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 .
Claim Status
In the reply filed on 31 August 2026, claims 1, 6-8 are amended, claims 4, 9, 11-32, 34-48 are canceled.
Therefore, claims 1-3, 5-8, 10, 33 are herein pending.
Election/Restrictions
Applicant previously elected without traverse of Group I, claims 1-3, 5-8, 10, 33 drawn to a method of expanding hepatoblasts with a Wnt pathway activator, a TGF beta inhibitor, and FGF19 in the reply filed on 17 December 2024.
In the reply filed 03 October 2025, Applicant has cancelled withdrawn Groups 2-3 (Claims 11-32 and 34-48).
Therefore, claims 1-3, 5-8, 10, 33 are herein under examination.
Withdrawn Rejections
In the reply filed on 31 August 2026, Applicant has amended claims 1 and 8 included the limitation to refer to "an equivalent thereof designated NGM282,” therefore, the breath of amended claims 1, 8 and 33 overcome indefiniteness. Accordingly, the prior rejection of claims 1-3, 5, 8, 10, 33 under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention is hereby withdrawn.
Similarly, breathe of the amendment of claims 1,8 and 33 overcome the 35 U.S.C. 112(a) written description requirement, therefore the prior rejection of claims 1, 8, and 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or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is hereby withdrawn.
Maintained/Modified Rejections 35 USC § 112(b)
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 6-7 are stand rejected in modified form rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. This rejection is maintained for reasons of record and further explained below.
Claims 6-7 are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as being incomplete for omitting essential steps, such omission rendering the claim indefinite. See MPEP § 2172.01. Specifically, claim 6 is directed to “A method of expanding hepatoblasts. In the remark, applicant states in the remark that claim 6 is a stand-alone independent claim and identifies the method disclosed in SPEC page 9, lines 3-31 as providing support for the recited method of expanding hepatoblasts (see remark 5 last ¶ filed 31 August 2026). However, claim 6 does not recited expansion of hepatoblasts under hypoxic conditions in the presence of an activator of the Wnt pathway, a TGF beta receptor inhibitor, and FGF19 or an equivalent thereof designated NGM282, under conditions sufficient to expand the hepatoblasts.
Accordingly, the claim 6 merely recites “a methos of expanding hepatoblasts” without positively reciting the essential culturing steps by which the claimed expansion is accomplished. Claim 7 depends therefrom and does not cure this deficiency. Therefore, claims 6 and 7 are incomplete and fail to particularly point out and distinctly claim the subject matter regarded as invention.
RESPONSE TO ARGUMENTS
Applicants argument filed on 31 August 2026 are acknowledged.
Applicants argue that Claim 6 is a stand-alone independent claim and is not dependent upon claim 1. Both the methods described in independent claim 1 as well as the method described in independent claim 6 are effective methods for expanding hepatoblasts. See, for example, page 9, lines 3-31. The reference to "the hepatoblasts" in the culturing step of claim 6 was intended to refer to the hepatoblasts referenced in the preamble of claim 6 (see remark 5 last ¶).
The Applicant's arguments have been fully considered, but is not persuasive because MPEP 2163 states that “A claim which omits matter disclosed to be essential to the invention as described in the specification or in other statements of record may also be subject to rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as not enabling, or under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); In re Venezia, 530 F.2d 956, 189 USPQ 149 (CCPA 1976); and In re Collier, 397 F.2d 1003, 158 USPQ 266 (CCPA 1968)”. See also MPEP § 2172.01. Instant claim 6 does not recited expansion of hepatoblasts under hypoxic conditions in the presence of an activator of the Wnt pathway, a TGF beta receptor inhibitor, and FGF19 or an equivalent thereof designated NGM282, under conditions sufficient to expand the hepatoblasts. Accordingly, the claim 6 merely recites “a methos of expanding hepatoblasts” without positively reciting the essential culturing steps by which the claimed expansion is accomplished. Claim 7 depends therefrom and does not cure this deficiency. Therefore, claims 6 and 7 are incomplete and fail to particularly point out and distinctly claim the subject matter regarded as invention.
The rejection of claims 1, 8, and 33 under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (preAIA ), first paragraph have been withdrawn in view of the amendments to the claims filed on 31 August 2026 (see remark. p. 5 3rd-6th ¶). Therefore, Applicants argument are moot.
Conclusion
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for replying 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.
Claims 1-3, 5, 8, 10, 33 are allowed.
Claims 6-7 are rejected.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (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, Christopher Babic, can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
Prosecution Insights