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
Filing Receipt and Priority
The filing receipt mailed 12/10/2024 states that the instant application is a CON of application 18/463,157 (PAT 12,157,743), filed 09/07/2023, which is a CON of application 17/575,025 (PAT 11,795,176), filed 01/13/2022.
The filing receipt also states that the instant application claims foreign benefit of EPO 21151412.0, filed 01/13/2021, and EPO 21152317.0 filed 01/19/2021.
The EPO 21151412.0 document supports the instant application. Therefore, the effective filing date is 01/13/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted 12/02/2024, 10/03/2025, 10/27/2025, and 12/10/2025 have been considered.
Restriction/Species Election
Applications election without traverse of Group I, claims 1-11 and 14 is acknowledged.
Rejections
Claim Rejections - 35 USC § 112(d)
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.
Claims 2-7 are 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 1 states “A crystalline solid form of Alpha-1062 gluconate (Form B) wherein said crystalline form has prominent peaks at 10.69, 17.17, 21.00, 24.67 degrees 2-theta (±0.2) in a powder X-ray diffraction pattern.”
Claims 2-7 are drawn to characterization data which further characterizes Form B claimed in claim 1.
The full listing of XRPD peaks which characterize Form B is found in the instant specification, p. 12, shown below.
PNG
media_image1.png
420
522
media_image1.png
Greyscale
Additionally characterization data is found in Figures 13-18, which show an onset peak at 66 oC in using DSC (claims 4 and 5), a weight loss of 3.3% up to 114 oC (claims 6 and 7).
PNG
media_image2.png
720
680
media_image2.png
Greyscale
Because applicant explicitly uses “Form B” within claim 1, applicant is inherently claiming the entirety of the crystalline form, including the physical properties which lead to its characterization data. Essentially, applicant is claiming all peaks and characterization data in claim 1 by claiming “Form B”. Therefore, claims 2-7 are not further limiting as they simply claim the same characterization data.
Examiner suggests amending claim 1 to remove “Form B” or amending claim 1 to include the information of claims 2-7.
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.
Allowable Subject Matter
Claims 1, 8-11 and 14 are allowed.
A search did not result in art that could be applied to claim 1. As claims 8-11 and 14 are dependent and/or include the allowable subject matter of claim 1, they are also allowed.
Conclusion
Allowable subject matter indicated.
Claims 2-7 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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, Jeffrey Murray can be reached at (571) 272-9023. 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.
/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
Prosecution Insights