Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
This application is a continuation of 16/660,635, issued US Patent No. 11,891,430, which is a continuation of 15/444,018, abandoned, which is a continuation of 13/394,766, abandoned, which is a 371 of PCT/EP2010/064487.
The amendment filed on June 14, 2024 has been entered.
Status of Claims
Claims 1-5, 7-9, and 11-16 are pending.
Claims 1-5, 7-9, and 11-16 are under examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 13/394,766, filed on March 7, 2012.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C.120 and 365(c) as follows:
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: A method of producing trastuzumab and pertuzumab as the anti-HER2 antibody as recited in claims 11 and 14-15 and a method of producing a immunoglobulin solution by combining two first immunoglobulin solution and a second immunoglobulin solution as recited in claims 12-16 were not disclosed in any of the prior-filed application.
Also, the later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 13/394,766, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. A method of producing trastuzumab and pertuzumab as the anti-HER2 antibody as recited in claims 11 and 14-15 and a method of producing a immunoglobulin solution by combining two first immunoglobulin solution and a second immunoglobulin solution as recited in claims 12-16 were not disclosed in any of the prior-filed application.
Accordingly, claims 11-16 are not entitled to the benefit of the prior application and therefore, the effective filing of claims 11-16 is December 20, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 14, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation “wherein the immunoglobulin solution has a concentration from 100 g/l to 300 g/l”. The metes and bounds of the limitation in the context of the claim are not clear. Claim 4 depends from claim 1. Claim 1 recites an immunoglobulin solution in steps a), b), and a final immunoglobulin solution. Therefore, it is unclear if the immunoglobulin solution recited in claim 4 refers to the immunoglobulin solution in step a), b), or final immunoglobulin solution. Clarification is requested.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation “wherein the immunoglobulin solution has a volume of from 3 liter to 100 liter”. The metes and bounds of the limitation in the context of the claim are not clear. Claim 5 depends from claim 1. Claim 1 recites an immunoglobulin solution in steps a), b), and a final immunoglobulin solution. Therefore, it is unclear if the immunoglobulin solution recited in claim 5 refers to the immunoglobulin solution in step a), b), or final immunoglobulin solution. Clarification is requested.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation “wherein the immunoglobulin solution has a concentration of 160 g/l or more”. The metes and bounds of the limitation in the context of the claim are not clear. Claim 8 depends from claim 1. Claim 1 recites an immunoglobulin solution in steps a), b), and a final immunoglobulin solution. Therefore, it is unclear if the immunoglobulin solution recited in claim 8 refers to the immunoglobulin solution in step a), b), or final immunoglobulin solution. Clarification is requested.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation “wherein the immunoglobulin solution comprises a sugar and a surfactant and has a concentration of 125 mg/ml or more”. The metes and bounds of the limitation in the context of the claim are not clear. Claim 9 depends from claim 1. Claim 1 recites an immunoglobulin solution in steps a), b), and a final immunoglobulin solution. Therefore, it is unclear if the immunoglobulin solution recited in claim 9 refers to the immunoglobulin solution in step a), b), or final immunoglobulin solution. Clarification is requested.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation “wherein the immunoglobulin solution comprises a sugar and a surfactant and has a concentration of 125 mg/ml or more”. The metes and bounds of the limitation in the context of the claim are not clear. It is unclear if the immunoglobulin solution has a concentration of 125 mg/ml or more or if the sugar and surfactant has a concentration of 125 mg/ml or more. In the former case, claim 9 depends from claim 1 and claim 1 requires that the immunoglobulin solution in step a) has a concentration of at least 100 g/l. Therefore, it is unclear how the immunoglobulin solution recited in claim 9 has a concentration of 125 mg/ml. Clarification is requested.
Claim 13 and claims 14-15 depending therefrom 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.
Claim 13 recites the limitation “wherein the immunoglobulin is an anti-HER2 antibody”. The metes and bounds of the limitation in the context of the claim are not clear. Claim 13 depends from claim 12. Claim 12 recites a first immunoglobulin and a second immunoglobulin. Therefore, it is unclear if the anti-HER2 antibody is the first or the second immunoglobulin. Clarification is requested.
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation “wherein the immunoglobulin is an anti-IL13 receptor alpha antibody or an anti-HER2 antibody”. The metes and bounds of the limitation in the context of the claim are not clear. Claim 16 depends from claim 12. Claim 12 recites a first immunoglobulin and a second immunoglobulin. Therefore, it is unclear if the anti-IL13 receptor alpha antibody or anti-HER2 antibody is the first or the second immunoglobulin. Clarification is requested.
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 9 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 9 recites the limitation “wherein the immunoglobulin solution comprises a sugar and a surfactant and has a concentration of 125 mg/ml or more”. The metes and bounds of the limitation in the context of the claim are not clear. Claim 9 depends from claim 1 and claim 1 requires that the immunoglobulin solution in step a) has a concentration of at least 100 g/l. Therefore, claim 9 fails to further limit claim 1. Clarification is requested.
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.
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.
Claims 11-16 are 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(s) 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 11 and 14-15 are drawn to a method of producing trastuzumab and pertuzumab. Claims 12-16 are drawn to a method of producing a immunoglobulin solution by combining two first immunoglobulin solution and a second immunoglobulin solution as recited in claims 12-16. However, production of trastuzumab and pertuzumab and a method of producing an immunoglobulin solution by combining two first immunoglobulin solution and a second immunoglobulin solution as recited in claims 12-16 were not described in the application as originally filed nor in any of its parent applications. Therefore, claims 11-16 contain new matter.
Applicants in their remarks indicate that support for said amendments can be found in the specification at page 3, line 32 and in the second paragraph of Example 1. However, perusal of the specification at the above pages found no support for the amendments. Page 3, line 32 and the second paragraph of Example 1 are limited to the disclosure of production of anti-HER2 antibody.
Given this lack of description, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the inventions of claims 11-16 at the time of filing of the instant application.
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 1-5 and 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,891,430 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application and the claims of the reference patent are directed to a method of producing an immunoglobulin solution.
Regarding claim 1 of the instant application, claims 1 and 6 of the reference patent recite a method of producing an anti-HER2 antibody, wherein steps a) and b) are identical to the steps a) and b) of claim 1 of the instant application. Therefore, claim 1 of the instant application is anticipated by claims 1 and 6 of the reference patent.
Regarding claim 2 of the instant application, claims 2 and 13 of the reference patent recite a method of producing an anti-HER2 antibody, wherein steps a)-f) are identical to the steps a)-f) of claim 2 of the instant application. Therefore, claim 2 of the instant application is anticipated by claims 2 and 13 of the reference patent.
Regarding claim 3 of the instant application, claim 3 of the reference patent recites that the filter in the first and second filter unit have about the same filter area. Therefore, claim 3 of the instant application is anticipated by claim 3 of the reference patent.
Regarding claim 4 of the instant application, claim 4 of the reference patent that the immunoglobulin solution has a concentration of from 100 g/l to 300 gl. Therefore, claim 4 of the instant application is anticipated by claim 4 of the reference patent.
Regarding claim 5 of the instant application, claim 5 of the reference patent recites that the immunoglobulin solution has a volume of from 3 linter to 100 liter. Therefore, claim 5 of the instant application is anticipated by claim 5 of the reference patent.
Regarding claim 7 of the instant application, claim 7 of the reference patent recites a producing the immunoglobulin using identical chromatography. Therefore, claim 7 of the instant application is anticipated by claim 7 of the reference patent.
Regarding claim 8 of the instant application, claim 8 of the reference patent recites that the immunoglobulin solution has a concentration of 160g/l or more and the applying a combination of filters by applying a pressure of 1.45 bar or more. Therefore, claim 8 of the instant application is anticipated by claim 8 of the reference patent.
Regarding claim 9 of the instant application, claim 9 of the reference patent recites that the immunoglobulin solution comprises a sugar and a surfactant and has a concentration of 125 mg/ml or more and the applying to the combination of the filter by applying a pressure of 0.75 bar or less. Therefore, claim 9 of the instant application is anticipated by claim 9 of the reference patent.
Therefore, the conflicting claims are not patentably distinct from each other.
Claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,891,430 (reference patent) in view of Lee-Hoeflich (A central role for HER3 in HER2-amplified breast cancer: implications for targeted therapy. Cancer Res. 2008 Jul 15;68(14):5878-87. – form PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application and the claims of the reference patent are directed to a method of producing an immunoglobulin solution.
Regarding claim 1 of the instant application, claims 1 and 6 of the reference patent recite a method of producing an anti-HER2 antibody, wherein steps a) and b) are identical to the steps a) and b) of claim 1 of the instant application.
However, the claims of the reference patent do not recite that the anti-HER2 antibody is trastuzumab or pertuzumab.
Regarding claim 11, Lee-Hoeflich discloses that anti-HER2 antibodies trastuzumab and pertuzumab are used to treat breast cancer (abstract and page 5878).
Therefore, it would have been obvious to one having skill in the art to modify the claim 1 of the instant application by producing trastuzumab or pertuzumab as the anti-HER antibody. One having ordinary skill in the art would have been motivated to do so in order to produce trastuzumab or pertuzumab since trastuzumab and pertuzumab are used to treat breast cancer. One having ordinary skill in the art would have had a reasonable expectation of success since claims 1 and 6 of the reference patent recites a method of producing an anti-HER2 antibody and Lee-Hoeflich discloses that anti-HER2 antibodies trastuzumab and pertuzumab are used to treat breast cancer.
Therefore, the conflicting claims are not patentably distinct from each other.
Claims 12-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,891,430 (reference patent) in view of Lee-Hoeflich (A central role for HER3 in HER2-amplified breast cancer: implications for targeted therapy. Cancer Res. 2008 Jul 15;68(14):5878-87. – form PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application and the claims of the reference patent are directed to a method of producing an immunoglobulin solution.
Regarding claims 12-13 and 16 of the instant application, claims 1 and 6 of the reference patent recite a method of producing an anti-HER2 antibody or an anti-IL13 receptor alpha antibody, wherein steps a) and b) are identical to the steps a) i)-ii) or steps b) i)-ii) of claim 12 of the instant application.
However, the claims of the reference patent do not recite a method of producing an immunoglobulin solution comprising a first immunoglobulin and a second immunoglobulin, wherein the first and second immunoglobulin are trastuzumab and pertuzumab or vice versa.
Regarding claims 14-15, Lee-Hoeflich discloses that anti-HER2 antibodies trastuzumab and pertuzumab are used to treat breast cancer (abstract and page 5878). Lee-Hoeflich discloses that the combination of pertuzumab and trastuzumab augment the therapeutic benefit by blocking HER2/HER3 signaling (abstract).
Therefore, it would have been obvious to one having skill in the art to modify the claims of the reference patent by producing trastuzumab as the first immunoglobulin solution or second immunoglobulin solution and pertuzumab as the first immunoglobulin solution or second immunoglobulin solution and combining the two solutions. One having ordinary skill in the art would have been motivated to do so in order to produce trastuzumab and pertuzumab since trastuzumab and pertuzumab are used to treat breast cancer. One having ordinary skill in the art would have had a reasonable expectation of success since claims 1 and 6 of the reference patent recite a method of producing an anti-HER2 antibody and Lee-Hoeflich discloses that anti-HER2 antibodies trastuzumab and pertuzumab are used to treat breast cancer.
Therefore, the conflicting claims are not patentably distinct from each other.
Conclusion
Claims 1-5, 7-9, and 11-16 are pending.
Claims 1-5, 7-9, and 11-16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
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/YONG D PAK/Primary Examiner, Art Unit 1652