DETAILED CORRESPONDENCE
Application Status
1. The present application is being examined under the pre-AIA first to invent provisions.
2. Claims 1-6, 8-9, 11, 13, 18, 20, and 25-31 are pending.
Election/Restrictions
3. Applicant’s election without traverse of Group I, claims 1-6, in the reply filed on 07/06/2026 is acknowledged.
4. Claims 8-9, 11, 13, 18, 20, and 25-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/06/2026.
Claims 1-6 are pending and examined on the merits.
Priority
5. Acknowledgement is made of this continuation application of U.S. Non-provisional Application No. 18/490004, filed on 10/19/2023, which is a continuation of U.S. Non-provisional Application No. 18/052696, filed on 11/04/2022, which is a continuation of U.S. Non-provisional Application No. 17/709622, filed on 03/31/2022, which is a continuation of U.S. Non-provisional Application 17/408222, filed on 08/20/2021, which is a continuation of U.S. Non-provisional Application No. 17/138265, filed on 12/30/2020, which is a continuation of U.S. Non-provisional Application No. 16/271433, filed on 02/08/2019, which is a continuation of U.S. Non-provisional Application No. 15/909609, filed on 03/01/2018, which is a continuation of U.S. Non-provisional Application No. 14/776442, filed on 09/14/2015, which is a national stage entry of PCT/US2014/026491, filed n 03/13/2014, which claims domestic priority to U.S. Provisional Application No. 61/784594, filed on 03/14/2013.
Information Disclosure Statement
6. The IDS filed on 06/21/2024 has been considered by the examiner and a copy of the Form PTO/SB/08 is attached to the office action.
Drawings
7. The Drawings filed on 06/21/2024 are acknowledged and accepted by the examiner.
Claim Rejections - 35 USC § 102
8. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
9. Claim(s) 1-2, 4 and 6 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Shtraizent et al. (The Journal of Biological Chemistry, 2008; cited on IDS filed on 06/21/2024).
10. Claims 1-2, 4 and 6 are drawn to a method of producing a therapeutic composition, the method comprising: providing a medium containing an inactive acid ceramidase precursor; incubating the medium under conditions effective to transform a portion of the inactive acid ceramidase precursor to active acid ceramidase; and recovering the incubated medium as a ceramidase mixture comprising the inactive acid ceramidase precursor and an active acid ceramidase.
11. With respect to claim 1, Shtraizent et al. teach a method for producing a purified human acid ceramidase composition comprising providing an inactive acid ceramidase precursor purified from recombinant cells overexpressing acid ceramidase in media, incubating the precursor to induce autoproteolytic cleavage into active acid ceramidase and recovering the incubated medium after periods of time from 24 to 72 hours showing partial or complete transformation of inactive precursor to active acid ceramidase [see Abstract; p. 11254, column 1, third paragraph to second column, fourth paragraph; p. 11256-11257, figures 4-7]. The teachings of Shtraizent et al. is interpreted as reading on the limitation “therapeutic” as the term is specified at such a high level of generality, that the expression and autocleavage of the acid ceramidase due to the cellular environment can be interpreted as “therapeutic”.
With respect to claim 2, Shtraizent et al. teach incubating under conditions at higher pH 7.5 reduce the transformation rate of inactive acid ceramidase precursor to active acid ceramidase compared to the transformation rate achieved when incubating is carried out at a pH of 4 and a temperature of 37oC for 24 hours [see Figure 7; p. 11257, column 1 bottom to column 2].
With respect to claim 4, Shtraizent et al. teach incubating under conditions at higher pH 7.5 reduce the transformation rate of inactive acid ceramidase precursor to active acid ceramidase compared to the transformation rate achieved when incubating is carried out at a pH of 4 and a temperature of 37oC for 24 hours [see Figure 7; p. 11257, column 1 bottom to column 2].
With respect to claim 6, Shtraizent et al. teach a method for producing a purified human acid ceramidase composition comprising providing an inactive acid ceramidase precursor purified from recombinant cells overexpressing acid ceramidase in media, incubating the precursor to induce autoproteolytic cleavage into active acid ceramidase and recovering the incubated medium after periods of time from 24 to 72 hours showing partial or complete transformation of inactive precursor to active acid ceramidase [see Abstract; p. 11254, column 1, third paragraph to second column, fourth paragraph; p. 11256-11257, figures 4-7].
Claim Rejections - 35 USC § 103
12. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
13. Claim 3 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shtraizent et al. (The Journal of Biological Chemistry, 2008; cited on IDS filed on 06/21/2024).
14. The relevant teachings of Shtraizent et al. as applied to claims 1-2, 4, and 6 are set forth above.
With respect to claim 3, Shtraizent et al. teach incubating under conditions at higher pH 7.5 reduce the transformation rate of inactive acid ceramidase precursor to active acid ceramidase compared to the transformation rate achieved when incubating is carried out at a pH of 4 and a temperature of 37oC for 24 hours [see Figure 7; p. 11257, column 1 bottom to column 2]. Regarding incubating over 4.0 and up to 6.5, MPEP 2144.05.II.A states “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. In the instant case, Shtraizent et al. teach that higher pH reduces the transformation rate of inactive acid ceramidase precursor to active acid ceramidase compared to the transformation rate achieved when incubating is carried out at a lower pH. It would be obvious for one of ordinary skill in the art to optimize the pH of the mixture depending on the desired amount of inactive and active ceramidase.
Conclusion
15. Status of the claims:
Claims 1-6, 8-9, 11, 13, 18, 20, and 25-31 are pending.
Claims 8-9, 11, 13, 18, 20, and 25-31 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-4 and 6 are rejected.
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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, Manjunath Rao can be reached at 571-272-0939. 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.
/PAUL J HOLLAND/Primary Examiner, Art Unit 1656
Prosecution Insights