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Koehn v. Secretary of Health & Human Services
773 F.3d 1239
Fed. Cir.
2014
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Docket

*1 life, information, i.e., numbers, necessary and vitali- “give meaning, sequence into claim) (internal ty” quotation messages Patent, 4, of fixed '215 col. the size. to, omitted). The claim recites con- lines of (summary citation 49-54 the invention field,” only in “message but the structing identifying precisely ways those two does claim indicate the preamble system “optimiz[ing] Er- performance”). field be understood as a message is to only specific icsson’s argument against the protocol.” in ARQ response[ ] “feedback “minimizing” construction is to note the 19-20, Patent, 10, lines 24-27. '215 col. ways two minimizing specification response,” appear- phrase The “feedback at identifies. Ericsson Br. 39. But is preamble, crucial to ing nowhere but the is not an argument against pro- D-Link’s sense of the rest of the claim. See making posed construction —which covers both Bertina, 1029, (“se- v. ways those of minimizing. J.A. 5084 Griffin (Fed.Cir.2002) (holding limiting as a meth- lected multiple from available feedback re- preamble reciting “diagnosing od claim’s sponses in order to minimize the or size thrombosis,” risk for where increased responses”). number feedback I con- covering claim performed clude, therefore, nucleic-acid tests that it was error for the subject” on a with- meaningless “test reject district court D-Link’s “minimiz- is ... understanding “[diagnosis out ing” claim construction. invention”).

the essence of [the] undisputed It is that if claim 1 requires proposed by The construction Ericsson “minimizing,” the accused devices do by implicitly adopted the district court infringe. argues Ericsson never otherwise preamble limiting. recognizes is in its brief. Ericsson Br. at This 38-40. adopted “respon- construction of the is an ground reversing additional step requires “including sive” a field that judgment infringement pat- the '215 message type ent, identifies requiring judgment of non-in- feedback Ericsson, v. D- response message.” Inc. fringement instead. 6:10-cv-473, Corp.,

Link No. 2013 WL 2013) (E.D.Tex. (em- at *5 Mar. added). phrase

phasis “feedback construction, claim

sponse,” adopted in the except

comes nowhere claim preamble. court Where district Cheryl KOEHN, as Mother and Next preamble to in- parsing erred was of, Koehn, Friend limiting phrase clude one —“feed- Petitioners-Appellants, responses” excluding back —while “minimizing” appears word immedi- SECRETARY OF HEALTH AND ately phrase respons- before “feedback SERVICES, Re HUMAN es.” I see no basis for that distinc- sound spondent-Appellee.

tion. No. 2014-5054. Indeed, the specification, as described above, centrally invention shows of Appeals, United States Court minimizing responses-which about such . Federal Circui t can minimizing be done either size Dec. (status response messages individual units) protocol by minimizing data messages by of such packing

number *2 Crow, Allen, O’Dell, Beasley, Leigh

P. P.C., Prortis, Miles, Methvin, of Mont- & AL, petitioners-appel- argued for gomery, lants. Wishard, Attorney, Trial

Darryl R. Division, Branch, States Civil United Torts DC, Justice, Washington, Department himWith argued respondent-appellee. for Delery, F. Assis- the brief were Stuart General, Bhattachary- Rupa Attorney tant Matanoski, Director, Deputy ya, Vincent J. Director, Fielding, Assis- M. Gabrielle tant Director. O’MALLEY, MOORE,

Before REYNA, Judges. Circuit by court filed Circuit Opinion for the Concurring opinion Judge O’MALLEY. by Judge for the court filed Circuit MOORE.

O’MALLEY, Judge. Circuit appeals from U.S. Court Cheryl Koehn upholding a judgment of Federal Claims compensation Master’s denial juvenile systemic daughter’s (“SJIA”) allegedly idiopathic arthritis Although by á vaccine. caused of Koehn’s medical assessment Master’s flaws, several theory of causation contains a sufficient rash disappeared Master had basis within three days. On 28, 2008, June which to determine Koehn did went upon Vanessia to Marian demonstrating meet Medical joint her burden of Center for severe pain relationship high proximate temporal between fever. had stopped taking time, daughter prednisone vaccine and which coincided *3 developing knees, with pain SJIA. We therefore her developing her affirm. thighs, and Vanessia calves. saw a rheu-

Background matologist hospital at the and an- received other prednisone. prescription SJIA, with an autoinflammato- Children hospital 2, her on discharged July 2008 disease, ry symptoms including exhibit ar- with a presumptive diagnosis juvenile of thritis, rash, fever, may expe- a and a and idiopathic only symp- arthritis. Vanessia’s symptoms flares involving rience similar as tom at a discharge was rash. joint pain. Many well muscle and of symptoms dysfunctional these result from 8, 2008, July On Vanessia saw Dr. Debo- proteins cytokines, of called production rah McCurdy, pediatric a rheumatologist, certain cells almost immedi- which release who noted family history that Vanessia’s ately after the into comes contact juvenile included idiopathic arthritis and an antigen. Cytokines signal with other a likely concluded that SJIA was diagnosis. generate an immune response. cells McCurdy findings communicated these Pro-inflammatory cytokines, like those as- to Dr. Regala, who administered Vanes- SJIA, can lead to sociated fever or 19, sia’s August third dose of Gardasil on Examples of other inflammation. SJIA 2008. no longer taking Vanessia was pred- prednisone, medication include which re- time, nisone at but taking had started inflammation suppresses duces and the im- etanercept. experienced Vanessia a flare system, etanercept, mune and which inhi- rash, fever, joint SJIA with and on pain a linked to bits SJIA. 25, August September 2008, that, McCurdy though concluded Vanessia is a vaccine immunizes improved, had still signs she showed against papillomavi- four human strands of McCurdy SJIA. noted that Vanessia (“HPV”). vaccine, rus administered complained symptoms of SJIA after she' doses, particles in three contains virus-like stopped taking prednisone, and that she protein, created HPV as well as had swollen and knees. ankles adjuvant, in generating which assists a promote immune response long- robust II. immunity.

term Vanessia, On behalf Koehn I. injury filed an claim off-Table Vanessia, injuries, daughter, was born in Vaccine Act. For off-Table which 1995, February generally healthy appear and was those that do not on the statu Table, tory Injury of her years for the first twelve life. Dr. Vaccine C.F.R. (2014), § Regala petitioner prove Elena administered Vanessia’s first 100.3 must Sec’y causation-in-fact. Andreu v. February dose Gardasil 2008 and her Servs., Health & Human in April second dose 2008. On June (Fed.Cir.2009). experienced petitioner a rash all A must over body. prove it a Regala, believing following preponderance to be an (1) reaction, a allergic prescribed Benadryl the evidence causation: and to establish causally prednisone days connecting three later. Vanessia’s medical (2) As an ly epidemiological data. logical a se injury; vaccination presented an article demonstrating example, Dr. McCabe and effect of cause quence the medi- injury; discussing study evaluated caused that the vaccination 189,000 wom- (3) relationship history approximately be cal temporal injury. they developed Althen en to whether the vaccine and determine tween Servs., receiving a Human 418 an after & autoimmune Sec’y Health article”). (“Chao (Fed.Cir.2005). 1274, 1278 quadrivalent HPV vaccine F.3d find such Though the article did not Chao opinion of Dr. Mi- presented Koehn connection, -Dr. McCabe relied McCabe, a Ph.D. in micro- who has chael so rare article that SJIA is to demonstrate immunology has biology size, large it was despite sample factors that affect environmental searched enough to an increased large detect support her claim. response, *4 following vaccination. rate of SJIA HPV that had a Dr. McCabe asserted that, be- Finally, suggested Dr. McCabe SJIA, and that for Gardasil predisposition cause who receive devel- patients Gardasil trigger because the was an environmental immunity with- op sufficient antibodies response in the strong caused a vaccine months, development in Vanessia’s dysregulated in seven cytokines same which receiv- of SJIA within seven months after sup- He relied on several articles to SJIA. ing was evidence of a theory, including an Gardasil his article dis- port temporal relationship. study cytokine cussing a that tested levels an HPV on in women who received vaccine government’s expert, The Dr. Carlos regimen a three-dose similar Gardasil Rose, pediatric rheumatologist ais article”). (“Pinto study In the referred to SJIA, but routinely treats children with article, gave Pinto by the researchers has not researched the vaccine or HPV twenty participants female vac- HPV cytokines role of SJIA. Dr. Rose assert- regimen on the same three dose cine likely a ed that SJIA was more Vanessia’s Gardasil, and drew blood before the first Rose, According Dr. coincidence. after injection and one month each of most Pinto arti- relevant results The injections. and third research- second samples cle were that the vaccinated blood samples either the blood ers stimulated relatively with had consis- no stimulation varying parti- of a virus-like with amounts levels, cytokine pa- tent whereas SJIA provided cle in the vaccine or no stimu- pattern tients experience up-regulated at all. levels Cytokine lation were rela- Dr. cited an levels. Rose also tively consistent in the vaccinated blood 60,- referring study roughly article to a Cytokine that received no stimulation. increased individuals which found no however, increased, for the levels vaccinat- partici- risk for autoimmune disorders for parti- that ed blood received virus-like vaccines, pants including an who received cle, cytokines and the elevated were HPV called Cervarix that uses a vaccine dysregulated as those Dr. same SJIA. (“Ver- than adjuvant different Gardasil commonality asserted that this McCabe article”). straeten theory triggered his that Gardasil supports SJIA. Vanessia’s III. The Master Koehn com- Special

Dr. McCabe further testified that denied . pensation. held that epidemiological lack of studies on SJIA The Master too for Koehn not meet her shows that the disease is rare did burden that Dr. prong, finding to be generate scientists able to statistical- patients unprece- develop a McCabe’s medical was sufficient immune re- peer-reviewed been dented and had not sponse, which is Spe- seven months. The addition, published. Mas- found, however, cial Master that both that ter found scientific McCabe agreed Rose pediatric did munity, rheumatologists, not system releases soon theory, primarily accept McCabe’s after antigen, encounters an basing conclusion Dr. Rose’s testi- which is inconsistent McCabe’s he, mony pediatric as head rheu- theory that onset of the disease could take matology hospital, at his did not recall many months. Dr. attempted hearing theory. Spe- ever of such explain this contradiction asserting acknowledged cial Ver- “amplification there process,” but the straeten article a different involved HPV Special Master concluded that he did than sample vaccine Gardasil and that its sufficiently explanation. likely produce size insufficient to sta- But, tistically upheld Court Federal Claims significant results. because timely involved Chao had than Master’s decision. Koehn sample appealed. double the size of the jurisdiction Verstraeten have We under article, 300aa-12(f) (2012). held § U.S.C. “[tjaken together” weighed against

articles *5 theory. Finally, Dr. McCabe’s J.A. 143. Discussion the Special Master focused on the Pinto indicating article’s results that cases, Act we the apply Vaccine levels increased when the researchers same standard review the Court of blood, stimulated the and Dr. Rose’s state- applied Federal the Special Claims Mas ment that when you “[o]f course stimulate Moberly Sec’y ter’s decision. v. Health antigen you get with an more Servs., & Human 592 F.3d 1321 released.” (Fed.Cir.2010). Although legal we review deference, determinations without re we Moving to the prong, second Althen the view the Special findings Master’s of fact Special Master held that Koehn did not arbitrary capricious under the stan a logical sequence establish of cause and dard. Human Griglock Sec’y Health & effect between Gardasil and Vanessia’s (Fed.Cir. rvs., Se 1374 F.3d conclusion, reaching SJIA. In the Spe- 2012). cial Master found Dr. Rose’s opinion more persuasive because he is a doctor Though Special Master had suffi- patients,

treats whereas Dr. McCabe does cient grounds deny petition Koehn’s be- patients. not treat cause Koehn failed to meet her burden prong, begin by under the third Althen we Special held Master further recognizing Special Master Koehn did not meet burden under the mitted several errors in the assessment prong third Althen because the record did prongs. first and second Althen As to not support Dr. McCabe’s assertion that instance, prong, development of within a SJIA seven-month Special Master based his conclusion proxi- interval was sufficient to establish community the relevant scientific did not temporal relationship. mate Dr. McCabe accept theory on Dr. McCabe’s Dr. Rose’s aligns reasoned that the onset of SJIA period during with the time which Gardasil statement that he did recall hear- not ever to infer medically acceptable it is impute etiology, theory.1 To ing of such v. Sec’y Bazan to the scientific causation-in-fact.” de statement Rose’s anecdotal Servs., An- & Human wholly unreasonable. Health community was (Fed.Cir.2008). find- Master’s example is other prong, Althen under second ing not record did persuasive opinion Dr. Rose’s appropriate suggestion that McCabe’s because Dr. opinion Dr. McCabe’s than exhibiting symptoms of for first timeframe does and McCabe patients treats Rose up can extend caused Gardasil SJIA why basis for no not. We see reasonable asserted that months. seven any meaningful effect has this distinction within seven of SJIA can occur onset case, inquiry in this cause and effect on the because it receiving months none. provided Master af- months normally patients takes seven recognize that it is within we While develop a suffi- ter Gardasil to weigh discretion Special Master’s response. Dr. McCabe did immune cient evidence, can- Special Master not, however, timing explain why the manner analysis in a manipulate timing of aligns onset SJIA that he to arrive at a conclusion calculated patients sufficient already has reached. or she the vaccine. Even Dr. McCabe ceiving meet her bur- Because Koehn failed to system produces that the immune agreed prong, third howev- Althen den body encoun- cytokines quickly after the er, any failure to under one db so inconsistent with antigen, ters an which is dispositive of this prongs the Althen theory that onset of the disease could his ease, correctly denied position many months. Dr. McCabe’s take petition. developing the amount of time for immunity after re- sufficient antibodies for agree with the We ceiving always a vaccine is consistent with *6 a failed to establish that Koehn’s evidence proposition a injury from the vaccine is relationship between temporal any evidentiary support, we without develop Gardasil vaccine Vanessia’s accept. simply cannot prong. third of SJIA under Althen’s ment ex- proof argues Koehn that Dr. McCabe prong “requires preponderant This by referring occurred symptoms plained the onset contradiction which, But given “amplification an process.” within a timeframe for only there was speculated the disorder’s understanding medical 5:24-6:56, sample assay. Arg. properly Oral at 1. Had the blood evaluated evidence, http://oralarguments.cafc. at we available believe the uscourts.gov/default. likely aspx?fl=2014-5054.mp3. have found that Koehn met would necessary prong. to meas- A stimulus was therefore burden under given partici- cytokine Especially ure levels. Pinto article demonstrated that SJIA, requiring in- pants who received HPV vaccine had low incidence rate of dy- would cytokines measurement without a stimulus have levels of the same creased compelled present Koehn to more than what sregulated in SJIA. Rose asserted scientifically possible legally necessary. only levels is Thus, the. article showed increased viable, likely presented a "le- a stimu- Koehn when the vaccinated blood received however, probable” explains, gally that "there Koehn that meas- medical lus. upregulation an in cytokine only occur in would be urement of levels can body, if those samples SJIA] and the are associated with cells [that blood outside the [by "replicate going vaccine.]" told to do so the HPV only way to what is 6:50-6:56; Moberly, F.3d at body" antigen to the Id. at 1322. is to introduce certain delay in the onset of SJIA because HOLDINGS, LLC, DDR inflammatory cells and media-

regulatory Plaintiff-Appellee, in the that are also purportedly tors may antigen coun- active cytokines, and teract the effects of admit- HOTELS.COM, L.P., Cendant Travel that “none of this was in” ted measured Group, Inc., Distribution Services Ex Vanessia. J.A. 232. We find the pedia, Inc., Travelocity.Com, L.P., Master’s conclusion Dr. McCabe’s ex- Site59.Com, LLC, International planation lacked sufficient neither Gallery, Inc., Cruise & Excursion Our arbitrary capricious. nor vacationstore, Inc., Internetwork Pub Thus, fault aspects while we find lishing Corporation, and Orbitz analysis, Master’s Althen we Worldwide, LLC, Defendants, ultimately deny affirm his decision pensation agree Koehn. We Koehn Group, National Leisure why Inc. and sufficiently

did not establish onset of Holdings, Inc., World Travel occur SJIA can within seven months after Gardasil, Defendants-Appellants, dose espe- the first cially generally when release is response. more immediate Digital River, Inc., Defendant. AFFIRMED. No. 2013-1505. States of Appeals, United Court Costs Federal Circuit.

No costs. Dec. MOORE, Judge, concurring. Circuit join fully majority’s analysis

I in the prong. recognize

the third Althen I

strength by major- the reasons cited

ity being troubled the Special Mas- analysis

ter’s on the first and second Al- *7 believe, however,

then I prongs. do they present adequate grounds for given highly

reversal deferential stan- apply.

dard of review we must

Case Details

Case Name: Koehn v. Secretary of Health & Human Services
Court Name: Court of Appeals for the Federal Circuit
Date Published: Dec 4, 2014
Citation: 773 F.3d 1239
Docket Number: 2014-5054
Court Abbreviation: Fed. Cir.
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