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 .
DETAILED ACTION
Claims 1-2, 8-15, and 20-23 are pending.
Claims 4-7 and 16-19 have been canceled.
Claims 21-23 are new
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/12/2025 has been entered.
Claim Objections and Rejections Withdrawn
The objection to the specification is withdrawn in view of amendment of the specification to remove SEQ ID NO:60-62 to recite the three amino acids of the corresponding sequences for the light chain CDR2 disclosed within the light chain of SEQ ID NO:11-21 as defined by the IMGT numbering scheme and the priority document EP 22158552.4.
The rejections of claims 4-7 and 16-19 are moot in view of claim cancelation.
The rejection of claims 1-2, 8-15, and 20 under 35 § 103 is withdrawn in view of claim amendment.
The rejection of claims 1-2 and 20 under nonstatutory double patenting is withdrawn in view of claim amendment.
New Claim Objections and Rejections Necessitated by Amendment
Claim Rejections
Claims 1-2, 8-15, and 20-23 are objected to because of the following informalities:
Regarding instant claim 1, while the claim is clear that two sequences are required to be selected from each group, the claim requires exchange of “a variable region” to ---variable regions--- in line 5 to be grammatically correct. Claims 2, 8-15, and 20-23 are dependent on claim 1 and include the grammatically incorrect phrasing.
Appropriate correction is required.
Claim 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.
Claim 15 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.
Regarding claim 15, a method of treating ad/or preventing a disease or condition in a subject associated with administration of “fentanyl or a derivative thereof” is claimed in claim 15. The claims and instant specification do not clearly define a derivative of fentanyl to a degree that a person having ordinary skill in the art would be able to define the metes and boundaries of the claim. The instant specification states, “Derivatives of fentanyl envisaged in accordance with the present invention comprise structurally and/or functionally related derivatives of fentanyl...” (instant specification, page 15, paragraph 1). It is unclear to what amount of structurally or functionally similarity the compounds are to fentanyl to be defined as a derivative. Thus, the metes and boundaries of a derivative of fentanyl is unclear.
Response to Arguments
Applicant has amended claim 1 to obviate the previous rejection to claim 1. A 112(b) rejection for the indefinite “fentanyl or a derivative thereof” of claim 15 is above.
Double Patenting
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.
Claims 1-2 and 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/841,673. Although the claims at issue are not identical, they are not patentably distinct from each other because:
‘673 copending claim 6 taught an antibody that specifically binds the hapten fentanyl, wherein the Kd is at most 1000 pM, wherein said antibody is capable of protecting mice from adverse fentanyl actions when administered at a dosage (antibody compound (mg) / mouse body weight (kg)) of at most 1 mg/kg, wherein the heavy chain comprises ‘673 SEQ ID NO:5, which has an identical sequence to instant SEQ ID NO:5 and meets the claim limitations for an antibody wherein the antibody comprises a variable region which binds to a hapten (instant claim 1) which specifically binds to the hapten fentanyl (instant claims 2), wherein the Kd is at most 1000 pM (instant claim 22) and is capable of protecting mice from adverse fentanyl actions when administered at a dosage (antibody compound (mg) / mouse body weight (kg)) of at most 1 mg/kg (instant claim 23),
Response to Arguments
Applicant has amended claim 1. The updated rejection is above.
Claims 1-2, 8-15, and 20-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/841,673 in view of Frenzel A et al. (Frontiers in Immunology 2013 4, 1-20).
The claims of ‘673 taught the limitations of claims 1-2 and 22-23 for the reasons set forth above.
‘673 further taught an antibody which specifically binds to a hapten being fentanyl or a derivative thereof, wherein the dissociation constant (Kd) is at most 1000 pM, wherein the binding pocket for the hapten comprises amino acids from all three complementary determining regions (CDRs) of each chain and wherein said antibody is capable of protecting mice from adverse fentanyl actions when administered at a dosage (antibody compound (mg) / mouse body weight (kg)) of at most 1 mg/kg (claim 1); wherein the heavy chain comprises ‘673 SEQ ID NO:5 in copending claim 6 and:
wherein the light chain comprises ‘673 SEQ ID NO:15 in copending claim 7;
as a polynucleotide encoding the antibody in copending claim 8, wherein the polynucleotide is DNA in copending claim 9, wherein the polynucleotide is comprised within a vector or expression construct in copending claim 10, wherein the polynucleotide is comprised within a host cell of an animal cell in copending claim 11-12, wherein the polynucleotide is comprised within a non-human transgenic organism of an animal or plant in copending claims 13-14; and
wherein the antibody was administered in a method for treating and/or preventing a disease or condition in a subject associated with administration fentanyl or a derivative thereof in copending claim 15.
The claims of ‘673 did not teach a single embodiment of a heavy chain variable region comprising instant SEQ ID NO:5 and a light chain variable region comprising instant SEQ ID NO:15 as a polynucleotide encoding the antibody, wherein the polynucleotide is DNA, wherein the polynucleotide is comprised within a vector or expression construct, wherein the polynucleotide is comprised within a host cell of an animal cell, wherein the polynucleotide is comprised within a non-human transgenic organism of an animal or plant, but this is obvious in view of Frenzel.
Frenzel taught almost all therapeutic antibodies are still produced in mammalian cell lines in order to reduce the risk of immunogenicity due to altered, non-human glycosylation patterns (abstract). Frenzel taught recent developments of glycosylation-engineered transgenic plants are promising to obtain antibodies with “human-like” post-translational modifications (abstract). Frenzel taught the generation of stable master cell lines is a prerequisite for GMP compliant IgG production in the therapeutic sector in order to guarantee long term production stability, wherein antibody gene expression cassettes have to be stably integrated into the host cell genome, wherein strong promoters for improved mRNA stability and translation efficiency are usually implemented into the expression vector (page 5, right column, paragraphs 2-3).
Regarding instant claims 8-14, it would have been obvious for a person having ordinary skill in the art to take the antibody of ‘673 copending claim 6 of an antibody that specifically binds the hapten fentanyl, wherein the Kd is at most 1,000 pM, wherein said antibody is capable of protecting mice from adverse fentanyl actions when administered at a dosage (antibody (mg) / mouse body weight (kg)) of at most 1 mg/kg, wherein the heavy chain comprises ‘673 SEQ ID NO:5 – and:
1) produce a complete variable heavy and light chain antibody by including ‘673 SEQ ID NO:15 in copending claim 7, which would produce an antibody with a VH comprising a sequence identical to instant SEQ ID NO:5 and a VL comprising a sequence identical to instant SEQ ID NO:15; and 2) include the heavy and light chain paired antibody together as: a polynucleotide encoding the antibody as taught in copending claim 8, wherein the polynucleotide is DNA as taught in copending claim 9, wherein the polynucleotide is comprised within a vector or expression construct as taught in copending claim 10, wherein the polynucleotide is comprised within a host cell of an animal cell as taught in copending claim 11-12, wherein the polynucleotide is comprised within a non-human transgenic organism of an animal or plant as taught in copending claims 13-14.
This is obvious because: 1) a variable heavy chain would require a variable light chain to complete the antibody for hapten binding; 2) ‘673 taught a polynucleotide encoding the antibody in copending claim 8, wherein the polynucleotide is DNA in copending claim 9, wherein the polynucleotide is comprised within a vector or expression construct in copending claim 10, wherein the polynucleotide is comprised within a host cell of an animal cell in copending claim 11-12, wherein the polynucleotide is comprised within a non-human transgenic organism of an animal or plant in copending claims 13-14.
There is a reasonable expectation of success because: 1) a variable heavy chain would require a variable light chain to complete the antibody with a complete set of 6 CDR binding determinants and light chains were further taught by ‘673; and 2) Frenzel taught almost all therapeutic antibodies are still produced in mammalian cell lines to reduce the risk of immunogenicity, wherein the generation of stable master cell lines is a prerequisite for GMP compliant IgG production, wherein antibody gene expression cassettes contain strong promoters for improved mRNA stability and translation efficiency are usually implemented into the expression vector. Thus, recombinant antibodies produced as DNA polynucleotide encoding the antibody, wherein the polynucleotide is comprised within a vector or expression construct, wherein the polynucleotide is comprised within a host cell of an animal cell is effective. Further, Frenzel taught recent developments of glycosylation-engineered transgenic plants are promising to obtain antibodies with “human-like” post-translational modifications. Thus, inclusion of the polynucleotide within a non-human transgenic organism of an animal or plant has a reasonable expectation of success for antibody production.
Regarding instant claims 20-21, an antibody comprising a VH comprising ‘673 SEQ ID NO:5 that is identical to instant SEQ ID NO:5 and a VL comprising ‘673 SEQ ID NO: 15 that is identical to instant SEQ ID NO:15, would naturally not specifically bind to naloxone and further bind carfentanil.
Regarding instant claim 15, it would have been obvious for a person having ordinary skill in the art to take the antibody comprising a VH comprising ‘673 SEQ ID NO:5 and a VL comprising ‘673 SEQ ID NO: 15 – and: 1) use it in the method of ‘673 copending claim 15 wherein the antibody was administered in a method for treating and/or preventing a disease or condition in a subject associated with administration fentanyl or a derivative thereof.
This is obvious because: 1) ‘673 copending claim 15 taught an antibody which specifically binds to a hapten being fentanyl or a derivative thereof, was administered in a method for treating and/or preventing a disease or condition in a subject associated with administration fentanyl or a derivative thereof.
There is a reasonable expectation of success because: 1) the antibody specifically binds the hapten fentanyl, wherein the Kd is at most 1,000 pM, wherein said antibody is capable of protecting mice from adverse fentanyl actions when administered at a dosage (antibody (mg) / mouse body weight (kg)) of at most 1 mg/kg. Thus, it would be effective to bind fentanyl and sequester it within the subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant has amended claim 1. The updated rejection is above.
Conclusion
Claims 1-2, 8-15, and 20-23 are rejected.
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/J.J.S./Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643