DETAILED ACTION
Acknowledgment and entry of the Amendment submitted on 11/17/25 is made. Claims 17, 18, 20 and 37 are currently under examination.
Claims 1, 2, 3, 6, 7, 9, 11, 13-16, 22, 23, 26, 27, 32, 36, 38 and 39 remain withdrawn for being drawn to a non-elected invention.
The following rejections were necessitated by the amendment to the claims:
Claim Rejections - 35 USC § 112-2nd paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17, 18, 20 and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 17 and 20 recite that the nucleic acid encodes S. mansoni cathepsin B which they have identified by GenBank accession number. The claims refer to position 183 yet the actual nucleic acid sequence is not recited in the claims or instant specification. A patent claim that identifies a sequence solely by a GenBank accession number is indefinite, as the underlying sequence data can change over time. While an accession number (e.g., "M58708") remains constant throughout the lifetime of a record, the actual sequence data associated with it can be updated. These updates can be made by the person who initially submitted the sequence, inventors or third parties.
Claim Rejections - 35 USC § 112-Written Description
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.
Claims 17, 18, 20 and 37 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification does not have a nucleic acid sequence which encodes cathepsin B, nor does it provide the amino acid sequence for cathepsin. There is no sequence listing provided for these molecules. The sequence of cathepsin B across different organisms/species can vary greatly.
The amended claims recite GenBank accession number AAA29865 which is mentioned in the original specification. See, for instance:
Top of page 16 of the instant specification:
Known immunogenic cathepsin B fragments include, but are not limited to, fragments described in Noya et al. (2001). In a specific embodiment, the cathepsin B protein corresponds to the S. mansoni cathepsin B protein in which a putative glycosylation site has been removed. In yet a further specific embodiment, the cathepsin B protein corresponds to the S. mansoni cathepsin B (GenBank accession number AAA29865) at which, at position 183, the asparagine residue has been replaced with a glycine residue.
However, the actual nucleic acid sequence or the amino acid sequence of the protein has not been provided. They are not in a properly filed sequence listing or contained in the original specification, drawings or claims.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of claimed nucleotides such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
The purpose of the "written description" requirement is broader than tomerely explain how to "make and use"; the applicant must convey with reasonableclarity to those skilled in the art that, as of the filing date sought, he or she was inpossession of the invention. The invention is, for purposes of the "writtendescription" inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar,935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).Furthermore, the written description provision of 35 USC § 112 is severable fromits enablement provision; and adequate written description requires more than amere statement that it is part of the invention and reference to a potential methodfor isolating it. The nucleic acid itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, "'Written Description" Requirement (66 FR 1099-1111, January 5,2001) state, "[p]ossession may be shown in a variety of ways including description of an actualreduction to practice, or by showing the invention was 'ready for patenting' such asby disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention" (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. The Guidelines further state, "[f]or inventions in an unpredictable art, adequatewritten description of a genus which embraces widely variant species cannot beachieved by disclosing only one species within the genus'" (Id. at 1106);accordingly, it follows that an adequate written description of a genus cannot beachieved in the absence of a disclosure of at least one species within the genus.
"Possession may not be shown by merely describing how to obtain possession of members of the claimed, genus or how to identify their common structural features" (See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895). A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the. gene does (function), rather what it is (structure), see University of California v. Eli Lilly & Co., 43 USPQ2d 1938, thus above claims lack adequate written description.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Incorporation by Reference
The attempt to incorporate subject matter into this application by reference to this Genbank accession number is ineffective because the root words “incorporate by reference” are omitted.
The amended claims recite GenBank accession number AAA29865 which is mentioned in the original specification, but is not in compliance with MPEP 37 CFR 1.57(b).
The instant specification does not clearly state “This material is to be incorporated by reference.” The attempt to incorporate subject matter into this application by reference to this Genbank accession number is ineffective because the root words “incorporate by reference” are omitted.
“Essential material” may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. However, MPEP 37 CFR 1.57 (g)(1): A correction … is permitted only if the application as filed clearly conveys an intent to incorporate the material by reference. A mere reference to material does not convey an intent to incorporate the material by reference.
With regards to Genbank accession numbers, a sequence which has only one version submitted prior to the filing date may be considered uniquely identified. If multiple versions of the sequence were submitted to the database prior to the effective filing date, the sequence may not be considered as uniquely identified.
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(f).
The amino acid sequence of the recited S. mansoni cathepsin is considered essential material because it is necessary to meet the requirements of 35 U.S.C. 112, 1st paragraph. 37 CFR 1.57(c). Upon review, the examiner noticed that the specification did not include a sequence for the protein or for nucleic acid molecule which encoded the protein.
In order for applicants to comply with 1.57(c) they must:
•provide a copy of the essential material,
•amend the specification to include the essential material,
•providing a statement under 1.57(e) and/or (f).
If applicant adds the sequence, Applicant should also comply with the sequence requirements 37 CFR 1.821-1.825.
A claim that identifies a sequence by database accession number will usually be accepted as clear intent to incorporate the sequence by reference. This claim must be an original claim that is present as of the filing date.
Language identifying a source only in passing as other prior work of no identified relevance is unlikely to be incorporated by reference.
In summary:
To comply with 1.57(b)(1): Applicants need to add root words “incorporat(e) and “reference” to the specification and to address 1.57(b)(2) as to whether the sequence was uniquely identified (only one version present in GenBank prior to the filing date).
Applicant's amendment necessitated the new 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Because the rejection under 35 U.S.C. 112, first paragraph was necessitated by the applicant’s amendment, the finality of the Office action is proper. If the applicant wishes to overcome the rejection under 35 U.S.C. 112, first paragraph by filing an amendment under 37 CFR 1.57(f) to add the subject material disclosed in the GenBank into the specification, applicant may file the amendment as an after final amendment in compliance with 37 CFR 1.116.
Alternatively, applicant may file an RCE under 37 CFR 1.114 accompanied by the appropriate fee, and an amendment per 37 CFR 1.57(f) within the time period for reply set forth in the final Office action.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Thursday from 8:00 AM-6:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/ Primary Examiner, Art Unit 1645 12/11/25