DETAILED ACTION
Applicant’s response, filed Nov 3 2025, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Status
Claims 46, 48-57, and 59-65 are pending.
Claims 1-45, 47, and 58 are canceled.
Claims 46, 48-57, and 59-65 are rejected.
Priority
The instant Application claims domestic benefit to US provisional application 62/536,028, filed 24 Jul 2017.
Accordingly, each of claims 46, 48-57, and 59-65 are afforded the effective filing date of 24 Jul 2017.
Claim Rejections- 35 USC § 112
The outstanding rejections to the claims are withdrawn in view of the amendments submitted herein.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
A. Claims 46, 48-53, 55-57, 59-63, and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Wensley et al. (US 2013/0205719; previously cited) in view of Samaritani et al. (US 2006/0147480; previously cited), Kinsley (Chemical Engineering Progress, February 2001, p. 57-61; previously cited), and Abrahamson et al. (US 2002/0010164; previously cited). Any newly recited portions are necessitated by claim amendment.
Claim 46 recites a method of controlling oxygen content in a headspace of a sealed container containing a recombinant protein.
Wensley discloses vial preparation methods (abstract). Wensley, indicated by the bullet points, teaches the instant features as follows.
The method of claim 46 comprises:
(a) performing a cycle of oxygen reduction by evacuating an unsealed container containing the recombinant protein in a liquid pharmaceutical formulation that includes water in a vacuum chamber at Pvacuum, wherein Pvacuum is a pressure of from about 0.05 bar to about 0.15 bar, and aerating the unsealed container in the vacuum chamber with non-oxidizing gas at an aeration pressure of from 800 mbar to 1000 mbar;
Wensley teaches housing vials with a volume of a substance and an unfilled volume in a temperature-controlled environment, where the vial stoppers are partially inserted to allow gas transfer between the unfilled volume and an external volume [0008]. Wensley teaches that the substance may be in a liquid form which is an aqueous solution (i.e., water) [0026] and may be oxygen-sensitive pharmaceutical compositions [0123]. Wensley teaches applying a vacuum to the environment to reduce pressure in the environment and in the unfilled volume of each vial to a first pressure level, and venting an inert gas into the environment to raise the pressure in the environment and in the unfilled volume of each vial to a second pressure level [0009-0010].
Wensley teaches that when a first temperature set-point is greater than freezing, the first pressure level (i.e., Pvacuum) is between 10 mbar to 300 mbar [0022]. Wensley therefore teaches an overlapping range which encompasses or alternatively makes obvious the instantly claimed range of 0.05 bar to 0.15 bar, or 50 mbar to 150 mbar. It would have been prima facie obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that: “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages” In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Wensley teaches that when the first temperature set-point is greater than freezing, the second pressure level (i.e., aeration pressure) is between 800 mbar to 1000 mbar [0022], which encompasses the instantly claimed range of 800-1000 mbar.
See below for teachings by Samaritani regarding a recombinant protein.
(b) calculating an end % oxygen content following step (a) via equation (I):
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wherein %O2,start is the % oxygen content at the start of the cycle, Pvacuum is an evacuation pressure applied in the cycle of oxygen reduction, Paeration is a pressure higher than Pvacuum but less than 1 bar, and %O2,end is the % oxygen content at the end of the cycle;
Wensley teaches a first pressure which is lower than a second pressure, as described above.
See below for teachings by Kinsley regarding equation (I).
(c) repeating steps (a) and (b) until the end % oxygen content is below a desired % oxygen content; and
Wensley teaches repeating applying the vacuum, venting an inert gas into the environment, and resting the vials in the inert gas at least once [0012].
(d) sealing the container;
Wensley teaches fully inserting the stopper into each opening to seal each vial after repeating their method [0013].
wherein the unsealed container starts with air having about 21% oxygen above the liquid pharmaceutical formulation in the initial cycle, and
Wensley teaches that prior to applying the vacuum, the unfilled volume contains a substantially atmospheric level of oxygen gas [0024; 0039; 0059; 0084; 0122; 0137; 0150]. As the specification as published discloses that atrmospheric levels of oxygen are ~21% [0100], it is considered that Wensley fairly teaches the limitation.
wherein the method is performed without change of concentration of the recombinant protein in the liquid pharmaceutical formulation.
Wensley does not explicitly teach this limitation. See Abrahamson below.
Although Wensley teaches that the liquid formulation may be suitable for use as a pharmaceutical composition and may comprise an oxygen-sensitive cancer treatment formulation, an oxygen-sensitive cardiovascular treatment formulation, an oxygen-sensitive anaesthetic formulation, an oxygen-sensitive pain management formulation or an oxygen-sensitive antibiotic formulation [0123], Wensley does not explicitly teach a substance which is a recombinant protein. Wensley also does not teach the formula of step (b) or a method which is performed without change of concentration of the recombinant protein in the liquid pharmaceutical formulation.
However, Samaritani discloses pharmaceutical formulations of multiple recombinant proteins (abstract and at least [0003]). Samaritani teaches storing the recombinant proteins in liquid formats, at least at [0010].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Wensley and Samaritani because both references disclose methods for storing pharmaceutical formulations. Samaritani motivates removing oxygen from the stored recombinant proteins by teaching that oxidation can lead to protein formulation instability [0052]. It would have been obvious to modify the method of Wensley to select parameters appropriate for proteins, because Wensley already teaches those parameters (a single temperature set-point [0016]; a temperature of less than 10°C or 5°C [0017]). One could have therefore combined the elements as claimed by the known methods of Wensley and Samaritani, and that in combination, each element merely would have performed the same function as it did separately for the predictable result of removing oxygen in the headspace of a vial storing a recombinant protein.
Neither Wensley nor Samaritani teach the formula of step (b) or a method which is performed without change of concentration of the recombinant protein in the liquid pharmaceutical formulation.
However, Kinsley discloses methods for purging and inerting process vessels (p. 57, col. 2, par. 1). Kinsley teaches that the steps in a vacuum purge are (1) drawing a vacuum on the vessel until the desired level is achieved, (2) relieving the vacuum with an inert gas such as nitrogen to atmospheric pressure, and (3) repeating Steps 1 and 2 until the desired oxygen concentration is reached (p. 58, col. 2, par. 1). Kinsley teaches at p. 58, col. 2, par. 2, calculating the oxygen concentration x after k purge cycles (vacuum and relief) (i.e., %O2,end) based on the pressure limits PL (i.e., Pvacuum) and PH, (i.e., Paeration) using equation 1:
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.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Wensley in view of Samaritani with Kinsley because Wensley and Kinsley both teach methods for vacuum purging of vessels. The motivation to apply the calculation taught by Kinsley would have been to calculate the number of repeat cycles required to reach the desired oxygen concentration (p. 58, col. 2, par. 2). One could have therefore combined the elements as claimed by the known methods of Wensley in view Samaritani and Kinsley, and that in combination, each element merely would have performed the same function as it did separately for the predictable result of removing oxygen in the headspace of a vial storing a recombinant protein over the course of a number of cycles until the desired oxygen content is reached.
Neither Wensley, Samaritani, nor Kinsley teach a method which is performed without change of concentration of the recombinant protein in the liquid pharmaceutical formulation.
However, the prior art to Abrahamson discloses a process for preparing a stable unit dose of 1α, 25-dihydroxycholecalciferol (i.e., a liquid pharmaceutical formula) in a sealed vial (abstract). Abrahamson teaches drawing a vacuum on the headspace of the container in a sealed container and purging the headspace for any remaining undesirable gas to substantially remove any remaining undesirable gasses in the process environment and in the composition, filling the chamber with an inert gas, and regulating the pressure within the chamber during the process using a programmable logic controller (PLC) to alternately draw a vacuum inside the chamber and flush the chamber with nitrogen [0074]. Abrahamson teaches that the process is monitored to avoid evacuation vacuum levels that asymptotically approach the critical vapor pressure or boiling point of the drug solution in order to achieve vacuum levels as close as is practicable to the boiling point of the composition [0075]. Abrahamson teaches that the single completion of the vacuum and purging steps results in a portion of the original oxygen and other undesirable gasses in the headspace being evacuated from the chamber [0075], and that successive flushing and purging cycles further reduce total concentration of oxygen and other undesirable gasses in the headspace and allow for controlled manipulation of the levels of undesirable gasses, particularly oxygen, in the container headspace, to extremely low levels [0076].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Wensley in view of Samaritani with Kinsley with Abrahamson because Wensley and Abrahamson both teach methods for preparing aqueous pharmaceutical compositions for storage by removing oxygen from the headspace of the storage container. The motivation to monitor the pressure of the container during the vacuum and purging stage would have been to avoid evacuation vacuum levels that approach the critical vapor pressure or boiling point, as taught by Abrahamson [0075]. Therefore, it would have been obvious to one of ordinary skill in the art to modify the pressure ranges of Wensley to approach, but not go below, the vapor pressure of water in order to avoid boiling the sample, using the method of Abrahamson, thereby also avoiding changes in the concentration of the sample in the liquid formulation.
Regarding claims 48-52, Wensley in view of Samaritani, Kinsley, and Abrahamson teach the method of claim 46. The claims add that the desired % oxygen content is less than about 5% (claim 48), less than about 2% (claim 49), less than about 1% (claim 50), about 0.1% (claim 51), and less than about 0.1% oxygen (claim 52). Wensley teaches achieving average headspace oxygen levels between 0.20%-0.30%, but down to 0.01% [0168]. Wensley therefore teaches an overlapping range which encompasses or alternatively makes obvious the instantly claimed range of 5% down less than 0.1% oxygen. Regarding claim 51, it would have been prima facie obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that: “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages” In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Regarding claim 53, Wensley in view of Samaritani, Kinsley, and Abrahamson teach the method of claim 46. The claim adds that the method is performed at a temperature in a range from about 15-25°C. Wensley also teaches a range of 18 to 24°C applied during both reduced pressure and at 900 mbar [0156-0163]. As Wensley teaches a range of 18 to 24°C, it is considered that this range anticipates the instantly claimed range of 15-25°C.
Regarding claims 55-56, Wensley in view of Samaritani, Kinsley, and Abrahamson teach the method of claim 46. The claims add that the cycle is performed fewer than 8 times (claim 55) and that the cycle is performed twice (claim 56). Wensley teaches that repeating of the applying, venting and allowing (i.e., the cycle) may be performed at least twice [0023]. Wensley therefore teaches an overlapping range which encompasses or alternatively makes obvious the instantly claimed range of repeating the cycle twice or fewer than 8 times. It would have been prima facie obvious, in view of the fact that Wensley discloses that the cycles can be repeated a number of times effective to reduce an oxygen gas content to a desired content [0023], to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that: “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages” In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Regarding claim 57, Wensley in view of Samaritani, Kinsley, and Abrahamson teach the method of claim 46. The claim adds that the liquid pharmaceutical formulation contains the recombinant protein at a concentration of from 1 mg/ml to 200 mg/ml. Wensley does not teach a recombinant protein.
However, Samaritani teaches that the protein hormone in the formulation from concentrations of about 1.0 µg/ml to about 50 mg/ml, although lower and higher concentrations are operable [0171]. Samaritani therefore teaches an overlapping range which anticipates or alternatively makes obvious the instantly claimed range of 1 mg/ml to 200 mg/ml. It would have been prima facie obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). See also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Regarding claim 59, Wensley in view of Samaritani, Kinsley, and Abrahamson teach the method of claim 46. The claim adds that the pressure in the chamber is measured via a Pirani vacuum gauge. Wensley teaches that the pressure sensor may comprise a thermal conductivity Pirani gauge [0115], which is considered to read on a Pirani vacuum gauge.
Regarding claim 60, Wensley in view of Samaritani, Kinsley, and Abrahamson teach the method of claim 46. The claim adds that the evacuation and aeration of the chamber is controlled to eliminate bubbling of the liquid pharmaceutical formulation, which Wensley does not teach.
However, Abrahamson teaches that the process is monitored to avoid evacuation vacuum levels that asymptotically approach the critical vapor pressure or boiling point of the drug solution in order to achieve vacuum levels as close as is practicable to the boiling point of the composition [0075]. The boiling point is considered to read on bubbling as recited in instant claim 60.
Regarding claim 61, Wensley in view of Samaritani, Kinsley, and Abrahamson teach the method of claim 46. The claim adds that the container is a vial. Wensley teaches methods for vial preparation (see at least the abstract and [0007-0014]).
Regarding claim 62, Wensley in view of Samaritani, Kinsley, and Abrahamson teach the method of claims 46 and 61. The claim adds that the vial comprises a stopper having one or more vent legs. Wensley teaches that the stoppers used in the method are disc shaped and have a pair of downward projections (i.e., legs) that define a straight diametrical slot or gap therebetween with one or more apertures formed in the downward projections which allow adequate gas transfer (i.e., venting) between the headspace and the external volume of the chamber when the stopper is partially inserted [0124-0125].
Regarding claim 63, Wensley in view of Samaritani, Kinsley, and Abrahamson teach the method of claim 46. The claim adds that the recombinant protein in the liquid pharmaceutical formulation is stable for a period of at least three months when stored at 45°C, wherein stable for at least three months refers to an increase in percentage of high molecular weight species of no more than 1% over the period. While Wensley does not teach a recombinant protein, the method of Wensley in view of Samaritani, Kinsley, and Abrahamson is considered to teach the method of claim 46 as described above. Claim 63 does not add any active steps to the method of claim 46, but only further limits the product of the method. Therefore the limitations is interpreted as a functional limitation which only states a problem solved or a result obtained (see MPEP 2173.05(g)), and as the method Wensley in view of Samaritani, Kinsley, and Abrahamson which teaches claim 46, it is considered to produce a recombinant protein in the liquid pharmaceutical formulation which would be stable for a period of at least three months when stored at 45°C, as instantly claimed.
Regarding claim 65, Wensley in view of Samaritani, Kinsley, and Abrahamson teach the method of claim 46. The claim adds that the non-oxidizing gas is nitrogen, which Wensley teaches at least at [0127].
B. Claims 54 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Wensley, Samaritani, Kinsley, and Abrahamson, as applied to claims 46 and 63 above, and in further view of Ogez et al. (US 2018/0043020; priority to 20 Apr 2016; previously cited). Any newly recited portions are necessitated by claim amendment.
Regarding claim 54, Wensley in view of Samaritani, Kinsley, and Abrahamson teach the method of claim 46. Claim 54 adds that a duration of the cycle is about 7 minutes. Wensley teaches only a cycle of 15 minutes at the shortest [0021].
However, the prior art to Ogez discloses formulations of drug substances with reduced immunogenicity or stabilized drug products (abstract). Ogez teaches that drug products include biological drug substances, like protein drugs [0002; 0038]. Ogez teaches a method for filling a container with an aqueous drug substance solution, subjecting the container with aqueous drug substance solution to a pressure vacuum [0027; 0036] from about 22-100 mbar [0028], purging the container with at least one soluble gas, inserting a stopper into the open end of the container to create a headspace of soluble gas, and storing the container [0026; 0036]. Ogez teaches that the degassing and purging steps may be repeated [0036]. Ogez teaches that suitable soluble gases include non-reactive or inert gases [0205; 0210-0211]. Ogez teaches that degassing, or removing molecules in a gaseous state from a container, may occur for 2 minutes or more, from 0.5 minutes to 60 minutes, including about 1, 2, 3, 5, and 10 minutes [0202]. Ogez specifically teaches examples of performing degassing at 2 minutes at a pressure 250 Torr or less [0298; 0316; 0328]. Ogez teaches that the duration that a vacuum is applied to a container, a container is purged with a soluble gas, or a solution is exposed to a soluble gas does not exceed 5 seconds up to 1800 seconds (i.e., 3 minutes) [0405]. Therefore, the teachings of Ogez cover an embodiment where repeated cycles (i.e., 2 cycles) each consist of applying a vacuum to a container, purging with a soluble gas, and exposing the solution to a soluble gas for up to 3 minutes each. Ogez therefore teaches an overlapping range which encompasses or alternatively makes obvious the instantly claimed range of a duration of a cycle of about 7 minutes. It would have been prima facie obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that: “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages” In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Regarding claim 64, Wensley in view of Samaritani, Kinsley, and Abrahamson teach the method of claims 46 and 63. The claim adds that the recombinant protein is an antigen-binding protein, monospecific antibody, or a bispecific antibody. Wensley does not teach a recombinant protein.
However, Ogez teaches that the biological drug substance can be antibody (claim 15; [0038; 0187-0190]), which reads on antigen-binding molecule because the instant specification as published discloses that an “antigen-binding molecule” includes antibodies [0031]. Ogez also teaches monoclonal antibodies [0003; 0188; 0468], which reads on a monospecific antibody as instantly claimed.
Regarding claims 54 and 64, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Wensley in view of Samaritani, Kinsley, and Abrahamson with Ogez because Wensley and Ogez both teach methods for preparing aqueous pharmaceutical compositions for storage. The motivation to use the method of Ogez would have been to reduce or eliminate headspace in containers for pharmaceutical use in order to produce a stable drug without the use of surfactants or other stabilizing excipients, as taught by Ogez [0018].
Response to Applicant Arguments
At p. 5-9, Applicant submits that Wensley does not teach a method which avoids evaporation of the liquid sample in the vial and that none the other applied references remedy Wensley’s deficiencies.
Applicant submits that Abrahamson teaches flushing a container with its aqueous formulation prior to vacuum and purging, which would likely result in evaporation. Applicant submits that the Abrahamson’s teaching of “stringent control of the oxygen levels in the headspace” to decrease total oxygen levels would encourage evaporation. Applicant submits that Abrahamson teaches starting with an unsealed container which already has a reduced oxygen content. It is respectfully submitted that this is not persuasive. The portions of Abrahamson regarding flushing a container with its aqueous formulation prior to vacuum and purging and starting with an already reduced oxygen content vial are not relied upon in the above rejection. Only the teaching of regulating the pressure within the chamber during the process using a programmable logic controller (PLC) to alternately draw a vacuum inside the chamber and flush the chamber with nitrogen in order to avoid boiling the composition is relied upon. Combining this feature of Abrahamson with the method of Wensley for filling a vial, applying a vacuum, and purging with an inert gas is considered to result in a safeguard which would prevent boiling of the sample during vacuum and purging cycles, and therefore would avoid sample loss and changes in concentration. MPEP 2123 discloses that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art.
Applicant submits that Samaritani relates to freeze drying formulations/evaporating all of the solvent in a liquid formulation, thereby teaching away from the method of claim 46 which does not change the concentration of the recombinant protein. It is respectfully submitted that this is not persuasive. The portions of Samaritani regarding freeze drying are not relied upon in the above rejection. Samaritani is merely relied upon to teach that pharmaceutical formulations may contain recombinant proteins, which can be stored in liquid formats.
Applicant submits that Kinsley is not related to a method of controlling oxygen content in a headspace of a sealed container containing a liquid pharmaceutical formulation, but rather a method for controlling oxygen content to reduce flammability. Applicant submits that there is no need for the method of Kinsley for a container that includes a liquid pharmaceutical formulation because it would not be flammable, and the combined disclosures would not have suggested the subject matter of the claimed invention. It is respectfully submitted that this is not persuasive. Kinsley clearly teaches a formula for reducing oxygen in the headspace of a container through successive vacuum and purging cycles. It is considered that such a formula would be applicable to a container containing any liquid, including a liquid pharmaceutical, and that one of ordinary skill in the art would consider such a formula when attempting to lower the amount of oxygen in the headspace of a container for any reason. As set forth in MPEP 2141.01(a), a reference is analogous to the claimed invention if the reference is reasonably pertinent to the problem faced by the inventor. As the problem addressed in the instant application, Wensley, and Kinsley is reducing the level of oxygen in the headspace of a container, it is considered that Wensley and Kinsley are analogous art and that one of ordinary skill art would look for solutions to this common problem in both references.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANNA NICOLE SCHULTZHAUS whose telephone number is (571)272-0812. The examiner can normally be reached on Monday - Friday 8-4.
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/J.N.S./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685