DETAILED 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 .
1. The Amendment filed February 5, 2026 in response to the Office Action of November 6, 2025, is acknowledged and has been entered. Claims 4, 21 and 22 are now pending and being examined. Claims 1-2, 5-20 are canceled. Claim 4 is amended. Claims 21 and 22 are new.
New Rejection
(necessitated by amendments)
Claim Rejections - 35 USC § 112
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.
2. Claims 4, 21, and 22 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 for the reasons in (A)-(B) below:
Claim 4 recites: A transgenic rodent, wherein the transgenic rodent comprises a genome comprising a nucleic acid encoding a companion animal DNA, wherein the companion animal DNA expresses or encodes canine IGHV4-1 to IGHV3-4, IGHD1-6, IGHJ1-6, IGLV3-1 to IGLV4-6, IGLJ1-9, and IGLC1-9. The claim language is unclear with regard to what canine immunoglobulin alleles are expressed or encoded in the genome of the transgenic rodent.
(A) It is unclear if the phrases “IGHV4-1 to IGHV3-4” and “IGLV3-1 to IGLV4-6” recite ranges of IGHV alleles or if they recite two alleles. If these are ranges, what alleles are encompassed by these ranges?
IMGT.org (printed April 2026) lists numerous canine IGHV alleles encompassed by IGHV4 and IGHV3, and it is unclear which are encompassed in a range of “IGHV4-1 to IGHV3-4.” IMGT.org (printed April 2026) lists numerous canine IGLV alleles encompassed by IGLV3 and IGLV4, and it is unclear which are encompassed in a range of “IGLV3-1 to IGLV4-6”.
The metes and bounds of the claimed invention cannot be determined.
(B) The language of “IGHV4-1 to IGHV3-4” and “IGLV3-1 to IGLV4-6” utilize hyphenated names (i.e., “IGHV4-1”) and the word “to” between the names, presumably to indicate a range of alleles (i.e., “IGHV4-1 to IGHV3-4”), therefore, given this terminology, it is unclear if the other recited hyphenated terms (i.e., IGHD1-6, IGHJ1-6, IGLJ1-9, and IGLC1-9) indicate a range of alleles or a hyphenated name.
Dependent claims 21 and 22 are rejected or encompassing the rejected limitations of claim 4.
Examiner Suggestion: Amend claim 4 to individually recite/identify each canine immunoglobulin allele required to be expressed and encoded by the DNA comprised in the transgenic rodent genome.
3. Claim 22 is 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.
Claim 22 recites: “… wherein the companion animal DNA further expresses or encodes IGHV3-5.”
The claim is unclear with regard to what companion animal DNA sequence is encompassed by “IGHV3-5”. The instant specification provides non-limiting examples of companion animals including dogs, cats, horses, birds, rabbits, goats, reptiles, fish and amphibians from which the companion animal DNA may be derived (see published specification at paragraphs [39], [83]). The instant specification does not disclose a defined sequence represented by the term IGHV3-5 or provide a limiting definition of what is encompassed by companion animals.
IMGT.org (printed April 2026) for canine lists IGHV alleles comprised by canines, including IGHV3-5 (IGHV3-5*01). IMGT.org (printed April 2026) for zebrafish lists IGHV alleles comprised by zebrafish, but does not disclose any “IGHV3-5”. IMGT.org (printed April 2026) for horses lists IGHV alleles comprised by horses, and does not disclose any “IGHV3-5”. Therefore, the scope of “IGHV3-5” companion animal DNA sequence comprised by the claimed transgenic rodent is unclear. The metes and bounds of the claimed invention cannot be determined.
Examiner Suggestion: Amend claim 22 to recite: “…wherein the companion animal DNA further expresses or encodes canine IGHV3-5.”
4. All other rejections recited in the Office Action mailed November 6, 2025 are hereby withdrawn in view of claim amendments.
The rejection of claims under 35 USC 103 are withdrawn in view of claim amendments. US Patent 10,662,256, Wabl, does not teach or suggest inserting all of the specifically claimed companion animal IGHV4, IGHV3, IGHD, IGLV3, IGLV4, IGLJ, and IGLC alleles into their transgenic mouse.
5. Conclusion: No claim is allowed.
Conclusion
6. 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.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA B GODDARD whose telephone number is (571)272-8788. The examiner can normally be reached Mon-Fri, 7am-3:30pm.
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/Laura B Goddard/Primary Examiner, Art Unit 1642
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