DETAILED ACTION
This action is in response to amendments received on 1/5/2026. Claims 1-20 were previously rejected. Claims 1, 7, 9-10, 14 and 16 have been amended and claim 8 canceled. A complete action on the merits of claims 1-7 and 9-20 follows below.
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 .
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 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.
Drawings
The drawings were received on 1/5/2026. These drawings are acceptable.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 and 9-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Each of independent claims 1 and 7 have been amended to recite the limitation "the base portion comprises a loading stage configured to substantially conform to the shape of the tweezer when the tweezer is rested thereon" in lines 6-8 of claim 1 and lines 6-7 of claim 7. Based on the description “a loading stage” is the section labeled 110 in Fig. 1B (see the figure below). Since the description does not state the material of the loading stage and no figures depict the area once the tweezers are rested thereon, it is unclear if at the time of the invention, the applicant made the area of a conformable material to conform to the shape of the tweezers once placed thereon or not. Paragraph [0038] of the publication teaches “Base portion 102 of activation station 100 comprises a loading stage 110, a conical element 112 and a shield element 114. The treatment end of the tweezer may rest on loading stage 110 when inserted through opening 106”. It is further unclear if the loading stage is configured to conform to the shape of the tip of the tweezers (the area placed thereon) or the whole tweezers as claimed. Clarification and appropriate correction is required.
Claims 2-6 and 9-13 are rejected due to dependency over claims 1 and 7.
PNG
media_image1.png
455
558
media_image1.png
Greyscale
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 and 9-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Each of independent claims 1 and 7 recite the limitation "the base portion comprises a loading stage configured to substantially conform to the shape of the tweezer when the tweezer is rested thereon" in lines 7-9 of claim 1 and lines 6-7 of claim 7. It is at most unclear what “substantially conform to the shape of the tweezer” means since the loading stage is not claimed to be flexible or in any way conformable when the tweezers are positioned thereon. It is unclear if “substantially conformable” refers to the material being flexible to re-shape once the tweezers are rested thereon or the area having walls configured to contain the tweezers therein when the tweezers are positioned therein. For analysis, the limitation is interpreted to be the shaped to contain the tweezers therein; however, clarification and appropriate correction is required.
Claims 2-6 and 9-13 are rejected due to dependency over claims 1 and 7.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 7 and 9-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lind (US Pub. No. 2013/0012932).
Regarding Claim 1, Lind teaches a method of treating a skin lesion (abstract), comprising:
activating a treatment region of a tweezer with a cryogenic agent by inserting the treatment region into an activation station comprising a base portion and a loading portion ([0011], [0057]-[0065] by inserting the treatment region 201 in the canister cap 205/52 through the opening 210 here interpreted to be the loading region and all the way down to the end where nozzle 207 is (the round section in Fig. 5) here interpreted to be the base portion as in Figs. 1-8, 10); wherein the base portion and the loading portion collectively form a receiving chamber that facilitates localization of the cryogenic agent onto the treatment region of the tweezer upon injection of the cryogenic agent into the activation station (Figs. 1-8 and 10 and [0057]-[0064]) and wherein the base portion comprises a loading stage configured to substantially conform to the shape of the tweezer when the tweezer is rested thereon (as best understood in view of the 112 rejections above, the base section has a rounded wall (tweezer guides 216) here interpreted to be the loading stage which is configured to substantially conform to the shape of the treatment region of the tweezer when the tweezer is rested thereon (see Figs. 2, 7 and 10);
positioning the treatment region of the tweezer on the skin lesion, wherein positioning comprises aligning a pair of absorbent pads (64/65, 201, 170a/170b in various figures 1-10) provided at the treatment region of the tweezer on opposing sides of the skin lesion ([0010], [0018], [0025], [0055] and [0064]);
squeezing an articulating end of the tweezer to secure the skin lesion between the pair of absorbent pads to deliver the cryogenic agent to the skin lesion; and maintaining grasp of skin lesion secured between the pair of absorbent pads for a predetermined treatment time ([0018], [0055]-[0065]).
Regarding Claim 2, Lind teaches wherein the cryogenic agent comprises dimethyl ether, liquid nitrogen, or nitrous oxide ([0061]).
Regarding Claim 3, Lind teaches further comprising applying a skin shield to an area of treatment comprising the skin lesion, the skin shield enabling isolation and validation of the skin lesion in the area of treatment (“when the cryogenic matter is applied to the lesion, the surrounding collateral skin tissue is protected from contact with the cryogenic matter” in [0055] and as seen only the inward-facing exposed sections of pads demonstrated as 212af/212bf in Fig. 8 are configured to directly touch the skin tag for treatment while the sides and opposite outwardly facing of the pads are shielded within the squeezer arms distal ends of 212a/212b in Fig. 8, “the tweezer arms protect the collateral skin tissue during the cryogenic treatment” [0056]; thereby the sides and back of the arms are here interpreted to be a skin shield to an area of treatment comprising the skin lesion, the skin shield enabling isolation and validation of the skin lesion in the area of treatment).
Regarding Claim 7, Lind teaches a system for treating a skin lesion (abstract), comprising:
a tweezer comprising a treatment region (Figs. 1-8 & 10); and an activation station comprising a base portion and a loading portion (combination of canister cap 205/52 and nozzle unit 207 seen separated in Figs. 4-5 and assembled in Figs. 1-8, 10, [0061]-[0064] wherein the tweezer is inserted into the canister cap through the opening 210 here interpreted to be the loading region and all the way down to the end where nozzle 207 is (the round section in Fig. 5) here interpreted to be the base portion as in Figs. 1-8, 10); wherein the base portion and the loading portion collectively form a receiving chamber that facilitates localization of the cryogenic agent onto the treatment region of the tweezer upon injection of the cryogenic agent into the activation station (Figs. 1-8 and 10 and [0057]-[0064]) and wherein the base portion comprises a loading stage configured to substantially conform to the shape of the tweezer when the tweezer is rested thereon (as best understood in view of the 112 rejections above, the base section has a rounded wall (tweezer guides 216) here interpreted to be the loading stage which is configured to substantially conform to the shape of the treatment region of the tweezer when the tweezer is rested thereon (see Figs. 2, 7 and 10), the activation station comprises a first receiving end and a second receiving end (distal/proximal ends of canister 205/52 in Figs. 1-8, 10), wherein the activation station is configured to receive the tweezer at the first receiving end (distal end of cap 205/52 including tweezer opening guides 210 best seen in Fig. 4), and wherein the activation station is configured to receive the cryogenic agent at the second receiving end (nozzle outlet 208 best seen in Figs. 7 and [0064]), the first receiving end being fluidly coupled to the second receiving end to facilitate delivery of the cryogenic agent to the treatment region of the tweezer ([0018], [0055]-[0065] and [0069]-[0070]).
Regarding Claim 9, Lind teaches wherein the base portion (the round section in Fig. 5) and the loading portion (section 210 in Fig. 4) are separate components that are mechanically coupled together to form the activation station (Figs. 1-8, 10 and [0061]-[0064]).
Regarding Claim 10, Lind teaches wherein the base portion (the round section in Fig. 5) further comprises a shield element (tweezer guides 216) and a conical element (nozzle 208, shown in Fig. 10 to be conical) both protruding from the loading stage (Fig. 5), and wherein the loading stage, the conical element, the shield element, and the loading portion collectively form a receiving chamber that facilitates localization of the cryogenic agent onto the treatment region of the tweezer when resting on the loading stage upon injection of the cryogenic agent into the activation station (Fig. 10 and [0056]-[0070]).
Regarding Claim 11, Lind teaches further comprising a container 206/50 comprising the cryogenic agent ([0057], [0061] and [0069]).
Regarding Claim 12, Lind teaches wherein the cryogenic agent comprises dimethyl ether, liquid nitrogen, or nitrous oxide ([0061]).
Regarding Claim 13, Lind teaches wherein the second receiving end comprises one or more protrusions (one way valve 54 or 62 or release valve 218 which when the tweezers arms are inserted engage and release cryogenic fluid from the canister to the applicator buds) configured to engage with and actuate the container 206/50 when an actuatable portion of the container is inserted into the second receiving end of the activation station (Figs. 1-8, 10 and “depressing the nozzle unit 207. The pressurized refrigerant 214 then flows through the release valve 218 and through the nozzle outlets 208. The absorbent buds 201 are thereby saturated with refrigerant 214” in [0064] and “In order to apply Cryogenic matter to the applicator buds, the tweezer arms are inserted in the canister cap 52 that is deployed on pressurized canister 50 that contains the cryogenic matter. Once the tweezer arms are inserted into the canister cap, one-way valve 54 is operated thereby allowing cryogenic matter to enter the dosing chamber 60 which is designed to hold a predetermined dose of the cryogenic matter. When the dosing chamber is filled, one-way valve 62 is operated so as to direct the cryogenic matter onto the applicator buds, thereby saturating them with the cryogenic matter” [0069]).
Regarding Claim 14, Lind teaches a tweezer (Figs. 1-10 and 25) comprising:
an articulating region to actuate the tweezer (arms 212a/212b in Figs. 1-8, 10, best shown in Fig. 8 disclosed in [0056] & [0067], section 4/5 in Fig. 9 and closure grips 172a/172b in Fig. 25 disclosed in [0087]); and
a treatment region, the treatment region comprising: a pair of absorbent pads (14/15, 64/65, 201, 170a/170b in various figures 1-10 & 25) forming tips of the tweezer and suitable for absorbing a cryogenic agent, each of the absorbent pads having an inward-facing surface and an outward-facing surface ([0010], [0018], [0025], [0055], [0064], [0068] and [0087]); and
for each absorbent pad 201, a pair of substantially flat treatment shields extending along opposing edges of the absorbent pad (each tweezer arm 212a/212b includes side walls, tip section 212at/212bt and an outer section wherein once closed about a target area only the interior faces 212af/212bf allow passage of the cryogen and treatment at that area thus the side walls and the outer section are here interpreted to be shields configured to protect the collateral skin tissue during the cryogenic treatment. At least two of side walls or a side wall and a tip section are here interpreted to be a pair of substantially flat treatment shields extending along opposing edges of the absorbent pad, see Figs. 2-3 and 7-11), the treatment shields shaped to allow contact of the inward-facing surface of the absorbent pad 212af/212bf and limit contact of the outward-facing surface of the absorbent pad during skin treatment (inward-facing exposed sections of pads demonstrated as 212af/212bf in Fig. 8, interior faces 14/15 in Fig. 9 are configured to directly touch the skin tag for treatment while “the tweezer arms protect the collateral skin tissue during the cryogenic treatment” [0056], see Figs. 2-3 and 7-11).
Regarding Claim 15, Lind teaches wherein the absorbent pads each comprise a foam material ([0068]).
Regarding Claim 16, Lind teaches wherein each of the pair of treatment shields is formed integrally with the tweezer (see Figs. 2-3 and 7-11, “the tweezer arms protect the collateral skin tissue during the cryogenic treatment” [0056]; thereby the arms themselves, specifically the sides and tip are interpreted to be the shields which are integral with the tweezer itself).
Regarding Claim 17, Lind teaches further comprising: for each pair of treatment shields, a stabilizer bridge (the back side of the arms that are attached to the sides of the tweezer arms) affixed therebetween to substantially cover the outward-facing surface of the respective absorbent pad (the opposite outwardly facing of the pads are shielded within the squeezer arms distal ends of 212a/212b in Fig. 8, section 4/5 in Fig. 9, “the tweezer arms protect the collateral skin tissue during the cryogenic treatment” [0056]; thereby the arms including the sides and the oppositive back side are interpreted to be the shields, see Figs. 2-3 and 7-11).
Regarding Claim 18, Lind teaches wherein the absorbent pads comprise absorbed cryogenic agent ([0059], [0063]-[0064]).
Regarding Claim 19, Lind teaches a kit (Figs. 1-10 show a pressurized canister 206/50 that contains cryogenic matter, a canister cap 205/52 coupled to the canister comprising tweezer opening guides 210 through which a tweezer 203/203a may be inserted, all of which is here interpreted to be a kit) comprising the tweezer 203/203a of claim 14 (see the rejection of claim 14 above), and an activation station 205/52 configured to facilitate delivery of a cryogenic agent to the treatment region of the tweezer when the tweezer is inserted therein (canister cap 205/52 shown in Figs. 1-10, see [0057] & [0069]-[0070]).
Regarding Claim 20, Lind teaches further comprising a container 206/50 comprising the cryogenic agent ([0057]-[0061] and [0069], also see Figs. 1-10).
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.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lind as applied above, in view of McDow (US Patent No. 5,516,505).
Regarding Claim 4, Lind teaches the invention as applied above, but does not specifically teach wherein the predetermined treatment time is from about 10 seconds to about 50 seconds.
In the same field of invention, McDow teaches “the suitable length of time employed for introducing the cryogenic agent from the synthetic plastic foam applicator onto the skin lesion surface can vary widely depending, at least in part, upon the type of skin lesion, its size and thickness, it has been found that a period of from about 20 to about 35 seconds is generally suitable for epithelial skin lesions that are benign” in Col. 5, ll. 20-26.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to treat the tissue with the applicators for about 20-35 seconds (which lie in the range claimed) in order to sufficiently permit cryogenic agent to reduce the temperature of the skin lesion tissue to a temperature to freeze the skin for best results as McDow teaches.
Regarding Claim 5, Lind teaches the invention as applied above, but is silent in teaching wherein each step of the method are performed sequentially for a total of one, two, or three or more treatments.
In the same field of invention, McDow teaches “it is often desirable and highly beneficial that after permitting the skin lesion to thaw completely after removing the synthetic plastic foam applicator, to sequentially repeat the method. Such repetition of freeze-thaw cycles promotes increased cellular destruction and thus improved removal of skin lesions” in Col. 5, ll. 14-19.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to sequentially repeat the method steps claimed in order to improve treatment and removal of the skin lesion/tag.
Regarding Claim 6, Lind in view of McDow teaches wherein subsequent treatments are performed no less than about 10 seconds to about 20 seconds after a prior treatment (McDow teaches “permitting the frozen skin tissue of the skin lesion to slowly thaw, preferably over a period of time that is at least about 40 to about 60 seconds” in Col. 3, ll. 29-31).
Response to Arguments
Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive.
Regarding independent claims 1 and 7, in view of the 112 rejections above and being unclear what is meant by "the base portion comprises a loading stage configured to substantially conform to the shape of the tweezer when the tweezer is rested thereon" examiner takes the position that as best understood, it refers to the base having a shape to enclose at least the treatment section of the tweezer. Based on that interpretation, Lind teaches the claimed invention as applied above and applicant’s arguments are not found persuasive.
Regarding independent claims 14 and 19, applicant’s arguments on the grounds that “Lind does not teach or disclose each absorbent pad being disposed between a pair of substantially flat treatment shields that extend along opposing edges of the absorbent pad. The Office Action alleges that the sides of Lind's tweezer arms (distal ends of 212a/212b, section 4/5, and grips 172a/172b) correspond to the claimed "treatment shields." … where each absorbent pad is "disposed between" a pair of treatment shields that extend along opposing edges of each absorbent pad. In Lind, the tweezer arms themselves house the absorbent buds; there are no discrete treatment shields between which each absorbent pad is disposed, nor are the treatment shields "substantially flat" in shape.” Examiner respectfully disagrees and maintains that given the broadest reasonable interpretation, by each tweezer arm housing each pad 201 of Lind’s invention, each pad is interpreted to be disposed between at least the side walls of each tweezer arm, especially in view of claim 16 of the current application claiming “wherein each of the pair of treatment shields is formed integrally with the tweezer”. Moreover, each side wall has a flat cross-section and thus interpreted to be substantially flat. Lind specifically teaches “the tweezer arms protect the collateral skin tissue during the cryogenic treatment” [0056] therefore, the purpose of the design of the sidewalls are to act as shields protecting the surrounding tissue, thus applicant’s arguments are not found persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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, Linda Dvorak can be reached on (571) 272-4764. 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.
/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
Prosecution Insights