They Invented What? (No. 53)

U.S. Pat. No. 5,329,672:  Metal wire paper clip structure.

JW Note:  The paper clip – patented in 1994.  Many thanks to Michael Barclay at WSGR for bringing this one (and many others) to our attention! 

  

We claim:

1. A metal wire paper clip comprising 

         a unitary length of spring-quality metal wire bent into an elongated configuration presenting an elongated U-shaped inner loop, an elongated U-shaped outer loop, and an arcuately-curved interconnecting portion therebetween;   

          each such U-shaped loop having an open end, a closed end, and a pair of longitudinally-extending legs;

         such closed end of the elongated U-shaped outer loop defining one longitudinal end of such bent wire elongated configuration, such inner loop being nested within such outer loop with such open end of each such U-shaped loop facing in the same longitudinal direction;

         such pair of longitudinally-extending legs of each such U-shaped loop including a free leg having a distal end located at the open end of its respective U-shaped loop, and a connecting leg, such arcuately-curved interconnecting portion extending between such connecting legs at the open end of each such U-shaped loop and defining at its longitudinally outward midpoint the remaining longitudinal end of such bent wire configuration;

          each such inner and outer loop free leg extending at least to the juncture of such longitudinally-extending connecting legs with such curved interconnecting portion while not extending beyond a location which is contiguous to a laterally transverse plane normal to the longitudinal axis of the clip which is longitudinally inward of a tangent to the longitudinally inward midpoint of the arcuately-curved interconnecting portion, and each such U-shaped loop and such curved interconnecting portion being substantially coplanar so that the paper clip lies substantially flat when not in use.

Does Your Business Card Say “Inventor”?

 

We’ve recently come across a few articles relating to a company called Intellectual Ventures, which we found interesting.  Intellectual Ventures is a self-proclaimed “invention company” located in Bellevue, Washington.  The company was founded by ex-Microsoft executive Nathan Myhrvold in 2000 with the goal to nurture fundamental innovation and invention. 

According to this BusinessWeek article and this Wikipedia entry,  the company both purchases patents (giving rise to some disparaging “troll” name-calling) and develops technology in-house, sometimes through the use of brainstorming sessions with the nation’s best and brightest scientists and engineers (with IP counsel at the ready for identifying potential patents).  Intellectual Ventures has apparently bankrolled about 44 different inventors thusfar, is building an “invention lab,” and has been applying for about 450 patents per year.  Although it has yet to have a commercial hit (the company is not interested in manufacturing, but in licensing of the technology), Intellectual Ventures apparently sees itself as filling a void in the market for pure invention, with signficant long-term potential for profitability.

See also this video article at CNN about Intellectual Ventures.  An interesting bit if you have a few minutes to spare.

They Invented What? (No. 52)

U.S. Pat. No. 4,645,677: Process for removing flatulence-causing sugars from bean products.

MD Note: I think we would all agree this solves a long-felt need. 

Abstract:

Flatulence-causing sugars can be removed from beans that contain such sugars through ultrafiltration. An ultrafiltration membrane system with a molecular weight cut-off between 30,000 and 100,000 daltons will permit the sugars to permeate through it, but it will retain most proteins.

Claims:

What is claimed is:

1. A method of processing navy beans, including the steps of:

(a) grinding the beans to produce a particulate bean product;

(b) suspending the particulate bean product in water to produce a filterable feed, the water to bean product ratio being between approximately 10:1 and 60:1 by weight;

(c) ultrafiltering the filterable feed using an ultrafiltration membrane system which as a molecular weight cut-off between approximately 30,000 and 100,000 daltons, thereby producing a permeate and a retentate, the ultrafiltration comprising two sequential phases:

(i) a first phase in which water is added to the filterable feed at the same rate as permeate is being produced, until the total permeate produced is approximately 1.0 to 3.0 times the original volume of the filterable feed, and

(ii) a second phase in which no water is added to the filterable feed while ultrafiltration is continued, until the total volume of permeate produced is approximately 1.0 to 3.0 times the original volume of the filterable feed; and

(d) recovering the retentate.

Pfizer v. Apotex (formerly known as TorPharm, Inc.)

Statement made in an FDA submission showed a “reasonable expectation of success,” used to find the claims obvious.

(Fed. Cir. 2007, 06-1261, 06-1261o) 

 

Pfizer alleged that Apotex’s filing with the FDA of an Abbreviated New Drug Application (“ANDA”) seeking approval to commercially sell amlodipine besylate tablets before the expiration Pfizer’s U.S. Patent No. 4,879,303 (“the ’303 patent”), infringed claims 1-3 of the ’303 patent.   The District Court (N.D. Ill.) found for Pfizer on the issues of validity.  On appeal, the CAFC reversed, finding that the claims were invalid as obvious, and thus unenforceable.  On May 21st, 2007, a petition to the CAFC for rehearing and rehearing en banc was denied.

The technology at issue, amlodipine besylate tablets, is commercially sold in the United States by Pfizer under the trademark Norvasc®.  Amlodipine is a member of a class of compounds referred to as dihydropyridines. Active drug molecules, such as amlodipine, are frequently made into pharmaceutically-acceptable acid addition salts to improve their bioavailability. Amlodipine besylate is an acid addition salt form of amlodipine, formed from the reaction of amlodipine, a weak base, and benzene sulphonic acid.  Amlodipine has anti-hypertensive and anti-ischemic pharmacological properties and is used in the treatment of hypertension and angina.

During development, Pfizer had first designated a maleate salt of amlodipine for further development.  However, upon further testing, the maleate salt was determined to have poor stability and processing characteristics (too sticky).  The besylate salt was later recommended to resolve these issues, and it was the besylate salt that was pursued for patent protection in the ‘303 patent. Pfizer also submitted a supplemental to the FDA stating that the dosage form anticipated for commercial use would be a tablet of amlodipine besylate and that all future clinical trials with amlodipine would use this new formulation.  Notably, in the supplement, Pfizer stated: “We feel that the change in salt form is justified since benzenesulfonate is a commercially acceptable salt, as exemplified by the tranquilizer mesoridazine (Serentil).”

As a preliminary matter, the CAFC stated that the District Court erred in holding that the court must accept a finding of obviousness by an Examiner asserted during prosecution of the ‘303 patent.  “Our case law consistently provides that a court is never bound by an examiner’s finding in an ex parte patent application proceeding.” An Examiner’s interim finding of prima facie obviousness the claims of an issued patent prima facie obvious! Since the court must presume a patent valid, the patent challenger bears the burden of proving the factual elements of invalidity by clear and convincing evidence.   The burden of proof never shifts to the patentee to prove validity.   The basis (as opposed to the mere existence) of an Examiner’s initial finding of prima facie obviousness of an issued patent is at most only one factual consideration that the court must consider “in determining whether the party asserting invalidity has met its statutory burden by clear and convincing evidence.”

Motivation to Combine Prior Art References to Achieve the Claimed Invention

In conducting the obviousness analysis (citing Dystar), the CAFC first stated:

Subsumed within the Graham factors is a subsidiary requirement articulated by this court that where, as here, all claim limitations are found in a number of prior art references, the burden falls on the challenger of the patent to show by clear and convincing evidence that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so. . . . A reasonable fact-finder could only conclude that Apotex has shown by clear and convincing evidence that the skilled artisan would indeed have been so motivated to combine the prior art to produce the besylate salt of amlodipine.

A suggestion, teaching, or motivation to combine relevant prior art teachings to achieve a claimed invention does not have to be found explicitly in the prior art references sought to be combined.  Rather, the suggestion, teaching or motivation “may be found in any number of sources, including common knowledge, the prior art as a whole, or the nature of the problem itself.”  Specifically, the testimony of record evidences that one skilled in the art would have been motivated to choose an anion having a different structure than that of maleate. 

The CAFC further held that irrefutable evidence showed that a skilled chemist at the time would simply make known pharmaceutically-acceptable salts of whatever active ingredient with which he or she was working at the time. Indeed, an inventor of the ’303 patent testified that it “would have been a mistake” to choose a novel anion.   One of ordinary skill in the art would have favorably considered benzene sulphonate because of its known acid strength, solubility, and other known chemical characteristics as reported in several other publications Pfizer had admitted were prior art.  Thus, the district court clearly erred when it ignored the significance of prior art references suggesting the besylate salt, even though the pharmaceuticals disclosed in those prior art references were not described as useful to treat hypertension or angina.

Reasonable Expectation of Success

The district court found that the skilled artisan would have had no expectation of success in making a besylate salt of amlodipine because there was no reliable way to predict the influence of a particular salt species on the active part of the compound.  The CAFC disagreed.  Obviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success.

The evidence would convince a reasonable finder of fact that the skilled artisan would have had a reasonable expectation of success that an acid addition salt of besylate would form and would work for its intended purpose.  In particular, the CAFC pointed to the suggestion in Pfizer’s supplemental filing with the FDA that it was known that the besylate salt of amlodipine would work for its intended purpose!

“Obvious-to-Try”

The CAFC also weighed in on the “impermissible” obvious-to-try  standard for obviousness.   “Undue dependence on mechanical application of a few maxims of law, such as “obvious to try,” that have no bearing on the facts certainly invites error as decisions on obviousness must be narrowly tailored to the facts of each individual case.”  Simply put, to conclude that amlodipine besylate would have been obvious, “the prior art, common knowledge, or the nature of the problem, viewed through the eyes of an ordinary artisan” merely had to suggest reacting amlodipine base with benzene sulphonic acid to form the besylate acid addition salt, and that that acid addition salt form would work for its intended purpose.  The CAFC held that they did.

Secondary Considerations

The CAFC further noted that evidence of secondary considerations, such as unexpected results, can be used to rebut a prima facie case of obviousness.  The District Court had cited unexpected results (stability and processability) in finding the claims nonobvious.  However, when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.  The CAFC noted that Pfizer had simply failed in this matter to prove that the results were unexpected.

Amlodipine besylate is obvious because the prior art suggested, and Pfizer researches expected, that every other potential salt form of amlodipine would be adequate for its intended purpose, i.e., to increase bioavailability of amlodipine, and would solve the stickiness problem of the maleate salt. The fact that amlodipine besylate was the best of the acid addition salts actually tested proved nothing more than routine optimization that would have been obvious to one of ordinary skill in the art.

REVERSED.

JW Note:  Although the holding here was levied before KSR v. Teleflex, it is worth noting that the CAFC applied an apparently adjusted framework for obviousness analyses in anticipation of the KSR ruling (See, e.g., Dystar Textilfarben GMBH & Co Deutschland KG v. C.H. Patrick, Co., et al.,  Alza Corporation v. Mylan Laboratories, Inc., et al., and Ormco Corporation, et al. v. Align Technology, Inc. etc).

They Invented What? (No. 51)

U.S. Pat. No. 5,107,620:  Electrified table cloth. 

  

Abstract:

An electrified table cloth for preventing crawling insects from gaining access to the consumer’s food or drink comprises a cloth formed of electrically insulated material which has at least one pair of parallel electrically conductive strips secured to the edge or border of the cloth to completely encircle the cloth and which are connected to a low voltage DC battery also secured to the cloth. The strips of electrical conductive material are spaced apart sufficiently to normally prevent completion of a circuit across the strips and for completion of a circuit across said strips through an insert’s body as the insect attempts to traverse the strips when crawling acorss the edge of the cloth. The current passing through the insect’s body is sufficient to produce a sensation which will discourage further travel across the edge of the cloth. A consumer who may come into contact with the strips will usually not feel the current and, even if the consumer is wet, the current will produce only a slight tingling sensation. The electrical apparatus may also be provided in kit form to be installed on table cloths by the consumer.  

Claims:

1. An electrified table cloth to prevent crawling insects from gaining access to the consumer’s food or drink comprising;
          a cloth formed of electrical-insulating material having at least one surface for supporting containers of food or drink,
          at least one first strip of electrical-conducting material secured to the surface of the cloth to completely encircle the cloth,
          at least one second strip of electrical-conducting material secured to the surface of the cloth to completely encircle the cloth and spaced parallel to said first strip, and
          a low voltage DC battery operatively secured to the cloth,
said first strip of electrical-conducting material being connected to one terminal of said battery and said second strip of electrical-conducting material connected to the other terminal of said battery by electrical leads, and
          said first and second strips of electrical-conducting material spaced apart along their entire length and operable to complete a circuit across said strips through an insect’s body as the insect attempts to traverse the strips.

Patent Reform Bill Stalling?

According to a number of reputable sources in the patent blogosphere (e.g., Promote the Progress, Patent Prospector, 271 Patent Blog), the Patent Reform Act of 2007 may be stalling in the U.S. Senate.  Following the hearings on June 6th, a number of Senators have issued a letter asking for more hearings, with notable concerns being stated as follows: 

Specifically, we believe that the issue of mandatory apportionment of damages, post-grant opposition, and broad rulemaking authority for USPTO need to be more carefully examined to ensure that they do not undermine innovation, increase frivolous litigation, or undermine property rights.

The Patent Prospector has provided a copy of the letter here.

They Invented What? (No. 50)

U.S. Pat. No. 5,246,396:  Method for the humane slaughter and processing of domesticated ostrich.

 

1. A method for humanely slaughtering and efficiently processing ostrich on a large scale in a facility, comprising the steps of:

          stunning said ostrich via an electrical discharge;
          hanging said ostrich in an inverted position by placing a first shackle around one leg of said ostrich, hoisting said ostrich to an inverted position, affixing said shackle to a rail system to permit mobility, placing a second shackle around the free leg of said ostrich, and affixing said second shackle to said rail system to enhance the stability of said ostrich hanging in said inverted position;
          bleeding said ostrich by cutting the arteries in the neck region and the windpipe of said ostrich and permitting the blood of said ostrich to leave said ostrich;
          decapitating said ostrich;
          de-feathering said ostrich by isolating said ostrich via air curtains, providing a pressurized air dispenser having a needle-like probe, injecting air between the ostrich hide and the ostrich muscle structures by inserting said probe into the base of the neck region of said ostrich, into the base of both wing regions, and into both lower leg regions below the metatarsal joint, such that said probe penetrates said hide and rests at the outside of said muscle structures, and pulling said feathers from said hide;
          tieing the colon, urinary track, and reproductive organs of the ostrich by making a circular cut around the vent opening of said ostrich, grasping the colon, urinary track, and reproductive organs, pulling said colon, urinary track, and reproductive organs approximately two to six inches from said ostrich, and affixing a constricting device around said organs;
          removing the feet and wings from said ostrich;
removing the neck region of said ostrich by making a vertical cut along the length of the neck region of said ostrich, separating the esophagus and windpipe from the muscle tissue in said neck region, tieing said esophagus, while permitting said windpipe to remain functionally attached to said ostrich, and removing said neck region while permitting said esophagus and said windpipe to remain functionally attached to said ostrich;
          skinning said ostrich;
          removing the viscera from said ostrich by cutting vertically along the entire frontal region of the ostrich below the ostrich membrane from the anal region to the breast plate, around said breast plate, and to the neck region, said membrane being the layer below the ostrich hide, pulling said gizzard out from said ostrich, tieing said gizzard at the gizzard base, and cutting said gizzard above the tie off point to thereby separate said gizzard from said ostrich; and
          removing the edible meat products from said ostrich.

McKesson Information Solutions, Inc. v. Bridge Medical, Inc.

Failure to disclose material rejections and allowances in related applications was inequitable conduct. 

(Fed. Cir. 2007, 06-1517)

McKesson appealed the final decision of the District Court (E.D. Cal.) that dismissed McKesson’s infringement suit against Bridge.  The District Court had found that the only patent at issue, McKesson’s U.S. Patent No. 4,857,716 (the ‘716 patent), was unenforceable due to inequitable conduct.  The CAFC affirmed.

The technology at issue pertains to a patient identification system for relating items with patients and ensuring that an identified item corresponds to an identified patient. 

During prosecution of the ‘716 patent application, the prosecuting attorney simultaneously prosecuted two related applications (the ‘149 application; and the ‘195 application). The prosecuting attorney failed to disclose a reference (“Baker”) brought to his attention in the ‘149 prosecution.  Also, the prosecuting attorney failed to disclose rejections and an allowance of claims in the related applications.

In affirming the holding of the District Court, the CAFC stated that the duty of candor extends throughout the patent’s entire prosecution history. The Baker patent described technology of the very type the prosecuting attorney used to differentiate the claims of the ‘716 patent from the prior art, and thus was material.  Additionally, the attorney’s cancellation of a claim in the ‘149 application when confronted with the Baker patent gives rise to an inference of an intent to deceive – he should have recognized Baker would also present a significant obstacle to the patentability of the ‘716 patent application. Thus, the overwhelming circumstantial evidence, coupled with the lack of any credible explanation for nondisclosure of Baker, supported the finding of inequitable conduct.

With respect to the rejections asserted in the related ‘149 application, the CAFC stated:

The term “information” is intended to be all encompassing . . . . [Section 1.56(a)] is not limited to information which would render the claims unpatentable, but extends to any information “where there is a substantial likelihood that a reasonable examiner would consider it important in deciding whether to allow the application to issue as a patent.”

In light of this broad understanding of information, there is “no doubt that material rejections in co-pending applications fall squarely within the duty of candor.”

Finally, in relation to the allowed claims that were not disclosed, that CAFC further stated that “[m]aterial information is not limited to information that would invalidate the claims under examination.”  The appropriate test for materiality is “whether a reasonable examiner would have considered the information important, not whether the information would conclusively decide the issue of patentability.”  Thus, the allowance of claims in the related ‘195 application is material, and should have been disclosed. 

The failure to disclose the Baker patent, the rejections in the related application over the Baker patent, and the allowances support a finding of inequitable conduct.  AFFIRMED.

In dissent, J. Newman argued:

[I]t is not clear and convincing evidence of deceptive intent that the applicant did not inform the examiner of the examiner’s grant of a related case of common parentage a few months earlier, a case that was examined by the same examiner and whose existence has previously been explicitly pointed out by the same applicant. Nor is it clear and convincing evidence of deceptive intent that the applicant did not cite a reference that the applicant had cited in the same related case, and that had been explicitly discussed with the same examiner in the related case. . . .

This court returns to the “plague” of encouraging unwarranted charges of inequitable conduct, spawning the opportunistic litigation that here succeeded despite consistently contrary precedent.