DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/25/2025 has been entered.
Response to Arguments
Applicant’s amendment filed 09/25/2025 is accepted and entered. Applicant’s amendment to the specification has overcome the previous specification objection and the previous specification objection has been withdrawn.
Applicant's arguments filed 09/25/2025 have been fully considered but they are not persuasive.
Applicant alleges that Baker does not disclose a handpiece comprising a tip for contacting a skin tissue being treated because instead Baker teaches a system for providing treatment fluids into an orifice such as a nostril (Remarks, pg. 2). However, this is not found persuasive. Baker indicates in ¶ [0065] that the device is for irrigation and/or aspiration of biological tissues or fluids and can be used in a body cavity. Baker further discloses the body cavity can be “the nasal cavity, the mouth and/or throat, the ear, the eye, a skin fold, the bellybutton, a wound, or combinations thereof” (¶ [0065]). When the device is used in any of these locations, the tip is capable of contacting the skin being treated (for example, the tip can be used to treat a skin fold, and the tip is fully capable of coming into direct contact with the skin fold and therefore coming into direct contact with the skin being treated). As such, Baker is considered to disclose the claimed limitations as set forth below.
Applicant did not specifically argue the dependent claims, and Applicant did not argue the previous double patenting rejection. The previous double patenting rejection is maintained.
Claim Objections
Claim 23 is objected to because the language “the main body” should read “the main body portion” to remain consistent with the other claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 2-13 and 16-23 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Baker et al (US 2008/0154183).
Regarding Claim 2, Baker discloses a skin treatment system (¶ [0065]) comprising:
a handpiece (device 2, Figs. 1-3) comprising a main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3) and a tip (nozzle 59, Figs. 1-3) configured to secure to a distal end (head 14, Figs. 1-3; ¶ [0110]) of the main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3), wherein the tip (59, Figs. 1-3) is configured to contact and be moved relative to a skin tissue of a subject during use (¶ [0065]); and
a canister (combination of irrigant reservoir 54 and aspirant reservoir 56, Figs. 1-3) configured to removably secure to a proximal end (die body 4, Figs. 1-3; ¶ [0091, 0093] indicate the reservoirs 54 and 56 can both be removably placed within the die body 4) of the main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3), the proximal end (4, Figs. 1-3) and the distal end (14, Figs. 1-3) being located on opposite ends of the main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3), the canister (54 and 56, Figs. 1-3) comprising a waste compartment (56, Figs. 1-3; [0089-0091]);
wherein the waste compartment (56, Figs. 1-3) collects waste drawn from the tip (59, Figs. 1-3) during a procedure (¶ [0089-0091]);
wherein the canister (54 and 56, Figs. 1-3) is physically attached to and incorporated into the handpiece (2, Figs. 1-3) when the canister (54 and 56, Figs. 1-3) is secured to the main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3; ¶ [0091-0093]);
wherein the canister (54 and 56, Figs. 1-3) is configured to separate from the main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3; ¶ [0091, 0093]); and
wherein the waste compartment (56, Figs. 1-3) is configured to be in fluid communication with the handpiece (2, Figs. 1-3) when the canister (54 and 56, Figs. 1-3) is secured to the main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3; ¶ [0076] indicates the aspirant reservoir is connected to pump 8 via pressure line 18, and as such, the waste container is in fluid communication with the handpiece as the pump is located within the handpiece).
Regarding Claim 3, Baker discloses the canister (54 and 56, Figs. 1-3) comprises a delivery compartment (54, Figs. 1-3), the delivery compartment (54, Figs. 1-3) configured to store a fluid to be delivered to the tip (59, Figs. 1-3) during the procedure (¶ [0093-0095]).
Regarding Claim 4, Baker discloses the fluid is water (¶ [0098]).
Regarding Claim 5, Baker discloses the fluid comprises at least one serum configured to treat a skin disease or disorder (¶ [0098]; vitamin C is commonly used as a skin serum).
Regarding Claim 6, Baker discloses the delivery compartment (54, Figs. 1-3) and the waste compartment (56, Figs. 1-3) are separated by a baffle (the walls of compartments 54 and 56 can be considered a baffle, Figs. 1-3) of the canister (54 and 56, Figs. 1-3).
Regarding Claim 7, Baker discloses the skin treatment system further comprises a fluid transfer device (pump 8, Figs. 1-3), wherein the fluid transfer device (8, Figs. 1-3) is configured to create a vacuum along the tip (59, Figs. 1-3) and help move waste toward the waste compartment (56, Figs. 1-3) when the canister (54 and 56, Figs. 1-3) is secured to the handpiece (2, Figs. 1-3; ¶ [0076]).
Regarding Claim 8, Baker discloses the fluid transfer device (8, Figs. 1-3) comprises an electric pump (¶ [0022, 0076]).
Regarding Claim 9, Baker discloses the handpiece (2, Figs. 1-3) comprises at least one controller (32, Figs. 1-3) that permits a user to selectively regulate at least one operational parameter of the system (¶ [0155]).
Regarding Claim 10, Baker discloses the tip (59, Figs. 1-3) is configured to be positioned along the distal end (14, Figs. 1-3) of the handpiece (2, Figs. 1-3) when the tip (59, Figs. 1-3) is secured to the main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3).
Regarding Claim 11, Baker discloses the tip (59, Figs. 1-3) extends to a distal-most portion of the handpiece (2, Figs. 1-3).
Regarding Claim 12, Baker discloses the tip (59, Figs. 1-3) is removably secured to the handpiece (2, Figs. 1-3; ¶ [0110]).
Regarding Claim 13, Baker discloses a skin treatment system (¶ [0065]) comprising:
a handpiece (device 2, Figs. 1-3) comprising a main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3) and a tip (nozzle 59, Figs. 1-3) for contacting a skin tissue being treated (¶ [0065]);
a delivery container (irrigant reservoir 54, Figs. 1-3) containing a treatment material to be delivered to the tip (59, Figs. 1-3) during use (¶ [0093-0095]);
a waste container (aspirant reservoir 56, Figs. 1-3) configured to receive waste created during use (¶ [0089-0091]);
wherein the waste container (56, Figs. 1-3) is in fluid communication with the handpiece (2, Figs. 1-3) during a procedure when the waste container (56, Figs. 1-3) is secured to the handpiece (2, Figs. 1-3; ¶ [0076] indicates the aspirant reservoir is connected to pump 8 via pressure line 18, and as such, the waste container is in fluid communication with the handpiece as the pump is located within the handpiece); and
wherein each of the tip (59, Figs. 1-3; ¶ [0110] indicates the nozzle 59 is removably attached since it can be manually replaced; the nozzle 59 is attached to the head 14 of the device), the delivery container (54, Figs. 1-3; ¶ [0093] indicates the irrigant reservoir 54 can be in the die body 4, neck 12, or head 14), and the waste container (56, Figs. 1-3; ¶ [0091] indicates the aspirant reservoir 56 can be in the die body 4, neck 12, or head 14) are configured to removably secure to different areas of the main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3) of the handpiece (2, Figs. 1-3; ¶ [0091-0093]; the irrigant reservoir can be placed in the die neck 12, the nozzle can be placed on the head 14, and the waste container can be placed in the die body 4, for example; these are different areas of the handpiece); and
a fluid transfer device (pump 8, Figs. 1-3) configured to help move waste from the tip (59, Figs. 1-3) to the waste container (56, Figs. 1-3) when the waste container (56, Figs. 1-3) is secured to the handpiece (2, Figs. 1-3) during use (¶ [0076).
Regarding Claim 16, Baker discloses the fluid transfer device (8, Figs. 1-3) comprises an electric fluid transfer device (¶ [0022]).
Regarding Claim 17, Baker discloses the electric fluid transfer device (8, Figs. 1-3) comprises a vacuum pump (¶ [0076]).
Regarding Claim 18, Baker discloses the treatment material comprises water (¶ [0098]).
Regarding Claim 19, Baker discloses the treatment material comprises at least one serum configured to treat a skin disease or disorder (¶ [0098]; vitamin C is commonly used as a skin serum).
Regarding Claim 20, Baker discloses the handpiece (2, Figs. 1-3) comprises at least one controller (32, Figs. 1-3) that permits a user to selectively regulate at least one operational parameter of the system (¶ [0155]).
Regarding Claim 21, Baker discloses the tip (59, Figs. 1-3) is configured to be positioned along a distal end of the handpiece (2, Figs. 1-3) when the tip (59, Figs. 1-3) is secured to the main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3).
Regarding Claim 22, Baker discloses the waste container (56, Figs. 1-3) is configured to secure to a proximal end of the main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3; ¶ [0091] indicates the waste container 56 can secure to the die body 4 which is the proximal end of the device), and wherein the delivery container (54, Figs. 1-3) is configured to secure to the main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3) at a location distal of the waste container (56, Figs. 1-3; ¶ [0091, 0093] indicates the irrigant reservoir can be placed in the neck 12, which is distal of the waste container when the waste container is placed in the die body 4).
Regarding Claim 23, Baker discloses the delivery container (54, Figs. 1-3) further comprises a locking feature configured to mate with a corresponding portion of the main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3) to secure the delivery container (54, Figs. 1-3) to the main body portion (combination of die body 4, neck 12, and head 14, Figs. 1-3; ¶ [0159] indicates the device can have latches on the cartridge and on the device to secure the cartridge into the device).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2, 7-9, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8, and 10 of U.S. Patent No. 11,883,621. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are merely broader than the patented claims. Since it has been held that the species anticipates the genus, the patented species claims anticipate the pending genus claims.
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781