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 .
Claims 1-35 are presented for examination.
Applicants’ drawings and preliminary amendment filed April 8, 2022 have been received and entered.
Applicants’ election filed December 15, 2025 in response to the restriction requirement of October 17, 2025 has been received and entered. The applicants elected the invention described in claims 27-29 (Group V) without traverse.
Claims 1-26 and 30-35 are withdrawn from consideration as being drawn to the non-elected invention (37 CFR 1.142(b)).
Priority
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.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 27 and 28 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 27 is rendered indefinite by the phrase, “pretreating sodium lauryl sulfate” and the phrase, “an accelerate condition”. What is this “accelerated condition”? What caused this “accelerated condition”?
Claim 28 is rendered indefinite to the extent that it incorporates the above terminology.
Claims 27 and 28 are not allowed.
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.
The factual inquiries 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.
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Tomohira et al. (US 2003/0161873 A1).
Tomohira et al. teach a method of stabilizing a pharmaceutical preparation containing a pharmacological substance (a pharmaceutical formulation) and sodium lauryl sulfate (see page 4, claim 1). Note sodium lauryl sulfate that is commercially available and generally distributed may or may not contain impurities (or may contain very few impurities or produce impurities that are formed a slow rate), depending on the lot, and it is clear before the filing date of the present invention.
The instant invention differs from the cited reference in that the cited reference does not teach impurities detection on sodium lauryl sulfate or a pharmaceutical formulation the contains sodium lauryl sulfate after a pretreatment under accelerated aging conditions. Regarding this matter, in the technical field of pharmaceutical formulations and compositions, performing a stability test is common practice for persons skilled in the art, and testing of stability using a hot acceleration aging test was a well-known feature before the priority date of the present application.
Claim 27 is not allowed.
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.
The factual inquiries 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.
Claim(s) 28 and 29 are ejected under 35 U.S.C. 103 as being unpatentable over Shiraki et al. (US 2017/0217927 A1) in view of Nakagaki et al., “Acid-Catalyzed Hydrolysis of Sodium Dodecyl Sulfate”, Journal of Pharmaceutical Sciences, Vol. 74, No. 10, pages 1047-1052 (1985).
Shiraki et al. teach the compound represented by formula (I) of the present application as alectinib, and in TABLE 4 (page 7) teaches sodium lauryl sulfate.
Note sodium lauryl sulfate that is commercially available and generally distributed may or may not contain impurities (or may contain very few impurities or produce impurities that are formed a slow rate), depending on the lot, and it is clear before the filing date of the present invention.
The instant invention differs from the cited reference in that the cited reference does not teach impurities detection on sodium lauryl sulfate or a pharmaceutical formulation the contains sodium lauryl sulfate after a pretreatment under accelerated aging conditions. Regarding this matter, in the technical field of pharmaceutical formulations and compositions, performing a stability test is common practice for persons skilled in the art, and testing of stability using a hot acceleration aging test was a well-known feature before the priority date of the present application. A person skilled in the art could easily: perform accelerated aging tests on the pharmaceutical formulation containing sodium lauryl sulfate to detect impurities resulting from the degradation of sodium lauryl sulfate; perform accelerated aging tests on the sodium lauryl sulfate itself to detect impurities; and optimize the conditions of the accelerated aging tests using the formation of impurities as an indicator, etc.
Note Nakagaki et al. teach the degradation of sodium dodecyl sulfate (also known as sodium lauryl sulfate) produces dodecanol and hydrogen sulfate ions and that during the process that sodium lauryl sulfate and dodecanol combine to form a complex. Clearly, a person skilled in the art could predict the effect that the amount of alectinib dissolving from the formulation will decrease as the detected amount of dodecanol increases.
Claims 28 and 29 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629