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 Objections
Claim 12 is objected to because of the following informalities:
It is hard to determine the method step which improves the disturbance of vaginal bacterial flora based on the current wording.
Suggested correction would be “A method for improving the disturbance of vaginal flora during menstruation: comprising the steps of using the sanitary product according to claim 1.”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-6, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aviles et al. US 2016/0354507 A1.
Regarding Claim 1, Aviles discloses a sanitary product carrying lactoferrin or a composition comprising lactoferrin and an auxiliary substance ([0001], [0007], and [0011] which discloses an absorbent article (also known as a sanitary product [0030]) containing a microorganism and [0109-113] disclose the microorganism could be a prebiotic such as lactoferrin).
Regarding Claim 2, Aviles discloses wherein the sanitary product is a tampon or a napkin ([0030] discloses the term “absorbent article” includes napkins or tampons).
Regarding Claim 3, Aviles discloses wherein the composition is in the form of a powdery preparation, an oily liquid preparation, or an oily semi-solid preparation ([0183] discloses the composition can include a dermatological acceptable carrier and maybe in the form of a powder or liquid or semi solid such as cream, gel, paste, ect.).
Regarding Claim 4, Aviles discloses the amount of lactoferrin in the composition is 0.1 to 99.9% by weight based on the weight of the composition ([0109-113], in particular [0113] which notes the about of prebiotic can range from 0.01-30% weight based, thereby falling within the claimed range).
Regarding Claim 5, Aviles discloses the amount of lactoferrin in the composition is 1 to 99% by weight based on the weight of the composition ([0109-113], in particular [0113] which notes the about of prebiotic can range from 0.01-30% weight based, thereby falling within the claimed range).
Regarding Claim 6, Aviles discloses the amount of lactoferrin in the composition is 10 to 90% by weight based on the weight of the composition ([0109-113], in particular [0113] which notes the about of prebiotic can range from 0.01-30% weight based, thereby falling within the claimed range).
Regarding Claim 10, Aviles discloses kit ([0015] discloses the microorganism can be embedded into the article or supplied as a kit) comprising a sanitary product, and lactoferrin or a composition comprising lactoferrin and an auxiliary substance ([0001], [0007], and [0011] which discloses an absorbent article (also known as a sanitary product [0030]) containing a microorganism and [0109-113] disclose the microorganism could be a prebiotic such as lactoferrin).
Regarding Claim 11, Aviles discloses wherein the sanitary product is a tampon or a napkin ([0030] discloses the term “absorbent article” includes napkins or tampons).
Regarding Claim 12, Aviles discloses a method for improving the disturbance of vaginal bacterial flora during menstruation by using the sanitary product according to Claim 1 (claim 17 which discloses a method of treating the urogenital skin by using the sanitary product).
Claim Rejections - 35 USC § 103
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.
Claim(s) 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Aviles et al. US 2016/0354507 A1.
Regarding Claim 7, Aviles fails to disclose the amount of lactoferrin carried by the sanitary product is 5 to 1,000 mg/product.
Regarding Claim 8, Aviles fails to disclose the amount of lactoferrin carried by the sanitary product is 10 to 500 mg/product.
Claim 9, Aviles fails to disclose amount of lactoferrin carried by the sanitary product is 20 to 200 mg/product.
Regarding claims 7-9, while Aviles fails to disclose a specific amount of product; however, Aviles makes it clear the sanitary product plus composition are designed to have a positive outcome by improving the vaginal health [0002]. In [0004] Aviles notes concerns are providing a high enough dose to prevent loss of viability and providing successful skin transfer as such the amount of product needed would fall under routine optimization.
“"[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” MPEP 2144.05 II. A
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have added enough of the composition so that the composition will function as intended while keeping safety and drug toxicity in mind. Furthermore, optimizing the amount lowers the cost as adding more product than necessary creates waste and potential for harm.
Conclusion
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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781