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Petito v. Puritan's Pride, Inc.

United States District Court, S.D. New York

July 31, 2014

GEORGE D. PETITO, ANITA M. PETITO, CONNECTIVE LICENSING, LLC, Plaintiffs,
v.
PURITAN'S PRIDE, INC.; REXALL SUNDOWN, INC.; NATURE'S BOUNTY, INC.; PHYSIOLOGICS, LLC, Defendants

Page 495

For George D. Petito, Anita M. Petito, Connective Licensing, LLC, Plaintiffs (1:13-cv-08040-PAE): Darrell G. Dotson, PRO HAC VICE, The Dotson Law Firm, Longview, TX; Scott Stevens, Stevens Love, Longview, TX; Steven Michael Hayes, Hanly Conroy Bierstein Sheridan Fisher & Hayes, LLP, New York, NY.

For Puritan's Pride, Inc., Defendant (1:13-cv-08040-PAE): Steven M Lieberman, LEAD ATTORNEY, Rothwell, Figg, Ernst & Manbeck, Washington, DC; Rachel M Echols, PRO HAC VICE, Christina Nichole Gifford, Rothwell, Figg, Ernst & Manbeck, P.C., Washington, DC.

For Puritan's Pride, Inc., Counter Claimant (1:13-cv-08040-PAE): Steven M Lieberman, LEAD ATTORNEY, Rothwell, Figg, Ernst & Manbeck, Washington, DC; Christina Nichole Gifford, Rachel M Echols, Rothwell, Figg, Ernst & Manbeck, P.C., Washington, DC.

For Connective Licensing, LLC, Anita M. Petito, George D. Petito, Counter Defendants (1:13-cv-08040-PAE): Darrell G. Dotson, The Dotson Law Firm, Longview, TX; Scott Stevens, Stevens Love, Longview, TX; Steven Michael Hayes, Hanly Conroy Bierstein Sheridan Fisher & Hayes, LLP, New York, NY.

For George D. Petito, Anita M. Petito, Connective Licensing, Llc (1:13cv8128, 1:13cv8077), Plaintiffs: Darrell G. Dotson, PRO HAC VICE, The Dotson Law Firm, Longview, TX USA; Scott Stevens, PRO HAC VICE, Stevens Love, Longview, TX USA; Steven Michael Hayes, Hanly Conroy Bierstein Sheridan Fisher & Hayes, LLP, New York, N.Y. USA.

For Physiologics, Llc, Defendant, Counter Claimant (1:13cv8128): Steven M Lieberman, LEAD ATTORNEY, Rothwell, Figg, Ernst & Manbeck, Washington, DC USA; Christina Nichole Gifford, Rachel M Echols, Rothwell, Figg, Ernst & Manbeck, P.C., Washington, DC USA; Scott Stevens, Stevens Love, Longview, TX USA.

For Connective Licensing, Llc, Anita M. Petito, George D. Petito (1:13cv8128, 1:13cv8074), Counter Defendants: Darrell G. Dotson, The Dotson Law Firm, Longview, TX USA; Scott Stevens, Stevens Love, Longview, TX USA; Steven Michael Hayes, Hanly Conroy Bierstein Sheridan Fisher & Hayes, LLP, New York, N.Y. USA.

For Nature's Bounty, Inc., Defendant (1:13cv8077): Steven M Lieberman, LEAD ATTORNEY, Rothwell, Figg, Ernst & Manbeck, Washington, DC USA; Christina Nichole Gifford, PRO HAC VICE, Rachel M Echols, Rothwell, Figg, Ernst & Manbeck, P.C., Washington, DC USA.

For Nature's Bounty, Inc., Counter Claimant, Counter Defendant (1:13cv8077): Steven M Lieberman, LEAD ATTORNEY, Rothwell, Figg, Ernst & Manbeck, Washington, DC USA; Christina Nichole Gifford, Rachel M Echols, Rothwell, Figg, Ernst & Manbeck, P.C., Washington, DC USA.

For George D. Petito, Anita M. Petito, Connective Liscensing, Llc, Plaintiffs (1:13cv8074): Darrell G. Dotson, PRO HAC VICE, The Dotson Law Firm, Longview, TX USA; Scott Stevens, Stevens Love, Longview, TX USA; Steven Michael Hayes, Hanly Conroy Bierstein Sheridan Fisher & Hayes, LLP, New York, N.Y. USA.

For Rexall Sundown, Inc., Defendant (1:13cv8074): Steven M Lieberman, LEAD ATTORNEY, Rothwell, Figg, Ernst & Manbeck, Washington, DC USA; Rachel M Echols, PRO HAC VICE, Christina Nichole Gifford, Rothwell, Figg, Ernst & Manbeck, P.C., Washington, DC USA.

For Rexall Sundown, Inc., Counter Claimant (1:13cv8074): Steven M Lieberman, LEAD ATTORNEY, Rothwell, Figg, Ernst & Manbeck, Washington, DC USA; Christina Nichole Gifford, Rachel M Echols, Rothwell, Figg, Ernst & Manbeck, P.C., Washington, DC USA.

Page 496

OPINION & ORDER

Paul A. Engelmayer, United States District Judge.

In these four related cases, George Petito, Anita Petito, and Connective Licensing, LLC allege that Puritan's Pride, Inc., Rexall Sundown, Inc., Nature's Bounty, Inc., and Physiologics, LLC, respectively, have each infringed U.S. Patent No. 6,645,948 (" the '948 patent" ), entitled " Nutritional Composition for the Treatment of Connective Tissue." Defendants now move for summary judgment on two grounds.

Page 497

First, they argue that the '948 patent is invalid because it fails the utility and written description requirements of 35 U.S.C. § 112. Second, defendants argue that the '948 patent, if valid, is not entitled to an earlier filing date under 35 U.S.C. § 120 because it was not filed before the patenting of an earlier, related application. For the reasons that follow, the Court grants defendants' first motion for summary judgment, and finds the '948 patent invalid. The Court does not, therefore, have occasion to reach defendants' alternative motion for summary judgment.

I. Background[1]

George and Anita Petito (the " Petitos" ) are the owners and inventors of the '948 patent. Def. 56.1 ¶ 1. Connective Licensing, LLC is the exclusive licensee of the '948 patent. Id. ¶ 2.

The '948 patent is the result of a series of patent applications by the Petitos. Because defendants' challenge turns on the sufficiency of the applications underlying and incorporated in the '948 patent, the Court reviews the facts concerning these successive patent applications in detail.

A. The '710 Application

On March 24, 1998, the Petitos filed U.S. Patent Application No. 09/046,710. Dotson Decl. Ex. A (the " '710 application" or the " grandparent application" ). The '710 application claimed a nutritional composition to support " the creation of new body tissue and cartilage growth in humans and animals," which could be administered orally or by injection. Id. at 6. It also promised other benefits: " the enhancement of chondrocyte synthesis, the maintenance of healthy muscle and tissue, increasing the desirable concentration of hyaluronic acid, and being anti-inflammatory." Id.

The claimed composition contained six ingredients: (1) glucosamine hydrochloride,

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(2) chondroitin sulfate, (3) hydrolyzed or native collagen, (4) sodium hyaluronate, (5) a manganese salt, and, optionally (6) L-malic acid. Id. at 1, 8. For each ingredient, the application listed a preferred concentration and two ranges of concentrations (an " optional range" and a " broad range" ), with the dosage amounts described in terms of milligrams per kilogram of bodyweight. Id. at 9. For example, for the first ingredient, glucosamine hydrocholoride, the application stated that the preferred concentration was 5 mg, the optional range was 3 to 8 mg, and the broad range was 2 to 10 mg. Id.

On June 23, 1998, the examiner rejected the claims in the '710 application, on two grounds. Echols Aff. Ex. D. First, he found the claims were indefinite within the meaning of 35 U.S.C. § 112, because they " fail[ed] to particularly point out and distinctly claim the subject matter which applicant regards as the invention" and because, although certain claims referred to " effective amounts," they did not " recite for what purpose the effective amounts are to be directed against." Id. at 2. Second, the examiner concluded, the claimed composition was obvious over the prior art. Id. at 2-6. The examiner explained:

The composition claims appear to be a combination of previously known compositions (with the exception of the addition of malic acid) which were successful for a particular purpose i.e. healing and/or maintenance of connective tissue. However, it has previously been held that it is obvious to combine ingredients which have been separately employed for a particular purpose in order to obtain the expected combination of benefits. See In re Greenfield, 571 F.2d 1185, 197 U.S.P.Q. 227 (CCPA 1978).[2] With regard to the addition of malic acid, one of ordinary skill in the art would have found obvious to add a flavor enhancer to a food/drink product for the purpose of making the composition more palatable for the user.

Id. at 4.

On August 21, 1998, the Petitos filed an Amendment and Response. Echols Aff. Ex. G (" '710 amendment" ). In their response, the Petitos attempted to refute the examiner's reasons for rejecting the '710 application. Id. at 2-7. They also submitted a letter dated August 14, 1998 from David C. Polen, President of DP Nutritionals, to George Petito, describing three patients who benefited from the administration of the composition.[3] '710 amendment Ex. A. The body of Polen's letter is as follows:

The cases below are people who have benefited from the use of the composition:
R.R. is a 78-year-old white female widow that has a part time job on weekends working in [a] supermarket. She states that she needs the job because she needs to be in contact with people. In November of 1997, she was afraid that she was going to have to give up her job due to the pain that she would experience in her hips and knees when she was on her feet for over a half hour and the pain was getting increasingly more difficult for her to live with. She was put on Osteocaps in September of 1997

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and at her visit in November, she stated that all of her pain was gone and was looking forward to keeping her part time job. She was taken off Osteocaps in April of 1998 and at her last appointment on June 27, 1998 she was still pain free.
M.S. is a 61-year-old housewife from Brooks[,] Kentucky. Her complaints were digestive disorders, Arthritis, Back aches and headaches. She was tested and found to have food allergies so she was put on the appropriate diet and nutritional supplements for this condition. As the food allergies started to clear up she still complained about arthritic pain and was put on Osteocaps on her next visit. One month later she stated that her pain started to clear up in about four days and was completely gone in a week. She also stated that she does not want to be without them.
L.G. is a 62-year-old patient who resides in West Point, Kentucky. She came into the office stating that she was bitten by a spider about 18 months ago and still had a lot of joint pain from the bite. The patient was put on Osteocaps and Vitamin C. At her second appointment in thirty day[s] she stated that her pains in her joints had gotten much better, and at her third visit she was totally pain free. She has been taking Osteocaps for six months and has not had any pain in her joints since.

'710 amendment Ex. A.

On November 24, 1998, the examiner concluded that the Petitos' arguments were " not persuasive" and reaffirmed his rejection of the claims on the grounds of indefiniteness and obviousness. Echols Aff. Ex. I. He explained that " [i]nvention can reside in a composition of matter formed by the intermixture of two or more ingredients which result in a product possessing characteristics of utility that are new, additional and materially different from the property or properties which the individual ingredients do not possess in common," but that " there is nothing patentable unless the applica[nt] by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function." Id. at 3-4 (citing In re Levin, 178 F.2d 945, 37 C.C.P.A. 791, 1950 Dec. Comm'r Pat. 101 (CCPA 1949)). The examiner determined that the Polen letter did not show that the results were " unexpected and significant." Id. at 4 (citing Manual of Patent Examining Procedure § 716.02(b)).

On May 24, 1999, the Petitos filed a notice of appeal. See Echols Aff. Ex. H. They did not, however, file an appeal brief. See id. On January 3, 2000, the Patent and Trademark Office sent the Petitos a notice stating that the '710 application had been abandoned. Id.

B. The '169 Application and the '005 Patent

On July 26, 1999, the Petitos filed U.S. Patent Application No. 09/360,169 as a continuation-in-part of the '710 application. Dotson Decl. Ex. B (the " '169 application" or ...


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