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 .
This is the first action on the merits.
Claims 1-6 are pending and under examination.
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.
Claim 4 is 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 pre-AIA the applicant regards as the invention.
The phrase, "effective amount," in claim 4 is indefinite where the claim fails to state the function which is to be rendered effective. See In re Frederiksen, 102 USPQ 35 (CCPA 1954).
To overcome the rejection, the phrase may be removed from the claim.
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the [fifth paragraph of 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 3 and 4 are rejected under 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. Claims 3 and 4 do not further limit claim 1 since claim 1 is drawn to a specific crystalline form CSII, which is described in the specification with Figure 1. Therefore, claiming less peaks does not further limit claim 1. 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.
To overcome the rejection, claim 1 may be amended to remove “CSII.”
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 1-6 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The following claims fail to meet the written description requirement with regards to identifying the specific crystalline form of the compound 1.
The x-ray pattern of a pure crystalline substance can be used to identify compounds because the diffraction pattern is considered to be a "fingerprint" of a compound. The d value for the most intense line is found and compared, followed by the next two intense lines, and so on.
Identification of crystal structures is taught by Bhattacharya et al. (Brittain, ed. Polymorphism in Pharmaceutical Solids, 2009, page 334). As noted in the fourth full paragraph, "it is usually convenient to identify the angles of the 10 most intense scattering peaks in a powder pattern" or the last paragraph which states 5 characteristic XRD (X-ray diffraction) scattering peaks of sodium ibandronate was sufficient to determine the difference in the two polymorphic forms.
Moreover, the preamble of claim 1 is drawn to the crystalline form CSII which is described in the specification by Figure 1. Thus, less peaks than in Figure 1 cannot be claimed in claim 1.
Thus, only four peaks cannot be used to identify an unknown compound.
The rejection may be overcome by removing the term “CSII” from claim 1 and adding additional peaks.
Examiner’s comments
The closest prior art is US 10590087 (‘087), which teaches different crystalline form of compound 1 as currently claimed. The closest crystalline compounds identified in the ‘087 patent are found in Figures 17 and 26, which correlate to Form F and L. Figure 17 (Form F) does not have a peak at 12º and Figure 26 (Form L) does not have a peak at 7.6º.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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