DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I (i.e. claims 1-11) in the reply filed on 12/22/2025 is acknowledged. The following office action addresses claims 1-11. Claims 12-20 are withdrawn from consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/26/2024 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,127,879 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because they both involve 1) methods for detecting endometrial peristalsis by transmitting an ultrasound wave to an endometrium; receiving echoes of the ultrasound wave; obtaining an ultrasound image; determining peristaltic displacement; calculating a peristaltic parameter and displaying the peristaltic parameter and 2) ultrasound imaging devices for carrying out the method. The following chart is a comparison of the claims.
18/897,662
US 12,127,879 B2
1. A method for detecting endometrial peristalsis, the method comprising: transmitting an ultrasound wave to an endometrium, and receiving echoes of the ultrasound wave to obtain ultrasound echo data; obtaining an ultrasound image of the endometrium based on the ultrasound echo data; determining a peristaltic displacement or a peristaltic velocity of a point in the endometrium within a preset time length based on the ultrasound echo data; calculating a peristaltic parameter of the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length, wherein the peristaltic parameter is used to describe a motion status of the endometrial peristalsis; and displaying the peristaltic parameter.
1. A method for detecting endometrial peristalsis, applied to an ultrasound imaging device, wherein the ultrasound imaging device at least comprises an ultrasound probe, a processor and a human-machine interaction apparatus; and the method comprises: transmitting, by the ultrasound probe controlled by the processor, an ultrasound wave to an endometrium, and receiving, by the ultrasound probe controlled by the processor, echoes of the ultrasound wave to obtain ultrasound echo data; performing, by the processor, imaging on the ultrasound echo data to obtain an ultrasound image of the endometrium; determining, by the processor, peristaltic displacements of points in the endometrium within a preset time length based on the ultrasound echo data, wherein determining, by the processor, the peristaltic displacements of points in the endometrium within the preset time length based on the ultrasound echo data comprises: selecting, from the ultrasound echo data, a first one-dimensional ultrasound echo data segment centered on a first point in the endometrium at a first moment, searching, in a one-dimensional search region covering the first point, a second one-dimensional ultrasound echo data segment at a second moment in a greatest correlation with the first one-dimensional ultrasound echo data segment, a position of a center point of the second one-dimensional ultrasound echo data segment being a position of the first point at the second moment, and obtaining a peristaltic displacement of the first point between the first moment and the second moment; and obtaining, by analogy, the peristaltic displacements of the points in the endometrium at different moments within the preset time length; calculating, by the processor, a peristaltic parameter of the endometrium based on the peristaltic displacements of the points in the endometrium within the preset time length, wherein the peristaltic parameter is used to describe a motion status of the endometrial peristalsis; and displaying, by the human-machine interaction apparatus controlled by the processor, the peristaltic parameter.
2. The method of claim 1, wherein the peristaltic parameter comprises at least one of amplitude of the peristalsis, frequency of the peristalsis, total significant peristaltic movement time within the preset time length, propagation direction of the peristaltic movement, propagation speed of the peristaltic movement, range of the peristaltic movement, degree of disorder in the peristaltic movement, degree of unevenness in the peristaltic amplitude, degree of unevenness in the peristaltic direction, and distribution of the peristaltic movement in the endometrium.
2. The method of claim 1, wherein the peristaltic parameter comprises at least one of peristaltic amplitude of the endometrial peristalsis, a frequency of the endometrial peristalsis, total significant peristaltic movement time within the preset time length, a propagation direction of a peristaltic movement, a propagation speed of the peristaltic movement, a range of the peristaltic movement, a degree of disorder in the peristaltic movement, a degree of unevenness in the peristaltic amplitude, a degree of unevenness in a peristaltic direction, and a distribution of the peristaltic movement in the endometrium.
3. The method of claim 1, wherein the preset time length is greater than or equal to a period of the peristalsis.
3. The method of claim 1, wherein the preset time length is greater than or equal to a period of the endometrial peristalsis.
4. The method of claim 1, wherein the peristaltic parameter comprises at least one of tissue strain caused by the peristalsis, tissue strain rate caused by the peristalsis, and acceleration of the peristaltic movement.
4. The method of claim 1, wherein the peristaltic parameter comprises at least one of a tissue strain caused by the endometrial peristalsis, a tissue strain rate caused by the endometrial peristalsis, and an acceleration of a peristaltic movement.
5. The method of claim 1, wherein the peristaltic parameter comprises at least one statistical quantity of the peristaltic displacement or the peristaltic velocity.
5. The method of claim 1, wherein the peristaltic parameter comprises-statistical quantity of the peristaltic displacements.
6. The method of claim 1, wherein determining a peristaltic displacement of a point in the endometrium within a preset time length based on the ultrasound echo data comprises: detecting, from the ultrasound echo data, ultrasound echo data segments for the point in the endometrium at different moments; selecting an ultrasound echo data segment for the point in the endometrium at one moment, searching an ultrasound echo data segment at another moment for a point in the greatest correlation with the ultrasound echo data segment for the selected point, the position of the found point being the position of the selected point at the another moment, and obtaining a peristaltic displacement of the selected point between the two moments; and obtaining, by analogy, peristaltic displacements of the point in the endometrium at different moments within the preset time length.
1. […] wherein determining, by the processor, the peristaltic displacements of points in the endometrium within the preset time length based on the ultrasound echo data comprises: selecting, from the ultrasound echo data, a first one-dimensional ultrasound echo data segment centered on a first point in the endometrium at a first moment, searching, in a one-dimensional search region covering the first point, a second one-dimensional ultrasound echo data segment at a second moment in a greatest correlation with the first one-dimensional ultrasound echo data segment, a position of a center point of the second one-dimensional ultrasound echo data segment being a position of the first point at the second moment, and obtaining a peristaltic displacement of the first point between the first moment and the second moment; and obtaining, by analogy, the peristaltic displacements of the points in the endometrium at different moments within the preset time length […]”
7. The method of claim 1, wherein calculating a peristaltic parameter of the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length comprises: generating a relationship curve of the peristaltic displacement versus time or a relationship curve of the peristaltic velocity versus time based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length; and calculating at least one of the amplitude of the peristalsis, the frequency of the peristalsis, and the total significant movement time within the preset time length based on the relationship curve.
6. The method of claim 1, wherein calculating the peristaltic parameter of the endometrium based on the peristaltic displacements of the points in the endometrium within the preset time length comprises: generating a relationship curve of the peristaltic displacements versus time based on the peristaltic displacements of the points in the endometrium within the preset time length; and calculating at least one of an amplitude of the endometrial peristalsis, a frequency of the endometrial peristalsis, and total significant movement time within the preset time length based on the relationship curve.
8. The method of claim 1, wherein calculating a peristaltic parameter of the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length comprises: calculating a motion parameter of the point in the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length, the motion parameter comprising at least one of maximum peristaltic displacement, minimum peristaltic displacement, average peristaltic displacement, and total significant movement time; and obtaining the propagation direction of the peristalsis according to the order in which the points in the endometrium reach a preset motion parameter.
7. The method of claim 1, wherein calculating the peristaltic parameter of the endometrium based on the peristaltic displacements of the points in the endometrium within the preset time length comprises: calculating motion parameters of the points in the endometrium based on the peristaltic displacements of the points in the endometrium within the preset time length, the motion parameter comprising at least one of a maximum peristaltic displacement, a minimum peristaltic displacement, an average peristaltic displacement, and total significant movement time; and obtaining a propagation direction of the endometrial peristalsis according to an order in which the points in the endometrium reach a preset motion parameter.
9. The method of claim 8, wherein after the propagation direction of the peristalsis is obtained, the method further comprises: obtaining the propagation speed of the peristalsis based on a distance between at least two points in the propagation direction and a time difference between moments at which the two points reach the preset motion parameter.
8. The method of claim 7, wherein after the propagation direction of the endometrial peristalsis is obtained, the method further comprises: obtaining a propagation speed of the endometrial peristalsis based on a distance between at least two points in the propagation direction and a time difference between moments at which the two points reach the preset motion parameter.
10. The method of claim 8, wherein after the motion parameter of the point in the endometrium is calculated, the method further comprises: determining whether the motion parameter of the point in the endometrium exceeds a preset parameter threshold; and using a region formed by points with the motion parameter exceeding the parameter threshold as the peristalsis range.
9. The method of claim 7, wherein after the motion parameters of the points in the endometrium are calculated, the method further comprises: determining whether the motion parameters of the points in the endometrium exceed a preset parameter threshold; and using a region formed by points with the motion parameters exceeding the preset parameter threshold as a range of a peristaltic movement of the endometrium.
11. The method of claim 1, wherein displaying the peristaltic parameter comprises: displaying a relationship curve of the peristaltic parameter versus time.
10. The method of claim 1, wherein displaying the peristaltic parameter comprises: displaying a relationship curve of the peristaltic parameter versus time.
Claim Objections
Claims 6, and 8-9 are objected to because of the following informalities:
Regarding claim 6, as written it reads “selecting an ultrasound echo data segment for the point in the endometrium at one moment, searching an ultrasound echo data segment at another moment for a point in the greatest correlation with the ultrasound echo data segment for the selected point”. However, to avoid potential antecedent basis issues, the examiner would recommend updating the term “the greatest correlation” to be “greatest correlation” or “a greatest correlation”.
Regarding claim 8, as written it reads “and obtaining the propagation direction of the peristalsis according to the order in which the points in the endometrium reach a preset motion parameter”. However, to avoid potential antecedent basis issues, the examiner would recommend updating the terms: “the propagation direction” to “propagation direction” and “the order” to be “an order”.
Regarding claim 9, as written it reads “obtaining the propagation speed of the peristalsis based on a distance between at least two points in the propagation direction and a time difference between moments at which the two points reach the preset motion parameter”. However to avoid potential antecedent basis issues, the examiner would recommend updating the term “the propagation speed” to “propagation speed” or “a propagation speed”.
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.
Claims 6 and 10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 6, as written it reads “selecting an ultrasound echo data segment for the point in the endometrium at one moment, searching an ultrasound echo data segment at another moment for a point in the greatest correlation with the ultrasound echo data segment for the selected point, the position of the found point being the position of the selected point at the another moment, and obtaining a peristaltic displacement of the selected point between the two moments”. However, when stated in this way it is unclear whether the second recitation of “an ultrasound echo data segment” corresponds to the same or a different segment as the first recitation of “an ultrasound echo data segment” (see underlined portions above).
Additionally, there is a lack of antecedent basis for the terms “the selected point” and “the found point” within the claim, thus it is unclear what the selected point and the found point correspond to in this context. Therefore, it is unclear whether this “found point” refers to the initial point selected (i.e. found) by a user or a point in greatest correlation to the initial point selected. Furthermore, it is unclear whether the selected point and the found point are intended to be the same or different points. Additionally, there is a lack of antecedent basis for the term “the two moments”, thus it is unclear whether these moments correspond to the “different moments” stated in the detecting step or separate moments from the detecting step. The examiner recommends clarifying the concepts/terms identified above.
Regarding claim 10, as written it reads “determining whether the motion parameter of the point in the endometrium exceeds a preset parameter threshold; and using a region formed by points with the motion parameter exceeding the parameter threshold as the peristalsis range”. however there is a lack of antecedent basis for the terms “the parameter threshold” and “the peristalsis range”. Thus, it is unclear whether “the parameter threshold” is intended to be the same as the “preset parameter threshold, or a different parameter threshold. The examiner recommends maintaining the same term within the claim if they represent the same value. Additionally, it is unclear what this “peristalsis range” represents and/or what it is used for within the context of the method. The examiner recommends clarifying what is meant by this term.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea, specifically a mental process, without significantly more.
Regarding claim 1, the examiner notes that the claim is directed to a method for detecting endometrial peristalsis. Therefore, the claim falls within one of the statutory categories of invention.
With reference to Step 2A, Prong One, the claim recites “determining a peristaltic displacement or a peristaltic velocity of a point in the endometrium within a preset time length based on the ultrasound echo data; calculating a peristaltic parameter of the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length, wherein the peristaltic parameter is sed to describe a motion status of the endometrial peristalsis”.
The limitations, under broadest reasonable interpretation, cover performance of the limitation in the mind and/or read on analyzing an ultrasound image. In this case, the steps of “determining a peristaltic displacement or a peristaltic velocity of a point in the endometrium […]”; and “calculating a peristaltic parameter based on the peristaltic displacement or the peristaltic velocity […]”, represent actions which can be practically performed in the human mind by a user viewing a ultrasound echo data, selecting a point in the endometrium, determining a peristaltic displacement or peristaltic velocity of that point during a preset time length, and calculating (i.e. determining) a peristaltic parameter based on the peristaltic displacement or velocity, the peristaltic parameter describing a motion status of the endometrial peristalsis. If a claim limitation under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components (i.e. a processor), then it falls within the “mental processes” grouping of abstract ideas.
Following step 2A, Prong Two of the two-prong analysis, the claim recites the following additional elements: “transmitting an ultrasound wave to an endometrium, and receiving echoes of the ultrasound wave”; “obtaining an ultrasound image of the endometrium based on the ultrasound echo data”, and “displaying the peristaltic parameter”. These additional elements do not integrate the judicial exception into a practical application because the claim as written does not include elements to 1) improve the functioning of a computer (See MPEP 2106.05(a)); 2) effect a particular treatment or prophylaxis (See MPEP 2106.04(d)(2)); 3) use a particular machine (See MPEP 2106.05(b)); 4) use the judicial exceptions in a meaningful way beyond generally linking the use to a particular technological environment (See MPEP 2106.05(h)). Furthermore, these transmitting, receiving, obtaining and displaying steps do not integrate the judicial exception into a practical application because they add insignificant extra-solution activity to the judicial exception using a well-known device (i.e. ultrasound transducer, display) (See MPEP 2106.05(g)).
Following step 2B, the additional element(s) (i.e. transmitting an ultrasound wave to an endometrium, and receiving echoes of the ultrasound wave”; “obtaining an ultrasound image of the endometrium based on the ultrasound echo data”, and “displaying the peristaltic parameter”) do not amount to significantly more than the judicial exception the these limitations represent data gathering steps and/or insignificant extra-solution activity which utilize conventional tools (i.e. ultrasound transducer, display) to perform well understood, routine and conventional activity (i.e. monitoring peristaltic displacement/velocity of the endometrium/uterine, see Kunz, G et al., "The dynamics of rapid sperm transport through the female genital tract: evidence from vaginal sonography of uterine peristalsis and hysterosalpingoscintigraphy", (1996), Human Reproduction, Vol. 11, no. 3, pp. 627-632. “Kunz”: [Page 627]; [Page 628: Vaginal sonography of uterine peristalsis, Lines 1-5]; [Page 630: Discussion; Para. 1, Lines 12-16]; [Page 628: Vaginal sonography of uterine peristalsis, Lines 5-9]; [Page 630: Discussion; Para. 1, Lines 3-7]; and displaying the peristaltic parameter: see Hisanori et al. JP 2006263282 A “Hisanori”: [Page 15, Para. 8, Lines 1-2] and [Page 16, Para. 5, Lines 6-7]) in the field, to perform the abstract idea.
Regarding claims 2-11, the claims add additional limitations that append the judgement of claim 1 and/or do not include additional elements that are sufficient to amount to significantly more than the judicial exception, nor a practical application of the judicial exception because they disclose:
steps that can be practically performed within the mind (i.e. “wherein determining a peristaltic displacement of a point in the endometrium within a preset time length based on the ultrasound echo data comprises: detecting, from the ultrasound echo data, ultrasound echo data segments for the point in the endometrium at different moments; selecting an ultrasound echo data segment for the point in the endometrium at one moment, searching an ultrasound echo data segment at another moment for a point in the greatest correlation with the ultrasound echo data segment for the selected point, the position of the found point being the position of the selected point at the another moment, and obtaining a peristaltic displacement of the selected point between the two moments; and obtaining, by analogy, peristaltic displacements of the point in the endometrium at different moments within the preset time length”, see claim 6; “wherein calculating a peristaltic parameter of the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length comprises: generating a relationship curve of the peristaltic displacement versus time or a relationship curve of the peristaltic velocity versus time based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length; and calculating at least one of the amplitude of the peristalsis, the frequency of the peristalsis, and the total significant movement time within the preset time length based on the relationship curve”, see claim 7; “wherein calculating a peristaltic parameter of the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length comprises: calculating a motion parameter of the point in the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length, the motion parameter comprising at least one of maximum peristaltic displacement, minimum peristaltic displacement, average peristaltic displacement, and total significant movement time; and obtaining the propagation direction of the peristalsis according to the order in which the points in the endometrium reach a preset motion parameter”, see claim 8; “wherein after the propagation direction of the peristalsis is obtained, the method further comprises: obtaining the propagation speed of the peristalsis based on a distance between at least two points in the propagation direction and a time difference between moments at which the two points reach the preset motion parameter”, see claim 9); “wherein after the motion parameter of the point in the endometrium is calculated, the method further comprises: determining whether the motion parameter of the point in the endometrium exceeds a preset parameter threshold; and using a region formed by points with the motion parameter exceeding the parameter threshold as the peristalsis range”, see claim 10);
provide additional information about the peristaltic parameter or preset time length (i.e. “wherein the peristaltic parameter comprises at least one of amplitude of peristalsis, frequency of the peristalsis, total significant peristaltic movement time within the preset time length, propagation direction of the peristaltic movement, propagation speed of the peristaltic movement, range of the peristaltic movement, degree of disorder in the peristaltic movement, degree of unevenness in the peristaltic amplitude, degree of unevenness in the peristaltic direction, and distribution of the peristaltic movement in the endometrium”, see claim 2; “wherein the preset time length is greater than or equal to a period of the peristalsis”, see claim 3; “wherein the peristaltic parameter comprises at least one of tissue strain caused by the peristalsis, tissue strain rate caused by the peristalsis, and acceleration of the peristaltic movement”, see claim 4; “wherein the peristaltic parameter comprising at least one of statistical quantity, of the peristaltic displacement or the peristaltic velocity”, see claim 5.);
and/or constitute insignificant extra-solution activity (i.e. “wherein displaying the peristaltic parameter comprises: displaying a relationship curve of the peristaltic parameter versus time”, see claim 11).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Kunz, G et al., "The dynamics of rapid sperm transport through the female genital tract: evidence from vaginal sonography of uterine peristalsis and hysterosalpingoscintigraphy", (1996), Human Reproduction, Vol. 11, no. 3, pp. 627-632. “Kunz” and further in view of Hisanori et al. JP 2006263282 A “Hisanori”.
Regarding claim 1, Kunz teaches “A method for detecting endometrial peristalsis, the method comprising: transmitting an ultrasound wave to an endometrium, and receiving echoes of the ultrasound wave to obtain ultrasound echo data; obtaining an ultrasound image of the endometrium based on the ultrasound echo data” (“Materials and methods” [Page 627]; “Vaginal sonography of uterine peristalsis: VSUP was performed with a 7.5 MHz probe (Sonoline SI-45; Siemens, Erlangen, Germany). The probe was placed in such a position to yield a sagittal section of the whole uterus. It was kept in a fixed position for a period of 5 min. The whole scan was videotaped for a quantitative assessment of uterine peristalsis.” [Page 628: Vaginal sonography of uterine peristalsis, Lines 1-5] and “The peristaltic waves of the endometrium and the subendometrial layer of the myometrium are directed from the cervical canal to the fundal part of the uterus, while only during menstruation do they exhibit a fundo-cervical direction (Lyons et al. 1991)” [Page 630: Discussion; Para. 1, Lines 12-16]. Therefore, since the vaginal sonography is performed with a 7.5 MHz probe to yield a sagittal section of the whole uterus, a quantitative assessment of uterine peristalsis is performed and the uterus includes the endometrium (i.e. layer), the method is for detecting endometrial peristalsis, the method comprising transmitting an ultrasound wave to an endometrium, and receiving echoes of the ultrasound wave to obtain ultrasound echo data; obtaining an ultrasound image (i.e. of the sagittal section) of the endometrium based on the ultrasound echo data
“determining a peristaltic displacement or a peristaltic velocity of a point in the endometrium within a preset time length based on the ultrasound echo data” (“To obtain a precise estimation of the frequency of the contraction waves, the tape was replayed at five times the regular speed. This also facilitated the determination of the wave direction (cervico-fundal versus fundo-cervical peristalsis)” [Page 628: Vaginal sonography of uterine peristalsis, Lines 5-9]; “High-resolution sonography has made is possible to demonstrate these contractions without invasive techniques. These contractions mostly involve the subendometrial layer of the myometrium and may only be detected by endometrial movements (Birnholz, 1984)” [Page 630: Discussion; Para. 1, Lines 3-7]. Therefore, since the tape was replayed at five times regular speed to facilitate the determination of the wave direction (i.e. cervico-fundal versus fundo-cervical peristalsis) and high-resolution sonography is used to detect endometrial movements (i.e. contractions), the method involves determining a peristaltic displacement (i.e. peristaltic movement) of a point in the endometrium within a preset time length (i.e. the 5 minute scan period, see [Page 628: Vaginal sonography of uterine peristalsis, Lines 1-5]) based on the ultrasound echo data.);
“calculating a peristaltic parameter of the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length, wherein the peristaltic parameter is used to describe a motion status of the endometrial peristalsis” (“To obtain a precise estimation of the frequency of the contraction waves, the tape was replayed at five times the regular speed. This also facilitated the determination of the wave direction (cervico-fundal versus fundo-cervical peristalsis)” [Page 628: Vaginal sonography of uterine peristalsis, Lines 5-9]. Therefore, since the frequency of the contraction waves (i.e. the contraction waves resulting in peristalsis) is estimated, the method involves calculating a peristaltic parameter of the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length, wherein the peristaltic parameter is used to describe a motion status of the endometrial peristalsis. Kunz does not explicitly teach “displaying the peristaltic parameter”.
Hisanori is within the same field of endeavor as the claimed invention because it involves utilizing diagnostic imaging to visualize the peristalsis of the uterus (see [Abstract]).
Hisanori teaches “displaying the peristaltic parameter” (“When the phase difference between the two pixels is obtained for the frequency component corresponding to the uterine peristalsis, the speed of the uterine peristalsis can be calculated based on this phase difference. By providing the calculated speed of uterine peristalsis, for example, by displaying it on a display device, it is possible to provide more information about uterine peristalsis and to support image diagnosis more effectively” [Page 7, Para. 2, Lines 1-5]; “The operator determines the direction of uterine peristalsis from the amplitude image and/or phase image displayed on the display 13 and instructs the direction from the input device 11” [Page 14, Para. 3, Lines 2-4]; “The image display control unit 70 displays the peristaltic speed data stored in the peristaltic speed data storage unit 63 on the display 13 (for example, numerical display)” [Page 15, Para. 8, Lines 1-2]; “Then, the calculated speed of the peristaltic movement is displayed on the display 13 (step S19)” [Page 16, Para. 5, Lines 6-7]. Therefore, the method involves displaying the peristaltic parameter.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kunz so as to include displaying the peristaltic parameter as disclosed by Hisanori in order to provide more information about uterine peristalsis and to support image diagnosis more effectively” [See Hisanori: [Page 7, Para. 2, Lines 1-5]). Although Hisanori utilizes a different imaging modality than Kunz, one of ordinary skill in the art would recognize that since both of these imaging modalities can be used to visualize peristaltic movement, it would be obvious to substitute one imaging modality for another when performing imaging to assess uterine peristalsis. Therefore, by displaying the peristaltic parameter calculated in Kunz according to the method of Hisanori, more information can be provided to a physician for use in image diagnosis.
Regarding claim 2, Kunz in view of Hisanori discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kunz further teaches “wherein the peristaltic parameter comprises at least one of amplitude of peristalsis, frequency of peristalsis, total significant peristaltic movement time within the preset time length, propagation direction of the peristaltic movement, propagation speed of the peristaltic movement, range of the peristaltic movement, degree of disorder in the peristaltic movement, degree of unevenness in the peristaltic amplitude, degree of unevenness in the peristaltic direction, and distribution of the peristaltic movement in the endometrium” (“To obtain a precise estimation of the frequency of the contraction waves, the tape was replayed at five times the regular speed. This also facilitated the determination of the wave direction (cervico-fundal versus fundo-cervical peristalsis)” [Page 628: Vaginal sonography of uterine peristalsis, Lines 5-9]. Therefore, since the frequency of the contraction waves (i.e. corresponding to the frequency of peristalsis) and the wave direction (i.e. corresponding to the propagation direction of the peristaltic movement) are determined, the peristaltic parameter comprises at least one of frequency of peristalsis and/or propagation direction of the peristaltic movement.).
Regarding claim 3, Kunz in view of Hisanori discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kunz further teaches “wherein the preset time length is greater than or equal to a period of the peristalsis” (“Vaginal sonography of uterine peristalsis: VSUP was performed with a 7.5 MHz probe (Sonoline SI-45; Siemens, Erlangen, Germany). The probe was placed in such a position to yield a sagittal section of the whole uterus. It was kept in a fixed position for a period of 5 min. The whole scan was videotaped for a quantitative assessment of uterine peristalsis.” [Page 628: Vaginal sonography of uterine peristalsis, Lines 1-5]. Therefore, since the probe was kept in place for 5 minutes while the scan was being performed, this 5 minute time period represents the preset time length. Furthermore, since the whole scan (i.e. 5 minute scan) was videotaped such that a quantitative assessment of uterine peristalsis could be performed, a period of peristalsis occurred during the five minute time period. Therefore, the preset time length is greater than or equal to a period of the peristalsis.).
Claim(s) 4-6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kunz, G et al., "The dynamics of rapid sperm transport through the female genital tract: evidence from vaginal sonography of uterine peristalsis and hysterosalpingoscintigraphy", (1996), Human Reproduction, Vol. 11, no. 3, pp. 627-632. “Kunz” and further in view of Hisanori et al. JP 2006263282 A “Hisanori” as applied to claim 1 above, and further in view of Massimo et al. WO 2019/053249 A1 “Massimo”.
Regarding claim 4, Kunz in view of Hisanori discloses all features of the claimed invention as discussed with respect to claim 1 above, however, the combination does not teach “wherein the peristaltic parameter comprises at least one of tissue strain caused by the peristalsis, tissue strain rate caused by the peristalsis, and acceleration of the peristaltic movement”.
Massimo is within the same field of endeavor as the claimed invention because it discusses a method for quantitative visualization of uterine strain (see [Abstract]).
Massimo teaches “wherein the peristaltic parameter comprises at least one of tissue strain caused by the peristalsis, tissue strain rate caused by the peristalsis, and acceleration of the peristaltic movement” (“Transvaginal ultrasound (TVUS) is treated as an effective, invasive and safe approach for the measurement of uterine peristalsis (UP)” [Page 1, Lines 16-18]; “A first aspect of the invention provides a method for quantitative visualization of uterine strain, the method comprising: receiving a number of 2D or 3D image frames acquired via an imaging technique […] tracking and estimating the displacement of tracking points between frames; calculating, from a varying distance between each couple or set of tracking points, at least one of: a transversal strain, a longitudinal strain, a circular strain, an area strain and a volume strain, to obtain a strain map, wherein the orientation of the grid of tracking points and of the calculated strain is dependent on the determined orientation of the uterus” [Page 1, Line 30-Page 2, Line 12]. Therefore, since the method involves receiving 2D or 3D image frames (i.e. through transvaginal ultrasound (see [Page 5, Line 33-Page 6, Line 7])) such that the displacement of tracking points can be estimated and different types of strain can be calculated for the uterus (i.e. the uterus experiencing contractions/peristalsis), the peristaltic parameter comprises at least one of tissue strain cause by the peristalsis.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kunz in view of Hisanori so as to include the peristaltic parameter comprising tissue strain caused by the peristalsis as disclosed in Massimo in order to allow the physician to assess the strain experienced by the uterus. The uterus experiences strain as is contracts and therefore, studying the strain evolution of a patient over time (i.e. through segmented strain mapping or generating strain rate maps), might also contribute to a better understanding of the functionality of a patient’s uterus (see Massimo: [Page 13, Lines 29-31]). Furthermore, the obtained strain estimates can also be evaluated for their support with the prediction of successful embryo implantation following in-vitro fertilization procedures (see Massimo: Page 13, Lines 34-36]). Thus, it would be obvious to one of ordinary skill in the art to modify the method of Kunz to include the peristaltic parameter comprising tissue strain, such that this peristaltic parameter can be provided to a physician for assessment of the patient.
Regarding claim 5, Kunz in view of Hisanori discloses all features of the claimed invention as discussed with respect to claim 1 above, however, the combination does not teach “wherein the peristaltic parameter comprises at least one statistical quantity of the peristaltic displacement or the peristaltic velocity”.
Massimo teaches “wherein the peristaltic parameter comprises at least one statistical quantity of the peristaltic displacement or the peristaltic velocity” (“In reality, the endometrium does not hold a fixed location due to the probe manipulation and the global movement of the myometrium. To make sure that the dots-map can always follow and cover the same part of the endometrium chosen in the first frame, a fast block matching algorithm […] may be applied block to the start and end points of the endometrium line. The principle of block matching is to choose an NxM in the reference frame and then search for its new position in the next frame by minimizing a cost function (error metrics) within the entire predefined search area, see Figure 2. The search area can be defined based on the maximum expected tissue displacement between two subsequent frames. The position where the highest similarity (HS) is found is then considered as the best match” [Page 7, Lines 23-26]. This global movement of the myometrium, and thus the endometrium, is the result of peristaltic movement. Therefore, since the search area used to perform endometrium tracking is defined based on the maximum expected tissue displacement (i.e. maximum peristaltic displacement) between two subsequent frames, the peristaltic parameter comprises at least one statistical quantity of the peristaltic displacement.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kunz in view of Hisanori so as to include the peristaltic parameter comprising at least one statistical quantity of the peristaltic displacement (i.e. the maximum expected tissue displacement) as disclosed in Massimo in order to allow the physician to assess the movement experienced by the endometrium. The endometrium (i.e. contained within the uterus) experiences contractions (i.e. peristalsis), so defining the search area (i.e. of the image) based on the maximum expected tissue displacement will allow for the assessment of a point within the endometrium during a scan session. A statistical quantity of peristaltic displacement (i.e. maximum expected tissue displacement) is one of a finite number of quantities which can be used to assess the movement of an endometrium with a reasonable expectation of success. Therefore, it would be obvious to one of ordinary skill in the art to modify the method of Kunz to include the peristaltic parameter comprising at least one statistical quantity of the peristaltic displacement (i.e. maximum expected tissue displacement), such that this peristaltic parameter can be provided to a physician for assessment of the patient.
Regarding claim 6, Kunz in view of Hisanori discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kunz teaches “determining a peristaltic displacement of a point in the endometrium within a preset time length based on the ultrasound echo data comprises: […] within the preset time length” (see [Page 628: Vaginal sonography of uterine peristalsis, Lines 1-5] as discussed with respect to claims 3 and 6 above).
However, Kunz in view of Hisanori does not teach “detecting, from the ultrasound echo data, ultrasound echo data segments for the point in the endometrium at different moments; selecting an ultrasound echo data segment for the point in the endometrium at one moment, searching an ultrasound echo data segment at another moment for a point in the greatest correlation with the ultrasound echo data segment for the selected point, the position of the found point being the position of the selected point at the another moment, and obtaining a peristaltic displacement of the selected point between the two moments; and obtaining, by analogy, peristaltic displacements of the point in the endometrium at different moments within the preset time length”.
Massimo teaches “detecting, from the ultrasound echo data, ultrasound echo data segments for the point in the endometrium at different moments; selecting an ultrasound echo data segment for the point in the endometrium at one moment, searching an ultrasound echo data segment at another moment for a point in the greatest correlation with the ultrasound echo data segment for the selected point, the position of the found point being the position of the selected point at the another moment, and obtaining a peristaltic displacement of the selected point between the two moments; and obtaining, by analogy, peristaltic displacements of the point in the endometrium at different moments within the preset time length” (“Figure 10 shows a flow chart of a method 90 according to an embodiment of the invention. The method 90 starts with a step 91 of receiving a number of 2D or 3D image frames acquired via an imaging technique. A next step 92 represents the selecting a number of confidential points. A next step 93 represents the determining the orientation of the uterine using the confidential points. Then at step 94, a region of interest is selected. A next step 95 represents the generating a grid of tracking points inside the region of interest. A next step 96 represents the tracking and estimating the displacement of tracking points between frames. A next step 97 represents the calculating, from a varying distance between each couple or set of tracking points to obtain a strain map, wherein the orientation of the grid of tracking points and of the calculated strain is dependent on the determined orientation of the uterus” [Page 12, Lines 21-31].
In this case, since the method involves selecting a number of confidential points (i.e. step 92) in order to determine the orientation of the uterus (i.e. uterine, see step 93) and tracking and estimating the displacement of tracking points between frames (see step 96), the method involves detecting, from the ultrasound echo data (i.e. obtained in step 91), ultrasound echo data segments for the point in the endometrium at different moments (i.e. within different frames).
Furthermore, since the method includes selecting a region of interest, generating a rid of tracking points inside the region of interest and tracking and estimating the displacement of tracking points between frames, the method involves selecting an ultrasound echo data segment for the point in the endometrium at one moment (i.e. a region of interest, see step 94), searching an ultrasound echo data segment at another moment for a point in the greatest correlation with the ultrasound echo data segment for the selected point, the position of the found point being the position of the selected point at the another moment (i.e. through tracking, see step 96), and obtaining a peristaltic displacement of the selected point between the two moments (i.e. between frames); and obtaining, by analogy, peristaltic displacements of the point in the endometrium at different moments within the preset time length (i.e. the 5 minute scan of Kunz).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kunz in view of Hisanori so as to include the determination of peristaltic movement being performed by detecting ultrasound echo data segments at different moments, selecting an ultrasound echo data segment at one moment, searching an ultrasound echo data segment for another moment for a point in the greatest correlation with the selected point to obtain a peristaltic displacement of the selected point between the two moments as disclosed in Massimo in order to allow the user to track and estimate the displacement of the endometrium over time. Tracking and estimating the displacement of tracking points corresponding to the endometrium is one of a finite number of techniques which can be used to assess the displacement of the endometrium during a preset time length with a reasonable expectation of success, therefore, it would be obvious to include this step within the method of Kunz in order to properly assess the movement of the endometrium.
Regarding claim 8, Kunz in view of Hisanori discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kunz teaches “wherein calculating a peristaltic parameter of the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length comprises: […] obtaining the propagation direction of the peristalsis according to the order in which the points in the endometrium reach a preset motion parameter (“To obtain a precise estimation of the frequency of the contraction waves, the tape was replayed at five times the regular speed. This also facilitated the determination of the wave direction (cervico-fundal versus fundo-cervical peristalsis)” [Page 628: Vaginal sonography of uterine peristalsis, Lines 5-9]. Therefore, since the tape is replayed at five time the regular speed to facilitate the determination of the wave direction (i.e. the peristaltic/contraction wave), the method involves calculating a peristaltic parameter of the endometrium based on the peristaltic displacement of the point in the endometrium within the preset time length (i.e. 5 minutes (see [Page 628: Vaginal sonography of uterine peristalsis, Lines 1-5]) and involves obtaining the propagation direction of the peristalsis according to the order in which the points in the endometrium reach a preset motion parameter (i.e. cervico-fundal or fundo-cervical peristalsis).).
However, Kunz in view of Hisanori does not teach wherein calculating a peristaltic parameter of the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length comprises: “calculating a motion parameter of the point in the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length, the motion parameter comprising at least one of maximum peristaltic displacement, minimum peristaltic displacement, average peristaltic displacement, and total significant movement time”.
Massimo teaches “calculating a motion parameter of the point in the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length, the motion parameter comprising at least one of maximum peristaltic displacement, minimum peristaltic displacement, average peristaltic displacement, and total significant movement time” (“In reality, the endometrium does not hold a fixed location due to the probe manipulation and the global movement of the myometrium. To make sure that the dots-map can always follow and cover the same part of the endometrium chosen in the first frame, a fast block matching algorithm […] may be applied block to the start and end points of the endometrium line. The principle of block matching is to choose an NxM in the reference frame and then search for its new position in the next frame by minimizing a cost function (error metrics) within the entire predefined search area, see Figure 2. The search area can be defined based on the maximum expected tissue displacement between two subsequent frames. The position where the highest similarity (HS) is found is then considered as the best match” [Page 7, Lines 23-26]. This global movement of the myometrium, and thus the endometrium, is the result of peristaltic movement. Therefore, since the search area used to perform endometrium tracking is defined based on the maximum expected tissue displacement (i.e. maximum peristaltic displacement) between two subsequent frames, the method involves calculating a motion parameter of the point in the endometrium based on the peristaltic displacement of the point in the endometrium within the preset time length, the motion parameter comprising at least one of maximum peristaltic displacement (i.e. maximum expected tissue displacement).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kunz in view of Hisanori so as to include calculating a motion parameter, the motion parameter comprising at least one of maximum peristaltic displacement (i.e. the maximum expected tissue displacement) as disclosed in Massimo in order to allow the physician to assess the movement experienced by the endometrium. The endometrium (i.e. contained within the uterus) experiences contractions (i.e. peristalsis), so defining the search area (i.e. of the image) based on the maximum expected tissue displacement will allow for the assessment of a point within the endometrium during a scan session. A statistical quantity of peristaltic displacement (i.e. maximum expected tissue displacement)/motion parameter is one of a finite number of quantities which can be used to assess the movement of an endometrium with a reasonable expectation of success. Therefore, it would be obvious to one of ordinary skill in the art to modify the method of Kunz to include calculating a motion parameter such as the maximum peristaltic displacement, so that this peristaltic parameter can be provided to a physician for assessment of the patient.
Regarding claim 9, Kunz in view of Hisanori and Massimo discloses all features of the claimed invention as discussed with respect to claim 8 above, and Hisanori further teaches “wherein after the propagation direction of the peristalsis is obtained, the method further comprises: obtaining the propagation speed of the peristalsis based on a distance between at least two points in the propagation direction and a time difference between moments at which the two points reach the preset motion parameter” (“In step S11, the operator designates the calculation direction of the phase gradient by designating, from the input device 11, two points on the phase image of the frequency component determined to reflect the uterine peristalsis” [Page 16, Para. 4, Lines 1-3]. “When obtaining the speed of uterine peristalsis, the operator selects two points in the image from the input device 11 in any of the phase image (step S8), the phase gradient distribution image (step S13),and the overlay image (step S15). Is input as a speed measurement point (step S16). In response to this, a difference (phase difference) in phase data between the two input velocity measurement points is obtained (step S17), and the velocity of the peristaltic motion is obtained using this phase difference (step S18). Then, the calculated speed of the peristaltic movement is displayed on the display 13 (step S19)” [Page 16, Para. 5, Lines 1-7]. Therefore, since the user designates the calculation direction (i.e. corresponding to the propagation direction) in step S11 and the following steps S17-S18 are performed to determine the velocity/speed of the peristaltic movement, the method involves, after the propagation direction of the peristalsis is obtained, obtaining the propagation speed of the peristalsis based on a distance between at least two points in the propagation direction and a time difference between moments at which the two points reach the preset motion parameter.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kunz so as to include displaying the peristaltic parameter (i.e. the speed of peristaltic movement/the propagation speed of peristalsis) as disclosed by Hisanori in order to provide more information about uterine peristalsis and to support image diagnosis more effectively” [See Hisanori: [Page 7, Para. 2, Lines 1-5]). Although Hisanori utilizes a different imaging modality than Kunz, one of ordinary skill in the art would recognize that since both of these imaging modalities can be used to visualize peristaltic movement, it would be obvious to substitute one imaging modality for another when performing imaging to assess uterine peristalsis. Furthermore, obtaining the propagation speed of the peristalsis is one of a finite number of techniques which can be used to assess the peristaltic movement of the patient’s endometrium. Therefore, by displaying the peristaltic parameter calculated in Kunz according to the method of Hisanori, more information can be provided to a physician for use in image diagnosis.
Regarding claim 10, Kunz in view of Hisanori and Massimo discloses all features of the claimed invention as discussed with respect to claim 8 above, and Hisanori further teaches “wherein after the motion parameter of the point in the endometrium is calculated, the method further comprises: determining whether the motion parameter of the point in the endometrium exceeds a preset parameter threshold; and using a region formed by points with the motion parameter exceeding the parameter threshold as the peristalsis range” (“In the above-described embodiment, in order to select the frequency component corresponding to the uterine peristalsis, the maximum amplitude frequency distribution image is displayed on the display 13, and the frequency component for which the amplitude image and the phase image are to be created is determined by the operator. […] In addition, the frequency component selection processing unit 46 automatically selects one or a plurality of frequency components corresponding to maximum amplitude data equal to or greater than a predetermined threshold as frequency components having a high probability of corresponding to uterine peristalsis” [Page 21, Para. 6, Lines 1-12]. The maximum amplitude data corresponds to the maximum peristaltic displacement of the endometrium/tissue. In this case, when the frequency component corresponding to the maximum amplitude data is equal to or greater than a predetermined threshold, this frequency component has a high probability of corresponding to the peristalsis range (i.e. to uterine peristalsis). Therefore, since the frequency component selection processing unit automatically selects one or a plurality of frequency components which correspond to maximum amplitude data equal to or greater than a predetermined threshold and those frequency components have a high probability of corresponding to uterine peristalsis, the method further comprises determining whether the motion parameter of the point in the endometrium exceeds a preset parameter threshold, and using a region formed by points within the motion parameter exceeding the parameter threshold as the peristalsis range (i.e. corresponding to the frequency component(s) with a high probability of uterine peristalsis, since they equal or exceed the predetermined threshold.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kunz so as to include determining whether the motion parameter of the point in the endometrium exceeds a preset parameter threshold as disclosed by Hisanori in order to provide more information about uterine peristalsis and to support image diagnosis more effectively” [See Hisanori: [Page 7, Para. 2, Lines 1-5]). Although Hisanori utilizes a different imaging modality than Kunz, one of ordinary skill in the art would recognize that since both of these imaging modalities can be used to visualize peristaltic movement, it would be obvious to substitute one imaging modality for another when performing imaging to assess uterine peristalsis. Furthermore, determining whether a motion parameter (i.e. such as the maximum peristaltic displacement as determined in Massimo) exceeds a preset threshold is one of a finite number of techniques which can be used to assess the peristaltic movement of the patient’s endometrium. Therefore, it would be obvious to one of ordinary skill in the art to modify the method of Kunz so as to include determining whether the motion parameter exceeds a present parameter threshold as disclosed in Hisanori in order to provide a physician with more information for use in image diagnosis.
Claim(s) 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kunz, G et al., "The dynamics of rapid sperm transport through the female genital tract: evidence from vaginal sonography of uterine peristalsis and hysterosalpingoscintigraphy", (1996), Human Reproduction, Vol. 11, no. 3, pp. 627-632. “Kunz” and further in view of Hisanori et al. JP 2006263282 A “Hisanori” as applied to claim 1 above, and further in view of Meirzon et al. "A new method for analysis of non-pregnant uterine peristalsis using transvaginal ultrasound" (2011) Ultrasound Obstet Gynecol, vol. 38, pages 217-224 “Meirzon”.
Regarding claims 7 and 11, Kunz in view of Hisanori discloses all features of the claimed invention as discussed with respect to claim 1, however, the combination does not teach “wherein calculating a peristaltic parameter of the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length comprises: generating a relationship curve of the peristaltic displacement versus time or a relationship curve of the peristaltic velocity versus time based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length; and calculating at least one of the amplitude of the peristalsis, the frequency of the peristalsis, and the total significant movement time within the preset time length based on the relationship curve” (Claim 7) or “wherein displaying the peristaltic parameter comprises: displaying a relationship curve of the peristaltic parameter versus time” (Claim 11).
Meirzon is within the same field of endeavor as the claimed invention because it discloses a method for analysis of uterine peristalsis using transvaginal sonography (TVS) (see [Abstract]).
Meirzon teaches “wherein calculating a peristaltic parameter of the endometrium based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length comprises: generating a relationship curve of the peristaltic displacement versus time or a relationship curve of the peristaltic velocity versus time based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length; and calculating at least one of the amplitude of the peristalsis, the frequency of the peristalsis, and the total significant movement time within the preset time length based on the relationship curve” (“Figure 4 Motility of upper (green line) and lower (magenta line) endometrium-myometrium interfaces about the cavity centerline at ζ = 7.5 mm from the fundus (Subject 2, Day 12), y represents distance from cavity centerline. Unperturbed widths
W
0
U
and
W
0
L
and amplitudes
A
U
and
A
L
of motility are shown by solid and dashed lines, respectively” [Page 219, Figure 4]. In this case, the y variable represents the peristaltic displacement; while the amplitudes
A
U
and
A
L
represent the amplitude of the peristalsis. Therefore, since the displacement is displayed over time and the amplitudes
A
U
and
A
L
are displayed, the method involves: generating a relationship curve of the peristaltic displacement versus time or a relationship curve of the peristaltic velocity versus time based on the peristaltic displacement or the peristaltic velocity of the point in the endometrium within the preset time length; and calculating at least one of the amplitude of the peristalsis, the frequency of the peristalsis, and the total significant movement time within the preset time length based on the relationship curve. Furthermore, since the plot shown in Figure 4 is generated, the method involves displaying a relationship curve of the peristaltic parameter versus time.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kunz in view of Hisanori so as to include generating a relationship curve of the peristaltic displacement versus time and calculating the amplitude of the peristalsis based on the relationship curve and displaying a relationship curve of the peristaltic parameter versus time as disclosed in Meirzon in order to provide a physician with a visual representation of the patient’s peristaltic parameter for use in assessing the status of the patient. Generating/displaying a relationship curve between peristaltic displacement (i.e. distance from cavity centerline, see FIG. 4 of Meirzon, peristaltic parameter) versus time and determining the amplitude (i.e.
A
U
and
A
L
) of the peristalsis based on that plot, is one of a finite number of techniques which can be used to provide physician with a visual representation with which an assessment of a patient’s peristalsis can be performed, with a reasonable expectation of success. Therefore, it would be obvious to modify the method of Kunz to perform the steps disclosed in Meirzon in order to allow the physician to assess the patient with a visual representation of the peristaltic parameter.
Conclusion
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797