DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on June 23, 2026 has been received and entered.
Claim Disposition
3. Claims 1-16 are pending. Claims 13-16 are under examination. Claims 1-12 are withdrawn from further consideration pursuant to 37CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
4. The Information Disclosure Statements filed on June 23, 2026, has been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action. Note that some references have been lined through because there is an incomplete date.
Claim Objections
5. Claims 13-16 are objected to for the following informalities:
For clarity it is suggested that claim 13 is amended to recite “…wherein the device is a test strip…”. The dependent claims hereto are also included.
For clarity it is suggested that claim 15 is amended to read, “The device of claim 13, wherein the device comprises at least one application zone and wherein the device is designed [[such that a]] to allow the sample [[which]] when applied in the application zone [[can]] to reach…..””.
Appropriate correction is required.
Claim Rejections - 35 USC §112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 13-16 are rejected under 35 U.S.C.112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to “a device” for the determination of the enzymatic activity of a transglutaminase in a sample, wherein the device comprises at least one reaction zone (which comprises immobilized glutamine donor) see claim 13 in its entirety. The claimed invention is not adequately described because the device is not described with sufficient structural detail to determine what the device is, instead primarily based on an enzymatic activity. The instant specification provides FIG 1 and a description; however, the limitations of the specification cannot be read into the claims which are overly broad. The specification discloses that the device one as shown in FIG. 1A…. In addition, at paragraph [0083] it is disclosed that, “the present invention also relates to a device for the determination of the enzymatic activity of transglutaminases…. in particularly a test strip, for example in the form of a lateral flow test…... [0084]The device comprises at least one reaction zone, preferably exactly one reaction zone. [0085] Preferably, the device comprises three or more zones, in particularly three zones. Preferably, the device comprises at least one application zone, at least one reaction zone and at least one suction zone. The device may comprise a carrier (for example made of a carrier material) onto which the materials of the different zones are applied. The presence of a carrier is an optional feature. In some embodiments of the invention the device does not comprise a carrier”.
The claimed invention recites in claim 13 is very broad with respect to the device. The claimed invention requires a transglutaminase in a sample and at least one reaction zone which means there is no upper limit on the reaction zones, the claimed invention encompasses a large genus that is not adequately described.
The scope of independent claim 13 far exceeds the scope in the specification and although the dependent claims recite some of the missing information, claim 13 is not limited to those and needs to stand on its own. The specification fails to provide any additional representative species of the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species which are adequately described are representative of the entire genus. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
The 'written description' requirement.., serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed ....The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The purpose of the written description requirement "is to ensure that the scope of the right to exclude ... does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed. Cir. 2000). The goal of the written description requirement is "to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4 (CCPA 1977) "A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date. Additionally, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed' (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of enzymes; and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required.
See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993). Thus for all these reasons the claimed invention is not adequately described.
Response to Arguments
7. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicants’ comments are moot. Note that the rejection under 112, first paragraph remains for the reasons stated above and herein and has been altered to reflect changes made to the claims. Applicant traverses the rejection and states that claim 13 has been amended, however, more details are required. The claim does not set forth enough structural information, the type of device, for example. Thus, the rejection remain. The examiner would welcome a conversation to reduce the remaining issues with applicant’s representative.
.
Conclusion
8. No claims are presently allowable.
9. Applicant’s amendment necessitated the new/modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE ROBINSON whose telephone number is (571)272-0957. The examiner can normally be reached on Monday-Friday from 9:00 a.m. to 5:00 p.m. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi, can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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