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
STATUS OF THE CLAIMS: Claims 1-17 are pending in this application. Claims 2-17 are allowed. Claim 1 is anticipated and obvious, and the rejection of claim 1 under 35 U.S.C. 102 and 103 are maintained for the reasons of record as set forth today, herein below, and in the Office Action dated November 26, 2025
Response to Amendment & Arguments regarding
Claim Rejections - 35 USC § 112, first paragraph
Applicant’s arguments, filed November 26, 2025, with respect to 35 USC § 112, first paragraph, have been fully considered and are persuasive. The rejections of claims 18-19 has been withdrawn.
Response to Arguments regarding
Claim Rejections - 35 USC § 102 and 103
Applicant's arguments filed November 26, 2025 have been fully considered but they are not persuasive.
MPEP 2112 states: “SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY.”
The claiming of a new use, new function or unknown property, which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)”.
In this case, the “unknown property” is the salt form structure. This is unknown because the reference is silent on this property (i.e., phosphoric sodium salt). MPEP further states: “A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC.
Where Applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the Examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection.”
Again, the “CHARACTERISTIC”, which the prior art is silent is the crystalline salt form.
This is not an ordinary inherency situation where is it is not explicitly stated what the product actually is. Here the reference explicitly teaches exactly what the compound is. The only difference is a characteristic about which the reference happens to be silent. See also Ex parte Anderson, 21 USPQ 2nd 1241 at 1251, discussion of Rejection E. There, the decision states, “There is ample precedent for shifting the burden to an applicant to reproduce a prior art product whose final structure or properties are, at least, in part determined by the precise process used in its manufacture.” (See page 1253). The “properties” branch of that statement applies here.
Applicants are reminded that the USPTO has no testing facilities. If Applicants’ reasoning were accepted, then any anticipation rejection of an old compound could always be overcome by tacking on some characteristic or property which the reference was silent, regardless of whether the prior art material was any different from the claimed material. For example, if it did not happen to mention the color, one could patent an old compound just by adding “which is green” or “which is not indigo”. One could put in a limitation about density (e.g., density is not 1.4”), melting point, refractive index, solubility, and etc., and then simply point to the silence of the reference, as Applicants have done here. Or one could add properties like or “does not explode on tapping” or “in the form of micro-needles”.
Thus, the rejection of claim 1 under 35 U.S.C. 102, set forth in the Office action dated October 19, 2016 and today has been maintained for the reasons of record for the reasons set forth herein.
Allowable Subject Matter
Claims 2-17 are allowed. The crystalline compounds comprising XRPD patterns were not found to be obvious or anticipated by the prior art of record. The prior art does not teach or suggest the crystalline compounds in the manner claimed by the Applicant comprising the XRPD patterns, thermogravimetric analysis curves , endothermic peaks, and differential scanning calorimetric curves. Therefore, these claims are allowed.
Examiner Notes
Examiner suggests to Applicant to schedule an Examiner Interview to discuss the rejection herein above, and possibly place all of the claims in condition for allowance.
Conclusion
Claims 1-17 are pending. Claim 1 is rejected. Claims 2-17 are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL V WARD whose telephone number is (571)272-2909. The examiner can normally be reached M-F 9am 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, James Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622
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