DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status
Acknowledgment is made of the amendment filed on 7/1/2025, which amended claims 1-4, 6-10, 14, 17, 19, and 20. Claims 1-23 are currently pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/1/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8-9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 8, the limitation “wherein said container pressure is an overpressure generated inside said container due to natural warming of said container after sealing said container at cold conditions” is recited in lines 1-3. However, parent claim 1 requires “obtaining a container pressure inside said container during sealing of said container using heat to seal said container” in lines 3-4. Claim 8 appears to require sealing said container at cold conditions instead of “using heat to seal said container” as recited in the parent claim. Therefore, claim 8 does not include the limitation of “using heat to seal said container” and fails to include all the limitations of the claim upon which it depends.
Regarding claim 9, the limitation “wherein said container pressure is an overpressure generated inside said container due to intentional warming of said container after sealing said container at cold conditions” is recited in lines 1-3. However, parent claim 1 requires “obtaining a container pressure inside said container during sealing of said container using heat to seal said container” in lines 3-4. Claim 9 appears to require sealing said container at cold conditions instead of “using heat to seal said container” as recited in the parent claim. Therefore, claim 9 does not include the limitation reciting “using heat to seal said container” and fails to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Thus, claims 8 and 9 are rejected as being of improper dependent form. Appropriate correction is required.
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.
Claims 1-7, 10, 11, 13, 14, 16, 17, 19, 20, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Forestelli et al. (US PGPub 2013/0199127, Forestelli hereinafter) in view of Bardou et al. (US PGPub 2008/0156804, Bardou hereinafter).
Regarding claim 1, Forestelli discloses a method of determining an integrity of a container (Figs. 1-2, abstract, paras. [0009]-[0010], [0089]-[0090], a container 11 is inspected to determine sealing), said method comprising:
obtaining a container pressure inside said container during sealing of said container (Figs. 1-2, abstract, paras. [0003], [0006], [0009],[0018]-[0019], [0051], [0058], [0089]-[0090], [0096], a pressure inside the container 11 is produced by sealing the container under conditions including a temperature of the container);
transmitting a light signal through a headspace of said container using an optical sensor (Fig. 1, paras. [0038]-[0045], [0052]-[0055], [0098]-[0101], the device 16 includes a laser source 17 to emit a laser beam 18 through the head space 13. The transmitted beam is detected by detector 19);
said optical sensor being sensitive to at least one gas (Fig. 1B, paras. [0015], [0043]-[0046], [0100]-[0101], the emission wavelength is selected to coincide with the absorption wavelength of the gas of interest, and the detector 19 detects the laser beam and provides information on the spectrum for the absorption by the carbon dioxide in the head space 13);
detecting a transmitted light signal (Fig. 1B, paras. [0015], [0043]-[0046], [0055], [0100]-[0101], the detector 19 detects the transmitted laser beam);
determining, based on said transmitted light signal being detected, said integrity of said container (Figs. 1-2, paras. [0054]-[0055], [0058], [0089], [0090], [0100]-[0112], the detection of the carbon dioxide concentration over time is used to indicate loss of sealing). Forestelli does not appear to explicitly describe using heat to seal said container, said container pressure inside said container being different from a surrounding pressure outside of said container.
Bardou discloses obtaining a container pressure inside said container during sealing of said container using heat to seal said container, said container pressure inside said container being different from a surrounding pressure outside of said container (Figs. 4-6, paras. [0015], [0019], [0034], [0046]-[0048], [0054], [0060]-[0067], [0069], containers are sealed using heat, and the internal container pressure is different from the ambient pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included using heat to seal said container, said container pressure inside said container being different from a surrounding pressure outside of said container as taught by Bardou in obtaining the container pressure in the method as taught by Forestelli since including using heat to seal said container, said container pressure inside said container being different from a surrounding pressure outside of said container is commonly used to package material for preservation and storage (Bardou, paras. [0002], [0009]).
Regarding claim 2, Forestelli as modified by Bardou discloses having a temperature of said container to reach an equilibrium with the surrounding before transmitting the signal (Forestelli, Figs. 1-2, paras. [0096]-[0100], the container 11 is placed in measuring area 20 and subjected to thermal mixing to bring the container 11 to an equilibrium condition prior to measuring partial pressure or concentration of carbon dioxide).
Regarding claim 3, Forestelli as modified by Bardou discloses comprising determining said container pressure inside said container and/or a concentration of said at least one gas inside said container based on said transmitted signal being detected (Forestelli, Figs. 1-2, paras. [0015]-[0016], [0038], [0043]-[0046], [0058], [0097]-[0101], the concentration or partial pressure of carbon dioxide present in the head space of the container is detected using the detector 19 of laser spectroscopy device 16).
Regarding claim 4, Forestelli as modified by Bardou discloses using said container pressure inside said container and/or a concentration of at least one gas inside said container for determining the integrity of said container (Forestelli, Figs. 1-2, paras. [0015]-[0016], [0038], [0043]-[0046], [0058], [0089]-[0090], [0097]-[0112], the concentration or partial pressure of carbon dioxide present in the head space is used to indicate loss of sealing).
Regarding claim 5, Forestelli as modified by Bardou discloses wherein said optical sensor is a light source and a detector and said light is transmitted between said light source and said detector, wherein said detected light signal is an absorption signal (Forestelli, Figs. 1-2, paras. [0015], [0038]-[0046], [0052]-[0055], [0058], a laser spectroscopy device 16 includes a laser source 17 and a detector 19 that detects the absorption of the laser beam by the carbon dioxide present in the headspace).
Regarding claim 6, Forestelli as modified by Bardou does not appear to explicitly describe where said container pressure is an under pressure generated inside said container due to natural cooling of said container after sealing said container using heat (Bardou, Figs. 4-6, paras. [0015], [0019], [0034], [0036], [0046]-[0049], [0054], [0060]-[0067], [0069], containers are sealed using heat, and the internal container pressure is lower than the ambient pressure due to natural cooling).
Regarding claim 7, Forestelli as modified by Bardou does not appear to explicitly describe where said container pressure is an under pressure generated inside said container due to intentional cooling of said container after sealing said container using heat (Bardou, Figs. 4-6, paras. [0015], [0019], [0034], [0036], [0046]-[0049], [0054], [0060]-[0067], [0069], containers are sealed using heat, and the internal container pressure is lower than the ambient pressure due to cooling by refrigeration).
Regarding claim 10, Forestelli as modified by Bardou discloses determined said container pressure inside said container using an absorption signal of said gas being present in said container (Forestelli, Figs. 1-2, paras. [0015], [0038]-[0046], [0052]-[0055], [0058], a laser spectroscopy device 16 detects the absorption of the laser beam by the carbon dioxide present in the headspace).
Regarding claim 11, Forestelli as modified by Bardou discloses detecting a leak in said container, compared to an intact container, by observing an increase or decrease of said pressure inside said container (Forestelli, Figs. 1-2, paras. [0054]-[0055], [0058], [0089], [0090], [0100]-[0112], the detection of the carbon dioxide concentration over time is used to indicate loss of sealing by comparing with acceptability ranges).
Regarding claim 13, Forestelli as modified by Bardou discloses detecting a leak by not detecting said gas expected to be present in said container, or a lower concentration than expected of said gas (Forestelli, Figs. 1-2, paras. [0054]-[0055], [0058], [0089], [0090], [0100]-[0112], the detection of the carbon dioxide concentration over time is used to indicate loss of sealing by comparing with acceptability ranges).
Regarding claim 14, Forestelli as modified by Bardou discloses wherein said gas is present in the surrounding (Forestelli, Figs. 1-2, paras. [0015]-[0016], [0038], [0043]-[0046], [0058], [0097]-[0101], laser spectroscopy device 16 detects the absorption of the laser beam by the carbon dioxide present in the headspace, and carbon dioxide is present in a surrounding atmosphere).
Regarding claim 16, Forestelli as modified by Bardou discloses wherein a force is applied on said container using a mechanical member (Forestelli, Figs. 1-2, paras. [0047]-[0050], [0096]-[0100], mixing means 12 includes a mechanical mixer to apply a force to container 11).
Regarding claim 17, Forestelli discloses a system for determining an integrity of a container (Figs. 1-2, abstract, paras. [0009]-[0010], [0089]-[0090], a container 11 is inspected to determine sealing), wherein said system comprises:
a position for filling and/or sealing said container using heat or at cold conditions thereby obtaining a pressure inside said container (Figs. 1-2, abstract, paras. [0003], [0006], [0009], [0019], [0051], [0058]-[0063], [0089]-[0090], [0096], a pressure inside the container 11 is produced by filling the containers 11 at filling station 110 and by capping and sealing the containers 11 at closing station 120 under conditions that include a temperature of the containers);
an optical sensor (Figs. 1-2, device 16 for spectroscopy) for transmitting a light signal through a gas filled portion of said container, and detecting a transmitted light signal (Fig. 1, paras. [0038]-[0046], [0052]-[0055], [0098]-[0101], the device 16 includes a laser source 17 to emit a laser beam 18 through the head space 13. The transmitted beam is detected by detector 19);
said optical sensor being sensitive to at least one gas (Fig. 1B, paras. [0015], [0043]-[0046], [0100]-[0101], the emission wavelength is selected to coincide with the absorption wavelength of the gas of interest, and the detector 19 detects the laser beam and provides information on the spectrum for the absorption by the carbon dioxide in the head space 13); and
a control unit (Fig. 2, control stations 140 and processing unit 150) configured for determining, based on said transmitted light signal being detected, said integrity of said container (Figs. 1-2, paras. [0038]-[0040], [0054]-[0056], [0058]-[0059], [0075]-[0081], [0086]-[0092], [0095], [0098]-[0112], the group 10 measures the quantity of dissolved carbon dioxide measured by device 16 for spectroscopy, and control stations 140 and processing unit 150 determines the loss of sealing and unsuitability of the container). Forestelli does not appear to explicitly describe then sealing said container using heat to seal said container, the pressure inside the container is different from a pressure surrounding said container.
Bardou discloses a position for filling and then sealing using heat to seal said container, thereby obtaining a pressure inside said container which is different from a pressure surrounding said container (Figs. 4-6, paras. [0015], [0019], [0033]-[0034], [0043], [0046]-[0048], [0054]-[0056], [0060]-[0067], [0069], containers are filled and sealed using heat, and the internal container pressure is different from the ambient pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a position for filling and then sealing using heat to seal said container, thereby obtaining a pressure inside said container which is different from a pressure surrounding said container as taught by Bardou in the system as taught by Forestelli since including a position for filling and then sealing using heat to seal said container, thereby obtaining a pressure inside said container which is different from a pressure surrounding said container is commonly used to package material for preservation and storage (Bardou, paras. [0002], [0009]).
Regarding claim 19, Forestelli as modified by Bardou discloses wherein said under pressure is a partial vacuum (Bardou, Figs. 4-6, paras. [0015], [0019], [0034], [0036], [0046]-[0049], [0054], [0060]-[0067], [0069], containers are sealed using heat, and the internal container pressure is lower than the ambient pressure due to natural cooling).
Regarding claim 20, Forestelli as modified by Bardou discloses wherein said under pressure is a partial vacuum (Bardou, Figs. 4-6, paras. [0015], [0019], [0034], [0036], [0046]-[0049], [0054], [0060]-[0067], [0069], containers are sealed using heat, and the internal container pressure is lower than the ambient pressure due to cooling by refrigeration).
Regarding claim 21, Forestelli as modified by Bardou as modified by discloses wherein said surrounding is a normal atmosphere (Forestelli, Figs. 1-2, paras. [0015]-[0016], [0038], [0043]-[0046], [0058], [0075]-[0080], [0089]-[0090], [0097]-[0101], the closed container 11 is inspected in inspection area 20’ in a plant 100).
Regarding claim 22, Forestelli as modified by Bardou discloses wherein said normal atmosphere is air (Forestelli, Figs. 1-2, paras. [0015]-[0016], [0022]-[0023], [0026]-[0027], [0038], [0043]-[0046], [0058], [0075]-[0080], [0089]-[0090], [0097]-[0101], the closed container 11 is inspected in inspection area 20’ in a plant 100).
Regarding claim 23, Forestelli as modified by Bardou discloses wherein said gas filled portion is a headspace (Forestelli, Figs. 1-2, abstract, paras. [0015]-[0019], [0038]-[0048], [0051], [0058]-[0063], [0089]-[0090], [0096]-[0102], the containers 11 include head space 13 filled with gas).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Forestelli as modified by Bardou as applied to claim 1 above, and further in view of Outreman (US PGPub 2010/0018166).
Regarding claim 8 Forestelli as modified by Bardou discloses sealing said container (Forestelli, Figs. 1-2, paras. [0047]-[0051], [0096]-[0100], the container 11 is produced and sealed, and as modified by Bardou, Figs. 4-6, paras. [0015], [0019], [0034], [0046]-[0048], [0054], [0060]-[0067], [0069], containers are sealed using heat, and the internal container pressure is different from the ambient pressure), but Forestelli as modified by Bardou does not appear to explicitly describe wherein said container pressure is an overpressure generated inside said container due to natural warming of said container after sealing said container at cold conditions.
Outreman discloses wherein said container pressure is an overpressure generated inside said container due to warming of said container after treating said container at cold conditions (para. [0097], the container is produced and filled while cooling the container and further heated to generate internal overpressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein said container pressure is an overpressure generated inside said container due to warming of said container after treating said container at cold conditions as taught by Outreman after sealing in the method as taught by Forestelli since including wherein said container pressure is an overpressure generated inside said container due to warming of said container sealing said container at cold conditions is commonly used to relieve stresses and compensate for deformations of the container (Outreman, para. [0097]). Although Forestelli as modified by Bardou in view of Outreman discloses warming of said container (Outreman, para. [0097]), Forestelli as modified by Bardou Outreman does not appear to explicitly describe natural warming. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included natural warming of said container as the warming in the method as taught by Forestelli as modified by Bardou in view of Outreman since including wherein said container pressure is an overpressure generated inside said container due to natural warming of said container after sealing said container at cold conditions is commonly used to relieve stresses and compensate for deformations of the container (Outreman, para. [0097]) in conditions in which the wait time for warming is non-critical to the process and excess heat input is undesired to prevent damage to the container material.
Regarding claim 9, Forestelli discloses sealing said container (Figs. 1-2, paras. [0047]-[0051], [0096]-[0100], the container 11 is produced and sealed, and as modified by Bardou, Figs. 4-6, paras. [0015], [0019], [0034], [0046]-[0048], [0054], [0060]-[0067], [0069], containers are sealed using heat, and the internal container pressure is different from the ambient pressure), but Forestelli as modified by Bardou does not appear to explicitly describe wherein said container pressure is an overpressure generated inside said container due to intentional warming of said container after sealing said container at cold conditions.
Outreman discloses wherein said pressure is an overpressure generated inside said container due to intentional warming of said container after treating said container at cold conditions (para. [0097], the container is produced and filled while cooling the container and further heated to generate internal overpressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein said container pressure is an overpressure generated inside said container due to intentional warming of said container after treating said container at cold conditions as taught by Outreman after sealing in the method as taught by Forestelli as modified by Bardou since including wherein said container pressure is an overpressure generated inside said container due to intentional warming of said container after sealing said container at cold conditions is commonly used to relieve stresses and compensate for deformations of the container (Outreman, para. [0097]).
Claims 12, 18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Forestelli as modified by Bardou as applied to claims 1, 5, and 21 above, and further in view of Lundin (US PGPub 2018/0095000).
Regarding claim 12, Forestelli as modified by Bardou does not appear to explicitly describe detecting a leak by detecting said gas not expected to be present in said container, or a higher concentration than expected of said gas.
Lundin discloses detecting a leak by detecting said gas not expected to be present in said container, or a higher concentration than expected of said gas (Fig. 1, paras. [0007]-[0013], [0055]-[0062], [0084], [0090]-[0091], the container is subjected to outside pressure or gas composition, and a leak is detected by determining a change in pressure or gas composition inside the container).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included detecting a leak by detecting said gas not expected to be present in said container, or a higher concentration than expected of said gas as taught by Lundin in the method as taught by Forestelli as modified by Bardou since including detecting a leak by detecting said gas not expected to be present in said container, or a higher concentration than expected of said gas is commonly used to efficiently and non-destructively determine container integrity at high speed (Lundin, paras. [0006]-[0008], [0065]).
Regarding claim 18, Forestelli as modified by Bardou does not appear to explicitly describe wherein said absorption signal is a tunable diode laser spectroscopy signal (TDLAS).
Lundin discloses wherein an absorption signal is a tunable diode laser spectroscopy signal (TDLAS) (Fig. 2, paras. [0021], [0038], [0062], [0085], the bottle is inspected by a tunable diode laser absorption spectroscopy sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein an absorption signal is a tunable diode laser spectroscopy signal (TDLAS) as taught by Lundin in the method as taught by Forestelli as modified by Bardou since including wherein an absorption signal is a tunable diode laser spectroscopy signal (TDLAS) is commonly used to non-intrusively detect the presence of oxygen in a bottle (para. [0085]).
Regarding claim 22, a further interpretation of Forestelli as modified by Bardou does not appear to explicitly describe wherein said normal atmosphere is air.
Lundin discloses wherein said normal atmosphere is air (Fig. 1, paras. [0007], [0011]-[0013], [0034]-[0036], [0055]-[0056], the container is surrounded by atmospheric air).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein said normal atmosphere is air as taught by Lundin in the method as taught by Forestelli as modified by Bardou since including wherein said normal atmosphere is air is commonly used to increase diffusion into the container to effectively detect leakage (Lundin, paras. [0012], [0056]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Forestelli as modified by Bardou as applied to claim 1 above, and further in view of Hansen (US PGPub 2016/0120749).
Regarding claim 15, Forestelli as modified by Bardou does not appear to explicitly describe wherein said container is an ampoule or a Blow Fill Seal package.
Hansen discloses wherein said container is an ampoule or a Blow Fill Seal package (Figs. 1-5, abstract, para. [0007], a blow-fill-seal package is produced).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein said container is an ampoule or a Blow Fill Seal package as taught by Hansen in the method as taught by Forestelli as modified by Bardou since including wherein said container is an ampoule or a Blow Fill Seal package is commonly used to provide a sterile container for pharmaceutical products (Hansen, paras. [0005], [0037]).
Response to Arguments
Applicant’s arguments with respect to claims 1-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA A. RIDDLE whose telephone number is (571)270-7538. The examiner can normally be reached M-Th 6:30AM-5PM.
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/CHRISTINA A RIDDLE/Primary Examiner, Art Unit 2882