DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s response received April 2, 2026 is acknowledged.
Claims 1-172, 181, 194-196, 198, and 202 have been canceled.
Claims 173-180, 182-193, 197, 199-201, and 203-215 are pending in the instant application.
Applicant's election with traverse of the election of “Group I” in the reply filed on April 2, 2026 is acknowledged. The traversal is on the ground(s) that the claimed antibody compositions were prepared in a special way not taught in the cited art. This is not found persuasive because applicant’s arguments are not responsive to the restriction requirement mailed December 19, 2025. Specifically, said restriction requirement asked applicant to elect for initial prosecution a single species of contaminant or a specific combination of contaminants for initial prosecution on the merits. See in particular section 3 of said office action. NO RESTRICTION BETWEEN “GROUP I” AND “GROUP II” AS ARGUED BY APPLICANT WAS SET FORTH IN THE RESTRICTION REQUIERMENT. As such applicant has “invented” groupings of inventions which were not identified as per the 12/19/2025 action, and applicant is strongly cautioned that since no restriction of independent claims 173 and 197 into separate groups was made in the 12/19/2025 action and thus there is no shield under 35 USC 121 separating the instant independent claims from one another and refiling one of the independent claims as a “divisional” is voluntary and will not necessarily preclude a non-statutory double patenting rejection from being set forth as no restriction requirement necessitates it being filed as a separate application. Further, applicant is reminded that they have claimed a product, NOT a method of making a product, and that product by process claims are limited by what the product actually is rather than how it was made. See MPEP 2113.
However, upon consideration of the prior art, the species requirement has been withdrawn.
Claims 173-215 are under examination in this office action.
Information Disclosure Statement
The IDS received 3/29/2023 is acknowledged and the references cited therein have been considered.
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 173, 182-193, 197, 199-201, and 203-209 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.
In independent claim 173, applicant has claimed an antibody composition wherein contaminating proteins are at a level of “less than about 100 ppm (as measured by LCMS)”. Such a recitation has multiple problems. First, the claim uses the term “about” to modify a recited numerical value, yet the specification does not appear to define how far away from the recited number a value can be and yet still qualify as being “about” said number. Second, how is the recitation “(as measured by LCMS)” to be interpreted? Applicant has claimed a product, NOT a process, so is applicant trying to invoke a product by process type limitation? Alternatively, given the parenthetical notation around such a step in an non-method claim, is it more properly interpreted as exemplification of how the amount of contaminant could be measured if an artisan chose to do so but being exemplification the material inside the parentheses is non-limiting? Note that exemplification should not be recited in claims, see MPEP 2173.05(d). Given that applicant has claimed a product and not a process, and the fact that any recitation of how the claimed product can be characterized does not change the physical product to something else, it is unclear what limitation (if any as exemplification is non-limiting) applicant is trying to add to the claimed antibody product. It should be apparent that the issue of “about” as well as a process step in parenthetical notation appears in numerous dependent and independent claims, including 182-193, 197, 199-201, and 203-209, none of which adequately resolve the interpretation issues discussed above. Amendment of the claims in question to clearly and unambiguously point out that which is presently claimed is suggested.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 173-180, 182-193, 197, 199-201, and 203-212 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 8,679,498) in view of Yoon et al. (WO 2013/089477).
Lu et al. disclose antibodies that bind human N3pGlu Abeta and their administration to subjects to treat diseases including Alzheimer’s disease (see entire document particularly the abstract and claims). Notably, the antibody claimed and administered in the issued patent is 100% identical in sequence to that of the instant claims (see enclosed alignments, noting that instant SEQ ID NO:15 is the same as issued SEQ ID NO:14 while issued SEQ ID NO:15 is the same as instant SEQ ID NO:16, and that the full length heavy and light chains necessarily comprise the subsequences of the VH, VL, and their CDRs). Notably, their antibody is disclosed as being made in CHO cells (see particularly example 1, most notably lines 44-50 of column 10). These teachings differ from the instant claimed products in that even though antibodies with identical biological sequences made in CHO cells are disclosed by Lu et al., the amount of host cell protein contaminants in such preparations are not specified.
Yoon et al. disclose that when CHO cels are used for antibody production, in addition to the desired recombinant antibody numerous contaminants including host cell proteins (HCP) are present which must be removed (see entire document, particularly page 2 and paragraph [15]). As such they disclose methods for purifying recombinantly produced antibodies that yield purity of 99.9% and reduce the amount of total HCP to below 1 ppm (see most particularly paragraph [87] and Table 13).
Therefore, it would have been obvious to a person of ordinary skill in the art to make the antibody claimed and administered by Lu et al. using the methods taught by Yoon et al. Artisans would be motivated to do so as recombinant antibody production in CHO cells results in HCP contamination that must be removed and the methods of Yoon et al. are disclosed are reducing such contaminants to 1 ppm or less. It is noted that neither Lu et al. nor Yoon et al. disclose the identity of any specific HCP, but given that total HCP is in the 1 ppm range as per Yoon et al., no one particular contaminant can be greater than the total HCP content, and thus the instant claim limitations concerning very low levels of specific contaminants are necessarily met. Additionally, given that the full length antibody heavy and light chains are identical, Lu et al. disclosed donanemab even though they did not call it by that name (see also applicant’s informal sequence listing beginning on page 75 of the instant specification which explicitly teaches that instant SEQ ID Nos:15 and 16 are donanemab).
Claims 173-176, 182-193, 197, 199-201, and 203-215 are rejected under 35 U.S.C. 103 as being unpatentable over Demattos et al. (US 10,647,759) in view of Yoon et al. (WO 2013/089477).
Demattos et al. disclose antibodies that bind human N3pGlu Abeta and their administration to subjects to treat diseases including Alzheimer’s disease (see entire document particularly the abstract and claims). Notably, the antibody claimed and administered in the issued patent is 100% identical in sequence to that of the instant claims (see enclosed alignments, noting that instant SEQ ID NO:25 is the same as issued SEQ ID NO:13 while issued SEQ ID NO:12 is the same as instant SEQ ID NO:26, and that the full length heavy and light chains necessarily comprise the subsequences of the VH, VL, and their CDRs). Notably, their antibody is disclosed as being made in CHO cells (see particularly example 1, most notably lines 50-62 of column 10). These teachings differ from the instant claimed products in that even though antibodies with identical biological sequences made in CHO cells are disclosed by Demattos et al., the amount of host cell protein contaminants in such preparations are not specified.
Yoon et al. disclose that when CHO cels are used for antibody production, in addition to the desired recombinant antibody numerous contaminants including host cell proteins (HCP) are present which must be removed (see entire document, particularly page 2 and paragraph [15]). As such they disclose methods for purifying recombinantly produced antibodies that yield purity of 99.9% and reduce the amount of total HCP to below 1 ppm (see most particularly paragraph [87] and Table 13).
Therefore, it would have been obvious to a person of ordinary skill in the art to make the antibody claimed and administered by Demattos et al. using the methods taught by Yoon et al. Artisans would be motivated to do so as recombinant antibody production in CHO cells results in HCP contamination that must be removed and the methods of Yoon et al. are disclosed are reducing such contaminants to 1 ppm or less. It is noted that neither Demattos et al. nor Yoon et al. disclose the identity of any specific HCP, but given that total HCP is in the 1 ppm range as per Yoon et al., no one particular contaminant can be greater than the total HCP content, and thus the instant claim limitations concerning very low levels of specific contaminants are necessarily met.
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 173-180, 182-193, 197, 199-201, and 203-212 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 8,679,498 in view of Yoon et al. (WO 2013/089477).
The issued claims recite antibodies that bind human N3pGlu Abeta at various levels of structural specificity by SEQ ID number, as well as methods of administering such antibodies to treat diseases including Alzheimer’s disease. Notably SEQ ID NOs: 14 and 15 of the issued claims are 100% identical to SEQ ID numbers 15 and 16 respectively of the instant specification, and these full length antibody light and heavy IgG1 sequences necessarily comprise the variable domains and CDRs recited by SEQ ID number as they are subsequences of the full length sequences (see enclosed sequence alignments). The issued product claims differ from what is presently claimed in that the level of contaminating host cell proteins in such antibody compositions (see particularly issued claim 5) are not recited.
Yoon et al. disclose that when CHO cels are used for antibody production, in addition to the desired recombinant antibody numerous contaminants including host cell proteins (HCP) are present which must be removed (see entire document, particularly page 2 and paragraph [15]). As such they disclose methods for purifying recombinantly produced antibodies that yield purity of 99.9% and reduce the amount of total HCP to below 1 ppm (see most particularly paragraph [87] and Table 13).
Therefore, it would have been obvious to a person of ordinary skill in the art to make the antibody claimed and administered by the issued claims using the methods taught by Yoon et al. Artisans would be motivated to do so as recombinant antibody production in CHO cells results in HCP contamination that must be removed and the methods of Yoon et al. are disclosed are reducing such contaminants to 1 ppm or less. It is noted that neither the issued claims nor Yoon et al. disclose the identity of any specific HCP, but given that total HCP is in the 1 ppm range as per Yoon et al., no one particular contaminant can be greater than the total HCP content, and thus the instant claim limitations concerning very low levels of specific contaminants are necessarily met.
Claims 173-180, 182-193, 197, 199-201, and 203-212 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,312,763 in view of Yoon et al. (WO 2013/089477).
The issued claims recite methods of administering antibodies that bind human N3pGlu Abeta at various levels of structural specificity by SEQ ID number to treat diseases including Alzheimer’s disease. Notably SEQ ID NOs: 28 and 29 of the issued claims are 100% identical to SEQ ID numbers 15 and 16 respectively of the instant specification, and these full length antibody light and heavy IgG1 sequences necessarily comprise the variable domains and CDRs recited by SEQ ID number as they are subsequences of the full length sequences (see enclosed sequence alignments). The issued method claims differ from what is presently claimed in that the level of contaminating host cell proteins in the administered antibody compositions are not recited.
Yoon et al. disclose that when CHO cels are used for antibody production, in addition to the desired recombinant antibody numerous contaminants including host cell proteins (HCP) are present which must be removed (see entire document, particularly page 2 and paragraph [15]). As such they disclose methods for purifying recombinantly produced antibodies that yield purity of 99.9% and reduce the amount of total HCP to below 1 ppm (see most particularly paragraph [87] and Table 13).
Therefore, it would have been obvious to a person of ordinary skill in the art to make the antibodies administered by the issued claims using the methods taught by Yoon et al. Artisans would be motivated to do so as recombinant antibody production in CHO cells results in HCP contamination that must be removed and the methods of Yoon et al. are disclosed are reducing such contaminants to 1 ppm or less. It is noted that neither the issued claims nor Yoon et al. disclose the identity of any specific HCP, but given that total HCP is in the 1 ppm range as per Yoon et al., no one particular contaminant can be greater than the total HCP content, and thus the instant claim limitations concerning very low levels of specific contaminants are necessarily met.
It is noted that the issued claims are methods rather than products as presently claimed. However, the application giving rise to the ‘763 patent was not filed as a result of a restriction requirement filed in the instant application (as is readily evidenced by the filing receipt of 9/12/2023 in the instant application) and thus the protections of 35 USC 121 are not applicable to the instant situation. Further, method of administering a product necessarily comprises additional limitations as compared to the product itself. Thus that which is presently claimed is an obvious variation that which was previously issued to applicant.
Claims 173-176, 182-193, 197, 199-201, and 203-215 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,647,759 in view of Yoon et al. (WO 2013/089477).
The issued claims recite antibodies that bind human N3pGlu Abeta at various levels of structural specificity by SEQ ID number, as well as methods of administering such antibodies to treat diseases including Alzheimer’s disease. Notably SEQ ID NOs: 13 and 12 of the issued claims are 100% identical to SEQ ID numbers 25 and 26 respectively of the instant specification, and these full length antibody light and heavy IgG1 sequences necessarily comprise the variable domains and CDRs recited by SEQ ID number as they are subsequences of the full length sequences (see enclosed sequence alignments). The issued product claims differ from what is presently claimed in that the level of contaminating host cell proteins in such antibody compositions (see particularly issued claim 5) are not recited.
Yoon et al. disclose that when CHO cels are used for antibody production, in addition to the desired recombinant antibody numerous contaminants including host cell proteins (HCP) are present which must be removed (see entire document, particularly page 2 and paragraph [15]). As such they disclose methods for purifying recombinantly produced antibodies that yield purity of 99.9% and reduce the amount of total HCP to below 1 ppm (see most particularly paragraph [87] and Table 13).
Therefore, it would have been obvious to a person of ordinary skill in the art to make the antibody claimed and administered by the issued claims using the methods taught by Yoon et al. Artisans would be motivated to do so as recombinant antibody production in CHO cells results in HCP contamination that must be removed and the methods of Yoon et al. are disclosed are reducing such contaminants to 1 ppm or less. It is noted that neither the issued claims nor Yoon et al. disclose the identity of any specific HCP, but given that total HCP is in the 1 ppm range as per Yoon et al., no one particular contaminant can be greater than the total HCP content, and thus the instant claim limitations concerning very low levels of specific contaminants are necessarily met.
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/ Primary Examiner, Art Unit 1641
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