HSDETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application, filed 05/09/2023, claims domestic benefit to US provision applications 63/495,762; 63/371,697; and 63/364,559; filed 04/12/2023, 08/17/2022, and 05/11/2022, respectively.
Claim Status
Claims 1-26 are pending in the instant application and are examined on the merits herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/29/2023 has been considered by the examiner.
Applicant is notified the listing of references in the specification is not a proper information disclosure statement (pg 170-172). 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (pg 109, line 22). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the term “KinExA” (pg 39, line 19), “EpiMatrix” (pg 109, line 34), “Tween” (pg 114, lines 13, 14, 17, and 20; pg 115, line 13; pg 133, lines 16 (x2), 24, and 27; pg 135, lines 8, 10, 13, and 16; pg 138, lines 27 and 28; pg 139, lines 1 and 4), “LabChip” (pg 139, line 18; pg 152, line 16), “ImageQuant” (pg 141, line 16), “Superdex” (pg 149, lines 19 and 21; pg 167, line 11), “LSRFortessa” (pg 156, line 23; pg 163, line 27), “EasySep” (pg 166, line 6), which are trade names or marks used in commerce, have been noted in this application. Each term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 3 is objected to because of the following informalities:
Unique germline framework identifiers for VH sequence (IGHV1-18*01, IGHV1-46*01, IGHV3-7*01, and IGHV1-2*02) and VL sequences (IGKV1-39*01, IGKV3-11*01 and IGKV3D-7*01) are repeated multiple times throughout the claim. It is unclear if the repetitions are intentional (i.e. a list of VH/VL framework pairs - e.g. species listed in Table 5) or if this is a typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The instant claim recites a TL1A-VH sequence (SEQ ID NO:80), which comprises heavy chain CDRs (SEQ ID NOs: 61, 51, and 35) not recited in base claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)
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.
Claim 14 is rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ novel biological materials, specifically plasmids encoding sequences of four polypeptide chains of an isolated p40TL1A binding antibody (ATCC Designation Nos. PTA-127349, PTA-127346, PTA-127350, and PTA-127203). Since the biological material is essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 USC 112, first paragraph, may be satisfied by a deposit of the plasmids.
It is noted that Applicants have deposited biological material at American Type Culture Collection (ATCC) under ATCC Designation Nos. PTA-127349, PTA-127346, PTA-127350, and PTA-127203, but there is no indication in the specification as to the public availability. If the deposit was made and accepted under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by the attorney of record over his/her signature and registration number, stating such is required. To satisfy the deposit requirement made herein, the affidavit, declaration, or statement must state that the specific plasmids have been deposited and accepted under the Budapest Treaty and that they will be available to the public under the conditions specified in 37 CFR 1.808.
If the deposit has NOT been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.80-1.809, applicants may provide assurance or compliance by an affidavit or declaration, or by a statement by an attorney of record over their signature and registration number showing that:
during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
upon granting of the patent the plasmids will be available to the public under the conditions specified in 37 CFR 1.808;
the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
a test of the validity of the biological material at the time of the deposit will be made (See 37 CFR 1.807); and
the deposit will be replaced if it should ever become inviable.
Allowable Subject Matter
Sequences claimed are free from prior art, as such claims 1-2, 5-13, 15-26 are allowed.
The following is considered the closest prior art: US 9,683,998 B2
Conclusion
Claims 1-2, 5-13, and 15-26 are allowed; claim 3 is objected to; and claims 4 and 14 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNAH SUNSHINE whose telephone number is (571)270-7417. The examiner can normally be reached M-Th & Second Friday 8:30am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANNAH SUNSHINE/Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647