DETAILED ACTION
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 .
Claim Status
1. In the Preliminary Amendment filed 6/24/24 is acknowledged. Claims 2-44 have been canceled without prejudice or disclaimer. Claim 1 is pending and under consideration.
Priority
2. The priority date for the instant application is January 27, 2016. This application is a continuation of US Application No. 18/053,001, filed on November 7, 2022, which is a continuation of US Application No. 17/696,190 filed on March 16, 2022, which is a continuation of US Application No. 17/477,825 filed on September 17, 2021, which is a continuation of US Application No. 16/073,349 filed on July 27, 2018, which is a national stage entry of International Application No. PCT/US2017/015301 filed on January 27, 2017, which claims priority to US Provisional Patent Application Number 62/287,679 filed on January 27, 2016, US Provisional Patent Application Number 62/293,872 filed on February 11, 2016, and US Provisional Patent Application Number 62/345,470 filed on June 3, 2016.
Information Disclosure Statement
3. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the Examiner on form PTO-892 or Applicant on PTO-1449 cited the references they have not been considered.
Specification
4. The disclosure is objected to because of the following informalities: The cross reference section should be updated to indicate the current status of the continuing applications. The following applications are abandoned 16/073,349 - 17/477,825 – 17/696,190 – 18/053,001. Please correct the first section of the specification. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.-The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventors, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. V. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04. A generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California V. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of genus must be capable of doing, not of the substance and structure of the members. For a claim drawn to a genus, the written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice or by disclosure of relevant, identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
A "representative number of species" means that the species, which are adequately described, are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus (see Official Gazette 1241 OG 174, January 30, 2001).
In the instant case, the claim recites a large and structurally varied genus of "anti- sTn antibodies" in the independent claims, which is defined solely in terms of the desired function. Any of a plethora of structures that possess the desired function are encompassed by the claims. The specification describes two structurally related antibodies 3F1 (SEQ ID NO. 1 and 2, VH and VL, respectively) and SIA101 (SEQ ID NO. 3 and 4, VH and VL, respectively). There is no evidence that these two species of anti-sTn antibodies described, all of which are from a similar class of structures, are representative of anti-sTn antibodies in general.
In summary, the specification fails to describe at least a substantial number of antibodies within the genera of anti-sTn antibodies claimed and furthermore fails to describe a representative number of anti-sTn antibodies encompassed by the claims. Moreover, the specification does not describe a correlation between any particular identifying (i.e., substantial) structural feature that describes the presupposed representative species and is shared by at least most of the other members of the genus, and any one particular identifying, shared, functional feature that may be attributed to the presence of the structural feature.
In an unpredictable art, as here, the disclosure of only one or a few closely related species does not provide the skilled artisan with a representative number of species sufficient to show applicants were in possession of the claimed genus. For these reasons, the skilled artisan would not recognize that applicants were in possession of the invention as broadly claimed at the time the application was filed.
Claim Rejections - 35 USC § 103
6. 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 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. The factual inquiries set forth in Graham V. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
7. Claim 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Da Silva et al WO 2015/054600 in view of Liu et al Gynelocologic Oncology vol. 133 p. 362 (2014), Tahara et al US 2011/0081356, Starbuck et al Gynelogic Oncology vol. 139 page 560 (12/2015), Numa et al Journal of Obstetrics and Gynaecology vol. 21 p. 385 (1995) and Dearnley et al Curr Opin Obstet Gynecol vol. 18 p. 3 (2006).
Da Silva et al discloses antibodies to sTn and their used in the treatment of cancers, such as ovarian cancer (summary, page 49-50, 60-62, 82-84 and entire reference). The reference also discloses the use of these antibodies in conjugate form and in combination with other anti-cancer agents (page 70+, 110+). The reference also discloses the dosage of these antibodies as ranging from 0.0001-100 mg/kg with smaller ranges of 0.1-10 mg/kg and 1-25 mg/kg (page 113). It is the Examiner's positions that a treatment of ovarian cancer would result in a reduction of tumor volume.
The only differences between the instant invention and the reference are (1) the combination with olaparib, (2) the order of administration, (3) the targeting of chemotherapy resistant cancer stem cells and (4) the consolidation cancer treatment.
The use of olaparib for the treatment of ovarian cancers (platinum resistant, platinum sensitive and BRCA associated) is well known in the art disclosed by the review article by Liu. This article discloses several clinical trials using olaparib (AKA AZD2281) to treat the aforementioned ovarian cancers (pages 363-366) and the reference also discloses that olaparib can be used in combination with other anticancer agent (such as temozolimde and paclitaxel) (page 365). Tahara et al discloses the administration of antibodies in combination with AZD2281 for the treatment of cancers, such as ovarian cancer (para. 80 and 72 and entire reference). Starbuck et al discloses that antibodies that target sTn eradicate ovarian cancer stem cells (see entire abstract). Numa et al discloses that antibodies to sTn target ovarian cancer cells (abstract and discussion). Dearnley et al discloses that consolidation therapy is well known in the art of ovarian cancer treatment (see entire reference).
Since Da Silva et al discloses that the anti-sTn antibodies can be used in combination with other anti-cancer agents for the treatment of ovarian cancer and since olaparib is a well known drug used for the treatment of ovarian cancers (platinum resistant, platinum sensitive and BRCA associated) (Liu et al) and since olaparib (AZD2281) can be used in combination with antibodies to treat ovarian cancers (Tahara et al), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the anti-Stn antibodies of Da Silva et al with oalaprib with the expected benefit of treating ovarian cancers, such as platinum resistant, platinum sensitive and BRCA associated ovarian cancers.
Additionally, the use of anti-sTn antibodies for the treatment of ovarian cancers (specifically, ovarian cancer stem cell) is further supported by Starbuck et al and the fact anti-Stn antibodies can target ovarian cancer cells is also supported by Numa et al. The further use of consolidation treatment in ovarian cancer treatment is obvious since it is well known the art (Dearnley et al). Additionally, the combination of two composition each of which is used for the same purpose (i.e. the combination of anti-sTn antibodies and olaparib, in the instant case) to form a third compositions to be used for the very same purpose is supported by In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.. [T]he idea of combining them flows logically from their having been individually taught in the prior art." With respect to the order of administration, absent any unexpected objective evidence or criticality, the selection of any order of administration is prima facie obvious (MPEP 2144.04(IV)(C)). "Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.)."
8. Claim 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Starbuck et al Gynelogic Oncology vol. 139 page 560 (12/2015) in view of Liu et al Gynelocologic Oncology vol. 133 p. 362 (2014), Tahara et al US 2011/0081356 and Dearnley et al Curr Opin Obstet Gynecol vol. 18 p. 3 (2006).
Starbuck et al discloses that antibodies and drug conjugates thereof that target sTn eradicate ovarian cancer stem cells in vitro and clearly indicates that the use in vivo (see entire abstract). It is the Examiner's positions that an "eradication" of ovarian cancer cells reads on "about 90%". The only differences between the instant invention and the reference are (1) the combination with olaparib, (2) the order of administration and (3) the consolidation cancer treatment. The use of olaparib for the treatment of ovarian cancers (platinum resistant, platinum sensitive and BRCA associated) is well known in the art disclosed by the review article by Liu. This article discloses several clinical trials using olaparib (AKA AZD2281) to treat the aforementioned ovarian cancers (pages 363-366) and the reference also discloses that olaparib can be used in combination with other anticancer agent (such as temozolimde and paclitaxel) (page 365). Tahara et al discloses the administration of antibodies in combination with AZD2281 for the treatment of cancers, such as ovarian cancer (para. 80 and 72 and entire reference). Dearnley et al discloses that consolidation therapy is well known in the art of ovarian cancer treatment (see entire reference).
Since Starbuck et al discloses that antibodies and drug conjugates thereof that target sTn eradicate ovarian cancer stem cells and since olaparib is a well-known drug in the treatment of ovarian cancers (platinum resistant, platinum sensitive and BRCA associated) and since antibodies can be combined with olaparib for the treatment of ovarian cancer (Tahara et al), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the anti-sTn antibodies of Starbuck et al with oalaprib with the expected benefit of treating ovarian cancers (platinum resistant, platinum sensitive and BRCA associated). Additionally, the combination of two composition each of which is used for the same purpose (i.e. the combination of anti-sTn antibodies and olaparib, in the instant case) to form a third compositions to be used for the very same purpose is supported by In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose [T]he idea of combining them flows logically from their having been individually taught in the prior art." The further use of consolidation treatment in ovarian cancer treatment is obvious since it is well known the art (Dearnley et al).
With respect to the order of administration, absent any unexpected objective evidence or criticality, the selection of any order of administration is prima facie obvious (MPEP 2144.04(IV)(C)). "Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).'
9. Claim 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Da Silva et al WO 2016/077526 (priority to 11/12/2014) in view of DeSander et al US 9879087, Liu et al Gynelocologic Oncology vol. 133 p. 362 (2014), Tahara et al US 2011/0081356, Starbuck et al Gynelogic Oncology vol. 139 page 560 (12/2015), Numa et al Journal of Obstetrics and Gynaecology vol. 21 p. 385 (1995) and Dearnley et al Curr Opin Obstet Gynecol vol. 18 p. 3 (2006).
Da Silva et al discloses antibodies to sTn (specifically discloses antibody 3F1 comprising SEQ ID NO. 53 and 54 which are applicant's SEQ ID NO. 1 and 2, respectively) and anti-sTn antibody conjugates with a payload of MMAE and their used in the treatment of cancers, such as ovarian cancer (ovarian cancer stem cells) and for the reduction of tumor volume (summary, pages 97-98, 142, examples 20, 22 and 30 and entire reference). The reference also discloses the use of these antibodies/conjugates in combination with other anti-cancer agents (pages 144+). The reference also discloses the dosage of these antibodies as ranging from 0.0001-100 mg/kg with smaller ranges of 0.1-10 mg/kg and 1-25 mg/kg (page 170). With respect to the percentage of reduction in tumor volume, US 9879087, which is the US document off of the WO, shows that the percentage in reduction is 20-99% (col. 7, lines 13+).
The only differences between the instant invention and the reference are (1) the combination with olaparib, (2) the order of administration, (3) the targeting of chemotherapy resistant cancer stem cells and (4) the consolidation cancer treatment. The use of olaparib for the treatment of ovarian cancers (platinum resistant, platinum sensitive and BRCA associated) is well known in the art disclosed by the review article by Liu. This article discloses several clinical trials using olaparib (AKA AZD2281) to treat the aforementioned ovarian cancers (pages 363-366) and the reference also discloses that olaparib can be used in combination with other anticancer agent (such as temozolimde and paclitaxel) (page 365).
Tahara et al discloses the administration of antibodies in combination with AZD2281 for the treatment of cancers, such as ovarian cancer (para. 80 and 72 and entire reference). Starbuck et al discloses that antibodies that target sTn eradicate ovarian cancer stem cells (see entire abstract). Numa et al discloses that antibodies to sTn target ovarian cancer cells (abstract and discussion). Dearnley et al discloses that consolidation therapy is well known in the art of ovarian cancer treatment (see entire reference).
Since Da Silva et al discloses that the anti-sTn antibodies can be used in combination with other anti-cancer agents for the treatment of ovarian cancer and since olaparib is a well-known drug used for the treatment of ovarian cancers (platinum resistant, platinum sensitive and BRCA associated) (Liu et al) and since olaparib (AZD2281) can be used in combination with antibodies to treat ovarian cancers (Tahara et al), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the anti-Stn antibodies of Da Silva et al with oalaprib with the expected benefit of treating ovarian cancers, such as platinum resistant, platinum sensitive and BRCA associated ovarian cancers. Additionally, the use of anti-sTn antibodies for the treatment of ovarian cancers (specifically, ovarian cancer stem cell) is further supported by Starbuck et al and the fact anti-Stn antibodies can target ovarian cancer cells is also supported by Numa et al. The further use of
consolidation treatment in ovarian cancer treatment is obvious since it is well known the art (Dearnley et al).
Additionally, the combination of two composition each of which is used for the same purpose (i.e. the combination of anti-sTn antibodies and olaparib, in the instant case) to form a third compositions to be used for the very same purpose is supported by In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.. [T]he idea of combining them flows logically from their having been individually taught in the prior art."
With respect to the order of administration, absent any unexpected objective evidence or criticality, the selection of any order of administration is prima facie obvious (MPEP 2144.04(IV)(C)). "Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.)."
10. Claim 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Da Silva et al WO 2016/057916 (priority to 10/10/2014) in view of Liu et al Gynelocologic Oncology vol. 133 p. 362 (2014), Tahara et al US 2011/0081356, Starbuck et al Gynelogic Oncology vol. 139 page 560 (12/2015), Numa et al Journal of Obstetrics and Gynaecology vol. 21 p. 385 (1995) and Dearnley et al Curr Opin Obstet Gynecol vol. 18 p. 3 (2006).
Da Silva et al discloses antibodies to sTn (specifically discloses antibody 3F1 comprising SEQ ID NO. 59 and 60 which are applicant's SEQ ID NO. 1 and 2, respectively) and anti-sTn antibody conjugates with a payload of MMAE and their used in the treatment of cancers, such as ovarian cancer (ovarian cancer stem cells) and for the reduction of tumor volume (at least 1-75%) (summary, pages 56, 67-68, 100-107 and entire reference). The reference also discloses the use of these antibodies/conjugates in combination with other anti-cancer agents (pages 132+). The reference also discloses the dosage of these antibodies as ranging from 0.0001-100 mg/kg with smaller ranges of 0.1-10 mg/kg and 1-25 mg/kg (page 134). Furthermore, the reference discloses that the order of administration for the components of combination therapy can be before or after the other. The only differences between the instant invention and the reference are (1) the combination with olaparib, (2) the targeting of chemotherapy resistant cancer stem cells and (3) the consolidation cancer treatment.
The use of olaparib for the treatment of ovarian cancers (platinum resistant, platinum sensitive and BRCA associated) is well known in the art disclosed by the review article by Liu. This article discloses several clinical trials using olaparib (AKA AZD2281) to treat the aforementioned ovarian cancers (pages 363-366) and the reference also discloses that olaparib can be used in combination with other anticancer agent (such as temozolimde and paclitaxel) (page 365). Tahara et al discloses the administration of antibodies in combination with AZD2281 for the treatment of cancers, such as ovarian cancer (para. 80 and 72 and entire reference). Starbuck et al discloses that antibodies that target sTn eradicate ovarian cancer stem cells (see entire abstract). Numa et al discloses that antibodies to sTn target ovarian cancer cells(abstract and discussion). Dearnley et al discloses that consolidation therapy is well known in the art of ovarian cancer treatment (see entire reference).
Since Da Silva et al discloses that the anti-sTn antibodies can be used in combination with other anti-cancer agents for the treatment of ovarian cancer and since olaparib is a well-known drug used for the treatment of ovarian cancers (platinum resistant, platinum sensitive and BRCA associated) (Liu et al) and since olaparib (AZD2281) can be used in combination with antibodies to treat ovarian cancers (Tahara et al), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the anti-sTn antibodies of Da Silva et al with oalaprib with the expected benefit of treating ovarian cancers, such as platinum resistant, platinum sensitive and BRCA associated ovarian cancers.
Additionally, the use of anti-sTn antibodies for the treatment of ovarian cancers (specifically, ovarian cancer stem cell) is further supported by Starbuck et al and the fact anti-sTn antibodies can target ovarian cancer cells is also supported by Numa et al. The further use of consolidation treatment in ovarian cancer treatment is obvious since it is well known the art (Dearnley et al). Additionally, the combination of two composition each of which is used for the same purpose (i.e. the combination of anti-sTn antibodies and olaparib, in the instant case) to form a third compositions to be used for the very same purpose is supported by In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose [T]he idea of combining them flows logically from their having been individually taught in the prior art."
Double Patenting
11. 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 §§ 706.02(I)(1) - 706.02(I)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-into Lisp.
12. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. DeSander et al US 9879087 in view of Liu et al Gynelocologic Oncology vol. 133 p. 362 (2014), Tahara et al US 2011/0081356, Starbuck et al Gynelogic Oncology vol. 139 page 560 (12/2015), Numa et al Journal of Obstetrics and Gynaecology vol. 21 p. 385 (1995) and Dearnley et al Curr Opin Obstet Gynecol vol. 18 p. 3 (2006).
DeSanders et al claims methods of reducing tumor volume (at least 20% about about 80-99%) and treating sTn expressing cancers by administering antibodies to sTn in the amount of about 0.25-25 mk/kg. The only differences between the instant invention and the reference are (1) the combination with olaparib, (2) the order of administration, (3) the targeting of chemotherapy resistant cancer stem cells (4) the targeting of ovarian cancer cells and (5) the consolidation cancer treatment. The use of olaparib for the treatment of ovarian cancers (platinum resistant, platinum sensitive and BRCA associated) is well known in the art disclosed by the review article by Liu. This article discloses several clinical trials using olaparib (AKA AZD2281) to treat the aforementioned ovarian cancers (pages 363-366) and the reference also discloses that olaparib can be used in combination with other anticancer agent (such as temozolimde and paclitaxel) (page 365).
Tahara et al discloses the administration of antibodies in combination with AZD2281 for the treatment of cancers, such as ovarian cancer (para. 80 and 72 and entire reference). Starbuck et al discloses that antibodies that target sTn eradicate ovarian cancer stem cells (see entire abstract). Numa et al discloses that antibodies to sTn target ovarian cancer cells (abstract and discussion). Dearnley et al discloses that consolidation therapy is well known in the art of ovarian cancer treatment (see entire reference).
Since DeSanders et al claims the treatment of sTn expressing cancers and the reduction of tumor volume in such cancers and since ovarian cancers express sTn (Starbuck and Numa) and since olaparib is a well-known drug used for the treatment of ovarian cancers (platinum resistant, platinum sensitive and BRCA associated) (Liu et al) and since olaparib (AZD2281) can be used in combination with antibodies to treat ovarian cancers (Tahara et al), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the anti-Stn antibodies of DeSanders et al with oalaprib with the expected benefit of treating ovarian cancers, such as platinum resistant, platinum sensitive and BRCA associated ovarian cancers. Additionally, the use of anti-sTn antibodies for the treatment of ovarian cancers (specifically, ovarian cancer stem cell) is further supported by Starbuck et al and the fact anti-sTn antibodies can target ovarian cancer cells is also supported by Numa et al. The further use of consolidation treatment in ovarian cancer treatment is obvious since it is well known the art (Dearnley et al).
Additionally, the combination of two composition each of which is used for the same purpose (i.e. the combination of anti-sTn antibodies and olaparib, in the instant case) to form a third compositions to be used for the very same purpose is supported by In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose [T]he idea of combining them flows logically from their having been individually taught in the prior art." With respect to the order of administration, absent any unexpected objective evidence or criticality, the selection of any order of administration is prima facie obvious (MPEP 2144.04(IV)(C)). "Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.)
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Cook whose telephone number is 571-272-0816. The examiner works a flexible Part-Time schedule but can normally be reached on Monday, Thursday, and Friday from 9am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached at telephone number 571-270-3505. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only.
For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Lisa V. Cook
Patent Examiner
Art Unit 1642
Remsen
571-272-0816
6/27/26
/LISA V COOK/Primary Examiner, Art Unit 1641
Prosecution Insights