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 .
Status of Claims
Claims 1-20 are pending, of which Claim 1 is independent. All claims are examined on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities:
Re Claim 1, the term “planer,” is believed to be a misspelled word, because “planer” is a woodworking tool used to smooth a wood surface. The correct spelling for a word that means “flat or relating to a plane,” is “planar.” Additionally at the end of the claim, “the compound formulation configured to absorb through the skin…” should be “the compound formulation configured to be absorbed through the skin…”
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.
Claims 1-2, 4-5, 9-10, 12, 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silguero et al. (US 2006/0222693).
Re Claim 1, Silguero discloses a transdermal patch (12, Figs. 2-4), comprising:
a substrate (backing layer 32, Fig. 3) configured as a planar member with a first major face and a second major face opposite the first major face, the substrate configured to mount to skin, the substrate including:
a bottom side (in direct contact with adhesive layer 34, Fig. 3) defining the first major face of the substrate, the bottom side facing the skin when the substrate is mounted to the skin; and
a top side (the side that supports pigment layer 30) opposite the bottom side and defining the second major face of the substrate, the top side including an ornamental design ([0019] “the pigment layer having the image 14 formed therein”);
an adhesive (adhesive layer 34) disposed on the bottom side of the substrate, the adhesive configured to selectively couple the substrate to the skin ([0017] “adhesive layer 34 also serves to adhere the transdermal patch 12 to the skin of the user 10”); and a
compound formulation operatively disposed on the bottom side of the substrate ([0017] “the adhesive layer is labeled 34, and is also the layer that bears the one or more drugs”), the compound formulation configured to be absorbed through the skin into a bloodstream below the skin ([0013]).
Re Claim 2, Silguero discloses claim 1 and further disclosing wherein the compound formulation is mixed with the adhesive layer ([0017]).
Re Claim 4, Silguero discloses claim 1 and further disclosing wherein the substrate has a thickness selected to make the substrate visually unapparent when the substrate is mounted to the skin (the patch is designed to appear to be a tattoo and is therefore must be thin enough to appear like it is ingrained into the skin).
Re Claim 5, Silguero discloses claim 4 and further disclosing wherein the substrate has rounded corners (Fig. 2).
Re Claim 9, Silguero discloses claim 1 and further disclosing wherein the substrate appears to be a tattoo in the form of the ornamental design when the substrate is mounted to the skin (Fig. 1).
Re Claim 10, Silguero discloses claim 1 and further disclosing wherein the compound formulation includes a therapeutic compound ([0013]).
Re Claim 12, Silguero discloses claim 1 and further disclosing wherein the compound formulation includes a psychoactive compound ([0013] where nicotine is a well-known psychoactive compound because it binds to nicotinic acetylcholine receptors in the central nervous system).
Re Claim 14, Silguero discloses claim 1 and further disclosing wherein the adhesive layer is clear ([0020]) to make it visually unapparent when the substrate is mounted to the skin.
Re Claim 15, Silguero discloses claim 1 and further disclosing a backing sheet (release liner layer 36) and the substrate is removably mounted to the backing sheet (via adhesive layer 34, see [0017] “The release liner layer 36 is removed from the transdermal patch 12 prior to applying the transdermal patch 12 to the skin of the user 10.”).
Re Claim 16, Silguero discloses claim 15 and further disclosing wherein the adhesive layer (34) is formulated to removably adhere the substrate to the backing sheet and to the skin (see [0017]).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Silguero.
Re Claim 3, Silguero discloses claim 1 but does not teach wherein the adhesive layer is disposed between the compound formulation and the bottom side of the substrate. However, a person of ordinary skill has good reason to pursue the known options (dispose the drug in the adhesive layer, between the skin and the adhesive layer, or between the adhesive layer and the backing layer/substrate) within his or her technical grasp. If this leads to the anticipated success (the drug is delivered transdermally at a controlled rate), it is likely that product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under § 103. See MPEP 2143 (E).
Claims 6-8, 11 & 13 are rejected under 35 U.S.C. 103 as being unpatentable over Silguero in view of Kanios et al. (US 2006/0078604).
Re Claim 6, Silguero discloses claim 4 but does not explicitly disclose wherein the substrate has a thickness of 80 microns or less. Silguero simply discloses that the patch appears to be a tattoo ingrained into the skin of the user, thus suggesting a very thin patch. Kanios discloses a transdermal patch for delivering drug(s) to a person, wherein the backing layer of the patch (18, Fig. 1) is less 0.2 to 3 mil in thickness (equivalent to 5-76 microns, see [0364]). It would have been obvious to one skilled in the art at the time of filing to modify Silguero with Kanios’ teaching such that the patch appears to be body art rather than a medical treatment.
Re Claim 7, Silguero and Kanios combine to disclose claim 6, and Silguero further discloses wherein the ornamental design is printed ([0028]) onto the top side of the substrate. The language “with a digital printer” is product-by-process language. As explained in MPEP 2113, 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 ornamental design of Silguero has been shown to be a print as required by the claim. Although Silguero does not disclose that it is made with a digital printer, the burden now shifts to the Applicant to come forward with evidence establishing an unobvious different between the claimed product and the prior art product.
Re Claim 8, Silguero and Kanios combine to disclose claim 6 and Silguero also discloses wherein the substrate has rounded corners (Fig. 2).
Re Claim 11, Silguero discloses claim 1 but does not teach wherein the compound formulation includes a narcotic compound. Kanios discloses a transdermal patch for delivering drug(s) to a person, wherein the patch comprises an adhesive layer that may have the drug(s) admixed therein, and wherein the drug(s) can be a narcotic compound ([0066]). It would have been obvious to one skilled in the art at the time of filing to modify Silguero with compounds taught by Kanios such that the transdermal patch may have a larger consumer market.
Re Claim 13, Silguero discloses claim 1 but does not teach wherein the compound formulation includes a mixture of different compounds. Kanios discloses a transdermal patch for delivering drug(s) to a person, wherein the patch comprises an adhesive layer that may have the drug(s) admixed therein, and wherein the drug(s) can be a mix of various active agents ([0055]). It would have been obvious to one skilled in the art at the time of filing to modify Silguero with compounds taught by Kanios such that the transdermal patch may have a larger consumer market.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Silguero in view of Lee (US 2005/0232958).
Re Claims 17-20, Silguero discloses claim 15 and further disclosing the transdermal patch (12) removably mounted to the backing sheet (36) defines a transdermal patch sheet and the transdermal patch defines a first transdermal patch.
Silguero does not teach that the transdermal patch sheet includes multiple transdermal patches configured the same as the first transdermal patch, wherein at least one of the transdermal patches on the transdermal patch sheet has a different shape than the first transdermal patch, wherein each transdermal patch in the transdermal patch sheet has a different ornamental design, and wherein the different ornamental designs of the transdermal patches in the transdermal patch sheet are related to each by having a common theme.
Lee discloses a sheet of temporary tattoos wherein the tattoos have the same configuration (i.e., they are individually adhered to the base sheet 28 in the same way), wherein at least one of the tattoos on the sheet has a different shape (see Fig. 3) and a different ornamental design (Fig. 3, the tattoos are replicas of what various celebrities have on their bodies, [0023]), and wherein the different ornamental designs of the transdermal patches in the transdermal patch sheet are related to each by having a common theme (the designs are all based on what celebrities have on their bodies). It would have been obvious to one skilled in the art at the time of filing to modify with Lee such that all the transdermal patches can be kept in one place and a user would have an assortment of designs to choose from.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sozzafava (US 2005/0016211) discloses a sheet of ornamental patterns that are suitable for adhering and decorating the human body, wherein the ornamental patterns are different but share the same theme (see Fig. 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN S SU whose telephone number is (408)918-7575. The examiner can normally be reached M-F 9:00 - 5:00 Pacific.
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, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSAN S SU/Primary Examiner, Art Unit 3781 21 February 2026