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
This office action is in response to applicant’s reply filed on August 3, 2026.
Restrictions/Elections.
Applicant's election with traverse of Group II (Claims 2-8 and 10) in the reply filed on August 3, 2026, is acknowledged.
Status of Claims
Claims 2-8 and 10 are currently pending and are the subject of this office action.
Claims 2-8 and 10 are presently under examination.
Priority
The present application is a 371 of PCT/CN2023/078993 filed on 03/01/2023 and claims priority to foreign application CHINA CN202210056299.7 filed on 01/18/2023.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 2-3, 5-8 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dunman et. al. (WO 2018/035183, 02/22/2018, cited by Applicant).
For claims 2 and 8, Dunman teaches a pharmaceutical composition comprising: a polymyxin antibiotic (Polymyxin B) and an antimicrobial agent, wherein the antimicrobial agent is dronedarone HCl (MW 592) (see Example 2 on pages 36-38 and Table 2 on pages 37-38). The composition is effective in the treatment of gram-negative bacteria like Pseudomonas aeruginosa.
For claim 3, Dunman teaches that the concentration of dronedarone HCl (MW 592) is 5 µM (See Table 2 on page 37) which translates into 2.97 µg/mL, which anticipates the instantly claimed range (0.1562 µg/mL to 20 µg/mL).
For claim 5, Dunman teaches that the concentration of the polymyxin antibiotic is 1.2 µg/mL (see Table 2 on page 37), which anticipates the instantly claimed range (0.03 µg/mL to 16 µg/mL).
For claim 6, Dunman teaches that the concentration of the polymyxin antibiotic is 1.2 µg/mL (see Table 2 on page 37), which anticipates the instantly claimed range (1.0 µg/mL to 16 µg/mL).
For claim 7, Dunman teaches that the concentration of dronedarone HCl can be 50 µM (See Table 2 on page 37), which translates into 29.7 µg/mL; and the polymyxin antibiotic is 1.2 µg/mL (see Table 2 on page 37), which results in a mass ratio of 24.75:1.00 (29.7 / 1.2) of dronedarone HCl to polymyxin antibiotic (which anticipates the instantly claimed ratio: 19-167:1:00)
Dunman teaches all the structural limitations of claim 10 (see above claim 2), except for the following statements:
“wherein the polymyxin antibiotic and the polymyxin antibiotic synergist (dronedarone HCl) are used in combination” or “the polymyxin antibiotic and the polymyxin antibiotic synergist (dronedarone HCl) are mixed to prepare a formulation for use”.
However, the above statements don’t add any structural limitation to the claims and simply state an intended use of a composition anticipated by the prior art.
The above statements are considered intended uses and do not add any new limitation to the claim. Catalina Mktg. Int’l, Inc. V. Coolsavings.com, Inc., 289 F.3d 801, 808, 62 USPQ2d 1781, 1785 (fed. Cir. 2002). “The recitation of a new intended use for an old product does not make a claim to that old product patentable.” In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dunman et. al. (WO 2018/035183, 02/22/2018, cited by Applicant).
For claim 4, Dunman teaches that the concentration of dronedarone HCl (MW 592) is 5 µM (See Table 2 on page 37) which translates into 2.97 µg/mL, or 50 µM (See Table 2 on page 37), which translates into 29.7 µg/mL, which are very close to the instantly claimed range (10 µg/mL to 20 µg/mL).
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575
16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower
claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also
In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
All this will result in the practice of claim 4 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
August 4, 2026.
