In University of Strathclyde v. Clear-Vu Lighting LLC, [2020-2243], (November 4, 2021) the Federal Circuit reversed the PTAB’s determination holding unpatentable as obvious claims 1-4 of U.S. Patent No. 9,839,706, directed to photoinactivation of Methicillin-resistant Staphylococcus aureus (MRSA), and other Gram-positive bacteria, without using a photosensitizing agent.

The Board determined that claims 1 and 3 of the ’706 patent would have been obvious over Ashkenazi in view of Nitzan, and that claims 2 and 4 would have been obvious in further view of Jones. The Board found that Ashkenazi and Nitzan teach or suggest all the limitations of claims 1 and 3,” and that a person of ordinary skill in the art would have been motivated to combine these two references and “would have had a reasonable expectation of successfully doing so.

On appeal, Strathclyde challenges the Board’s obviousness determination, arguing that the Board erred in finding that the combination of Ashkenazi and Nitzan teaches inactivating one or more Gram-positive bacteria without using a photosensitizer. It also asserts that the Board’s
finding of a reasonable expectation of success is not supported by substantial evidence. Whether the prior art discloses a claim limitation, whether a skilled artisan would have been motivated to modify or combine teachings in the prior art, and whether she would have had a reasonable expectation of success in doing so are questions of fact.

The Federal Circuit said that both parties agreed that most of the limitations found in claims 1 and 3 are disclosed by Ashkenazi or Nitzan, and that the only dispute is whether these references teach inactivating one of the claimed Gram-positive bacteria without using a photosensitizer. The Federal Circuit found that the Board’s finding that this was taught by the combination of Ashkenazi and Nitzan is not supported by substantial evidence. The Federal Circuit said that all of Ashkenazi’s P. acnes cultures were grown in the presence of a photosensitizer—either riboflavin alone, or riboflavin together with ALA. The Federal Circuti found nothing in Ashkenazi that discloses or suggests inactivating P. acnes, or any other bacteria, without using a photosensitizer.

The Federal Circuit noted that while Nitzan provides an example in which MRSA and other bacteria were exposed to blue light without ALA or any other photosensitizer, there is no evidence that Nitzan successfully achieved inactivation under this condition. The Federaal Circuit noted that in finding that Nitzan did not anticipate claims 1 and 3, the Board found Clear-Vu failed to establish that Nitzan’s non-ALA MRSA demonstrated “inactivation” as required by the claims.

The Federal Circuit said that given neither Ashkenazi nor Nitzan teaches or suggests inactivation of any bacteria without using a photosensitizer, it failed to see why a skilled artisan would opt to entirely omit a photosensitizer when combining these references. The Federal Circuit said that the Board articulated no rational basis—and it could discern none—for combining Ashkenazi’s P. acnes experiments, which at all times used a photosensitizer, with Nitzan’s non-ALA MRSA experiment, which did not achieve inactivation, to arrive at an embodiment in which MRSA is inactivated by exposing it to 407–420 nm blue light without
using a photosensitizer.

On this record, the Federal Circuit concluded that no reasonable fact finder could have found that the combination of Ashkenazi and Nitzan discloses inactivating one or more Gram-positive bacteria without using a photosensitizer.

Regarding whether there was a reasonable expection of success, the Federal Circuit disagreed with the Board’s finding that a skilled artisan would have expected that MRSA could be inactivated by blue light without using a photosensitizer due to the presence of at least some amount of naturally produced porphyrin in the bacteria. The Federal Circuit said that the only suport for the finding was “pure conjecture coupled with hindsight reliance on the teachings in the [challenged patent].”

The Federal Circuit said that the Board, relying on Ashkenazi’s teaching that “blue light may” inactivate “other bacterial cells that produce porphyrins,” reasoned that because light-activated
porphyrin molecules were shown in Ashkenazi to cause inactivation for P. acnes (even though Ashkenazi’s experiments applied a photosensitizer), the fact that MRSA has some level of endogenous porphyrin suggests to a skilled artisan that MRSA, too, would exhibit some amount of inactivation after exposure to 407–420 nm blue light. But, the Federal Circuit said that there is simply no evidence of record at the time of the ’706 patent to support this assumption. The Federal Circuit said that the evidence of record—Nitzan and an earlier publication by Nitzan, showed the opposite. The data Dr. Nitzan reported would have indicated to a person of ordinary skill in the art that those natural levels are insufficient to inactivate MRSA using 407–420 nm blue light without also using a photosensitizer.

Thus, the Federal Citcuit found, not only is there a complete lack of evidence in the record that any bacteria were inactivated after exposure to 407–420 nm blue light without using a photosensitizer, there is also evidence showing that others had failed to inactivate MRSA—one of the claimed Gram-positive bacteria— without using a photosensitizer, despite experimenting with different light doses and different wavelength ranges of blue light.

The Federal Circuit raffirmed that absolute predictability of success is not required, only a reasonable expectation. Howver in the present case, where the prior art evidences only failures to achieve that at which the inventors succeeded, no reasonable fact finder could find an expectation of success based on the teachings of that same prior art.

In Becton, Dickinson and Company v. Baxter Corporation Englewood, [2020-1937] (May 28, 2021), the Federal Circuit reversed that PTAB determination that certain claims of U.S. Patent No. 8,554,579 were not invalid as obvious. The’579 Patent is directed to systems for preparing patient-specific doses and a telepharmacy method in which data captured while following a protocol associated with each received drug order and specifying a set of steps to fill the drug order are provided to a remote site for review and approval by a pharmacist.

At issue was whether the art disclosed a verification step. Baxter successfully argued to the PTAB that the art taught that there may be a verification step, but not that there must be a verification step. The Federal Circuit concluded that the Board’s determination was not supported by substantial evidence. The Federal Circuit said that in the context of the prior art, “may” does not mean “occasionally,” but rather that one “may” choose to systematically check each step. Examining the reference, the Federal Circuit concluded that the purpose was to provide verification, and thus it satisfied the verification step.

Also at issue was whether the art diclosed the highlighting limitation, which requires “an interactive screen that includes prompts that can be highlighted by an operator to receive additional information relative to one particular step.” The Federal Circuit found that one of the references teaches highlighting in the pharmacy context, and said that the Board erred in looking to the reference as the only source a person of ordinary skill would consider for what “additional information might be relevant. A person of ordinary skill is also a person of ordinary creativity, not an automaton.

Finally, the Federal Circuit said that Baxter does not meaningfully argue that the weak showing of secondary considerations here could overcome the showing of obviousness based on the prior art.

Obviousness may not be established using hindsight or in view of the teachings or suggestions of the inventor. Para-Ordnance Mfg., Inc. v. SGS Importers Int’l, Inc., 73 F.3d 1085, 1087, 37 U.S.P.Q.2d 1237, 1239 (Fed. Cir. 1995), citing W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1551, 1553, 220 USPQ 303, 311, 312-13 (Fed.Cir.1983), cert. denied, 469 U.S. 851, 105 S.Ct. 172, 83 L.Ed.2d 107 (1984).

Hindsight is inherent in the patent examination process. Examiner’s look at what the inventor claims, and with this information look for prior art to determine whether or not the claimed invention is obvious, flirting with “tempting but forbidden zone of hindsight.” See, Loctite Corp. v. Ultraseal Ltd., 781 F.2d 861, 873, 228 USPQ 90, 98 (Fed.Cir.1985). The problem of hindsight is exacerbated by modern search technology which allows Examiner to quickly and easily find each and every element of the claimed invention, and all that the is needed is to stitch the individual elements together. Patent law has developed several tools to combat hindsight. First, 35 USC 103 requires obviousness of the invention “as a whole,” so merely finding the elements individually in the prior art does not mean that the invention was obvious. Ruiz v. A.B. Chance Co., 357 F.3d 1270, 69 U.S.P.Q.2d 1686 (Fed. Cir. 2004). Second, there is the requirement that there be some reason to modify or combine the prior art. Ruiz v. A.B. Chance Co., 357 F.3d 1270, 69 U.S.P.Q.2d 1686 (Fed. Cir. 2004). Without some reason the modification/combination is not obvious, and neither is the invention. Finally, there are objective indicia of non-obvious, often called “secondary considerations,” that guard against the hindsight reconstruction of the invention. See, In re Sernaker, 702 F.2d 989, 996, 217 USPQ 1, 7 (Fed.Cir.1983).

When confronted with a hindsight reconstruction, there are a number of colorful descriptions of hindsight that can help frame the argument:

Using the Claims as a Frame, and the Prior Art as a Mosaic. In W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1551, 1553, 220 USPQ 303, 311, 312-13 (Fed.Cir.1983), the Federal Circuit reversed the district court’s finding of obviousness, noting that “[t]he result is that the claims were used as a frame, and individual, naked parts of separate prior art references were employed as a mosaic to recreate a facsimile of the claimed invention.”  721 F.2d at  1551, 220 USPQ at 311.

Using What the Inventor Taught Against its Teacher. Also in W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1551, 1553, 220 USPQ 303, 311, 312-13 (Fed.Cir.1983), in reversing the district court’s finding of obviousness, the Federal Circuit explained the problem of hindsight: “To imbue one of ordinary skill in the art with knowledge of the invention in suit, when no prior art reference or references of record convey or suggest that knowledge, is to fall victim to the insidious effect of a hindsight syndrome wherein that which only the inventor taught is used against its teacher.” 721 F.2d at  1553, 220 USPQ at 312-13.

Throwing Metaphorical Darts at a Metaphorical Dartboard. In re Kubin, 561 F.3d 1351, 90 U.S.P.Q.2d 1417 (Fed. Cir. 2009), in affirming a finding of obviousness, the Federal Circuit cautioned that in the situation where a challenger, “merely throws metaphorical darts at a board filled with combinatorial prior art possibilities, courts should not succumb to hindsight claims of obviousness.” See, also, Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 107 U.S.P.Q.2d 1943 (Fed. Cir. 2013); In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.(Eurand, Inc. v. Mylan Pharm., Inc.), 676 F.3d 1063, 102 U.S.P.Q.2d 1760 (Fed. Cir. 2012).

Collapsing the Obviousness Analysis into a Hindsight-Guided Combination. In Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 107 U.S.P.Q.2d 1943 (Fed. Cir. 2013), the Federal Circuit reversed the obviousness determination in a reexamination, finding that “the Board erred by collapsing the obviousness analysis into a hindsight-guided combination of elements.”

A Hindsight Combination of Components Selectively Culled from the Prior Art to fit the Parameters of the Invention. In ATD Corp. v. Lydall, Inc., 159 F.3d 534 , 546 (Fed. Cir. 1998), the Federal Circuit reversed a judgment of invalidity, stating “Determination of obviousness can not be based on the hindsight combination of components selectively culled from the prior art to fit the parameters of the patented invention. There must be a teaching or suggestion within the prior art, or within the general knowledge of a person of ordinary skill in the field of the invention, to look to particular sources of information, to select particular elements, and to combine them in the way they were combined by the inventor.”

Using the Inventor’s Disclosure as a Blueprint. In Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 227 U.S.P.Q. 543 (Fed. Cir.1985), the Federal Circuit vacated the district court’s summary judgment of invalidity, noting that the court reconstructed the invention, using the blueprint of the inventor’s claims, and saying [t]he invention must be viewed not with the blueprint drawn by the inventor, but in the state of the art that existed at the time.” See, also, In re Dembiczak, 175 F.3d 994, 50 U.S.P.Q.2d 1614 (Fed. Cir. 1999); Ecolochem, Inc. v. So. Cal. Edison Co., 227 F.3d 1361, 1371-72 (Fed.Cir.2000);

A Poster Child for Impermissible Hindsight Reasoning. In Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 102 U.S.P.Q.2d 1729 (Fed. Cir.2012), in affirming the district court’s determination that the claims were not invalid, the Federal Circuit noted that the district court’s careful analysis exposed the Defendants’ obviousness case for what it was — “a poster child for impermissible hindsight reasoning.”

Simplicity is not inimical to patentability. In re Oetiker, 977 F.2d 1443, 24 U.S.P.Q.2d 1443, citing Goodyear Tire & Rubber Co. v. Ray-O-Vac Co., 321 U.S. 275, 279, 64 S.Ct. 593, 594, 88 L.Ed. 721 (1944) (simplicity of itself does not negate invention); Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1572, 1 USPQ2d 1593, 1600 (Fed.Cir.) (the patent system is not foreclosed to those who make simple inventions), cert. denied, 481 U.S. 1052, 107 S.Ct. 2187, 95 L.Ed.2d 843 (1987). Roberts v. Sears, Roebuck, Co., 723 F.2d 1324, 1334, 221 U.S.P.Q. 504 (7th Cir. 1983)(“[I]ntuitive analysis distorted by the invention’s simplicity and retrospective self-evidence must be avoided. Simplicity is not to be equated with obviousness.”); Chore-Time Equip., Inc. v. Cumberland Corp., 713 F.2d 774, 218 U.S.P.Q. 673 (Fed.Cir. 1983)(“That is not to say that simplicity of the invention, or its ready understandability by a judge, constitute evidence of obviousness.”) 

In DatCard Sys., Inc. v. PacsGear, Inc., No. 8:10-cv-01288-MRP, 2013 BL 440221 (C.D.Cal. Mar. 12, 2013), the district court said:

To be sure, the Court’s characterization of the patents-in-suit as “simple” is hardly a clue regarding its opinion regarding their validity under, for example, Section 103 . Patent law lacks a doctrine of simplicity. To be sure, as a matter of logic, technically simple patents are perhaps more vulnerable to obviousness-based invalidity than technically complex patents. But they are not obvious because they are technically simple.

(emphasis added)

But, see, Skee-Trainer, Inc. v. Garelick Mfg. Co., 361 F.2d 895, 150 U.S.P.Q. 7 (8th Cir. 1966)(“[A]lthough the simplicity of a mechanical innovation will not automatically render it unpatentable, simplicity is itself strong evidence that ‘invention’ is lacking.”)

In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 , 416 , 127 S. Ct. 1727 , 167 L. Ed. 2d 705 (2007), the Supreme Court cemented the role of common sense in the obviousness inquiry, noting that “[r]igid preventative rules that deny factfinders recourse to common sense, however, are neither necessary under our case law nor consistent with it.” The Supreme Court instructed that “[c]ommon sense teaches, however, that familiar items may have obvious uses beyond their primary purposes, and in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Thus the Supreme Court said that:

When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.

550 U.S. at 421; 127 S.Ct. at 1742; 167 L.Ed.2d at 723-4.

After KSR, the Federal Circuit has affirmed the application of common sense in a number of cases. In B/E Aerospace, Inc. v. C&D Zodiac, Inc, 962 F.3d 1373, 1379-80, 2020 U.S.P.Q.2d 10706 (Fed.Cir. 2020), the Federal Circuit affirmed the PTAB’s determination of obviousness of U.S. Patent Nos. 9,073 ,641 and 9,440,742 relating to space-saving technologies for aircraft enclosures such as lavatory enclosures, agreeing with the PTAB that it would have been a matter common sense to modify the prior art. In Perfect Web Techs., Inc. v. Infousa, Inc., 587 F.3d 1324, 92 U.S.P.Q.2d 1849, (Fed. Cir. 2009), the Federal Circuit affirmed summary judgment of invalidity of U.S. Patent No. 6,631,400 directed to managing bulk e-mail distribution to groups of targeted consumers, affirming the district court application of common sense and noting that common sense has long been recognized to inform the analysis of obviousness if explained with sufficient reasoning. In Koninklijke Philips N.V. v. Google LLC, 948 F.3d 1330, 2020 U.S.P.Q.2d 32509 (Fed.Cir. 2020), the Federal Circuit affirmed a PTAB decision that relied on common sense to supply a missing claim element, where corroborated expert testimony established that that element was not only in the prior art, but also within the general knowledge of a skilled artisan.

Of course, what is important to prosecutors is combatting the misapplication of common sense in the obviousness inquiry. That is what happened in Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 119 U.S.P.Q.2d 1822 (Fed. Cir. 2016) where the Federal Circuit reversed the PTAB determination that challenged claims of U.S. Patent No. 7,917,843 were obvious, because the Board misapplied the law on the permissible use of common sense in an obviousness analysis. The Federal Circuit identified at least three caveats to note in applying “common sense” in an obviousness analysis: First, common sense is typically invoked to provide a known motivation to combine, not to supply a missing claim limitation. Second, as in Perfect Web, when common sense is invoked to supply a limitation that was admittedly missing from the prior art, the limitation in question must be unusually simple and the technology particularly straightforward. Third, references to “common sense”—whether to supply a motivation to combine or a missing limitation—cannot be used as a wholesale substitute for reasoned analysis and evidentiary support, especially when dealing with a limitation missing from the prior art references specified.  The Federal Circuit said that the Board relied upon conclusory statements and unspecific expert testimony in drawing its conclusion that the invention would have been “common sense.” Because the application of “common sense” was conclusory and unsupported by substantial evidence, the missing limitation was not a “peripheral” one, and there was nothing in the record to support the Board’s conclusion that supplying the missing limitation would be obvious to one of skill in the art, the Federal Circuit reversed the Board’s finding of unpatentability.

In DSS Tech. Mgmt., Inc. v. Apple Inc., 885 F.3d 1367, 126 U.S.P.Q.2d 1084 (Fed. Cir.2018), the Federal Circuit reversed the PTAB’s determination that the challenged claims of U.S. Patent No. 6,218,290 were invalid for obviousness, because the Board did not provide a sufficient explanation for its conclusions, and because it could not glean any such explanation from the record.

The PTAB invoked the “ordinary creativity” which the Federal Circuit said was no different from the reference to “common sense” that it considered in Arendi. The Board relied on a gap-filler—”ordinary creativity” instead of “common sense”—to supply a missing claim limitation. The Federal Circuit said that in cases in which “common sense” is used to supply a missing limitation, as distinct from a motivation to combine, the search for a reasoned basis for resort to common sense must be searching. The Federal Circuit said that the Board’s reliance on “ordinary creativity” calls for the same “searching” inquiry. The Federal Circuit found that the Board’s decision did not satisfy the standard set forth in Arendi. The full extent of the Board’s analysis is contained in a single paragraph. In reaching its conclusion that the missing element would have been obviousness, the Board made no citation to the record, referring instead to the “ordinary creativity” of the skilled artisan. This was not enough to satisfy the Arendi standard.

In re Van Os, 844 F.3d 1359, 121 U.S.P.Q.2d 1209 (Fed. Cir. 2017), the Federal Circuit vacated and remanded the PTAB affirmance of the Examiner’s rejection of Van Os’ claims. The Federal Circuit said that it has repeatedly explained that obviousness findings grounded in “common sense” must contain explicit and clear reasoning providing some rational underpinning why common sense compels a finding of obviousness. ” The Federal Circuit said that “[a]bsent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.'” The Federal Circuit concluded that “Such a conclusory assertion with no explanation is inadequate to support a finding that there would have been a motivation to combine. This type of finding, without more, tracks the ex post reasoning KSR warned of and fails to identify any actual reason why a skilled artisan would have combined the elements in the manner claimed.”

When faced with an obviousness rejection based upon “common sense” or “ordinary creativity” or “intuition,” it is important to note that these are not a substitute for reasoned analysis and evidentiary support. This is especially true when dealing with a limitation missing from the prior art references specified. Demand this reasoned analysis where it is lacking.