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 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.
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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the collection and analyzing of data. More specifically, independent claim 1 and dependents are directed to the mental process (i.e. abstract idea) of collecting and processing displacement data from images of skin landmarks before and after a skin procedure through an energy-based medical device.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim(s) to a process, machine, manufacture or composition of matter?
Yes, independent claim 1 and dependents are to a machine (device).
Step 2A (Prong 1): Does the claim(s) recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claim(s) recite an abstract idea of data collection and usage. The steps of data collection and usage carried out in Applicant's claims are akin to a mental process because they are the type of calculations that could theoretically be carried out mentally, but are merely implemented using generic collection technology. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology; please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016).
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claim(s) does not recite additional elements that integrate the judicial exception into a practical application because the claim(s) merely use preprocessor configured to take captured images(s) to collect data with already well-known technology. The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TIJ Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
It is further noted that merely collecting the necessary data using known, generic sensors (or other data gathering components) only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g). The fundamental data collection and processing steps performed by Applicant's claimed invention could theoretically be carried out manually by a person. Applicant's claimed invention does not affect/change the functionality of the technology being used. Rather, Applicant's claimed invention uses the claimed technology for its standard, well-known purpose, e.g. known sensors are used to collect data which they are known to be capable of collecting, known generic processing circuitry is used to perform data calculations/ comparisons, etc. Applicant's invention does not result in improved performance of the sensors, the processing circuitry, etc.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, in addition to the relevant discussion in Step 2A (Prong 2) above, please note, as explained in MPEP § 2106.05(I) (A), limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception include those listed therein.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements are well- known, routinely-used generic devices/technologies.
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. 18/561229 (reference application); published as US 20250072965 A1; latest claim set filed 7/17/2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claim(s) is/are broader than the corresponding claim(s) in the reference application and thus the corresponding claim(s) is/are a species of the more generic instant claim(s). It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Furthermore, they are not patentably distinct from each other because the instant application claim(s) overlap in scope with and are anticipated and/or obvious over the reference claim(s).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, Application No. 18/561229 teaches a device factor calculation system based on skin surface displacement comprising:
a preprocessor (claim 5 “preprocessor”) configured to take captured images before and after a skin procedure through an energy-based medical device as input to preprocess landmarks of skin as location data in the captured images before and after the skin procedure (claim 1 “before and after”; claim 3); and
a displacement calculator configured to derive landmark displacement data from landmark location data of the skin derived by the preprocessor (claim 1 “displacement calculator”).
Regarding claim 2, Application No. 18/561229 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, Application No. 18/561229 teaches wherein the 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 captured images before and after the skin procedure through the energy-based medical device (claim 4).
Regarding claim 4, Application No. 18/561229 teaches wherein the preprocessor is configured to:
collect location data of land marks before the skin procedure on a skin surface in the captured image before the skin procedure (claim 5); and
collect location data of landmarks after the skin procedure on the skin surface in the captured image after the skin procedure as locations of the landmarks before the skin procedure on the skin surface become closer to a contraction center by the skin procedure (claim 5; claim 7).
Regarding claim 5, Application No. 18/561229 teaches wherein the displacement calculator is configured to:
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 6).
Regarding claim 6, Application No. 18/561229 teaches the displacement calculator calculates, 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 (claim 5).
Regarding claim 7, Application No. 18/561229 teaches wherein 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, Application No. 18/561229 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, Application No. 18/561229 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 R 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, Application No. 18/561229 teaches wherein the graph deriver is configured to:
derive a graph representing the magnitude of displacement vectors of the landmark according to the position of the displacement vectors (claim 10).
Regarding claim 11, Application No. 18/561229 teaches wherein the graph deriver is configured to:
derive a graph representing the magnitude of displacement vectors of the landmark according to the position of the displacement vectors based on the direction of the displacement vectors relative to the contraction center (claim 11).
Regarding claim 12, Application No. 18/561229 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 § 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 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.
Claim(s) 1, 3-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eggers (US 20080097558 A1; 4/24/2008).
Regarding claim 1, Eggers teaches a device factor calculation system based on skin surface displacement (Abstract; Fig. 34A) comprising:
a preprocessor (Fig. 27; [0127]) configured to take captured images before and after a skin procedure through an energy-based medical device as input to preprocess landmarks of skin as location data in the captured images before and after the skin procedure (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
a displacement calculator (Fig. 27; [0127]) configured to derive landmark displacement data from landmark location data of the skin derived by the preprocessor (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 3, Eggers teaches wherein the 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 captured images before and after the skin procedure through the energy-based medical device ([0221]; [0227]).
Regarding claim 4, Eggers teaches wherein the preprocessor (Fig. 27; [0127]) is configured to:
collect location data of land marks before the skin procedure on a skin surface in the captured image before the skin procedure (Fig. 34B, 790; Fig. 34C, 794; Fig. 34H, 1010; [0221]; [0227]); and
collect location data of landmarks after the skin procedure on the skin surface in the captured image after the skin procedure as locations of the landmarks before the skin procedure on the skin surface become closer to a contraction center by the skin procedure (Fig. 34B, 790; Fig. 34C, 794; Fig. 34H, 1010; [0221]; [0227]; the reference is teaching measuring shrinkage as a result of the skin treatment, while the reference does not explitly teach the landmarks become closer to a contraction center, this an inherent result of the method step of applying the skin procedure; Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex Parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993)).
Regarding claim 5, Eggers teaches wherein the displacement calculator is configured to:
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]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eggers 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, Eggers 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 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 to include this feature as taught by Anderson because this enables treatment of skin for improved aesthetics ([0057]-[0058]).
The combination of Eggers and Anderson teaches include high-frequency (Eggers [0062] “radiofrequency energy”; Anderson [0034]), laser (Eggers [0230] “laser therapy”; Anderson [0034]).
The combination of Eggers and Anderson does not explicitly teach high-intensity focused ultrasound (HIFU) devices. Note that the combination of Eggers and Anderson teaches 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 and Anderson to include this feature as taught by Lau because this enables treating tissue to achieve desired shrinkage ([0004]; [0018]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eggers as applied to claim 1 above, in view of Johnson (US 20170296268 A1; 10/19/2017).
Regarding claim 6, Eggers does not teach the displacement calculator calculates, 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. However, Johnson teaches in the same field of endeavor ([0002]; [0037]-[0038]) teach the displacement calculator calculates, 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 ([0031] “vector”; [0037]-[0038]). 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]).
Allowable Subject Matter with respect to 102/103
Claims 7-12 would be allowable with respect to prior art under 102/103. However, these claims have other rejections 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.
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