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 and 12-15 are presented for examination.
Claims 1-9, 16 and 17 are withdrawn from examination.
The amendments and remarks filed on 01/07/2026 have been received and 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 (I), 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. A fter 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 the like 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, the water content and the
reconstitution time of the lyophilized formulation. However in the examples on page 56 of specification comparing the claimed composition with Kawasaki as comparative example, the surface area in some Examples is very close or overlap 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%.
It would have been obvious to a person skilled in the art to modify the manufacturing steps in order to
obtain the desired surface area in the absence of evidence to the contrary. The amount of water of less
than 0.5% is taught for Kawasaki’s composition in the example on page 56.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 10 and 12-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 29 of U.S. Patent No. 9949982. Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap. The claims of the instant application are drawn to a lyophilized composition comprising formulas (I) and (II) with the specific surface of lyophilization. The claims of the U.S. Patent are drawn to the composition of formulas (I) and (II), which can be in a lyophilized form. The claims of the instant application are within the scope of the claims of the U.S. Patent.
Response to Arguments
Applicant’s arguments have been noted. Applicant in his remarks argues that “Kawasaki does not disclose spraying a mist into the chamber. The method of Kawasaki does not produce a lyophilized formulation that has beneficial features, which the lyophilized formulation according to claim 10 has, as shown in the Examples. Comparative Example 1 in Table 4 at page 52 of the present specification was prepared under conditions corresponding to Kawasaki (without the mist-spraying step). As shown in Table 6 (see page 56), the specific surface area of Comparative Example 1 was 1.2815 m²/g, which falls outside our claimed range and had a longer reconstitution time. As Kawasaki does not teach or suggest the lyophilizing method comprising spraying a mist into a chamber, nor the specific surface area of the lyophilized formulation and its correlation with the shorter reconstitution time, a person having ordinary skill in the art would not have expected that the method aspects of claim 10 would produce a lyophilized formulation that has a specific surface area in a range from 0.6 to 1.1 m²/g and has beneficial features of shorter reconstitution time and lower water content”. It is the examiner’s position that spraying a mist into the chamber is part of the process of manufacturing the claimed composition and not the composition itself . 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. Claims 10 and 14 are drawn to product by process. When a claim is drawn to a product by process, such claim will be examined to the extent that it reads on the product. Therefore, the manufacturing steps in such claims have not been given any patentable weight. Claims 10 and 14 read on the withdrawn claims based on the restriction requirement.
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 ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. 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