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 .
DETAILED ACTION
2. Claims 1-3, 5-16, 18, 20, 22, 24 and 27 are pending and currently under prosecution.
Priority
Applicant’s claim under 35 U.S.C. §§ 119(e) and 120 for benefit of the earlier filing date of applications, is acknowledged.
4. 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.
Claim Rejections - 35 USC § 102
5. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
6. Claims 1-3, 6-11, 16, 18 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tjønnfjord et al. (BMJ Case Rep. 2017. doi:10.1136/bcr-2016-219066, pages 1-4).
Claims 1-3, 6-11, 16, 18 and 27 are herein drawn to a method of reducing or preventing hemolysis in a subject in need thereof undergoing a major surgery, comprising maintaining in the subject a therapeutic serum concentration of a proximal classical complement pathway inhibitor, wherein the subject has cold agglutinin disease (CAD) and the therapeutic serum concentration is effective to reduce or prevent hemolysis.
Tjønnfjord et al. teach that eculizumab was used prophylactically to prevent
an exacerbation of hemolysis following major surgery in a patient who has cold agglutinin disease (CAD), wherein eculizumab is a classical complement pathway C5 inhibitor used for treating CAD; see entire document, e.g., title, abstract, right col. of page 1, left col. of page 4.
Tjønnfjord et al. teach that the patient received 600 mg of eculizumab the day before the operation and a second dose (600 mg) 1 week later; see page 3.
For claim 16, Tjønnfjord et al. teach that the patient was scheduled for cardiac surgery; see abstract.
Claim Rejections - 35 USC § 103
7. 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 of this title, 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.
8. 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.
9. Claims 1, 5, 12-15, 20, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Tjønnfjord et al. (BMJ Case Rep. 2017. doi:10.1136/bcr-2016-219066, pages 1-4) in view of Jager et al. (Blood, 2019,133(9):893-901).
Claims 5, 12-15 are herein drawn to a method of reducing or preventing hemolysis in a subject in need thereof undergoing a major surgery, comprising: assessing a serum concentration of a proximal classical complement pathway inhibitor in a subject who has cold agglutinin disease (CAD) and is undergoing treatment with a proximal classical complement pathway inhibitor; and performing the major surgery on the subject within seven days of the assessing.
Claims 20, 22 and 24 are herein drawn to the method of claim 1, wherein the inhibitor is sutimlimab.
The teachings of Tjønnfjord et al. have been set forth in the above rejection of claims 1-3, 6-11, 16, 18 and 27 under 35 U.S.C. 102(a)(1).
Tjønnfjord et al. do not teach the classical complement pathway inhibitor is sutimlimab, which can be used to treat CAD, and assessing a serum concentration of sutimlimab.
However, these deficiencies are remedied by Jager et al.
Jager et al. teach that sutimlimab rapidly stopped C1s complement–mediated hemolysis in patients with cold agglutinin disease, a dose of 10-mg/kg sutimlimab followed by a full dose of 60 mg/kg 1 to 4 days later and 3 additional weekly doses of 60 mg/kg; see entire document, e.g., abstract. Jager et al. teach that sutimlimab is a classical complement pathway C1 inhibitor; see second paragraph of left col. and last paragraph of right col. on page 895. Jager et al. teach a method of determining serum sutimlimab levels; see bridging paragraph of left and right col. on page 895.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to use sutimlimab for preventing hemolysis in a subject undergoing a major surgery, wherein the subject has cold agglutinin disease (CAD). One would have been motivated to do so because Tjønnfjord et al. teach that eculizumab was used prophylactically to prevent an exacerbation of hemolysis following major surgery in a patient who has cold agglutinin disease (CAD), wherein eculizumab is a classical complement pathway C5 inhibitor used for treating CAD; Jager et al. teach that sutimlimab rapidly stopped C1s complement–mediated hemolysis in patients with cold agglutinin disease, wherein sutimlimab is a classical complement pathway C1 inhibitor. Thus, one of ordinary skill in the art would have a reasonable expectation of success that by combining the teachings of the references so as to substitute the classical complement pathway inhibitor eculizumab of Tjønnfjord et al. for another classical complement pathway inhibitor sutimlimab of Jager et al. to arrive the instant claimed invention, because simple substitution of the classical complement pathway inhibitor eculizumab of Tjønnfjord et al. for another classical complement pathway inhibitor sutimlimab of Jager et al. would obtain predictable results.
Given the examination guidelines for determining obviousness under 35 U.S.C. 103 in view of the Supreme Court decision in KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007) and the Examination Guidelines set forth in the Federal Register (Vol. 72, No. 195, October 10, 2007) and incorporated recently into the MPEP (Revision 9, March 2014), the following rationales to support rejection under 35 U.S.C. 103(a) are noted:
A) Combining prior art elements according known methods to yield predictable results.
B) Simple substitution of one known element for another to obtain predictable results.
C) Use of known technique to improve similar devices (methods, or products) in the same way.
D) Applying known technique to a known device (method, or product) ready for improvement to yield predictable results.
E) “Obvious to try” --- choosing form a finite number of identified, predictable solutions, with a reasonable expectation of success.
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art.
G) Some teachings, suggestion, or motivation in the prior art that would lead to one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In this case, simple substitution of the classical complement pathway inhibitor eculizumab of Tjønnfjord et al. for another classical complement pathway inhibitor sutimlimab of Jager et al. would obtain predictable results.
Obviousness is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007). From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Conclusion
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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