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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-7 and 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kannan et al. (2024/0024312)(based on its earlier filing date). Claims 1-2 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khan et al. (2023/0133326). Claims 1-2 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2015/114152. Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2023083990. Each discloses a sitagliptin preparation and a method of storing the same, comprising a sitagliptin containing tablet (see paragraph 0042; see paragraph 0009; see page 1, lines 2-4 and page 17, lines 5-9; see paragraph 0001), and a case or packing (see paragraph 0116; see paragraph 0008; blister pack, see page 17, lines 5-9; see paragraph 0011) sealing the sitagliptin containing tablet, wherein an equilibrium relative humidity of the sitagliptin containing tablet when the sitagliptin preparation is stored for one month under a condition of 25 degrees C and a relative humidity of 60% (see paragraphs 0037-0039 and 0116-119; see paragraph 0008, lines 10-16; see page 17, lines 5-9; see paragraph 0137) is inherently converted at 24 degrees C is 0.3% or less. The USPTO is not equipped to perform specialized tests upon prior art devices in order to determine an inherent property of a prior art device. Once a reference teaching the claimed product and appearing to be substantially identical is made the basis of a rejection, the burden shifts to the applicant to show an unobvious difference. See MPEP 2112(V). “The PTO can require an applicant to prove that the prior art product does not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on inherency under 35 U.S.C. 102 or prima facie obviousness under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same”. The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980)(quoting In re Best, 562 F. 2d 1252, 1255, 195 USPQ 430, 433-434 (CCPA 1977).
As to claims 2 and 7, each discloses the packing or container being sealed to maintain the sitagliptin its stabile undegraded state (see paragraphs 0116-0119; see paragraph 0008, sealed blister pack; see page 17, lines 5-9, sealed blister pack; see paragraph 0011, PTP and aluminum pillow).
As to claims 3-4 and 8-9, JP 2023083990 discloses a blister pack (PTP) sealed in a pillow package (see claims 1 and 2 and paragraph 0011) along with a desiccant (see paragraph 0041)..
As to claims 5 and 10, Kannan et al. and JP 2023083990 each disclose the tablet sealed in an airtight case along with a desiccant (see paragraphs 0116-0119; see paragraph 0041).
Prior Art not relied upon: Please refer to the additional references listed on the attached PTO-892, which, while not relied upon for the claim rejection, these references are deemed relevant to the claimed invention as a whole.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYON P GEHMAN whose telephone number is (571) 272-4555. The examiner can normally be reached on Tuesday through Thursday from 7:30 am to 5:00 pm.
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, Orlando Aviles, can be reached on (571) 270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRYON P GEHMAN/Primary Examiner, Art Unit 3736
Bryon P. Gehman
Primary Examiner
Art Unit 3736
BPG
Prosecution Insights