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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
This action is in response to claim amendments filed 3/26/24. Claims 2-16 are pending and under examination.
Claim Objections
Claim 15 is objected to because of the following informalities: the “wherein” clause of the claim would be better presented as “wherein the detectable label is” or similar to clearly indicate that the Markush group defines the choices for the detectable label of claim 14, not that the “is conjugated to” in claim 15 represents a separate molecule than the conjugated detectable label in claim 14. Note that this latter interpretation is not a reasonable interpretation as claim 15 is not “is further conjugated to”. Thus, while definite, the claim should be amended to improve readability. 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.
Claims 7-9, 12, 13, and 16 are 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.
Claims 7, 8, and 9 recites the limitation "the cloning or expression vector". There is insufficient antecedent basis for this limitation in the claim. These claims reference either claims 3 or 4; however, there is no previous recitation of either a cloning vector or an expression vector as these claims are isolated nucleic acid molecules.
Claim 12 recites the limitation “a carrier and an isolated monoclonal Tau-binding antibody or binding fragment according to claim 2”. Claim 2 does not recite a carrier and so this limitation “according to claim 2” is unclear.
Claim 13 recites the limitation “one or more effector molecule or detectable label according to claim 2”. There is insufficient antecedent basis for this limitation in the claim. These claims reference claim 2; however, there is no previous recitation of either an effector molecule or a detectable label in claim 2.
Claim 16 recites the limitation “a carrier and a conjugated Tau-binding antibody or binding fragment according to claim 2”. Claim 2 does not recite either a carrier or conjugation and so these limitations “according to claim 2” are unclear.
Therefore, claims 7-9, 12, 13, and 16 are indefinite.
For the purpose of examination, claims 7-9 are interpreted as depending from a hypothetical claim “A cloning or expression vector comprising the nucleic acid molecule of claim” 4, 5, or 3, respectively. Claims 12 and 13 are interpreted as referring to the antibody or fragment according to claim 2, wherein the antibody or fragment is conjugated to one or more effector molecules or detectable labels or a composition comprising the antibody of claim 2 and further a carrier. Claim 16 is interpreted as a composition comprising the antibody or fragment according to claim 2, wherein the antibody or fragment is conjugated to an effector molecule or detectable label (similar to claim 13) and further comprising a carrier.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 requires a nucleic acid encoding SEQ ID NO: 8. The antecedent basis of “the cloning or expression vector” notwithstanding (see above), claim 4 expressly claims the nucleic acid encodes SEQ ID NO: 7, not 8. Thus, claim 8 fails to include the limitations of claim 4 from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 2-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11746145 in view of Nitsch (US 20120087861; form 892). Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed antibody and reference antibody of claim 1 are structurally the same.
Regarding claim 2, reference claim 1 claims monoclonal anti-Tau antibodies comprising CDRs of SEQ ID NOs: 1-6 (claim 1). The reference claims do not explicitly claim this antibody comprises instant SEQ ID NOs: 7 and 8. However, instant SEQ ID NOs: 7 and 8 comprise the same CDRs as reference SEQ ID NOs: 1-6.
Those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized ‘that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,’ but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’ The court pointed out that ‘this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.’’’ MPEP §804(II)(B)(1).
In this case, as the reference claims cover anti-tau antibodies of particular CDRs, the portions of the specification which disclose these specific CDRs in an intact antibody support the reference claim. The reference specification discloses the preferred embodiment of the claimed CDRs in the context of SEQ ID NOs: 7 and 8, which are the same as instantly claimed (C3 under the heading “Objectives and Summary of the Invention). As such, the reference claims are drawn to an antibody binding the same target with the same CDR sequences and disclosing that claim in an embodiment which is now instantly claimed, making instant claim 2 an obvious variation of the reference claims.
Regarding claim 3, the reference document does not claim a nucleic acid encoding the antibody of the reference claims. However, using nucleic acids to encode antibodies represents a widely used, predictable technique in the art. For example, Nitsch teaches an anti tau antibody (claim 1) encoded by a nucleic acid (claim 6). It would have been obvious at the time of filing to apply the nucleic acid encoding techniques of Nitsch to encode the antibody of the reference claims for the established reasons in the art, such as production of the antibody.
Regarding claims 4 and 5, the heavy and light chain sequences are obvious variants as above. It would have been obvious to encode these chains according to Nitsch as above.
Regarding claim 6, the reference document discloses SEQ ID NO: 26 and SEQ ID NO: 27 as the nucleic acids that encode SEQ ID NOs: 7 and 8. First, the nucleic acid codons which encode specific amino acids was well-established at the time of the invention. These codons are limited and predictable such that, given a particular amino acid sequence, the nucleic acid sequence encoding that amino acid sequence would have been obvious. Further, instant SEQ ID NOs: 26 and 27 support the reference claims to antibodies of SEQ ID NOs: 1-6 as these are exemplified nucleic acid sequences that encode those claimed sequences.
Regarding claims 7-9, these claims are indefinite as above. However, placing a nucleic acid encoding an antibody into a cloning or expression vector would have been obvious; see, e.g., Nitsch claim 7.
Regarding claim 10, placing the above vector in a host cell would have been obvious; see e.g., Nitsch claim 8.
Regarding claim 11, Nitsch teaches culturing the above host cell and isolating the antibody (claim 9), making the instant method obvious.
Regarding claim 12, the reference claims the antibody in conjunction with a carrier (claim 18), making the inclusion of a carrier obvious.
Regarding claim 13, the reference claims the antibody conjugated to an effector molecule or detectable label (claim 1), making such conjugation obvious.
Regarding claim 14, the reference claims the same detection method (claim 16), making such a method obvious.
Regarding claim 15, the reference claims the same conjugated moieties (claim 17), making such moieties obvious.
Regarding claim 16, the claim is indefinite as above. However, both the carrier and conjugation would have been obvious as above. Further, the reference claims both the conjugated antibody combined with a carrier (claim 18).
Claims 2-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10906966 in view of Nitsch (US 20120087861). Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed antibody and reference antibody of claim 1 are structurally the same.
Regarding claim 2, reference claim 1 claims monoclonal anti-Tau antibodies comprising CDRs of SEQ ID NOs: 1-6 (claim 1). The reference claims do not explicitly claim this antibody comprises instant SEQ ID NOs: 7 and 8. However, instant SEQ ID NOs: 7 and 8 comprise the same CDRs as reference SEQ ID NOs: 1-6.
Those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized ‘that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,’ but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’ The court pointed out that ‘this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.’’’ MPEP §804(II)(B)(1).
In this case, as the reference claims cover anti-tau antibodies of particular CDRs, the portions of the specification which disclose these specific CDRs in an intact antibody support the reference claim. The reference specification discloses the preferred embodiment of the claimed CDRs in the context of SEQ ID NOs: 7 and 8, which are the same as instantly claimed (C3 under the heading “Objectives and Summary of the Invention). As such, the reference claims are drawn to an antibody binding the same target with the same CDR sequences and disclosing that claim in an embodiment which is now instantly claimed, making instant claim 2 an obvious variation of the reference claims.
Regarding claim 3, the reference document does not claim a nucleic acid encoding the antibody of the reference claims. However, using nucleic acids to encode antibodies represents a widely used, predictable technique in the art. For example, Nitsch teaches an anti tau antibody (claim 1) encoded by a nucleic acid (claim 6). It would have been obvious at the time of filing to apply the nucleic acid encoding techniques of Nitsch to encode the antibody of the reference claims for the established reasons in the art, such as production of the antibody.
Regarding claims 4 and 5, the heavy and light chain sequences are obvious variants as above. It would have been obvious to encode these chains according to Nitsch as above.
Regarding claim 6, the reference document discloses SEQ ID NO: 26 and SEQ ID NO: 27 as the nucleic acids that encode SEQ ID NOs: 7 and 8. First, the nucleic acid codons which encode specific amino acids was well-established at the time of the invention. These codons are limited and predictable such that, given a particular amino acid sequence, the nucleic acid sequence encoding that amino acid sequence would have been obvious. Further, instant SEQ ID NOs: 26 and 27 support the reference claims to antibodies of SEQ ID NOs: 1-6 as these are exemplified nucleic acid sequences that encode those claimed sequences.
Regarding claims 7-9, these claims are indefinite as above. However, placing a nucleic acid encoding an antibody into a cloning or expression vector would have been obvious; see, e.g., Nitsch claim 7.
Regarding claim 10, placing the above vector in a host cell would have been obvious; see e.g., Nitsch claim 8.
Regarding claim 11, Nitsch teaches culturing the above host cell and isolating the antibody (claim 9), making the instant method obvious.
Regarding claim 12, the reference claims the antibody in conjunction with a carrier (claim 1), making the inclusion of a carrier obvious.
Regarding claim 13, the reference does not claim conjugating the antibody to an effector or detectable label. However, the reference does claim using the antibody to diagnose a disease by detecting the antibody (claim 18). Thus, it would have been obvious to include a detectable label in order to accomplish the detection step. Nitsch teaches detecting the antibody (claim 15) as well as conjugation to a detectable label (claim 11), making such modifications obvious.
Regarding claim 14, Nitsch teaches administering the antibody to the patient, which meets the limitations of contacting a biological sample with the antibody, followed by detection (wherein said in vivo detection comprises…).
Regarding claim 15, Nitsch teaches detectable labels include, e.g., enzymes, making such a choice obvious.
Regarding claim 16, the claim is indefinite as above. However, both the carrier and conjugation would have been obvious as above.
Finally, to the extent that the reference claims a composition of matter, e.g., claim 1, the utility of those composition may be reviewed. See the decisions in Sun Pharmaceuticals v Eli Lily Fed Cir July 28, 2010; Geneva v GlaxoSmithKline 349, F.3d 1373; and Pfizer v Teva 518 F3d 1353 supporting the Office’s use of disclosed utilities of compositions when applying double patenting rejections to method claims. The reference specification discloses the same antibodies being used in the same detection methods when conjugated to the same detectable labels, e.g., C23-24.
Claims 2-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 10344081. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed antibody and reference antibody of claim 1 are structurally the same.
Regarding claim 2, reference claim 1 claims monoclonal anti-Tau antibodies comprising CDRs of SEQ ID NOs: 1-6 (claim 1). The reference claims do not explicitly claim this antibody comprises instant SEQ ID NOs: 7 and 8. However, instant SEQ ID NOs: 7 and 8 comprise the same CDRs as reference SEQ ID NOs: 1-6.
Those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized ‘that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,’ but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’ The court pointed out that ‘this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.’’’ MPEP §804(II)(B)(1).
In this case, as the reference claims cover anti-tau antibodies of particular CDRs, the portions of the specification which disclose these specific CDRs in an intact antibody support the reference claim. The reference specification discloses the preferred embodiment of the claimed CDRs in the context of SEQ ID NOs: 7 and 8, which are the same as instantly claimed (C3 under the heading “Objectives and Summary of the Invention). As such, the reference claims are drawn to an antibody binding the same target with the same CDR sequences and disclosing that claim in an embodiment which is now instantly claimed, making instant claim 2 an obvious variation of the reference claims.
Regarding claim 3, the reference document claims a nucleic acid molecule encoding the antibody, making such an obvious variation.
Regarding claims 4 and 5, the heavy and light chain sequences are obvious variants as above. It would have been obvious to encode these chains as above.
Regarding claim 6, the reference document discloses SEQ ID NO: 26 and SEQ ID NO: 27 as the nucleic acids that encode SEQ ID NOs: 7 and 8. First, the nucleic acid codons which encode specific amino acids was well-established at the time of the invention. These codons are limited and predictable such that, given a particular amino acid sequence, the nucleic acid sequence encoding that amino acid sequence would have been obvious. Further, instant SEQ ID NOs: 26 and 27 support the reference claims to antibodies of SEQ ID NOs: 1-6 as these are exemplified nucleic acid sequences that encode those claimed sequences.
Regarding claims 7-9, these claims are indefinite as above. However, placing a nucleic acid encoding an antibody into a cloning or expression vector would have been obvious; see, e.g., reference claim 8.
Regarding claim 10, placing the above vector in a host cell would have been obvious; see e.g., reference claim 9.
Regarding claim 11, the reference claims culturing the above host cell and isolating the antibody (claim 10), making the instant method obvious.
Regarding claims 12-16, reference claim 13 is a method of diagnosing tauopathy comprising contacting a biological sample with the antibody and detecting the antibody and so those portions of the specification which provide support for such detection may be examined. The reference specification discloses, e.g., carriers and using enzymes as detectable labels conjugated to the antibody (C23-24). Thus, the instant claims are an obvious variation of the reference claims.
Allowable Subject Matter
The claims are allowable over the prior art for the same reasons as set forth in parent applications 15/742070, 16/458217, and 17/136440, now US 10344081, US 10906966, and US 11746145, respectively. Briefly, CDRs define the binding properties of an antibody and a single mutation can unpredictably alter the function of an antibody (Chen and Kussie, both cited on the IDS). The instant claims all require a specific set of six CDRs comprised within the claimed sequences and these CDRs were not discovered in the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20140294731 (form 892) is cited as further evidence of others in the art encoding antibodies in to nucleic acids, vectors, host cells, as well as the propagation and use thereof.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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/Adam Weidner/ Primary Examiner, Art Unit 1675