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 .
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 Status
Claim 1-11 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Obviousness Rejection
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 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 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.
1) Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Northey (US 2012/0164235 A1).
Northey teaches a hydrogel formulation containing a mixture of hypochlorous acid (HClO) and hypochlorite ions (ClO-) (pgs 1-2, [0014]), and a gelling agent such as sodium magnesium silicate (pg 3, [0032]).
For claim 1, Northey teaches the amount of fluorosilicate gelling agent/thickener is from about 1.0% to about 5% by weight (pg 3, [0033]), overlapping the claimed range. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
Northey teaches the typical total amount of free chlorine species present in the composition is about 10 ppm to about 400 ppm ([0014]), within the claimed range. Northey also teaches that the ratio of hypochlorous acid to hypochlorite ion is dependent upon pH. Northey further teaches that, in one embodiment, when the pH is 7.4, hypochlorous acid levels are typically from about 5 ppm to about 75 ppm and the amount of hypochlorite is generally in the range of about 0.1 ppm to about 50 ppm (pg 2, [0015]).
Northey teaches the claimed composition in Example 1 (col 10):
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The claim term “wherein a viscosity change of the hypochlorous acid after a pressure is applied” is considered a product-by-process limitation, where the process is application of pressure to convert the composition to a gel. As set forth in MPEP, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In the instant case, the product is a hypochlorous acid composition comprising fluorosilicate and free available chlorine in specific amounts, and the viscosity in the claimed range. As discussed above, Northey teaches these limitations, as well as the composition as a gel (claim 1). As such, the method of gelation is part of the process of making and the composition of the product is independent of this process. It is further noted that Northey teaches a viscosity of about 1,000 cP to about 20,000 (pg 1, [0006]), overlapping the range recited in claim 2.
The transformation of the composition to a gel when pressure is applied, as recited in claim 1, and the “composition features a viscosity ranging from 6000 to 20000 cP after pressure is applied”, as recited in claim 3, may also be considered a physical property of the claimed composition. Since the composition of Northey appears to overlap with the claimed composition, the skilled artisan would have expected that the composition of Northey would have had the same viscosity characteristics under pressure as that which is instantly claimed. Something which is old (e.g. the composition of Northey) does not become patentable upon the discovery of a new property (e.g. the viscosity under pressure), and this feature need not have been recognized at the time of the invention. See MPEP 2112(I & II). Put another way, "When the claimed compositions are not novel they are not rendered patentable by recitation of properties, whether or not these properties are shown or suggested in the prior art." In re Spada, 911 F .2d 705, 709, (Fed. Cir. 1990).
For claims 4 and 5, Northey teaches a pH of the composition of from about 5.0 to about 8.5 ([0006]), overlapping the claimed range.
For claim 6, Northey teaches the gelling agent most preferred is sodium magnesium fluorosilicate (pg 3, [0032]).
Claims 7-10 are in the form of product-by-process claims. As set forth in MPEP 2113, “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant case, the product as set forth in independent claim 1 is a hypochlorous acid composition comprising a fluorosilicate and free available chlorine comprising hypochlorous acid and hypochlorite while Northey teaches a hydrogel formulation containing a mixture of hypochlorous acid (HClO) and hypochlorite ions (ClO-), and a gelling agent such as sodium magnesium silicate; of note is that Northey teaches amounts of each within the ranges claimed. As set forth in MPEP 2113, the patentability of a product does not depend upon the process of producing the claimed product since Northey explicitly teaches that product. As set forth in MPEP 2113(II), “Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product.”
For claim 11, Northey teaches addition of sodium chloride to the hypochlorous acid composition (col 10, Example 1).
The prior art of Northey discloses compositions containing hypochlorous acid, hypochlorite ion, and a fluorosilicate gelling agent present in the claimed range, wherein the free available chlorine has a concentration within the claimed range. Together these would provide a composition as claimed instantly. As set forth in MPEP 2143 part (I)(A), it is prima facie obvious to combine prior art elements according to known methods to yield predictable results. As discussed above, the prior art of Northey teaches each element of the claimed composition, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single embodiment or example. However, one of ordinary skill in the art could have combined the elements as claimed by methods taught by Northey, and that in combination, each element merely performs the same function as it does separately. Furthermore, one of ordinary skill in the art would have recognized that the results of the combination were predictable since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See KSR v. Teleflex, 82 USPQ2d 1385, 1396 (2007).
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick Krass can be reached on (571)272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612