DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group II (claims 10-15) in the reply filed on June 23, 2026, is acknowledged.
Response to Amendment
Applicant’s amendment filed June 23, 2026, has been entered in full. Claims 1-9 are cancelled. Claim 14 is amended. New claims 16-25 are added. Accordingly, claims 10-25 are now pending.
Claim Objections
Claim(s) 10 is/are objected to because of the following informalities:
In claim 10, eighth line, “the” should be inserted after “analyzing” and before “at least two healthy images”
Appropriate correction is required.
Claim Interpretation
Claims are given their broadest reasonable interpretation (BRI) during examination. MPEP 2111. Under BRI, the words of a claim are given their plain meaning, unless such meaning is inconsistent with the specification. MPEP 2111.01, Subsection I. The plain meaning of a term is the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. Id.
Claim 13 recites “a coordinate” at the last line. The ordinary and customary meaning of a “coordinate” is a distance along an axis from an origin of a coordinate system. A position in multi-dimensional space is defined by a set of plural coordinates. For example, a position in three-dimensional space may be defined as
(
x
,
y
,
z
)
,
x
being a coordinate,
y
being a coordinate, and
z
also being a coordinate. Under the ordinary and customary meaning, the singular “coordinate” would refer to only one of
x
,
y
, or
z
.
However, such a plain meaning would be inconsistent with the specification. For example, consider par. [0045] of the specification (as published), which is reproduced below:
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This clearly indicates that the singular “coordinate” is meant to include a set of plural lengths along plural axes of a coordinate system (i.e., plural “coordinates” in the conventional sense). I.e., as used in the specification, the singular “coordinate” includes all measurements needed to define a position in space, such as
(
x
,
y
,
z
)
in the example given above. This is the meaning of “coordinate” under BRI.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
the “cross-section detection device” of claim 10,
the “interpretation module” in claims 22-23, and
the “guiding module” in claim 24.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Examiner notes that the corresponding structure for the “guiding module” of claim 24 includes guiding module 30 illustrated in Figs. 3-4 and described at par. [0054] et seq. of the specification (as published).
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 10-25 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.
As explained below, claims 10-25 include at least one means-plus-function limitation that has been found to be indefinite under 35 U.S.C. 112(b) based on failure of the specification to disclose corresponding structure, material or act that performs the entire claimed function. Such limitations also lack adequate written description. See MPEP 2181, Subsection IV.
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 10-25 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 10 recites “scoping an outline” at line 8. It is unclear what is meant by this phrase and the resulting ambiguity renders the claim indefinite.
Claims are given their broadest reasonable interpretation (BRI) during examination. MPEP 2111. Under BRI, the words of a claim are given their plain meaning, unless such meaning is inconsistent with the specification. MPEP 2111.01, Subsection I. The plain meaning of a term is the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. Id.
“Scope” is not commonly used as a verb (or, in this case, a gerund). The Oxford English Dictionary (see attached definition) identifies three meanings of scope used as a verb. Two of the meanings are obsolete and rare. The third is the slang phrase “to scope out.” None appear to be related to analyzing an image or determining (or otherwise obtaining) an outline that could be used to define a centroid point as is apparently required by the claimed invention.
Examiner has looked to the specification for guidance, but finds the only mentions of scoping are at original claim 10 and par. [0009] (as published), which substantially repeats the phrase from claim 10.
Examiner has also searched the prior art, but finds no examples of the term “scoping” being used in conjunction with an outline as recited in the present claims.
As established above, the plain meaning of “scoping an outline” is unclear, so its scope under BRI is also unclear. While “applicant is free to be his or her own lexicographer,” “[t]he meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed.” MPEP 2173.05(a). “Until the meaning of a term or phrase used in a claim is clear, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph is appropriate.” Id.
Claim 10 is rejected as indefinite under 35 U.S.C. 112(b) because the meaning of the phrase “scoping an outline” is unclear.
Claims 11-25 are also indefinite at least because they include the limitations of claim 10.
The term “strong” in claim 10 is a relative term which renders the claim indefinite. The term “strong” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
It is unclear what sites qualify as “strong sites” and what sites do not. Similarly, it is unclear what center zones qualify as “strong center zones” and what center zones do not.
Par. [0014] (as published) is reproduced below:
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This suggests that the term “strong” refers to the mechanical strength of a certain region of anatomy shown in a healthy image. However, it is unclear whether any center zone found using the procedure defined in claim 10 qualifies as “strong”, or not. The image analysis procedure described in claim 10 is based on a geometric analysis of an image. The strength of the tissue is not directly measured or evaluated. Does a “strong center zone” have to actually be of sufficient strength to support a pulling force generated by a surgical suture? Or, does any zone identified by defining a centroid point, forming connecting lines, etc. qualify as a “strong center zone,” whether or not it is actually of sufficient strength to support a pulling force generated by a surgical suture?
Furthermore, the specification does not explain what would make any particular site on a connecting line specifically a “strong” site. Is any site on one of these connecting lines a “strong site,” or does some other strength condition have to be satisfied for a site to be considered “strong”?
Claim 10 is indefinite because it specifically requires “strong sites” and a “strong center zone” but it is unclear how to determine whether or not any given site or central zone qualifies as “strong.”
Claims 11-25 are also indefinite at least because they include the limitations of claim 10.
Claim 10 recites “defining multiple strong sites on each connecting line” at the second-to-last line.
“A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty.” MPEP 2173.03.
The plain meaning of the noted phrase from claim 10 is that multiple (i.e., more than one) strong sites are defined on each connecting line. So, a first connecting line has at least two strong sites, a second connecting line has at least two strong sites, and so on.
However, Figs. 7C-D apparently illustrate only a single strong site 43 on each connecting line H. Specifically, a single strong site 43 is defined on each connecting line H, each of the single strong sites then being connected to form strong center zone 50.
Claim 10 is indefinite because, although it appears to clearly require multiple strong cites on each connecting line, it apparently contradicts the disclosure, which illustrates only a single strong site on each connecting line at Figs. 7C-D.
Claims 11-25 are also indefinite at least because they include the limitations of claim 10.
Regarding claim 10, the “cross-section detection device” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. See Claim Interpretation above. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Examiner has reviewed the specification in search of corresponding structure, material, or acts and finds pars. [0030]-[0035] (as published) and Figs. 1-3 to be most relevant. These portions of the specification describe a cross-section detection device 21 that is included in detection equipment 20. The specification describes functions performed by the cross-section detection device 21, such as that it “can perform real-time imaging and capture multiple cross-section images along a detection direction on a surface of an injury area A to obtains an image group 22” ([0030]). However, the specification never describes any specific structure that performs the functions of the cross-section detection device 21. Fig. 1 illustrates cross-section detection device 21 only as a 3D box without providing any details of its structure. Par. [0034] states that detection equipment 20 (which, as noted above, includes cross-section detection device 21) “is not limited in the present invention, it can be implemented by an ultra-sound technology, an X-ray technology, a tomography technology or other medical imaging technology” and par. [0035] states that “the detection equipment 20 is implemented by the ultrasound technology.” However, even if the detection equipment 20 is understood to use ultrasound technology, that still does not describe any specific structure of the cross-section detection device 21 that is a sub-component of the detection equipment 20.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2181, Subsection II.A. Claims 11-25 are also indefinite at least because they include the limitations of claim 10.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 11 requires that a distance “is less than 30 to 50 percent of a length”. The meaning of this phrase is unclear.
On the one hand, it could mean that the distance must be less than 30 percent of the length, as only values less than 30 percent are “less than” the range 30-50%.
On the other hand, it could mean that the distance must be less than a number, the number falling somewhere on the range of 30-50% of the length.
As can be seen above, the two possible ranges of values for the distance (i.e., either 0-30% or 30-50%) are mutually exclusive. The claim is indefinite because it is unclear what range of percentages of the length the distance is allowed to be.
Claims 12-15, 18-20, and 24-25 are also indefinite at least because they include the indefinite limitation of claim 11.
Claim 12 recites, “The assessment method as claimed in claim 11, wherein marking the strong center zone on each of the at least two healthy images after the strong center zone is determined, and forming a coordinate of the strong center zone.” It is unclear how claim 12 intends to modify the method of claim 11, which makes the scope of the claim indefinite.
The first clause after “wherein” is “marking the strong center zone on each of the at least two healthy images after the strong center zone is determined.” It is unclear what relation this clause has to the method of claim 11. Does the claim require further marking the strong center zone? If so, the claim needs to clearly state as such. For example, by inserting “the method further comprises” after “wherein”.
Also, the meaning of “after the strong center zone is determined” is unclear. Claim 10, from which claims 11 and 12 depends, recites “forming a strong center zone” (emphasis added). Is the “forming” in claim 10 the “determin[ation]” referenced in claim 12, or is some other determination required? Examiner suggests either replacing “determined” with “formed” to more-clearly reference the step of claim 10, or further explaining what is meant by the strong center zone being “determined”.
The second clause after “wherein” is “forming a coordinate of the strong center zone.” Again, it is unclear whether the claim requires performing this forming as part of the method. As above, Examiner recommends inserting “the method further comprises” after “wherein” (or equivalent).
Claims 13-15, 18-20, and 24-25 are also indefinite at least because they include the indefinite limitation of claim 12.
Regarding claims 22-23, the “interpretation module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. See Claim Interpretation above. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Examiner has reviewed the specification and finds par. [0049] (as published) to be most pertinent. It is reproduced below:
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The specification does not identify any particular structure that performs the functions of the “interpretation module”. See MPEP 2181, Subsection II.A. The specification also does not describe any algorithm for performing the interpretation functions of the interpretation module, such as identifying the injury site, identifying a level of damage, or providing surgical advice. See MPEP 2181, Subsection II.B.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
See the earlier rejection of claim 10 regarding the “cross-section detection device” for further guidance regarding Applicant’s response to this type of rejection.
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 10-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The patent subject matter eligibility (SME) test is set forth in MPEP 2106. It includes multiple steps, sub-steps, and prongs.
Step One
Claims 10-23 are to a process and thus fall within one of the statutory categories.
Step 2A, Prong One
The claims do recite a judicial exception.
Claim 10 recites a mental process abstract idea of applying rules to identify a strong center zone on an image. Mental process abstract ideas are discussed at MPEP 2106.04(a)(2), Subsection III. Claim 10 recites “obtaining an image group …”, which can be performed mentally by observing a group of images on a display screen, printed on a sheet of paper, etc. Claim 10 further requires identifying an injury image and at least two healthy images, which can be performed mentally by choosing specific ones of the group of images. Claim 10 further recites scoping an outline corresponding to a cross-sectional edge of the healthy images. While the meaning of this limitation is unclear (see §112(b) rejection), this apparently involves recognizing an outline of an object portrayed in an image, which can be performed mentally. Claim 10 further recites defining a centroid point according to the outline. This can be performed mentally by judging where the center of an outline is. A human could also, for example, mark this centroid point on a printed image using a pencil. Note that use of a physical aid does not negate the mental nature of a limitation. MPEP 2106.04(a)(2), Subsection III.B. A human could also mathematically determine a centroid point by, for example, drawing the outline on a printed image, using a ruler to measure coordinates of selected points along that outline, and perform basic arithmetic to compute an average of the points’ coordinates (i.e., the centroid point). Claim 10 further recites forming connecting lines by connecting the centroid point to the outline radially, which could be performed mentally by, for example, drawing straight lines from the centroid to the outline on a printed image. Claim 10 further recites defining strong sites on the connecting lines, which could also be performed mentally by, for example, drawing points on the lines with a pencil. Claim 10 further recites forming a strong center zone by connecting each adjacent strong site, which could also be performed mentally by, for example, drawing lines between the points of the strong sites.
Claim 11 specifies further rules for defining the strong sites, which could be followed mentally.
Claims 12-15 and 19-20 discuss determining coordinate information of the image, which could be performed mentally by, for example, using a ruler to measure distances within an image with respect to a selected origin point. Examiner notes that medical images are often provided as a group of slice images within a volume, the distances between the slices being known/provided with the images, which would allow for mental determination of distance between different image planes.
Claims 12 and 18 require marking, which can be performed mentally by, for example, marking a mentally determined point/area with a pen or a pencil as discussed above.
Claim 17 recites rules for selecting healthy images, which could be applied mentally.
Claims 22-23 recite learning, image interpretation, identifying an injury site, identifying a level of damage, and providing advice, all of which can be performed mentally.
Some elements of the claims also recite mathematical concepts, such as defining a centroid, mathematical relationships of coordinate systems, etc. Mathematical concepts are another category of abstract idea. MPEP. 2106.04(a)(2), Subsection I.
Some elements of the claims also recite laws of nature. For example, claim 10 recites “strong sites” and a “strong center zone”. While the meanings of these limitations are somewhat uncertain (see §112(b) rejection), it does appear from the specification that the term “strong” refers to a law of nature that a relatively central portion of a of a tendon (or ligament or muscle) has sufficient mechanical strength to support a pulling force generated by a surgical suture during suturing. See, e.g., [0014] (as published).
While the claims involve multiple types of judicial exceptions, they are being considered together so as not to improperly parse the claim. MPEP 2106.04, Subsection II.B.
Step 2A, Prong Two
None of the additional elements recited in the claims integrate the judicial exception into a practical application because none of the additional elements go beyond:
Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and
Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
Claim 10 recites that its method is “of a repairing assist system” and that the images include an injury image and healthy images. Claim 16 describes a technological environment in which the obtained images are captured. Claim 21 recites the user of ultrasound technology and that the injury is damage of a tendon, a ligament or a muscle. Claim 22 recites that deep learning is performed. Claim 23 recites “surgical” advice. All of these limitations amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use.
Claim 10 requires obtaining an image group. This is insignificant extra-solution activity at least because it amounts to necessary data gathering. An image cannot be analyzed to form a strong center zone unless the image is first obtained. Claim 16 further recites that the images are “on a screen in real time”, that the images are captured and stored, and that the capture occurs while the cross-section detection device is moving in a displacement direction. This is also insignificant extra-solution activity at least because it does not impose meaningful limits on the claim. Whether or not images are displayed in real time does not affect the steps/rules applied to form a strong center zone on them. Capture and storage of images is necessary data gathering – images cannot be analyzed unless they are captured and preserved over time (i.e., stored) until the analysis can be performed and completed. The scope of the claimed “cross-section detection device” is unclear (see §112(b) rejection), but the specification indicates that any kind of medical imaging technology can be used (par. [0034], as published), which suggests that the limitations requiring certain use of the cross-section detection device do not meaningfully limit the scope of the claim.
Step 2B
The claims do not recite additional elements that amount to significantly more than the abstract idea.
The identification of additional elements and conclusions from Step 2A, Prong Two, are carried over. MPEP 2106.05, Subsection II. Additional elements considered to be insignificant extra-solution activity are re-evaluated to determine whether they are more than what is well-understood, routine, conventional activity in the field. Id.
The limitations requiring obtaining, capturing and storing a group of images are generally and broadly enough to cover, for example, storing and retrieving information in memory, which has been recognized by the courts as well‐understood, routine, and conventional functions. MPEP 2106.05(d), Subsection II.
As noted above, various limitations require obtaining images “from a cross-section detection device imaging along a detection direction” (claim 10), “imaging the image group on a screen in real time as the cross-section detection device moves along a surface of an injury area” (claim 16), and capturing and storing the images “in sequence according to a displacement direction of the cross-section detection device” (claim 16). While the scope of the “cross-section detection device” is unclear (see §112(b) rejection), it appears to cover well-understood, routine and conventional ultrasound scanning activity. For example, ‘Obst’ (“In Vivo Measurement of Human Achilles Tendon Morphology Using Freehand 3-D Ultrasound,” 2014) describes a system using an ultrasound cross-section detection device to obtain an image group (e.g., Page 62, Introduction, 2nd paragraph, freehand 3-D ultrasound obtains a group of 2D images as it is swept over an areas of interest; e.g., Fig. 2, lower, illustrates the set of images), where the image group is imaged on a screen in real-time as the detection device moves along a surface of an injury area (see above and, e.g., Fig. 1, display screen showing real-time ultrasound image), and images are captured and stored in sequence according to a displacement direction of the cross-section detection device (see above). Obst was published a decade before the instant application was filed and also cites many earlier references describing ultrasound image acquisition. Also see further description of ultrasound imaging in the other cited prior art. This evidence demonstrates that, at least at the level of generality recited in the claims, the image acquisition limitations noted above were well-understood, routine and conventional activity.
As explained above, none of the additional elements (or combinations thereof) go beyond merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea; adding insignificant extra-solution activity to the judicial exception; or generally linking the use of a judicial exception to a particular technological environment or field of use, and none otherwise amount to significantly more than a judicial exception.
Conclusion
Claims 10-23 are patent-ineligible under 35 U.S.C. 101 because they are directed to a judicial exception and do not recite additional elements that amount to significantly more than that judicial exception.
Examiner notes that claims 24 and 25 are not rejected under 35 U.S.C. 101. The specification does describe an improvement that allows for less-invasive repair surgery by identifying a strong zone for suturing through medical image analysis without a need to turn up skin adjacent to an injured area (e.g., [0003], [0014], [0018]-[0019], as published). Claims 24 and 25 do reflect the disclosed improvement in technology. Specifically, claim 24 recites using a guiding module to assist in marking the strong center zone on a surface of an injury area, which concerns identifying the strong zone without a need to turn up adjacent skin, and claim 25 recites using images to confirm that a needle has entered the strong center zone (rather than turning up skin to make a visual confirmation). In contrast, none of claims 10-23 reflect the disclosed improvement. For example, claim 10 stops at forming a strong center zone on an image and does not recite any further steps using the formed strong center zone for performing improved, less-invasive surgery.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
‘Obst’ (“In Vivo Measurement of Human Achilles Tendon Morphology Using Freehand 3-D Ultrasound,” 2014)
Describes ultrasound cross-sectional image acquisition for an Achilles tendon – e.g., page 62, right column, and Figs. 1-2
Finds centroid of outline of tendon in each of multiple cross-sectional images – e.g., Fig. 3
Does not form a strong center zone using the centroid points. The centroid points are used to measure Achilles tendon (AT) length.
‘Cross’ (“Percutaneous Achilles Tendon Repair Using Ultrasound Guidance: An Intraoperative Ultrasound Technique,” 2023)
Describes a minimally-invasive Achilles Tendon repair technique using ultrasound images for guidance
Ultrasound is used to identify and mark the midportion of the Achilles tendon – page e175, Operative Technique and Fig. 1
Ultrasound is also used to confirm “mid-substance placement” of suture needles – page e175, Operative Technique, and Figs. 3-4
The images are analyzed directly by the surgeon – no centroids, lines, center zone, etc. are explicitly identified on the images.
‘Paczesny’ (“Mini-Invasive, Ultrasound Guided Repair of the Achilles Tendon Rupture–A Pilot Study,” 2021)
Another example of using ultrasound guidance to pass a suturing needle through the center of an Achilles tendon – e.g., page 4, 1st par.
‘Wang’ (“Ultrasound-Guided Minimally Invasive Surgery for Achilles Tendon Rupture: Preliminary Results,” 2012)
Another example of using ultrasound guidance to pass a suturing needle through the center of an Achilles tendon – e.g., pages 583-584, SURGICAL METHODS; Fig. 2
The following are examples of other prior art identifying outlines, centroid points, connecting lines, sites, center zones, etc. in medical imagery, albeit not in the same context as the claimed invention:
‘Celi’ (US 2015/0213629 A1) – e.g., Figs. 8A-C
‘Chang’ (US 2011/0181614 A1) – e.g., Figs. 3C-D
‘Choi’ (US 2018/0357770 A1) – e.g., Fig. 3A
‘De Bliek’ (US 2008/0123914 A1) – e.g., Figs. 1-6
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/GEOFFREY E SUMMERS/Examiner, Art Unit 2669
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