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`09/558,447
`
`RECEIVED
`FEB 0 7 zoni
`TECH CENTER l600:2900
`
`Case7544M
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFI CE
`
`In the Application of
`
`DavidS. Dunlop
`Susan M. Guskey
`Vicente E. Leyba
`Douglas A. Royce
`
`Serial No. 09/558,447
`
`Confirmation No. 9221
`
`Filed April 25, 2000
`
`For ANTI-DANDRUFF AND CONDmONING:
`
`S~OSCONTA~G
`
`POLY ALKYLENE GLYCOL AND
`
`CATIONIC POLYMERS
`
`Group Art Unit 1615
`
`Examiner P. McQueeney
`
`AMENDMENT UNDER 37 CFR 1.111
`
`Commissioner of Patents
`
`Washington, DC 20231
`
`Dear Sir:
`
`In response to the May 11, 2001 Office Action in the above-entitled application,
`
`please amend the above-identified application as follows, please enter the attached
`
`Terminal Disclaimers and consider the following remarks. Attached hereto is a Petition
`
`for a Three-Month Extension of Time, and the fee required under 37 CFR § 1.17(a),
`
`providing for a timely response up to and including November 13, 2001 (November 11th
`
`falls on a Sunday and November 12th is a federal holiday).
`
`In the Claims
`
`Please amend claims 11 and 21 as follows:
`
`. I .
`
`

`

`7544M
`
`091558.447
`
`11.
`
`(Amended) A shampoo composition according to Claim 1, wherein said non-
`
`volatile conditioning agent comprises silicone.
`
`21.
`
`(Amended) A shampoo composition comprising:
`
`a) from about 10% to about 25%, by weight of the composition, of an anionic
`
`surfactant;
`
`b) from about 0.01% to about 10%, by weight of the composition, of an insoluble,
`
`non-volatile silicone conditioning agent;
`
`c) from about 0.3% to about 2%, by weight of the composition, of a zinc salt of 1-
`
`h ydrox y-2-pyridi nethione;
`
`d) from about 0.1% to about 2%, by weight of the composition, of at least one
`
`cationic polymer selected from the group consisting of guar derivatives, cellulose
`
`derivatives, and mixtures thereof;
`
`e) from 0.025% to about 1.5%, by weight of the composition, of a polyalkylene
`
`glycol corresponding to the formula:
`
`i) wherein R is selected from the group consisting of hydrogen, methyl and
`
`mixtures thereof,
`
`ii) wherein n is an integer having an average value from about 3,500 to about
`
`15,000; and
`
`f) water.
`
`Please cancel claims 13 and 14 without prejudice.
`
`Please add new claims 26 and 27:
`
`26. A shampoo composition according to Claim 18, wherein said polyalkylene glycol
`
`has an average value of n frorr. about 3,500 to about 15,000 .
`
`. 2-
`
`

`

`7544M
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`09/558,447
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`'21. A shampoo composition according to Claim 20, comprising from about 0.025% to
`
`about 1.5%, by weight of the composition, of said polyalkylene glycol.
`
`Claims 1-12 and 15-27 are pending in the present application. No additional
`
`Remar ks
`
`claims fee is due.
`
`Claims 13 and 14 are canceled without prejudice. They have been replaced by
`
`new claims 26 and 27. New claims 26 and 27 are supported by, at least, original claims
`
`13 and 14. This amendment was made to correct the order of the claims and not in
`
`response to an issue of patentability.
`
`Claim II has been amended to remove the word "dispersed." Support for the
`
`amendment is found, at least, at page 8 lines 4-5 of the specification. In addition, Claim
`
`21 has been amended to correct a typographical error regarding the percentage of cationic
`
`polymer. Support for this amendment is found, at least, in the Applicants' specification
`
`at page 2 1, line 16.
`
`Attached hereto is a marked-up version of the changes made to claims 11 and 21
`
`by the current amendment. The attached page is captioned "Version with markings to
`
`show changes made."
`
`The Claim Objections
`
`Response to the Office Action
`
`Claims 13 and 14 have been objected to as being in improper dependent form. In
`
`response, Applicants have cancelled these claims and added new claims 26 and 27.
`
`Applicants contend that the claims are now in proper dependent form.
`
`The Double Patenting Rejection
`
`Claims l-25 have been rejected as claiming the same invention as that claimed in
`
`Applications 09/558,466 and 09/558,465.
`
`In response, Applicants are submitting
`
`herewith two Terminal Disclaimers. Applicants contend that the Terminal Disclaimers
`
`moot the double patenting rejection.
`
`. 3-
`
`

`

`09/558,447
`
`The Rejection under 35 U.S. C. 112. second paragraph
`
`Claims I I and 2 1 have been rejected under 35 U.S.C. 1I2, second paragraph as
`
`being indefinite. Specifically, claim I1 has been rejected due to the term "dispersed,
`
`silicone." In response, Applicants have amended claim II to simply recite "silicone."
`
`Claim 21 has been rejected due to an indefinite range for subsection (d). In response,
`
`Applicants have amended the claim to correct this typographical error. Claim 2I now
`
`recites a range of "from about 0.1% to about 2%" in subsection (d). Accordingly,
`
`Applicants respectfully submit that the rejection under 35 U.S.C. 1I2, second paragraph
`
`has been overcome.
`
`The Rejection under 35 U.S. C. 102(e) over Guskey
`
`Claims I-I4 and 22 have been rejected under 35 U.S.C. 102(e) as being anticipated
`
`by Guskey (US 5,977,036). Applicants respectfully traverse this rejection since Guskey
`
`does not specifically disclose the anti-dandruff particulate claimed by Applicants.
`
`In
`
`addition, Applicants' claimed range of anti-dandruff particulate is not disclosed with
`
`sufficient specificity in Guskey to qualify as anticipation.
`
`First, Applicants' claim 1 requires the presence of from about 0.1% to about 4% of
`
`an anti-dandruff particulate. The anti-dandruff component is required to be a particulate
`
`since the invention concerns depositing the anti-dandruff component from a coacervate(cid:173)
`
`forming shampoo. Guskey, in Col. 17,line 38, mentions "anti-dandruff agents" as one of
`
`many possible optional components. The term "anti-dandruff agent" is broader than just
`
`particulates and includes all other forms (e.g. liquid, etc.) of anti-dandruff compositions.
`
`The Guskey reference does not disclose anti-dandruff particulates.
`
`Second, Applicants' claim 1 specifies that "from about 0.1 to about 4%" of the anti(cid:173)
`
`dandruff particulate is present. Guskey's disclosure of "from about 0.001% to about
`
`10%" for any of the optional components does not qualify as an anticipation of
`
`Applicants' claimed range. For a prior art range to anticipate the claimed invention's
`
`range, it must be disclosed with "sufficient specificity" (see MPEP 2131.03). Applicants
`
`contend that Guskey's range is too broad to sufficiently specify Applicants' range of
`
`from about 0.1 to about 4%. For example, Applicants' low end of the range is 2M
`
`hundred times higher than that disclosed in Guskey.
`
`- 4-
`
`

`

`7544M
`
`091558,441
`
`GuskeY:s brief mention of anti-dandruff agents as one of many optional ingredients
`
`and a blanket range for any of the optional ingredients does not anticipate Applicants'
`
`claim l. Guskey does not teach using an anti-dandruff particulate, as claimed by
`
`Applicants. Further, Guskey's disclosed range is too broad to anticipate Applicants'
`
`claimed range of anti-dandruff particulate. Therefore, Applicants contend that the
`
`claimed invention is novel and that the rejection should be withdrawn.
`
`The Rejection under 35 U.S. C. 103(a) over Guskey in view of Cardin et al.
`
`Claims 1-25 have been rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Guskey in view of Cardin et al. Applicants respectfully traverse this rejection. The
`
`references do not establish a prima facie case of obviousness for two reasons. First, they
`
`do not teach or suggest all of Applicants' claim limitations.
`
`Specifically, the
`
`combination of references does not suggest combining an anti-dandruff pa.rticulate, a
`
`cationic polymer, a conditioning agent, and polyalkylene glycol
`
`in a shampoo
`
`composition. Secondly, combining the anti-dandruff particles of Cardin et al. with the
`
`shampoo formula of Guskey would not have given a reasonable expectation of success.
`
`Therefore, Applicants contend that the claimed invention is unobvious and that the
`
`rejection should be withdrawn.
`
`As discussed in the Background of the Invention, the purpose of the present
`
`invention is to provide anti-dandruff shampoos with improved conditioning performance.
`
`In the past, there has been a problem trying to achieve this because conditioning
`
`ingredients interfere with the deposition of the anti-dandruff material. As a result,
`
`consumers had to choose between conditioning shampoos with no anti-dandruff
`
`component or anti-dandruff shampoos with little or no conditioning effect.
`
`The inventors of the claimed subject matter have surprisingly found a solution to
`
`this problem. By using a shampoo comprising cationic polymer, anti-dandruff
`
`particulates and polyalkylene glycol in particular amounts, the inventors have found that
`
`they can provide the conditioning benefits of a cationic polymer-containing shampoo
`
`while still getting adequate coverage of the anti-dandruff material on the scalp.
`
`Cationic polymer causes the shampoo composition of the present invention to
`
`form a coacervate upon dilution. The coacervate provides improved wet hair
`
`conditioning benefits by forming particles that cling to the hair shafts. This coacervate
`
`- 5-
`
`

`

`7S44M
`
`091558,447
`
`structure re~ults in a different deposition mechanism than standard shampoos, such as
`
`that disclosed by Cardin et al. The Cardin reference does not teach the use of cationic
`
`polymer to form a coacervate.
`
`Furthermore, while
`
`the Guskey reference discloses a coacervate-forming
`
`shampoo, a person skilled in the art would not have been led to use a coacervate with
`
`anti-dandruff (AD) particulates in a shampoo. Coacervates produce the opposite effect of
`
`what is traditionally desired for AD particulates. Those skilled in the art believed that an
`
`AD shampoo must maximize deposition and dispersion of the particulates on the scalp to
`
`be effective. However, coacervates are sponge-like particles that tend to collect and
`
`concentrate the AD particulates. Therefore, a skilled person in the art would not look at
`
`coacervates as a useful technology for anti-dandruff.
`
`The inventors of the present invention have surprisingly found that anti-dandruff
`
`particulates can be used in a coacervate-forming shampoo when the claimed polyalkylene
`
`glycol is used in the shampoo formulation. The polyalkylene glycol alters the physical
`
`characteristics of the coacervate to the point where it effectively distributes the AD
`
`particles while retaining the conditioning benefit.
`
`There is no hint of this discovery in either Guskey or Cardin et al. Guskey does
`
`not disclose the anti-dandruff particulates claimed by Applicants. Cardin et at. do not use
`
`cationic polymer to form a coacervate. Neither reference addresses the issues of using
`
`AD particulates in a coacervate-forming shampoo. Certainly, neither reference teaches or
`
`suggests that polyalkylene glycol could improve the ability of AD particulates to deposit
`
`from a shampoo.
`
`Lack of prima facie case
`
`As stated above, the combination of Guskey and Cardin et at. does not teach or
`
`suggest all of Applicants' claim limitations (combining an anionic surfactant, a
`
`conditioning agent, an anti-dandruff particulate, a cationic polymer, and polyalkylene
`
`glycol in a shampoo composition). Therefore, the cited references do not establish a
`
`prima facie case of obviousness (see MPEP 2143.03). Specifically, neither Guskey nor
`
`Cardin et al. teach or suggest depositing anti-dandruff particles from a coacervate(cid:173)
`
`forming shampoo.
`
`Furthermore, combining the anti-dandruff particles of Cardin et al. with the
`
`shampoo formula of Guskey would not have given a reasonable expectation of success.
`
`-6-
`
`

`

`7S44M
`
`09ISS8,441
`
`As stated above, a coacervate-fonning shampoo, such as that disclosed in Guskey, form
`
`sponge-like particles that tend to collect and concentrate AD particulates. One skilled in
`
`the art would not have expected such a shampoo to adequately deposit and disperse the
`
`anti-dandruff particulates. Applicants have surprisingly discovered that the addition of
`
`the claimed polyalkylene glycol alters the physical characteristics of the coacervate to the
`
`point where it effectively distributes the AD particles while retaining the conditioning
`
`benefit.
`
`As stated in MPEP 2143.02, a prima facie case of obviousness requires a reasonable
`
`expectation of success. Such an expectation could not be found by the combination of
`
`Guskey and Cardin et al. One skilled in the art would not have expected the AD
`
`particulates to be effective in Guskey's shampoo. Therefore, Applicants contend that the
`
`rejection under 35 U.S.C. 103(a) should be withdrawn.
`
`In addition, the combination of Guskey and Cardin et al. does not adequately suggest
`
`the combination of elements claimed by Applicants. Applicants' claim l has six required
`
`elements (an anionic surfactant, a non-volatile conditioning agent, an anti-dandruff
`
`particulate, at least one cationic polymer, a polyalkylene glycol, and water). Guskey's
`primary invention (i.e. claim 1) only requires three of these elements (anionic surlactant,
`
`cationic polymer and water). Three of Applicant's required elements - an anti-dandruff
`
`particulate, a polyalkylene glycol, and a non-volatile conditioning agent are either
`
`optional or not disclosed by Guskey. The rejection relies on Cardin to supply the anti(cid:173)
`
`dandruff particulate. However, there is no motivation given to pick and choose from the
`
`huge number of optional ingredients disclosed by Guskey to arrive at Applicants'
`
`claimed invention (all six elements present in the claimed amounts). In fact, it is unlikely
`
`that one skilled in the art would look to a styling shampoo (intended to add hold and
`
`stiffness to the hair) when attempting to formulate an anti-dandruff/conditioning
`
`shampoo. As a result, Applicants contend that their claimed shampoo composition is
`
`novel and unobvious and that the rejection under 35 U.S.C. 103(a) should be withdrawn.
`
`Conclusion
`
`Applicants have made an earnest effort to place their application in proper form
`
`and to distinguish
`
`the invention as now claimed from
`
`the applied references.
`
`-7-
`
`

`

`7544M
`
`09/55&,447
`
`WHEREFORE, Applicants respectfully request reconsideration of this application, entry
`
`of the amendments presented herein and allowance of Claims 1-12 and 15-27.
`
`Respectfully submitted,
`DavidS. Dunlop et al.
`
`By~
`Brent M. Peebles
`Attorney for Applicants
`Registration No. 38,576
`(5 13) 626-2404
`
`November 13, 2001
`Cincinnati, Ohio
`
`- 8 -
`
`

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