`

`Transmittal of Communication to
`Third Party Requester
`Inter Partes Reexamination
`
`Control No.
`
`95/000,686
`Examiner
`
`Patent Under Reexamination
`
`6,481,468
`Art Unit
`
`3993
`•• The MAILING DATE of this communication appears on the cover sheet with the correspondence address. -·
`
`PATRICIA ENGLE
`
`r-1 --(THIRD PARTY REQUESTER'S CORRESPONDENCE ADDRESS) ---,1
`
`THE LAW OFFICE OF MARC R. LABGOLD, P.C.
`12007 SUNRISE VALLEY DRIVE
`SUITE110
`RESTON, VA 20191
`
`Enclosed is a copy of the latest communication from the United States Patent and Trademark Office
`in the above-identified reexamination prceeding. 37 CFR 1.903.
`
`Prior to the filing of a Notice of Appeal, each time the patent owner responds to this communication,
`the third party requester of the inter partes reexamination may once file written comments within a
`period of 30 days from the date of service of the patent owner's response. This 30:-day time period is
`statutory (35 U.S.C. 314(b)(2)), and, as such, it cannot be extended. See also 37 CFR 1.947.
`
`If an ex parte reexamination has been merged with the inter partes reexamination, no responsive
`submission by any ex parte third party requester is permitted.
`
`All correspondence relating to this inter partes reexamination proceeding should be directed to the
`Central Reexamination Unit at the mail, FAX, or hand-carry addresses given at the end of the
`communication enclosed with this transmittal.
`
`U.S. Patent and Trademark Office
`PTOL-2070 (Rev. 07-04)
`
`PaperNo.20131029
`
`

`

`ACTION CLOSING PROSECUTION
`(37 CFR 1.949)
`
`Control No.
`
`95/000,686
`Examiner
`
`PATRICIA ENGLE
`
`Patent Under Reexamination
`
`6,481,468
`Art Unit
`
`3993
`
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address. --
`
`Responsive to the communication(s) filed by:
`Patent Owner on 20 December. 2013
`Third Party(ies) on 17 January. 2014
`
`Patent owner may once file a submission under 37 CFR 1.951 (a) within 1 month(s) from the mailing date of this
`Office action. Where a submission is filed, third party requester may file responsive comments under 37 CFR
`1.951 (b) within 30-days (not extendable- 35 U.S.C. § 314(b)(2)) from the date of service of the initial
`submission on the requester. Appeal cannot be taken from this action. Appeal can only be taken from a
`Right of Appeal Notice under 37 CFR 1.953.
`
`All correspondence relating to this inter partes reexamination proceeding should be directed to the Central
`Reexamination Unit at the mail, FAX, or hand-carry addresses given at the end of this Office action.
`
`PART I. THE FOLLOWING ATTACHMENT(S) ARE PART OF THIS ACTION:
`1. 0 Notice of References Cited by Examiner, PT0-892
`2 .. l~llnformation Disclosure Citation, PTO/SB/08
`·3.·0 __
`
`PART II. SUMMARY OF ACTION:
`1a.I:8J Claims 1.2.4-7.9-13.16.17.20-27 and 36-55 are subject to reexamination.
`1 b.i:8J Claims 3.8. 15. 18.19 and 32-35 are not subject to reexamination.
`2.
`I:8J Claims 14 and 28-31 have been canceled.
`3. 0 Claims
`are confirmed. [Unamended patent claims]
`4. 0 Claims __ are patentable. [Amended or new claims]
`5. 1:8J Claims 1.2.4-7.9-13.16.17.20-27 and 36-55 are rejected.
`6. 0 Claims __ are objected to.
`0 are not acceptable.
`0 are acceptable
`7. 0 The drawings filed on
`0 approved. 0 disapproved.
`8 0 The drawing correction request filed on_· __ is:
`9 0 Acknowledgment is made of the claim for priority under 35 U.S. C. 119 (a)-(d). The certified copy has:
`0 been received.
`0 not been received.
`0 been filed in Application/Control No __
`10.0 Other __
`
`U.S. Patent and Trademark Office
`PTOL-2065 (08/06)
`
`Paper No. 20131029
`
`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 2
`
`DETAILED ACTION
`
`The present application is being examined under the pre-AlA first to invent provisions.
`
`This Action Closing Prosecution (ACP) is in response to the Patent Owner's
`
`Amendments and Comments of December 20,2013 and the 3rd Party Comments of January 17,
`
`2014.
`
`It is noted that the Patent Owner filed a response and amendment on January 14, 2013
`
`and the 3rd Party Requester filed remarks on February 13, 2013. A Notice of Defective Paper
`
`was mailed on February 28,2013. In response to the Notice of Defective Paper, the Patent
`
`Owner submitted a corrected amendment and response on March 11, 2013. The 3rd Party
`
`Requester submitted supplemental remarks on April 1 0, 2013. Petitions were filed by the Patent
`
`Owner on May 17,2013 (dismissed on June 27, 2013) and the 3rd Party Requester on AprillO,
`
`2013 (dismissed on May 10, 2013). A Notice of Defective Paper was mailed on October 31,
`
`2013. The Patent Owner submitted a response on November 15, 2013. A Notice of Defective
`
`Paper was mailed on December 10,2013. A Patent Owner response was filed on December 19,
`
`2013 (with missing pages). On December 20, 2013, the Patent Owner resubmitted the response
`
`with all the pages. The 3rd Party Requester filed a response on January 17, 2014 along with a
`
`Petition to waive the page requirement. A Petition Decision granting the page limit extension
`
`was mailed on April22, 2013.
`
`Scope of Reexamination
`
`Reexamination was requested for claims 1-35 of United States Patent Number 6,481,468
`
`to Taggart (hereinafter, "the '468 patent"). The Decision Granting the Inter Partes
`
`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 3
`
`Reexamination of October 12, 2012 granted reexamination of claims 1, 2, 4-7, 9-14, 16, 17 and
`
`20-31. The Patent Owner canceled claims 14 and 28-31 and added claims 36-55.
`
`Claims 1, 2, 4-7, 9-13, 16, 17, 20-27 and 36-55 are within the scope of this
`
`reexamination.
`
`Preliminary Issues
`
`Claims 36, 43, 46 and 52 are multiple dependent claims. Claim 36 depends from claims
`
`9 and 23. Claim 43 depends from claims 9 and 21. Claims 46 and 52 depend from claims 1, 10,
`
`16 and 20. The rejections of these claims will ~e indicated as follows: claim 36 (9) means claim
`
`36 as dependent on claim 9 and claim 37(36/9) means claim 37 as dependent on 36 and 9.
`
`Statutory Basis for Grounds of Rejection- 35 USC§§ 102 and 103
`
`The following is a quotation ofthe appropriate paragraphs of35 U.S.C. § 102 that form
`
`the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless -
`
`(a) the invention was known or used by others in this country, or patented or. described in a printed publication in this
`or a foreign country, before the invention thereof by the applicant for a patent.
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on
`sale in this country, more than one year prior to the date of application for patent in the United States.
`
`(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the
`United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by
`another filed in the United States before the invention by the applicant for patent, except that an international
`application filed under the treaty defined in section 351 (a) shall have the effects for purposes of this subsection of an
`application filed in the United States only if the international application designated the United States and was
`published under Article 21 (2) of such treaty in the English language.
`
`The following is a quotation of35 U.S. C.§ 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 4
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section
`I 02 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the
`subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill
`in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the
`invention was made.
`
`The following is a quotation of35 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 of35 U.S.C. 112 (pre-AIA), first paragraph:
`The specification shall contain a written description of the invention, and of the manner and process of
`making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to
`which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth
`the best mode contemplated by the inventor of carrying out his invention.
`
`The following is a quotation of 35 U.S.C. 112(b):
`
`(B) CONCLUSION.-The specification shall conclude with one or more claims particularly pointing out
`and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph:
`
`The specification shall conclude with one or more claims particularly pointing out and distinctly claiming
`the subject matter which the applicant regards as his invention.
`
`References relied upon:
`
`Takei
`
`JP '226
`
`Satomi
`
`Japanese Patent App. Laid-Open Publ. No. 04-154501, May 27, 1992.
`
`Japanese Laid-Open Patent Application H01-182226, July 20, 1989.
`
`"Food Preservation Technology and Related Technology (2) Aseptic Filling and
`
`Packaging," Hiroharu Satomi (1994).
`
`David
`
`"Aseptic Processing and Packaging of Food: A Food Industry Perspective" by'
`
`In ada
`
`Kaga
`
`Jairus R. D. David, Ralph H. Graves and V.R. Carson (1996).
`
`US Patent No. 4,446,674 (May 8, 1984).
`
`European Patent Application 0 436 214 AI (December 24, 1990).
`
`Andersson
`
`US Patent No. 4,984,601 (January 15, 1991).
`
`Nishino
`
`JP '418
`
`Japanese Patent App. Laid-Open Pub I. No: 09-110094 (April 27, 1997).
`
`Japanese Patent App. Laid-Open Publ. No. 06-48418 (February 22, 1994).
`
`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 5
`
`Buchner
`
`..
`N. BUCHNER, Aseptic Filling of Glass and Plastic Containers, Special Print of
`
`ZFL magazine, November 1989, Heidelberg, Germany.
`
`Nelson
`
`James V. CHAMBERS and Philip E. NELSON, Principles of Aseptic Processing
`
`and Packaging, 1993 The Food Processors Institute, Washington, D.C., US.
`
`Miyazaki
`
`Kazuo MIYAZAKI, Development of PET Bottle In-line Formation Aseptic
`
`Filling Line, Packaging Technology August 1998, Vol. 36 No.8, Japan.
`
`Citations from the foreign publications are in reference to the translations.
`
`Proposed Claim Rejections
`Adopted and/or Maintained
`
`Claims 36 and 41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph,
`as failing to comply with the written description requirement. The claim(s) contains subject matter
`which was not described in the specification in such a way as to reasonably convey to one skilled in
`the relevant art that the inventor or a joint inventor, or for pre-AlA the inventor(s), at the time the
`application was filed, had possession of the claimed invention.
`New Claim 36 is neither enabled nor described with respect to the term "predetermined
`
`treatment time of the interior bottles." PO's asserted support provides no description of any
`
`"treatment time," much less a predetermined treatment time. The passage relied upon by PO
`
`95/000,686 pertains to a time required to empty the measuring cup of the sterilization apparatus -
`
`this is not proper support for the time for the predetermined treatment time of the interior of the
`
`bottles. In the disclosed embodiments, a certain amount of time is necessarily required for the
`
`transferring the sterilant from the sterilization apparatus into the interior ofthe each bottle.
`
`However, such times have no relevance to the new claim language. In addition, there is no
`
`statement in. the specification of the '468 patent that the interior of the bottles are treated in a
`
`predetermined time. As such, the claim should be rejected for failure to satisfy the enablement
`
`and written description requirements of 35 U.S.C. § 112, ~1.
`
`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 6
`
`New Claim 41 is neither enabled nor described with respect to the claimed "concentration
`
`sensor" or the "predetermined level" it claims to maintain. There is no description of any sensor
`
`that performs a function of ensuring the concentration of "peroxyacetic acid" is maintained to
`
`some undisclosed and non-enabled predetermined level. The passage relied upon by PO for
`
`support (col. 25, lines 21-23) states without more: "A concentration sensor to ensure that the
`
`concentration of oxonia is maintained above a predetermined level." As noted previously, oxonia
`
`is a mixture of hydrogen peroxide and peracetic acid. Thus, the specification does not describe or
`
`enable a concentration sensor for peroxyacetic acid. As such, the claim should be rejected for
`
`failure to satisfy the enablement and written description requirements of35 U.S.C. § 112, ~1.
`
`Claims 36, 41 and 52 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), second
`paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject
`matter which the inventor or a joint inventor, or for pre-AlA the applicant regards as the
`invention.
`Claim 36 recites the limitation "the sterilant" in line 5. There is insufficient antecedent
`
`basis for this limitation in the claim.
`
`Claim 41 is indefinite with respect to the term "wherein the peroxyacetic acid uses a
`
`concentration sensor." As phrased, the acid is using a sensor as opposed to the system using a
`
`sensor or a sensor being used to monitor the concentration.
`
`Claim 52 recites the limitation "the pressurized tank" in line 5. There is insufficient
`
`antecedent basis for this limitation in the claim.
`
`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 7
`
`Claims 1, 2, 5 and 7 are rejected under 35 U.S.C. § 102(b) as being anticipated by Takei.
`Additional to the following explanation below, the basis for rejecting these claims also
`
`includes the explanation set forth in Appendix 1 of the Request regarding said claims, which is
`
`incorporated by reference herein.
`
`Regarding claim 1, Takei discloses a method comprising: controlling the flow of an
`
`aseptic product using· a valve (p. 6, lines 4-14 ); surrounding a region (b) where the aseptic
`
`product exits the valve (Fig. 2) with a sterile region (p. 7, lines 9-15) wherein the sterile region is
`
`a sterile tunnel (b); and controlling the opening or closing of the valve with a sealed actuator
`
`(18), wherein the sealed actuator is surrounded with the sterile region (b). As to the sterile
`
`tunnel, the Examiner agrees with Third Party Requester that. the chamber b sufficiently defines a
`
`sterile tunnel.
`
`Regarding claim 2, Takei discloses the method of claim 1, further including providing a
`
`tank (p. 7, lines 30-33) (or containing a supply of pressurized aseptic product flowing to the
`
`valve.
`
`Regarding claim 5, Takei discloses the method of claim 1, further wherein the sealed
`
`actuator (18) is fully within the sterile tunnel (b; Fig. 1).
`
`Regarding claim 7, Takei discloses the method of claim 1, further including: connecting
`
`.,.
`
`the sealed actuator (18) to a control system with a control conduit (p. 7, lines 3-17).
`
`Claim 7 is rejected under 35 U.S.C. 103(a) as being unpatentable over Takei.
`Additional to the following explanation below, the basis for the rejecting this claim also
`
`includes the explanation set forth in Appendix 2 of the Request regarding said claims, which is
`
`incorporated by reference herein.
`
`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 8
`
`Takei discloses a deflection detector that converts a change of resistance due to strain into
`
`an electric signal to operate the operating means 18 of the valve body. For such an electrical
`
`signal to result in operation of the operating means, the Examiner agrees that there must exist a
`
`conduit extending from the deflection detector to the operating means 18. Accordingly such a
`
`conduit, though not expressly disclosed by the reference, would be sufficiently implied, so as to
`
`have made providing such a conduit obvious to one of ordinary skill in the art.
`
`It is further noted that claim 7 is dependent from claim 1, which calls for a sterile tunnel.
`
`To whatever the extent Takei's chamber b does not somehow define a tunnel, the Examiner
`
`agrees with the reasons stated by Requester that employing a sterile tunnel would have been
`
`obvious in view ofTakei's chamber b.
`
`Claim 42 is rejected under 35 U.S.C. 103(a) as being unpatentable over Takei in view of Buchner.
`Takei discloses the method of claim 1. Buchner discloses that it is known to aseptically
`
`disinfect a plurality of bottles to a level producing at least a 6 log reduction in spore organisms
`
`(p. 9). Buchner further teaches aseptic bottle filling at 6,000 bottles per hour (i.e., 100 bpm;
`
`Buchner at 11); an inclined cap channel 12 (see, e.g., Figure 1) in which caps are sterilized with
`
`saturated steam under overpressure or hydrogen peroxide and heat (see, e.g., p. 4) and then are
`
`"sealed onto the bottles" (see, e.g., p. 11).
`
`It would have been obvious to one of ordin~ry skill in the art at the time of the invention
`
`to provide a separate system for aseptic sterilization of lids and placing the lids on the bottles,
`
`since it was a known process in aseptic sterilization processing as taught by Buchner.
`
`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 9
`
`Claims 1, 2, 5, 7, 9, 10, 13,20-22,24-26, 36(9), 40(36/9), 42, 44 and 45 are rejected under 35 U.S.C.
`103(a) as being unpatentable over Takei in view of JP '226.
`Additional to the following explanation below, the basis for the rejecting these claims
`
`also includes the explanation set forth in Appendix 3 of the Request regarding said claims, which
`
`is incorporated by reference herein.
`
`.
`
`Regarding claim 1, Takei discloses a method comprising: controlling the flow of an
`
`aseptic product using a valve (p. 6, iines 4-14); surrounding a region (b) where the aseptic
`
`product exits the valve (Fig. 2) with a sterile region (p. 7, lines 9-15) wherein the sterile region is
`
`a sterile tunnel (b); and controlling the opening or closing of the valve with a sealed actuator
`
`(18), wherein the sealed actuator is surrounded with the sterile region (b). As to the sterile
`
`tunnel, the Examiner agrees with Third Party Requester that the chamber b sufficiently defines a
`
`sterile tunnel.
`
`JP '226 teaches a disinfecting containers and filling containers in an elongated aseptic
`
`chamber, and therefore a tunnel (seep 3, last line top 4, line 10; p 8, paragraphs beginning line
`
`15 and extending top. 9, line 2; p. 11, paragraph beginning line 15; Fig. 2). From JP '226 it
`
`would have been obvious to one of ordinary skill in the art to have disinfected the containers 1 of
`
`Takei, as well as fill them, within the sterile chamber b and to have made the chamber elongated,
`
`as a tunnel, to include such a disinfecting step in Takei, for the purpose of killing pathogens in
`
`the interior of the container prior to filling.
`
`JP '226.additionally teaches filling containers in stages (seep 4, paragraph beginning line
`
`25; p 11, paragraph beginning line 15), wherein each container is filled with a first fluid and with
`
`a second fluid from multiple filling stations. Therefore, regarding claim 1, it 'further would have
`
`been obvious in view of JP '226 to provide the filling operation of Takei with multiple filling
`
`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 10
`
`stations in the chamber b, and therefore to have niade the chamber elongated for accommodating
`
`multiple stations, wherein each container 1 is to be partially filled at a first station and wherein
`
`filling of the container is to be completed at a second station, for the purpose of including diverse
`
`contents in each container.
`
`Regarding claim 2, Takei as modified discloses the method of claim 1. Takei further
`
`discloses providing a tank (p. 7, lines 30-33) for containing a supply of pressurized aseptic
`
`product flowing to the valve.
`
`Regarding claim 5, Takei as modified discloses the method of claim 1. Takei further
`
`discloses that the sealed actuator (18) is fully within the sterile tunnel (b; Fig. 1 ).
`
`Regarding claim 7, Takei as modified discloses the method of claim 1. Takei further
`
`discloses connecting the sealed actuator ( 18) to a control system with a control conduit (p. 7,
`
`lines 3-17). The connection permits the actuator (operating means 18) to be operated by the
`
`control system (i.e., a measurement section 4) via an electrical signal, to cause actuation of the
`
`valve body 15 for closing it when the container is sufficiently filled.
`
`Regarding claim 9, Takei as modified discloses the method of claim i. JP '226 further
`
`discloses disinfecting containers prior to filling. Accordingly, it would have been obvious from
`
`the teaching JP '226 to have disinfected a plurality of containers in the chamber ofTakei for the
`
`purpose of killing any pathogens present in the interior of the container prior to filling.
`
`Regarding claim 10, Takei discloses a method comprising: controlling the flow of an
`
`aseptic product using a valve (p. 6, lines 4-14); surrounding a region where the aseptic product
`
`exits valve (Fig. 2) with a sterile region (p. 7, lines 9-15); controlling the opening or closing of
`
`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 11
`
`the valve with a sealed actuator (18), wherein the sealed actuator is surrounded with the sterile
`
`region (b).
`
`JP '226 additionally teaches filling containers in stages (seep 4, paragraph beginning line
`
`25; p 11, paragraph beginning line 15), wherein each container is filled with a first fluid and with
`
`a second fluid from multiple filling stations.
`
`Therefore, it would have been obvious in view of JP '226 to provide the filling operation
`
`of Takei with multiple filling stations in the chamber b, wherein each container 1 is to be
`
`partially filled at a first station and wherein filling of the container is to be completed at a second
`
`station, for the purpose of including diverse contents in each container.
`
`Regarding claim 13 which calls for the aseptic product to have been sterilized to a level
`
`producing at least about a 12 log reduc~ion in Clostridium, Takei discloses aseptic filling (seep.
`
`10, paragraphs beginning line 5) and thus a desire to kill all bacteria. Moreover, Additionally,
`
`Takei is concerned with reducing bacteria in the flow passageway (7) to zero (seep 6, paragraph
`
`beginning line 15). Accordingly, it would have been obvious to one of ordinary skill in the art
`
`from the teaching ofTakei of the art combination to have sterilized the product ofTakei to the
`
`extent wherein it is virtually devoid of bacteria, including to an extent having at least about a 12
`
`log reduction in Clostridium.
`
`Regarding claim 20, Takei discloses a method comprising: aseptically disinfecting a
`
`plurality of containers (1) in a sterile tunnel (b); controlling the flow of an aseptic product into
`
`the plurality of containers using a valve (p. 6, lines 4-14);; surrounding a region (b) where the
`
`aseptic product exits the valve (Fig. 2) with a sterile region (p. 7, lines 9-15) wherein the sterile
`
`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 12
`
`region is the sterile tunnel (b); and controlling the opening or closing of the valve with a sealed
`
`actuator ( 18), wherein the sealed actuator is surrounded with the sterile region. As to the sterile
`
`tunnel, the Examiner agrees with Third Party Requester that the chamber b sufficiently defines a
`
`sterile tunnel.
`
`JP '226 teaches a disinfecting containers and filling containers in an elongated aseptic
`
`chamber, and therefore a tunnel (seep 3, last line top 4, line 10; p 8, paragraphs beginning line
`
`15 and extending to p 9, line 2; p 11, paragraph beginning line 15; Fig. 2). JP '226 additionally
`
`teaches filling containers in stages (seep 4, paragraph beginning line 25; p 11, paragraph
`
`beginning line 15), wherein each container is filled with a first fluid and with a second fluid from
`
`multiple filling stations.
`
`Therefore, regarding claim 20, it would have been obvious in view of JP '226 to have
`
`disinfected the containers 1 of Takei, as well as fill them, within the sterile chamber b and to
`
`have made the chamber elongated, as a tunnel, to include such a disinfecting step in Takei for
`
`the purpose of killing pathogens in the interior of the container prior to filling.
`
`Regarding claim 21 which calls for the aseptically disinfecting to a level producing about
`
`a 6 log reduction in spore organisms, JP '226, as indicated above, teaches one qf ordinary skill
`
`art of filling containers to sterilize beverage containers prior to aseptic filling, and thus indicates
`
`that there is a desire to kill all bacteria. Moreover, Takei is concerned with reducing bacteria in
`
`the flow passageway (7) to zero (seep 6, paragraph beginning line 15), and thus achieve a state
`
`of no bacteria. Accordingly, it would have been obvious to one of ordinary skill in the art from
`
`the teachings ofTakei and JP '226 of the art combination to have sterilized the containers of
`
`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 13
`
`Takei to the extent wherein the product is virtually devoid of bacteria, including to an extent
`
`having at least about a 6 log reduction in spores.
`
`Regarding claim 22 which calls for the aseptic product to have been sterilized to a level
`
`producing at least about a 12log reduction in Clostridium, Takei discloses aseptic filling (seep
`
`10, paragraphs beginning line 5) and thus a desire to kill all bac~eria. Moreover, Takei is
`
`concerned with reducing bacteria in the flow passageway (7) to zero (seep 6, paragraph
`
`beginning line 15). Accordingly, it would have been obvious to one of ordinary skill in the art
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`from the teaching of Takei of the art combination to have sterilized the aseptic product of Takei
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`to the extent wherein the product is virtually devoid of bacteria, including to an extent having at
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`least about a 12 log reduction in Clostridium.
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`Regarding claim 24, Takei discloses a method comprising: controlling the flow of an
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`aseptic product using a valve (p. 6, lines 4-14); surrounding a region (b) where the aseptic
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`product exits the valve (Fig. 2) with a sterile region (p. 7, lines 9-15) wherein the sterile region;
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`controlling the opening or closing of the valve with a sealed actuator (18), wherein the sealed
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`actuator is surrounded with the sterile region.
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`JP '226 teaches a disinfecting containers and filling containers in an elongated aseptic
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`chamber, and therefore a tunnel (seep 3, last line top. 4, line 1 0; p 8, paragraphs beginning line
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`15 and extending to p. 9, line 2; p 11, paragraph beginning line 15; Fig. 2). JP '226 additionally
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`teaches filling containers in stages (seep 4, paragraph beginning line 25; p 11, paragraph
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`beginning line 15), wherein each container is filled with a first fluid and with a second fluid from
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`multiple filling stations.
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`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 14
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`Regarding the limitation in claim 24 calling for the exiting of aseptic product and the
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`aseptic disinfecting to occur in the same sterile region, JP '226 teaches this limitation. More
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`specifically, JP '226 teaches both disinfecting containers and filling the containers in the
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`chamber 21 (seep 2, section 2 "Claims"). It thus would have been obvious in view of JP '226 to
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`have both. disinfected containers and filled containers in the same chamber 1 and to have made
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`the chamber sized for performing these operations.
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`Further it would have been obvious to provide the filling operation of Takei with multiple
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`filling stations in the chamber b, and therefore to have made the chamber elongated for
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`accommodating multiple stations, wherein each container 1 is to be partially filled at a first
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`station and wherein filling of the container is to be completed at a second station, for the purpose
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`of including diverse contents in each container, as taught by JP '226.
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`Regarding claim 25 which calls for the aseptically disinfecting to a level producing about
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`a 6 log reduction in spore organisms, JP '226, as indicated above, teaches one of ordinary skill
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`art of filling containers to sterilize beverage containers prior to aseptic filling, and thus indicates
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`that there is a desire to kill all bacteria. Moreover, Takei is concerned with reducing bacteria in
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`the flow passageway (7) to zero (seep 6, paragraph beginning line 15), and thus achieve a state
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`of no bacteria. Accordingly, it would have been obvious to one of ordinary skill in the art from
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`the teachings ofTakei and JP '226 of the art combination to have sterilized the containers of
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`Takei to the extent wherein the product is virtually devoid of bacteria, including to an extent
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`having at least about a 6 log reduction in spores.
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`Regarding claim 26 which calls for the aseptic product to have been sterilized to a level
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`producing at least about a 12 log reduction in Clostridium, Takei discloses aseptic filling (seep
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`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 15-
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`10, paragraphs beginning line 5) and a desire to kill all bacteria. Moreover, Additionally, Takei
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`is concerned with reducing bacteria in the flow passageway (7) to zero (seep 6, paragraph
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`beginning line 15). Accordingly, it would have been obvious to one of ordinary skill in the art
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`from the teaching of Takei of the art combination to have sterilized the aseptic product of Takei
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`to the extent wherein the product is virtually devoid of bacteria, including to an extent having at
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`least about a 12 log reduction in Clostridium.
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`Regarding claim 36 (9), JP- 226 teaches aseptically disinfecting a plurality of bottles (see,
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`e.g., page 5); using a spray nozzle to aseptically disinfect (see, e.g., page 8 and Fig. 6; spray
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`nozzles 90A-90F spray hydrogen peroxide); the spray nozzle penetrates the interior of the bottles
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`(spray nozzles 90A-90F are "lowered into the mouth of the containers"); cbntroller 204 controls
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`the individual steps of the operation (see, e.g., 2 and Fig. 13),
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`Regarding claim 40 (36/9), claim 36 (as dependent upon Claim 9) is obvious over Takei
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`in view of JP-226. The additional limitations of Claim 40 are taught by Takei (see, e.g., page 8;
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`Figure 1, supply hole 8). Takei teaches a filling system having valves spaced above the plurality
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`of bottles such that the valves open and close while spaced from the bottles to prevent
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`contamination of the bottles. The gap between the mouth of the bottle being filled and the filling
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`nozzle is clearly shown in Figure 1 (see supply hole 8; page 8). Figure 2 shows cap 23 attached
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`to the nozzle. The cap 23, however, i.s only attached to the nozzle "when performing cleaning
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`and sterilization so that liquid is not supplied to the lower part." The cap 23 is not in place during
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`the filling operation so it would never contact the bottle.
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`

`

`Application/Control Number: 95/000,686
`Art Unit: 3993
`
`Page 16
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`Regarding claim 42, JP '226 teaches caps 102 are sterilized in cap conveyor 101 (see, p.
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`9) and are "engaged with and are fitted in the mouth of the containers" (i.e., placed on the
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`bottles).
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`Regarding claim 44, JP '226 teaches sterilizing bottles with vaporized hydrogen peroxide
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`followed by heat activation (see e.g., p. 8; Figure 2).
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`Claim 45 is identical to Claim 10 except that it adds the limitation of "a valve having a
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`spring." Takei teaches a spring 17 in the filling valve. (See e.g., Takei at Figure 2).
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`Claims 11-13,21-23, 25-27, 36(23), 40(36/23), 46(1,10,20), 47(46/1,10,20), 48(46/1,10,20),
`49(48/46/1,10,20) and 50(48/46/1,10,20) are rejected under 35 U.S.C. 103(a) as being unpatentable
`over Takei in view of JP '226 as applied to claim 10, 20 or 24 above, and further in