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
Priority and Status of the Claims
1. This application is a 371 PCT/US2022/013678 01/25/2022, which claims benefit of the provisional application: 63141081 01/25/2021.
2. Claims 1-9, 11-13, 16, 18, 20, 28, 41, 54, 69 and 85 are pending in the application.
3. 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 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.
Claim Rejections - 35 USC § 102
4. 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 1 is rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Baker’s US 2016/0058772 A1.
Applicants claim an amorphous form of bismuth-1,2-ethanedithiol (BisEDT), see claim 1.
Baker’s ‘772 discloses an amorphous form of bismuth-1,2-ethanedithiol (BisEDT), see section [0109] in column 16 and section [0270] in column 35. It clearly anticipates the instant amorphous form of bismuth-1,2-ethanedithiol (BisEDT) of claim 1.
Claim Rejections - 35 USC § 103
5. The following is a quotation of 35 U.S.C. 103(a) 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-9, 11-13, 16, 18, 20, 28, 41, 54, 69 and 85 are rejected under 35
U.S.C. 103(a) as being obvious over Baker’s US 2016/0058772 A1.
Applicant claim an amorphous form of bismuth-1,2-ethanedithiol (BisEDT), see claim 1. Dependent claims 2-9, 16, 18, 20, 28, 41, 54, 69 and 85 further limit the scope of compound, i.e., specific physical characters including XRPD pattern, methods of use for treating wound, infection and cystic fibrosis, formulation, and processes of making.
Applicant claim a composition comprising an amorphous from of bismuth-1,2- ethanedithiol (BisEDT) and at least one pharmaceutically acceptable carrier, see claim 11. Dependent claims 12-13 further limit the scope of composition, i.e., specific formulation including suspension.
Determination of the scope and content of the prior art (MPEP §2141.01)
Baker’s ‘772 discloses an amorphous form of bismuth-1,2-ethanedithiol (BisEDT), see section [0109] in column 16 and section [0270] in column 35. Baker’s ‘772 bismuth-1,2-ethanedithiol (BisEDT) can be formulated as suspension composition, see section [0092] in column 14. Baker’s ‘772 compositions can be used for treating wound and infection, see Example 11 in column 110. A process of making amorphous form of bismuth-1,2-ethanedithiol (BisEDT) is disclosed in section [0109] in column 16.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Baker’s ‘772 is that the instant claims are embraced within the scope of Baker’s ‘772.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1-9, 11-13, 16, 18, 20, 28, 41, 54, 69 and 85 prima facie obvious because one would be motivated to employ the compound/composition and methods of use of Baker’s ‘772 to obtain instant invention.
The motivation to make the claimed comound/compositions and methods of use derived from the known compound/composition and methods of use of Baker’s ‘772 would possess similar activity to that which is claimed in the reference.
Double Patenting
6. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
6.1 Claims 1, 11, 16 and 54 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of Baker et al. US 11,564,903, over claim 1 of Baker’s US 11,324, 715, over claims 1 and 4 Baker et
al. US 10.960,012, over claim 1 of Baker’s US 11,207,288, over claims 24-25 of Baker et al. US 10,835,510, over claims 1 and 17 of Baker’s US 12,036,200, and over claim 1 of Baker’s US 11,974,978 respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicant claim an amorphous form of bismuth-1,2-ethanedithiol (BisEDT) compound/composition, and methods of use for treating wound and infection, see claims 1, 11, 16 and 54.
Baker et al. ‘903 claims bismuth-thiol (BT) composition, comprising a plurality of solid microparticles, wherein at least 80% of the microparticles have a volumetric mean diameter (VMD) of from about 0.4 μm to about 5 μm, said microparticles comprising BisEDT (i.e., an amorphous form), see claim 1 in column 62.
Baker et al. ‘715 claims a pharmaceutical composition comprising BisEDT
(i.e., an amorphous form), suspended therein, wherein the composition comprises a plurality of microparticles comprising said BisEDT, wherein the microparticles have a D90 of less than 2 μm, see claim 1 in column 99.
Baker et al. ‘012 claims a bismuth-thiol composition, comprising a plurality of solid microparticles that comprise a bismuth-thiol (BT) compound, substantially all of said microparticles having a volumetric mean diameter of from 0.4 μm to 5 μm, wherein the BT compound comprises bismuth or a bismuth salt in association with 1,2-ethane dithiol, wherein BT is BisEDT(i.e., an amorphous form),, see claims 1 and 4 in columns 99-100.
Baker et al. ‘288 claims a method for healing a wound in a subject having a diabetic foot infection, comprising administering the subject a therapeutically effective amount of a composition comprising BisEDT, wherein the composition is a suspension of microparticles comprising said BisEDT(i.e., an amorphous form), see claim 1 in column 99.
Baker et al. ‘510 claims a method of treating an acute wound, a chronic wound or a wound of epithelial tissue surface that contains microbial biofilm in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a topical formulation that comprises the BT composition of claim 1, wherein the composition is applied to the surface of the infection, and BT is BisEDT (i.e., an amorphous form), see claims 24-25 in column 63.
Baker et al. ‘200 claims a method for treating, managing, or healing a wound in a subject, comprising topically applying to the wound a therapeutically effective amount of a pharmaceutical composition comprising a bismuth-thiol (BT) compound suspended therein, wherein the composition comprises a plurality of microparticles comprising said BT compound, wherein the microparticles have a D90 of less than 2 a D50 of less than or equal to 0.72 μm to 1.3 μm, and/or a D10 of less than or equal to 0.33 μm to 0.70 μm, and BT is BisEDT (i.e., an amorphous form), see claims 1 and 17 in columns 99 and 101-102.
Baker et al. ‘978 claims a method of treating, managing, or preventing a bacterial infection in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a liposome-free composition comprising a suspension of microparticles comprising a bismuth-thiol (BT) compound selected from
BisEDT (i.e., an amorphous form), see claim 1 in column 99
The difference between instant claims and Baker et al. ‘903, ‘715, ‘012, ‘288, ‘510, ‘200, and ‘978 is that the instant claims are embraced within on the scope of Baker et al. ‘903, ‘715, ‘012, ‘288, ‘510, ‘200, and ‘978.
One having ordinary skill in the art would find the claims 1, 11, 16 and 54 prima facie obvious because one would be motivated to employ the compounds/compositions and methods of use of Baker et al. ‘903, ‘715, ‘012, ‘288, ‘510, ‘200, and ‘978 to obtain instant invention.
The motivation to make the claimed compounds/compositions, methods of use derived from the known compounds/compositions and methods of use of Baker et al. ‘903, ‘715, ‘012, ‘288, ‘510, ‘200, and ‘978 would possess similar activity to that which is claimed in the reference.
6.2 Claim 16 and 54 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 64 of Baker et al. co-pending application No. 18/098,466. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicant claim an amorphous form of bismuth-1,2-ethanedithiol (BisEDT) compound/composition, and methods of use for treating wound and infection, see claims 16 and 54.
Baker et al. ‘466 claims method of treating an infection and/or a wound, comprising administering to a subject in need thereof a bismuth-thiol (BT) composition comprising a plurality of solid microparticles, wherein at least 80% of the microparticles have a volumetric mean diameter (VMD) of from about 0.4 gm to about 5 gm, said microparticles comprising BisEDT, see claim 64.
The difference between instant claims and Baker et al. ‘466 is that the instant claims are embraced within on the scope of Baker et al. ‘466
One having ordinary skill in the art would find the claims 16 and 54 prima facie obvious because one would be motivated to employ the compounds/ compositions and methods of use of Baker et al. ‘466 to obtain instant invention.
The motivation to make the claimed compounds/compositions, methods of use derived from the known compounds/compositions and methods of use of Baker et al. ‘466 would possess similar activity to that which is claimed in the reference.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
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examiner should be directed to REI TSANG SHIAO whose telephone number is
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
October 28, 2025