Paper No. __
`Filed: September 20, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________________
`
`PAIN POINT MEDICAL SYSTEMS, INC.,
`d/b/a MIBO MEDICAL GROUP,
`Petitioner,
`
`v.
`
`BLEPHEX, LLC,
`Patent Owner
`___________________
`
`Case IPR2016-01670
`Patent 9,039,718 B2
`___________________
`
`
`
`
`PETITIONER PAIN POINT MEDICAL SYSTEMS, INC.’S REPLY
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Filed: September 20, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________________
`
`PAIN POINT MEDICAL SYSTEMS, INC.,
`d/b/a MIBO MEDICAL GROUP,
`Petitioner,
`
`v.
`
`BLEPHEX, LLC,
`Patent Owner
`___________________
`
`Case IPR2016-01670
`Patent 9,039,718 B2
`___________________
`
`
`
`
`PETITIONER PAIN POINT MEDICAL SYSTEMS, INC.’S REPLY
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`
`
`I.
`
`II.
`
`INTRODUCTION …………………………………………………………..1
`
`STATEMENT OF FACTS ………………………………………...………..1
`
`III. PATENT OWNER IMPROPERLY ATTACKS
`THE PRIOR ART REFERENCES IN ISOLATION …………………..….17
`
`IV. GROUND 1: CLAIMS 1-11 AND 14-17 ARE OBVIOUS
`IN VIEW OF ALGERBRUSH II, SEMINARA AND STEVENS ……..…18
`
`V. GROUND 2: CLAIMS 1-11 AND 14-17 ARE OBVIOUS
`IN VIEW OF ALGERBRUSH II AND HAMBURG ………………..……21
`
`VI. GROUND 3: CLAIMS 1-11 AND 14-17 ARE OBVIOUS
`IN VIEW OF YAMAURA AND STEVENS ……………………….…….22
`
`VII. THE EVIDENCE OF SECONDARY CONSIDERATIONS
`DOES NOT OUTWEIGH THE STRONG SHOWING
`OF OBVIOUSNESS ………………………………………………………23
`
`
`a. Alleged Long-Felt Need …………………………………………….24
`
`b. Alleged Praise for the Invention ……………………………......…..24
`
`c. Alleged Copying ……………………………………………......…..24
`
`d. Alleged Commercial Success ……………………………………….25
`
`VIII. PATENT OWNER SHOULD BE PRECLUDED FROM
`RELYING ON THE TRATTLER DECLARATION ………………..……27
`
`IX. CONCLUSION ……………………………………………………………27
`
`
`APPENDIX – LIST OF EXHIBITS ………………………………...…….29
`
`
`
`
`
`
`i
`
`
`
`I.
`
`INTRODUCTION
`
`The record in this proceeding is clear and compelling. It establishes that
`
`claims 1-11 and 14-17 of U.S. Patent No. 9,039,718 (“the ‘718 Patent”) are
`
`unpatentable on each of the following instituted grounds: (1) claims 1-11 and 14-17
`
`are obvious over AlgerBrush II, Siminara, and Stevens; (2) claims 1-11 and 14-17
`
`are obvious over AlgerBrush II and Hamburg; and (3) claims 1-11 and 14-17 are
`
`obvious over Yamaura and Stevens.
`
`
`
`II.
`
`STATEMENT OF FACTS
`
`Petitioner Pain Point Medical Systems, Inc. d/b/a MiBo Medical Group
`
`highlights the following facts in support of the present petition for the convenience
`
`of the Board.
`
`The ‘718 Patent
`
`1.
`
`The ‘718 patent was issued on May 26, 2015 from an application that
`
`was filed on July 24, 2012. It is generally directed to a method for treating occular
`
`disorders, such as blepharitis, meibomitis, and dry eye syndrome. EX1001, p. 1.
`
`2.
`
`In response to a prior art rejection during prosecution, Patent Owner
`
`agreed to amend claim 1 of the ‘718 patent to require contacting a portion of the eye
`
`“between the eyelashes and the inner edge of the eyelid margin.” EX2001, pp. 174,
`
`186, 196, 203, 271, 277, and 279.
`
`
`
`1
`
`
`
`
`
`
`3.
`
`To avoid the same prior art during prosecution, Patent Owner presented
`
`a new claim 17 that requires “contacting at least an inner edge portion of the eyelid
`
`margin.” EX2001, pp. 174, 191, 199, and 203. 1
`
`4.
`
`As shown in the image below, the orifices, or pores, of the meibomian
`
`glands are located on the inner portion of the eyelid margin. EX2025, p. 10; EX1026,
`
`77:3-11.
`
`
`
`5.
`
`Blepharitis is inflamation of the eyelids. EX2025, ¶34. A primary cause
`
`of blepharitis is meibomian gland dysfunction (“MGD”), which in turn is primarily
`
`caused by obstruction of the meibomian glands. EX2025, ¶¶36-38.
`
`
`1 Application claims 1 and 29 became claims 1 and 17, respectively, in the ‘718
`
`patent. EX2001, p. 294.
`
`
`
`2
`
`
`
`
`
`
`6.
`
`Obstruction of the meibomian glands occurs when the orifices of the
`
`glands become capped or plugged by solidified meibum (an oily substance secreted
`
`by the glands) and clusters of desquamated skin cells. EX2025, ¶¶39-40.
`
`7.
`
`The Background section of the ‘718 patent admits that prior art
`
`techniques for treating ocular disorders such as blepharitis included the application
`
`of warm compresses followed by physicaly scrubbing the eyelid margins with a
`
`swab (EX1001, 1:40-55 (emphasis added)):
`
`Hygienic home treatment of such ocular disorders is
`
`generally a two-step process. First, the patient softens the
`
`debris and scurf by applying a warm compress, diluted
`
`baby shampoo, or a specialized liquid solution to the
`
`eyelid margin. This first step is intended to prepare the
`
`debris for removal while preventing further irritation to the
`
`eye. Second, the patient attempts to remove the debris by
`
`physically scrubbing the eyelid margin, the base of the
`
`eyelashes, and the pores of the meibomian glands. This
`
`scrubbing is routinely attempted with either a generic
`
`cotton swab, a fingertip, or a scrub pad placed over the
`
`fingertip and applied against the eye. By cleaning debris
`
`and scurf free from the base of the eyelashes and
`
`unclogging the pores of the meibomian glands, the
`
`patient may improve the overall health of the eyelid
`
`margin; thereby reducing irritation, burning, and other
`
`symptoms related to the disorder.
`
`
`
`3
`
`
`
`
`
`
`8.
`
`Because the pores of the meibomian glands are located between the
`
`eyelashes and the inner edge of the eyelid margin, the ‘718 patent admits that
`
`scrubbing the inner portion of the eyelid margin with a cotton swab was known in
`
`the prior art as a method of treating ocular disorders like blepharitis.2 EX1001, 1:45-
`
`55; EX1026, 77:3-11; EX1027, 64:16-65:12.
`
`9.
`
`Other methods that were known in the prior art for the treatment of
`
`blepharitis included:
`
`(a) manual expression of the meibomian glands through the use of special
`
`forceps (EX1026, 24:14-25:8, 26:4-27:7, 29:10-30:4, 82:23-84:12;
`
`EX1027, 74:5-75:17);
`
`(b)
`
`the insertion of needle-like probes directly into the meibomian gland
`
`orifices to remove obstructions (EX1026, 35:24-36:20, 84:13-19;
`
`EX1027, 52:11-53:19); and
`
`
`2 Patent Owner’s expert Dr. Paugh has taken the position that this passage in the
`
`‘718 patent is “incorrect.” EX1026, 100:3-103:25. However, Patent Owner’s other
`
`expert, Dr. McDonald, disagrees with Dr. Paugh and believes the passage in the ‘718
`
`patent correctly states the treatment technique that was used prior to the July 24,
`
`2012, filing date of the application for the ‘718 patent. EX1027, 63:21-65:13.
`
`
`
`4
`
`
`
`
`
`
`(c) mechanical debridement (i.e., scraping) of the lid margins with surgical
`
`instruments known as golf club spuds to remove the caps or plugs
`
`covering the meibomian gland orifices (EX1026, 31:7-15; EX1027,
`
`75:20-76:12, 77:3-8, 78:13-79:10, 83:16-23, 101:9-20).
`
`10. The inventor of the ‘718 patent set out to address two problems in the
`
`treatment of blepharitis and similar ocular disorders:
`
`(a)
`
`“the practical difficulties of cleaning one’s own eye with an imprecise
`
`instrument such as a fingertip or cotton swab” (EX1001, 1:57-58); and
`
`(b)
`
`“the failure of patients to totally cleanse the margin of the eyelid, the
`
`base of the eyelashes, and the meibomian glands” (EX1001, 2:1-3).
`
`11. The ‘718 patent admits that “Algerbrush I” and “Algerbruse II” were
`
`known in the prior art as examples of devices that could be used for the “mechanical
`
`drive unit 12” disclosed in the patent. EX1001, 5:12-19.
`
`12. The ‘718 patent disloses that, in at least one embodiment, the claimed
`
`“swab” must be capable of absorbing a liquid solution (EX1001, 5:64-67 (emphasis
`
`added)):
`
`Furthermore, a liquid solution configured to loosen the
`
`debris may be absorbed within the swab 14 to further aid
`
`in removing the debris from the eye 15 and/or minimizing
`
`irritation to the eye 15.
`
`
`
`5
`
`
`
`
`
`
`13. The article entitled “DEBS - a unification theory for dry eye and
`
`blepharitis,” written by Dr. Rynerson, the inventor listed on the ‘718 patent, was not
`
`published until 2016, long after the ‘718 patent was issued and after the present inter
`
`partes review was instituted. EX2020; EX1027, 112:8-114:25.
`
`14. Dr. Rynerson’s DEBS theory is not mentioned in the ‘718 patent.
`
`EX1026, 176:21-178:7; EX1027, 112:8-114:25.
`
`AlgerBrush II
`
`15. Patent Owner’s expert Dr. Paugh testified that, like eyelid tissue, the
`
`cornea and the conjunctiva of the eye are highly sensitive and highly delicate tissues.
`
`EX1026, 77:12-20.
`
`16. Dr. Paugh admits that removal of rust rings from the eye with a tool
`
`such as the AlgerBrush II necessarily involves removal of “debris” because the rings
`
`are formed from the presence of rust and residual metal (i.e., debris) in the eye.
`
`EX1013; EX1026, 132:2-135:7.
`
`17. Patent Owner’s expert, Dr. Paugh, admits that persons of ordinary skill
`
`in the art would have known as early as 1975 that automation of the manual process
`
`of removing rust rings from the cornea by using an electromechanical motor to
`
`operate the burr, as in the AlgerBrush II, was actually a more effective way to
`
`remove such rust rings. EX2027; EX1026, 143:13-145:4.
`
`
`
`6
`
`
`
`
`
`
`18. Dr. Paugh admits that the AlgerBrush II is an example of the
`
`automation of a process that was previously performed manually. EX2027; EX1026,
`
`156:11-157:3.
`
`19. Dr. Paugh admits he is not in a position to opine on what a person of
`
`ordinary skill in the art would understand from the use of the word “torque” in the
`
`AlgerBrush II reference. EX1013 (referring to a “low torque motor”); EX1026,
`
`135:8-136:15.
`
`20. Dr. Paugh admits that, based on a reading of the AlgerBrush II
`
`reference, a person of ordinary skill in the art would understand that different tips
`
`can be used with the device depending upon the particular purpose at hand. EX1014;
`
`EX1026, 137:22-140:21.
`
`21. Dr. Paugh admits that the device disclosed in the AlgerBrush II
`
`reference was used to remove pterygium from the corneas of patients. EX1026,
`
`140:22-142:13. A pterygium is a vascularized growth of the conjunctiva that extends
`
`over the cornea and can obstruct a patient’s vision. EX1023; EX1026, 141:6-9;
`
`EX2028, 22:15-20. A pterygium is shown in the image below (EX1023):
`
`
`
`
`
`7
`
`
`
`
`
`
`Seminara
`
`22. Patent Owner’s expert Dr. Paugh agrees that the Seminara reference
`
`teaches a person of ordinary skill in the art that the size of the disclosed sponge can
`
`be varied depending on the particular use or application. EX1016; EX1026, 153:14
`
`– 155:12.
`
`23. Petitioner’s expert Dr. Benjamin states that a person of ordinary skill in
`
`the art would understand that the sponge disclosed in Seminara can be made smaller
`
`for a particular purpose. EX2028, 62:7-21; 86:22-88:15.
`
`24. Dr. Paugh admits that the Seminara reference discloses a sponge having
`
`a capstan shape. EX1016, Fig. 8G; EX1026, 155:13-156:9.
`
`25. Dr. Paugh admits that Seminara teaches adapting the shape of a swab
`
`to confirm to anatomy within the body. EX1016; EX1026, 160:24-161:3.
`
`Stevens
`
`26. The Stevens reference states that one of the reasons for cleaning eyelids
`
`is “to remove crusting on the eyelid margins” associated with blepharitis. EX1017,
`
`p. 1 (emphasis added).
`
`27. The method disclosed in Stevens comprises three parts: (1) cleaning the
`
`“eyelashes,” (2) cleaning the “lower eyelid,” and (3) cleaning the “upper eyelid.”
`
`EX1017, p. 7.
`
`
`
`8
`
`
`
`
`
`
`28. Regardng the first step, cleaning the eyelashes, Stevens teaches that the
`
`swab should be used to “clean gently along the eyelashes.” Id.
`
`29. Regarding the second step, cleaning the lower eyelid, Stevens teaches
`
`that the caregiver should, “[w]ith the index finger of the other hand, gently hold
`
`down the lower eyelid.” EX1017, p. 7. Next, the swab should be used to “clean
`
`gently along the lower eyelid margin.” Id. (emphasis added). This is demonstrated
`
`in Figure 8 from the Stevens reference, which is reproduced below:
`
`
`
`30. Regarding the third step, cleaning the upper eyelid, Stevens teaches that
`
`the caregiver should, “[w]ith the thumb or finger of the other hand, gently ease the
`
`upper eyelid up against the orbital rim (just below the eyebrow), taking care not to
`
`put any pressure on the eyeball.” EX1017, p. 8. The swab or bud should then be used
`
`to “clean gently along the upper eyelid margin.” Id. (emphasis added). This is
`
`demonstrated in Figure 9 from the Stevens reference, which is reproduced below:
`
`
`
`9
`
`
`
`
`
`
`
`
`31. Finally, the Stevens reference teaches that the method should be
`
`repeated “until all debris or discharge is removed.” Id.
`
`32. Patent Owner’s expert Dr. Paugh testified that to “evert the eyelid”
`
`means to “pull it away from the eye in such a way that you expose the inner portion
`
`of the eyelid.” EX1026, 129:19 – 130:4.
`
`33. The Stevens reference was not alone in teaching that scrubbing the
`
`eyelid margin, including the inner portion of the eyelid margin where the meibomian
`
`gland orifices are located, is a useful method of treating blepharitis and similar ocular
`
`disorders. A group of six doctors published a paper in the December 2010 edition of
`
`the journal Cornea that stated (EX2021, p. 8 (emphasis added)):
`
`Eyelid scrubs, although primarily suggested for
`
`anterior blepharitis, can help
`
`remove crusts and
`
`inspissated secretions blocking the gland orifices. Eyelid
`
`scrubs are performed on the eyelid margin over the
`
`meibomian gland orifices
`
`to prevent obstructive
`
`overgrowth of material from sealing the orifice.
`
`
`
`10
`
`
`
`
`
`
`34. Petitioner’s expert Dr. Benjamin testified that a person of ordinary skill
`
`in the art would know how to “take a swab and clean the eyelid margin and do what
`
`you needed to do to focus on where the crusting was” without relying on the
`
`teachings of Stevens. EX2028, 28:3-15.
`
`35. Dr. Benjamin further testified that, when he received his training, he
`
`was taught to take a swab, dampen it, “rub along the eyelid margin gently to remove
`
`the caps on the eyelid margin,” and also remove the crusting on the eyelashes.
`
`EX2028, 31:21-32:11.
`
`36. Dr. Paugh admits that Stevens discusses using a swab to clean the
`
`“lower eyelid margin” and the “upper eyelid margin.” EX1026, 148:5-10.
`
`37. Despite the clear descriptions of cleaning eyelid margins in Stevens,
`
`however, Patent Owner’s expert Dr. Paugh claims that Stevens is “obviously
`
`wrong,” that her choice of words was “unfortunate,” and that she doesn’t actually
`
`teach using a swab to clean the eyelid margins. EX1026, 149:19-151:21; 157:25-
`
`158:15.
`
`38. Yet Dr. Paugh also testified that a patient performing the method
`
`described in Stevens at home would not have sufficient control over the swab to
`
`avoid crossing the gray line. EX1026, 183:17-21. The gray line is, of course, located
`
`on the inner portion of the eyelid margin behind the eyelashes. EX2025, p. 10.
`
`
`
`11
`
`
`
`
`
`
`Hamburg
`
`39. Dr. Paugh agrees that Hamburg teaches adapting a swab or sponge to
`
`conform to the anatomy of an eyelid margin. EX1018; EX1026, 161:5-7; 163:21-
`
`164:9.
`
`40. Dr. Paugh further agrees that the Hamburg refernce teaches using the
`
`swab to contact the inner portion of the eyelid margin. EX1018; EX1026, 164:10-
`
`166:13.
`
`41. Petitioner’s expert Dr. Benjamin testified that a person skilled in the art
`
`would easily know how to adapt or modify the shape of the swab disclosed in
`
`Hamburg to give it a capstan shape that is rotationally symetric. EX2028, 54:12-
`
`55:8; 83:20-85:10.
`
`42. Dr. Benjamin further testified that Figure 8D of the Seminara reference
`
`discloses a swab or sponge having a capstan shape. EX1016; EX2028, 85:11-86:21.
`
`Yamaura
`
`43. The Yamaura referance was cited during prosecution of the ‘718 patent,
`
`but there is nothing to indicate that the patent examiner had access to a full English
`
`translation of the reference. EX1001; EX2001, pp. 138-141.
`
`44. Yamaura discloses a electric device for automatically removing earwax
`
`to make ear-cleaning easier. EX1019, p.1. The device comprises a body 1 that houses
`
`a built-in electric motor 2 and a battery 3. EX1019, pp. 1-2. A cotton swab 11 is
`
`
`
`12
`
`
`
`
`
`
`inserted into the cotton swab holder pipe 9. Id. The first image from the Yamaura
`
`reference is reproduced below (EX1019):
`
`
`
`45. The Yamaura reference teaches that an automatic swab is safer and
`
`easier than a conventional ear pick for removing earwax. Id., p. 3. It also teaches that
`
`an “electrically-powered ear-cleaning device” can be used to replace the
`
`“conventional manual method” and that the spinning connon swab will not damage
`
`“delicate intra-aural skin.” Id., p. 3.
`
`46. Petitioner’s expert Dr. Benjamin testified that removing earwax from
`
`an ear is “conceptuallly similar” to removing debris from the eyelid margin because
`
`both involve “a buildup of oily waxy type material” and “a swab can be used to
`
`totally or partially remove both.” EX2028, 46:5-17.
`
`47. Dr. Benjamin also testified that the device of the Yamaura reference
`
`could be used to practice the method of the ‘718 patent without modification.
`
`EX2028, 63:2-64:8.
`
`
`
`13
`
`
`
`
`
`
`48. Patent Owner’s expert Dr. Paugh agrees that Yamaura discloses an
`
`electromechanical device for rotating a cotton swab, but he does not believe that a
`
`person of ordinary skill in the art would necessarily understand that the device could
`
`be used on the eyelid margin. EX1026, 166:16-167:9.
`
`49. But Dr. Paugh did not know that Yamaura teaches that a motorized
`
`swab is safer than a conventional ear pick for cleaning out the ear canal. EX1026,
`
`167:20-169:10.
`
`Level of Ordinary Skill in the Art
`
`50. Patent Owner’s expert Dr. Paugh does not dispute the description of the
`
`level of ordinary skill in the art provided by Petitioner’s expert Dr. Benjamin.
`
`EX2025, ¶24.
`
`Secondary Considerations
`
`51. Patent Owner’s expert on secondary consideration, Dr. McDonald, was
`
`not advised of the legal standards used by the courts or the Board for patent claim
`
`construction and therefore could not have applied such standards in formulating her
`
`opinions in this matter. EX2029; EX1027, 89:24-91:13.
`
`52. Dr. McDonald did not review the prosecution history of the ‘718 patent
`
`in formulating her opinions in this matter. EX1027, 66:14-24.
`
`53. Dr. McDonald did not review any of the prior art references that were
`
`cited during prosecution of the ‘718 patent. EX1027, 66:25-67:18.
`
`
`
`14
`
`
`
`
`
`
`54. Dr. McDonald failed to analyze whether any nexus exists between
`
`challenged claims 2-11 or 14-16 and her evidence of secondary considerations.
`
`EX2029, ¶¶27-36; EX1027, 98:9-99:20.
`
`55. Dr. McDonald failed to establish a sufficient nexus between the
`
`challenged method claims and the alleged evidence of praise for the invention and
`
`commercial success of the invention because her analysis improperly focused on the
`
`“Blephex device.” EX2029, ¶¶47-58 and 65-68 (consistently referring to the
`
`“Blephex device”).
`
`56.
`
`In formulating her opinions regarding alleged praise for the Blephex
`
`device, Dr. McDonald failed to analyze whether praise exists for any similar
`
`products in the same field. EX1027, 127:13-130:8.
`
`57.
`
`In formulating her opinions regarding alleged copying, Dr. McDonald
`
`failed to analyze whether Petitioner’s product or method fall within the scope of the
`
`claims of the ‘718 patent. EX2029, ¶¶59-64; EX1027, 134:13-136:4. Among other
`
`things, Dr. McDonald failed to analyze whether Petitioner’s LidPro product includes
`
`a “swab,” as required by the claims of the ‘718 patent. Id.
`
`58. Regarding commercial success, Dr. McDonald was unaware of the
`
`number of Blephex devices or Blephex treatment tips that had been sold as of the
`
`date of her deposition, and she was unaware of how such Blephex sales compared
`
`to sales of other products in the same field. EX1027, 136:24-138:16.
`
`
`
`15
`
`
`
`
`
`
`59. The Blephex device sold by Patent Owner includes a cutoff feature that
`
`automatically stops the tip from rotating if too much force is applied to the tip during
`
`use. EX2021; EX2028, 88:16-90:13; EX1027, 101:11-102:24. The cutoff feature is
`
`important for promoting consumer acceptance of the device. EX2021; EX2028,
`
`90:14-21. However, the ‘718 patent does not disclose or claim the cutoff feature as
`
`part of the patented method. EX1001; EX2028, 90:22-91:19.
`
`60. Use of the Blephex device requires use of anesthetic drops in both eyes
`
`of the patient. EX2004, p. 3; EX1027, 102:25-103:18. The ‘718 patent, however,
`
`does not disclose or claim the use of anesthetic drops as part of the patented method.
`
`EX1001.
`
`61. Use of the Blephex device requires premoistening of the tips in a lid
`
`cleaning solution. EX2004, pp. 3-4; EX1027, 103:19-104:1. Dr. McDonald believes
`
`the lid-cleaning solution contributes to the effectiveness of the Blephex procedure.
`
`EX1027, 104:8-17. Although the ‘718 patent discloses that “a liquid solution
`
`configured to loosen the debris may be absorbed within swab 14,” EX1001, 5:64-6,
`
`the use of such a solution is not claimed as part of the patented method.
`
`62. Use of the Blephex device requires treatment of the “entire width of the
`
`lid margin,” including the “lash line.” EX2004, p. 4; EX1027, 107:14-108:8. The
`
`claimed method of the ‘718 patent, in contrast, is limited to treatment of a portion of
`
`the eye “between the eyelashes and the inner edge of the eyelid margin” as recited
`
`
`
`16
`
`
`
`
`
`
`in claim 1, and “an inner edge portion of the eyelid margin” as recited in claim 17.
`
`EX1001.
`
`63. Doctors typically charge their patients between $120 and $140 per
`
`procedure for the Blephex treatment and recommend that the procedure be repeated
`
`every 3 to 6 months. EX1024, p.2; EX1027, 111:6-18.
`
`
`
`III. PATENT OWNER IMPROPERLY ATTACKS THE PRIOR ART
`REFERENCES IN ISOLATION
`
`The SupremeCourt has instructed that an expansive and flexible approach
`
`should be taken in determining whether a patented invention was obvious at the
`
`time it was made. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (207). In that
`
`regard, it is improper to attack prior art references in isolation from one another. In
`
`re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness
`
`cannot be established by attacking references individually where the rejection is
`
`based upon the teachings of a combination of references.”). Throughout its briefing,
`
`however, Patent Owner has improperly focused narrowly on each reference in
`
`isolation and closed its eyes to the collective teachings of the combined references
`
`as a whole. The Board should reject Patent Owner’s narrow approach and follow
`
`the expansive and flexible approach required by the Court. KSR, 550 U.S. at 415.
`
`
`
`
`
`17
`
`
`
`
`
`
`IV. GROUND 1: CLAIMS 1-11 AND 14-17 ARE OBVIOUS IN VIEW OF
`ALGERBRUSH II, SEMINARA AND STEVENS
`
`Contrary to Patent owner’s arguments, it was well known in the prior art that
`
`blepharitis and similar ocular disorders could be treated by physically scrubbing the
`
`lid margin – including the inner portion of the lid margin – with a cotton swab.
`
`Stevens clearly teaches this. SOF 26-313. Stevens refers to the “eyelid margin,” and
`
`there is no legitimate reason to interpret that as meaning anything less than the entire
`
`lid margin, including the inner portion of the lid margin. Id.
`
`
`
`Indeed, the specification of the ‘718 patent admits that it was known to use a
`
`cotton swab to clean the inner portion of the lid margin. SOF 4, 7-8. Patent Owner’s
`
`statements in the specification constitute admitted prior art. Pharmastem
`
`Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342, 1362 (Fed. Cir. 2007)
`
`(“Admissions in the specification regarding the prior art are binding on the patentee
`
`for purposes of a later inquiry into obviousness.”). Patent Owner made the same
`
`admission in a paper filed in this proceeding. Patent Owner’s Prelim. Resp., p. 18.
`
`Patent Owner’s narrow interpretation of Stevens should be rejected in view of its
`
`admission that scrubbing the pores of the meibomian glands was known in the prior
`
`art.
`
`
`3 “SOF 26-31” refers to paragraphs 26-31 contained in the Statement of Facts
`
`section of this reply.
`
`
`
`18
`
`
`
`
`
`
`
`
`The benefits of automating a manual process were also well known in the
`
`prior art. AlgerBrush II itself is an example of the automation of a manual process.
`
`SOF 17 and 18. Prior to the invention of AlgerBrush II, doctors would manually
`
`apply burrs to the cornea to remove rust rings from patients. Id. AlgerBrush
`
`automated the process by attaching the burr to an electric motor, and the
`
`modification was known to be successful as early as 1975. Id. The Yamaura
`
`reference, which automates the manual process of cleaning ears with a swab, is
`
`another example showing that the benefits of automation of a manual process were
`
`well known. SOF 43-45.
`
`
`
`AlgerBrush II teaches that the device is adapted to use different tips depending
`
`on the particular purpose at hand. SOF 20. The tips of the AlgerBrush II were
`
`mounted in a chuck for easy replacement and came in different levels of
`
`abrasiveness, with tips some being less abrasive than others. Id.
`
`
`
`Moreover, use of the AlgerBrush II was not limited to just removing tissue.
`
`Dr. Paugh admits in his testimony that, when used to remove rust rings, the
`
`AlgerBrush II necessarily removes debris from the eye as well. SOF 16.
`
`
`
`Seminara discloses a medical grade sponge having a shape that is adapted to
`
`access the inner edge portion of the lid margin, and a person of ordinary skill would
`
`understand that the sponge could be made of size appropriate for that task. SOF 22
`
`and 23. The sponge of Seminara is depicted as being attached to a handle, much like
`
`
`
`19
`
`
`
`
`
`
`a cotton swab is attached to a handle. EX1016, Fig. 20. A person skilled in the art
`
`would easily understand that the handle on the sponge of Seminara could be used to
`
`mount the sponge in the chuck of AlgerBrush II.
`
`
`
`In view of AlgerBrush II and Yamaura, a person skilled in the art would know
`
`of the benefits of automating the manual lid scrubbing process disclosed by Stevens
`
`(and which is admitted by Patent Owner in the specification of the ‘718 patent). As
`
`Patent Owner admits, the AlgerBrush II would be an obvious starting point. SOF 11.
`
`Pharmastem, 491 F.3d at 1362. But the AlgerBrush was also a well known example
`
`of the successful automation of a manual process, so it would be obvious for that
`
`reason as well. It would be a simple task to mount an appropriately sized sponge of
`
`Siminara in the chuck of the AlgerBrush II and use it to clean the inner portions of
`
`eyelids to treat blepharitis.
`
`
`
`A person skilled in the art would have a reasonable expectation of success
`
`with this combination because the AlgerBrush II (and the Yamaura reference) had
`
`already demonstrated the benefits of using an electromechanical motor to automate
`
`a manual process. There would be little concern of harming tissue because the
`
`sponge of Seminara is intended for use with fragile anatomical structures. EX1016,
`
`¶42.
`
`
`
`Therefore, the challenged claims of the ‘718 patent would have been obvious
`
`in view of AlgerBrush II, Seminara, and Stevens.
`
`
`
`20
`
`
`
`
`
`
`V. GROUND 2: CLAIMS 1-11 AND 14-17 ARE OBVIOUS IN VIEW OF
`ALGERBRUSH II AND HAMBURG
`
`The combination of AlgerBrush II with Hamburg is much the same as in
`
`Ground 1, except that Hamburg (as well as Patent Owner’s admittion, SOF 7-8)
`
`supplies the teaching of using a swab or sponge to clean the inner portion of an eyelid
`
`margin. Like Seminara, the swab of Hamburg is depicted on the end of a handle that
`
`could easily be mounted within the chuck of the AlgerBrush. EX1018, Figs. 1 and
`
`2.
`
`
`
`In view of AlgerBrush II, a person skilled in the art would appreciate the
`
`benefits of automating a manual process and would understand the AlgerBrush II
`
`itself would be a good starting point for the reasons discussed above. Similarly, it
`
`would be a simple matter to mount the swab of Hamburg in the chuck of the
`
`AlgerBrush II and use it to clean the inner portions of lid margins in the treatment
`
`of blepharitis. The combination would have a reasonable expectation of success
`
`because AlgerBrush II (and Yamaura) and already demonstrated the success of such
`
`a combination.
`
`
`
`Patent Owner argues that such a combination would not be successful because
`
`the swab of Hamburg is not rotationally symetrical. However, the claims of the ‘718
`
`patent do not require a swab of any particular shape. EX1001. But even if they did,
`
`a person of ordinary skill in the art would understand how to modify the shape of the
`
`
`
`21
`
`
`
`
`
`
`Hamburg swab to make it rotationally symetrical. SOF 41 and 42. Such a shape is
`
`disclosed in Figures 8G and 10 of Seminara.
`
`
`
`Accordingly, claims 1-11 and 14-17 of the ‘718 patent would have been
`
`obvious in view of AlgerBrush II and Hamburg.
`
`
`
`VI. GROUND 3: CLAIMS 1-11 AND 14-17 ARE OBVIOUS IN VIEW OF
`YAMAURA AND STEVENS.
`
`In view of Stevens (and as admitted in the ‘718 patent, SOF 7 and 8), a person
`
`skilled in the art would know that blepharitis can be treated by scrubbing the lid
`
`margin, including the inner lid margin, with a cotton swab. The Yamaura reference
`
`teaches that a manual cleaning method using a swab can be automated by attaching
`
`the swab to an electromechanical device. SOF 44. Of course, the AlgerBrush II also
`
`teaches the benefits of automating a manual process. In view of this knowledge, it
`
`would be simple matter to merely use the device of Yamaura to clean eyelids
`
`according to the method of Stevens (and as admitted in the ‘718 patent) for the
`
`treatment of blepharitis and similar ocular conditions.
`
`There would be a reasonable expectation of success because the Yamaura
`
`reference itself states that automation leads to a safer and easier process. AlgerBrush
`
`II is also evidence showing a reasonable expectation of success for this combination.
`
`Accordingly, the challenged claims of the ‘718 patent would have been
`
`obvious in view of Yamaura and Stevens.
`
`
`
`22
`
`
`
`
`
`
`VII. THE EVIDENCE OF SECONDARY CONSIDERATIONS DOES NOT
`OUTWEIGH THE STRONG SHOWING OF OBVIOUSNESS
`
`Patent Owner’s evidence of secondary considerations should not be given
`
`significant weight because Patent Owner has failed to establish a sufficient nexus
`
`between the evidence and the merits of the claimed method. In re GPAC Inc., 57
`
`F.3d 1573, 1580 (Fed. Cir. 1995); see also In re Huang, 100 F.3d 135, 140 (Fed. Cir.
`
`1996) (“[S]uccess is relevant in the obviousness context only if there is proof that
`
`the sales were a direct result of the unique characteristics of the claimed invention.”).
`
`Patent Owner bears the burden of showing that sufficient nexus exists. In re Paulsen,
`
`30 F.3d 1475, 1482 (Fed. Cir, 1994).
`
`Patent Owner’s expert on secondary considerations, Dr. McDonald, did not
`
`consider the prosecution history of the ‘718 patent or any of the prior art that was
`
`cited during examinarion of the patent. SOF 52 and 53. Without reviewing these
`
`documents, she cannot identify the unique or novel features of the claimed method,
`
`and she therefore cannot opine on whether any evidence of secondary considerations
`
`is the result of the “unique charistics of the claimed invention.” Huang, 100 F.3d at
`
`140.
`
`Further, Dr. McDonald failed to consider whether there is any nexus between
`
`dependent claims 2-11 and 14-16 and the evidence of secondary considerations. SOF
`
`54. Patent Owner has therefore not produced any reliable evidence of secondary
`
`considerations as to claims 2-11 and 14-16.
`
`
`
`23
`
`
`
`
`
`
`a. Alleged Long-Felt Need
`
`Patent Owner identifies the following long felt needs that are allegedly
`
`satisfied by the claimed invention: (1) the need for providing “long-lasting symptom
`
`relief” and (2) the need for “reducing the time and financial burden on the patient
`
`that had been associated with conventional treatment approaches.” Patent Ornwer’s
`
`Resp., p. 52. Nothing in the challenged claims, however, addresses long-lasting
`
`symptom relief or time and financial burdens. Rather than satisfying these identified
`
`needs, the evidence indicates that patients must undergo a repeat treatment procedure
`
`with the Blephex device every 3-6 months and must pay their doctors between $120
`
`and $140 per procedure. SOF 63.
`
`b. Alleged Praise for the Invention
`
`Patent Owner’s assertions regarding praise for the invention are based upon
`
`the Blephex device, not on praise for the claimed method. SOF 55. In addition, Dr.
`
`McDonald cites to claims of providing “immediate relief and results” and addressing
`
`“the root sourc
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
