Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Detailed Action
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 17 July 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. The instant application is a continuation of Application 17/164039 (currently abandoned) filed 1 February 2021, which is a continuation of Application 16/407737 (now U.S. Patent 10,933,022) filed 9 May 2019, which is a continuation of Application 14/376292 (now U.S. Patent 10,342,764) filed 1 August 20214 which is a national stage entry of PCT/IL2013/050091 filed 31 January 2013. Claims 1, 16-25, and 27-30 are currently pending. Claims 2-15, 26, and 31-33 are cancelled. Claims 1, 16-25, and 27-30 are examined on the merits within.
Examiner’s Note: A call was made on 4 November 2025 to the Attorney listed on the Arguments filed on 17 July 2024. A voicemail was left requesting Terminal Disclaimers to overcome the Double Patenting Rejections. A return call was not received in the time requested.
Claim Rejections – 35 U.S.C. 112(b)
3. 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.
4. Claim 1 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.
5. Claim 1 recites the limitations "the BBI preparation" and “the preparation” in lines 9, 11, 16 and 18. There is insufficient antecedent basis for this limitation in the claim. It appears that “the BBI preparation” and “the preparation” in lines 9 and 11 refer to the combination of step (b) and “the preparation” in lines 16 and 18 refer to the combination of step (d). The claim could be more clearly written as “(b) eluting and combining fractions from (a) that contain the BBI activity to form a BBI preparation” and then amending line 11 to state “the BBI preparation” and “(d) eluting and combining the fractions from (a) that contain the KTI activity to form a KTI preparation” and amending “the preparation” in lines 16 and 18 to state “the KTI preparation”.
Double Patenting
6. 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.
7. Claims 1, 16-25, and 27-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of U.S. Patent No. 10,342,764.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and U.S. Patent No. 10,342,764 are directed to oral pharmaceutical compositions produced by a specific process, comprising fish oil, a therapeutic protein having a molecular weight of up to 100 kilodalton, a chelator of divalent cations, a purified BBI product and a purified KTI product. The only difference lies in the fact that the instant application further includes a polyethylene glycol ester of a mono-, di- or triglyceride. However, U.S. Patent No. 10,342,764 discusses the addition of a polyethylene glycol ester of a mono-, di- or triglyceride to the composition in dependent claim 11. The dependent claims are included in this rejection as being directed to addition of similar components in similar amounts. U.S. Patent No. 10,342,764 is also directed to methods of making the pharmaceutical formulation, which would result in the composition as instantly claimed and orally administering the formulation. Since the instant claims are directed to an oral formulation, it would have been obvious to administer the formulation orally. Thus the claims are not patentably distinct.
8. Claims 1, 16-25, and 27-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,933,022.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and U.S. Patent No. 10,933,022 are directed to oral pharmaceutical compositions produced by a specific process, comprising fish oil, a therapeutic protein having a molecular weight of up to 100 kilodalton, a chelator of divalent cations, a purified BBI product and a purified KTI product. The only difference lies in the fact that the instant application further includes a polyethylene glycol ester of a mono-, di- or triglyceride. However, U.S. Patent No. 10,933,022 discusses the addition of a polyethylene glycol ester of a mono-, di- or triglyceride to the composition. See column 11. The dependent claims are included in this rejection as being directed to addition of similar components in similar amounts. Thus the claims are not patentably distinct.
9. Claims 1, 16-25, and 27-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,398,762.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and U.S. Patent No. 10,398,762 are directed to oral pharmaceutical compositions comprising an oil based liquid, a trypsin inhibitor, and a chelator of divalent cations. The difference lies in the fact that U.S. Patent No. 10,398,762 specifies insulin and exenatide whereas the instant application states a therapeutic protein. However, the specification of the instant application further states both insulin and exenatide as active ingredients. See page 14. U.S. Patent No. 10,398,762 also describes addition of polyethylene glycol components. See column 4. U.S. Patent No. 10,398,762 claims methods of administering the oral composition. Since both the application and Patent are directed to oral composition, it would have been obvious to administer them orally. The dependent claims are directed to similar additional agents, amounts, and ratios. Thus the two are not patentably distinct.
10. Claims 1, 16-25, and 27-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,395,848.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and U.S. Patent No. 11,395,848 are directed to oral pharmaceutical compositions comprising an oil based liquid, a protease inhibitor, and a chelator of divalent cations. The difference lies in the fact that U.S. Patent No. 11,395,848 specifies insulin and exenatide whereas the instant application states a therapeutic protein. However, the specification of the instant application further states both insulin and exenatide as active ingredients. See page 14. U.S. Patent No. 11,395,848 also describes addition of polyethylene glycol components. See column 4. U.S. Patent No. 11,395,848 claims methods of administering the oral composition. Since both the application and Patent are directed to oral composition, it would have been obvious to administer them orally. The dependent claims are directed to similar additional agents, amounts, and ratios. Thus the two are not patentably distinct.
11. Claims 1, 16-25, and 27-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-40 of copending Application No. 19/042433 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and Application No. 19/042433 are directed to oral pharmaceutical compositions comprising an oil based liquid, a protease inhibitor, and a chelator of divalent cations. The difference lies in the fact that Application No. 19/042433 specifies insulin and exenatide whereas the instant application states a therapeutic protein. However, the specification of the instant application further states both insulin and exenatide as active ingredients. See page 14. Application No. 19/042433 also describes addition of polyethylene glycol components. See page 5. Application No. 19/042433 claims methods of administering the oral composition. Since both the application and Patent are directed to oral composition, it would have been obvious to administer them orally. The dependent claims are directed to similar additional agents, amounts, and ratios. Thus the two are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Correspondence
12. No claims are allowed at this time.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615