# United States **Court of Appeals**  **for the Federal Circuit**

______________________
SCIENTIFIC PLASTIC P RODUCTS, INC., Appellant,

v.

BIOTAGE AB, Appellee.

______________________

2013

- 1219,

- 1220,

- 1221

______________________ Appeals from the United States Patent and Trad emark Office, Patent Trial and Appeal Board in Reexam ination No s. 95/000,495, 95/000,49 6 , and 95/000,497

.

______________________

Decided: September 10, 2014

______________________ F REDERICK C. L ANEY , Niro, Haller & Niro, of Chicago, Illinois, argued for appellant. With him on the brief w as P AUL K. V ICKREY . Of counsel on the brief was D AVID M. Q UINLAN , David M. Quinlan, P.C.

, of Princeton, New Jersey.

G EORGE C. B ECK , Foley & Lardner, LLP, of Washin gton, DC, argued for appellee. With him on the brief were M ICHAEL R. H OUSTON , of Chicago, Illinois, and D EBRA D. N YE , of San Diego, California.

______________________SCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 2

Before N EWMAN , M OORE , and W ALLACH , Circuit Judg es. Opinion for the court filed by Circuit Judge N EWMAN

. Dissenting opinion filed by Circuit Judge M OORE

. N EWMAN , Circuit Judge

. Scientific Plastics Products, Inc. ( SPP) is the owner of the three United States Patent s here at issue : No. 7,138,061 (the ’061 patent), No. 7,381,327 (the ’327 p atent), and No. 7,410,571 (the ’ 571 patent)

, which relate to

a re sealable cartridge for low pressure liquid chromato graphy ( LPLC). The ’061 patent claims a method of pe rforming LPLC using the cart ridge, the ’571 patent claims the cartridge , and t he ’327 patent claims a modified cartridge. After SPP filed suit against Biotage AG for patent infringement, Biotage requested inter partes reexamination of the three patents

. The district court then stay ed the in fringement litigation.

The patent examiner rejected all claims of the three patents on the ground of obviousness, and the Patent Trial and Appeal Board affirmed the rejections and ca ncelled all claims. 1 W e affirm the Board’s decisions

. B ACKGROUND
The SPP patents discuss the need for a lo w cost resealable cartridge for LPLC that provides a fluid tight seal under pre s sure

. T he claimed cartridge , illustrated at Figure 1 of the ’327 patent

, comprises a tubular container

1 Biotage AB v. Scientific Plastic Prods

. , Inc. , No. 2012

- 007321, 2012 WL 6043584 (P.T.A.B. Nov. 30, 2012) (’ 327 pat en t) ; No. 2012

- 007322, 2012 WL 6043585 (P.T.A.B. Nov. 30, 2012) (’061 patent) ; No. 2012

- 012468, 2012 WL 6043586 (’571 patent) ( P.T.A.B. Nov. 30, 2012 ). The opinion for each appeal is effec tively identical ; Board Op. citations herein are to the ’061 patent decision

.SCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 3

20 having a threaded polymer c ap 28 and a seal ing flange 40.

Claim 1 of the ’327 patent is the broadest cartridge claim :

1. A low pressure liquid chromatographic ca rtridge having a longitudinal axis, comprising: a tubular polymer container adapted to r eceive a chromatographic packing material, the container having an outlet port located at a dow nstream end of the container and configured for connecting to chromatographic equipment during use of the cartridge, the container having contai ner threads formed on an upstream end of the co ntainer and a lip defining an opening to theSCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 4

container with a n inward facing inclined sealing surface adjacent the lip and facing the longitud inal ax is; a polymer cap having an inlet port located on an upstream end of the container, th e port being configured for connecting to chromatographic equipment during use of the cartridge, the cap having cap threads located on a skirt of the cap to threadingly engage the container threads ; an annular sealing flange depending from the cap and located radially closer to the longitudinal axis than the skirt, the flange having an outward facing inclined sealing surface facing away from the axis with an upstream end of the flange being further from the axis than a downstream distal end of the flang e; the outward facing inclined su rface on the flange generally aligned with and l ocated to abut the inward facing inclined surface on the container to form a resilient fluid tight seal between the cap and container suitable for use in low pressure liquid chromatography when the cap is screwed onto the container.
The primary issue on reexamination concerned the obviousness of combining the LPLC cartridge shown in the Yamada reference with the King or Strassheimer

pressure

- resistant caps . These references ar e:
U.S. Patent No. 5,693,223 ( Yamada) :
Yamada shows a n LPLC cartridge having a tubular polymer container with an open upstream end and an outflow at the downstream end. Yamada shows a threa ded polymer cap for the cartridge that is “detachably” fitted
to the corresponding threaded upstream end of the ca rtridge body. Yamada further shows an O

- ring in the cap to ensure liquid tightness. The examiner found that Yama da discloses all of the features of the SPP cartridgeSCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 5

except for the complementary inclined sealing surfaces of the cap and the lip of the container.

PC T publication WO 2002/42171A1 ( King) : King relates to “ improved seals for container closure assemblies ,” and is “ especially applicable to the sealing of containers in substantially gas

- tight and li quid

- tight fashion, such as the sealing of . .

. beverage containers. ” King shows a “container closure assembly” with a threa ded polymer cap that ensure s a fluid tight seal

. The exa miner found that King shows sealing surfaces that have oppositely inclined surfaces with respect to the cap and lip of the container, as in the SPP closure.
U.S. Patent No. 5,100,013 (Strassheimer) :
Strassheimer relates to plastic bottles and closures therefor that are “ especially useful for carbonated beve rages. ” Stras sheimer shows a plastic threaded cap that ensures a fluid tight seal “even after repeated use.” The examiner found that Strassheimer shows a taper on the lip of the plastic container that corresponds to a taper on the cap

, as in the SPP closure

. The examiner concluded that it would have been obv ious to combine the cartridge of Yamada with the cap of either King or Strassheim er. On appeal to the Board, SPP challenged (1) the examiner’s determination that King and Strassheimer were “ analogous art ” and (2) that it would have been obvious to combine the LPL C cartridge of Yamada with the pressure

- resistant resealable cap of either King or Strassheim er.
T o be deemed “ analogous art ,” a reference outside an inventor’s field of endeavor must be “reasonably per t inent” to the particular problem with which the inventor is involved , such that a person of ordinary skill would re asonably have sought a solution to the problem in that outside field. The Board stated that “[h]ere, Patent Owner identifies one of the pur poses of the ’061 Patent asSCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 6

forming an LPLC cartridge that ‘would allow a user to easily vary and access the cartridge ’ s contents without destroying its ability to be sealed and function under the LPLC pressures. ’” Board Op. at * 6 ( quoting App ellant Br. 11 ). T he Board found that King and Strassheimer were relevant to SPP’s identified purpose, and therefore were analogous art : Therefore, it was reasonable for the Examiner to find that one of ordinary skill in the art would have found the disclosure s of Kin g and Stras sheimer relevant in constructing a plastic contai ner that achieves a fluid tight seal at elevated pressure, while preserving access to the container in order to easily vary its con tents. Board Op. at *7.

The Board also addressed SPP’s argument t hat the examiner failed to provide adequate reasoning for combi ning Yam ada with King or Strassheimer

. The Board found that the specifica tion of the SPP patents identified a leakage problem associated with threaded connections between the polymer cap and poly mer body in LPLC cartridges , and that Yamada’s use of an O

- rin g in the cartridge “implicitly acknowledges” potential leakage

. Id

. The Board concluded that this known problem “ provides a reason for one of ordinary skill to have turned to King or Strassheimer to improve the sealing arrangement set forth in Yamada. ” Id

. D ISCUSSION
C riteria for determining whether prior art is anal ogous may be summarized as “(1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not w ithin the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” In re Clay , 966 F.2d 656

, 658

–SCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 7

59 (Fed. Cir. 1992)

. The question here is whether King or Strassheimer meet s the second criterion. Precedent provides guidance as to when a refere nce is reasonably pertinent to the problem :

“ A reference is reasonably pertinent if . . . it is one which, because of the matter with which it deals, logically would have commended itself to an i nventor’ s attent ion in considering his problem. If a reference disclosure has the same purpose as the claimed invention, the reference relates to the same problem, and that fact supports use of that reference in an obviousness rejection.” Innovention Toys, LLC v. MGA Entm’t, Inc.

, 637 F.3d 1314, 1321 (Fed. Cir. 2011) ( quoting Clay

, 966 F.2d at 659 ) ; see also In re Klein , 647 F.3d 1343, 1348 (Fed. Cir. 2 011) (same standard ). The pertinence of the reference as a source of solution to the inventor’s problem must be recognizable with the foresight of a person of ordinary skill, not with the hind sight of the inventor’s successful achievement. See In re Oetiker , 977 F.2d 1443, 1447 (Fed. Cir. 1992) (“Patent examination is necessarily conducted by hindsight, with complete knowledge of the applicant’s invention . . . . ”) ; see also KSR Int’l Co. v. Teleflex Inc. , 550 U.S. 398, 421 (2006) ( “ A factfinder shoul d be aware, of course, of the distortion caused by hindsight bias and must be cautious of arguments reliant upon ex post re asoning.”).

T he Board found that the central purpose of the SPP inventors was to form “an LPLC cartridge that ‘would allow a user to easily vary and access the cartridge’s contents without destroying its ability to be sealed and fu nction under LPLC pressures.’” Board Op. at * 6 (quo ting App ellant Br. 1 1 ). T he Board concluded that a person of ordinary skill seeking such a cartridge would reason ably look to sealing arrangements for other pressurized systems. Thus the Board held that replacement of theSCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 8

sealing arrangement of Yamada with the sealing a rrangement of King or Strassheimer was an obvious sol ution to the problem of providin g a resealable cartridge that achieves a fluid tight seal at elevated pressures.

SPP disagrees with the Board’s characterization , and
states that t he purpose of its invention is to “ provide chemists with a low cost disposable chromatography cartridge that can function under LPLC pressures and simplify the chemist’s ability to control the chromat ographic packing material and the introduction of fluids into the cartridge under pressure.” Appellant Br. 25

– 26

. SPP argues that the needs ident ified in the speci fication

are sp ecific to flash chromatography, and that chemists in laboratories would not look to “soda

- pop” bottle caps to solve problems with flash chromatography cartridges. However, t he analogous art inquiry does not exclude references “not within the field of the inventor’s endea vor, ” if a person of ordinary s kill would reasonably look to that reference in order to solve the problem confronting the inventor

. In re Clay

, 966 F.2d at 659

.
SPP states that the purposes of the invention and the prior art must be considered as a whole

, in contrast to focusing on specific components. SPP argues that “[b]y focusing just on sealing issues, the Board improperly narrowed its focus to commonality for particular features instead of answering the central question of whether the reference’s field itself is even one a skilled artisan would have reasonably looked to, which requires a fo cus on the claimed invention.” Appellant Br. 33.

The Board observed that w hen the problem an inve ntion is designed to solve is not unique to the specific field of the invention, it is not improper for the trier of fact to consider whether a person of ordinary skill would consult

a different art in order to solve the problem

. See In re Paulsen , 30 F.3d 1475

, 1481

– 82 (Fed. Cir. 1994) (affir ming rejection of a laptop computer hinge as obvious overSCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 9

hinged cabinets, piano lids, etc., because the “problem is not unique to portable computers”); Pentec, Inc. v. Graphic Controls Corp. , 776 F.2d 309, 314 (Fed. Cir. 19 85) ( affir ming invalidation of a patent for a hinged pen arm because

a person skilled in pen art would have looked to hinge and fastener art for a way to attach a pen to a pen arm).

Other cases have found that a particular reference
was not analogous art when the field was not an obvious

area to be consulted . In In re Oetiker

, the court held that a person of or dinary skill, seeking to solve the problem of fastening a hose clamp, would not reasonably be expected to look to the field of fasteners for women’s garments. See 977 F.2d at 14 46

– 47 (“The Board apparently reasoned that all hooking problems are analogous.”)

. T he anal ogous art inquiry is a factual one, requiring inquiry into the similarities of the problem s and the closeness of the subject mat ter as viewed by a person of ordinary skill

. Here, the King and Strassheimer references address the problem of providing a fluid tight seal at elevated

pressures , between a container and a re sealable cap

. This is sufficiently close to the problem addressed by the claimed invention ; s ubstantial evidence supports the Board’s finding that King and Strassheimer are available as prior art

. The question remains as to whether combining the cartridge of Yamada with the pressure

- resistant cap of King or Strassheimer would have be en obviou s to a pe rson of ordinary skill in the field of liquid chromatography devices. In KSR

, the Court explained:
[A] patent composed of several elements is not proved obvious merely by demonstrating that each of its e lements was, independently, known in the prior art. Al though common sense directs one to look with care at a patent application that claims as innovation the combination of two known d evices according to their established functions, itSCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 10

can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.

550 U.S. at 4 18

. Applying these principles, the Board concluded that the “known problem of leakage in threaded connections of plastic LPLC cartridges under pressure identified in the [patents] provides a reason for one of ordinary skill in the art to have turned to King or Strassheimer to improve the sealing arrangement set forth in Yamada.” Board O p. at

* 8. The Board cited a statement in the SPP paten ts that explained that because prior art LPLC cartridges “leak at the seams[,] [t]hreaded connections are thus not used to form the body of [LPLC cartridges] when the body is made out of poly mers.” Id

. at *6 . The Board noted SPP’s arg ument that Yamada, a polymer cartridge with threaded connections, does not explicitly disclose a leakage pro blem . However, the Board found that “by providing for the presence of an O

- ring, Yamada implicitly acknowledges that there is a potential leakage issue between the cap and column body of the plastic cartridge.” Id. at *7.
SPP argues that the Board improperly relied on the inventors ’ description of the problem solved in order to find the solution obvious , an analyti c procedure that relies on hindsight by using the inventors ’ own reasoning against them

. SPP points out that the statement in the patents that threaded connections are not used with plastic LPLC cartridges was actually incorrect, as ev idenced by the Yamada reference

, which shows a plastic LPLC cartridge with threaded connections

. SPP argues that a person of ordinary skill would not have perceived any need to improve such cartridges , and that only through improper hindsight was the Board able to justify its finding of a known leakage problem

.SCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 11

SPP is correct that obviousness is not determined b y hindsight. However, the issue here is not whether the Yamada cartridge leaked , but whether there was a co ncern with leaka ge in LPLC cartridges such that a person of ordinary skill would have provided a known pressure

resistant cap, as in King or Strassheimer

, to the cartridge of Yamada. Substantial evidence supports the Board’s finding that there was such a concern.

We conclude that the Board did not err i n holding that it would have been obvious for a person of ordinary skill in the field of the invention to modify the chromato graphy cartridge of Yamada with the resealable threaded

cap of King or Strass heimer. This applies to the three patents whose reexamination decisions are here appealed

. T he Board’s decisions are

AFFIRMED

.

# United States **Court of Appeals**  **for the Federal Circuit**

______________________

SCIENTIFIC PLASTIC P RODUCTS, INC., Appellant,

v.

BIOTAGE AB, Appellee.

______________________

2013

- 1219,

- 1220,

- 1221

______________________ Appeals from the United States Patent and Trad emark Office, Patent Trial and Appeal Board in Reexam ination No s . 95/000,495 , 95/000,496, 95/000,497

.

______________________

M OORE , Circuit Judge

, dissenting

. I would find for the patentee. This is a two

- reference obviousness rejection (Yamada and King or Yamada and Strassheimer), which I would reverse. T he Board failed to provide substantial evidence that it would have been obvious to modify Yamada and it failed to determine the level of ordinary skill in the art.

The claims at issue are directed to a flash chromato graphy cartridge to be used in low pressure liquid chrom atography (LPLC)

. The primary reference, Yamada, is directed to a column device for u se in LPLC . The Board determined that Yamada disclosed all the elements of theSCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 2

claims at issue except the inclined abutting surfaces of the cap and the lip of the container. The Board concluded that one of skill in the art would have been motivated to

mo dify the Yamada structure by using the sealing stru cture disclosed in King or Strassheimer

, both of which are directed to container closures for soda pop bottles. I dissent from the majority because this record does not contain substantial evidence that o ne of skill in the rel evant art would have modified the chromatography ca rtridge in Yamada by replacing its sealing configuration with that of a soda pop bottle.

Th e Board conclu ded that “known problem of leakage in threaded connections of plastic LPLC cartridges . . . provides a reason for one of ordinary skill in the art to have turned to King or Strassheimer to improve the sealing arrangement [of] Yamada .” Boar d Op. at *8

. The majority cites two factual findings in support of this conclusion

— that Yamada’s use of an O

- ring “implicitly acknowledges” a “potential leakage issue ,” and that the inventors’ statements in the patent s alleged ly identify a prior art leakage problem. Maj. Op. at 6 ; see also Board Op. at *7

. Neither factual finding is support ed by su bstantial evidence. These were contested inter parte s reexaminations with experts on both sides, yet there is no testimony or other evidence of a known leakage problem in prior art car tridges that would have motivated one of skill in the art to modify Yamada.

T he Board ’s finding regarding Yamada’s O

- ring, Boar d Op. at *7

, ignores the reality of the situation, which is that Yamada did not have a leakage problem. Yamada does not disclose leakage problem s

. Id. Even Biotage ’ s expert admitted that Yama da’s configuration did not have leakage problems at the pressures identified by the p atents

- at

- issue

. J.A. 501 ¶ 9 , 613 ¶ 9 , 713 ¶ 9

. In fact, the Board found that Yamada’s configuration “ensure[s] liquid tightness.” B oard Op. at *5

. The time delay be-SCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 3

tween the Yamada configuration and the inventions at issue also supports the fact that one of skill in the art would not have modified Yamada because it did not have a leakage problem

. Yamada ’s earliest priority date is more than ten years before the earliest filing date of the patents

- at

- issue. There is absolutely no evidence even suggesting that one skilled in the art was aware of a leakage problem in Yamada’s design during those ten
years. T he Board ’s conclusion that Yamada’s O

- ring

“ implicitly ” acknowl edge s a “potential” leakage problem such that one of skill in the art would have been motiva ted to modif y Yamada is pure conjecture. We cannot rely

on the Board’s speculation about a “poten tial” problem that, according to all of the evidence on record, never actually existed, to support a finding of obviousness. One of skill in the art would not have modified Yamada to fix a leakage problem that never existed in the first place. You wouldn ’t seek to “improve [a] sealing arrangement” that doesn’t leak.

T he patent s at issue do say : “This operating pressure is sufficiently high that these cartridges, which have relatively large diameter bodies, leak at the seams. Threaded connections are th us not used to form the body when the body is made of polymer.” ’061 patent col. 1 l l

. 16– 19

. As a preliminary matter, the statement, as the parties acknowledge

, is inaccurate . Y amada , for example, uses threaded connections. This statement, in the p atent s , is not a recognition of a known prior art problem that would have motivated one of skill in the art to wan t to modify the Yamada design. It was a problem ident ified, not in the prior art, but by these inventors.

It is troubling that the majority an d the Board rely on the inventor s’ disclosure of the problem their invention s solve as the primary basis for modifying the prior art

. This is hindsight of the worst kind , “wherein that which only the invention taught is used against its teacher.”SCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 4

W.L. Go re & Assocs., Inc. v. Garlock, Inc. , 721 F.2d 1540, 1553 (Fed. Cir. 1983). The patent s do not indicate that leakage was a problem identified in the prior art or a problem known to those of skill in the art

. Rather they indicate that the claimed design wi ll avoid leakage. These inventors identified a design problem, articulated it, and solved it. There is absolutely no evidence of the existence of a known leakage problem that would have motivated skilled artisans to modify Yamada. The Board is taking th e ingenuity of these inventors and

, without any record basis, attributing that knowledge to all skilled artisans as the motivation to make the invention s at issue. Hindsight, hindsight, hindsight.

These were inter partes reexamination proceedings between sophisticated parties. Both parties put on expert testimony regarding obviousness. Yet there is no ev idence that the chromatography cartridges in Yamada had a leakage problem that skilled artisans would have been motivated to address. There is simply no eviden ce that one of skill in the art would have modified the Yamada cartridge using the soda pop bottle sealing mechanisms of King or Strassheimer to prevent a leakage problem that the Yamada cartridge did not have.

I dissent for a second , ind ependent reason . T he Board found the claims obvious without resolving the level of skill in the art

. Oral Arg ument at 24:59

– 25:31
, available
at http://oralarguments.cafc.uscourts.gov/default.aspx?fl= 2013

- 1219.mp3

. I t is axiomatic that this is a “ basic f act ual inquir[y]” required of any obviousness determination. Graham v. John Deere Co. , 383 U.S. 1, 17 (1966). In most cases, there is no dispute over the level of the skilled artisan. But in this case, t he parties contested this fact ual issue throughout the proceedings

, and inexplicably the Board never resolved it. Oral Argument at 19:57

– 20:32, 23:21

– 23:56 , 24:59

– 25:31

. The parties still dispute this issue on appeal. Compare Appellant’s Br. 21 (“A chemistSCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 5

analyzing organic compounds would no t look to soda

- pop bottles to solve problems with flash chromatography cartridges

. ”) (emphasis added)

, with Appellee’s Br. 28

– 29 ( “SPP[] mischaracterizes the relevant person of ordinary skill to whom knowledge of analogous art would be a ttributable . . . . [T] he relevant person of ordinary skill in the art . . . would include a designer . . . skilled in mecha nical engineering .”) (emphasis added)

. The Board’s failure to make this determination is e specially pernicious wh ere the analogous art question is f ar from clear. Soda pop bottles and methods for using chr omatography cartridges are clearly not in the same field of endeavor

. Instead, t he dispute on appeal is whether the soda pop bottle references are both reasonably pertinent to the inventors ’ proble m. Maj. Op. at 6

– 7; s ee also In re Oetiker , 977 F.2d 1443, 1447 (Fed. Cir. 1992)

. “Reason ably pertinent” means “which fields a person of ordinary skill would reasonably be expected to look for a solution to the problem facing the inventor.” Oetiker , 977 F.2d at 1447 (emphasis added). An ordinarily skilled chemist would have likely look ed to a different body of prior art than an ordinarily skilled mechanical engineer with industrial design experience. Even Biotage recognizes that the determination of the person of ordinary skill is inextricably linked to what art would have be en anal ogous. Oral Argument at 25:31

– 25:43. W e cannot an swer the analogous art question without knowing who the person of ordinary skill is

. I would reverse because I conclud e that the Board’s cancellation of the claims at issue was based entirely on hindsight reconstruction —there is no record evidence that one of skill in the art would have been motivated to modify Yamada with soda pop bottle sealing closures. And the Board cannot transfer the inventors’ identific ation of the motivation for their patented design to the skilled artisan when there is no record evidence that theSCIENTIFIC PLASTIC P RODUCTS v. BIOTAGE AB 6

skilled artisan possessed that knowledge. Finally, where the level of ordinary skill , as here, is ho tly contested and would affect the scope of the analogous art , the Board must decide that factual issue. I respectfully dissent

.