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 .
Response to Amendment
This Office Action is in response to an amendment filed on 11/17/2025. As directed by the amendment, claims 6-7 were canceled, claims 1, and 8-11 were amended, and claims 21-22 were added. Thus, claims 1-5 and 8-22 are pending for this application.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 9-11, and 14-21 are rejected under 35 U.S.C. 103 as being unpatentable over Hietanen (US 2018/0104087) in view of Perosino (US 20170158028).
Regarding claim 1, Heitanen discloses (Fig. 1A-1C) a patch configured for nonpermanent attachment to an exterior surface of a user (“detachably secure” to a patient’s skin, paragraph [0041]), wherein tissue is disposed beneath the exterior surface, the patch comprising:
a base (comprising backing layer 2 and adhesive layer 3) defining opposing substantially planar surfaces (top surface of adhesive layer 3 and bottom surface of adhesive layer 3, shown to be planar in Fig. 1A), the substantially planar surfaces including a user engaging surface (bottom surface of adhesive layer 3) and an opposite surface (top surface of adhesive layer 3), the user engaging surface including an adhesive (adhesive on adhesive layer 3) configured for non-permanent attachment to the user's exterior surface (paragraph [0041]), the adhesive being configured to form a sufficiently strong bond with the user's exterior surface such that movement of the base causes movement of the tissue beneath the user's exterior surface (paragraph [0077]); and
a handle (handle 4) projecting from the opposite surface of the base in a direction away from the user engaging surface (see Fig. 1C), the handle communicating with the base such that movement of the handle causes movement of the base (paragraph [0077]).
the handle includes a first handle member (middle handle 4 in Fig. 1C) that defines in cross section a linear bottom that is configured for attachment to the base (see flat bottom in Fig. 1C attaching to base 2,3), the first handle member also defining in cross section an arcuate top (paragraph [0042] states that handle may have half-circular shape and thus has an arcuate top) that extends furthest from the opposite surface of the base (see Fig. 1C).
Heitanen does not disclose the handle further includes a second handle member that defines in cross section a linear bottom that is configured for attachment to the base, the second handle member also defining in cross section an arcuate top that extends furthest from the opposite surface of the base, wherein the first handle member intersects the second handle member at a midpoint of the second handle member.
However, Perosino teaches (Fig. 3) a handle member comprising a first handle member (horizontal handle member 26) and a second handle member (vertical handle member 26) that defines in cross section a linear bottom (see linear bottom in Fig. 1) that is configured for attachment to the base (ring 18), the second handle member also defining in cross section an arcuate top that extends furthest from the opposite surface of the base (see in Fig. 3), wherein the first handle member intersects the second handle member at a midpoint of the second handle member (see point of intersection at axis 15 in Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Heitanen to include a second handle member that defines in cross section a linear bottom that is configured for attachment to the base, the second handle member also defining in cross section an arcuate top that extends furthest from the opposite surface of the base, wherein the first handle member intersects the second handle member at a midpoint of the second handle member, as taught by Perosino, for the purpose of improving grip of user when rotating the handle (paragraph [0030] Perosino).
Regarding claim 2, modified Heitanen discloses wherein the sufficiently strong bond provided by the adhesive is sufficient to provide myofascial release if the handle moves to cause the base to move (paragraph [0077] Heitanen).
Regarding claim 9, modified Heitanen discloses wherein the first and second handle members are integrally attached to each other (see integral attachment in Fig. 3 Perosino).
Regarding claim 10, modified Heitanen discloses wherein the first and second handle members are disposed perpendicular to each other (see perpendicular relationship in Fig. 3 Perosino).
Regarding claim 11, modified Heitanen discloses wherein the first and second handle members are unitarily formed (formed of continuous piece and thus unitarily formed, paragraph [0042] Heitanen).
Regarding claim 14, modified Heitanen discloses wherein the base and the handle are formed unitarily (base and handle attached and thus form a unitary structure as shown in Fig. 1C Heitanen).
Regarding claim 15, modified Heitanen discloses wherein the base and the handle are attached via adhesive (attached via adhesive, paragraph [0040] Heitanen).
Regarding claim 16, modified Heitanen discloses wherein the base and the handle are attached via mechanical attachment (threads, zipper, rivet, etc, see paragraph [0040] Heitanen).
Regarding claim 17, modified Heitanen discloses wherein the handle is configured such that the handle is moveable via manual manipulation (paragraph [0077] Heitanen).
Regarding claim 18, modified Heitanen discloses wherein the handle is moveable via the manual manipulation in at least the direction along the exterior surface of the user and along the direction orthogonal to the exterior surface of the user (paragraph [0077]-[0078] Heitanen).
Regarding claim 19, modified Heitanen discloses wherein at least the base is formed of material that is hypoallergenic (i.e. cotton, paragraph [0028] Heitanen).
Regarding claim 20, modified Heitanen discloses wherein the base is formed of material that is waterproof (hydrophobic, paragraph [0028] Heitanen).
Regarding claim 21, modified Heitanen discloses wherein the second handle member intersects the first handle member at a midpoint of the first handle member (see Fig. 3 Perosino).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hietanen (US 2018/0104087) in view of Folwarzny (US 2020/0101192).
Regarding claim 3, Heitanen does not disclose wherein the base is configured to define a circular cross section.
However, Felix teaches (Fig. 7-8) a patch comprising a base (comprising layers 12,402 and 302) is configured to define a circular cross section (“circular”, paragraph [0053] and Fig. 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the base of modified Heitanen to define a circular cross section, as taught by Folwarzny, for the purpose of allowing the patch to cover a greater width of the surface upon which it is placed. Furthermore, absent evidence of criticality, it has been held that changes in shape are merely a matter of design choice and would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. See in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Hietanen (US 2018/0104087) in view of Perosino (US 20170158028), and further in view of Eaves (US 11,229,555).
Regarding claims 4-5, modified Heitanen does not disclose a cover that is configured to cover at least a portion of the engaging surface of the base that includes the adhesive, and a second cover that is configured such that the cover and the second cover together cover the engaging surface.
However, Eaves teaches (Fig. 1-6) a cover (primary tab 1004, which covers adhesive layer 1002) that is configured to cover at least a portion of the engaging surface of the base that includes the adhesive and a second cover (central section 1005) that is configured such that the cover and the second cover together cover the engaging surface (see Fig. 1-6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patch of modified Heitanen to include a cover that is configured to cover at least a portion of the engaging surface of the base that includes the adhesive, and a second cover that is configured such that the cover and the second cover together cover the engaging surface, as taught by Eaves, for the purpose of protecting the adhesive layer from the environment until it is ready for use.
Claim 8 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Hietanen (US 2018/0104087) in view of Perosino (US 20170158028).
Regarding claim 8, modified Heitanen discloses wherein each of the first and second handle members define a circular cross section (paragraph [0042]), but does not disclose the cross section is sinusoidal. However, absent evidence of criticality, it has been held that changes in shape are merely a matter of design choice and would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. See in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 22, modified Heitanen discloses wherein the first handle member intersects the second handle member at a center point of the base (see Fig. 3 Perosino) and where the sinusoidal cross section of the first handle member and the second handle member is at a maximum height relative to the base (see Fig. 3 Perosino).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hietanen (US 2018/0104087) in view of Perosino (US 20170158028), and further in view of Nishimura (US 2018/0280609).
Regarding claims 12-13, modified Heitanen discloses wherein at least one of the base and the handle are formed of polyester (base made of polyester, paragraph [0028] Heitanen), and wherein both the base and the handle are formed of polyester (paragraph [0040] discloses base and handle made of same material, and because base made of polyester, handle also made of polyester Heitanen), but does not disclose the polyester is specifically non-woven polyester.
However, Nishimura teaches (Fig. 5) a patch comprising a base (application member 30) and handle (protrusion 36, which is part of application member 30, paragraph [0038] and [0051]) made of non-woven polyester (paragraph [0037]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the handle and base of modified Heitanen to be non-woven polyester, as taught by Nishimura, for the purpose of providing a resilient and biologically safe material, thereby improving user therapeutic outcome.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection relies on one or more new references not applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 MATTHEW R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
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, Justine Yu can be reached at 571-272-4835. 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.
/MATTHEW R MOON/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785