U.S,S.N, 12/495,148
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Serial No:
`
`Examiner:
`
`Art Group:
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`12/495,148
`
`Poon, Robert
`
`3728
`
`Reference No:
`
`BPMDL00051T (10055U)
`
`Appn. Filed:
`
`Applicants:
`
`June 30, 2009
`
`Tomes, Jennifer et al.
`
`Title:
`
`Catheter Tray, Packaging System, and Associated Methods
`
`April 3, 2013
`
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, Virginia 223 13- 145 0
`
`This paper is in response to an Office Action mailed October 4, 2012, a response
`
`thereto being due on or before April 4, 2013, without extension, and accompanies a
`
`request for extension of time and the appropriate fees. In View of the remarks herein,
`
`Applicants respectfiJlly request reconsideration of the above-identified patent application.
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`U.S.S.N. 12/495,148
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`Listing of the Claims:
`
`1-18. (Canceled)
`
`CLAIMS:
`
`19.
`
`(Previously presented) A method of manufacturing a packaged catheter assembly,
`
`comprising:
`
`providing a tray having at least a first compartment with a first compartment base
`
`member having an inclined, stair-step contour and a second compartment,
`
`wherein the first compartment and the second compartment are separated by a
`
`first barrier having an opening therein;
`
`disposing at least one syringe in the first compartment;
`
`disposing a catheter assembly in the second compartment;
`
`sealing the tray;
`
`enclosing printed instructions directing a user to discharge contents of the at least
`
`one syringe into the first compartment and to pass at least a portion of the
`
`catheter assembly through the opening and into the contents; and
`
`placing a sterile wrap about the tray.
`
`20.
`
`(Previously Presented) The method of claim 19, wherein the tray further comprises a
`
`third compartment separated from the second compartment by a second barrier having a
`
`second opening therein, further comprising:
`
`disposing at least one of a specimen container or a skin cleanser in the third
`
`compartment.
`
`21. (Previously Presented) The method of claim 20, further comprising disposing at least
`
`another syringe in one of the first compartment or within both the opening and the second
`
`opening.
`
`to
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`U.S.S.N. 12/495,148
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`22. (Previously Presented) The method of claim 19, wherein the tray comprises a
`
`contoured surface having at least three compartments separated by barriers and a
`
`perimeter wall.
`
`23. (Previously Presented) The method of claim 20, wherein a first opening depth of the
`
`first opening is less than a second opening depth of the second opening.
`
`24. (Previously Presented) The method of claim 20, wherein the second compartment
`
`comprises a second compartment base member and the third compartment comprises a
`
`third compartment base member, wherein the second compartment base member and the
`
`third compartment base member are substantially coplanar.
`
`25. (Previously Presented) The method of claim 19, wherein the first compartment base
`
`member comprises a first step portion and a second step portion, wherein the first step
`
`portion is disposed farther from the first barrier than the second step portion.
`
`26. (Previously Presented) The method of claim 25, wherein the second step portion is
`
`disposed at a greater depth within the tray than the first step portion.
`
`27. (Previously Presented) The method of claim 26, wherein the second compartment
`
`comprises a second compartment base member, wherein the first step portion and the
`
`second step portion are disposed in a non-parallel orientation relative to the second
`
`compartment base member.
`
`28. (Previously Presented) The method of claim 26, wherein each of the first step portion
`
`and the second step portion define a recess for accommodating a syringe flange.
`
`29. (Previously Presented) The method of claim 20, wherein a first opening width of the
`
`first opening is less than a second opening width of the second opening.
`
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`U.S.S.N. 12/495,148
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`30. (Previously Presented) The method of claim 19, wherein the first opening is bounded
`
`by a first opening base member and two inclined first opening side members.
`
`31. (Currently Amended) The method of claim 20. wherein the second opening is
`
`bounded by a second opening base member. an inclined second opening side member.
`
`and the perimeter wall.
`
`32. (Previously Presented) The method of claim 20, wherein the second compartment
`
`comprises a second compartment base member, wherein each of the first compartment,
`
`the second compartment, and the third compartment are open along a side of the tray
`
`opposite the second base member.
`
`33. (Previously Presented) The method of claim 19, wherein the second compartment
`
`comprises a second compartment base member, wherein first compartment base member
`
`is configured to support the at least one syringe at a shallower depth within the tray than a
`
`depth of the second compartment base member. and in a non-parallel configuration with
`
`the second compartment base member.
`
`34. (Previously Presented) The method of claim 32, wherein the at least one syringe
`
`comprises a plurality of syringes, wherein the first compartment base member is
`
`configured to support each of the plurality of syringes at different depths within the tray
`
`relative to the depth of the second compartment base member.
`
`35. (Previously Presented) A method of manufacturing a packaged catheter assembly.
`
`comprising:
`
`providing a tray having at least a first compartment with a first compartment base
`
`member having an inclined, stair-step contour and a second compartment.
`
`wherein the first compartment and the second compartment are separated by a
`
`first barrier having an opening therein, and a third compartment;
`
`disposing at least one syringe in the first compartment;
`
`disposing a catheter assembly in the second compartment;
`
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`U.S.S.N. 12/495,148
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`disposing a skin cleanser in the third compartment;
`
`sealing the tray;
`
`enclosing printed instructions directing a user to discharge contents of the at least
`
`one syringe into the first compartment and to pass at least a portion of the
`
`catheter assembly through the opening and into the contents; and
`
`placing a sterile wrap about the tray.
`
`36. (Previously Presented) The method of claim 35, further comprising disposing at least
`
`another syringe in the tray.
`
`37. (Previously Presented) A method of manufacturing a packaged catheter assembly,
`
`comprising:
`
`providing a tray having at least a first compartment with a first compartment base
`
`member having an inclined, stair-step contour and a second compartment,
`
`wherein the first compartment and the second compartment are separated by a
`
`first barrier having an opening therein, and a third compartment;
`
`disposing at least one syringe in the first compartment;
`
`disposing a catheter assembly in the second compartment;
`
`disposing another syringe in the tray;
`
`scaling the tray;
`
`enclosing printed instructions directing a user to discharge contents of the at least
`
`one syringe into the first compartment and to pass at least a portion of the
`
`catheter assembly into the contents; and
`
`placing a sterile wrap about the tray.
`
`38. (Currently Amended) The method of claim 37, wherein the second compartment
`
`comprises a second compartment base member, wherein the disposing another syringe
`
`comprises disposing the another syringe Within both the opening and the a second
`
`opening.
`
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`U.S.S.N. 12/495,148
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`39. (Previously Presented) A method of manufacturing a packaged catheter assembly,
`
`comprising:
`
`providing a tray having at least a first and a second compartment separated by a
`
`first barrier having an opening therein;
`
`disposing at least one syringe in the tray;
`
`sealing the tray; and
`
`enclosing with the tray printed instructions directing a user to discharge contents
`
`ofthe at least one syringe into the first compartment and to pass at least a
`
`portion of the catheter assembly into the contents.
`
`40. (Currently Amended) A tray configured to accommodate a catheter asscmbly and
`
`medical devices corresponding to catheter use, the tray comprising:
`
`a contoured surface defining at least three compartments separated by barriers and
`
`a perimeter wall, the at least three compartments comprising:
`
`a first compartment comprising a first compartment base member having
`
`at least one inclined stair-stepped contour defining a ramp upon which
`
`syringes may be placed so that a plunger of each syringe is
`
`predisposed to project upward and out of the tray;
`
`a second compartment comprising a second base member; a first barrier
`
`separating the first compartment from the second compartment,
`
`wherein the first barrier defines a first opening between the first
`
`compartment and the second compartment, the first opening having a
`
`first opening depth;
`
`a third compartment comprising a third base member; and
`
`a second barrier separating the second compartment from the third
`
`compartment, wherein the second barrier defines a second opening
`
`between the second compartment and the third compartment, the
`
`second opening having a second opening depth.
`
`41. (Previously Presented) The tray of claim 40, wherein the first opening depth and the
`
`second opening depth are different.
`
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`42. (Previously Presented) The tray of claim 41, wherein the first opening depth is less
`
`than the second opening depth.
`
`43. (Previously Presented) The tray of claim 40, wherein the first compartment is
`
`configured to accommodate a plurality of syringes, the second compartment is configured
`
`to accommodate the catheter assembly, and the third compartment is configured to
`
`accommodate at least one of a specimen container or a skin cleanser.
`
`44. (Previously Presented) The tray of claim 40, wherein the second base member and the
`
`third base member are substantially coplanar.
`
`45. (Previously Presented) The tray of claim 40, wherein the first compartment base
`
`member comprises a first step portion and a second step portion, wherein the first step
`
`portion is disposed farther from the first barrier than the second step portion.
`
`46. (Previously Presented) The tray of claim 45, wherein the second step portion is
`
`disposed at a greater depth within the tray than the first step portion.
`
`47. (Previously Presented) The tray of claim 46, wherein each ofthc first step portion and
`
`the second step portion are disposed in a non-parallel orientation relative to the second
`base member.
`
`48. (Previously Presented) The tray of claim 45. wherein each of the first step portion and
`
`the second step portion define a recess for accommodating a syringe flange.
`
`49. (Previously Presented) The tray of claim 40. wherein the first opening has a first
`
`opening width associated therewith width that is less than a second opening width
`
`associated with the second opening.
`
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`50. (Previously Presented) The tray of claim 40, wherein the first opening is bounded by
`
`a first opening base member and two inclined first opening side members.
`
`51. (Previously Presented) The tray of claim 50, wherein the second opening is bounded
`
`by a second opening base member, an inclined second opening side member, and the
`
`perimeter wall.
`
`52. (Previously Presented) The tray of claim 40, wherein each of the first compartment,
`
`the second compartment, and the third compartment are open along a side of the tray
`
`opposite the second base member.
`
`53. (Previously Presented) A catheter packaging system, comprising:
`
`a tray having a first compartment for accommodating syringes and a second
`
`compartment for accommodating a coiled medical device, wherein the first
`
`compartment comprises a first compartment base member and the second
`
`compartment comprises a second compartment base member, the tray further
`
`comprising a barrier having a first barrier opening therein, the barrier separating
`
`the first compartment from the second compartment;
`
`at least one syringe disposed in the first compartment; and
`
`a catheter assembly disposed in the second compartment;
`
`wherein the first compartment base member is configured to support the at least one
`
`syringe at a shallower depth within the tray than a depth of the second
`
`compartment base member, and in a non-parallel configuration with the second
`
`compartment base member.
`
`54. (Previously Presented) The catheter packaging system of claim 53, wherein the tray
`
`comprises a third compartment and a second barrier separating the third compartment
`
`from the second compartment, further comprising a specimen container disposed in the
`
`third compartment.
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`55. (Previously Presented) The catheter packaging system of claim 54, wherein the
`
`second barrier has a second barrier opening therein, further comprising at least a second
`
`syringe disposed within both the first barrier opening and the second barrier opening.
`
`56. (Previously Presented) The catheter packaging system of claim 54, wherein the at
`
`least one syringe comprises a plurality of syringes, wherein the first compartment base
`
`member is configured to support each of the plurality of syringes at different depths
`
`within the tray relative to the depth of the second compartment base member.
`
`57. (Previously Presented) The catheter packaging system of claim 53, further comprising
`
`printed instructions packaged with the tray, the printed instructions directing a user to
`
`discharge contents of the at least one syringe into the first compartment and to pass at
`
`least a portion of the catheter assembly through the first barrier opening, into the first
`
`compartment, and through the contents of the at least one syringe.
`
`58. (New) A tray configured to accommodate a catheter assembly and medical devices
`
`corresponding to catheter use, the tray comprising:
`
`a contoured surface defining at least three compartments separated by barriers and
`
`a perimeter wall, the at least three compartments comprising:
`
`a first compartment comprising a first compartment base member defining a
`
`contoured surface upon which syringes may be placed at different depths such
`
`that a plunger of each syringe is predisposed to project upward and out of the
`
`tray;
`
`a second compartment comprising a second base member; and
`
`a third compartment comprising a third base member;
`
`the contoured surface non-parallel with the second base member or the third base
`member.
`
`59. (New) A catheter packaging system, comprising:
`
`a tray having a first compartment for accommodating syringes and a second
`
`compartment for accommodating a coiled medical device, wherein the first
`
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`compartment comprises a first compartment base member and the second
`
`compartment comprises a second compartment base member;
`
`at least one syringe disposed in the first compartment; and
`
`a catheter assembly disposed in the second compartment;
`
`the first compartment base member contoured to support the at least one syringe
`
`at a shallower depth within the tray than a depth of the second compartment
`
`base member, and in a non-parallel configuration with the second
`
`compartment base member.
`
`10
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`U.S.S.N. 12/495,148
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`REMARKS — General
`
`Double Parenting:
`
`The Office Action rejects claims 40-57 under 35 USC §101 as containing
`
`conflicting claims with copending 12/846,675. Applicant respectfully traverses the
`
`rejection.
`
`Applicant initially notes that the Restriction Requirement mailed August 4, 2010,
`
`in the present case necessitated the filing of the ‘675 application. in the very next Office
`
`Action, the Examiner in the present case withdrew the Restriction Requirement. Sec
`
`Office Action mailed March 3, 201 1. This initiation/withdrawal ofthe Restriction
`
`Requirement not only caused Applicant to expend significant funds, but also resulted in
`
`the present double patenting rejection.
`
`This point notwithstanding, Applicant has amended claim 40 to recite a ramp
`
`upon which syringes may be placed so that the plunger of each syringe is predisposed to
`
`project upward and out of the tray. Support for the amendment is found in the
`
`specification as published at paragraph [0038]. This limitation appears nowhere in the
`
`‘675 application. This amendment overcomes the rejection because the rejection is a
`
`double patenting rejection under §101. As set forth in MPEP §804, this is “same
`
`invention” double patenting.
`
`The requirement for such a rejection is claims drawn to identical subject matter.
`
`Id. “Thus, the term ‘same invention,” in this context, means an invention drawn to
`
`identical subject matter.” 161., citing Miller v. Eagle M g. C0., 151 US. 186 (1894); In re
`
`Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Ockert, 245 F.2d 467, 114
`
`USPQ 330 (CCPA 1957). “Where the claims of an application are not the ‘same’ as those
`
`of a first patent, but the grant of a patent with the claims in the application would unjustly
`
`extend the rights granted by the first patent, a double patenting rejection under
`
`nonstatutory grounds is proper.” Id. “A reliable test for double patenting under 35 USC.
`
`101 is whether a claim in the application could be literally infringed without literally
`
`infringing a corresponding claim in the patent.” In re Vogel, 422 F.2d 438, I 64 USPQ
`
`619 (CCPA I970).
`
`11
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`In the present case, the claims are not identical in view of the amendment. Claim
`
`40 recites apparatus components not recited in the ‘675 application. Accordingly, there is
`
`an embodiment that falls Within the scope of one claim, but not the other. In accordance
`
`with MPEP §804, a double patenting rejection under §10l is thus improper. “If there is
`
`such an embodiment, then identical subject matter is not defined by both claims and
`
`statutory double patenting would not exist.” Id. Emphasis added. Applicant respectfully
`
`requests reconsideration of the rejection in light of these comments.
`
`
`Claim Rejections under 35 USC Q" l I 2:
`
`Claim 31 is rejected under 35 USC §1 12, second paragraph. Specifically, the
`
`Office Action rejects the claim as reciting a “second opening base member” and a
`
`“second opening side member” without referring first to a “first opening base member”
`
`and a “first opening side member.” Applicant respectfully traverses the rejection.
`
`Applicant has amended the claim to strike “second” in light of the Examiner’s
`
`comments set forth at pages 18-19 of the Office Action. Applicant submits that the
`
`rejection is overcome by way of the amendment. Applicant requests reconsideration of
`
`the rejection.
`
`
`Claim Rejections under 35 USC $102:
`
`The Office Action rejects claim 40 under §102 as being anticipated by US Pat.
`
`No. 5,339,955 to Horan. Applicant respectfully traverses the rejection.
`
`According to MPEP §213l, “A claim is anticipated only if each and every
`
`element as set forth in the claim is found, either expressly or inherently described, in a
`
`single prior art reference.” Verdegaal Bros. v. Union Oil Co. ofCalljbmia, 814 F.2d 628,
`
`631 (Fed. Cir. 1987). For anticipation, there must be no difference between the claimed
`
`invention and the reference disclosure. See, e. g., Scripps Clinic & Res. Found. V.
`
`Genentech, Inc, 927 F.2d 1565 (Fed. Cir. 1991). “[E]very element ofthe claimed
`
`invention must literally be present, arranged as in the claim. . .The identical invention
`
`must be shown in as complete detail as is contained in the patent claim.” See, e.g.,
`
`Richardson V. Suzuki iMotor Company Ca, 868 F.2d 1226, 1236 (Fed. Cir. 1989).
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`Applicant’s claim 40 recites inter alia a first compartment comprising a first
`
`compartment base member having at least one inclined stair-stepped contour.
`
`As is clearly shown in FIG. 4 of Horan, Horan teaches a flat stair shape. It is not
`
`inclined. Horan fails to teach an inclined stair-stepped member anywhere. Accordingly,
`
`Horan fails to teach “. . .the identical invention. . .shown in as complete detail as is
`
`contained in the patent claim” and the rejection is overcome. Richardson, supra.
`
`Applicant respectfully requests reconsideration of the rejection in View of the
`amendment.
`
`
`Claim Rejections under 3‘5 USC $103:
`
`The Office Action rejects claims 19-30 and 32-36 under 35 USC §103(a) as being
`
`unpatentable in view of Busch, US Published Pat. Appln. No. 2004/0004019, combined
`
`with Demisen et al., US Pat. No. 6,681,933, hereinafter “Demisen,” further combined
`
`with Fischer, US Pat. No. 5,031,768, and yet further combined with Paikoff et al., US
`
`Pat. No. 4,523,679. herafter “Paikoff.” Applicant respectfully traverses the rejection
`
`Busch is directed to an epidural anesthesia kit. Busch. Abstract. The Office
`
`Action submits at pages 3-4 that Busch teaches a package for a catheter assembly having
`
`a first compartment and a second compartment, disposing a syringe in the first
`
`compartment and a catheter disposed in the second compartment, and sealing the tray.
`
`The Office Action acknowledges that Busch fails to teach the remainder of the limitations
`
`appearing, e.g., in claim 19.
`
`Demisen is directed to a writing utensil case. Demisen, Abstract. The Office
`
`Action submits that Demiscn’s pen holder teaches a tray having a stair stepped contour.
`Fischer is directed to an instrument case. The Office Action submits that Fischer
`
`teaches a tray with an opening on a barrier for securing instruments.
`
`Paikoff is directed to a medical procedure kit. The Office Action then submits that
`
`Paikoff teaches a medical procedure kit where the tray is sealed and placed within the
`
`sterile wrap.
`
`The motivation for combining the four disparate references, as set forth by the
`
`Examiner, are as follows:
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`°
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`For combining Busch with Demisen: “. . .to facilitate the retrieval of the
`
`syringe for individuals with reduced dexterity (Demisen, col. 4, 1145-50).”
`
`Office Action, page 4.
`
`°
`
`°
`
`For combining Fischer with Busch and Demisen: “. . .to secure or hold
`
`additional surgical instruments (Fischer, col. 6, 11. 25-35).” Id.
`
`For combining Paikoffwith Busch, Demisen, and Fischer: “. . .to
`
`maximize sterility (Paikoff, abstract).” Office Action, page 5.
`
`Applicant respectfully disagrees. Applicant respectfully traverses the rejection for
`
`at least the following three reasons:
`
`1. Contrary to the assertions of the Office Action, Applicant respectfully
`
`submits one of ordinary skill in the art would Lot be motivated to make the
`combination.
`
`2. Applicant respectfully submits that the combination of Busch, Demisen,
`
`Fischer, and Paikoff fails to make known or obvious each and every
`
`limitation of Applicant’s claim 19, from which the remaining claims
`
`depend.
`
`3. Applicant includes herein secondary considerations as further evidence
`
`that Applicant’s invention is not obvious in view of Busch, Dcmisen,
`
`Fischer, and Paikoff. The secondary considerations include evidence
`
`submitted in the response filed November 19, 2010, and additional
`
`evidence ofsecondary considerations presented for the first time.
`
`
`One of'Ordinary Skill in the Art would NOT be iMotivated to Ala/(e the Combination:
`
`In the present case, Applicant very respectfully submits that one of ordinary skill
`
`in the art would Lot be motivated to combine the four different references of Busch,
`
`Demisen, Fischer, and Paikoff.
`
`It is clear that obviousness cannot be demonstrated merely by showing that the
`
`various elements recited in a claim existed in the prior art at the time the invention was
`
`made. “A patent composed of several elements is not proved obvious merely by
`
`14
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`U.S.S.N. 12/495,148
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`demonstrating that each of its elements was, independently, known in the prior art.” KSR
`
`International Co. v. Tale—flex Inc. (KSR), 550 US. 398, 412 (2007).
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`In addition to showing that an applicant’s claimed elements existed, the Examiner
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`should also demonstrate why one of ordinary skill in the art would have been motivated to
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`make the combination. “But it is not enough to simply show that the references disclose
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`the claim limitations; in addition, ‘it can be important to identify a reason that would have
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`prompted a person of ordinary skill in the art to combine the elements as the new
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`invention does.m Transooean Ofifshore Deepwater Drilling, Inc, v. Maersk Contractors
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`USA, Inc. 2010 US App. LEXIS 17181, 9, (Fed. Cir. 2010), citing KSR, 550 US. at 401.
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`This requirement exists to prevent the use of
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`. .the inventor’s disclosure as a blueprint
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`for piecing together the prior art to defeat patentability — the essence of hindsight.”
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`Ecolochem, Inc. v. So. Cal. Edison Co., 227 F.3d 1361, 1371-72 (Fed Cir. 2000) (quoting
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`In re Dembiczak, 175 F.3d 994, 999 (Fed. Cir. 1999)).
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`In the present case, contrary to the assertions of the Office Action, one would not
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`be motivated to combine the references. Specifically, one would not be motivated to
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`combine the teachings of Demisen with Busch for the reasons set forth in the Office
`Action.
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`As noted above, Busch is directed to an epidural kit. As is known in the art, and is
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`set forth in Busch’s specification at paragraph [0004], epidural procedures involve
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`inserting a needle between vertebrae and other components of the spine. The Office
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`Action submits that one of ordinary skill in the art would be motivated to combine the
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`teaching of Demisen with Busch “. . .to facilitate the retrieval ofthe syringe for
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`individuals with reduced dexterity (Demisen, col. 4, 11 45-50).” Applicant respectfully
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`disagrees. One of ordinary skill in the art would not be motivated to make the
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`combination for this reason because one of ordinary skill in the art understands that
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`the slightest misalignment of a needle during an epidural insertion process will cause
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`paralysis. For this reason, medical guidelines and medical liability insurance policies
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`preclude “individuals with reduced dexterity” from performing epidural processes
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`because doing so would greatly heighten the potential for paralysis or other injury to a
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`patient.
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`Medline Industries, Inc.; |PR2015-00511
`Exhibit 2108
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`Page 15 of 36
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`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2108
`Page 15 of 36
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`U.S.S.N. 12/495,148
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`It is not clear under the disclosed circumstances why one of ordinary skill in the
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`art would consider it necessary to adapt an epidural kit for people for whom the kit is not
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`intended, how or why doing so would be beneficial, and how the same could be achieved
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`without disrupting the desired precise medical procedure taking place in the primary
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`reference. As such, the alleged motivation is suspect, as it does not appear relevant given
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`the context of the primary reference.
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`The combination ofBuseh, Demisen, Fischer, and Paikofffails to make known or obvious
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`each and everv limitation ongplieant’s claims I 9, 35, and 37:
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`The above notwithstanding, assuming, arguendo, that Dcmiscn were combined
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`with Busch, Fischer, and Paikoff, the resulting combination fails to make known or
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`obvious each and every limitation of claims 19 and 35.
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`Applicant’s claim 19 recites, inter alia,
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`..a first compartment base member
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`having an inclined, stair-step contour.” Claim 35 recites the same limitations. In
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`accordance with these claims, the base member is both inclined and includes a stair-step.
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`It is well understood that the “. . .meaning of words used in a claim is not construed in a
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`‘lexicographic vacuum, but in the context of the specification and drawings’.” MPEP
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`§2111.01. See also, Tom Co. v. White Consolidated Industries Inc., 199 F.3d 1295, 1301
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`(Fed. Cir. 1999). Thus, consideration oprplicant’s specification is appropriate to
`determine the construction 0fthe limitations found in claims 19 and 35.
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`Turning to Applicant’s specification, an “inclined, stair-stepped” bottom mcmbcr
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`presents
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`. .thc plungers of each syringe at an easy to reach angle and at different heights
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`based upon order of use.” Applicant’s specification as published, paragraph [0026]. This
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`is because in an embodiment when the base member is “inclined,” the base member
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`“. . .forms a ramp upon which syringes may be placed so that the plunger of each syringe
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`is predisposed to project upward and out of the tray 100.” Applicant’s specification as
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`published, paragraph [0038]. When the base member also includes a “stair-step,” the base
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`member is “. . .suitable for accommodating a plurality of syringes at different heights. For
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`example, a first step portion 116 of the stair-stepped contour 115 may be at a different
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`height within the tray 100 than a second step portion 117 of the stair-stepped contour...
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`Said differently, the second step portion 117 is disposed at a greater depth within the tray
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`16
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`Medline Industries, Inc.; |PR2015—00511
`Exhibit 2108
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`Page 16 of 36
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`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2108
`Page 16 of 36
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`U.S.S.N. 12/495,148
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`100 than the first step portion 116.” Applicant’s specification as published, paragraph
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`[0035].
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`The combination of Busch, Demisen, Fisher, and Paikoff fails to teach a base
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`member that is both inclined and stair-stepped. It is clear that the combination of
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`Busch, Fisher, and Paikoff fails to teach this limitation because none of these references,
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`alone or in combination, suggest either an inclined base member or a stair-stepped base
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`member. The addition of Demisen to Busch, Fisher, and Paikoff fails to remedy this
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`deficiency because Demisen only teaches an inclined base member and fails to teach
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`any stair-step whatsoever.
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`Demisen teaches a writing instrument holder. Demison, Abstract. Pens or pencils
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`are held in a retaining panel 36 that is defined by a first gradient and a second gradient.
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`Demisen, col. 4, line 66, through col. 5, line 12. Channels within the retaining panel
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`either “. . .slope downward along a first gradient,” and conversely, other channels
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`. .slope upward along a second gradient. Id. Thus, “the first and second gradients of first
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`and second channels 80, 82, respectively, provide a crisscross pattern to writing utensils
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`12 engaged within upper housing 16.” Id. While Demisen’s gradients may provide an
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`inclined base member, they fail to make known or obvious an inclined, stair-stepped
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`base member. Accordingly, even if Demisen were combined with Busch, Fischer, and
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`Paikoff, the resulting combination fails to make known or obvious each and every
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`limitation of Applicant’s claims because none of Busch, Fischer, or Paikoff, alone or in
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`combination, suggest either an inclined base member or a stair-stepped base member. For
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`this reason, the combination fails to make known or obvious each and every limitation of
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`Applicant’s claims
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`Secondarv Considerations Demonstrate Agplicant ’s Invention is Non-obvious over Prior
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`Airt:
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`Rebuttal evidence may include evidence of "secondary considerations," such as
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`"commercial success, long felt but unsolved needs, [and] failure of others." Graham v.
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`John Deere C0., 383 US. 1, 17 (1966). Evidence pertaining to secondary considerations
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`must be taken into account whenever present. See, e.g., Rfizer, Inc. v. Apotex, Inc, 480
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`F.3d 1348, 1372 (Fed.