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 .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 9, 2025 has been entered.
3. Claims 1, 6-10, 17 and 18 are pending.
Claim 18 has been added.
Claim 17 has been amended.
Claims 1, 6-10, 17 and 18 are examined on the merits.
4. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 112
5. The rejection of claims 1, 6-10, 17 and new claim 18 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s arguments and corresponding evidence presented on pages 4-6 of the Remarks submitted October 9, 2025, as well as the state of the art.
New Objections
Claim Objections
6. Claim 1 is objected to because of the following informality: the proper full name for NASH disease is non-alcoholic steatohepatitis and not non-alcoholic steatopepatitis as cited in line 1.
Correction is required.
New and Maintained Grounds of Rejection
Claim Rejections - 35 USC § 112
7. 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.
8. Claim 10 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.
a. It is not clear how a subject with non-alcoholic steatohepatitis (NASH) does not have such hallmarks of the disease such as hepatic steatosis and hepatocyte apoptosis. Likewise, it is art known NASH is a form of chronic hepatitis, hence it is not clear how a NASH subject does not have this inflammation of the liver. Applicant is requested to clarify.
Claim Rejections - 35 USC § 103
9. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
10. Claim(s) 1, 6-10, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fujita et al., (Hepatology: 46(4): 762A-763A, October 2007/ IDS reference #4 submitted October 3, 2023), and further in view of Fontayne et al., (Thromb. Haemost. 100: 670-677, published online September 5, 2008) and Andrews et al., (Life 56(1): 13-18, January 2004). Fujita teaches NASH patients treated with antiplatelet agents have a therapeutic effect, see Background and Aims on page 762A. Three classes of antiplatelet agents (aspirin, ticlopidine, cilostazol) produced improvement of steatohepatitis in the treated subjects, see Background and Aims on page 762A; and Results on page 763A. Each agent rendered some alleviation or produced improvement of the steatohepatitis, see Results and Conclusion on page 763A.
Fujita does not teach the antiplatelet agent that can treat NASH is an anti-Gp1b antibody that inhibits Gp1b and its function.
However, Fontayne teaches h6B4-Fab, a humanized Fab fragment that is able to inhibit the human platelet glycoprotein (GP) 1ba and block the binding of von Willebrand factor (VWF) to platelets, thereby facilitating antithrombotic capacities, see page 670, Summary; and paragraph (para.) bridging the columns (cols.) in the Introduction; para. bridging pages 675 and 676; and page 676, last para. in 2nd column (col.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of both references to substitute one of the three antiplatelet agents of Fujita with the antiplatelet agent, h6B4-Fab of Fontayne to treat NASH. It is art known that platelets express GPIb, see Summary on page 13; Figure 1A on page 15 of Andrews; Co-association segment spanning pages 16 and 17; and entire document.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in both references to administer the antigen-binding fragment of an anti-Gp1b antibody, h6B4-Fab because like aspirin, clopidogrel or GPIIb/IIIa blockers, the said fragment is able to prevent the development of thrombi, see page 675, 2nd col., 1st paragraph. Furthermore, the taught fragment is able to block platelet dependent thrombus formation quite unlike the other aforementioned agents and inhibit the GPIba/VWF axis, see 2nd col. on page 675 and 1st column on page 676.
Double Patenting
11. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
12. The provisional nonstatutory double patenting rejection of claims 1, 6-10, 17 and new claim 18 as being unpatentable over claims 1, 3 and 10 of copending Application No. 17/639,315 (filed February 28, 2022) is maintained and made.
At this point in prosecution the claimed invention is not allowable. The Examiner will notify Applicant when the claims are allowable. Accordingly, the rejection is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims read on treating NASH, HCC in a NASH-patient at risk to develop cirrhosis and/or HCC with an inhibitor of GP1b that is a binding agent, an antigen binding construct that is an antibody or antigen-binding fragment of an anti-GP1b antibody.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
13. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached between the hours of 8AM-8PM, Monday through Friday.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
11 December 2025
/Alana Harris Dent/Primary Examiner, Art Unit 1643