Fighting Obviousness Rejections: Unexpected Results

When an invention possesses or provides unexpected results, this is often sufficient to show the invention is not obvious.

The case of Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293 (Fed. Cir. 2015) demonstrates this principle. Allergen sued Sandoz among others alleging infringement of five patents directed a drug and treatment for glaucoma. The defendants asserted that the patents were invalid. Each of the asserted claims required a composition comprising 0.01% bimatoprost and 200 ppm benzalkonium chloride (BAK)

Prior treatments for glaucoma included using .03% bimatoprost and 50 ppm BAK. Prior art U.S. Patent 5,688,819 (Woodward) reference disclosed a composition comprising 0.001% to 1% bimatoprost and 0 to 1000 ppm of preservative, including BAK.

Therefore Woodward disclosed a range that covered the claimed composition. When that occurs the question is whether there would have been a motivation to select the claimed composition from the prior art ranges.

The court found that the prior art taught that BAK should be minimized in ophthalmic formations to avoid safety problems.  BAK was known to cause increased IOP, hyperemia, dry eye, and damage to corneal cells, and to exacerbate other eye disorders. Therefore the prior art taught away from increasing BAK from 50 ppm to 200 pmm.

Further, the prior art taught that 200 ppm BAK would either have no impact on permeability of bimatoprost or decrease it. But Allergan’s inventors surprisingly determined that the opposite was true, 200 ppm BAK enhanced the permeability of the bimatoprost. The court concluded that his unexpected difference in kind supported nonobviousness of the claimed invention.

Moreover, the court found that the prior art taught that reducing bimatoprost from 0.03% to 0.01% resulted in reduced efficiency, but did not reduce red eye (hyperemia). However, the claimed, which comprises 0.01% bimatoprost and 200 ppm BAK, formulation unexpectedly maintained the IOP-lowering efficacy of Lumigan 0.03% (Allergen’s prior product), while exhibiting reduced incidence and severity of hyperemia (red eye), even though the prior art taught that BAK could cause hyperemia at high concentrations.

The court concluded that the results of the claimed formulation constituted an unexpected difference in kind, that is, “the difference between an effective and safe drug and one with significant side effects that caused many patients to discontinue treatment.” These unexpected results supported the conclusion that the challenged patent claims were not obvious in view of the prior art.

Therefore, when facing an obviousness rejection or challenge, look to see if you can show that the invention possesses or provides unexpected results in the art.

The five patents asserted in this case are: U.S. Patents 7,851,504, 8,278,353, 8,299,118, 8,309,605, and 8,338,479.

Fighting Obviousness Rejections: Invention Proceeds Contrary to Accepted Wisdom in The Art

When an invention proceeds contrary to the accepted wisdom in the prior art, this is a strong indication that the invention is not obvious in view of the prior art.

The case of W.L. Gore & Assocs. v. Garlock, Inc., 721 F.2d 1540, 1552 (Fed. Cir. 1983) demonstrates this principle. This is an old case from 1983, but the principle discussed today from the case is still valid. W.L. Gore & Associates (Gore) sued Garlock for infringing claims 3 and 19 of U.S. Patent 3,953,566 (the ‘566 patent).  The ‘566 patent was directed to a method of making high crystalline polytetrafluorethylene (PTFE), such as might be used as tape. PTFE is known by the trademark TEFLON. PTFE tape had been sold as thread seal tape, i.e., tape used to keep pipe joints from leaking.

Dr. Gore of W.L. Gore & Associates experienced unsintered PTFE tape breakage problems in its tape stretching machine. Dr. Gore Experimented with heating and stretching of high crystalline PTFE rods. But the rods broke even when slowly and carefully stretching them a relatively small amount.

The conventional wisdom in the art taught that breakage could be avoided only by slowing the stretch rate or by decreasing the crystalline content. But contrary to this teaching, Dr. Gore discovered that stretching the PTFE rods as fast as possible enabled him to stretch them to more than ten times their original length with no breakage. Further, the rod diameter remained about the same through out the length and the rapid stretching transformed the the hard, shiny rods into rods of a soft, flexible material. 

Ultimately, the appeals court concluded that claims 3 and 19 of the ‘566 patent were not obvious because Dr. Gore’s invention for making high crystalline PTFE proceeded contrary to accepted wisdom in the art.

If you can establish that your invention proceeds contrary to the accepted wisdom in the relevant art, then an obviousness rejection may be overcome on that basis.

Fighting Obviousness Rejections: Proposed Modification Would Make Inoperable for Intended Purpose

When the USPTO rejects patent claims to an invention as being obvious, it often combines two or more prior art references to make the rejection. The rejection may be improper if the combination proposed by the USPTO renders the prior art reference being modified inoperable for its intended purpose.

The case of Plas-Pak Indus. v. Sulzer Mixpac AG, 600 Fed. Appx. 755 (Fed. Cir 2015) provides an example of this principle (it also discloses another basis to challenge an obviousness rejection). Sulzer asserted that claims of Plas-Pak’s US Patent 7,815,384 (“Plas-Pak’s Patent”) were obvious in view of a combination of two references, U.S. Patent 6,241,125 (“Jacobsen”) and U.S. Patent Publication 2002/0170982 (“Hunter”). Plas-Pak’s Patent was directed to a device and method for mixing and dispensing multi-component paints.

Jacobsen discloses a device that dispenses fluid materials into a surface crack so as to minimize leakage. Sulzer proposed to modify the device of Jacobsen to include the spray nozzle from Hunter. 

But the court found that the spray nozzle of Hunter would not obtain the objective of dispensing fluid materials into a  surface crack so as to minimize leakage. 

The court noted that Jacobsen’s dispensing system, partially shown in figure 9 below, has the very “specific function of dispensing fluid materials directly into surface cracks to minimize leakage.” The court found that Jacobsen’s repeatedly recites this limited purpose. Further, Jacobsen did not teach how a spray nozzle might accomplish the “intended purpose” of “dispensing fluid materials directly into cracks.”

Therefore the court concluded that modifying Jacobsen to accommodate the spray nozzle of Hunter would render Jacobsen “inoperable for its intended purpose,” and a person of ordinary skill would thus not have been motivated to pursue the combination. As a result, the court concluded that the challenged claims of Plas-Pak’s patent were not obvious.

When an obviousness rejection is received, you must closely study the modified reference to determine whether the proposed modification would render it inoperable for its intended purpose. If it would, then the rejection may be improper and can be overcome on that basis.

Fighting Obviousness Rejections: Proposed Combination Changes Principle Operation of the Reference

When the USPTO rejects patent claims to an invention as being obvious, it often combines two or more prior art references to make the rejection. The rejection may be improper if the combination proposed by the USPTO changes the principle operation of the prior art reference being modified.

The case of Plas-Pak Indus. v. Sulzer Mixpac AG, 600 Fed. Appx. 755 (Fed. Cir 2015) provides an example of this principle. Sulzer asserted that the claims of Plas-Pak’s US Patent 7,815,384 (“Plas-Pak’s Patent”) were obvious in view of a combination of two references, U.S. Patent 4,745,011 (“Fukuta”) and U.S. Patent 3,989,228 (“Morris”). The Plas-Pak’s Patent was directed to a device and method for mixing and dispensing multi-component paints.

Fukuta disclosed a device for mixing two-component coatings but did not disclose two cylindrical cartridges and a mixing gun that were claimed in Plas-Pak’s patent. Morris disclosed two cylindrical cartridges and a mixing gun.

Sulzer proposed to replace Fukuta’s pumps, check valves, stop vales, and escape valves with the two cylindrical cartridges and a mixing gun of Morris. But, the court found that removing those pumps and valves would alter the principle operation of Fukuta. The pumps and valves where essential to the principle operation of Fukuta, which was to prevent back-flow even when the propensity for backflow occurs repeatedly and at high velocity. Fukuta was rife with statement defining the invention as adding stop valves to prevent backflow.

The court concluded that the claims of Plas-Pak’s patent were not obvious because the proposed modification of Fukuta would change its principle operation. A change in the principle operation “is unlikely to motivate a person of ordinary skill to pursue a combination with that reference.”

Therefore, when an obviousness rejection is received, you must closely study the modified reference to determine whether the proposed modification would change its principle operation. If it would, then the rejection may be improper and can be overcome on that basis.

Overcoming Obviousness Rejections: Prior Art Teaching Away From Combination

When the USPTO rejects patent claims based on alleged obviousness, it often combines two or more prior art references to make the rejection. This combination may be challenged if one of the prior art references teaches away from the proposed combination.

For an example of this principle, consider the case of Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1328 (Fed. Cir. 2009). There, Depuy Spine sued Medtronic Sofamor Danek for infringement of U.S. Patent No. 5,207,678 (“the ‘678 patent”). The ‘678 patent is directed to a pedicle screw used in spinal surgeries. A jury determined that Medtronic infringed the patent and awarded $149.1 million in lost profits damages for the sale of pedicle screws.

As a defense, Medtronic argued that the asserted claims of the ‘678 patent were invalid as obvious over the combination of two references U.S. Patent No. 5,474,555 (“Puno”) and U.S. Patent No. 2,346,346 (“Anderson”). But, the court found that Puno taught away from the proposed combination and therefore the challenged claim was not obvious over the combination of references.

The court noted, “A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” The court further said, “An inference of nonobviousness is especially strong where the prior art’s teachings undermine the very reason being proffered as to why a person of ordinary skill would have combined the known elements.”

Puno disclosed a polyaxial pedicle screw assembly that had all of the parts of the relevant claim except a “compression member” for pressing the screw head 30 against the receiver member 23. But Puno described that its design achieved a “shock absorber” effect allowing for some motion between the anchor seat 23 and the vertebrae (see fig. 7 below). The lack of a compression member allowed the shock absorber effect. Puno described that the shock absorber effect “prevent[s] direct transfer of load from the rod to the bone-screw interface prior to achieving bony fusion, thereby decreasing the chance of failure of the screw or the bone-screw interface.” 

Therefore, Puno taught away from the use of a compression member, which would have increased rigidity, decreased the shock absorber effect, and possibly increased the chance of failure of the screw or the bone-screw interface according to Puno. The court concluded, due to the teaching away, a person of ordinary skill would have been deterred from combining Puno and Anderson in the manner that Medtronic proposed. As a result, the challenged claim of the ‘678 patent was not invalid as obvious and the infringement judgement was upheld. 

When receiving an obviousness rejection, the cited references relied on in the rejection should be studied to determine whether they teach away from the combination. If there is such as teaching away, then a response may be filed with the USPTO arguing against the obviousness rejection on that basis.

Is The Invention Obvious?

In order to obtain a patent on an invention, the invention must not be obvious in view of the prior art. This requirement is provided in 35 USC 103, which states:

A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.

Obviousness determinations require a multifaceted consideration of the invention and the prior art.

The framework for obviousness determinations is provided by the Supreme Court in Graham v. John Deere Co., 383 U.S. 1 (1966). When considering obviousness one must (1) determine the scope and content of the prior art, (2) ascertain differences between the prior art and the claims at issue (the claimed invention), and (3) resolved the level of ordinary skill in the pertinent art. Obviousness or nonobviousness of the invention is determined against this framework.

Further, the USPTO fact finder must provide a rationale of why the invention is obvious. The Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415-421 (2007) made it easier for the USPTO to reject inventions as obvious. Prior to KSR, one could argue that an obviousness rejection was inproper if there was not teaching, suggestion, or motiviation to combine the prior art references. But, the court said “The obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion, and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents.” This opened the door to the use of additional rationales and evidence to support an obviousness rejection. And, this made life harder for some patent applicants.

After KSR, the USPTO reviewed several court cases and attempted to distill possible non-limiting example rationales that could support an obviousness determination. Therefore, even if there was no teaching, motivation, or suggestion, the patent examiner might be able to rely on the following other rationales:

  1. Combining prior art elements according to known methods to yield predictable results;
  2. Simple substitution of one known element for another to obtain predictable results;
  3. Use of known technique to improve similar devices, methods, or products in the same way;
  4. Applying a known technique to a known device, method, or product ready for improvement to yield predictable results;
  5. Choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; or
  6. Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. [MPEP 2143]

These rationales all rely on the predictability of the results of combining references. If the proposed combination would not have been recognized by one skilled in the art to produce predictable results, then these rationales should not apply.

Further, if one takes the example rationales of MPEP 2143 and considers them broadly it is possible that one could conclude that many patentable inventions are actually unpatentably obvious. However, you can’t take the rationales at face value because there are a host of rebuttal circumstances or circumstances where some of rationales don’t apply or would be applied only narrowly. In other words, don’t over generalize the MPEP 2143 rationales and conclude your invention is obvious.

For example, the following circumstances may prevent the combination of references in an obviousness rejection:

  1. one of the references teaches away from the combination of the other references,
  2. the proposed modification or combination will render the reference being modified unsatisfactory for its intended purpose,
  3. the proposed modification would change the principle operation of the prior art invention being modified, or
  4. the invention proceeds contrary to accepted wisdom in the art.

[See In re Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983), MPEP 2145(X)(D); In re Gordon, 733 F.2d 900 (Fed. Cir. 1984); MPEP 2143(V); In re Ratti, 270 F.2d 810, 813 (CCPA 1959); MPEP 2143(VI); In re Hedges, 783 F.2d 1038 (Fed. Cir. 1986); MPEP 2145(X)(D)(3).]

But these are just a few examples.

Further, the USPTO’s rationale for combining prior art references in an obviousness rejection must have an adequate evidentiary basis and there must be a connection between the rationale and the motivation to combine references in the obviousness rejection. In re NuVasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir. 2016); MPEP 2143. If the USPTO fails to meet these requirements the obviousness rejection can be improper.

In addition, so-called “secondary considerations” can be important to show nonobviousness. Secondary considerations may include: (1) commercial success of the claimed invention, (2) a long felt but unsolved need, or (3) failure of others.

As you can see there are several factors and elements to consider when attempting to establish obviousness or rebut it. And, the USPTO, district courts, and appeal courts, often disagree about whether a particular invention is obvious. For example, in Novartis AG v. Noven Pharmaceuticals Inc., 853 F. 3d 1289 (Fed. Cir. 2017), the PTAB of the USPTO found the challenged claims of U.S. Patent Nos. 6,316,023 and 6,335,031 were invalid as obvious. But, based on the same evidence, a prior District court found the claims of same patents were not obvious. The different results for the same patents on the same evidence were due in part to the different standards used by the PTAB and the district court. However, these varying results say something about the difficulty in applying and predicting whether an invention is obvious.

Nevertheless, obviousness of an invention can be assessed before a patent application is filed, usually after a patent novelty search is performed. And there are several possible angles for overcoming obviousness rejections at the USPTO.

Teaching Away Requires Clear Discouragement to Counter Obviousness

US6673532_Fig1Presense Persuasion Sensing petitioned the USPTO to reexamine (invalidate) certain claims of U.S. Patent 6,673,532 (the ‘532 patent) directed to methods of measuring parameters in a cell culture. The USPTO rejected the challenged claims of the ‘532 patent as obvious in view of a combination of two references, which I will refer to as “Bamboo” and “Weigl.”

University of Maryland Biotechnology Institute (Maryland), which owns the ‘532 patent, argued that Bamboo and Weigl should not be combined because Weigl teaches away from the claimed invention. Maryland  alleged that Weigl taught away because “(1) Weigl’s carbon dioxide sensor is unstable; (2) each of Weigl’s flow-through units has only one sensor, not multiple sensors; (3) Weigl’s various outlets are inconsistent with the claimed invention’s ‘continuous volume’ limitation; and (4) Weigl’s device is “invasive” because it requires extra-vessel sensors.”

The court rejected these arguments on appeal. University of Maryland Biotechnology Institute v. Presens Precision Sensing GMBH, Nos. 2016-2745, 2017-1075 (Fed. Cir. 2017). The court found that Maryland’s teaching away arguments focused too narrowly on Weigl’s physical arrangement.

The court said, the “mere disclosure of alternative designs does not teach away.” Instead, “teaching away requires ‘clear discouragement’ from implementing the technical feature.” And the court found no clear discouragement.

When a reference teaches away from the proposed combination, such a teaching would discourage one skilled in the art from making the combination.

Therefore, teaching away is a good argument for defending against an obviousness claim. However, usually the teaching away needs to be quite explicit in the reference for the argument to have traction.

Applying Computer and Internet Technology to Replace Older Electronics is Commonplace, Fed. Cir. Says

US20060218618A1_Fig 1Joseph Lorkovic filed a patent application directed to a home entertainment content delivery system for interactive content dissemination over the internet. The USPTO rejected Lorkovic’s claims as obvious based on a combination of U.S. Patent 5,918,012 (“Astiz”) in view of U.S. Publication 2005/0229233 (“Zimmerman”). Lorkovic claimed Astiz and Zimmerman could not be combined because the web browsing functionality in Astiz was not compatible with the analog based Zimmerman device.

The appeals court rejected this argument in In Re Lorkovic, No. 2017-1678 (Fed. Cir. 2017). The court stated, “We have previously observed that ‘applying computer and internet technology to replace older electronics has been commonplace in recent years’ and found obviousness in reliance on that observation.” citing W. Union Co. v. MoneyGram Payment Sys., Inc., 626 F.3d 1361, 1370 (Fed. Cir. 2010).

Obviousness determinations are hard to predict. However, when considering the patentability of an invention, it is important not to think too narrowly about whether prior art devices would be compatible or physically combine-able. But rather consider what would one skilled in the art would understand from the prior art device or disclosure in light of current state of the art at the time of application filing.