DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mangete et al., (EAST African Medical Journal 1993) in view of O’Connell et al., (Todays Veterinary Practice, July 2011) and further in view of Tomic-Canic et al., (WO 2011/082231).
Mangete et al. teaches hypertonic saline as “an effective wound dressing solution” (Ti).
The reference teaches treating “53 patients presenting with various types of ulcers . . . with different strengths of hypertonic saline 0.3, 0.9, 1.2, 1.5, 2 and 3 osmoles” (Abstract).
Mangete et al. does not teach one or more organic acids, ionic surfactant, or a pH from 3 to 6.
O’Connell et al. teaches “’old-school’ remedies” that have “shown to be beneficial in wound treatment”, wherein “[t]hese topical treatments will kill bacteria using pH and osmolarity, avoiding induction of bacterial resistance” (Abstract).
Concerning osmolarity, O’Connell et al. teaches, “Sugar has high osmolality, which draws water and nutrient-rich lymph into the wound, nourishing the regenerating tissues. In addition, the high osmotic stress caused by sugar on bacteria interferes with cell signaling and cell wall permeability, leading to bacterial death” (p. 12, left column, Mechanism of Action). Accordingly, it would have been obvious for the artisan to adjust the osmolarity of a wound treating composition for the advantage of drawing water and nutrient-rich lymph into the wound, nourishing the regenerating tissues. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)).
Concerning pH, O’Connell et al. teaches, “Honey’s pH (3.6-3.7) creates the desired acidic environment that has been shown to decrease bacterial growth, increase fibroblast activity, and increase oxygen release, all of which further promote wound healing” (p. 14, left column, Mechanism of Action).
O’Connell et al. also teaches “Vinegar (acetic acid) has been used to fight injections since 300 BC” (p. 14, right column, 4th pargraph). Further, “Acetic acid is applied directly onto the wound or soaked into the primary bandage layer prior to application” (p. 15, left column, 1st paragraph). Since acetic acid is typically sold as a salt, it would have been obvious to use the salt form of acids in the compositions, as per claim 8.
Tomic-Canic et al. teaches methods that “are useful to promote epithelialization and closure of wounds, such as chronic non-healing wounds” (Abstract).
The topical compositions are taught to “contain sufficient amounts of at least one pH buffering agent to ensure that the composition has a final pH of about 3 to about 11”, wherein suitable “pH modifying agents include, but are not limited to, . . . citric acid . . . acetic acid . . . sodium citrate . . .” (p. 34, 2nd paragraph), as per claims 1, 4-9.
The compositions of Tomic-Canic et al. further comprise ionic surfactants such as “benzalkonium chloride” (p. 34, last paragraph) and “sodium lauryl sulfate” (p. 35, last paragraph) and antihemorrhagic “fibrin”, where “[f]ibrin-based biomaterial preparations can be used as provisional growth matrices for cells important in tissue repair during wound healing in vivo” (p. 43, 3rd paragraph).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to combine with the hypertonic solution of Mangete et al. with one or more organic acids, ionic surfactant, antihemorrhagic, and a pH of 3 to 6 for the advantage of treating a wound, as taught by O’Connell et al. and Tomic-Canic et al.
Nonstatutory Obvious-type 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 obviousness-type 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
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).
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,752,083. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim introducing to a wound a mixture of organic acids, ionic surfactant and water, wherein the composition has a pH of 3-6 and a concentration of at least about 0.3 Osm/L.
2) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,128,120. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim introducing to a wound a mixture of organic acids, ionic surfactant and water, wherein the composition has a pH of 3-6 and a concentration of at least about 0.3 Osm/L.
3) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,314,017. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim introducing to a wound a mixture of organic acids, ionic surfactant and water, wherein the composition has a pH of 3-6 and a concentration of at least about 0.3 Osm/L.
4) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,427,417. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim introducing to a wound a mixture of organic acids, ionic surfactant and water, wherein the composition has a pH of 3-6 and a concentration of at least about 0.3 Osm/L.
5) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,486,420. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim a mixture of organic acids, ionic surfactant and water, wherein the composition has a pH of 3-6 and a concentration of at least about 0.3 Osm/L for application to a wound.
6) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,691,085. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim introducing to a an area of the body a mixture of organic acids, ionic surfactant and water, wherein the composition has a pH of 3-6 and a concentration of at least about 0.3 Osm/L.
7) Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 14-17, 34-37 of copending Application No. 18/031,644 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim introducing to a wound a mixture of organic acids, ionic surfactant and water, wherein the composition has a pH of 3-6 and a concentration of at least about 0.3 Osm/L.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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