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 .
Claim Rejections - 35 USC § 112
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.
Claim(s) 9-12, 15, 16, 18, 19 is/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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 9 and its dependents, claim 9 recites the limitation "wherein the boundary deriver comprises…a boundary deriver". It is unclear and thus indefinite how a boundary deriver comprises another boundary deriver and/or itself.
Claim 15 recites the limitation "the boundary deriver" in line 2. There is insufficient antecedent basis for this limitation in the claim. Note that claim 8 recites “a boundary deriver” but the instant claim dependency does not include claim 8.
Claim 16 recites the limitation "the boundary deriver" in line 2. There is insufficient antecedent basis for this limitation in the claim. Note that claim 8 recites “a boundary deriver” but the instant claim dependency does not include claim 8.
Claim 18 recites the limitation "the boundary deriver" in last line. There is insufficient antecedent basis for this limitation in the claim. Note that claim 8 recites “a boundary deriver” but the instant claim dependency does not include claim 8.
Claim 19 recites the limitation "the boundary deriver" in last line. There is insufficient antecedent basis for this limitation in the claim. Note that claim 8 recites “a boundary deriver” but the instant claim dependency does not include claim 8.
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.
Claim 19 is 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.
Claim 19 recites “when coagulation spots on the skin are spontaneously generated through the energy-based medical device”. However, a review of the instant disclosure does not reveal support for “spontaneously generated”. Since this is a new claim; this is new matter.
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.
Claim(s) 1-12 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-12 of copending Application No. 18/561217 (reference application); published as US 20250090084 A1; latest claim set filed 7/17/2024, in view of Johnson (US 20170296268 A1; 10/19/2017).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, Application No. 18/561217 teaches a skin procedure guidance and feedback system comprising:
a photographing unit configured to photograph skin before and after a procedure by an energy-based medical device (claim 1 “take captured images before and after a skin procedure through an energy-based medical device”);
a displacement calculator configured to derive landmark displacement data from landmark location data of the skin photographed by the photographing unit (claim 1 “displacement calculator”).
Application No. 18/561217 does not teach a procedure feedback unit configured to feed back optimal parameter information for the procedure based on the landmark displacement data. However, Johnson teaches in the same field of endeavor ([0002]) a procedure feedback unit configured to feed back optimal parameter information for the procedure based on the landmark displacement data (Fig. 1; [0040] “feedback…adjust the amount of energy delivered…”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Application No. 18/561217 to include this feature as taught by Johnson because this enables more precision in tissue treatment ([0003]).
Regarding claim 2, in the combination of Application No. 18/561217 and Johnson, Application No. 18/561217 teaches wherein the energy-based medical device is configured to:
apply energy to one focus of the skin to cause a local temperature rise, thereby generating a contraction zone based on the one focus of the skin (claim 2), and
include high-frequency, laser, and high-intensity focused ultrasound (HIFU) devices (claim 2).
Regarding claim 3, in the combination of Application No. 18/561217 and Johnson, Application No. 18/561217 teaches wherein the photographing unit photographs a skin surface before the procedure and a skin surface after the procedure based on the energy-based medical device (claim 1 “take captured images before and after a skin procedure through an energy-based medical device”).
Regarding claim 4, in the combination of Application No. 18/561217 and Johnson, Application No. 18/561217 teaches wherein landmarks of the skin comprise dots or lines marked with pigment, and sweat glands, hair glands, sebaceous glands, pigmented lesions, moles, skin tumors, blood vessels, and wrinkle lines on a skin surface as reference points enabling tracking of positional change of a skin procedure target part before and after the procedure in the photographed images before and after the skin procedure through the energy-based medical device (claim 3).
Regarding claim 5, in the combination of Application No. 18/561217 and Johnson, Application No. 18/561217 teaches wherein the displacement calculator comprises:
a preprocessor (claim 1 “preprocessor”) configured to collect location data of landmarks before the skin procedure on a skin surface in an image of the skin surface before the skin procedure (claim 4) and location data of landmarks after the skin procedure on the skin surface in an image of the skin surface after the procedure (claim 4); and
a displacement data calculator (claim 1 “displacement calculator”) configured to calculate, as the landmark displacement data, a displacement vector reflecting a result of movement from location data before the skin procedure to location data after the procedure based on the landmark location data of the skin derived by the preprocessor (claim 6).
Regarding claim 6, in the combination of Application No. 18/561217 and Johnson, Application No. 18/561217 teaches derive the landmark displacement data by comparing the location data of landmarks before the skin procedure and the location data of landmarks after the skin procedure (claim 5).
Regarding claim 7, in the combination of Application No. 18/561217 and Johnson, Application No. 18/561217 teaches the displacement calculator is configured to:
to derive location data of a contraction center based on the landmark displacement data (claim 7).
Regarding claim 8, in the combination of Application No. 18/561217 and Johnson, Application No. 18/561217 teaches a boundary deriver configured to derive a boundary of a contraction zone from the contraction center in the skin procedure (claim 8).
Regarding claim 9, in the combination of Application No. 18/561217 and Johnson, Application No. 18/561217 teaches wherein the boundary deriver comprises:
a graph deriver configured to derive a displacement graph of the landmark displacement data (claim 9); and
a boundary deriver configured to calculate a distance from the contraction center to the boundary of the contraction zone based on graph analysis result data derived by the graph deriver (claim 9).
Regarding claim 10, in the combination of Application No. 18/561217 and Johnson, Application No. 18/561217 teaches wherein the boundary deriver is configured to:
derive a graph representing the magnitude of displacement vectors of the landmark according to positions of the displacement vectors (claim 10).
Regarding claim 11, in the combination of Application No. 18/561217 and Johnson, Application No. 18/561217 teaches wherein the boundary deriver is configured to:
derive a graph representing the magnitude of displacement vectors of the landmark according to the positions of the displacement vectors based on the direction of the displacement vectors relative to the contraction center (claim 11).
Regarding claim 12, in the combination of Application No. 18/561217 and Johnson, Application No. 18/561217 teaches wherein the boundary deriver is configured to:
derive a graph of a regression curve based on the landmark displacement data (claim 12); and
calculate a distance from the contraction center to the boundary of the contraction zone from the captured image before the procedure based on a fact that the distance is close to a distance from the contraction center to a point where a slope of a tangent becomes 0 on the regression curve (claim 12).
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.
Claim(s) 1, 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eggers (US 20080097558 A1; 4/24/2008) in view of Johnson (US 20170296268 A1; 10/19/2017).
Regarding claim 1, Eggers teaches a skin procedure guidance and feedback system (Abstract; Fig. 34A) comprising:
a photographing unit configured to photograph skin before and after a procedure by an energy-based medical device (Fig. 34B, 790; Fig. 34C, 794; Fig. 34H, 1010; [0221] “starting pattern of visible indicia at the skin region for evaluating a percentage of shrinkage…digitally imaged to provide a pattern reference”; [0227] “ending indicia pattern may be digitally imaged such that average lineal shrinkage can be computed”);
a displacement calculator (Fig. 27; [0127]) configured to derive landmark displacement data from landmark location data of the skin photographed by the photographing unit (Fig. 34B, 790; Fig. 34C, 794; Fig. 34H, 1010; [0221] “starting pattern of visible indicia at the skin region for evaluating a percentage of shrinkage…digitally imaged to provide a pattern reference”; [0227] “ending indicia pattern may be digitally imaged such that average lineal shrinkage can be computed”).
Eggers does not teach a procedure feedback unit configured to feed back optimal parameter information for the procedure based on the landmark displacement data. However, Johnson teaches in the same field of endeavor ([0002]; [0037]-[0038]) a procedure feedback unit configured to feed back optimal parameter information for the procedure based on the landmark displacement data (Fig. 1; [0040] “feedback…adjust the amount of energy delivered…”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Eggers to include this feature as taught by Johnson because this enables more precision in tissue treatment ([0003]).
Regarding claim 3, in the combination of Eggers and Johnson, Eggers teaches wherein the photographing unit photographs a skin surface before the procedure and a skin surface after the procedure based on the energy-based medical device (Fig. 34B, 790; Fig. 34C, 794; Fig. 34H, 1010; [0221] “starting pattern of visible indicia at the skin region for evaluating a percentage of shrinkage…digitally imaged to provide a pattern reference”; [0227] “ending indicia pattern may be digitally imaged such that average lineal shrinkage can be computed”).
Regarding claim 4, in the combination of Eggers and Johnson, Eggers teaches wherein landmarks of the skin comprise dots or lines marked with pigment (Fig. 31; [0180]; Fig. 34B, 790; Fig. 34C, 794; Fig. 34H, 1010; [0221] “starting pattern of visible indicia at the skin region for evaluating a percentage of shrinkage…digitally imaged to provide a pattern reference”; [0227] “ending indicia pattern may be digitally imaged such that average lineal shrinkage can be computed”), and sweat glands, hair glands, sebaceous glands, pigmented lesions, moles, skin tumors, blood vessels, and wrinkle lines on a skin surface as reference points enabling tracking of positional change of a skin procedure target part before and after the procedure in the photographed images before and after the skin procedure through the energy-based medical device ([0221]; [0227]).
Regarding claim 5, the combination of Eggers and Johnson teaches wherein the displacement calculator comprises:
a preprocessor (Eggers Fig. 27; [0127]; Johnson Fig. 1; [0013]-[0014]) configured to collect location data of landmarks before the skin procedure on a skin surface in an image of the skin surface before the skin procedure and location data of landmarks after the skin procedure on the skin surface in an image of the skin surface after the procedure (Eggers Fig. 34B, 790; Fig. 34C, 794; Fig. 34H, 1010; [0221]; [0227]; Johnson [0013]-[0014]; [0037]-[0038]; [0048]); and
a displacement data calculator (Eggers Fig. 27; [0127]; Johnson Fig. 1; [0013]-[0014]) configured to calculate, as the landmark displacement data, a displacement vector reflecting a result of movement from location data before the skin procedure to location data after the procedure based on the landmark location data of the skin derived by the preprocessor (Johnson [0031] “vector”; [0037]-[0038]).
Regarding claim 6, the combination of Eggers and Johnson teaches derive the landmark displacement data by comparing the location data of landmarks before the skin procedure and the location data of landmarks after the skin procedure (Eggers Fig. 34B, 790; Fig. 34C, 794; Fig. 34H, 1010; [0221]; [0227]; Johnson [0013]-[0014]; [0031]; [0037]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eggers and Johnson as applied to claim 1 above, in view of Anderson (US 20020161357 A1; 10/31/2002), and further in view of Lau (US 20080125771 A1; 5/29/2008).
Regarding claim 2, the combination of Eggers and Johnson does not teach wherein the energy-based medical device is configured to:
apply energy to one focus of the skin to cause a local temperature rise, thereby generating a contraction zone based on the one focus of the skin. Note that Eggers and Johnson teaches wherein the energy-based medical device is configured to: apply energy to generate local temperature rise on skin thereby generating contraction zone (Eggers Fig. 2-3; [0227] “shrinkage”). However, Anderson teaches in the same field of endeavor (Fig. 22A; [0004]; [0052] “feedback”) apply energy to one focus of the skin to cause a local temperature rise, thereby generating a contraction zone based on the one focus of the skin (Fig. 22A-22B; [0056]; [0057] “a bump in the skin occurs when collagen is heated, the bump resulting from contraction of the collagen”; [0058] “collagen shrinkage”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Eggers and Johnson to include this feature as taught by Anderson because this enables treatment of skin for improved aesthetics ([0057]-[0058]).
The combination of Eggers, Johnson, and Anderson teaches include high-frequency (Eggers [0062] “radiofrequency energy”; Johnson [0043] “radiofrequency energy, microwave energy”; Anderson [0034]), laser (Eggers [0230] “laser therapy”; Johnson [0043] “laser”; Anderson [0034]).
The combination of Eggers, Johnson, and Anderson does not explicitly teach high-intensity focused ultrasound (HIFU) devices. Note that the combination of Eggers, Johnson, and Anderson teaches focused ultrasound (Johnson [0043] “focused ultrasound”; Anderson [0034]). However, Lau teaches in the same field of endeavor (Abstract; [0004]; [0050]; claim 16) high-intensity focused ultrasound (HIFU) devices ([0004]; [0018]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Eggers, Johnson, and Anderson to include this feature as taught by Lau because this enables treating tissue to achieve desired shrinkage ([0004]; [0018]).
Allowable Subject Matter with respect to 102/103
Claims 7-19 would be allowable with respect to prior art under 102/103.
Thus, claims 13-14, 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The other claims discussed in this section have other rejections such as double patenting and 112 as detailed above.
Regarding claim 7 and its dependents, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 7 when taken as a whole, comprising, in addition to the other recited claim elements, to derive location data of a contraction center based on the landmark displacement data.
The closest prior art of record for this limitation, Anderson (US 20020161357 A1; 10/31/2002), teaches [0057] “a bump in the skin occurs when collagen is heated, the bump resulting from contraction of the collagen”; [0058] “collagen shrinkage” and Johnson (US 20170296268 A1; 10/19/2017) teaches predicting and tracking contraction points of tissue (Fig. 1; [0031]; [0037]-[0040]) but the prior art of record does not teach/suggest the limitation as recited.
Regarding claim 13 and its dependents, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 13 when taken as a whole, comprising, in addition to the other recited claim elements (from claim 1), wherein the parameter information comprises locations of coagulation spots generated by the energy-based medical device, an arrangement of the coagulation spots and an output of the energy-based medical device.
Eggers (US 20080097558 A1; 4/24/2008) in view of Johnson (US 20170296268 A1; 10/19/2017) as discussed above regarding claim 1 teaches delivering feedback based on displacement data from photographs but does not teach the specific optimal parameters as recited. Johnson teaches [0040] “adjust the amount of energy delivered” which would read on “output of the energy-based medical device” but does not teach the other parameter information of locations and arrangement of coagulation spots.
Liu (US 20120226268 A1; 9/6/2012) teaches fractional photothermolysis of skin using laser (Fig. 9; [0006]; [0009]; [0013]) for skin tightening ([0010]) with displacement sensors which can be in the form of optical sensors to track and control the treatment as the device is moved across the skin surface (Fig. 1; Fig. 8A-8B; Fig. 43; [0295]-[0297]; [0354]-[0356]). However, Liu does not teach the feedback based on landmark displacement data is “the parameter information comprises locations of coagulation spots generated by the energy-based medical device, an arrangement of the coagulation spots and an output of the energy-based medical device” as recited.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792