Claims, amended

Claim amendement and response to rejection filed September 1, 2006... 

If the USPTO finds that a substantial new question of patentability has been raised, a reexamination will be ordered, and the applicant will have at least 2 months to file a reply including any claims that she wishes to cancel or amend. A copy of the patentee s response must be served to the party requesting the reexamination procedure and that party has 2 months to file a response to the patent holder s statement. Any claim amendment cannot broaden any of the claims of the patent. 

In the section emphasis has been placed on the three key components of written description, enablement, and best mode. Each of these three requirements is separate and distinct, so that is how they will be treated in this chapter. Though it might seem obvious, each of the three sections of the written description requirement applies to the claimed invention only. It is surprisingly easy to get caught up with peripheral aspects of the invention that do not directly involve claimed elements and, as a result, overinterpret the ambit of 112 f 1. Likewise, it is easy to forget that written description is required for all of the elements in a claim and as a result, attempt to make claim amendments during patent prosecution that do not find adequate written description support in the patent specification. Making the claim elements the focus will help to keep one on track with respect to 112 f 1 issues. 

Prosecution history estoppel may apply to any claim amendment made to satisfy a statutory requirement of the patent act,... 

In order to overcome rejections based on prior pubHcations or patents, the appHcant often must amend the patent claims to include aspects of the invention which are not found in the pubHcations cited by the examiner as a basis for the rejections. The appHcant may also wish to provide properties, characteristics, or advantages of the invention which are unexpected in view of these pubHcations and patents. 

In response to the first office action, the appHcant may file a series of amendments (step 6) and should provide substantial reasoning and analysis to explain the reasons that the pubHcation(s) cited by the examiner do(es) not disclose the invention as it has been claimed. The patent appHcant s response should also comply with the examiner s request for correcting formal problems in the appHcation. 

The Certificate of Correction. Another mechanism for correcting the patent is the "Certificate of Correction," which is essentially a petition filed by the patentee to correct minor errors in the patent produced either by the U.S. PTO or inadvertentiy by the appHcant. Unlike the Notice of Errors, a Certificate of Correction does result in an additional pubHcation from the U.S. PTO, and anyone requesting a copy of a patent in which a Certificate of Correction has been filed will also obtain the Certificate of Correction. A Certificate of Correction reflects amendments made during the examination of the patent which were entered by the examiner but not found within the issued patent. The omission of such amendments can be in the body of the patent or in the patent claims. The Certificate of Correction may also be used to correct errors in the issued patent which were not present in the patent appHcation when it was filed. If the error was caused by the patent appHcant prior to or during examination, the patent appHcant bears the cost of filing and... 

If the appHcant decides to proceed, the PCT patent appHcation will pubHsh. At this time, the appHcant may either proceed to file the PCT patent appHcation in each designated national country or request examination of the PCT appHcation within the framework of the PCT. If the appHcant requests examination of the patent appHcation within the PCT, an Examiner will file a written action. The appHcant may then amend the appHcation by resubmitting new claims and new appHcation pages. 

Other expansions of FDA s authority include the Dmg Price Competition and Patent Term Restoration Act of 1984, commonly known as the 1984 Amendments or the Waxman-Hatch Act, which was passed to attain quicker marketing of safe, effective, and less expensive generic dmgs and the Safe Medical Device Amendments of 1990, which was passed to correct perceived weaknesses in the implementation of the 1976 Device Amendments. Congress further expanded FDA authority over nutrition labeling and health and nutrient content claims on food labels with the Nutrition Labeling and Education Act of 1990. 

A distinct concern arises in the area of veterinary dmgs because of the possibiUty that dmg residues may be conveyed to humans by the food-producing animals. Therefore, dmg residues and their safety in human food remain a central issue for the Center for Veterinary Medicine (CVM). Animal dmgs also include those products which promotional Hterature claims to improve feed efficiency and increase milk production. An animal food product is regulated under the 1968 Animal Dmg Amendments if it contains a dmg used in feed or premixes (25). 

Class III Premarket Approval. Similar to a new dmg approval, a premarket approval grants the appHcant a Hcense to market a specific weU-characterized device. These devices are subject to the requirements of Section 515 of the Eood, Dmg, and Cosmetic Act. A post-amendment device is a device put ia commercial distribution after May 28, 1976. If it is not substantially equivalent to a preamendment device it is automatically ia Class 111, and a premarket approval appHcation (PMA) is required. The appHcation must iaclude reports of preclinical and clinical studies done ia support of claims of safety and efficacy as well as any labeling claims made for the device. Once the PMA is submitted, the PDA determines whether the appHcation iacludes the required information. If the PMA is suitable for scientific review, the PDA has 180 days from the filing date to approve or deny the appHcation. Polybutester, polydioxanone, polyglyconate, and ePTPE sutures are all regulated as Class 111 devices. 

An area of increasing importance financially is the program. Contractors are claiming large sums with respect to delays, and it is important to take note before the contractor is appointed of any qualifications he may make to the bid. For example, if a bidder says in his bid that he can carry out the works in 40 weeks and it is known that the period envisaged is 52 weeks to coincide with other trades, then if he is frustrated from doing the work he can sue for loss and/or expense for the 12 weeks when he will have, in theory, to lay off men. The solution is to challenge the period inserted, and if the bidder will not amend his period, then do not appoint him. 

Sherley Amendments prohibit labelling medicines with false therapeutic claims intended to defraud the purchaser. 

Both the Sixth Amendment and several national premarket laws and regulations authorize individual Member States to (1) contest companies claims that certain data (in the Annex VII base set) are not necessary or are not technologically possible (2) to require the development of additional information and data and (3) to impose production or use restrictions pending the development of such additional data. Further, EEC countries may act without having to follow many of the procedures that TSCA imposes upon EPA, and the findings necessary to take these actions appear to be less stringent than TSCA requires of the Agency. 

Passage of the Sherley Amendment. Specifically outlawed any false label claims as to curative effect. 

The Sherley Amendment passes to prohibit false therapeutic claims in medicines. 

Id. at 355(j)(2)(B). Although the patent holder and the NDA filer are often the same person, this is not always the case. The Hatch-Waxman Amendments require that all patents that claim the drug described in an NDA must be fisted in the Orange Book. Occasionally, this requires an NDA filer to list a patent that it does not own. 

One district court explicitly has held that a brand-name company may not list a metabolite patent in the Orange Book, because the metabolite patent does not claim the drug, as required by the listing statute. " The court looked to the precedent, Hoechst-Roussel Pharms., Inc. v. Lehman, which interpreted the term claims in the Patent Term Restoration portion of the Hatch-Waxman Amendments at 35 U.S.C. 156(a) and concluded that a metabolite patent does not claim the approved dmg product. 

In 1998, the Trade Practices Amendment (Country of Origin Representations) Act 1998 came into force. Manufacturers making unqualified statements about country of origin, such as Made in. .. must be able to demonstrate substantial transformation and exceed a 50% production costs threshold. They, therefore, tend to use qualified claims, such as Made in Australia from local and imported ingredients, to ensure that labels are not misleading or deceptive. 

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