Patents

Plachetka

“Treatment of Migraine Headache”

Current status: All Claims Rejected! (Apr. 6, 2006)

• Original Patent
  • Number 6,479,551
  • Issued Nov. 12, 2002
  • Summary: The patented composition is a treatment for migraine. Migraine is a painful syndrome characterized by unilateral, pulsating headaches, nausea, vomiting, and sensitivity to light and sound. Approximately 23 million Americans presently suffer from this disorder. Patients have found relief using analgesics (such as acetaminophen, naproxen sodium, and ibuprofen) called NSAIDS, but the body is slow to absorb these drugs during migraine attacks due to decreased gut motility. Previous attempts have been made to increase absorption of aspirin by administering it with metoclopramide, a drug known to increase gastric motility. However, such combinations have a short shelf life because the two components react with one another.
  • Original Assignee: Pozen Inc., Chapel Hill, NC (US)
• Reissue Application
  • Number 10/811,793
  • Filed Mar. 29, 2004
  • Summary: The reissue notes that a patent issued in 1983 described a combination of metoclompramide with paracetamol (acetaminophen), which is a non-acidic NSAID. Applicant admits that the prior patent renders two of his claims invalid. Applicant offers to cancel these claims, but wishes to keep the other claims intact.
• Protest
  • Received: Aug. 20, 2004
  • Summary: The protest notes that naproxen sodium has previously been used in combination with metoclopramide for the treatment of migraine headache. Several journal articles have also previously described the use of an analgesic and metoclopramide in a single pill. Protester asserts that acid-base storage stabilization is a common technique that could easily have been adapted to solve the problem of short shelf life.
• Applicant Response to Protest
  • Received: Oct. 19, 2004
  • Summary: Applicant responds that although acid-base storage stabilization is a common technique, it was not previously known that some metoclopramide-analgesic combinations would degrade due to an acid-base reaction
• Patent Office Non-Final Action
  • All 33 claims rejected. Specification objected to.
  • Summary: The examiner agreed with Patients not Patents that the term "coordinate" was indefinite. The examiner also decided that the literature sent to the patent office by Patients not Patents is valid prior art, even though the applicant claims to have filed his patent application before the articles had been published. The examiner disagreed with the remainder of the protest, finding that although the literature cited, when put together may have anticipated the invention, there was no evidence as to why a researcher would have wanted to combine the teachings of the literature. Independently, the Examiner found other problems with the patent. First, the examiner points out that some of the applicant's proposed changes to this patent go too far beyond the scope of the original patent. Second, the examiner finds the description of how to make the migraine medicine insufficient for a scientist of ordinary skill to make it. Finally, the examiner rejects all of the claims based largely on literature that was already disclosed in the original patent.
• Applicant Reponse to Non-Final Action
  • Received: Dec. 29, 2005
  • Summary: The applicant amended several parts of the patent in order to overcome the first two problems raised by the examiner.  As to the examiner's determination that all of the claims were based on previously published information, the applicant argues that none of the information in the literature recognizes that the combination drug would lose its potency over time because the acidic and basic components will react with each other.
• Patent Office Non-Final Action
  • Summary: The examiner reiterates his reasons for rejecting the patent.  Addressing the acid-base storage problem, the examiner notes that one combination drug had been found to be unstable by researchers, and the problem was fixed by separating the two layers with polymer.  Given the recognition of the problem in this one case, the examiner reasons that researchers in the field would have foreseen the acid-base problem in similar situations.

Zappala

“Preemptive Analgesic and Methods of Use”

Current status: Continuing Examination: Non-final Rejection of All Claims (Oct. 6. 2006)

• Original Patent
  • Number 6,329,398
  • Issued Dec. 11, 2001
  • Summary: The patent is for an anesthetic combination containing lidocaine and bupivacaine. Lidocaine has a rapid onset, but is short-acting. Bupivacaine is longer acting, but has a slower onset. By combining these two drugs in certain ratios, anesthesia can be accomplished which is continuous, has a rapid onset, and is long-acting.
  • Original Assignee: None
• Reissue Application
  • Number 10/734,070
  • Filed Dec. 11, 2003
  • Summary: The reissue seeks priority from two earlier patent applications. The purpose of seeking priority is to show that the invention was developed before the date on which the application was filed. This would protect the patent from challenges based on literature that was published prior to the filing date, but after the priority date.
• Protest
  • Received: Aug. 27, 2004
  • Summary: The protest first argues that the patent does not disclose a sufficient amount of information to enable a doctor to use the anesthetic combination for all of the different types of anesthetic procedures claimed by the patent. Second, the protest submits excerpts from a 1994 textbook that discuss how to mix anesthetics to achieve desired period of latency and duration. The textbook also refers to the ratio claimed in the patent as the "usual ratio."
• Patent Office Non-final Action
  • Summary: The examiner considered the argument set forth in the protest that there is insufficient guidance in the patent to enable a doctor to use the anesthetic combination in different settings.  The examiner rejected the claims on a slightly different ground, nothing that it is unclear how to use the invention in any setting.  The examiner then explicitly acknowledges and adopts the majority of Patients not Patents' arguments.
• Applicant Response to Non-final Action
  • Summary: The applicant argues that "secondary considerations" militate against rejecting the patent.  The secondary consideration argued here is that there was no prior commercialization of the invention.  The logic behind prior commercialization is that the patented invention was not obvious, for if it were, another company would already have marketed it.  The applicant argues that the only prior commercialization, Duocaine, involved a different ratio of lidocaine and bupivicaine.
• Patent Office Final Action
  • Summary: The examiner finds all of the applicant's arguments unpersuasive.  Most importantly, the examiner cites case law holding that it is not inventive, and therefore not patentable, to discover that an optimal ratio of two substances where a range including that ratio was already known in the field.  There is an exception to this rule where the optimal ratio was unexpected or could not have been discovered by routine experimentation.  However, the applicant does not claim that the exception applies to this patent.

Bonhomme

“Solid oral dosage form comprising a combination of metformin and glibenclamide.”

Current status: Abandoned (Sep. 20, 2005)

• Original Patent
  • Number 6,303,146
  • Issued Oct. 16, 2001
  • Summary: This patent is for the drug Glucovance made by Bristol-Myers Squibb. The drug is intended as a treatment for Type 2 diabetes.
    
    Type 2 diabetes (sometimes called non-insulin dependent diabetes) is a metabolic disorder which occurs when the pancreas does not secrete enough insulin or the body is unable to recognize the insulin and use it properly. The initial treatment of non-insulin dependent diabetes involves diet control and exercise. Only after this has been shown to be inadequate are oral antidiabetic drugs used, and then only to complement the effect of diet and not replace it. Using a single antidiabetic drug can be an effective treatment for many years. However the efficiency can decrease with time.
    
    This patent is for a combination of two antidiabetic drugs, metformin (Glucophage) and glibenclamide (also known as glyburide), which have complementary effects. Although both drugs individually are available as generics, the combination of the two is now a patented product known as Glucovance. Specifically, the patent covers the size of the particles of each drug in the combination. Particle size affects how quickly the drugs are available for the body to use.
  • Original Assignee: LIPHA (Lyons, FR)
• Reissue Application
  • Number 10/808,617
  • Filed Mar. 29, 2004
  • Summary: The reissue seeks broader coverage, claiming that the patent should include all combinations of glibenclamide and metformin where the bioavailability of glibenclamide in the combination is the same as the bioavailability of glibenclamide when administered alone. The original patent only made this claim for combination therapy with specific particle sizes. The reissue also seeks to correct typographical errors.
• Protest
  • Received: Aug. 30, 2004
  • Summary: The protest argues that combination therapy consisting of metformin and glibenclamide in a single pill was already being used for the treatment of type 2 diabetes at the time the patent was filed. Another reference predating the patent shows how the particle size of glibenclamide relates to its bioavailability.
• Patent Office Non-final Action
  • All 7 claims rejected
  • Summary: The patent office did not consider the merits of the protest. The office rejected all claims of the patent because the applicant did not file the reissue in a timely manner. The rules require a reissue application seeking to broaden the scope of a patent to be filed within two years.
• Patent Application Abandoned

Nair

“Metabolically Inert Anti-Inflammatory and Anti-Tumor Antifolates”

Current status: Abandoned (Oct. 14, 2005)

• Original Patent
  • Number 5,912,251
  • Issued Jun. 15, 1999
  • Summary: Antifolates are one of the earliest classes of drugs developed for clinical use in cancer chemotherapy. Antifolate compounds also have clinical utility in a number of non-oncology indications, including rheumatoid arthritis and psoriasis. As a class, antifolates are analogs of folic acids. The prototype antifolate for cancer therapy is methotrexate which inhibits one of the enzymes important to folate metabolism.
    
    This patent is for an antifolate compound which does not have the toxicity and resistance problems of methotrexate. Additionally, the patent claims that the compound is 1,000 to 10,000 times more active than methotrexate in inhibiting human tumor cells in culture.
  • Original Assignee: None
• Reissue Application
  • Number 10/819,080
  • Filed May 6, 2004
  • Summary: The reissue seeks to add a sentence acknowledging that the research was supported by a grant from the United States Public Health Service.
• Protest
  • Received: Sep. 27, 2004
  • Summary: The protest asserted that a researcher who read previous patents and articles by the Applicant would have been able to make the compound claimed in this patent.
• Applicant Response to Protest
  • Received: Nov. 2, 2004
  • Summary: Applicant responded that the Protest raised no issues that were different from those already covered in the original patent application process. Further, Applicant argues that research scientists would not have wanted to create the patented compound because nobody had recognized the importance of making the compound inert.
• Patent Office Non-final Action
  • All 32 claims are rejected because the reissue application was improper.
  • Summary: The Examiner determined that a Certificate of Correction should have been filed instead of a reissue application because the change sought by Applicant was non-substantive. Also, Examiner agreed that the Protest raised no new issues.
• Patent Application Abandoned

Apelqvist

“Glucocorticoid and thyroid hormone receptor ligands for the treatment of metabolic disorders.”

Current status: Abandoned (Nov. 8, 2006)

• Original Patent
  • Number 6,492,424
  • Issued Oct. 15, 2002
  • Summary: Thyroid hormones affect the metabolism of virtually every cell of the body. At normal levels, these hormones maintain body weight, the metabolic rate, body temperature, and mood, and influence serum low density cholesterol (LDL or so-called “bad cholesterol”). Synthetic thyroid hormones are currently used for replacement therapy in patients having hypothyroidism. Thyroid hormone therapy might be useful in treating non-thyroid diseases because the hormone has the ability to reduce weight, lower serum LDL levels, ameliorate depression and stimulate bone formation. However, replacement therapy has been limited in these instances because of the severe side effects of the hormone, particularly cardiac toxicity. The patent claims a new group of synthetic thyroid hormone ligands that can specifically bind to liver cells, reducing or eliminating the cardiac side effects. The patent contains 20 claims.
  • Original Assignee: Karo Bio AB, Huddinge (SE)
• Reissue Application
  • Number 10/827,696
  • Filed Apr. 19, 2004
  • Summary: Applicant wants to exclude a particular chemical from the entire group of chemicals claimed because that chemical was already in the public domain. Apparently, the exclusion was made in their British patent, but mistakenly omitted from the U.S. patent. Applicant also wants to correct a typographical mistake. Only Claim 1 amended.
• Protest
  • Received: Oct. 4, 2004
  • Summary: Patients not Patents argued that a scientist could not easily make and use the patented hormone receptor ligands because the patentee did not describe his procedures with sufficient detail. Additionally, the patent application was an open-ended formula, thereby including an infinite number of compounds. The narrative portion of the reissue application also had significant discrepancies with the claimed chemicals. Finally, the protest described a significant body of literature demonstrating that the applicant’s formulas included many substances that were already know to be liver-specific thyroid hormone ligands.
• Patent Office Non-Final Action
  • All 18 claims rejected
  • Summary: Examiner agreed with Patients not Patents that some of the claimed chemicals were not described well enough for a scientist to make and use them. Examiner further agreed that parts of the patent application contained discrepancies between the narrative and the claims which warrant all the claims to be rejected. Examiner rejected the portion of the protest that argued the patented compounds were already part of the public domain, stating that the original patent application in the UK predated the publication dates of the suggested articles. Additionally, Examiner rejected some of the claims on grounds not raised by Patients not Patents in its protest. The Examiner noted, for example, that just because a disease is “associated” with a metabolic dysfunction does not mean that the metabolic dysfunction caused the disease. Otherwise, the patent would include the treatment of almost any disease with the claimed compounds.
• Applicant Response to Non-Final Action
  • Summary: Applicant amended portions of the patent in compliance with the examiner's request.
• Patent Office Non-Final Action
  • Summary: Twelve of the eighteen patent claims are allowed.  The remaining six claims are rejected for being overly broad and unclear.
• Applicant Response to Non-Final Action
  • Summary: Applicant cancels the disputed claims.  Applicant presents one new claim which is limited to treating type I and II diabetes and Cushing's syndrome.
• Patent Allowed

Bissery

“Antitumor compositions containing taxane derivatives”

Current status: Abandoned (June 26, 2006)

• Original Patent
  • Number 6,441,026
  • Issued Aug. 27, 2002
  • Summary: Taxol, Taxotere and their analogs are useful in the treatment of cancers of the colon, breast, ovary and lung. Both Taxol and Taxotere are in the class of compounds known as taxanes. The patent claims a combination therapy which includes the taxane derivative below, along with a second anti-cancer agent.
    
  • Original Assignee: Aventis Pharma, S.A. (Anthony Cedex, FR)
• Reissue Application
  • Number 10/858,554
  • Filed Jun. 2, 2004
  • Summary: The patent claims are amended to use the word "combination" instead of "composition." The purpose of the change is to cover combinations which need to be prepared before being administered to the patient. As separate drugs they would not be considered to be a single composition. The reissue application also adds claims for using the combination to treat cancer, and not just the physical combination itself.
• Protest
  • Received: Oct. 12, 2004
  • Summary: The protest contains four parts. The first part asserts that the new "method of use" claims are impermissibly indefinite because the patent does not explain how the combination should be administered to the patient. The second part argues that some of the original claims should be rejected because the patent does not provide any guidance on how to combine the taxane derivative with several of the other anti-cancer agents listed. Third, the protest argues that an earlier patent which claimed the same taxane derivative was written broadly enough to encompass combination treatment, even though specific combinations were not disclosed. Alternatively, the protest argues that it would have been obvious to combine the taxane derivative of this patent with a second anti-cancer agent because it was already well-known in the field that other taxane derivatives were more effective when combined with a second anti-cancer agent.
• Patent Office Non-final Action
  • All 39 claims either rejected or withdrawn!
  • Summary: The Examiner required Applicant to withdraw the "method of use" claims because those claims constitute a separate invention which can only be patented through a new application. As a result, the first line of argument in the protest is moot. The Examiner also disagreed with the third part of Protestor's argument because the earlier patent does not specifically mention a combination with an additional anti-cancer agents. The Examiner agreed with the remainder of the Protest and based her rejection on the arguments contained therein.
• Applicant Response to Non-Final Action
  • Summary: Applicant withdrew the "method of use" claims as required by the Examiner.  Applicant cancels eleven of the remaining claims and adds four new claims.  With respect to the remaining claims, the applicant argues that the study of combination therapy for cancer is so unpredictable that it is impossible to know in advance which combinations of drugs will be effective. In the added claims, the applicant claims a smaller, but still broad number of combinations without testing each one.  However, Applicant now provides a method for determining whether a particular combination will be effective in cancer treatment that is based on how many cells are killed in laboratory tests. 
• Patent Office Non-Final Action
  • Summary: Examiner finds all of the applicant's arguments unpersuasive.  What the applicant is doing, according to the examiner, is putting together two anti-cancer substances and claiming that nobody would have expected the resulting combination to have anti-cancer activity. The reference presented to the Office by Patients not Patents remains the basis for rejecting several of applicants' claims.  As to the test based on how many cells are killed, the examiner finds that this is irrelevant because all of the combination treatments already known would be able to pass the test.

Skubitz

“Oral Glutamine to Reduce Stomatitis”

Current status: Reissue Allowed (Jan. 5, 2006)

• Original Patent
  • Number 5,545,668
  • Issued Aug. 13, 1996
  • Summary: In patients undergoing chemotherapy or radiotherapy for treatment of cancer, a common side effect is the inflammation of mucous membranes. Inflammation of the oral mucous tissue is known as oral mucositis, or stomatitis. The patent explains that oral administration of glutamine, an amino acid, to patients undergoing chemotherapy or radiotherapy may reduce the severity of stomatitis. This may enable patients to receive higher doses of chemotherapy or radiotherapy. The glutamine is administered in a liquid form because patients with severe stomatitis may have difficulty swallowing.
  • Original Assignee: None
• Reissue Application
  • Number 10/847,810
  • Filed May 18, 2004
  • Summary: Typically, when a patient is administered a pill, the active ingredient is not absorbed by the body until after it is swallowed. It may then be absorbed by the stomach or intestines. Medicine in the form of a liquid, gel, gummy chew tablet or lozenge can also be absorbed directly through the mouth, throat or pharynx while the medicine remains in contact with those tissues. The reissue seeks to add claims specifically covering this latter method of absorption. Additionally, the reissue adds claims which include sucrose (common table sugar) in the formula to make the medicine more palatable.
• Protest
  • Received: Nov. 22, 2004
  • Summary: The main argument of the protest is that an earlier European patent had already disclosed to the public that treatment with glutamine had the effect of reducing the severity of oral mucositis. Although the European patent had involved higher doses of glutamine, medical researchers routinely perform experiments in order to determine the smallest effective dose of a drug.
• Patent Office Non-final Action
  • Claims 1-8 are rejected.
  • Summary: Regarding the substantive arguments submitted, "Examiner essentially agrees with the protest." Additionally, Examiner holds that Applicant improperly attempts to distinguish between "oral" and "topical" administration based on where the substance is absorbed by the body. The substance is administered orally, regardless of how it is absorbed. Examiner also rejects several claims because it is a common practice for cancer patients to eat foods high in glutamine during chemotherapy. Such foods include milk and meat. A normal diet already contains 2-4g on glutamine and the Applicant fails to show that there is any benefit to ingesting glutamine above and beyond that amount.
• Applicant's Response to Examiner's Rejection
  • Received: Jul. 25, 2005
  • Summary: Applicant submits over 50 supposedly relevant documents to the Patent Office. The applicant also rephrases some of the claims in response to the Examiner's rejection. Applicant argues that some of the references applied by the Examiner (which were cited by Patients not Patents) discuss the use of glutamine for the treatment of conditions other than mouth ulcers. Additionally, the applicant argues that because so many similar experiments with other mouthwashes had failed, a scientist would have believed that research in this area was a dead-end.
• Patent Office Final Action
  • The examiner finds applicant's arguments persuasive.  However, the amendments submitted by the applicant were in incorrect form.
• Applicant's Response to Examiner's Rejection
  • Applicant corrects and resubmits the amendments
• Patent Allowed

Hayakawa

“Optically Active Pyridonecarboxylic Acid Derivatives”

Current status: Claims 1-9 Allowed, 10-12 Rejected (Apr. 11, 2005)

• Original Patent
  • Number 5,587,386
  • Issued Dec. 24, 1996
  • Summary: The patented compound is an antimicrobial compound which may be useful as a human or veterinary medicine, fish medicine, agricultural chemical, or antiseptic. Compounds having the chemical formula disclosed in the patent contain a mixture of (+) and (-) configurations. By isolating certain configurations from the mixture, the resulting compound may have more potent antimicrobial activity.
  • Original Assignee: Daichi Pharmaceutical Co., Ltd. (Tokyo, JP)
• Reissue Application
  • Number 10/859,587
  • Filed Jun. 3, 2004
  • Summary: The reissue adds three new claims to the patent. The new claims are identical to three original claims, except that the three original claims did not specifically refer to the isolation of a particular configuration. The reissue also fixes typographical and printing errors.
• Protest
  • Received: Nov. 29, 2004
  • Summary: The protest argues that Applicant is precluded from obtaining a U.S. patent because Applicant holds a Japanese patent which covers some of the same subject matter. The protest asserts that Applicant did not file his U.S. patent application in a timely manner after the Japanese patent had issued.
• Applicant Response to Protest
  • Received: Feb. 3, 2005
  • Summary: Applicant responds that the Japanese patent does not cover the same subject matter as the present patent application. Applicant asserts that it was not obvious to scientists that the six-membered ring in the Japanese could be changed to a five-membered ring in order to improve the potency of the compound.
• Patent Office Non-Final Action
  • Claims 1-9 are allowed and claims 10-12 are rejected.
  • Summary: Examiner rejects protestors assertion that a five-membered ring was an obvious variation of the 6-membered ring disclosed in the Japanese patent. The Examiner does note, however, that the Japanese patent was used in limiting the claims of the original patent. Thus, Examiner allows the same 9 claims that were part of the original patent. Examiner rejects the 3 new claims. The Applicant failed to timely file for a U.S. patent application by not submitting the application within one year of obtaining an Australian patent on a similar compound.
• Applicant Response to Non-Final Action
  • Summary: Applicant cancels all of the pending claims and presents new ones which are not directed to a particular stereochemistry.  Stereochemistry refers to the three-dimensional properties of molecules.
• Patent Office Final Action
  • Summary: The examiner rejects the new claims.  By eliminating the stereochemistry of a compound, the applicant is essentially claiming all three-dimensional forms of the molecule.
• Applicant Response to Final Action
  • Summary: Applicant cancels the new claims and presents further new claims that represent only a particular stereochemical configuration.  These claims are narrowed than those presented earlier.
• Patent Allowed

Watts

“Compositions Comprising Cannabinoids”

Current status: All claims rejected (Nov. 8, 2006)

• Original Patent
  • Number 6,383,513
  • Issued May 7, 2002
  • Summary: Cannabinoids are a class of pharmacologically active substances contained in marijuana. The patented invention is a composition of cannabinoids that is ready for administration through the nose. Advantages of nasal delivery, compared to smoked marijuana, include reduced stress on the lungs and the ability to precisely adjust the dosage administered.
  • Original Assignee: West Pharmaceutical Services Drug Delivery & Clinical Research Centre, Ltd. (Nottingham, GB)
• Reissue Application
  • Number 11/133,484
  • Filed May 19, 2005
  • Summary: The reissue seeks to narrow the scope of the patent. Narrowing reissues are often sought when a new reference is discovered and the applicant wants the patent office to reaffirm the validity of the patent, in light of the new reference. In this instance, the applicant cites a study in which rabbits' eyes were treated with cannabinoid compounds. Although the administration was not intranasal, the cannabinoid composition prepared by the researchers is similar to that described in the patent.
• Protest
  • Received: Nov. 29, 2004
  • Summary: The protest argues that two earlier patents issued to Illum describe the same invention claimed by Applicant. These patents disclose compositions that are suited for nasal delivery, and which are in many ways similar to the ones in the Watts patent. These earlier patents refer broadly to types of drugs that can be nasally administered, but do not mention marijuana specifically. The protest explains that it would have been obvious for researchers studying cannabinoids to make intranasal preparations like the ones described in Watts because it was a goal of these researchers to make cannabinoid compounds that would be more readily availably for the body to use.
• Patent Office Non-final Action
  • Summary: The Examiner rejected all of the arguments we made.  However, the Examiner relied on the references that we submitted in holding that almost all of the claims were anticipated and therefore ineligible for patent protection.  The Examiner also made a wide variety of rejections on technical grounds.

Banholzer

“Esters of Thienyl Carboxylic Acids and Amino Alcohols and Their Quaternization Products ”

Current status: 6 of 22 Claims Rejected (April 25, 2006)

• Original Patent
  • Number 5,610,163
  • Issued Mar. 11, 1997
  • Summary: The patent is for the active ingredient in Spiriva Handihaler, tiotropium bromide, and related substances.  Tiotropium bromide is part of a class of drugs known as anti-cholingerics which reduce muscle spasms by blocking nerve impulses.  When inhaled as a powder, the drug opens up airways and relieves the breathlessness associated with chronic obstructive pulmonary diseases (i.e. chronic bronchitis and emphysema).
  • Original Assignee: Boehringer Ingelheim (Ingelheim am Rhein, DE)
• Reissue Application
  • Number 11/254,213
  • Filed Oct. 18, 2005
  • Summary: The original patent did not specifically claim methods for treating chronic obstructive pulmonary diseases using tiotropium bromide.  Instead, it claimed a method for using any one of a broad range of anticholinergic compounds.  Although tiotropium was covered in this range, it is often useful for applicants to have additional, narrower claims to fall back on in case the broader claim is later declared invalid by a court.
• Protest
  • Received: Feb. 27, 2006
  • Summary: In obtaining the original patent, the applicant convinced the patent examiner that tiotropium was superior to other products already on the market.  The applicant presented evidence showing tiotropium provided longer-acting relief than an older drug called ipatropium.  Patients not Patents argues that the comparison to ipratropium is inappropriate, and that the patented chemical should have been compared to more modern drugs.  Additionally, Patients not Patents pointed out that the range of compounds claimed by the applicant are mostly ineligible for patent coverage because the applicant already patented many of the exact same compounds in Great Britain in 1974.  While tiotropium bromide itself was not explicitly mentioned in the British patent, researchers have long known that how the compound could be made from the substances described in the British patent.  Exacly how and why a researcher would make tiotropium bromide is described in a decades-old U.S. patent, as the protest points out.
• Patent Office Non-final Action
  • All claims are rejected.
  • Summary: The Examiner used a reference submitted by Patients not Patents in rejecting six of the claims, adopting reasoning similar to that argued in the protest.  Patients not Patents argued that a previously patented eight-member ring compound was so similar to Applicant's seven-member ring compound that it was unsurprising that both compounds were useful in treating asthma.  The reason that the seven- and eight-member rings behave so similarly is that they are geometrically similar.  The Examiner cites to principles of bioisosterism, the study of how the geometry of molecules affects their biologic properties.

D'Amato

“Methods and Compositions for Inhibition of Angiogenesis”

Current status: All claims rejected (Sep. 7, 2006)

• Original Patent
  • Number 5,712,291
  • Issued Jan. 27, 1998
  • Summary: The patent covers the application of 3-aminothalidomide and 3-hydroxythalidomide—derivatives of the morning sickness drug once banned for causing gross deformities in fetal development—to inhibit undesired growth of new blood vessels into a tissue or organ (angiogenesis). The patent claims a method of use that applies to a list of 79 diseases dependant on or associated with angiogenesis. Such conditions range from Vitamin A deficiency (claim 12) to contact lens overwear (claim 13) to acne rosacea (claim 18) to syphilis (claim 20) to chemical burns (claim 23) to trauma (claim 33) to solid or blood borne tumors (claims 64 and 65) to AIDS (claim 66) to chronic inflammation (claim 69). Undesired angiogenesis has been treated in the past with protamine, heparin, steroids, animal factors, synthetic human factors, ascorbic acid ethers, and other treatments. These other treatments depend on topical or injectable application, which the Applicant reports as inadequate for general angiogenic inhibition and ease of administration. Thalidomide may be self-administered by patients in oral form.
  • Original Assignee: The Children’s Medical Center Corporation, Boston, MA (US)
• Reissue Application
  • Number 11/384,188
  • Filed Mar. 17, 2006
  • Summary:  Applicant submits a correction that removes 3-aminothalidomide from claim 1 because Applicant admits that there is insufficient written description support. Applicant adds 80 additional claims that specifically apply to 3-hydroxythalidomide.
• Protest
  • Received: Jul. 10, 2006
  • Summary: The protest notes that a previous scientific publication discloses that 3-hydroxythalidomide and thalidomide are structurally and functionally similar, both having teratogenic effects. A person having ordinary skill in the art would have recognized that 3-hydroxythalidomide could be substituted for thalidomide as a method of treating unwanted angiogenesis. Protester also asserts that Applicant’s claims are inherently anticipated because thalidomide is metabolized in the body to form 3-hydroxythalidomide as disclosed by previous publications. Protester also argues that the term “undesired” is not defined by the claims or specification.
• Patent Office Non-final Action
  • All claims rejected
  • Summary: The Examiner accepted our argument that 3-hydroxythalidomide is an obvious variation of a patent issued to the same inventor, and therefore rejected all of the claims.  The Examiner also accepted our suggestion that the term "undesired" is vague.  Additionally, the information disclosed in the patent was deemed to be insufficient to allow another scientist in the field to make and use the metabolite.