DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 3-10, 12-20 are pending.
This action is Final.
Claim Objections
Claims 1, 10 are objected to because of the following informalities: Claim 1 line 5 “the severity” should read “a severity”; Claim 10 line 10 “the severity” should read “a severity”. Appropriate correction is required.
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.
Claims 1, 3-10, 12-20 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 claims 1 and 10, the limitations (claim 1 representative) recite the limitations
“wherein, the rating indicator in the indicator selection and assignment device comprises any one of the following:
(1) a size, a hypertrophy and a color:
(2) a size, a hypertrophy, a color and a number of nodules and/or a location;”
which renders the claims indefinite. First, it is not clear what constitutes the “any one of the following”. Is this in reference to any of the factors listed in either 1 or 2, or is it all of 1 and/or all of 2 as being the rating indicator? Second, it is not clear whether the duplicate terms are the same or different, such that it is unclear which is being further limited in the claim. If these are separate terms then a delineation such as first and second needs to be used or the second instance should refer to the same term by way of “the” or “said”. Lastly, the lack of punctuation and conjunctions between selection groups makes the claims unclear what constitutes the broadest claim for indicator from the any one of the following. For example, after (1) there is no usage of “and”, “or”, “and/or”; in (2), there is an “and…and/or” which makes it unclear what is required and what is an alternative in the groups. In addition, For claim 1, the claim is not clear how each of these results in “a value” where more than one is selected such as all of 1 or all of 2. It seems more likely that “a value” should be “at least one value” or “values” like in claim 12. For these reasons the metes and bounds of the claims are unclear which renders the claims indefinite.
Regarding claims 1 and 10, the limitations “one or more areas to be examined…the area to be examined is a region…the area to be examined” renders the claims indefinite. It is not clear whether these features are the same or different which makes the metes and bounds of the claims unclear. The original instance is to one or more areas, it is not clear that “the area” is the same scope for each instance as the claims never set out that the one or more areas means an area or an area of the one or more areas is limited. Additionally, each reference in a dependent claim is not clear if this is in reference to the “one or more areas to be examined” or to “the area” which instance is being further limited for “the area”. It is suggested to amend the limitations to more clearly set forth what is meant to be claimed and to carry forth the same claim language throughout all the claims.
Further regarding claims 1 and 10, the limitations “that contain or is suspected to contain a focus of port-wine stains…” renders the claims indefinite. It is not clear what is meant by “suspected to contain” in relations to the remaining limitations as all further functions appear to be only dependent on “contain” contingency for focus of port wine stains. Thus, it is not clear what steps must be completed for the “suspected” contingency. As such, the metes and bounds of the claim are not clear which renders the claims indefinite. For examination purposes, the limitation “contain or suspected to contain” is treated as a contingent limitation which means images with or images without such stains, wherein further processing is only afforded to the “with” contingency and thus the steps are not required to be completed. If this is not applicant intention, then the remaining elements of the claim should be amended to make clear that each of this clauses is present for each of the recited steps; for example in claim 10 P2 should read as following if such is desired “P2: performing a numerical quantitative assignment of at least one indicator of the skin of a site of the focus [[of ]]containing or suspected to containing the port wine stains defined in P1”.
Regarding claim 3, the limitations of “a value…a value…the value of the interval (Sv) is 0 or more…the value…the value…the value…the value…” renders the claim indefinite. This is a further issue of the independent claim as raised above (“For claim 1, the claim is not clear how each of these results in “a value” where more than one is selected such as all of 1 or all of 2. It seems more likely that “a value” should be “at least one value” or “values” like in claim 12. For these reasons the metes and bounds of the claims are unclear which renders the claims indefinite.”). How can the value be more than 1 value in the situation where all of 1 or all of 2 is the rating indicator? The rules set forth in claim 3 do not explain how the value includes all three.
Further in claim 3, is “a percentage” the same or different from “a region percentage” of claim 1? For these reasons the metes and bounds of the claim are unclear which renders the claim indefinite.
Further, regarding claim 3 “a skin surface of a healthy site of the area to be examined” is not clear if this is the same or different from the like terms of claim 1. This makes the metes and bounds of the claim unclear which renders the claim indefinite.
Further regarding claim 3, the limitation a body of the rating subject is unclear if this is the same or different from the amendment to claim 1 which added “the rating subject’s body”. This makes the metes and bounds of the claim unclear which renders the claim indefinite.
Regarding claim 4, based on the amendments to claim 3, it is not clear what is meant by the definitions in view of the requirements of claim 3. For example, claim 3 states when SV is 0 the percentage is 0, and when SV is max it is 100%, but claim 4 states when SV is 0 the percentage is now a range from 0 to 20. It does not seem that this can occur for the definitions being set forth for the scope being limited and then broadened.
Claim 5 recites the limitation "the lowest level" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 7, the phrase “more preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 recites the limitation "the clinical efficacy" in P4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12, the limitations of “values…the value of the interval (Sv) is 0 or more…the value…the value…the value…the value…a value” renders the claim indefinite. It is not clear if all reference are to the same terms or different terms. Are each “the value” subsets from the original “values” set forth? How does the last “a value” fit in with this frame work? For these reasons the metes and bounds of the claim are unclear which renders the claim indefinite.
Further in claim 12, is “a percentage” the same or different from “a region percentage” of claim 10? For these reasons the metes and bounds of the claim are unclear which renders the claim indefinite.
Regarding claim 13, based on the amendments to claim 12, it is not clear what is meant by the definitions in view of the requirements of claim 12. For example, claim 12 states when SV is 0 the percentage is 0, and when SV is max it is 100%, but claim 13 states when SV is 0 the percentage is now a range from 0 to 20. It does not seem that this can occur for the definitions being set forth for the scope being limited and then broadened.
The dependent claims are rejected for depending on a rejected claim.
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.
Claims 1, 3-10, 12-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 1:
selects a rating indicator for a divided rating range and assigns a value to the rating indicator (mathematical concepts, mental processes, certain methods of organizing human activity- rules for raters)
scores the severity of a port-wine stain focus, and rates the severity (mathematical concepts, mental processes, certain methods of organizing human activity- rules for raters)
score the severity of the port-wine stain focus (mathematical concepts, mental processes, certain methods of organizing human activity- rules for raters)
the division of the rating range refers to dividing one or more areas to be examined on skin of a rating subject, and the area to be examined is a region that is geometrically contiguous without overlapping and that contain or is suspected to contain a focus of a port-wine stain (mathematical concepts, mental processes, certain methods of organizing human activity- rules for raters);
wherein, the rating indicator comprises any one of the following:
(1) a size, a hypertrophy and a color:
(2) a size, a hypertrophy, a color and a number of nodules and/or a location;
wherein the size refers to a region percentage of the focus in the area to be examined:
the hypertrophy refers to a protruding degree of a skin surface of the focus relative to a skin surface of a healthy site in the area to be examined:
the color refers to a degree of color darkening of an epidermal layer of a site of the focus relative to an epidermal layer of the healthy site in the area to be examined;
the number of nodules refers to number of palpable localized and substantial skin lesions;
the location refers to a site where the focus is located on the rating subject’s body (mathematical concepts, mental processes, certain methods of organizing human activity- rules for raters)
Claim 10
P1: defining a rating range comprising one or more areas to be examined on skin of the rating subject, and the area to be examined is a region that is geometrically contiguous without overlapping and that contain or is suspected to contain a focus of port-wine stains (mathematical concepts, mental processes, certain methods of organizing human activity- rules for raters)
P2: performing a numerical quantitative assignment of at least one indicator of the skin of a site of the focus of the port-wine stains defined in P1 (mathematical concepts, mental processes, certain methods of organizing human activity- rules for raters)
P3: calculating numerical rating results of the severity of the port-wine stains in the area to be examined based on results of the quantitative assignment of the at least one indicator of the skin in P2 (mathematical concepts, mental processes, certain methods of organizing human activity- rules for raters)
P4: evaluating the clinical efficacy based on the numerical rating result (mathematical concepts, mental processes, certain methods of organizing human activity- rules for raters)
wherein, the at least one indicator in P2 comprises any one of the following:
(1) a size, a hypertrophy and a color:
(2) a size, a hypertrophy, a color and a number of nodules and/or a location;
wherein the size refers to a region percentage of the focus in the area to be examined; the hypertrophy refers to a protruding degree of a skin surface of the focus relative to a skin surface of a healthy site in the area to be examined; the color refers to a degree of color darkening of an epidermal layer of a site of the focus relative to an epidermal layer of the healthy site in the area to be examined; the number of nodules refers to number of palpable localized and substantial skin lesions; the location refers to a site where the focus is located on a body of the rating subject (mathematical concepts, mental processes, certain methods of organizing human activity- rules for raters)
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
Certain Methods Of Organizing Human Activity
managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
Claim 1:
an indicator selection and assignment device (computer structures used as tools)
an indicator processing device (computer structures used as tools)
a rating device (computer structures used as tools)
inputting the scoring result into the rating device, and the rating device outputs a rating result of the severity (insignificant pre and post solution activities of data input and data output of the processing structures)
Claim 10:
P0: obtaining an image of a patient suffering from port-wine stains by face-to-face diagnosis or by photo as a rating subject (data gathering, insignificant extra-solution)
outputting the numerical rating results through a rating module (insignificant extra solution activities)
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitation that is not directed to the abstract idea are the same as those identified above in step 2A. The computer structures cited above are claimed as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The additional limitations recited in the dependent claims are directed to further judicial exceptions, generic processor structures, and using further software modules to perform various functional limitations (A more specific abstraction is still an abstraction). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
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, 3-10, 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Madden et al. (Madden, US 2005/0033142).
Regarding claim 1, Madden teaches a severity rating system for port-wine stains comprising
an indicator selection and assignment device, an indicator processing device, and a rating device (see entire document, especially [0015] where these structures amount to lexicographic software of computer structures), wherein: the indicator selection and assignment device selects a rating indicator for a divided rating range and assigns a value to the rating indicator, the indicator processing device scores the severity of a port-wine stain focus, and the rating device rates the severity; wherein, the indicator processing module calls data in the indicator selection and assignment device to score the severity of the port-wine stain focus, followed by inputting the scoring result into the rating device, and the rating device outputs a rating result of the severity; the division of the rating range refers to dividing one or more areas to be examined on skin of a rating subject, and the area to be examined is a region that is geometrically contiguous without overlapping and that contain or is suspected to contain a focus of a port-wine stain; wherein, the rating indicator in the indicator selection and assignment device comprises any one of the following: (1) a size, a hypertrophy and a color: (2) a size, a hypertrophy, a color and a number of nodules and/or a location; wherein the size refers to a region percentage of the focus in the area to be examined: the hypertrophy refers to a protruding degree of a skin surface of the focus relative to a skin surface of a healthy site in the area to be examined; the color refers to a degree of color darkening of an epidermal layer of a site of the focus relative to an epidermal layer of the healthy site in the area to be examined; the number of nodules refers to number of palpable localized and substantial skin lesions; the location refers to a site where the focus is located on the rating subject’s body (see entire document, especially [0015] where these structures amount to intended use of the software/computer structures, hence the software and hardware are capable of being programed to achieve such functions).
Regarding claims 3-9, 17-19, the limitations are met by Madden as the limitations are to further software/hardware or to further limiting the intended use of the software/hardware, and as explained in the rejection of claim 1, in paragraph 15 of Madden these structures amount to intended use of the software/hardware, hence the software and hardware are capable of being programed to achieve such functions. Further structures of claims 8-9, 18-19 amount to input and output structures of the computer devices with intended use functions, which Madden computer structures are certainly capable of such (see [0015],[0043]).
Regarding claim 10, Madden teaches a rating method, comprising:
P0: obtaining an image of a patient suffering from port-wine stains by face-to-face diagnosis or by photo as a rating subject (see at least [0015], [0043]);
P1: defining a rating range comprising one or more areas to be examined on skin of a rating subject, and the area to be examined is a region that is geometrically contiguous without overlapping and that contain or is suspected to contain a focus of port-wine stains (see entire document, especially abstract, [0015], [0018]-[0019] Figures 2-4 where nevi are examined in defined image areas of photographs, and such could contain port-wine stains, but such also could not contain such stains and that contingency of any other navi monitored reads on the remaining claim elements of the method);
P2: performing a numerical quantitative assignment of at least one indicator of the skin of a site of the focus of the port-wine stains defined in P1; P3: calculating, numerical rating results of the severity of the port-wine stains in the area to be examined based on results of the quantitative assignment of the at least one indicator of the skin in P2, and outputting the numerical rating results through a rating module; P4: evaluating the clinical efficacy based on the numerical rating result wherein, the at least one indicator in P2 comprises any one of the following: (1) a size, a hypertrophy and a color; (2) a size, a hypertrophy, a color and a number of nodules and/or a location; wherein the size refers to a region percentage of the focus in the area to be examined; the hypertrophy refers to a protruding degree of a skin surface of the focus relative to a skin surface of a healthy site in the area to be examined; the color refers to a degree of color darkening of an epidermal layer of a site of the focus relative to an epidermal layer of the healthy site in the area to be examined; the number of nodules refers to number of palpable localized and substantial skin lesions; the location refers to a site where the focus is located on a body of the rating subject (see entire document, especially abstract, [0015], [0018]-[0019] Figures 2-4 where nevi are examined in defined image areas of photographs, and such could contain port-wine stains, but such also could not contain such stains and that contingency of any other navi monitored reads on the remaining claim elements of the method as the contingency is not required to be invoked due to the “may contain” limitation).
Regarding claims 12-14, 20 Madden teaches the limitations as these limitations further limit a contingent method step and as discussed in claim 10 rejection, such steps are not required due to the “suspected to contain” invoked limitation.
Regarding claim 15, Madden teaches a non-transitory computer-readable storage medium storing a computer program, wherein the computer program implements the rating method of claim 10 when executed by a processor (see entire document, especially [0015]).
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims filed 10/6/2025.
Applicant’s arguments regarding the claim objections have been fully considered and are partially persuasive due to the amendments to the claims; the objections are maintained as presented above.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112 have been fully considered and are partially persuasive due to the amendments to the claims. However, the amendments have not addressed all aspects of the rejections, and/or have necessitated new grounds of rejections.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered and are partially persuasive due to the amendments to the claims, but the amendments have necessitated new grounds of rejections under the Mayo/Alice analysis. Applicant’s arguments are that the inclusion of rules defining the scoring system being implemented on hardware are not a judicial exception. The examiner respectfully disagrees. The working definitions of the scoring are more details to the abstractions/exceptions being claimed but do not amount to significantly more than or a practical application of the claimed exceptions. the rejections are respectfully maintained as presented above.
Applicant’s arguments regarding the rejections of the claims in view of prior art have been fully considered but are not persuasive. The form of the device is still in an intended use form and thus computerized structures as cited in the art necessarily have the capabilities of the claimed system. For computerized products, the structures should be claimed in a manner that they are configured to perform functions should the functional limitations bear patentable weight. For the method, applicant’s amendments do not change the alternativeness of the features nor the contingency such created. A further amendment I suggested above if applicant wishes to bring weight to all the limitations after P2 where nevi are not present or suspected to be present. However, such suggested amendments are not an indication of allowable features as further search/consideration will be required. The rejections are respectfully maintained as presented above to account for the amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 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, Robert (Tse) Chen can be reached at (571)272-3672. 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.
/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791