially in view of the introduction term “an” in front of each AC voltage. Furthermore, other portions of the claims recite a comparison with operation using AC voltages, which would only be reasonable or make sense if the same AC voltage is used. However, since the claims introduced two “an” AC voltages, the claims also imply two such AC voltages. Accordingly, Examiners conclude the claims are indefinite as to whether these AC voltages are the same or different.
C. Indefiniteness Rejections – “producing an amount of ozone…”
Claims 24-30 are rejected under 35 U.S.C. §112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Claims 24-30 recite “producing an amount of ozone that is significantly less than that produced by applying only an AC voltage through the inspection electrode to the package…” Examiners are unable to determine the scope of this limitation. For example, does this limitation require producing both ozone with only an AC voltage and also with an AC voltage with a DC high voltage offset? And then comparing the two results and using only those results that produce less ozone? What are the parameters of the AC voltages and the DC high voltage? If a sufficiently low AC voltage is used, little or no ozone would be produced. Examiners are unable to determine from the limitation what steps are required in order to produce “less ozone” than other methods and thus conclude this limitation is indefinite.
Furthermore and alternatively, based on the specification of the 476 Patent, this “production” of less ozone is merely a result of applying an AC voltage with a DC high voltage offset in a testing system. See 476 Patent col. 17, lines 49-51. However, the step of “applying” this voltage is previously recited and required in the claims. Thus, Examiners find the additional step of “producing” this less ozone is unclear as to whether it requires additional action or is merely a result of already recited steps. Thus, Examiners conclude the claims are unclear and are indefinite.
D. Indefiniteness Rejections claims 24-30 – conditional language
Claims 24-30 are rejected under 35 U.S.C. §112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. The last step of claim 24, i.e., “the producing an amount of ozone…” step is replete with conditional limitations which makes the claim unclear as to its scope. For example, this limitation recites “the amount of ozone is measurable by hermetically sealing the package” (emphasis added), “wherein 0.004 ppm of ozone is detected when -18.5kV of the AC voltage with the DC high voltage offset is applied over 5 minutes” (emphasis added) and “whereas 0.150ppm of ozone us detected when only the AC voltage of 18.5kV is applied over 5 minutes” (emphasis added). In each of the quoted limitations above, a conditional phrase is provided which means the phrase may or may not be required, i.e., “measurable” may or may not require a step of actually measuring. Furthermore, “when” similarly may or may not require the application of the voltages.
The issue lies in one plausible interpretation by the Examiners that none of the conditional phrases are required, i.e., that the ozone is not “measured” and the “when” phrases of applying the voltages does not occur. Thus, these phrases can simply be interpreted as not affecting the scope of claims 24-30. However, a second plausible scope would be that Applicant has chosen to place all these limitations into claims 24-30 and thus Examiners cannot ignore the phrases. Accordingly, since these limitations are capable of two plausible interpretations and Examiners are unable to determine which interpretation to apply, Examiners conclude the claims are indefinite.
E. Indefiniteness Rejections – “exposing a substance…”
Claims 31-37 are rejected under 35 U.S.C. §112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Claims 31-37 recite “exposing a substance inside the vial to a voltage during the leak testing, wherein the voltage is significantly lower than that produced by applying only an AC voltage through the inspection electrode to the vial…” Examiners are unable to determine the scope of this limitation. For example, does this limitation require exposing using only an AC voltage with a DC high voltage offset or does this limitation also require exposing using an AC voltage without any offset? What are the parameters of the AC voltages and the DC high voltage as compared to the AC voltage only? Examiners are unable to determine from the limitation what steps are required in order to produce the voltage “that is significantly lower” than the other methods and thus conclude this limitation is indefinite.
Furthermore and alternatively, based on the specification of the 476 Patent, this “exposing” of the substance to a voltage less than a regular AC voltage is merely a result of applying an AC voltage with a DC high voltage offset in a testing system. See 476 Patent col. 16, line 66 to col. 17, line 44. However, the step of “applying” this voltage is previously recited and required in the claims. Thus, Examiners find the additional step of “exposing” to a lesser voltage is unclear as to whether it requires additional action or is merely a result of already recited steps. Thus, Examiners conclude the claims are unclear and are indefinite.
F. Indefiniteness Rejections claims 31-37 – conditional language
Claims 31-37 are rejected under 35 U.S.C. §112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. The last step of claim 31, i.e., “exposing a substance…” step is replete with conditional limitations which makes the claim unclear as to its scope. For example, this limitation recites “the voltage the substance is exposed to is measurable by positioning a voltage probe on an inside wall of the vial” (emphasis added), “wherein -300V is detected is measured by the voltage probe when -18.5kV of the AC voltage with the DC high voltage offset is applied” (emphasis added) and “whereas 7kV is measured by the voltage probe when only the AC voltage of 18.5kV is applied” (emphasis added). In each of the quoted limitations above, a conditional phrase is provided which means the phrase may or may not be required, i.e., “measurable” may or may not require a step of actually measuring. Furthermore, “when” similarly may or may not require the application of the voltages.
The issue lies in one plausible interpretation by the Examiners that none of the conditional phrases are required, i.e., that the ozone is not “measured” and the “when” phrases of applying the voltages does not occur. Thus, these phrases can simply be interpreted as not affecting the scope of claims 31-37. However, a second plausible scope would be that Applicant has chosen to place all these limitations into claims 31-37 and thus Examiners cannot ignore the phrases. Accordingly, since these limitations are capable of two plausible interpretations and Examiners are unable to determine which interpretation to apply, Examiners conclude the claims are indefinite.
VI. REJECTIONS – 35 U.S.C. §251
35 U.S.C. §251 Reissue of defective patents.
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
A. Defective Declaration Rejection
Claims 24-37 and this application as a whole are rejected as being based upon a defective reissue under 35 U.S.C. §251 as set forth above. See 37 C.F.R. §1.175. The nature of the defects in the 2022 Reissue Declarations is set forth in the discussion above in this Office action.
B. New Matter Rejection
Claims 24-30 and this application as a whole are rejected under 35 U.S.C. §251 as containing new matter. The new matter is discussed above in the rejection under 35 U.S.C. §112 relating the lack of disclosure of a hermetically sealed package.
VII. CLAIM INTERPRETATION
After careful review of the original specification, the prosecution history, and unless expressly noted otherwise by the Examiners, the Examiners find that they are unable to locate any lexicographic definitions (either express or implied) with the required clarity, deliberateness, and precision with regard to pending and examined claims. Because the Examiners are unable to locate any lexicographic definitions with the required clarity, deliberateness, and precision, the Examiners conclude that Applicant is not his own lexicographer for the pending and examined claims. See MPEP §2111.01(IV).
The Examiners further find that because the pending and examined claims herein recite neither “step for” nor “means for” nor any substitute therefore, the examined claims fail Prong (A) as set forth in MPEP §2181(I). Because all examined claims fail Prong (A) as set forth in MPEP §2181(I), the Examiners conclude that all examined claims do not invoke 35 U.S.C. §112(f). See also Ex parte Miyazaki, 89 USPQ2d 1207, 1215-16 (B.P.A.I. 2008)(precedential)(where the Board did not invoke 35 U.S.C. § 112(f) because “means for” was not recited and because applicant still possessed an opportunity to amend the claims).
Because of the Examiners’ findings above that Applicant is not his own lexicographer and the pending and examined claims do not invoke 35 U.S.C. §112(f) the pending and examined claims will be given the broadest reasonable interpretation consistent with the specification since patentee has an opportunity to amend claims. See MPEP §2111, MPEP §2111.01 and In re Yamamoto et al., 222 USPQ 934 (Fed. Cir. 1984). Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP §2111.01(I). It is further noted it is improper to import claim limitations from the specification, i.e., a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment. See MPEP §2111.01(II).
Compact Prosecution
The Examiners find that because claims 24-37 are indefinite under 35 U.S.C. §112(B) as outlined above, it is impossible to properly construe claim scope at this time. See Honeywell International Inc. v. ITC, 68 USPQ2d 1023, 1030 (Fed. Cir. 2003) (“Because the claims are indefinite, the claims, by definition, cannot be construed.”). However, in accordance with MPEP §2173.06 and the USPTO’s policy of trying to advance prosecution by providing art rejections even though these claims are indefinite, the claims are construed and the art is applied as much as practically possible in the following art rejections. For example, because Examiners are unable to determine the scope of claims 24-37 as discussed above, particularly related to the “producing an amount of ozone…” as recited in claims 24-30 and the “exposing a substance…” as recited in claims 31-37. Specifically, Examiners will be taking at most a best guess as to the scope of the steps or actions required in method claims 24-37. Thus, the rejections for these claims are merely for information purposes only until the indefiniteness issues are resolved.
conditional language – claims 24-37
As discussed above, Examiners find claims 24-37 are replete with conditional language, i.e., “measurable” and “when” which makes the claims indefinite as to whether the conditional language is required. Since these limitations are indefinite and the claims are interpreted using the broadest reasonable interpretation, Examiners will assume for purposes of application of prior art, that the conditions are not met or required and thus provide no limitation to the scope of the claims.
Specific Interpretations
Examiners further provide the following specific claim phrase interpretations based on a review of the 476 Patent. Furthermore, since these interpretations are based on the explicit disclosure used in the 476, Examiners find they are reasonable interpretations.
product-by-process limitations
Examiners find that while claims 24, 26-31 and 33-37 are recited as method claims, Examiners find within each of these claims a product-by-process limitation is recited. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. See MPEP §2113.
For example, claims 24, 26-31 and 33-37 recite the AC voltage with the DC high voltage offset is “generated by …” several steps in a process which are used to generate the AC voltage with the DC high voltage offset. Thus, Examiners find the presence of the “AC voltage with the DC high voltage offset” is a product-by-process limitation.
Specifically, Examiners find the process of generating this “AC voltage with the DC high voltage offset” is not positively recited in claims 24, 26-31 and 33-37, rather the process is included in the product-by-process limitation. Conversely, Examiners do find that the process of generating is positively recited in claims 25 and 32. Thus, by claim differentiation, Examiners find that by positively reciting the process to “generate” the “AC voltage with the DC high voltage offset” in claims 25 and 32 implies Applicant intended to not positively claim the process of generating in claims 24, 26-31 and 33-37.
In view of these findings and interpretations and using the broadest reasonable interpretation, Examiners will interpret the “AC voltage with the DC high voltage offset generated by …” limitation as a product-by-process limitation, which is only limited by the product itself without regard or limitation as to how it is generated and thus this limitation is limited to merely an “AC voltage with the DC high voltage offset.”
producing less ozone – claims 24-30
Claims 24-30, in the last paragraph, recite “producing an amount of ozone that is significantly less than that produced by applying only an AC voltage...” Following a review of the specification of the 476 Patent, Examiners find the specification states “[a]nother important advantage of the HVLD technology based on an ADHV is that it produces much less ozone than the conventional HVLD technologies.” See 476 Patent col. 17, lines 49-51. Thus, for this “reducing ozone” step recited in claims 24-30, Examiners find that simply using an ADHV testing system, wherein an AC voltage with a DC high voltage is used for testing, would provide such a reduction in ozone production over typical HVLD testing.
producing lower voltage inside vial – claims 31-37
Claims 31-37 recite “exposing a substance inside the vial to a voltage during the leak testing, wherein the voltage is significantly lower than that produced by applying only an AC voltage through the inspection electrode to the vial.” Following a review of the specification of the 476 Patent, Examiners find the specification states “[o]ne of the main advantages of ADHV testing over the conventional HVLD technology is that the product inside the containers is not exposed to high voltage directly.” See 476 Patent col. 16, line 66 to col. 17, line 1. Thus, for this “lower voltage” step recited in claims 31-37, Examiners find that simply using an ADHV testing system, wherein an AC voltage with a DC high voltage is used for testing, would provide such a lower voltage over typical HVLD testing.
VIII. CLAIM REJECTIONS – 35 U.S.C. §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.
Examiners note the art rejections are being provided herein based on compact prosecution in view of the indefiniteness of the claims and the rejections merely provide guidance as to the state of the prior art.
A. Obviousness Rejections Applying Schonhoff and Hamada
Claims 24, 27, 29-31, 34, 36 and 37 are rejected under 35 U.S.C. §103 as being unpatentable over U.S. Patent Application Publication No. 2018/0100829 to Klaus Schonhoff et al. (hereinafter “Schonhoff”) in view of U.S. Patent No. 4,914,395 to Yoshikazu Hamada (hereinafter “Hamada”).
Regarding claim 24, Schonhoff teaches a method for testing objects for the presence of holes or cracks (See Schonhoff FIGS. 1 and 2, reprinted below) , comprising:
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positioning an object between an inspection electrode and a detection electrode;
See Schonhoff FIGS. 1 and 2 above, object 2 placed between inspection and detection electrodes 3a/3b.
applying an AC voltage with a DC high voltage offset through the inspection electrode to the object, wherein the AC voltage with the DC high voltage offset is generated by electrically connecting the inspection electrode to a high voltage rectifier that is electrically connected to a high voltage pulse autotransformer or a high voltage pulse transformer that is connected to a first DC voltage power supply;
See Schonhoff FIGS. 1 and 2 above, note HV AC and HV DC signals applied through object 2. Further see Schonhoff ¶0018 wherein “[i]n order to safely control such large test voltages, the test voltage is generated by a first controlled voltage source and a second voltage source, the two voltage sources being connected in electrical series” and “[t]he sum of the voltages generated by the two voltage sources is applied as test voltage to the electrodes.” Finally, see ¶0048 wherein “[t]hanks to this circuit arrangement, a series connection of the d.c. voltage source (6) to the alternating voltage source (5) across the discharge path (3c) is produced.”
Note also the product-by-process limitation regarding how the AC voltage with the DC high voltage offset is generated. Since Schonhoff teaches the product, i.e., the same AC voltage with DC high voltage offset, Schonhoff reads on the limitation.
detecting using the detection electrode an electrical current flow through the object induced by the applied AC voltage with the DC high voltage offset; and determining whether there is a leak in the package based on the detected electrical current.
See Schonhoff ¶0017 wherein:
In order to detect microholes and cracks in the test objects, the size of the test voltage is controlled so that it is greater than or equal to the breakdown voltage between the electrodes in air, but smaller than the breakdown voltage through a flawless test object without holes or cracks between the electrodes. By breakdown voltage is meant here that voltage which is needed to let current flow through an insulator.
Further see Schonhoff ¶0021 wherein:
The determination of whether a hole or crack is present in the test object is done by recognizing a breakdown on the discharge path between the electrodes. If a hole or crack occurs in the bottom surface of the object, the insulating action of the test object is lacking in the region of the hole or crack. Since the test voltage is greater than or equal to the breakdown voltage between the electrodes in air, a breakdown occurs on the discharge path between the electrodes, manifested as a current flowing between the electrodes.
Thus, Examiners find that Schonhoff teaches monitoring the voltage across the inspection and detection electrodes 3a/3b to detect a “current flowing between the electrodes” which indicates a leak, i.e., a hole or crack, in the insulating objection.
However, while Schonhoff teaches it method for detecting hole and cracks in general objects, and specifically insulating caps (See Schonhoff ¶0027 testing is for “test objects” or “plastic closure caps”), Schonhoff does not teach testing containers or packages. Nevertheless, Hamada teaches a method for electrical testing insulating objects, particularly, packages, ampules and other containers using a high AC voltage between electrodes for detecting pinholes in the package or container by detecting a discharge current through the electrodes. See Hamada col. 1, lines 7-18, col. 2, lines 49-57 and col. 3, lines 50-62.
Based on these teachings, it would have been obvious at the time the invention was filed to use the testing system and method of Schonhoff to test other objects, such as packages, ampules or other containers as taught by Hamada. One having ordinary skill in the art would do so because as noted in Schonhoff, use of its system and method provides “improved reliability” of testing of the test objects. See Schonhoff ¶0020.
Furthermore, Examiners find such a use of Schonhoff to test the packages, ampules or other containers is merely applying a known techniques to a known products using an identified predictable solution with a reasonable expectation of success. See MPEP §2144(I)(E). First, Examiners find that as noted in each of Schonhoff and Hamada, there is a need in the art to reliably detect defects in container parts, i.e., test objects and caps as taught in Schonhoff (See ¶0013 thereof wherein “the problem which the invention proposes to solve is to create a method for testing consistent test objects for the presence of holes or cracks”), and to detect pinholes in packages, ampules and other containers as taught by Hamada (See col. 2, lines 33-37 thereof, “it is possible to detect a pinhole with high detection accuracy”). Thus, both systems and methods of Schonhoff and Hamada are concerned with detecting holes in test objects with high accuracy. Second, as found above, Examiners find that each of Schonhoff and Hamada teach testing systems for detecting cracks or holes in insulating objects using electrical fields through electrodes. Such detection is accomplished via the monitoring of the discharge or breakdown voltage caused by such cracks or holes in the objects. Third, Schonhoff teaches that the particular applied voltage used for the detection is based object “is controlled so that it is greater than or equal to the breakdown voltage between the electrodes in air, but smaller than the breakdown voltage through a flawless test object without holes or cracks between the electrodes.” See Schonhoff ¶0017. Thus, the testing of packages, ampules, or other containers by the testing system of Schonhoff would be a predictable solution wherein only the applied voltage would merely need to be modified for the specific test object, i.e., the package, ampule or other container, by a simple calibration of the applied voltage. Then, the system and method of Schonhoff could be used to reliably test the specific test object, such as containers or packages, for cracks or holes.
producing an amount of ozone that is significantly less than that produced by applying only an AC voltage through the inspection electrode to the package, wherein the amount of ozone is measurable by hermetically sealing the package, the inspection electrode and the detection electrode inside a chamber and using an ozone detector to detect an ozone level produced when the AC voltage with the DC hich voltage offset is applied, wherein 0.004 ppm of ozone is detected when —18.5 kVpx of the AC voltage with the DC high voltage offset is applied over 5 minutes, whereas G.150 ppm of ozone is detected when only the AC voltage of 18.5 kVp. is apphed over 5 minutes.
As discussed above in the claim interpretation sections, this producing step which results in a lower ozone output is a result of applying the AC voltage with a DC high voltage offset. Since as evidenced above, Schonhoff and Hamada in combination teaches using such a AC voltage with a DC high voltage offset, its operation would similarly produce less ozone compared to AC voltage alone as contemplated and suggested in the 476 Patent. Furthermore, the remaining limitations in this claim paragraph are conditional phrases and thus do not further limit the otherwise positively recited steps in claim 24. Additionally, Examiners find these conditional phrases are met by Schonhoff and Hamada if similar conditions were presented within the system of Schonhoff and Hamada.
Regarding claim 31, Schonhoff teaches a method for testing objects for the presence of holes or cracks (See Schonhoff FIGS. 1 and 2, reprinted below), comprising:
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positioning an object between an inspection electrode and a detection electrode;
See Schonhoff FIGS. 1 and 2 above, object 2 placed between inspection and detection electrodes 3a/3b.
applying an AC voltage with a DC high voltage offset through the inspection electrode to the object, wherein the AC voltage with the DC high voltage offset is generated by electrically connecting the inspection electrode to a high voltage rectifier that is electrically connected to a high voltage pulse autotransformer or a high voltage pulse transformer that is connected to a first DC voltage power supply;
See Schonhoff FIGS. 1 and 2 above, note HV AC and HV DC signals applied through object 2. Further see Schonhoff ¶0018 wherein “[i]n order to safely control such large test voltages, the test voltage is generated by a first controlled voltage source and a second voltage source, the two voltage sources being connected in electrical series” and “[t]he sum of the voltages generated by the two voltage sources is applied as test voltage to the electrodes.” Finally, see ¶0048 wherein “[t]hanks to this circuit arrangement, a series connection of the d.c. voltage source (6) to the alternating voltage source (5) across the discharge path (3c) is produced.”
Note also the product-by-process limitation regarding how the AC voltage with the DC high voltage offset is generated. Since Schonhoff teaches the product, i.e., the same AC voltage with DC high voltage offset, Schonhoff reads on the limitation.
detecting using the detection electrode an electrical current flow through the object induced by the applied AC voltage with the DC high voltage offset; and determining whether there is a leak in the package based on the detected electrical current.
See Schonhoff ¶0017 wherein:
In order to detect microholes and cracks in the test objects, the size of the test voltage is controlled so that it is greater than or equal to the breakdown voltage between the electrodes in air, but smaller than the breakdown voltage through a flawless test object without holes or cracks between the electrodes. By breakdown voltage is meant here that voltage which is needed to let current flow through an insulator.
Further see Schonhoff ¶0021 wherein:
The determination of whether a hole or crack is present in the test object is done by recognizing a breakdown on the discharge path between the electrodes. If a hole or crack occurs in the bottom surface of the object, the insulating action of the test object is lacking in the region of the hole or crack. Since the test voltage is greater than or equal to the breakdown voltage between the electrodes in air, a breakdown occurs on the discharge path between the electrodes, manifested as a current flowing between the electrodes.
Thus, Examiners find that Schonhoff teaches monitoring the voltage across the inspection and detection electrodes 3a/3b to detect a “current flowing between the electrodes” which indicates a leak, i.e., a hole or crack, in the insulating objection.
However, while Schonhoff teaches it method for detecting hole and cracks in general objects, and specifically insulating caps (See Schonhoff ¶0027 testing is for “test objects” or “plastic closure caps”), Schonhoff does not teach testing containers or packages. Nevertheless, Hamada teaches a method for electrical testing insulating objects, particularly, packages, ampules (vials) and other containers using a high AC voltage between electrodes for detecting pinholes in the package or container by detecting a discharge current through the electrodes. See Hamada col. 1, lines 7-18, col. 2, lines 49-57 and col. 3, lines 50-62.
Based on these teachings, it would have been obvious at the time the invention was filed to use the testing system and method of Schonhoff to test other objects, such as packages, ampules (vials) or other containers as taught by Hamada. One having ordinary skill in the art would do so because as noted in Schonhoff, use of its system and method provides “improved reliability” of testing of the test objects. See Schonhoff ¶0020.
Furthermore, Examiners find such a use of Schonhoff to test the packages, ampules (vials) or other containers is merely applying a known techniques to a known products using an identified predictable solution with a reasonable expectation of success. See MPEP §2144(I)(E). First, Examiners find that as noted in each of Schonhoff and Hamada, there is a need in the art to reliably detect defects in container parts, i.e., test objects and caps as taught in Schonhoff (See ¶0013 thereof wherein “the problem which the invention proposes to solve is to create a method for testing consistent test objects for the presence of holes or cracks”), and to detect pinholes in packages, ampules and other containers as taught by Hamada (See col. 2, lines 33-37 thereof, “it is possible to detect a pinhole with high detection accuracy”). Thus, both systems and methods of Schonhoff and Hamada are concerned with detecting holes in test objects with high accuracy. Second, as found above, Examiners find that each of Schonhoff and Hamada teach testing systems for detecting cracks or holes in insulating objects using electrical fields through electrodes. Such detection is accomplished via the monitoring of the discharge or breakdown voltage caused by such cracks or holes in the objects. Third, Schonhoff teaches that the particular applied voltage used for the detection is based object “is controlled so that it is greater than or equal to the breakdown voltage between the electrodes in air, but smaller than the breakdown voltage through a flawless test object without holes or cracks between the electrodes.” See Schonhoff ¶0017. Thus, the testing of packages, ampules (vials), or other containers by the testing system of Schonhoff would be a predictable solution wherein only the applied voltage would merely need to be modified for the specific test object, i.e., the package, ampule or other container, by a simple calibration of the applied voltage. Then, the system and method of Schonhoff could be used to reliably test the specific test object, such as containers or packages, for cracks or holes.
exposing a substance inside the vial to a voltage during the leak testing, wherein the voltage is significantly lower than that produced by applying only an AC voltage through the inspection electrode to the vial, wherein the voltage the substance is exposed to is measurable by positioning a voltage probe on an inside wall of the vial, wherein -300Ver; is measured hy the voltage probe when —18.5 kVp. of the AC voltage with the DC high voltage offset is applied, whereas 7 kK Ver is measured by the voltage probe when only the AC voltage of 18.5 kVp. is applied.
As discussed above in the claim interpretation sections, this exposing step which results in a lower voltage in the substance within the ampule (vial) is a result of applying the AC voltage with a DC high voltage offset. Since as evidenced above, Schonhoff and Hamada teaches using such an AC voltage with a DC high voltage offset, its operation would similarly produce a lower voltage within the substance of the vial in the same manner as contemplated and suggested in the 476 Patent. Furthermore, the remaining limitations in this claim paragraph are conditional phrases and thus do not further limit the otherwise positively recited steps in claim 24. Additionally, Examiners find these conditional phrases are met by Schonhoff and Hamada if similar conditions were presented within the system of Schonhoff and Hamada.
Regarding claims 27, 29, 34 and 36, Schonhoff and Hamada teach the features of claims 24 and 31 as discussed above. However, the combination as proposed above, does not teach the use of a conveyor and moving the inspection electrode along the length of the package/vial. Nevertheless, Hamada further teaches the use of a conveyor system to move the multiple packages between the inspection electrode and the detection electrode and further moving the inspection electrode along a length of the package during testing. See Hamada FIG. 3, conveyor 3 for moving tested object 2 such that the object moves with respect to the conductive elements 4. It would have been obvious at the time the invention was filed to incorporate a conveyer as taught by Hamada into the proposed combination of Schonhoff and Hamada as applied to claims 24 and 41. One having ordinary skill in the art would do so to sequentially test multiple objects moving along the conveyor.
Regarding claims 30 and 37, the proposed combination of teachings of Schonhoff and Hamada teaches the method of claims 29 and 36 and further comprising:
determining a location of the leak based on a position of maximum amplitude of the detected voltage signal levels.
Note combination proposed above for claims 29 and 36. Further see Schonhoff ¶0060 wherein:
The evaluation device (8) recognizes a breakdown on the discharge path (3c) between the upper and the lower electrode (3a, 3b) by the occurrence of a flow of current in the d.c. voltage source (6). If a defective test object is recognized in this way, it is automatically sorted out.
Thus, Schonhoff teaches that the system and method locates a crack or hole in a defective test object on the conveyor based on the detected voltage signal level and automatically sorts it out from the non-defective test objects. This is consistent with the 476 Patent wherein a positional location of the leak is not detected but mere wherein the system “notifies the location of the leak,” i.e., the presence thereof. See 476 Patent col. 18, lines 39-43.
B. Obviousness Rejections Applying Schonhoff, Hamada and Yasumoto
Claims 26 and 33 are rejected under 35 U.S.C. §103 as being unpatentable over Schonhoff and Hamada as applied to claim 18 above, and further in view of U.S. Patent No. 6,634,216 to Kenji Yasumoto (hereinafter “Yasumoto”).
Regarding claims 26 and 33, Examiners find that the proposed combination of Schonhoff and Hamada teaches the testing of packages, ampules, test objects and other containers, but not necessarily a container with water in it. Nevertheless, Yasumoto teaches a method for electrical testing insulating objects, particularly, packages, ampules and other containers using a high AC voltage between electrodes for detecting pinholes in the package or container by detecting a discharge current through the electrodes. See Yasumoto FIG. 2A and disclosure related thereto. Yasumoto further teaches that the contents of the package may contain water, cosmetics, fluids, etc. See Yasumoto col. 5, lines 18-22.
Based on these teachings, it would have been obvious at the time the invention was filed to use the testing system and method of Schonhoff to test other objects, such as packages, ampules or other containers as taught by Hamada and further the package containing water. One having ordinary skill in the art would do so because as noted in Schonhoff, use of its system and method provides “improved reliability” of testing of the test objects. See Schonhoff ¶0020.
Furthermore, Examiners find such a use of Schonhoff to test the packages, ampules or other containers, whether containing water or other materials is merely applying a known techniques to a known products using an identified predictable solution with a reasonable expectation of success. See MPEP §2144(I)(E). First, Examiners find that as noted in each of Schonhoff, Hamada and Yasumoto, there is a need in the art to reliably detect defects in container parts, i.e., test objects and caps as taught in Schonhoff (See ¶0013 thereof wherein “the problem which the invention proposes to solve is to create a method for testing consistent test objects for the presence of holes or cracks”), and to detect pinholes in packages, ampules and other containers as taught by Hamada (See col. 2, lines 33-37 thereof, “it is possible to detect a pinhole with high detection accuracy”) and to inspect completely hermetically sealed packages…for pinholes as taught by Yasumoto (See col. 1, lines 6-8 thereof). Thus, each of the systems and methods of Schonhoff and Hamada are concerned with detecting holes in test objects with high accuracy. Second, as found above, Examiners find that each of Schonhoff, Hamada and Yasumoto teach testing systems for detecting cracks or holes in insulating objects using electrical fields through electrodes. Such detection is accomplished via the monitoring of the discharge or breakdown voltage caused by such cracks or holes in the objects. Third, Schonhoff teaches that the particular applied voltage used for the detection is based object “is controlled so that it is greater than or equal to the breakdown voltage between the electrodes in air, but smaller than the breakdown voltage through a flawless test object without holes or cracks between the electrodes.” See Schonhoff ¶0017. Thus, the testing of packages, ampules, or other containers by the testing system of Schonhoff would be a predictable solution wherein only the applied voltage would merely need to be modified for the specific test object, i.e., the package, ampule or other container, by a simple calibration of the applied voltage. Thus, the system and method of Schonhoff could be used to reliably test the specific test objects, such as packages or containers, for cracks or holes, which may contain water, cosmetics, fluids or other materials as taught by Hamada and Yasumoto.
C. Obviousness Rejections Applying Schonhoff, Hamada and Kovalchick
Claims 28 and 35 are rejected under 35 U.S.C. §103 as being unpatentable over Schonhoff and Hamada as applied to claims 24 and 31 above, and further in view of U.S. Patent No. 6,009,744 to Matthew Kovalchick et al. (hereinafter “Kovalchick”). Regarding claims 28 and 35, the proposed combination of Schonhoff and Hamada teach the features of claims 24 and 31, respectively, as discussed above, but not any rotating of the package. Nevertheless, Kovalchick teaches a turret assembly for rotating several objects about an axis during testing of multiple objects. See Kovalchick FIG. 6, note rotatable turret 50 having multiple testing stations 51 for testing objects. It would have been obvious at the time the invention was made to incorporate a rotating testing assembly as taught by Kovalchick in the combination of Schonhoff and Hamada. One having ordinary skill in the art would do so to allow testing of multiple objects per minute. See Kovalchick col. 3, lines 32-45.
IX. ALLOWABLE SUBJECT MATTER
While all claims are rejected under various grounds as provided above, Examiners nevertheless, find that claims 25 and 32 contain allowable subject matter over the prior art if rewritten in independent form.
For example, regarding claims 25 and 32, while Examiners find the Schonhoff teaches applying an AC voltage signal with a DC high voltage signal to a test object for determining the presence of cracks or pinholes in the test object, such is only performed with a signal DC voltage source in combination with an AC signal source. Specifically, Examiners do not find that Schonhoff or the other prior art of record herein teaches the specific manner of connecting the components as recited in claims 25 and 32 wherein:
“electrically connecting the first DC voltage power supply to the high voltage pulse autotransformer or the high voltage pulse transformer that is electrically connected to a high voltage control board, wherein the high voltage control board is configured to switch the electrical current flow from the first DC voltage power supply through the high voltage pulse autotransformer or the high voltage pulse transformer on and off, in order to generate an AC high voltage at outputs of the high voltage pulse autotransformer or the high voltage pulse transformer;
electrically connecting a second DC voltage power supply to the high voltage control board, a detection board, and a programmable logic controller, wherein the second DC voltage power supply is configured to supply power to the high voltage control board, the detection board, and the programmable logic controller; and
electrically connecting the detection electrode to the detection board, wherein the detection board is electrically connected to the programmable logic controller, wherein the programmable logic controller is configured to determine whether there is a leak in the vial based on the detected electrical current”
in the manner as recited and in combination with the other features of claims.
X. EXAMINERS’ RESPONSES TO APPLICANT’S ARGUMENTS
Examiners have fully considered the Applicant arguments asserted along with the amendments to the claims. However, these arguments are generally moot in view of the new grounds of rejection provided above.
Regarding the art-based rejections that are a