DETAILED ACTION
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 12, 14, and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “in a concentration between 0.1% to 3%”, but fails to define what the concentration units are. Concentration may be mass, molar, number, or volume. As such, it is unclear which are being claimed.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “organic material”, and the claim also recites “blood” and “bodily fluids”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 12, 14, and 16 recite anesthetic agent and disinfectant alcohol, but then label them as inactive ingredients. By nature of the active labels, the components have bioactive properties. As such, it is unclear how a bioactive can be an inactive.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12, and 14-18 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Zayas-Rivera et al (US 7,157,499).
Zayas-Rivera et al discloses administering 1% PCO, POH, and combinations to treat P. aeruginosa, which is taught to be a well-known pathogen causing infections of wounds and burns (Example 2 and Claims 1-2). The compositions may also treat S. aureus when applied to skin infections (Example 5). The formulation may be a cream with octadecanol, propanediol, hexadecanol, oleic acid, and mineral oil, as inactive ingredients and applied to the skin to treat infections (Example 9). The active is taught to remain active for 96 hours after application (Table 2). Candida albicans can be treated (Example 8) as well as Aspergillus (Example 9). Formulations include propanol (Table 44).
With regards to the limitation regarding activity, given the purpose of the composition is to treat infection when applied to a wound and remains active for 96 hours, it is reasonably expected that the ability to remain active in the presence of other materials is inherent. This is further supported by the fact that the only limitation directed to the formulation itself is the inclusion of a monoterpene at a given concentration. Where that limitation is met, again, it is reasonably expected that the properties of the formulation are inherent in the composition.
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.
Claims 1-32 are rejected under 35 U.S.C. 103 as being unpatentable over Zayas-Rivera et al (US 7,157,499) in view of Baker (US 2013/0058983).
Zayas-Rivera et al is discussed above and further teaches it was known to formulate the active in various forms (Tables 10.1-12). It does not teach the specific additional agents of claims 13 or 20-32.
Baker teaches antibacterial formulations were known to include common excipients, such as PEG, its derivatives, and NMP (¶ 103), magnesium stearate (¶ 162), wax and mineral oils (paragraph 167), ethanol (¶ 157), sodium sulfonates (¶ 206), ethanols, propanols and pyrrolidones (¶ 208), beeswax (¶ 210), isopropyl myristate (¶ 221), polyacrylic acids (¶ 225), cyclodextrins (¶ 232),
It would have been obvious to one of ordinary skill in the art to formulate the actives of Zayas-Rivera et al using well known excipients which are known to provide benefits in various formulations, such as taught by Baker. See MPEP 2144.07.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri (9am-6pm + mid-day flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612