Trials@uspto.gov Paper 25
`571-272-7822
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`Entered: April 6, 2022
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GLOBAL HEALTH SOLUTIONS LLC,
`Petitioner Application 15/672,197,1
`Petitioner,
`v.
`MARC SELNER,
`Respondent Application 15/549,111,2
`Respondent.
`____________
`
`DER2017-00031
`____________
`
`Before JAMESON LEE, JAMES T. MOORE, and
`JONI Y. CHANG, Administrative Patent Judges.
`
`LEE, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Derivation Proceeding
`35 U.S.C. § 135(a)
`
`INTRODUCTION
`I.
`A petition alleging derivation of invention was filed on August 11,
`
`2017. Paper 3. Both parties’ application claims changed during the course
`of examination. On January 28, 2022, with authorization from the Board,
`
`
`1 Bradley Burnham is the sole named inventor on Petitioner’s Application.
`2 Marc Selner is the sole named inventor on Respondent’s Application.
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`571-272-7822
`
`Entered: April 6, 2022
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GLOBAL HEALTH SOLUTIONS LLC,
`Petitioner Application 15/672,197,1
`Petitioner,
`v.
`MARC SELNER,
`Respondent Application 15/549,111,2
`Respondent.
`____________
`
`DER2017-00031
`____________
`
`Before JAMESON LEE, JAMES T. MOORE, and
`JONI Y. CHANG, Administrative Patent Judges.
`
`LEE, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Derivation Proceeding
`35 U.S.C. § 135(a)
`
`INTRODUCTION
`I.
`A petition alleging derivation of invention was filed on August 11,
`
`2017. Paper 3. Both parties’ application claims changed during the course
`of examination. On January 28, 2022, with authorization from the Board,
`
`
`1 Bradley Burnham is the sole named inventor on Petitioner’s Application.
`2 Marc Selner is the sole named inventor on Respondent’s Application.
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`DER2017-00031
`Petitioner Application 15/672,197
`Respondent Application 15/549,111
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`and without objection from Respondent, Petitioner filed a “Supplemental
`Brief.” Paper 19. The Supplemental Brief is a “Supplemental Petition” that
`replaces the initially filed petition in its entirety, such that the petition as
`originally filed need not be considered in any respect. Paper 18, 2.
`Hereinafter, we refer to Petitioner’s Supplemental Brief/Supplemental
`Petition simply as “Petition” and cite to it as “Pet.”3
`
`The parties jointly filed a listing of both parties’ pending claims.
`Paper 17. The list identifies claims 1–10 in Petitioner’s Application
`15/672,197. Id. at 2. It also identifies claims 24–38 in Respondent’s
`Application 15/549, 111. Id. at 7–9. However, Respondent’s claims 37 and
`38 have been cancelled by the Examiner. Ex. 3001. Thus, Respondent has
`only claims 24–36.
`35 U.S.C. § 135(a)(1) reads as follows:
`(a) Institution of Proceeding.–
`(1) In General.–An applicant for patent may file a petition
`with respect to an invention to institute a derivation
`proceeding in the Office. The petition shall set forth with
`particularity the basis for finding that an individual named
`in an earlier application as the inventor or joint inventor
`derived such invention from an individual named in the
`petitioner’s application as the inventor or a joint inventor
`and, without authorization, the earlier application claiming
`such invention was filed. Whenever the Director
`determines that a petition filed under this subsection
`demonstrates that the standards for instituting a derivation
`proceeding are met, the Director may institute a derivation
`proceeding.
`
`
`3 Petitioner relies on three Declarations, one from inventor Bradley Burnham
`(Ex. 1011), one from attorney Todd M. Malynn (Ex. 1012), and one from
`Dr. Eric C. Luo (Ex. 1013).
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`2
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`DER2017-00031
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`Respondent Application 15/549,111
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`This panel has authority to institute a derivation proceeding on behalf of the
`Director. See 37 C.F.R. § 42.408(a). The threshold showing for institution
`of a derivation proceeding is whether the petition demonstrates substantial
`evidence that, if unrebutted, would support a determination of derivation.
`37 C.F.R. § 42.405(c). For reasons that follow, we conclude that Petitioner
`has made a sufficient showing as to the requirements of 37 C.F.R.
`§ 42.405(b) to warrant institution. Accordingly, pursuant to
`35 U.S.C. § 135(a) and 37 C.F.R. § 42.408(a), we institute a derivation
`proceeding.
`
`II. DISCUSSION
`
`A.
`
`Principles of Law
`Although a derivation proceeding is a creation of the Leahy-Smith
`America Invents Act (“AIA”), Pub. L. No. 112-29, § 3(i), 125 Stat. 284
`(September 16, 2011),4 the charge of derivation of invention as a basis for
`finally refusing application claims and cancelling patent claims had been
`adjudicated under 35 U.S.C § 135(a) as it existed prior to the enactment of
`AIA. On the substantive law of derivation of invention, the Board applies
`the jurisprudence which developed in that context, including the case law of
`the United States Court of Appeals for the Federal Circuit and the United
`States Court of Customs and Patent Appeals. Catapult Innovations Pty Ltd.
`v. Adidas AG., DER2014-00002, Paper 19 at 3 (PTAB July 18, 2014).
`
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`4 Leahy-Smith America Invents Technical Corrections Act, Pub. L. No. 112-
`274, § 1(e)(1), (k)(1), 126 Stat. 2456 (Jan. 14, 2013).
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`The threshold showing for institution of a derivation proceeding is
`whether the petition demonstrates substantial evidence, which if unrebutted,
`would support the assertion of derivation.5 35 U.S.C. § 135(a); 37 C.F.R.
`§ 42.405(c). For establishing derivation, a petitioner must show that the
`respondent, without authorization, filed an application claiming a derived
`invention. 35 U.S.C. § 135(a); 37 C.F.R. § 42.405(b)(2). The party
`asserting derivation must establish prior conception of an invention and
`communication of that conception to an inventor of the other party. Cooper
`v. Goldfarb, 154 F.3d 1321, 1332 (Fed. Cir. 1998); Price v. Symsek,
`988 F.2d 1187, 1190 (Fed. Cir. 1993); Hedgewick v. Akers, 497 F.2d 905,
`908 (CCPA 1974).
`“Conception must be proved by corroborating evidence which shows
`that the inventor disclosed to others his completed thought expressed in such
`clear terms as to enable those skilled in the art to make the invention.”
`Coleman v. Dines, 754 F.2d 353, 359 (Fed. Cir. 1985). A rule of reason
`applies to determining whether the inventor’s testimony has been
`corroborated. Price, 988 F.2d at 1195. “The rule of reason, however, does
`not dispense with the requirement for some evidence of independent
`corroboration.” Coleman, 754 F.2d at 360. Also, proof of conception must
`encompass all limitations of the invention. See Singh v. Brake, 222 F.3d
`1362, 1367 (Fed. Cir. 2000); Kridl v. McCormick, 105 F.3d 1446, 1449
`
`
`5 Substantial evidence is defined as that which a reasonable person might
`accept as adequate to support a conclusion. Falkner v. Inglis, 448 F.3d
`1357, 1363 (Fed. Cir. 2006); see also In re Zurko, 258 F.3d 1379, 1384
`(Fed. Cir. 2001).
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`(Fed. Cir. 1997); Sewall v. Walter, 21 F.3d 411, 415 (Fed. Cir. 1994);
`Coleman, 754 F.2d at 359; Davis v. Reddy, 620 F.2d 885, 889 (CCPA 1980).
`Likewise, communication of the conception to an inventor of the other
`party must be corroborated. 37 C.F.R. § 42.405(c) (“The showing of
`communication must be corroborated.”). The purpose of the requirement of
`corroboration is to prevent fraud. Berry v. Webb, 412 F.2d 261, 266 (CCPA
`1969). An inventor “must provide independent corroborating evidence in
`addition to his own statements and documents.” Hahn v. Wong, 892 F.2d
`1028, 1032 (Fed. Cir. 1989); Reese v. Hurst, 661 F.2d 1222, 1225 (CCPA
`1981).
`Also applicable to derivation proceedings are regulations in Subpart E
`of Part 42 of Title 37, Code of Federal Regulations. 37 C.F.R. §§ 42.400–
`412. In particular, as noted above, under 37 C.F.R. § 42.405(b)(3), a
`petitioner has to show that each challenged claim is the same or substantially
`the same as the invention disclosed by petitioner to the respondent. And
`under 37 C.F.R. § 42.405(a)(2), a petitioner has to show that it has at least
`one claim that is (i) the same or substantially the same as the respondent’s
`claimed invention, and (ii) the same or substantially the same as the
`invention disclosed to the respondent.
`Assuming that corroborated conception and communication both are
`established, and that the regulatory requirements are met, a petitioner would
`be able to regard as a derived invention those challenged claims of the
`respondent which are shown by the petitioner to be “same or substantially
`the same” as petitioner’s disclosed invention, i.e., that which was conceived
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`by petitioner’s inventor and communicated to the respondent.6 See
`37 C.F.R. § 42.405(b)(3).
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`B.
`
`The Invention Allegedly Conceived
`and Disclosed by Bradley Burnham
`The Petition specifically identifies the invention allegedly conceived
`by Bradley Burnham and disclosed to Marc Selner as:
`a stable suspension composition comprising an aqueous phase
`containing at least one ionic biocide compound dissolved in
`water in particular amounts, with the aqueous phase suspended
`as nanodroplets in a petrolatum carrier, and without the
`composition containing an emulsifier to stabilize the ionic
`biocide aqueous phase in the hydrophobic petrolatum carrier.
`Pet. 5 (emphasis added). According to Petitioner, this stated invention
`encompasses a method Bradley Burnham conceived and disclosed to Marc
`Selner, because “it was not known prior to Burnham’s conception and the
`February 14, 2014 communication of specific method steps whether the
`stable suspension could be prepared at all.” Id. at 6. The Petition states:
`“Since Burnham conceived of the first method of preparing the stable
`suspension, Burnham is the inventor of the stable suspension as well as the
`communicated method of preparing the stable suspension.” Id. at 7.
`
`On the present record, and for purposes of determining whether a
`derivation proceeding should be instituted, we accept that prior to
`Petitioner’s conception of a method of preparing the suspension, it was not
`known how such a stable suspension could be made. Specifically, that
`
`
`6 “Same or substantially the same” means patentably indistinct, 37 C.F.R.
`§ 42.401, and in this specific context, patentably indistinct is evaluated one-
`way in the direction from the invention disclosed to the respondent to each
`challenged claim.
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`6
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`Respondent Application 15/549,111
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`method, as identified by Petitioner (Pet. 6), is the one described in an email
`sent by Bradley Burnham on February 14, 2014 (Ex. 1028):
`Place the petrolatum in ingredients of 1kg in a clean stainless
`steel container. Heat the petrolatum until semi-solid which will
`appear white not clear (40-45 c). The consistency will be of an
`almost liquid. Stir constantly if possible once this state is
`achieved.
`1. Add heated (50 c): 25 gm of preservative with 25gm of
`USP water. *Add the heated liquid slowly while mixing
`into the petrolatum. 50gm liquid/1kg petrolatum
`2. Mix while cooling slowly until the mixture has reached
`a solid state. As it cools the mixture will get more solid
`and whiter.
`3. Fill vessels with mixture immediately above solidified
`temperature of mixture.
`*The liquid is heavier than the petrolatum so it will always
`go to the bottom. Make sure you continue stirring all the
`way to the bottom until the mixture has congealed.
`4. Wait 4-6 hours until sealing vessel.
`Ex. 1028, 2 (emphasis added).7
`
`Petitioner also identifies an email communication, dated February 7,
`2014, which more generally describes the method without any specific
`temperature or temperature range. Pet. 5. Because Petitioner relies on the
`specifics of the steps in the email communication of February 14, 2014, in
`performing its analysis under 37 C.F.R. § 42.405(b)(3), we understand and
`
`7 Petitioner explains that Burnham’s conceived and disclosed method
`differed from prior unsuccessful attempts to produce the stable suspension in
`at least two ways: “First, it called for heating the petrolatum to 40–45ºC
`prior to mixing with the aqueous phase. . . . Second, it called for heating the
`aqueous phase slightly hotter, to 50ºC, just before adding the aqueous phase
`to the petrolatum.” Pet. 7.
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`Respondent Application 15/549,111
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`take the method described in the email communication of February 14, 2014,
`as Petitioner’s identification of the method that was conceived by Bradley
`Burnham and communicated to Marc Seller. Pet. 40–45. However, the
`email of February 7, 2014, is useful in indicating that the “preservative”
`mentioned in the email of February 14, 2014, is “PHMB.” Exs. 1026, 1028.
`Thus, Petitioner identifies the invention Bradley Burnham conceived
`and communicated to Marc Selner as both the stable suspension and the
`method reproduced in italics above.
`
`1.
`Conception
`
`A known ionic biocide liquid, polyhexanide, is referred to as
`“PHMB.” Pet. 13. Petitioner acknowledges that an emulsion comprising
`PHMB in a petrolatum carrier was not novel. Id. Petitioner’s invention,
`however, as stated above, is a “stable suspension composition comprising an
`aqueous phase containing at least one ionic biocide compound dissolved in
`water in particular amounts, with the aqueous phase suspended as
`nanodroplets in a petrolatum carrier, and without the composition
`containing an emulsifier to stabilize the ionic biocide aqueous phase in the
`hydrophobic petrolatum carrier.”
`
`Petitioner relies on Exhibits 1026, 1028, 1041, and 1042 to prove
`conception of the disclosed invention. Id. at 5. Exhibit 1026 purportedly is
`an email, dated February 7, 2014, sent by Bradley Burnham to a company
`“Pro-Tech,” which would make the suspension according to his instructions,
`and Marc Selner allegedly was copied on that email. Id. Exhibit 1028
`purportedly is an email, dated February 14, 2014, sent by Bradley Burnham
`to Pro-Tech, and, again, Marc Selner allegedly was copied on that email. Id.
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`DER2017-00031
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`at 6. Exhibit 1041 purportedly is an email from Bradley Burnham, dated
`February 28, 2014, to Marc Selner to report the successful production of a
`stable suspension at Pro-Tech following Bradley Burnham’s instructions.
`Id. Exhibit 1042 purportedly is a manufacturing outline from Pro-Tech
`which Bradley Burnham signed and returned to Pro-Tech to confirm the
`manufacturing steps carried out by Pro-Tech to make the stable suspension.
`Id,
`Exhibits 1026, 1028, 1041, and 1042, constitute sufficient evidence,
`
`under the substantial evidence standard, to support Petitioner’s assertion of
`conception, except for the requirement of independent corroboration. For
`instance, there is no declaration testimony from any of the recipients of the
`email communications or people who were copied on those email
`communications to corroborate those email communications. There is no
`testimony from anyone at Pro-Tech to corroborate the nature and existence
`of the signed manufacturing outline that is Exhibit 1042.
`
`There is, however, a declaration from Todd M. Malynn, counsel for
`Petitioner in this proceeding. Ex. 1012. Mr. Malynn represents that he tried
`to obtain a declaration from Brad Meeuwsen who “was the sales
`representative at Pro-Tech Design and Manufacturer, Inc. (‘Pro-Tech’) that
`interfaced with Bradley Burnham (‘Burnham’) in connection with
`Burnham’s efforts to manufacture novel antimicrobial gel.” Id. ¶ 2.
`Mr. Malynn explained that he was unable to obtain a declaration from Brad
`Meeuwsen because he was informed by an attorney at Pro-Tech that “Pro-
`Tech, as a business matter, did not want to divert resources away from its
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`business, and we would need a subpoena to obtain any documents or
`testimony from Meeuwsen.” Id. ¶¶ 3–4.
`
`Mr. Malynn, however, was able to interview Mr. Meeuwsen and
`learned from Mr. Meeuswen what Mr. Meeuswen would testify to and what
`documents he would produce in response to a subpoena. Id. ¶ 8. Among the
`things Mr. Meeuswen would testify to is authenticating “his email
`correspondence with Burnham and other documents related to the project.”
`Id. ¶ 8e. Also among the things Mr. Meeuswen would testify to is “[t]o his
`surprise and relief, Meeuswen recalled that the new production protocol
`[from Bradley Burnham] seemed to work.” Id. ¶ 8k. Further among the
`things Mr. Meeuswen would testify to is his recalling “Burnham completing
`and returning the Pro-Tech manufacturing documents.” Id. ¶ 8l.
`
`If a derivation proceeding were instituted, given the testimony of
`Mr. Malynn discussed above, we may authorize Petitioner to file a motion
`seeking authorization to apply to a U.S. District Court for a subpoena for
`Mr. Meeuswen to provide testimony and documents. See 35 U.S.C. § 24.
`Thus, under this unique factual situation, the lack of independent
`corroboration at this time for the alleged conception of the disclosed
`invention does not render the Petition insufficient to support institution of a
`derivation proceeding.
`
`2.
`Communication
`
`The circumstance with regard to communication of the conception to
`Marc Seller is essentially the same as that regarding conception as discussed
`above. Petitioner likewise depends on Exhibits 1026, 1028, 1041, and 1042.
`Pet. 2, 5, 6. Similar to the circumstance regarding conception, Exhibits
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`1026, 1028, 1041, and 1042 constitute sufficient evidence, under the
`substantial evidence standard, to support Petitioner’s assertion of
`communication to Marc Selner of Bradley Burnham’s conceived invention,
`except for the requirement of independent corroboration. However,
`Mr. Malynn’s testimony concerning what Mr. Meeuswen would testify to in
`response to a subpoena, e.g., authenticating the email correspondences with
`Bradley Burnham, makes the lack of corroboration at this time not a critical
`deficiency for the Petition.
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`
`
`C.
`Petitioner Having at Least One Claim
`Satisfying 37 C.F.R. § 42.405(a)(2)(i)
`
`Per 37 C.F.R. § 42.405(a)(2)(i), Petitioner must have at least one
`
`claim that is “[t]he same or substantially the same as the respondent’s
`claimed invention.” Specifically, Petitioner identifies Petitioner’s claim 1
`and Respondent’s claim 36. Pet. 9. In an order dated December 17, 2021,
`we explained that for this determination under 37 C.F.R. § 42.405(a)(2)(i),
`“Petitioner need only show one claim in its application that is same or
`substantially the same as one claim of Respondent, and that the
`determination is made one-way in the direction from the Petitioner claim to
`the Respondent claim.” Paper 18, 2–3. “Same or substantially the same”
`means patentably indistinct, 37 C.F.R. § 42.401.
`Petitioner’s claim 1 reads as follows:
`1.
`A stable suspension, comprising water, greater than
`about 80% by weight petrolatum, and at least one ionic biocide
`compound, wherein the suspension contains no emulsifier, and
`all ionic biocide compounds present are either all cationic or all
`anionic, wherein the at least one ionic biocide is contained within
`nanodroplets having a diameter of from about 10 nm to about
`10,000 nm.
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`Paper 17, 1.
`Respondent’s claim 36 reads as follows:
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`36. A non-separating, non-coalescing, non-flocculating
`stable suspension essentially consisting of water, petrolatum and
`at least one cationic biocide; and optionally mineral oil, where
`the at least one ionic biocide is contained within nanovescicles
`having a diameter of 100 microns or less.
`Id. at 9.
`
`A “stable suspension” is “non-separating, non-coalescing, non-
`flocculating.” A suspension “comprising water, greater than about 80% by
`weight petrolatum, and at least one ionic biocide,” and not reciting any other
`component is one that is “essentially consisting of water, petrolatum and at
`least one cationic biocide” or at least would have rendered the latter obvious.
`The phrase “consistently essentially of” permits inclusion of components not
`listed in the claim, provided that they do not materially affect the basic and
`novel properties of the invention.” PPG Indus. v. Guardian Indus. Corp.,
`156 F.3d 1351, 1354 (Fed. Cir. 1998). Although Petitioner’s claim 1 uses
`the more open-ended phrase “comprising,” it would have been obvious to
`one with ordinary skill in the art to exclude the presence of materials that
`would materially affect the basic and novel properties of the stable
`suspension invention.
`Claim 1 recites that all ionic biocide compounds present are either all
`cationic or all anionic, which would have suggested the at least one cationic
`biocide of claim 36. The recitation in claim 36 of mineral oil is expressly
`stated as optional and thus need not be met. The diameter of the
`nanodroplets of claim 1 ranges from 1x10-5 to 1x10-8 meters, which is
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`completely within the range of the diameter of the nanovescicles of claim
`36, i.e., less than 1x10-4 meters. The former anticipates the latter.
`
`For the foregoing reasons, Petitioner’s claim 1 would have rendered
`obvious Respondent’s claim 36. The requirement of 37 C.F.R.
`§ 42.405(a)(2)(i) is met.
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`D.
`Petitioner Having at Least One Claim
`Satisfying 37 C.F.R. § 42.405(a)(2)(ii)
`
`Per 37 C.F.R. § 42.405(a)(2)(ii), Petitioner must have at least one
`
`claim that is “[t]he same or substantially the same as the invention disclosed
`to the respondent.” In an order dated December 17, 2021, we explained that
`for this determination under 37 C.F.R. § 42.405(a)(2)(ii), “Petitioner need
`show only one claim of Petitioner that is the same or substantially the same
`as ‘the invention disclosed to the respondent,’ and that is also a one-way
`analysis in the direction from Petitioner’s claim to ‘the invention disclosed
`to the respondent.’” Paper 18, 3. See Catapult Innovations Pty Ltd. v.
`Adidas AG, DER2014-00002, Paper 19 at 17 (PTAB July 18, 2014). That
`means the invention disclosed to respondent either must be anticipated by or
`would have been obvious over a Petitioner claim.
`Specifically, Petitioner identifies Petitioner’s claim 1. Pet. 39.
`Petitioner asserts: “all the limitations of Petitioner’s Claim 1 are present in
`Petitioner’s invention disclosed to Respondent.” Id. at 44. Corresponding
`explanation is provided on pages 39–44 of the Petition. Id. at 39–44. For
`this analysis, Petitioner selected the “method” articulation of the “invention
`disclosed to the respondent.” Id.
`There are two deficiencies with Petitioner’s approach. First, the
`analysis is in the opposite direction. Petitioner is asserting that the invention
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`disclosed to the respondent anticipates Petitioner’s claim 1, rather than what
`is required, i.e., the invention disclosed to respondent either must be
`anticipated by or would have been obvious over a Petitioner claim. Second,
`it is not true that all the limitations of Petitioner’s claim 1 are present in
`Petitioner’s invention disclosed to Respondent. Indeed, Petitioner’s claim 1
`requires as a component of the suspension “greater than about 80% by
`weight petrolatum.” Petitioner’s accounting for that element does not
`identify anything in the invention disclosed to respondent which satisfies
`that limitation. See Pet. 40–41.
`Those deficiencies are inconsequential, because the appropriate
`analysis is whether claim 1 anticipates or would have rendered obvious the
`invention disclosed to Respondent. It is manifestly evident, without need of
`any explanation, that for institution purposes Petitioner’s claim 1 anticipates
`the suspension articulation of the invention disclosed to Respondent:
`a stable suspension composition comprising an aqueous phase
`containing at least one ionic biocide compound dissolved in
`water in particular amounts, with the aqueous phase suspended
`as nanodroplets in a petrolatum carrier, and without the
`composition containing an emulsifier to stabilize the ionic
`biocide aqueous phase in the hydrophobic petrolatum carrier.
`Pet. 5 (emphasis added).
`
`For the foregoing reasons, in this particular situation, the requirement
`of 37 C.F.R. § 42.405(a)(2)(ii) is met.
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`E.
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`Showings under 37 C.F.R. § 42.405(b)(3)
`Under 37 C.F.R. § 42.405(b)(3), a comparison should be made by
`Petitioner between each challenged claim and the “invention disclosed to
`respondent” which in this case has been expressly defined by the Petitioner
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`in two ways, an articulation in a “suspension” form, and another articulation
`in a “method” form. Depending on the challenged claim, Petitioner may
`rely on either articulation. As discussed above, in a derivation proceeding, a
`challenged claim would be deemed a derived invention under 37 C.F.R.
`§ 42.405(b)(3), if it is the same or substantially the same as the invention
`Petitioner’s inventor conceived and disclosed to a Respondent inventor.8
`Petitioner asserts that Respondent’s claims 24–35 are the same or
`substantially the same as the invention disclosed to Respondent’s inventor
`Marc Seller. Pet. 50–51. As discussed above in Section B, as identified by
`Petitioner (Pet. 6), the “method” articulation of the invention disclosed to
`Respondent is:
`Place the petrolatum in ingredients of 1kg in a clean stainless
`steel container. Heat the petrolatum until semi-solid which will
`appear white not clear (40-45 c). The consistency will be of an
`almost liquid. Stir constantly if possible once this state is
`achieved.
`1. Add heated (50 c): 25 gm of preservative with 25gm of
`USP water. *Add the heated liquid slowly while mixing
`into the petrolatum. 50gm liquid/1kg petrolatum
`2. Mix while cooling slowly until the mixture has reached
`a solid state. As it cools the mixture will get more solid
`and whiter.
`3. Fill vessels with mixture immediately above solidified
`temperature of mixture.
`
`
`8 The Petition makes no showing with respect to Respondent’s claim 36
`under 37 C.F.R. § 42.405(b)(3). Thus, Petitioner has not, for institution
`purposes, adequately shown that Respondent’s claim 36 is the same or
`substantially the same as the invention disclosed to Respondent.
`15
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`DER2017-00031
`Petitioner Application 15/672,197
`Respondent Application 15/549,111
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`*The liquid is heavier than the petrolatum so it will always
`go to the bottom. Make sure you continue stirring all the
`way to the bottom until the mixture has congealed.
`4. Wait 4-6 hours until sealing vessel.
`And also as discussed above in Section B, the “preservative” is PHMB.
`1.
`Respondent’s Claim 24
`Respondent’s claim 24 reads as follows:
`24. A method of making a non-separating, non-coalescing,
`non-flocculating stable suspension comprising combining
`petrolatum at a temperature about 37ºC to about 45ºC, with a
`liquid biocide to form nanovesicles of liquid biocide suspended
`in said petrolatum, said liquid biocide comprising biocide and
`water mixture, said biocide comprising substantially all cationic
`molecules or all anionic molecules.
`Paper 17, 7–8.
`Petitioner explains that a stable suspension is non-separating, non-
`coalescing, non-flocculating. Pet. 52. The explanation is rational and
`persuasive at this stage without contrary evidence and argument from
`Respondent. Thus, the invention disclosed to Respondent is a method of
`making a non-separating, non-coalescing, non-flocculating stable
`suspension. The invention disclosed to Respondent includes combining
`PHMB (a liquid ionic biocide) and water mixture with petrolatum where the
`petrolatum is at a temperature between 40ºC to 45ºC. The temperature range
`substantially overlaps with the range recited in claim 24, i.e., 37ºC to about
`45ºC. Petitioner explains:
`Because the “about 37ºC to about 45ºC” temperature range
`recited in Claim 24 overlaps with the optimal 40–45ºC range
`communicated to Selner, Respondent’s claimed range is
`anticipated by or obvious over Burnham’s communicated range
`and is therefore the same or substantially the same as Burnham’s
`16
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`DER2017-00031
`Petitioner Application 15/672,197
`Respondent Application 15/549,111
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`communicated heating range, which resulted in the stable
`suspension composition claimed by Petitioner.
`Pet. 51. We agree. Because the 40–45ºC range is completely within the
`about 37ºC to about 45ºC range, the former anticipates the latter. Further,
`overlapping range sufficiently supports an obviousness determination,
`subject to rebuttal. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir.
`2003). Accordingly, the claimed range of about 37ºC to about 45ºC would
`have been reasonably suggested by the disclosed range of 40–45ºC.
`Petitioner explains that PHMB “is a known liquid ionic biocide
`having a cationic nature” and is the only biocide added in the invention
`disclosed to the Respondent. Pet. 52 (citing Ex. 1011 ¶ 19). This is
`sufficient to meet the requirement in claim 24 of “said biocide comprising
`substantially all cationic molecules or all anionic molecules.”
`Regarding claim 24’s recitation of the intention “to form nanovesicles
`of liquid biocide suspended in said petrolatum,” even assuming that the
`phrase is limiting, Petitioner makes two contentions both of which we find
`sufficiently persuasive on the current record. First, Petitioner asserts that to
`form nanovesicles of liquid biocide suspended in said petrolatum “is
`inherent to the method communicated to Respondent.” Pet. 53. In that
`regard, Petitioner explains:
`Respondent’s application admits that nanovesicles are an
`inherent feature of the heating method and the use of an ionically
`charged cationic biocide, stating: “Due to the heat and the ionic
`charge, these nanovesicles remain separate and do not join or
`coalesce, due to ionic repulsion forces between neighboring
`nanovesicles.” Ex. 1001, [0009].
`Id. Second, Petitioner asserts:
`
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`DER2017-00031
`Petitioner Application 15/672,197
`Respondent Application 15/549,111
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`A POSITA at the time of the invention would understand that a
`stable suspension would inherently have a vesicle or droplet size
`of 100 microns or less since that broad range encompasses the
`entire spectrum of stable suspensions contemplated by a
`POSITA. Pet., p. 42; Ex. 1013 at ¶¶40–44. As a result, the
`feature ‘to form nanovesicles of liquid biocide suspended in said
`petrolatum’ in Claim 24 is obvious in view of Petitioner’s
`method disclosed to Respondent.
`Id. at 54. The assertion is supported by the cited evidence.
`
`For institution purposes, and on the current record, Petitioner has
`adequately shown that Respondent’s claim 24 is the same or substantially
`the same as the invention disclosed to Respondent.
`
`2.
`Respondent’s Claim 25
`
`Respondent’s claim 25 reads as follows: “A method as in claim 24,
`wherein said petrolatum is at a temperature within the range just above its
`melting point of approximately 37ºC.” Paper 17, 8.
`Petitioner explains:
`While Burnham’s February 14, 2014 email specified heating the
`petrolatum to 40–45ºC, Burnham’s February 7, 2014 email
`communicated general information on ointment preparation
`discussing the use of heat to melt components after which
`Burnham wrote “[h]eat the PHMB liquid AND the petrolatum
`. . . [m]ix together at the lowest possible heat to allow complete
`mixing.” Ex. 1026 at 2. Heating at the petrolatum at the lowest
`possible heat for mixing, at approximately the 37ºC heating
`range recited in Claim 25, is anticipated by or obvious over the
`method steps communicated to Respondent. See Titanium
`Metals Corp. of America v. Banner, 778 F.2d 775, 783 (Fed. Cir.
`1985). Therefore, Respondent’s Claim 25 is the same or
`substantially the same as Petitioner’s communicated invention.
`Pet. 55.
`
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`DER2017-00031
`Petitioner Application 15/672,197
`Respondent Application 15/549,111
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`We see two problems with Petitioner’s approach. First, Petitioner is
`permitted a coherent and complete articulation of the method disclosed to
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