How does the “was-was” analysis apply to product-by-process claims?
The “was-was” analysis is a key concept in evaluating product-by-process claims. According to MPEP 2113: “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or…
Read MoreWhat are the Wands factors for determining undue experimentation?
The Wands factors, established in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), are a set of criteria used to determine whether a patent disclosure satisfies the enablement requirement. According to MPEP 2164.01(a), these factors include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior…
Read MoreWhat is the Waiver of Statement Program in ex parte reexamination?
The Waiver of Statement Program is an initiative to expedite ex parte reexamination proceedings. According to MPEP 2249, “If the patent owner waives the right to file a patent owner’s statement in response to a request from the Office, the examiner will be able to act on the first Office action on the merits immediately…
Read MoreCan an applicant voluntarily identify grace period inventor-originated disclosures?
Yes, an applicant can voluntarily identify grace period inventor-originated disclosures. The MPEP encourages this practice: “Applicants can include a statement identifying any grace period inventor-originated disclosures in the specification upon filing. See 37 CFR 1.77(b)(6) and MPEP § 608.01(a). An applicant is not required to identify any prior inventor-originated disclosures or to use the format…
Read MoreWhy are viruses mentioned in both direct and indirect self-replication categories?
The MPEP 2403.01 mentions viruses in both direct and indirect self-replication categories to illustrate that these categories are not mutually exclusive. The MPEP states: “The list of representative examples of each type of replicating material includes viruses to demonstrate that the two lists in the rule are not intended to be mutually exclusive.” This inclusion…
Read MoreWhat information must be included in a viability statement for non-Budapest Treaty deposits?
For biological material deposits not made under the Budapest Treaty, a viability statement must be filed with the patent application. According to MPEP 2409 and 37 CFR 1.807(b), this statement must contain: The name and address of the depository The name and address of the depositor The date of deposit The identity of the deposit…
Read MoreWhat are the requirements for viability of deposited biological materials?
The viability of deposited biological materials is a crucial aspect of the deposit process. According to MPEP 2410.01, the following requirements apply: The deposit must be viable at the time it is made. The deposit must be tested for viability. The deposit must be replaced if it becomes non-viable. As stated in the MPEP: “The…
Read MoreWhat is the viability requirement for biological material deposits in patent applications?
According to MPEP 2409, the viability requirement for biological material deposits is essentially a requirement that the deposited material is capable of reproduction. This is outlined in 37 CFR 1.807(a), which states: “A deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and…
Read MoreHow does the Vanda case relate to the treatment or prophylaxis consideration in Step 2A Prong Two?
The Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd. case is significant in the context of the treatment or prophylaxis consideration in Step 2A Prong Two. According to MPEP 2106.04(d)(2): “Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). The claims in Vanda recited a method of…
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