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 .
Claims 91-110 are under consideration in the instant Office Action.
NOTE: Examiner attempted multiple times and left voicemails for attorney of record to try and propose claim amendments and request terminal disclaimers to place the case in condition for allowance. No response was received.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 uses the language of “…comprising a heavy/light chain comprising a mature heavy/light chain variable region of SEQ ID NO: …”.and should use language of “…comprising a heavy/light chain comprising the mature heavy/light chain variable region of SEQ ID NO:65…”. This would make it clear that the claim requires the full length of the sequence set forth in the sequence identifier. Appropriate correction is required.
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.
Claim 109 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 109 is towards a method of diagnosing a transthyretin-mediated amyloidosis by contacting a sample with the claimed antibody. There is no further active step besides contact required besides the sample so it is unclear how one would go about determining the diagnosis. Does one collect a sample from any subject? What is the assay used to determine the diagnosis? Is a subject diagnosed if the test detects a protein? Is there a specific level of detection that leads to the confirmation of a diagnosis? Due to these unknown steps it is unclear when you has achieved the intended method. For these reasons, the claim is indefinite
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 91-110 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-78 of U.S. Patent No.10,464,999. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘999 claims the same antibody that binds to human transthyretin. ‘999 claims the same mature heavy and light chain variable regions (see claims 8, 10-11, 19, 16 and 29) light and heavy chains (see for example their claims 26-27,29, 43-47) as the ones in the instant claims. ‘999 claims pharmaceutical compositions, nucleic acids and host cells (see claims 30-36) that are the same as the instant claims. ‘999 claims methods of humanizing and producing antibodies (see claims 37-39,46, 50, 58 and 66). ‘999 claims the method of treating and diagnosis a transthyretin-mediated amyloidosis in a subject (see their claim 70 as an example) and a method of detection (see their claim 76) that are the same as the instant claims. Therefore, the claims of ‘999 anticipate the instantly claimed invention.
Claims 91-110 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 11,028,158. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘158 claims a vector to express an antibody the same mature heavy and light chain variable regions (see claims 8, 11-12). Therefore, the vectors are an obvious variant of the instantly claimed antibodies since they produce the same antibody. ‘158 also claims the same light and heavy constant regions (see for example their claims 33-35) as the ones in the instant claims. ‘158 claims, nucleic acids and host cells (see claims 18-36) that are the same as the instant claims. While ‘158 claims methods of expressing antibodies in mammalian cells (see claims 22- 36), ‘158 does not claim methods of diagnosing and detecting. The courts have held that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use," which extend to any and all such uses disclosed in the specification of the earlier patent. Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d at 1363 (Fed. Cir. 2008), and Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d at 1385-86 (Fed. Cir. 2003). Indeed, as both cases recognized, [i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, … and then prevent the public from making a beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Sun Pharmaceuticals Industries, Ltd. v. Eli Lilly and Co., 611 F.3d 1381 (Fed, Cir. 2010), citing Pfizer, 518 F.3d at 1363 n.8 (emphases added); and Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 (CCPA 1931)). The ‘158 specification (see columns 21 and 43) teaches treating and diagnosing transthyretin. Therefore, the antibodies produced by the disclosed vectors are capable of being used in the instantly claimed methods and therefore, obvious variants of the instant claims.
Claims 91-110 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,912,759. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘759 claims the same antibody that binds to human transthyretin. ‘759 claims the same mature heavy and light chain variable regions (see claims 1, 10-12 light and heavy chains (see for example their claim 12) as the ones in the instant claims. ‘759 claims pharmaceutical compositions, nucleic acids and host cells (see claims 13-17) that are the same as the instant claims. ‘759 claims methods of humanizing and producing antibodies (see claims 16-18). ‘While ‘759 claims methods of expressing antibodies in mammalian cells (see claims 22- 36), ‘759 does not claim methods of diagnosing and detecting. The courts have held that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use," which extend to any and all such uses disclosed in the specification of the earlier patent. Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d at 1363 (Fed. Cir. 2008), and Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d at 1385-86 (Fed. Cir. 2003). Indeed, as both cases recognized, [i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, … and then prevent the public from making a beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Sun Pharmaceuticals Industries, Ltd. v. Eli Lilly and Co., 611 F.3d 1381 (Fed, Cir. 2010), citing Pfizer, 518 F.3d at 1363 n.8 (emphases added); and Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 (CCPA 1931)). The ‘759 specification (see columns 20-21 and 43) teaches treating and diagnosing transthyretin. Therefore, the antibodies produced by the disclosed vectors are capable of being used in the instantly claimed methods and therefore, obvious variants of the instant claims.
Claims 91-110 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,873,332. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘332 claims the same antibody that binds to human transthyretin. ‘332 claims the same mature heavy and light chain variable regions and light and heavy chains (see for example their claims 1 and 8) as the ones in the instant claims. ‘332 claims pharmaceutical compositions that are the same as the instant claims. ‘332 does not claim methods of treating, diagnosing and detecting. The courts have held that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use," which extend to any and all such uses disclosed in the specification of the earlier patent. Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d at 1363 (Fed. Cir. 2008), and Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d at 1385-86 (Fed. Cir. 2003). Indeed, as both cases recognized, [i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, … and then prevent the public from making a beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Sun Pharmaceuticals Industries, Ltd. v. Eli Lilly and Co., 611 F.3d 1381 (Fed, Cir. 2010), citing Pfizer, 518 F.3d at 1363 n.8 (emphases added); and Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 (CCPA 1931)). The ‘332 specification (see columns 20-21 and 43) teaches treating and diagnosing transthyretin. Therefore, the antibodies produced by the disclosed vectors are capable of being used in the instantly claimed methods and therefore, obvious variants of the instant claims.
Conclusion
No claims are allowed.
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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