DETAILED ACTION
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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 8-10, 14-17, 19, 21-26, 28-29 are objected to because of the following informalities: the claims are grammatically incorrect because they are missing a comma before the terms “wherein” and “further”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-2, 4-5, 7-10, 14-17, 19, 21-26 and 28-29 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 1 is directed to form A of monohydrate of calcium oxybate. However, no characteristics defining Form A are present in the claim. “Form A” is not a term of the art directed to a specific crystal form of a compound that definitively specifies what the crystal structure is. There is nothing preventing applicant or another inventor from discovering a different crystal form of monohydrate of calcium oxybate and also calling it Form A. A crystal form is defined by having a specific unique Xray powder diffraction peaks and by DSC endotherm(s). Without specifying the above parameters, it is unclear what limitations the term “Form A” imposes on the claim.
Claims 28 and 29 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. The claims depend from claim 27 which has been canceled. The scope of the claims is unclear.
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 and 4 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 is directed to form A of monohydrate of calcium oxybate. Claims 2 and 4 are directed to specific physical characteristics of calcium oxybate monohydrate. The physical characteristics of a crystal form, such as currently claimed X-ray powder diffraction peaks and DSC data are derived from the specific structure of the crystal form and are inseparable from the crystal form itself. Form A in claim 1 already encompasses the claimed powder diffraction peaks and endothermic DSC event of claims 2 and 4 because a crystal form and its properties are inseparable. In fact, Form A is defined by the physical properties in claims 2 and 4. 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.
Claim Rejections - 35 USC § 112(a)
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.
Claim 2 is 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. Claim 2 is directed to Form A of monohydrate of calcium oxybate having one or more listed powder diffraction peaks. The claim encompasses monohydrate of calcium oxybate having a peak at 7.2 but not 14.2 2θ. No such crystal form has been prepared. The only crystal form of monohydrate of calcium oxybate that has been prepared is one that has all of the listed peaks. Figure 1 depicts the powder diffraction 2θ peaks for the prepared crystal form. Figure 1 contains peaks at 7.2, 8.1 and 14.2. All three peaks must be present in the claimed Form A. Form A where only 1 or 2 of the peaks are present were not in applicant’s possession at the time of filing.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 2, 4 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walsh et al (US 2020/0330393). In Example 1, paragraph [0191], Walsh discloses a composition prepared by addition of calcium oxybate monohydrate. While Walsh does not disclose the XRPD 2θ peaks, Examiner is interpreting recitation of calcium oxybate monohydrate to correspond to the currently claimed Form A. Both, the claimed product and the one disclosed by Walsh are crystal forms of calcium oxybate monohydrate. Examiner was unable to find examples where a DCS and XRPD for calcium oxybate monohydrate is provided. Absent evidence that multiple crystal forms of calcium oxybate monohydrate exist, Examiner has no option but to conclude that the only crystal form that exists is the one described by the applicant. Therefore, the crystal form disclosed by Walsh and the one currently claimed is the same.
Conclusion
Claims 1-2, 4-5, 7-10, 14-17, 19, 21-26 and 28-29 are pending
Claims 1-2, 4-5, 7-10, 14-17, 19, 21-26 and 28-29 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-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, Amy L Clark can be reached at 571-272-1310. 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.
/YEVGENY VALENROD/Primary Examiner, Art Unit 1628