`

`Transmittal of Communication to
`Third Party Requester
`Inter Partes Reexamination
`
`Control No.
`
`95/001,452
`Examiner
`
`Patent Under Reexamination
`
`6,945,013
`Art Unit
`
`GLENN K. DAWSON
`
`3993
`
`-- The MAILING DATE of this com1J7unication appears on the cover sheet with the correspondence address. --
`
`I r---(THIRD PARTY REQUESTER'S CORRESPONDENCE ADDRESS) ---.1
`
`GIBBONS P.C.
`ONE GATEWAY CENTER
`NEWARK, NJ 07102
`
`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.20130930
`
`

`

`ACTION CLOSING PROSECUTION
`(37 CFR 1.949)
`
`Control No.
`
`95/001,452
`Examiner
`
`Patent Under Reexamination
`
`6,945,013
`Art Unit
`
`GLENN K. DAWSON
`
`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 28 November. 2012
`Third Party(ies) on 28 December. 2012
`
`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 ~his 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. ['gJ Information Disclosure Citation, PTO/SB/08
`·
`3.0 __
`
`PART II. SUMMARY OF ACTION:
`1 a. ['gJ Claims 1-35.37-39 and 44-65 are subject to reexamination.
`1 b. 0 Claims
`are not subject to reexamination.
`['gJ Claims 36 and 40-43 have been canceled.
`2.
`['gJ Claims 2 and 3 are confirmed. [Unamended patent claims]
`3.
`['gJ Claims 22. 23 and 28 are patentable. [Amended or new claims]
`4.
`['gJ Claims 1.4-21.24-27.29-35.37-39 and 44-65 are rejected.
`5.
`6. 0 Claims
`are objected to.
`Dare acceptable Dare not acceptable.
`7. 0 The drawings filed on__
`8 D The drawing correction request filed on
`is:
`D approved. D disaJ:?proved.
`9 0 Acknowledgment is made of the claim for priority under 35 U.S. C. 119 (a)-( d). The certified copy has:
`D been received.
`D not been received.
`D been filed in Application/Control No __
`10.0 Other __
`
`U.S. Patent and Trademark Office
`PTOL-2065 (08/06)
`
`Paper No. 20130930
`
`

`

`Application/Control Number: 95/001,452
`Art Unit: 3993
`
`Page 2
`
`The present application is being examined under the pre-AlA first to invent provisions.
`
`Reexamination
`
`In order to ensure full consideration of any amendments, affidavits or declarations, or
`
`other documents as evidence of patentability, such documents must be submitted in
`
`response to this Office action. Submissions after this Office action, which is an Action
`
`Closing Prosecution (ACP), are governed by 37 CFR 1.116(b) and (d), which will be strictly
`
`enforced.
`
`Service of Papers
`
`37 CFR 1.903. Service of papers on parties in inter partes reexamination. The patent
`owner and the third party requester will be sent copies of Office actions issued during the
`inter partes reexamination proceeding. After fiiing of a request for inter partes reexamination
`by a third party requester, any document filed by either the patent owner or the third party
`requester must be served on every other party in the reexamination proceeding in the
`manner provided in §1.248. Any document must reflect service or the document may be
`refused consideration by the Office. The failure of the patent owner or the third party
`reql!ester to serve documents may result in their being refused consideration.
`
`Extensions of Time
`
`Extensions of time under 37 CFR 1.136(a) will not be permitted in interpartes
`reexamination proceedings because the provisions of 37 CFR 1.136 apply only to "an
`applicant" and not to parties in a reexamination proceeding. Additionally, 35 U.S.C. § 314(c)
`requires that inter partes reexamination proceedings "will be. conducted with special
`dispatch" (37 CFR 1.937). Patent owner extensions of time in interpartes reexamination
`proceedings are provided for in 37 CFR 1.956. Extensions of time are not available for third
`party requester comments, because a comment period of 30 days from service of patent
`owner's response is set by statute. 35 U.S.C. § 314(b)(3). ·
`
`Notification of Concurrent Proceedings
`
`The patent owner is reminded of the continuing responsibility under 37 CFR 1.985(a)
`to apprise the Office of any litigation activity, or other prior or co_ncurrent proceeding,
`
`

`

`Application/Control Number: 95/001,452
`Art Unit: 3993
`
`Page 3
`
`involving U.S. Patent No. 6,945,013 throughout the course of this reexamination
`proceeding. The third party requester is also reminded of the ability to similarly apprise the
`Office of any such activity or proceeding throughout the course of this reexamination
`proceeding. See MPEP §§ 2686 and 2686.04 ..
`
`This ACP considers the response filed on 11-28-2012 by the Patent Owner (PO) to
`
`the office action mailed on 09-28-2012, and considers the respective comments thereto
`
`and to the office action by the Third Party Requestor (TPR) filed on 12-28-2012.
`
`The declarations of Mr. Taggart and Mr. Olsen on 12-28-2012 have not been entered
`
`as per the petition decision of 05-06-2013.
`
`Status of previous Rejections
`
`1. Claims 18 and 19 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Bosch in view of Kramer (maintained).
`
`·
`
`2. Claim 20 is rejected under 35 U.S.C. 103(a) as being unpatentable over Bosch in
`
`view of Bjerborn (maintained).
`
`3. Claim 20 is rejected under 35 U.S.C. 103(a) as being unpatentable over Bosch in
`
`view of FDA Regulation 21 C.F.R. 178.1005 (maintained).
`
`4. Claim 21 is rejected under 35 U.S.C. 103(a) as being unpatentable over Bosch in
`
`view of Bjerborn and Lisiecki (maintained).
`
`5. Claim 24 is rejected under 35 U.S.C. 103(a) as being unpatentable over Bosch in
`
`view of Bjerborn and Lisiecki (maintained).
`
`

`

`Application/Control Number: 95/001,452
`Art Unit: 3993
`
`Page 4
`
`6. Claims 1, 4, 5, 7, 8 and 10-17 are rejected under 35 U.S.G. 103(a) as being
`
`unpatentable over Buchner in view of Campden, Gustaffson, ZFL and either Rippen or
`
`Kramer (maintained).
`
`7. Claims 18-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Buchner in view of Campden, Gustaffson, ZFL, and either Rippen or Kramer (maintained).
`
`8. Claim 6 is rejected under 35 U.S.C. 103(a) as being unpatentable over Buchner in
`
`view of Campden, Gustaffson, ZFL, either Rippen or Kramer, as applied to claim 5 above,
`
`and further in view of Miyazaki or Willhoft (maintained).
`
`9. Claim 9 is rejected under 35 U.S.C. 103(a) as being unpatentable over Buchner in
`
`view of Campden, Gustaffson, ZFL, and either Rippen or Kra~er, as applied to claim 5
`
`above, and further in view of Willhoft or Scholle-4,417,607 (maintained).
`
`10. Claims 21, 24 and25 are rejected under 35 U.S.C. 103(a) as being unpatentable
`
`over Buchner in view of Campden, Gustaffson, ZFL, and either Rippen or Kramer, as applied
`
`to claim 20 above, and further in view of Lisiecki (maintained).
`
`11. Claim 25 is objected to (maintained).
`
`12. Claims 40-43 are rejected under 35 U.S'. C. 314(a) as enlarging the scope of the
`
`claims of the patent being reexamined (overcome by claim cancellation).
`
`13. Claim 36 is rejected under 35 U.S.C. 112, first paragraph, as failing to comply
`
`with the written description requirement (overcome by cancellation of claim)
`
`14. Claim 36 is rejected under 35 U.S.C. 112, first paragraph, as failing to comply
`
`with the enablement requirement (overcome by cancellation of claim).
`
`15. Claim 36 is rejected under 35 U.S.C. 112, second paragraph, as being indefinite
`
`(overcome by cancellation of claim).
`
`

`

`Application/Control Number: 95/001,452
`Art Unit: 3993
`
`Page 5
`
`16. Claims 26 and 29 are rejected under 35 U.S.C. 103(a) as being unpatentable
`
`over ZFL in view of Kramer, Lisjecki and Campden (maintained).
`
`17. Claims 27 and 28 are rejected under 35 U.S.C. 103(a) as being unpatentable
`
`over ZFL in view of Kramer, Lisiecki and Campden, as applied to claim 26 above, and further
`
`in view of Hoshi no, Hada and Bjerborn (overcome, the examiner refuses to adopt this
`
`rejection).
`
`18. Claims 30, 31, 33, 34, 38 and 39 are ~ejected under 35 U.S.C. 103(a) as being
`
`unpatentable over Bosch in view of Lisiecki, Buchner, Bjerborn, Gustaffson and Willhoft
`
`(maintained).
`
`19. Claims 30, 31, 33, 34, 35 and 39 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over ZFL in view of Gustaffson (maintained).
`
`20. Claims 32 and 36 are rejected under 35 U.S.C. 103(a) as being unpatentable
`
`over ZFL in view of Gustaffson, as applied to claim 30 above, and further in view of David
`
`(claim 32-maintained; claim 36-overcome by claim cancellation).
`
`21. Claims 40-43 are rejected under 35 U.S.C. 103(a) as being unpa!entable over
`
`Bosch in view of Buchner and Kramer (overcome by claim cancellation).
`
`22. Claims 40-43 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`ZFL in view of Kramer (overcome by claim cancellation).
`
`Patent Owner's Response and Examiner's Response Thereto
`
`PO identified the portions of the specification which PO believes provides support for
`
`the newly amended claims.
`
`

`

`Application/Control Number: 95/001,452
`Art Unit: 3993
`
`Page 6
`
`PO argued that the cited references are not enabling.
`
`The examiner disagrees. All of the method steps are disclosed or made obvious by
`
`the prior art. Prior art references of any kind are presumed to be enabling when they
`
`expressly anticipate or make obvious all of the elements of the claimed invention. The
`
`burden then shifts to the PO to provide facts rebutting the presumption of operability by a
`
`preponderance of the evidence. The examiner contends that PO hal? failed to provide an
`
`adequate and persuasive rebuttal and therefore the burden has not shifted back to the PTO.
`
`A reference contains an enabling disclosure if the public was in possession of the claimed
`
`invention before the date of the invention. This is effected if one of ordinary skill in the art
`
`could have combined the publication's description of the invention with his or her own
`
`knowledge to make and use the claimed invention. It is to be presumed that skilled workers
`
`would, as a matter of course, if they do not immediately obtain desired results, experiment
`
`and make certain modifications and adaptations within the skill of the competent worker.
`
`The examiner contends that PO has failed to establish by a preponderance of the evidence
`
`that the references do not enable the claimed invention.
`
`PO maintains that the claimed speed and level of sterilization were not previously
`
`achieved.
`
`The examiner disagrees. Bosch and ZFL achieved the speed and sterility attained by
`
`PO before PO. PO's main problem with Bosch appears to be that the reference is
`
`presumably non-enabled. PO admits that Bosch produced speeds of 100 bottles/minute.
`
`The claims of the '013 patent cover bottling speeds down to only 101 bottles/minute. ZFL
`
`discloses 200 bottles/minute. There certainly does not seem to be any discussion in the
`
`

`

`Application/Control Number: 95/001,452
`Art Unit: 3993
`
`Page 7
`
`prior art that a speed of over 100 bottles/minute is some threshold that is able to meet
`
`some guideline, solve some problem, etc. over and above bottling at "only" 100
`
`b<?ttlesjminute. Buchner and ZFL teach the level of sterility claimed. The affidavits provided
`
`by PO concerning the non-enabling prior art continue to hone in on .,undue experimentation.,
`
`with no persuasive evidence to explain how the declarants determined the experimentation
`
`needed would have been .,undue ... Absolutely no experimentation was documented
`
`regarding taking the disclosure of Bosch, Buchner, ZFL etc. and attempting to make the
`
`claimed invention. Mere conclusory statements that undue experimentation would have
`
`been necessary are unpersuasive.
`
`PO argues crucial to the problems facing the inventors was the ability to achieve high
`
`speed bottling and disinfection at rates and levels far higher than achieved by the prior art
`
`combinations.
`
`The e~aminer disagrees and is of the opinion that the combinations disclose rates
`
`and levels in the claimed ranges.
`
`PO argues that it would have been "impossible" to add additional lines to Bosch and
`
`even if possible it would have resulted in an inoperable device.
`
`The examiner disagrees. Even if adding lines would require extensive time for re-
`
`engineering, which the examiner does not agree with, such does not necessarily equate to
`
`undue experimentation. In making this obviousness rejection, the examiner is not physically
`
`dismantling a preexisting machine and adding lines and then reconstructing it. One can take
`
`the disclosure of the machine, including the actual machine itself, and design a different
`
`machine having more lines or parallel lines. At least 4 different references disclosed the
`
`idea of adding lines in order to increase a plant's production. At least in parallel lines
`
`

`

`Application/Control Number: 95/001,452
`Art Unit: 3993
`
`Page 8
`
`providing second, third, fourth ... etc. lines which do the same thing as the 1st line is deemed
`
`to be well within the knowledge and capabilities of one having ordinary skill in the art of
`
`designing and manufacturing these types of machines and plants. There is no teaching
`
`away in the prior art of adding additional lines to any of the prior art references. PO's
`
`argument that adding lines requires "consideration of edge effect" would need to be
`
`examined and the problems caused by such would create an inoperable device unable to
`
`aseptically fill and disinfect bottles at any speed much less the claimed speed is
`
`, unpersuasive because there is no evidence that overcoming any or all of these problems
`
`requires undue experimentation. Just because problems need to be addressed fails to prove
`
`undue experimentation is required. No evidence was submitted that one of ordinary skill in
`
`the art attempted to solve these problems and failed. Furthermore parallel lines require no
`
`such consideration of edge effect.
`
`PO contends that Bosch is not enabled and Kramer teaches away from using
`
`hydrogen peroxide as a sterilant when attempting to achieve high bottling output.
`
`The examiner disagrees. As noted above Bosch is indeed enabled. According to PO,
`
`Kramer supposedly won't work on a bottle because bottles have a geometry making them
`
`very difficult to sterilize. Even assuming that PO's definition of "bottle" is correct in that it
`
`must have a smaller top opening than its height and greatest diameter, this definition would
`
`cover a structure where the top opening was only minutely smaller than its height and
`
`greatest diameter making it essentially a cylinder. Col. 9 of the '013 patent indicates that
`
`the top opening being smaller than just the height makes bottles harder to sterilize. It would
`
`appear as if all of the statements by PO or its declarants with respect to the difficulty of
`
`sterilizing bottles are based on a rather large difference between these structures (i.e. a
`
`

`

`Application/Control Number: 95/001,452
`Art Unit: 3993
`
`Page 9
`
`much smaller top opening than height and greatest body diameter) resulting in a
`
`constrictive "neck", however this is not required even by PO's own definition of bottle. PO
`
`states that Kramer sterilizes an elongated cup with an opening as wide as the diameter of
`
`its bottom portion. The examiner contends that such would not be much easier to sterilize
`
`than a "bottle" whose top opening were only minutely smaller in diameter than its maximum
`
`body diameter. There is no requirement that the exact same physical structure and
`
`parameters used by Kramer be used by Bosch. One of ordinary skill in the art when making
`
`any combination might require modifying structure or parameters in order to make elements
`
`of the two methods effectively coexist. Kramer taught that hydrogen peroxide could be used
`
`to achieve a 6 log reduction in spore organisms and such teaching can be incorporated into
`
`Bosch. The test for obviousness is not whether the features of a secondary reference may
`
`be bodily incorporated into the structure of the primary reference; nor is it that the claimed
`
`invention must be expressly suggested in any one or all ofthe references. Rather, the test is
`
`what the combined teachings of the references would have suggested to those of ordinary
`
`skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). It also appears
`
`as if PO is arguing against Kramer individually. See MPEP 2145 IV·One cannot show
`
`nonobviousness by attacking references individually where the rejections are based on
`
`combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re
`
`Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
`
`PO entirely relies on mere conclusory statements by declarants which are not
`
`supported by any factual data, experiments ... etc. Accordingly this evidence is deemed
`
`insufficient to establish non·obviousness. PO argues that applying the Combibloc system to
`
`Bosch's bottling process could never achieve the necessary level of aseptic at the claimed
`
`

`

`Application/Control Number: 95/001,452
`Art Unit 3993
`
`Page 10
`
`bottling speeds, but this argument is mitigated by the addition of more lines or parallel lines
`
`to the Bosch machine. Kramer does not teach away from using hydrogen peroxide as a
`
`sterilant in a high speed bottle filler. PO fails to mention that Kramer also mentions that
`
`increased temperatures can be used to achieve the desired germ killing effect when using
`
`hydrogen peroxide. Furthermore even if application and drying needs to be performed
`
`several times it is not clear that the total time would be such that the claimed bottling
`
`speeds could not still be reached through adding more lines.
`
`PO argues that the Wands factors prove the prior art is not enabling of the claimed
`
`invention.
`
`The examiner disagrees. PO failed to provide any analysis of the quantity of
`
`experimentation necessary because none of the experts which provided testimony regarding
`
`non-enablement provided any evidence of any experimentation they performed. A
`'
`.
`
`conclusory statement that the experimentation would have been "undue" is not an analysis.
`
`PO argued that no guidance or direction was given to arrive at the invention without undue
`
`experimentation. Some guidance was clearly provided, such as the type of sterilant, where
`
`the sterilant was applied, the temperature of the sterilant, the manner in which the sterilant
`
`is dried, how the caps or seals were sterilized, the types of filler used, the product being
`
`bottled, etc ... PO makes a lot of the geometry" of a bottle and why it is so difficult to sterilize
`
`when compared to other containers. However, it should be noted that a "bottle" could have
`
`dimensions such that the top opening is only very slightly smaller than the body (i.e. a bottle
`
`with a negligible constriction). A bottle such as this is covered by the claims but sterilization
`
`of such a bottle would not be much different than a cylinder with no constriction. Contrary to
`
`PO's position Bosch, Buchner, ZFL, etc. used in the rejections are presumed enabled. It is
`
`

`

`Application/Control Number: 95/001,452
`Art Unit: 3993
`
`Page 11
`
`irrelevant if it is a U.S. Patent or not. See MPEP 2121. The examiner again is of the opinion
`
`that one of ordinary skill in the art would have been able to perform the cl_aimed method
`
`given the disclosure of the references combined with their own knowledge when using
`
`experimentation which would not be considered undue. Dr. Sastry provides no persuasive
`
`evidence that it would take undue experimentation. The examiner contends that the Bosch
`
`system which existed at the time of the present invention which PO states is the one
`
`disclosed by Buchner, ZFL and Bosch was capable of operating at 100 bottles/minute.
`
`Therefore there was a presence of at least one working example. Again as for any difference
`
`in the production speed the examiner still considers adding more lines/parallel lines to
`
`Bosch, Buchner or ZFL's system would have been obvious. The examiner admits that the
`
`nature of the apparatus or system used by PO to perform the claimed methods is
`
`complicated. However the rejected claims are method claims and do not require the
`
`specifics of the apparatus disclosed by PO. In other words one could perform the claimed
`
`method using a different and possibly less complicated apparatus than the one disclosed by
`
`PO. PO points to the fact that it took Buchner years to make an aseptic bottling apparatus;
`
`however, Buchner's developmental work was started many years prior to that of the
`
`Patentee and would not have been able to take advantage of any of the information gleaned
`
`in the industry from when Buchner started up until the effective filing date of the '013
`
`patent. Starting from scratch would be totally different than starting from Buchner's
`
`disclosure. Buchner also had built his apparatus as of 1991 and therefore one of ordinary
`
`skill in the art would have in his possession not only the disclosure of Buchner but also the
`
`knowledge gained in the industry from 1991 until the effective filing date of the '013 patent,
`
`which is at least 8 years. Furthermore, the fact that it took the present inventor years to
`
`

`

`Application/Control Number: 95/001,452
`Art Unit: 3993
`
`Page 12
`
`arrive at the machine used to perform the claimed method is not persuasive evidence
`
`because the examiner has determined that increasing production speed could be achieved
`
`through adding additional/parallel lines to an existing machine. The large amount of time
`
`the inventor took to arrive at his invention may have stemmed from experimenting to find a
`
`different way to increase speed, not the time it took to perfect sterilizing bottles to the
`
`claimed degree and filling them with aseptically sterilized foodstuffs. Experimentation
`
`regarding the Patentee finding the proper temperature to sterilize the bottles without
`
`softening them is only germane to those method claims requiring plastic bottles with low
`
`heat resistance. Again just because the PO took years to develop his particular machine
`
`does not mean that it would have taken a person of ordinary skill in the art a similar amount
`
`of time to be able to make a different apparatus capable of performing the claimed
`
`methods, or that that person would have needed to address the same issues as Patentee
`
`did in order to be able to perform the claimed methods. PO states that the Patentee took
`
`time to find the "best way to process the sterilant and found:". It is not required that a
`
`person of ordinary skill in the art be required to take the time to find the "best way" to do
`
`anything. It should also be stated that comments by experts concerning a determination of
`
`the ability or not to practice the claimed invention would necessitate the ability of the
`
`declarant to be able to determine claim scope. It is not clear from the comments by the
`
`declarants that the breadth of the method claims and the rejections thereof herein are fully
`
`appreciated by the declarants. PO states that the state of the prior art lacked any ability to
`
`sterilize bottles at a high rate of speed. The examiner disagrees. The state of the prior art
`
`included the Bosch system which sterilized·bottles at a high rate of speed and aseptically
`
`filled bottles at a rate of 100 bottles/minute. Buchner stated in paragraph 18 of his
`
`

`

`Application/Control Number: 95/001,452
`Art Unit: 3993
`
`Page 13
`
`declaration that the information in the articles such as the Bosch reference and the Pharma
`
`Technology journal was "intended to inform about the achieved technical success, show
`
`what Bosch has achieved" .... The Bosch machine has been characterized as being the only
`
`apparatus prior to Patentee's as passing FDA muster. It is unclear exactly what would
`
`constitute "high rate of speed". PO's statement that because Dr. Buchner ran into air
`
`press·ure problems when making a machine with a number of lines that this equates to the
`
`art being highly unpredictable is unpersuasive. This does not speak to the predictability of
`
`the art. Furthermore, the method claims are extremely broad. Accordingly, when examining
`
`all of the Wands factors the examiner disagrees that such examination proves the prior art
`
`to be non-enabling. On page 23, PO states that the prior art lacked any ability to sterilize
`
`bottles at a high rate of speed. This is simply not true. PO admits that Bosch aseptically .
`
`sterilized (passed FDA muster) and filled bottles at a rate of 100 bottles/min prior to P9's
`
`invention. Is PO arguing that 100 bottles/min. is not high speed while 101 bottles/min
`
`(which the claims cover) is high speed?
`
`PO argues that there must be some reasoning with rational underpinning to support
`
`obviousness. Adding lines would lack a predictable result and also require undue
`
`experimentation. PO provided declarations by Dr. Buchner and Dr. Sastry to establish the
`
`non-obviousness of adding more lines.
`
`The examiner disagrees. It is not necessary to physically incorporate these lines into
`
`the actual machines of Bosch, Buchner or ZFL. The examiner contends that incorporating
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`additional lines into the design and method disclosed by Bosch, Buchner and ZFL would
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`have been an obvious modification and one of ordinary skill in the art would have been
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`enabled as to how to incorporate such additionaljparallel lines into such a design and
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`

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`Application/Control Number: 95/001,452
`Art Unit: 3993
`
`Page 14
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`method so as to increase production and arrive at the claimed speed. Dr. Buchner only
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`states that many features need to be considered, and anticipating all problems that may
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`arise when adding lines is not possible. These statements fail to be persuasive as to non-
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`enablement via undue experimentation and also fail to provide any persuasive evidence of
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`non-obviousness. While certainly some experimentation would be needed to add additional
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`lines there is no persuasive evidence that said experimentation would be "undue". No
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`evidence was submitted establishing that the declarers ever attempted to take the
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`information of the methods disclosed by Bosch, Buchner and ZFL and incorporate additional
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`or parallel lines to increase production and ran into problems which could not be solved or
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`could but only when using undue or extreme experimentation. Indeed, parallel lines (parallel
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`sterilizers, fillers, cappers, ... etc.}, only require making duplicate sections of a known
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`assembly line and adding them in p_arallel and are designed to operate exactly as the known
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`1st section, which together the duplicate sections allow for higher overall production
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`throughput. For example a single supply of bottles could be delivered to each of multiple
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`sterilizers which would sterilize the bottles .in the same manner and taking the same amount
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`of time as the original sterilizer ... after which the bottles pass to one of multiple fillers which
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`would fill the bottles in the same manner and taking the same amount of time as the
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`original filler, followed by transport to one of multiple cappers or closing machines which
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`would cap or close the filled bottles in the same manner and taking the same amount of
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`time as the original capper or closer, ... etc. Adding lines by using a larger sterilizer (such as
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`indicated by Buchner which discloses use of 6 and 9 line sterilizers}, more filling nozzles and
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`more cappers are also possible and could be used to also increase production, even if
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`confronted with the "edge effect problems", which were identified by Dr. Buchner and which
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`

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`Application/Control Number: 95/001,452 ·
`Art Unit: 3993
`
`Page 15
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`were not declared to be unsolvable or requiring "undue experimentation" to solve. This is
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`the articulated reasoning with rational underpinning. The motivation to increase production
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`clearly existed and the predictable result of adding more or parallel lines to the machines of
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`Bosch, Buchner and ZFL is indeed increased production.
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`PO argued that Claim 19 is patentable over Bosch and Kramer because sterilizing
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`bottles to a 6 log reduction of spore organisms is not taught by these references.
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`The examiner disagrees. Kramer discloses the claimed degree of sterilization ori
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`other types of packaging. Furthermore PO admits that the Bosch machine passed FDA
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`muster indicating it would have had to meet this level of sterilization as well. Dr. Sastry
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`states in paragraph 45 of his 11-28-2012 declaration that the only reasonable definition of
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`the term "spore organism" used in the claims is "surrogate spore organisms" and that a 6
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`log reduction in surrogate spore organisms translate into a 12 log reduction in C. botulinum.
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`The examiner disagrees. There is no reason to construe or limit the claimed "spore
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`organism" as a surrogate spore organism which is used to "test" machines. The claims are
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`drawn to a method for automatically aseptically bottling aseptically sterilized foodstuffs. If
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`that were the case the claimed method would be including a step of testing the disinfecting
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`capabilities of the machine rather than the actual aseptically disinfecting step performed
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`during the actual bottling process.
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`PO again argues that Bosch, Bjerborn and FDA Regulati,ons are non-enabling. PO
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`states that Bjerborn does provide some details of applying hydrogen peroxide vapor to
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`sterilize a bottle but fails to teach how to accomplish this at a high rate of speed.
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`The examiner disagrees that the references are not enabling. In addition to the
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`previous argumer:tts by the examiner Bjerborn provides significant detail about the hydrogen
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`

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`Application/Control Number: 95/00.1,452
`Art Unit: 3993
`
`Page 16
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`peroxide parameters for sterilizing of PET bottles and the residual level of hydrogen peroxide
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`on bottles which are ready to be filled. PO is again arguing the references individually
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`instead of what the combination of the references teaches to one skilled in the art. Bosch's
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`system passed. FDA muster which PO maintains must meet the claimed 0.5 ppm level of
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`residual level of hydrogen peroxide. Therefore the know-how existed in the knowledge of one
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`skilled in the art of how to achieve this goal.
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`PO argues that claims 21 and 24 are patentable over Bosch, Bjerborn and Lisiecki as
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`the references do not enable the claimed invention for the same reasons noted above. The
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`combination does not teach providing a time and temperature for removal of the sterilant
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`wherein a residual level of 0.5 ppm. and at least about a 6 log reduction in B. subtilis.
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`The examiner disagrees. Bjerborn teaches at least 5 log reduction of B. subtilis which
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`could read on the at least about 6 log limitation without any modification. Clearly since the
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`removal of the sterilant takes a certain amount of time and is done at a certain temperature
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`then the providing time and temperature steps are met.
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`PO argues that Buchner, Campden, Gustaffson, ZFL and Rippen or Kramer do not
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`enable the claimed invention citing basically the same argument