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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
The amendments made to claims 1, 10, and 12-13 in the response filed on 11/21/2025 are acknowledged. Claims 1-4 and 8-14 are still pending in the application and are examined below.
Response to Arguments
Applicant's arguments, see page 5, filed 11/21/2025, with respect to the objections of claims 10 and 12-13 have been fully considered and are persuasive. Therefore, the objections have been withdrawn.
Applicant's arguments, see page 5, filed 11/21/2025, with respect to the rejection of claims 12-13 under 35 U.S.C. 101 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant's arguments, see pages 5-6, filed 11/21/2025, with respect to the rejection of claims 12-13 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant's arguments, see pages 6-11, filed 11/21/2025, with respect to the rejection of claim 1 under 35 U.S.C. 103 have been fully considered but are not persuasive. Please see arguments below.
Applicant argues “Claim 1 of the instant application specifies the following: ‘(...) tab into which at least one finger can engage for application of the patch (...)’. A tab like that defined in the Tab Limitation is not found in Cleary and this prior art does not teach this aspect of claim 1”; however, examiner respectfully disagrees. In Cleary, it discloses a tab (A – see annotated figure 1, a tab for a user to engage their fingers with) that allows a user to grasp onto to aid in the handling of the patch (20) (paragraph 0044-0045).
Applicant argues “Applicant does not dispute that there is an adhesive layer that keeps the handle 21 adhered to the thin film 23 until it is removed in the system of Cleary. However, the patch of claim 1 includes not only the application layer of clause (d) but also a bonding layer and an application parting layer per clause (d)(ii). These two clauses define three layers. In the rejection, the Examiner equates the handle layer 21 to the claimed application layer and notes the adhesive layer as a bonding layer in Figure 4. However, in Clearly, there are only two layers, the handle 21 and the adhesive layer beneath it that adheres the handle to the film until the handle is removed. Section (d)(ii) includes the addition of the bonding layer and the application parting layer to the application layer of clause (d) and these three layers are not taught in Cleary. Therefore, Cleary does not support a rejection of claim 1 when considering (d) and (d)(ii) of claim 1. The Office Action is silent with regard to features (d)(ii) and (d)(iii) of claim 1. The failure of the Examiner to provide a basis to reject claim 1 when considering features d ii) and d iii) means that the rejection is tainted and it must be at least clarified if another Office Action is issued, such Office Action being a non-final one so that Applicant has the opportunity to address the Examiner's clarified opinion regarding the prior art teaching of features (d)(ii) and (d)(iii) of claim 1 of claim 1”; however, examiner respectfully disagrees. The inclusion of the phrase "or" in the claimed limitation for clause (d) requires that only one of the presented options are necessary for the invention. Therefore, only clause (d)(i) was examined.
Applicant argues “In addressing the Protruding Limitation of clause (d)(iii), the Examiner uses the same language with respect to Figure 4 to allege that the Protruding Limitation is taught in Clearly. The Examiner actually does not explain how the Protruding Limitation is taught by Cleary as the comments regarding Figure 4 pertain to the presence of the adhesive layer underneath the handle 21. In fact, the Examiner has failed to provide a basis to say that the Protruding Limitation is found in Cleary and this alone taints the rejection. In fact, neither Cleary nor Gilman discloses a patch carrier layer that is creased and/or has a dent and/or is folded at an angle between 0° to 170° along a center axis and the rejection of claim 1, clause (d)(iii) fails for this reason”; however, examiner respectfully disagrees. The inclusion of the phrase "or" in the claimed limitation for clause (d) requires that only one of the presented options are necessary for the invention. Therefore, only clause (d)(i) was examined.
Applicant's arguments, see page 11, filed 11/21/2025, with respect to the rejection of claim 2 under 35 U.S.C. 103 have been fully considered but are not persuasive. Please see arguments above.
Applicant's arguments, see page 11, filed 11/21/2025, with respect to the rejection of claims 12-13 under 35 U.S.C. 103 have been fully considered but are not persuasive. Please see arguments above.
Applicant's arguments, see pages 11-12, filed 11/21/2025, with respect to the rejection of claims 2-4 and 8-13 under 35 U.S.C. 103 have been fully considered but are not persuasive. Please see arguments above.
Applicant's arguments, see page 12, filed 11/21/2025, with respect to the species election requirement have been fully considered but are not persuasive. Please see arguments below in regards to the restriction.
Applicant argues “According to the Office Action, claim 7 concerns the embodiment of figure 19. The application layer of the embodiment of figure 19 can be removed in one piece and therefore complies with species 1 as elected. Regarding claims 5 and 6, it should be noted that a cut does not prevent removing the application layer in one piece, because neither claim 5 nor claim 6 requires a cut that fully separates the application layer in two completely separated pieces”; however, examiner respectfully disagrees. These various implementations are different embodiments of the application layer.
Claim Objections
Claim 1 objected to because of the following informalities: “A patch for covering a body site” should be “A patch configured to cover a body site” in line 1. Appropriate correction is required.
Claim 12 objected to because of the following informalities: “A method for applying the patch as claimed in claim 1 to the body site” should be “A method for applying the patch of claim 1 to the body site” in lines 1-2. Appropriate correction is required.
Claim 12 objected to because of the following informalities: “wherein the patch is applied to the body site” should be “wherein the patch is configured to be applied to the body site” in line 2. Appropriate correction is required.
Claim 13 objected to because of the following informalities: “A method of using of the patch as claimed in claim 1 for covering a body site” should be “A method of using the patch of claim 1 for covering a body site” in lines 1-2. Appropriate correction is required.
Claim 14 objected to because of the following informalities: “The method according to claim 14” should be “The method according to claim 13” in line 1. Appropriate correction is required. Examiner proposes claim 14 to depend on claim 13 based on the claim limitations presented.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 3-4, and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Cleary et al. (US 20040138603 A1) in view of Gilman (US 20030220597 A1), with extrinsic evidenced provided by “Cleveland Clinic” for the rejection of claim 14.
Regarding claim 1, Cleary et al. discloses a patch (20 – figure 3/figure 4, a transdermal delivery system: paragraph 0044) for covering a body site (the patch [20] is used to conform readily to the user’s skin or mucosa: paragraph 0028), where the patch (20), b. has a patch carrier layer (23 – figure 3/figure 4, an ultra-thin film that can be a polyurethane film: paragraph 0028/0044), c. has a bonding layer of the patch carrier layer (24 – figure 3/figure 4, an adhesive layer containing an active ingredient: paragraph 0044), characterized in that the bonding layer of the patch carrier layer (24) in as-designated usage of the patch is configured for complete adhesion on the body site (the bonding layer of the patch carrier layer [24] adheres to the user: paragraph 0008-0009/0044), and d. has an application layer (21 – figure 3/figure 4, handle layer: paragraph 0044), which i. has a tab (A – see annotated figure 1, a tab that users can engage their fingers with: paragraph 0044-0045) into which at least one finger can engage for application of the patch (20) (the tab [A] allows user’s fingers to grasp onto it to aid in the handling of the patch [20] until it is applied to the patient’s skin or mucosa: paragraph 0045), or ii. has a bonding layer of the application layer, to which at least one finger is bonded temporarily for application of the patch, and an application parting layer, or iii. protrudes at least partially beyond the patch carrier layer, where at least the patch carrier layer on as- designated application of the patch is creased and/or bent and/or folded at an angle of 0* to 170* along a center axis, by virtue of the application layer on as-designated application of the patch being creased and/or bent and/or folded along the center axis or cut through along the center axis and e. wherein an adhesive connection exists between the application layer (21) and the patch carrier layer (23) (figure 4, there is an adhesive layer between the application layer [21] and patch carrier layer [23]; this ensures that the application layer [21] can be removed once the bonding layer of the patch carrier layer [24] adheres to the patient’s skin or mucosa: paragraph 0009), said application layer (21) and said patch carrier layer (23) being connected to one another by electrostatic adhesion and/or other adhesion properties or a bonding layer (the adhesive layer comprises adhesion properties that allows the application layer [21] to adhere to the patch carrier layer [23]: paragraph 0009/0045), and f. comprises a parting layer (25 – figure 4, a release liner that protects the bonding layer of the patch carrier layer [24]: paragraph 0044) for the bonding layer of the patch carrier layer (24).
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Annotated figure 1: left image is the top view while right image is the cross-section view taken at IV
However, Cleary et al. fails to disclose where the patch a. has a thickness in a range from 5 to 5000 µm.
Gilman teaches where an analogous patch (a film dressing: paragraph 0018) a. has a thickness in a range from 5 to 5000 µm (the patch is well under 5mm [5000 µm], which overlaps the range of the instant application [5 to 5000 µm]: paragraph 0018).
It would have been prima facie obvious to one of ordinary skills in the art before the filing date to have modified the thickness of the patch to 5-5000 µm to ensure flexibility and conformability of the patch applied to the user (paragraph 0009/0018, Gilman). Additionally, the claimed value lies within the range disclosed by the prior art (please see MPEP 2144.05 I., “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)”). Further, applicant places no criticality on the range claimed, indicating simply that the thickness of the patch is “preferably” within the claimed ranges (specification page: 9).
Regarding claim 3, Cleary et al. in view of Gilman discloses the invention as discussed in claim 1. Cleary et al. further discloses in that the patch carrier layer (23) has no pores and/or venting holes (the patch carrier layer [23] is made of a polyurethane film that allows passage of oxygen for breathability and comprises no venting holes: paragraph 0028; the term “vent-hole” is defined as “an opening deliberately made in or through something” by https://www.thefreedictionary.com/vent-hole).
Regarding claim 4, Cleary et al. in view of Gilman discloses the invention as discussed in claim 1. Cleary et al. further discloses in that the application layer (21) is detachable in one piece from the patch carrier layer (23) (figure 3/figure 4, the application layer [21] is rectangularly-shaped and is removed in one piece via the tabs [29]: paragraph 0045).
Regarding claim 9, Cleary et al. in view of Gilman discloses the invention as discussed in claim 1. Cleary et al. further discloses in that the patch (20) has no nonwoven, no foam material, and no wound pad (the patch [20] is made of polyurethane film and adhesive [such as acrylate-based adhesives]: paragraph 0028/0042/0044).
Regarding claim 10, Cleary et al. in view of Gilman discloses the invention as discussed in claim 1. Cleary et al. further discloses in that the bonding layer of the patch carrier layer (24) and/or the patch carrier layer (23) comprise one or more additives, the additives being selected from the group encompassing antimycotic agents, antibacterial agents, antiviral agents, anti-inflammatory agents, antipruritic agents, humic substances, moisture-absorbing agents, gas absorption agents, buffer agents for pH regulation, drying agents, fluid-absorbing materials, hydrophilic agents, starch, cellulose, hydrophilic polymers, hydrophilic salts, calcium anhydride sulfate, odor-absorbing agents, activated carbon, siccatives, silica gel, vitamins, D-mannose, and 2QR complex (the bonding layer of the patch carrier layer [24] comprises antibiotics and antimicrobials: paragraph 0027/0046).
Regarding claim 11, Cleary et al. in view of Gilman discloses the invention as discussed in claim 1. Cleary et al. further discloses in that the tab (A) is embodied as a slit (B – see annotated figure 1, the tab [A] has a slit [opening] between the removable layer [25] and the application layer [21]: paragraph 0045; the term “slit” is defined “A long, straight, narrow cut or opening” by https://www.thefreedictionary.com/slit), where the slit (B) is configured with angling at one end (C – see annotated figure 1, an angling at one end of the slit) up to the border of the application layer (D – see annotated figure 1, a border of the application layer) (see annotated figure 1, the angling at one of the slit [C] goes up to the border of the application layer [D]).
Regarding claim 12, Cleary et al. in view of Gilman discloses the invention as discussed in claim 1. Cleary et al. further discloses a method for applying the patch (20) as claimed in claim 1 to the body site (the patch [20] is used to conform readily to the user’s skin or mucosa: paragraph 0028), wherein the patch (20) is applied to the body site by means of the application layer (21) (the patch [20] is applied to the body site via the application layer [21] and its tab [A]: paragraph 0045), said method comprising the steps of a) handling the patch (20) by means of the application layer (21) (the application layer [21] comprises a tab [A] that allows user’s fingers to grasp onto it to aid in the handling of the patch [20] until it is applied to the patient’s skin or mucosa: paragraph 0045), b) removing the parting layer (25) from the bonding layer of the patch carrier layer (24) (the parting layer [25] comprises two separate sections [25a/25b] that facilitates ease of removal from the bonding layer of the patch carrier layer [24]: paragraph 0045), and c) placing the patch carrier layer (23) with the bonding layer of the patch carrier layer (24) facing the body site by use of the application layer (21) (the patch carrier layer [23] is applied to the user’s skin via the bonding layer of the patch carrier layer [24] once the parting layer [25] is removed: abstract/paragraph 0045).
Regarding claim 13, Cleary et al. in view of Gilman discloses the invention as discussed in claim 1. Cleary et al. further discloses a method of using the patch (20) as claimed in claim 1 for covering a body site (the patch [20] is used to conform readily to the user’s skin or mucosa: paragraph 0028) for temporarily preventing the emergence of microbes/bacteria from the body site and/or for preventing the transfer of microbes/bacteria to skin portions surrounding the body, the method comprising the step of applying said patch (20) to the body site (the patch [20] is applied to a body site and its surrounding skin portion and is capable of preventing the transfer of microbes/bacteria to the body site; the patch [20] is flexible, which allows the patch [20] to conform to the user’s skin and protects the skin site: paragraph 0027-0028/0048).
Regarding claim 14, Cleary et al. in view of Gilman discloses the invention as discussed in claim 13. Cleary et al. further discloses wherein the body site is an anus or the anus and a surrounding skin portion thereof (the patch [20] is applied to the mucosal tissue [which includes the anus as evidenced by “Cleveland Clinic”]; the patch [20] is flexible, which allows the patch [20] to conform to the user’s skin and protects the skin site: paragraph 0002/0007/0027-0028/0048).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Cleary et al. (US 20040138603 A1) in view of Gilman (US 20030220597 A1) and in further view of Kay (US 5713842 A).
Regarding claim 2, Cleary et al. in view of Gilman discloses the invention as discussed in claim 1.
However, Cleary et al. in view of Gilman fails to explicitly disclose that the patch carrier layer and/or the bonding layer of the patch carrier layer is transparent.
Kay teaches that an analogous patch carrier layer (11 – figure 2, a polyurethane film layer: column 8, lines 57-63) and/or analogous bonding layer of the patch carrier layer (13 – figure 2, an adhesive layer: column 8, lines 57-63) is transparent (the patch carrier layer [11] and bonding layer of the patch carrier layer [13] are both transparent: column 7, lines 44-51).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patch carrier layer and/or the bonding layer of the patch carrier layer of Cleary et al. in view of Gilman to be transparent as taught by Kay in order to provide a patch that has an improved patch carrier layer and bonding layer of the patch carrier layer to facilitate placement and positioning of the patch onto the user’s skin (column 7, lines 44-51, Kay).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Cleary et al. (US 20040138603 A1) in view of Gilman (US 20030220597 A1) and in further view of Schultz (US 5960795 A).
Regarding claim 8, Cleary et al. in view of Gilman discloses the invention as discussed in claim 1.
However, Cleary et al. in view of Gilman fails to disclose that the application layer has a marking along the center axis.
Schultz teaches that an analogous application layer (412 – figure 3, a removable elongated handle member: column 6, lines 22-67/column 7, lines 1-18) has a marking (470 – figure 3, an alignment pattern that can be grid pattern: column 6, lines 22-36) along the center axis (E – see annotated figure 2, a center axis) (see annotated figure 2, since the marking [470] can be a grid, there will be markings [470] along the center axis [E]: column 6, lines 22-35).
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Annotated figure 2: wound covering device of Schultz
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the application layer of Cleary et al. in view of Gilman to have a marking along the center axis as taught by Schultz in order to provide a patch that has an improved application layer to aid the care giver in positioning the patch onto the user’s skin (column 6, lines 22-35, Schultz).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cleary et al. (US 20040138603 A1) in view of Gilman (US 20030220597 A1) and in further view of Cox (US 5695484 A).
Regarding claim 14, Cleary et al. in view of Gilman discloses the invention as discussed in claim 13.
However, Cleary et al. in view of Gilman fails to explicitly disclose wherein the body site is an anus or the anus and a surrounding skin portion thereof.
Cox teaches an analogous method comprising an analogous step of applying an analogous patch (10 – figure 1, an anal patch configured to contact the anus: column 3, lines 11-27) to an analogous body site (the patch [10] adheres to the anus: column 3, lines 11-27), wherein the analogous body site is an anus or the anus and a surrounding skin portion thereof (the patch [10] adheres to the skin within the natal cleft and contacts the anus as well: column 3, lines 11-27).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the patch of Cleary et al. in view of Gilman be applied to the anus and a surrounding skin portion thereof as taught by Cox in order to provide an improved patch that can treat additional medical conditions such as hemorrhoids (column 2, lines 46-55, Cox).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW JUN-WAI MOK whose telephone number is (703)756-4605. The examiner can normally be reached 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571) 270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786