Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/1/2025 has been entered.
Status of the Claims
2. Claims 1-21 are the original claims filed for this application on 11/19/2021. In the Response of 3/7/2024, Claims 2-3, 5-7 and 9-18 are amended, claims 20-21 are canceled, and new Claims 22-23 are added. In the Response of 11/14/2024, Claims 3, 6-7 and 22 are amended, claims 1-2, 4-5, and 9-19 are canceled, and new Claims 24-25 are added. In the Response of 7/1/2025, Claims 3, 6-8 and 22-23 are canceled and new Claims 26-31 are added. Claims 24-31 are the claims for this application and all the claims under examination. This Office Action contains new grounds for rejection.
Priority
3. USAN 17/530,542, filed 11/19/2021, and having 1 RCE-type filing therein, is a Divisional of 16/298,032, filed 03/11/2019, now abandoned, 16/298,032 is a Divisional of 14/680,250, filed 04/07/2015, now U.S. Patent # 10253091 and having 2 RCE-type filing therein, 14/680,250 is a Divisional of 13/257,145, filed 11/22/2011, now abandoned and having 3 RCE-type filing therein, 13/257,145 is a National Stage entry of PCT/JP2010/054767, International Filing Date: 03/19/2010, claims foreign priority to JP 2009-213901, filed 09/16/2009, and claims foreign priority to JP 2009-068631, filed 03/19/2009.
Information Disclosure Statement
4. As of 7/31/2025, a total of thirteen (13) IDS are filed for this application: 2/17/2022; 5/12/2022; 6/30/2022; 8/9/2022; 9/7/2022; 9/21/2022; 11/8/2022; 2/27/2023; 5/10/2023; 8/3/2023; 1/16/2024; 11/14/2024; and 7/1/2025. The corresponding initialed and dated 1449 form is considered of record.
Withdrawal of Objections
Claim Objections
5. The objection to Claims 3, 6-8, and 22-25 because of informalities is withdrawn for the pending claims and moot for the canceled claims.
a) Claims 3, 6-8, and 22-25 are canceled.
Withdrawal of Rejections
Double Patenting
6. The rejection of Claims 22-21 on the ground of nonstatutory double patenting as being unpatentable over claims 15-25 of U.S. Patent No. 10253091 is moot for canceled claims 22-21.
Rejections Maintained
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.
7. The rejection of Claims
Applicants allege the term "comprising" is considered to be a "transitional" term that marks where the preamble ends and the body of the claim begins. See, e.g., MPEP 2163(II)(A)(1): "'Preamble language' is that language in a claim appearing before the transitional phase, e.g., before 'comprising, ''consisting essentially of,' or 'consisting of."' Thus, the preamble of each of independent claims 24 and 25 is not "drawn to substitutions," as asserted in the Office action; rather, the preambles both say simply "An antibody constant region."
Response to Arguments
A. Instances when a preamble is not likely to limit a claim pursuant to MPEP 2111.02 & 2111.02(II):
• The body of the claim following the preamble is a self-contained description of the structure and does not depend on the preamble for completeness- here the amino acid sequence of the constant region (SEQ ID NO: 24) is otherwise a self-contained description of the actual invention to which the amino acid modifications are made.
• A preamble that describes the purpose or intended use of the claimed invention generally does not limit the claims- here the “simply” stated antibody constant region does not define a purpose or use, and is in fact a constant region of SEQ ID NO: 2.
• The preamble merely extols benefits or features of the claimed invention and there is no clear reliance on those benefits or features as patentably significant (e.g., preamble recites, “[a] head for a lacrosse stick which provides improved handling and playing characteristics.”) – here there is no clear reliance on the feature of a generic antibody constant region when the invention is self-contained within the same meaning. The language in the body of Claims 24 and 25 sets out the complete invention, hence the preamble serves no limitation. The preamble is not essential to understanding the limitations and terms in the body portion of the claims.
B. Applicants will note that Claims 24 and 25 recite “comprising”, per se, and impliedly by the phrase “with the following”. The term “with” is not defined in the specification to exclude open language being imputed into its meaning. The term is construed being an equivalent of “comprising.” Accordingly, and based on the analysis under section A above, the first instance of transitional language is the phrase “with the following substitutions.”
The rejection is maintained because the claims are drawn to substitutions in one instance and deletions in another where the language is confusing and contradictory much less in the context of confusing transitional phrases.
New Grounds for Rejection
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.
8. Claims 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-25 of U.S. Patent No. 10253091.
A. Applicants do not dispute the truth of the matter asserted that the reference patent claims the modified human kappa constant region that is overlapping for the shared sequence of SEQ ID NO: 32 with the instant claimed invention (cited in the Office Action of 1/14/2025 for ref patent claims 15-25). Applicants do not dispute that both claim sets are drawn to an overlapping invention for the kappa chain portion of the antibody.
B. Applicants allege the rejection improperly selects disclosure of a particular embodiment in the reference specification and relies on it as though the disclosure is prior art, even though that is contrary to law. See, e.g., MPEP § 804(II)(B)(1):
When considering whether the invention defined in a claim of an application would have been anticipated by or is an obvious variation of the invention defined in the claim of a patent or copending application, no part of the reference patent or application may be used as if it were prior art. GeneralFoods Corp. v. StudiengesellschaftKohle mbH, 972 F.2d 1272, 1281, 23 USPQ2d 1839, 1846 (Fed. Cir. 1992).
Response to Arguments
Applicants failed to include in their excerpt of MPEP § 804(II)(B)(1) in the Response of 7/1/2025 the remainder of the statement under that section:
“This does not mean that one is precluded from all use of the reference patent or application disclosure to understand the meaning of the reference claims.”
“The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”). “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ ” Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference 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 reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). 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 or application which provides support for the 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.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
Accordingly claims drawn to the antibody comprising a modified constant region sequence of SEQ ID NO: 24 and a modified kappa light chain of SEQ ID NO:32 are fully supported by the MPEP and the case law to be within the purview of routine examination for non-obviousness double patenting.
Conclusion
9. No claims are allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643