DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Continued Examination Under 37 CFR 1.114
3. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/17/2025 has been entered.
Response to Arguments
4. Applicant’s arguments with respect to claim(s) 1-15 and 18-21 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1, 4, 8, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over McMillan U.S. 2013/0197473 (herein referred to as “McMillan”) and in view of DeBenedictis U.S. 2016/0089550 (herein referred to as “DeBenedictis”).
7. Regarding Claim 1, McMillan teaches a method for performing an energy-based dermatological procedure for heating a target embedded in skin of a patient without use of an injectable anesthetic (Figs. 17 and 19), the method comprising:
a. applying a topical anesthetic over an area of skin in which the target is embedded (Fig. 17, “apply topical anesthetic”; para 0133, “application of topical anesthetic to the tumor site on the skin”);
b. monitoring a surface temperature of the area of skin (para 0111, “sensors needles 10 for measuring tissue temperature”; para 0100, “the temperature at one or more points within the skin region being treated can be monitored using the temperature sensors”; Fig. 17, “initiate temperature monitoring”);
c. cooling the area of skin (Fig. 17, “initiate cooling”; para 0128, “skin cooling”) by passing a stream of cold air over the area of skin (para 0128, “skin cooling may take the form of a cryogen spray, a chilled contact element such as a window or a lens, a cooling fluid, cold air applied to the skin surface before, during and/or after a laser pulse”) such that the surface temperature of the area of skin, as monitored (Fig. 17, “initiate temperature monitoring”), for a duration of at least 30 seconds (para 0070, “the effect of irradiating skin with… for 28 s with a 28 degrees Celsius… sapphire window in contact with the skin surface”); and
d. administering an energy dose to the area of skin after the duration (Fig. 17, “initiate irradiation of skin”),
e. wherein administering the energy dose includes administering a laser pulse with appropriate laser parameters (para 0128, “model is used with pulses”) so as to damage the target without damaging the skin in which epidermis and dermis layers of skin that overlay and surround the target (para 0128, “these laser parameters would require skin cooling to protect and preserve the epidermis for topical cosmetic outcome”), while reducing a pain level experienced by the patient compared to administering the laser pulse with only cooling the area of skin without applying the topical anesthetic (para 0133, “to produce numbering of the treatment site… tumor treatment is achieved with a concomitant reduction in pain from the thermal laser irradiation”; para 0142, “the thermal laser irradiation is applied after the anesthetic drug has been on the skin for a sufficient time to produce numbering of the treatment site”).
McMillan fails to teach the surface temperature of the area of skin is maintained between 0 degrees and 15 degrees Celsius for a duration of 30 seconds.
DeBenedictis teaches a method for performing a dermatological procedure of analogous art (para 0057), wherein the method comprising cooling the skin to a temperature maintained between 0 degrees Celsius and 15 degrees Celsius for a duration of 30 seconds (para 0082, “the tissue at the treatment site can be cooled…30 seconds…cooling rates of the skin surface or target tissue can be equal to or greater than…other desired cooling rates…”; para 0083, “A=5o Celsius” which refers to the temperature reached at epidermis/dermis depth as shown in Fig. 13). It would have been obvious to one having ordinary skill in the art at the time the invention was made to apply the cold air over the area of the skin for 30 seconds to maintain the temperature of the skin to the desired temperature, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
8. Regarding Claim 4, McMillan teaches the surface temperature of the skin is monitored in real-time (para 0088, “method for measuring temperature during irradiation, at precise locations within the tissue that are fixed and defined relative to the skin surface”; para 0133).
9. Regarding Claim 8, McMillan teaches removing the topical anesthetic from the area of skin prior to passing the stream of cold air over the area of skin (Fig. 17, “remove topical anesthetic”).
10. Regarding Claim 13, McMillan teaches administering the energy dose is performed using a photo-thermal energy apparatus (para 0012, 0124).
11. Regarding Claim 14, McMillan teaches a method for performing an energy-based dermatological procedure for heating a target embedded in skin of a patient without use of an injectable anesthetic (Figs. 17 and 19), the method comprising:
a. applying a topical anesthetic over an area of skin in which the target is embedded (Fig. 17, “apply topical anesthetic”; para 0133, “application of topical anesthetic to the tumor site on the skin”);
b. monitoring a surface temperature of the area of skin (para 0111, “sensors needles 10 for measuring tissue temperature”; para 0100, “the temperature at one or more points within the skin region being treated can be monitored using the temperature sensors”; Fig. 17, “initiate temperature monitoring”);
c. cooling the area of skin (Fig. 17, “initiate cooling”; para 0128, “skin cooling”) by passing a stream of cold air over the area of skin (para 0128, “skin cooling may take the form of a cryogen spray, a chilled contact element such as a window or a lens, a cooling fluid, cold air applied to the skin surface before, during and/or after a laser pulse”) such that the surface temperature of the area of skin, as monitored (Fig. 17, “initiate temperature monitoring”), for a duration of at least 30 seconds (para 0070, “the effect of irradiating skin with… for 28 s with a 28 degrees Celsius… sapphire window in contact with the skin surface”); and
d. performing a dermatological procedure on the area of skin after the duration (Fig. 17, “initiate irradiation of skin”; para 0128, “model is used with pulses”), so as to damage the target without damaging the skin in which epidermis and dermis layers of skin that overlay and surround the target (para 0128, “these laser parameters would require skin cooling to protect and preserve the epidermis for topical cosmetic outcome”), while reducing a pain level experienced by the patient compared to administering the laser pulse with only cooling the area of skin without applying the topical anesthetic (para 0133, “to produce numbering of the treatment site… tumor treatment is achieved with a concomitant reduction in pain from the thermal laser irradiation”; para 0142, “the thermal laser irradiation is applied after the anesthetic drug has been on the skin for a sufficient time to produce numbering of the treatment site”).
McMillan fails to teach the surface temperature of the area of skin is maintained between 0 degrees and 15 degrees Celsius for a duration of 30 seconds.
DeBenedictis teaches a method for performing a dermatological procedure of analogous art (para 0057), wherein the method comprising cooling the skin to a temperature maintained between 0 degrees Celsius and 15 degrees Celsius for a duration of 30 seconds (para 0082, “the tissue at the treatment site can be cooled…30 seconds…cooling rates of the skin surface or target tissue can be equal to or greater than…other desired cooling rates…”; para 0083, “A=5o Celsius” which refers to the temperature reached at epidermis/dermis depth as shown in Fig. 13). It would have been obvious to one having ordinary skill in the art at the time the invention was made to apply the cold air over the area of the skin for 30 seconds to maintain the temperature of the skin to the desired temperature, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
12. Regarding Claim 15, McMillan teaches the surface temperature of the skin is monitored in real-time (para 0088, “method for measuring temperature during irradiation, at precise locations within the tissue that are fixed and defined relative to the skin surface”; para 0133).
13. Claims 2, 3, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over McMillan and DeBenedictis, and further in view of Pongpeerapat U.S. 2015/0104497 (herein referred to as “Pongpeerapat”).
14. Regarding Claims 2 and 3, McMillan teaches the method of claim 1, as well as applying the topical anesthetic over the area of skin comprises applying a first application of topical anesthetic (Fig. 17, “apply topical anesthetic”; para 0133, “application of topical anesthetic to the tumor site on the skin”).
McMillan fails to teach applying at least a second application of topical anesthetic and cleaning the area of skin between applications.
Pongpeerapat teaches a method for performing a dermatological procedure (abstract, para 0008), wherein the method comprises of applying a topical composition to an area of skin (para 0077). This topical composition may be applied a plurality of times, such that between applications, the first application is cleaned/removed from the skin before applying the second application (para 0077, “after the topical composition has been applied to the skin site for the desired amount of time….the composition may be removed from the skin site…a new topical composition may be applied to the same skin site”). This is done to ensure that the active agent of the topical composition has been sufficiently applied to the target area (para 0077). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of McMillan to include a first and second application of a topical anesthetic, and cleaning the skin between applications, in order to achieve the desired effect of the skin before the rest of the treatment is applied.
15. Regarding Claim 18, McMillan teaches the method of claim 14, as well as applying the topical anesthetic over the area of skin comprises applying a first application of topical anesthetic (Fig. 17, “apply topical anesthetic”; para 0133, “application of topical anesthetic to the tumor site on the skin”).
McMillan fails to teach applying at least a second application of topical anesthetic.
Pongpeerapat teaches a method for performing a dermatological procedure (abstract, para 0008), wherein the method comprises of applying a topical composition to an area of skin (para 0077). This topical composition may be applied a plurality of times, such that between applications, the first application is cleaned/removed from the skin before applying the second application (para 0077, “after the topical composition has been applied to the skin site for the desired amount of time….the composition may be removed from the skin site…a new topical composition may be applied to the same skin site”). This is done to ensure that the active agent of the topical composition has been sufficiently applied to the target area (para 0077). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of McMillan to include a first and second application of a topical anesthetic, and cleaning the skin between applications, in order to achieve the desired effect of the skin before the rest of the treatment is applied.
16. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over McMillan and DeBenedictis, and further in view of Carter U.S. 2006/0222687 (herein referred to as “Carter”).
17. Regarding Claim 5, McMillan teaches the method of claim 1, but fails to teach massaging the topical anesthetic into the area of skin for at least 20 seconds.
Carter teaches a method of performing a dermatological procedure of analogous art (para 0022), wherein the method includes applying a topical anesthetic to the skin (para 0022). The topical anesthetic is massaged into the area of skin for at least 20 seconds (para 0022, “sample is typically rubbed in a circular pattern for approximately 30 seconds”). This ensures the formula is absorbed by the skin to achieve the numbing effect (para 0022). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McMillan to have the topical anesthetic massaged for at least 20 seconds to achieve the numbing effect of the agent.
18. Claims 6, 9, 10, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over McMillan and DeBenedictis, and further in view of Kauvar U.S. 2008/0234669 (herein referred to as “Kauvar”).
19. Regarding Claim 6, McMillan teaches the method of claim 1, but fails to teach applying the topical anesthetic comprise allowing the topical anesthetic to dwell on the area of the skin for at least 30 minutes
Kauvar teaches a method of analogous art (para 0022-0023, 0027, 0042), wherein the method comprises applying a topical anesthetic (para 0029, 0048), such that the topical anesthetic dwells on the area of the skin for at least 30 minutes (para 0029, 0048). While McMillan does not explicitly teach leaving the anesthetic for 30 minutes, McMillan does discuss that the topical anesthetic should remain in order for the numbing effect to take place (para 0133, “ anesthetic drug has been on the purpuric skin for a sufficient time to produce numbing of the treatment site and after the topical drug is removed from the skin”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McMillan to have the topical anesthetic on the skin for at least 30 minutes, as this ensures that the time is sufficient for the numbness to take effect.
20. Regarding Claim 9, McMillan teaches the method of claim 1, but fails to teach the target is a sebaceous gland.
Kauvar teaches a method of analogous art (para 0022-0023, 0027, 0042), such that the target for the procedure is a sebaceous gland (para 0022, 0042). Selecting the appropriate target for the procedure is well-known in the area (McMillan, para 0020; Kauvar, 0022). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of McMillan to treat a sebaceous gland as this is a recognized method within the field to select the appropriate target for the procedure.
21. Regarding Claim 10, McMillan teaches the method of claim 1, as well as a topical anesthetic (Fig. 17, “apply topical anesthetic”). However, McMillan fails to explicitly teach that the active ingredient of the topical anesthetic comprises at least one selected from a group of lidocaine, epinephrine, and prilocaine.
Kauvar teaches an active ingredient of the topical anesthetic comprises at least one selected from a group of lidocaine, epinephrine, and prilocaine (para 0048). It is well known in the art that these ingredients are readily found in topical anesthetics (para 0048), therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected one of these active ingredients to be found in the topical anesthetic of McMillan, as these produce the same effect of numbing the target site.
22. Regarding Claim 19, McMillan teaches the method of claim 1, but fails to teach applying the topical anesthetic comprise allowing the topical anesthetic to dwell on the area of the skin for at least 30 minutes
Kauvar teaches a method of analogous art (para 0022-0023, 0027, 0042), wherein the method comprises applying a topical anesthetic (para 0029, 0048), such that the topical anesthetic dwells on the area of the skin for at least 30 minutes (para 0029, 0048). While McMillan does not explicitly teach leaving the anesthetic for 30 minutes, McMillan does discuss that the topical anesthetic should remain in order for the numbing effect to take place (para 0133, “ anesthetic drug has been on the purpuric skin for a sufficient time to produce numbing of the treatment site and after the topical drug is removed from the skin”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McMillan to have the topical anesthetic on the skin for at least 30 minutes, as this ensures that the time is sufficient for the numbness to take effect.
23. Regarding Claim 20, McMillan teaches the method of claim 1, but fails to teach the target is a sebaceous gland.
Kauvar teaches a method of analogous art (para 0022-0023, 0027, 0042), such that the target for the procedure is a sebaceous gland (para 0022, 0042). Selecting the appropriate target for the procedure is well-known in the area (McMillan, para 0020; Kauvar, 0022). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of McMillan to treat a sebaceous gland as this is a recognized method within the field to select the appropriate target for the procedure.
24. Regarding Claim 21, McMillan teaches the method of claim 1, as well as a topical anesthetic (Fig. 17, “apply topical anesthetic”). However, McMillan fails to explicitly teach that the active ingredient of the topical anesthetic comprises at least one selected from a group of lidocaine, epinephrine, and prilocaine.
Kauvar teaches an active ingredient of the topical anesthetic comprises at least one selected from a group of lidocaine, epinephrine, and prilocaine (para 0048). It is well known in the art that these ingredients are readily found in topical anesthetics (para 0048), therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected one of these active ingredients to be found in the topical anesthetic of McMillan, as these produce the same effect of numbing the target site.
25. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over McMillan and DeBenedictis, and further in view of Das U.S. 2020/0345696 (herein referred to as “Das”).
26. Regarding Claim 7, McMillan teaches the method of claim 1, but fails to teach occluding the topical anesthetic on the area of skin.
Das teaches a method of performing a dermatological procedure of analogous art (para 0003-0004), wherein the method includes applying a topical anesthetic to skin, including occluding the topical anesthetic (para 0007). This ensures a sustained delivery of the active agents provided by the topical anesthetic, as well as reduces the ability to rub and/or wash the topical anesthetic away prematurely (para 0005, 0007). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McMillan to occlude the topical anesthetic on the area of the skin, as this ensures the active agent is properly absorbed, and that it is not prematurely removed.
27. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over McMillan and DeBenedictis, and further in view of Bean U.S. 2014/0121631 (herein referred to as “Bean”).
28. Regarding Claim 11, McMillan teaches the method of claim 1, as well as administering a first laser pulse to the area of skin (Fig. 17, “initiate irradiation of skin”) and continuing to monitor the surface temperature of the area of skin (Fig. 17, “initiate monitoring temperature”).
McMillan fails to teach updating at least one of the laser parameters; and administering a second laser pulse, with the laser parameters so updated, to the area of skin.
Bean teaches a method of analogous (Fig. 6), wherein after administering a first laser pulse (Fig. 6, ref num 105), at least one of the laser parameters is updated (para 0093, “a temperature measurement feedback device can be deployed in the system to measure temperature during the treatment cycle. This temperature measurement is used to change one or more of the laser parameters (including laser power or intensity, pulse width, and time delay between pulses) to reach the desired temperature level and maintain this temperature level relatively constant for a period of time”), such that a second laser pulse is administered with the updated laser parameters (para 0092-0093). This allows the control of energy to applied to reach the desired outcome (para 0092). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McMillan to update the laser parameters before applying a second laser pulse in order to reach the desired outcome.
29. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over McMillan and DeBenedictis, and further in view of Berube U.S. 2010/0262135 (herein referred to as “Berube”).
30. Regarding Claim 12, McMillan teaches the method of claim 1, but fails to teach displaying a measured surface temperature of the area of skin and a total time that the skin surface has been below a targeted temperature.
Berube teaches a method of performing a dermatological procedure of analogous art (para 0002), wherein the method includes displaying a measured surface temperature of the area of skin (para 0204, “display screen 606 can display a variety of information…tissue temperature, treatment duration…can be displayed”; para 0157, “the time or amount of energy used to place the target in a desired state (e.g., at a pre-determined temperature) is included in the total treatment cycle”; para 0212, “real-time feedback of tissue temperature”). This facilitates effective and efficient treatment so that the user may use the information to make any necessary adjustments (para 0204). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method as taught by McMillan to display the surface temperature of the area of the skin, as well as display the total time the skin was below a target temperature, in order to facilitate effective and efficient treatment.
Conclusion
31. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794