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 .
Claims 10, 12-15 are presented for examination
Claims 1-9, 16 and 17 are withdrawn from consideration.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/23/2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki et al. (US 20170281639). Kawasaki teaches a pharmaceutical formulation comprising the compound of Formula (1), its pharmaceutically acceptable salt, or a solvate thereof, 2) one or more ingredients selected from the group consisting of alkali metal chlorides, alkaline earth metal chlorides, transition metal chlorides and magnesium chloride; and 3) sugar and/or a sugar alcohol. See the abstract. The sodium salt of formula (I) is taught in Para [0026]. The lyophilized product of the claimed composition is taught in Para [0053]. The example of salts is taught to be alkali metal salt, alkali earth metal salt, transition metal chloride or magnesium salt of organic acid or inorganic acid or its hydrate include sodium salt, lithium salt, potassium salt, calcium salt, zinc salt magnesium salt, and the like, preferably sodium salt, magnesium salt, more preferably sodium salt. See para [0075]. Kawasaki teaches that the lyophilized preparation of is administered after adding the dissolved solution such as injectable distilled water, physiological saline or glucose solution and dissolving the preparation, timely. Kawasaki teaches that The pharmaceutical preparation of the present invention after lyophilizing is administered after adding a solution such as a distilled water for injection, normal saline solution or glucose solution at the time of use to dissolve. Kawasaki teaches that the pharmaceutical composition of the present invention exhibits a strong antibacterial spectrum against Gram-positive bacteria and Gram-negative bacteria, especially ß- lactamase producing Gram-negative bacteria, and it does not exhibit cross-resistance with existing cephem drugs and carbapenems. See Para [0119]. Kawasaki teaches 1000 mg I type crystalline was weighed, which is converted by the compound represented by formula (I), and this crystal was added into the vial bottle, and it was suspended in the injectable distilled water. The suspended solution was adjusted to pH 5.5 to 6 by 3N sodium hydroxide, and the solution was dissolved as the sodium salt of compound represented by formula (II). 900 mg sucrose (Merck) and 216 mg sodium chloride (Merck) was added into this solution. The solution was stirred and dissolved; the injectable distilled water was added into the solution and the concentration of the compound represented by formula (I) was adjusted to 10 w/w %. The solution was filtered aseptically and the pharmaceutical preparation solution was prepared. The given amount of obtained solution was filled into the vial or ample and it was lyophilized. As the condition of lyophilization, 1) cooling at 5° C., 2) cooling at -5° C. for 2 hours, 3) freezing at -47.5° C. for 4 hours, 4) freezing at -25° C. for 2 hours, 5) freezing at -40° C. for 1 hour, 5) primary drying at -20° C. for more than 130 hours under 10 Pa degree of vacuum. 6) secondary drying at 60° C. for more than 6 hours under 10 Pa degree of vacuum, was conducted and the lyophilized product was manufactured.
Kawasaki does not teach the surface area of the lyophilized as claimed here and the reconstitution time of the lyophilized formulation. However, the determination of optimum surface area, and the reconstitution time is considered to be within the skill of artisan. Additionally, the submitted declaration refers to the examples on page 56 of specification comparing the claimed composition with Kawasaki as comparative example to show the difference in surface area. However, the surface area in some Examples is very close or overlaps with the comparative example, if the standard deviation is added. The water amount of the comparative example reads on the claimed water amount of less than 0.5%.
Response to arguments
Applicant’s arguments and affidavit have been noted. Applicant in his remarks and declaration alleges criticality to the differences in the process by which the lyophilized formulation was formed by the instant application and Kawasaki et al. Applicant in his declaration argues that “In the method of Kawasaki '982, the spraying a mist into a chamber as recited in present claim 10 was not performed. Applicant further argues that Comparative Example I shown in Table 6 on page 56 of the present specification as filed substantially followed the lyophilization conditions disclosed at column 26, lines 51-57 of Kawasaki '982 (which corresponds to paragraph [0191] of US '639 publication of Kawasaki) except that the mist spraying was not performed. With respect to the method for preparing the pharmaceutical preparations, Kawasaki '982 discloses "[a]s the condition of lyophilization, 1) cooling at 5°C., 2) cooling at -5°C. for I hour, 3) freezing at -40°C. for 4 hours, 4) primary drying at -22°C. for 129 hours under 10 Pa degree of vacuum, and 5) second drying at 60° C for 6 hours under 10 Pa degree of vacuum was conducted and the lyophilized product was produced (Example 1,2, Comparative example 1 to 4)". In the present Comparative Example 1, the primary drying was performed at -20°C for 145 hours and the secondary drying at 60°C. for 6 hours. Although the primary drying temperature was slightly modified from those disclosed in Kawasaki '982, i.e., 2°C higher, the primary drying time was extended and therefore the drying efficiency was not adversely affected. The specific surface area and the reconstitution time of the present Comparative Example I discussed below are significantly larger than the upper limits of the ranges recited in present claim 10. Accordingly, the differences in the specific surface area and reconstitution time of the present Comparative Example I from the ranges thereof recited in present claim 10 discussed below are considered to be the results of the absence of the mist spraying, rather than the results of the minor differences in lyophilization conditions”. It is the examiner’s position that spraying mist into the chamber is part of the process of making a lyophilized formulation and not the formulation itself. The process by which a product is made does not create a patentably distinct product. Applicant's attention is drawn to MPEP 2113, which states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) ".
It is also the examiner's position that in certain examples, such as example 2, by adding the standard deviation 014, or 0.2 as claimed in claim 13 the surface area of the claimed invention is very close or overlaps with the comparative example. Furthermore, the water content of the comparative example is 0.17, which reads on the claimed water content of less than 0.5%. Therefore, the lyophilized formulations having the same or very close surface area and water content is expected to have the same or very close reconstitution time. Additionally, reconstitution time is part of the process of making and not a composition, which reads on a compound and carriers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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, Sue Liu can be reached at571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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