DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention, filed 14 July 2023, in the matter of Application N° 18/221,943. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No additions, amendments, or cancellations have been made to the claims as originally filed. No new matter has been added.
Thus, claims 1-20 represent all claims currently under consideration.
Information Disclosure Statement
Two Information Disclosure Statements (IDS) filed 14 July 2023 and 15 February 2024 are acknowledged and have been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP §608.01.
Claim Rejections - 35 USC §112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8 and 16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Both claims directly depend from independent claims 1 and 11, respectively.
Each of the independent claims recites the application of a therapeutic foot patch to the bottom of a human’s foot wherein the patch comprises a flexible backing having an adhesive skin side, and an active ingredient carrier section that carries a cough-reducing active ingredient.
The broadest reasonable interpretation of the independent claims is that the active ingredient is already present in the applied patch.
Thus, the limitations of claims 8 and 16 reciting that the method further comprises the application of the cough-reducing active ingredient on the active ingredient carrier section immediately prior to the application of the patch, are not considered to further limit the claimed method since the active ingredient is already present.
Applicants may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Herein, for the purposes of consideration on the merits, the Examiner will consider the limitations of claims 8 and 16 met where the limitations of claims 1 and 11 are taught by the art. Alternatively, the Examiner submits that the instantly claimed invention is directed to a method of treating and not a method of manufacturing the administered foot patch. Therein, the limitations of claims 8 and 16 are also considered to recite product-by-process limitations as they appear to limit the applied patch by applying the active to the patch ahead of its application. See MPEP §2113.
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 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.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicants are advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Viana et al. (US Pre-Grant Publication Nº 2011/0313371 A1; IDS reference) in view of Graedon (The People’s Pharmacy; Wayback-dated publication 17 January 2022) and Zhang et al. (US Pre-Grant Publication Nº 2019/0290597 A1).
The instantly claimed invention is directed to treating cough in a human (e.g., pediatric patient) by applying a therapeutic foot patch to a bottom of the human’s foot, wherein the patch comprises:
a flexible backing having an adhesive skin contact side that is adhered to the bottom of the foot; and
an active ingredient carrier section on the adhesive, skin contacting side.
Said active ingredient carrier section contains a cough-reducing, active ingredient that imparts a chemesthetic sensation to the foot.
Independent claim 11 recites the same method and adds to the limitations of the applied patch:
at least one strap that wraps around the foot and attaches the therapeutic foot patch thereto.
Viana discloses a medicated foot patch comprising an adhesive layer which is used to adhere the patch to the skin of the foot upon application, whereby the adhesive layer is in direct contact with the skin (see e.g., Abstract; claim 1). Claim 6 discloses that the deliverable active ingredient may be impregnated within the adhesive layer, while claim 7 discloses that the foot patch may be formed with a reservoir that contains the transdermal active ingredient. Claim 8 discloses that the reservoir is formed between a cushioning layer employed as a backing of said patch and said adhesive layer, in which the active agent(s) are contained for controlled release through a membrane. Thus, the reference discloses different configurations for the containment of the deliverable active agent.
Regarding the deliverable active ingredient, Viana discloses using actives categorized as pain-relieving compounds which are inclusive of menthol and camphor (see e.g., claim 10).
Paragraphs [0019], [0027], and [0030] each discuss the Figures of the practiced invention further teaching that the applied patches are fitted to a particular area of the foot, for example, a ball, heel, or side of the foot.
The foregoing disclosure is considered to immediately teach that the practiced patch is: applied to a human foot, that it may be shaped as needed to fit any particular region of said foot, and, lastly, minimally suggest that an area of the foot to which it may be applied is a toe.
Regarding the shape of the applied patch, the Examiner advances that such a change in size or proportion (i.e., heel, arch, toe-sized patch) for application to a specific portion of the foot would have been well within the purview of the ordinarily skilled artisan (e.g., consumer) to obtain and apply. See MPEP §2144.04(IV)(A) wherein it is stated that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.”
Viana is deficient with respect to the following aspects of the claimed method.
First, the Examiner acknowledges that while the positively recited application of a transdermal patch to the foot is disclosed, Viana discloses that the delivered active agents of interest (i.e., menthol and camphor) are as pain-relievers.
Second, Viana discloses that its foot patches are shaped and applied to the foot of a given patient, and while this is considered to teach application to a human foot, it does not further delineate that the application is pediatric.
Graedon is considered to provide disclosure which would have in combination with the disclosure of Viana, placed the claimed invention within the ordinarily skilled artisan’s (consumer’s) purview. The cited publication provides continuing discussion of the practice of putting Vicks® VapoRub™ on the soles of the afflicted person’s feet to treat them for cough. It is further discussed as being done for children (see ‘Gayle’ entry, pg. 3). Vicks® VapoRub™ is well-known and established in the art as being a topically-administered ointment that contains: camphor, and eucalyptus oil, and menthol (see e.g., vicks.com/en-us/shop-products/vapo/vicks-vaporub-topical-cough-suppresant).
The Examiner has referred to the cited article as a ‘continuing discussion’ since the January 2022 update of the article is being relied upon in the rejection. The original article citing such use was published on 19 January 2021. The 2022 update is cited because it also refers to the awarding of the 2021 Nobel Prize for Physiology and Medicine being awarded to the researchers that laid the groundwork for the science behind why the method works (i.e., TRP channels) (see Graedon, pg. 4). See also the attached Press Release published by Nobelförsamlingen (www.nobelprize.org/prizes/medicine/2021/press-release/).
The foregoing combination of teachings in the art is considered to supplement the teachings of Viana such that a person of ordinary skill in the art, before the effective filing date of the claimed invention, would have had a reasonable expectation of treating a pediatric cough by applying to the feet, a transdermal patch formulation comprising camphor, menthol, and eucalyptus oil.
Stated another way, the disclosure of Graedon is considered to provide the skilled artisan with the understanding that compositions comprising menthol, eucalyptol, and camphor such as those disclosed by Viana, have been shown to provide relief from cough in humans, including children.
Another deficiency with the teachings of Viana is that it does not appear to disclose that the patch is applied with the use of at least one strap that wraps around the foot to attach the therapeutic patch. Rather, Viana appears to disclose that the medicated foot patch is adhere to the foot without any further means for securing it the foot.
Zhang, like Viana, discloses the administration of transdermal drug-delivery systems to the skin, where along with the drug of interest, one or more pharmaceutically acceptable excipients or carriers are formulated into the TDS (see e.g., Abstract; claim 1). Regarding the pharmaceutically acceptable excipients, the reference discloses that “[d]elivery of a therapeutic agent into the skin in sufficient concentration often requires some means for reducing the stratum corneum’s hindrance of penetration” and that “[c]hemical permeation/penetration enhancers can effectively and temporarily increase skin permeability by reversibly disrupting the lipid bilayers of the stratum corneum.” See ¶[0043]. Chemical penetration enhancers are further defined in ¶[0058] as including such terpenes and terpenoids as eucalyptol and menthol.
The reference discloses that the TDS may be applied onto the skin of a subject at any location appropriate for treatment of the medical condition being treated such as the foot (e.g., dorsal and lateral foot and plantar foot arch). See ¶[0096].
Regarding the application of the medicated transdermal patches, Zhang additionally teaches that to prevent detachment of the patch from the skin, a separate, protective adhesive layer (e.g., medical/surgical tape or a PatchProtect™ or Tegraderm™ dressing) can optionally be applied over the entire patch and beyond the edges of the patch. See ¶[0107], ¶[0127], and ¶[0214].
What the added disclosure of Zhang provides the ordinarily skilled artisan is a method by which the medicated transdermal foot patch teachings of Viana may be modified to add an extra layer of protection and security for the applied patch. As is expressly disclosed by Zhang, adding an extra layer of medical/surgical tape over the patch at the site of application serves to prevent detachment of the patch from the skin.
Thus, absent a clear showing of evidence to the contrary, the Examiner submits that the ordinarily skilled consumer would have been motivated to modify Viana to arrive at the claimed method.
The limitations recited by claims 5 and 15 are considered to be met by the above disclosure pertaining to the use of menthol, camphor, and eucalyptol. Viana places such administers such compositions either on a foot patch or integrated within the adhesive layer of a patch. Graedon establishes that it is understood and known in the art to apply a composition containing all three (e.g., Vicks VapoRub) to the soles of children’s feet to treat cough. Zhang also discloses employing the compounds in a transdermal patch application and teaches further that the terpene compounds act as penetration enhancers, thereby establishing them as an absorbent material.
Alternatively, the Examiner broadly and reasonably interprets that the claims recite the cough-reducing active ingredient as being within a liquid-absorbing material in the active carrier section of the patch. In this instant, the Examiner submits that Viana discloses this limitation teaching that active agents such as camphor and menthol are either impregnated into the adhesive layer of the patch or within a reservoir that is adjacent to the adhesive layer (see e.g., claims 6-8). Either way the reference further discloses the administered active agent(s) as being absorbed into the skin from the foot patch. See e.g., ¶[0024] and ¶[0026]. In view of such additional teachings as provided above, such as Zhang, the person of ordinary skill will again note that the disclosed terpene/terpenoid compounds of Viana also function as penetration enhancers, thereby facilitating their own absorption from the device and into the skin.
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success of arriving at the instantly claimed method of treatment.
The teachings of Viana disclose the application of a therapeutic foot patch comprising such actives as camphor and menthol. The practiced patch is disclosed as being made to a desired shape and applied to different parts of the foot. Though the reference does not expressly disclose that the condition being treated is “cough,” the Examiner advances that a person of ordinary skill in the art (e.g., the everyday consumer) would reasonably expect Viana to convey this, particularly in view of Graedon. Graedon is relied upon to demonstrate two key points. First, it presents evidence of the application of Vicks VapoRub (comprising menthol, camphor, and eucalyptus oil) to soles of children’s feet is not only known, but has been practiced for years as an in-home remedy for treating cough. Secondly, it is relied upon for its mention of and reference to Nobel Prize Award-winning research that was conducted in the field of medicine which investigated the neurological pathway responsible for why compounds such as menthol were effective for such a use.
Thus, in further view of the contributions of Graedon, the Examiner submits that a person of skill in the art would have expected the application of Viana’s foot patch to have rendered the instantly claimed method prima facie obvious.
Lastly, the contributions of Zhang, largely aligned with Viana in terms of disclosing transdermal patches for the delivery of an active ingredient. Here, the actives camphor, menthol, and eucalyptol are taught as penetration enhancers. The Examiner has argued that this showing in combination with Viana, would produce an expectation of that actives disclosed by Viana would possess this property and thus penetrate the skin of the foot and confer upon the user, their therapeutic properties. Zhang is also relied upon for its disclosure that it would be obvious to reinforce the application of Viana’s foot patch with additional, secondary adhesive wrapping, to prevent the dislocation of the applied patch.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615