DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Reissue Applications
The instant reissue application seeks to correct an alleged error in U.S. Patent No. 8,945,594 (“the ‘594 Patent”) which has an effective filing date of September 9, 2011. For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
Status of Claims
Claims 1-13 are pending. Claims 1, 2, 8, 10, and 11 are amended.
Specification
The amendment filed 2 October 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The specification has been amended so as recite octyldodecyl isostearate when characterizing the BIOSIL BASIC C-38. However, Applicant has not provided any objective evidence or a signed declaration attesting that at the time the instant invention was made the material sold under the trademark BIOSIL BASIC C-38 is/was in fact octyldodecyl isostearate. It is noted that Applicant has filed along with the instant application several non-patent literature references which appear to indicate that material in BIOSIL BASIC C-38 is octyldodecyl isostearate. However, all of these references were either published after the time the instant invention was made or have an unknown publication date. As such, these reference cannot be relied upon to objectively establish that at the time the instant invention was made, BIOSIL BASIC C-38 was octyldodecyl isostearate.
Furthermore, the non-patent literature references from BIOSIL TECHNOLOGIES and knowde.com filed with the application on 28 May 2024 indicate that BIOSIL BASIC C-38 is octyldodecyl octyldodecanoate which in itself raises uncertainty as what BIOSIL BASIC C-38 is/was. Applicant is required to cancel the new matter in the reply to this Office Action.
Defective Oath/Declaration
The reissue oath/declaration filed with this application is defective because it does not indicate that the instant application seeks to broaden at least one of claims 1, 2, 8, 10, and/or 11.
It is noted that in each of the above listed claims the term “octyldodecyl octyldecanoate” is replaced with tradename “BIOSIL BASIC® C-38”. According to Applicant Argument/Remarks filed 2 October 2024 the material sold under the tradename “BIOSIL BASIC® C-38” is and always has been octyldodecyl isostearate. In light of Applicant’s remarks and the 2017 technical data sheets for BIOSIL BASIC® C-38 cited by Applicant, it is evident that the scope of the newly presented claims has been changed from a composition comprising octyldodecyl octyldecanoate to a composition comprising octyldodecyl isostearate.
It is further noted that MPEP 1412.03 I establishes that if any amended or newly added claim in the reissue contains within its scope any conceivable product or process which would not have infringed the patent, then that reissue claim would be broader than the patent claims. In the instant case, since 1, 2, 8, 10, and/or 11 no longer recite octyldocecyl octyldecanoate the instant claims encompass within their scope a product or process which would not have infringed the patent. As such, the instant application is a broadening reissue application.
Regarding reissue applications seeking to broaden a claim, 37 C.F.R. 1.175 recites the following (see also MPEP 1414.01):
(b) If the reissue application seeks to enlarge the scope of the claims of the patent (a basis for the reissue is the patentee claiming less than the patentee had the right to claim in the patent), the inventor’s oath or declaration for a reissue application must identify a claim that the application seeks to broaden. A claim is a broadened claim if the claim is broadened in any respect.
In this instant case, the reissue oath/declaration filed with the application does not identify any claims which the application seeks to broadened and therefore is defective.
Claim Rejections - 35 USC § 112
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, 2, 8, 10, and 11 contain the trademark BIOSIL BASIC C-38. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark BIOSIL BASIC C-38 is used to identify/describe a material in the claimed composition and, accordingly, the identification/description is indefinite. For the purpose of examination, the term “BIOSIL BASIC C-38” recited in the claims will be interpreted as meaning octyldodecyl isostearate. Claims 3-7, 9, 12, and 13 are rejected for inheriting the indefiniteness of claims 1 or 10. Appropriate correction is required.
Claim 14 is rejected under 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 Applicant regards as the invention.
Claim 14 recites a viscosity comprised between 15,000 to 23,000 mpa however the unit “mpa” is not a unit associated with viscosity measurements. As such, it is unclear how the claimed viscosity range is measured and/or if the claimed range is actually a viscosity range. As such, one of ordinary skill in the art would not be fully apprised of the metes and bounds of claim 14 and thus the claim is indefinite. For the purpose of examination, the unit “mpa” recited in the claim will be interpreted as being mPaꞏs which is the SI unit for dynamic viscosity measurements. Appropriate action is required.
Claim Rejection – 35 U.S.C. 251
Claims 1-13 are rejected under 35 U.S.C. 251 as broadened in a reissue application filed outside the two year statutory period.
As is described above when addressing the defective reissue oath/declaration, the claims filed in this reissue application seek to broaden claims 1, 2, 8, 10, and 11. Regarding reissue applications, 35 U.S.C. 251 establishes that no reissued patent shall be granted enlarging the scope of the claims of the original patent unless applied for within two years from the grant of the application. The instant application was filed 28 May 2024 which is more than two years after the 3 February 2015 issuance date of the ‘594 Patent. Thus, the instant reissue applications seeks to improperly broaden the scope of the claims of the ‘594 Patent outside of the two year statutory period.
Claims 1-13 are rejected as being based upon a defective reissue oath/declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the oath/declaration is set forth in the discussion above in this Office action.
Recapture
Claims 17-39 are rejected under 35 U.S.C. 251 as being an impermissible recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based.
See Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984).
A broadening aspect is present in the reissue which was not present in the application for patent. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
In Clement, 131 F.3d at 1468-70, 45 USPQ2d at 1164-65, the Court of Appeals for the Federal Circuit set forth a three step test for recapture analysis. In North
American Container, 415 F.3d at 1349, 75 USPQ2d at 1556, the court restated this test as follows:
We apply the recapture rule as a three-step process:
(1) first, we determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims;
(2) next, we determine whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution; and
(3) finally, we determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
Analysis
As to STEP 1, independent claims 1, 8, and 10 do not include the limitation “8-15% by weight of octyldodecyl octyldodecanoate”. Thus, claims 1, 8, and 10 are broader in scope than original patent claims 1, 8, and 10.
With respect to STEP 2, if an original patent claim limitation now being omitted or broadened in the present reissue application was originally relied upon by Applicant in the original application to make the claims allowable over the art, the omitted limitation relates to subject matter previously surrendered by applicant. The reliance by Applicant to define the original patent claims over the art can be by presentation of new/amended claims to define over the art, or an argument/statement by Applicant that a limitation of the claim(s) defines over the art.
During prosecution of application 16/635,980 which matured into the ‘594 Patent Applicant filed remarks on 20 June 2014 in which they asserted that:
“The results described in Applicants’ specification demonstrate that stabilization of retinoic acid in a cosmetic formulation (e.g., vinyl mask) requires including octyldodecyl octyldecanoate as an ester therein. Based on this comparison, one of ordinary skill in the art would conclude that Applicants’ invention would not have been obvious to one of ordinary skill in the art with a reasonable expectation of success at the time the invention was made because the claimed composition’s stability is an unexpected result that was not taught or suggested by the prior art” (pages 11 and 12 bridging paragraph).
Subsequently, on 3 October 2014, a notice of allowance was issued in which the Examiner indicated that the claimed invention was allowable over the cited prior art because of a persuasive showing of the unexpected result asserted by Applicant (page 5).
Thus, during prosecution of the application which became the ‘594 Patent, it was persuasively argued that the presence of octyldodecyl octyldecanoate in the claimed composition rendered the claims patentable over the cited prior art. It is noted that any limitation, argued or stated to make the claims patentable over the art “generates” the surrender of claimed subject matter that omits in its entirety, i.e., surrender of any claims whose scope does not contain this limitation.
Thus, claims 1, 8, and 10 relate to subject matter surrendered in the original prosecution.
As to STEP 3, claims 1, 8, and 10 are not materially narrowed in any other respect.
Accordingly, claims 1, 8, and 10 are rejected as being improper recapture of broadened claimed subject matter.
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 1-3 and 5-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dole et al., US 2003/0044366 (“Dole”) in view of Sanders, P.J., Healthy Skin Plain and Simple, iUniverse Inc, Bloomington, IN, 2008 (“Sanders”) (copy provided herewith).
Regarding claim 1, Dole discloses a skin care composition comprising from about 0.1 to about 5 wt% of retinoic acid based on the total weight of the composition [abstract, title, 0002, 0011, 0025]. The range of amounts of retinoic acid disclosed by Dole renders obvious the claimed range of amounts (see MPEP 2144.05). Dole teaches that when the cosmetic composition is to be used as a peel-off mask it may comprise polyvinyl alcohol [0045] which corresponds to the claimed polyvinyl alcohol.
Dole further teaches that the composition may comprise from about 0.1 to about 30 wt% of an emollient based on the total weight of the composition [0016]. The emollient may be, inter alia, a fatty ester [0016].
Dole is silent regarding the composition comprising octyldodecyl isostearate.
Sanders is described by the publisher as being a book of useful information to all who care about keeping their skin in good health and looking its best (page 1 – under “About this edition”). Sanders teaches that octyldodecyl isostearate is an emollient ester (page 65).
Dole and Sanders are both directed towards skin care. In light of the teachings of Sanders, it would have been obvious to one of ordinary skill in the art at the time the instant invention was made to have utilized octyldodecyl isostearate as the emollient component in the skin care composition of Dole because it was art recognized to be useful as an emollient in skin care applications (see MPEP 2144.07). The resulting composition would have comprised from about 0.1 to about 30 wt% of an octyldodecyl isostearate based on the total weight of the composition which renders obvious the amount of BIOSIL BASIC C-38 recited in claim 1.
Regarding claim 2, the ranges of amounts of octyldodecyl isostearate and retinoic acid taught by modified Dole would have encompassed, and therefore rendered obvious, the claimed weight ratio range.
Regarding claim 3, Dole teaches that the composition may comprise from about 1 to about 20 wt% of polyvinyl alcohol based on the total weight of the composition [0045] which renders the claimed range obvious.
Regarding claim 5, Dole teaches that the composition may additionally comprise propylene glycol [0030].
Regarding claim 6, Dole teaches forming a mask from the composition [0043].
Regarding claim 7, Dole teaches applying the composition to skin and using the composition for wrinkle reduction (i.e., treatment of wrinkles) [0042].
Claim 4 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dole in view of Sanders as applied to claim 1 above, and further in view of Estrin, N.F. Ed. The Cosmetic Industry – Scientific and Regulatory Foundations, Marcel Dekker, New York and Basel, 1984 (“Estrin”)(copy provided herewith).
Regarding claim 4, Dole teaches that the disclosed composition may comprise from about 1 to about 20 wt% of ethyl alcohol [0015]. Dole is silent regarding the ethyl alcohol being denatured.
Estrin teaches that the use of alcohol in cosmetic products must comply with BATF regulations. Estrin further teaches that specially denatured alcohol may be used in a cosmetic without being taxed if there is full compliance with the BATF regulation (page 124).
Dole and Estrin are both directed towards the use of ethyl alcohol in cosmetics. In light of teachings of Estrin it would have been obvious to one of ordinary skill in the art at the time the instant invention was made to have utilized a specially denatured ethyl alcohol as the ethyl alcohol component of the composition of modified Dole in order to avoid taxation. The denatured ethyl alcohol in the resulting composition would have read on the claimed denatured ethyl alcohol.
Claims 10, 11, and 13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dole in view of Sanders and Estrin.
Regarding claim 10, Dole discloses a skin care composition from about 0.1 to about 5 wt% of retinoic acid and from about 1 to about 20 wt% of ethyl alcohol (i.e., ethanol) based on the total weight of the composition [abstract, title, 0002, 0011, 0015, 0025]. The range of amounts of retinoic acid and ethyl alcohol disclosed by Dole renders obvious the claimed ranges of amounts (see MPEP 2144.05). Dole teaches that when the cosmetic composition is to be used as a peel-off mask it may comprise polyvinyl alcohol [0045] which corresponds to the claimed polyvinyl alcohol.
Dole further teaches that the composition may comprise from about 0.1 to about 30 wt% of an emollient based on the total weight of the composition [0016]. The emollient may be, inter alia, a fatty ester [0016].
Dole is silent regarding the composition comprising octyldodecyl isostearate. Dole is silent regarding the ethyl alcohol being denatured.
Sanders is described by the publisher as being a book of useful information to all who care about keeping their skin in good health and looking its best (page 1 – under “About this edition”). Sanders teaches that octyldodecyl isostearate is an emollient ester (page 65).
Estrin teaches that the use of alcohol in cosmetic products must comply with BATF regulations. Estrin further teaches that specially denatured alcohol may be used in a cosmetic without being taxed if there is full compliance with the BATF regulation (page 124).
Dole and Sanders are both directed towards skin care. In light of the teachings of Sanders, it would have been obvious to one of ordinary skill in the art at the time the instant invention was made to have utilized octyldodecyl isostearate as the emollient component in the skin care composition of Dole because it was art recognized to be useful as an emollient in skin care applications. The resulting composition would have comprised from about 0.1 to about 30 wt% of an octyldodecyl isostearate based on the total weight of the composition which renders obvious the amount of BIOSIL BASIC C-38 recited in claim 10.
Dole and Estrin are both directed towards the use of ethyl alcohol in cosmetics. In light of teachings of Estrin it would have been obvious to one of ordinary skill in the art at the time the instant invention was made to have utilized a specially denatured ethyl alcohol as the ethyl alcohol component of the composition of modified Dole in order to avoid taxation. The denatured ethyl alcohol in the resulting composition would have read on the claimed denatured ethyl alcohol.
Regarding claim 11, the ranges of amounts of octyldodecyl isostearate and retinoic acid taught by modified Dole would have encompassed, and therefore rendered obvious the claimed weight ratio range.
Regarding claim 13, Dole teaches applying the composition to skin and using the composition for wrinkle reduction (i.e., treatment of wrinkles) [0042].
Claim 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dole in view of Sanders and Estrin as applied to claim 10 above, and further in view of Mitchell et al., US 2011/0236325 (“Mitchell”).
Regarding claim 12, as is described above, Dole as modified by Sanders and Estrin renders obvious all of the limitations of claim 10.
Additionally, Dole teaches that the disclosed composition has a viscosity of from 20,000 to 750,000 cps (i.e., from about 20,000 to about 750,000 mPaꞏs) [0031] which is interpreted as overlapping, and therefore rendering obvious, the claimed viscosity.
Modified Dole is silent regarding the pH of the composition.
Mitchell discloses a skin care composition [abstract, 0003, 0025, 0358]. Mitchell teaches that at the time the instant invention was made it was widely recognized in the art that compositions for topical skin application should have a pH of between 4.0 and 7.0 so as to avoid irritation [0365].
Modified Dole and Mitchell are both directed towards skin care compositions. In light of the teachings of Mitchell, it would have been obvious to one of ordinary skill in the art at the time the instant invention was made to have adjusted the pH of the composition of modified Dole so as to between 4.0 and 7.0 in order to avoid irritation. The pH range of the resulting composition would have rendered obvious the claimed range.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior art or concurrent proceeding in which U.S. Patent No. 8,945,594 is or was involved. The proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examination, and litigations. Applicant is further reminded of the continuing obligations under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See MPEP §§ 1404, 1442.01, and 1442.04.
Conclusion
Claims 1-13 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEE E SANDERSON whose telephone number is (571) 270-1079. The examiner can normally be reached M-F: 9:30AM to 7:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle can be reached at 571-272-6600. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEE E SANDERSON/ Reexamination Specialist, Art Unit 3991
Conferees:
/ELIZABETH L MCKANE/ Specialist, Art Unit 3991
/Patricia L Engle/ SPRS, Art Unit 3991