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 .
Claim Interpretation
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: “a portion for sampling or intervention” in claim 1.
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.
The “portion for sampling or intervention” has been interpreted as a sampling channel as set forth in paragraphs [0023]-[0024] of Applicant’s PG-Pub 2025/0000370, 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.
Claim Objections
Claims 1-17 are objected to because of the following informalities:
In claim 1, in line 1, it is suggested that “Device” be replaced with “A device”.
In claim 1, in line 2 “micro circulation” should be replaced with ---- microcirculation ---.
In claim 1, in line 4, “visionalizati0on” should be replaced with --- visualization ---.
In claim 1, commas should be inserted in line 4, after “choice”, “probe portion” and “visualizat0on portion and in line 5, after “intervention”.
In claim 4, in line 2, “related to the study of the microcirculation” should be replaced with --- for studying the microcirculation ---.
In claim 4, in the last line, “bio markers” should be replaced with --- biomarkers --.
In claim 6, in line 1, --- to --- should be inserted after “addition”.
In claim 6, in lines 2-3, “anti prematurity” should be replaced with --- anti-prematurity---.
In claim 8, in line 2, “related to the study of the microcirculation” should be replaced with --- for studying the microcirculation ---.
In claim 8, in line 2, “allows to” should be changed to --- allows for---.
In claim 8, in line 3, “the” should be deleted.
In claim 9, in line 2, “related to the study of the microcirculation” should be replaced with --- for studying the microcirculation ---.
In claim 9, in line 3, “the” should be deleted.
In claim 10, in line 2, “related to the study of the microcirculation” should be replaced with --- for studying the microcirculation ---.
In claim 10, in line 3, “the” should be deleted.
In claim 11, in line 2, “related to the study of the microcirculation” should be replaced with --- for studying the microcirculation ---.
In claim 12, in line 2, “related to the study of the microcirculation” should be replaced with --- for studying the microcirculation ---.
In claim 12, in line 2, a comma should be inserted after “microcirculation”.
In claim 12, in line 3, “the” should be deleted.
In claim 13, in line 2, “related to the study of the microcirculation” should be replaced with --- for studying the microcirculation ---.
In claim 13, in line 3, “the” should be deleted.
In claim 13, in line 3, “these” should be replaced with ---the changes in the cervical microflow ---.
In claim 14, in line 2, “related to the study of the microcirculation” should be replaced with --- for studying the microcirculation ---.
In claim 14, in line 3, “the” should be deleted.
In claim 14, in line 3, “corelate” should be replaced with ---- correlate ---.
In claim 14, in line 3, “this” should be replaced with ---the changes in the cervical microflow ---.
In claim 15, in line 2, “related to the study of the microcirculation” should be replaced with --- for studying the microcirculation ---.
In claim 15, in line 3, “the” should be deleted.
In claim 16, in line 2, “related to the study of the microcirculation” should be replaced with --- for studying the microcirculation ---.
In claim 17, in line 2, “related to the study of the microcirculation” should be replaced with --- for studying the microcirculation ---.
In claim 17, in line 3, “Uterine Cervix” should be changed to --- uterine cervix ---.
In claim 17, in line “Pre-Eclampsia” should be changed to ---pre-eclampsia ---.
Appropriate correction is required.
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 2-3 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.
With regards to claims 2-3, the claims recite “wherein any combination of elements in an embodiment can be used to reach such areas…” (see lines 3-4 of claim 2) and “the device is used in any embodiment to shorten the time required to develop and test new drugs” (see lines 3-4 of claim 3). Though the specification does refer to different embodiments of the present invention and provides examples of the different embodiments in Figure 3, the claimed “an embodiment” and “any embodiment” is broader than the disclosed embodiments, and therefore the specification fails to provide, in sufficient detail, a description of any and all embodiments that may encompass the claimed “an embodiment” and “any embodiment”. The claims therefore fail to comply with the written description requirement.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 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.
Claims 1-17 are rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
With regards to claims 1-17, the claim(s) are narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited. Examiner emphasizes that the claims are directed to a device/apparatus; however, claims 2-17 appear to describe the apparatus in terms of what the apparatus can be used for and allows for, rather than setting forth further structure for the claimed apparatus. Applicant should consider amending claims to set forth the structure which makes up the device and is configured to perform the claimed functions/uses.
With regards to claim 1, in line 1, the limitation “surface/subsurface” is recited. It is unclear as to whether the slash (/) is referring to “and” or “or”. For examination purposes, Examiner assumes the latter.
With regards to claim 1, in line 2, the limitation “the tumor” is recited. It is unclear as to whether “the tumor” is referring to one of the “tumors” set forth in line 1 or referring to a different tumor. For examination purposes, Examiner assumes the former.
Claim 1 recites the limitation "the body" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the micro circulation" in line 2. There is insufficient antecedent basis for this limitation in the claim.
With regards to claim 1, in line 3, the limitation “other diseases” is recited. The claim does not define the initial elements/diseases in the group of “diseases” and thus the claim is indefinite as the boundary of the “other diseases” group is unclear.
Claim 1 recites the limitation "the per patient therapy" in line 3. There is insufficient antecedent basis for this limitation in the claim.
In claim 1, in lines 1-4, the limitation “wherein the tumor may be located in cavities in the body for studying the micro circulation in other diseases for diagnostic use and to timely select the per patient therapy of choice” is recited, wherein it is unclear as to whether the limitations of “for studying the micro circulation…and to timely select the per patient therapy of choice” are referring to the device (i.e. the device is usable “for studying…” and usable “to timely select…”) or referring to the “tumor” or the “body” as performing the “studying..” and “to timely select”. For examination purposes, Examiner assumes that it is the “device” that is usable “for studying the micro circulation..” and usable “to timely select…”.
Regarding claim 2, the phrase "etc." in line 4 renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "etc."), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
With regards to claim 2, in line 3, the limitation “any combination of elements in an embodiment” is recited. The limitation renders the claim indefinite as (1) it is unclear as to whether the “elements” is referring to elements of the device or elements of some additional structures intended to be used with the device (for examination purposes, Examiner assumes the latter) and (2) the claim(s) include(s) elements not actually disclosed (those encompassed by "any combination of elements in an embodiment"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
In claim 2, in line 4, the limitation “such areas” is recited. It is unclear as to which “areas” is being referred to. For examination purposes, Examiner assumes Applicant is referring to the “surface/subsurface areas” set forth in line 1 of claim 2.
With regards to claim 2, the limitation “wherein surface/subsurface areas are not reachable directly by the device” is recited. It is unclear as to whether the “surface/subsurface” areas correspond to surface/subsurface areas of the tumor or of the patient. For examination purposes, Examiner assumes the former, and in such a case, the above limitation setting forth that the tumor’s surface/subsurface areas are not reachable “directly” by the device appears to conflict with claim 1 which sets forth in line 1 “Device usable directly in tumors” (i.e. how can a tumor’s surface/subsurface areas be “not reachable directly” by the device [as set forth in claim 2] but at the same time the device is usable “directly” in the tumors [as set forth in claim 1]?). For examination purposes, Examiner assumes that Applicant intended to set forth that the device can be used with a laparoscope or a trocar (see last line of claim 2) to directly reach the surface/subsurface areas of the tumors. Note under this interpretation, the Laparoscope, trocar are directed to structures that are intended to be used with the device, but are not part of the claimed device itself.
Claim 3 recites the limitation "the timely decision of per case" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The term “best” in claim 3 is a relative term which renders the claim indefinite. The term “best” 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. As such, it is unclear as to what characteristics of a therapy would render it to be the “best therapy”.
Claim 3 recites the limitation "the time" in line 3. There is insufficient antecedent basis for this limitation in the claim.
With regards to claim 3, the limitation “any embodiment to shorten the time” is recited which renders the claim indefinite as the claim(s) include(s) elements not actually disclosed (those encompassed by “any embodiment”) thereby rendering the scope of the claim(s) unascertainable. For examination purposes, Examiner assumes Applicant intended to set forth that the device is capable of being used to shorten the time required to develop and test new drugs.
Claim 4 recites the limitation "the biochemical markers" in line 3. There is insufficient antecedent basis for this limitation in the claim.
With regards to claim 4, in lines 4-5, the limitation “other case related bio markers” is recited. The claim does not define the initial elements/case related biomarkers in the group of “biomarkers” and thus the claim is indefinite as the boundary of the “other case related bio markers” group is unclear.
With regards to claim 4, in line 4, the limitation “ct-DNA/miRNA” is recited. It is unclear as to whether the slash (/) is referring to “and” or “or”. For examination purposes, Examiner assumes the latter.
Claim 5 recites the limitation "the per patient values" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
The term “best” in claim 5 is a relative term which renders the claim indefinite. The term “best” 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. As such, it is unclear as to what characteristics of a therapy would render it to be the “best personalized therapy for a patient”.
Regarding claim 6, the limitation “(e.g. Chemotherapy)” is recited in line 3, wherein the use of the parenthesis and the use of "e.g." renders the claim indefinite because it is unclear whether the limitation(s) within the parenthesis and following the term “e.g.” are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, Examiner assumes that the limitation is not part of the claimed invention.
With regards to claim 7, the claim includes two periods (see line 2 and the last line), thus rendering the claim indefinite as it is unclear as where the claim ends. For examination purposes, Examiner assumes the claim ends at the first period, wherein the limitations following the first period are not part of the claimed invention. Examiner notes that if the limitations following the first period were considered to be part of the claimed invention, there are multiple indefinite issues (i.e. use of “E.g” and parenthesis which would render such limitations as indefinite as it is unclear whether the limitation(s) within the parenthesis and following the term “e.g.” are part of the claimed invention, wherein for examination purposes, Examiner would assume that the limitations are not part of the claimed invention; see MPEP § 2173.05(d)) that would need to be addressed.
The term “best” in claim 7 (line 2) is a relative term which renders the claim indefinite. The term “best” 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. As such, it is unclear as to what characteristics of a therapy would render it to be the “best personalized therapy”.
In claim 10, in the last line, it is unclear as to what is meant by “related to trial to get FDA for drugs delaying labor”. Assuming “FDA” stands for “Food and Drug Administration”, it is unclear as to what is meant by “…to get [Food and Drug Administration] for drugs delaying labor”. For examination purposes, Examiner assumes that Applicant meant --- related to a trial for drugs for delaying labor---.
The term “best” in claim 12, last line, is a relative term which renders the claim indefinite. The term “best” 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. As such, it is unclear as to what characteristics of a drug would render it to be the “best alternative drug”.
With regards to claim 12, in lines 2-3, the limitation “the device can detect changes…after such induction is started and best alternative drug” is recited, wherein it is unclear as to what is meant by “after such induction is started and best alternative drug”. The claim appears unfinished and Examiner assumes Applicant intended to set forth --- after such in duction is started and best alternative drug is used ---.
Claim 16 recites the limitation "the FDA trials" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 17, line 4, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, Examiner assumes the limitations are not part of the claimed invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Yu (WO 2021/090056).
With regards to claim 1, Yu discloses a device usable directly in tumors with surface/subsurface angiogenesis wherein the tumor may be located in cavities in the body for studying the micro circulation in other diseases for diagnostic use and to timely select the per patient therapy of choice (Abstract; paragraph [0055], referring to the examples of procedures which can be performed with the combined ultrasound and endoscopy systems (CUES), which includes endometrial cancer detection, screening, and/or diagnosis, etc. and can be used to generate three-dimensional images of various organs and body parts, such as ovaries, fallopian tube(s), and various tumors and/or polyps); paragraph [0056], referring to the methods and apparatus being used to treat any tissue of the body and any organ and vessel of the body; Figure 1B) wherein the device comprises
a probe portion (240, 440 or 410) (paragraph [0035], referring to the handheld portion (110) including a cannula (240); paragraphs [0042], [0054], referring to the ultrasound probe assembly (410), or the shaft (440) of the ultrasound probe assembly (410); Figures 2A, 3A, 4A,B),
a visionalizati0on portion (252) (paragraphs [0031], [0035]-[0036], referring to the ultrasound probe head (252) which includes an ultrasound transducer that can be used for general imaging to cover the entire uterus and bladder; Figures 1B, 2A, 3A, 4A,B, 6);
a portion for sampling or intervention (paragraph [0046], referring to the working channel distal port (280) in which standard surgical devices, such as biopsy needles, forceps, snares, etc. may be disposed within; paragraph [0053], referring to the ultrasound image guiding a biopsy tool to collect tissue samples; Figure 6); and
a control station (paragraph [0022], referring to the controller/processor which comprises a tangible medium to store instructions to implements steps of a process; paragraph [0035], referring to mechanisms for controlling the rotation and steering of the probe head (252)).
With regards to the limitations directed to the use of the device (i.e. device “usable directly in tumors with surface/subsurface angiogenesis…for studying the micro circulation in other disease for diagnostic use and to timely select the per patient therapy of choice”), Examiner notes that the claim is directed to a device/apparatus. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114, Section II. Since the device of Yu is capable of being used directly in tumors and can provide images (i.e. via the disclosed needles, forceps, etc. as set forth in paragraph [0046] and further paragraphs [0055]-[0056] set forth that the device can be used in any organ and vessel and used for cancer detection as well as providing three-dimensional images of tumors, etc.; paragraph [0053], referring to the use of the ultrasound image to guide a biopsy tool to collect tissue samples) which can be used to study the micro circulation and guide decisions for therapy, such as timely selection of the per patient therapy of choice, etc., Yu meets the limitation.
With regard to claim 2, Yu discloses that surface/subsurface areas are not reachable directly by the device because the tumors are in internal organs, wherein any combination of elements in an embodiment can be used to reach such areas via Laparoscope, trocars etc. (paragraphs [0054]-[0056], referring to the probe assembly (410) being inserted into the working channel of a conventional reusable rigid, semirigid or flexible hysteroscopes, cystoscope or other conventional endoscopy system, wherein the apparatus can be used to treat any tissue of the body and any organ and vessel of the body, and thus surface/subsurface areas are not reachable directly by the device (410), but when combined with the endoscopy system, the device (410) can be used to reach such areas in an internal organ; Figures 1A-C).
With regards to claims 3-16, the claims set forth limitations which are directed to an intended use of the claimed device/apparatus, wherein a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114, Section II. Specifically, claims 3-16 are directed to the use of the device and/or manner of operating the device (i.e. see claim 3, “the device is used in any embodiment to shorten the time required to develop and test new drugs”; see claim 6, “the device is also used to deliver local anti-tumor…; see claim 9, “the device can monitor changes or lack of changes in the cervical microcirculation…”; see claim 10, “the device can monitor changes or lack of changes in the cervical microcirculation…”; see claim 11, “the device can detect changes associated with successful induction of labor…”, see claim 12, “the device can detect changes in the cervical microcirculation associated with failed induction of labor”; see claim 13, the device can detect changes in the cervical microflow and correlates these with hormonal changes...”; see claim 14, “the device can detect changes in the cervical microflow and correlate this with hormonal changes…”; see claim 15, “the device can detect changes in the microflow in body areas at risk for amputation…”; see claim 16, the device can monitor the effectiveness of new drugs aiming to delay amputation time…”) or what the device allows (i.e. see claim 4, “the device also allows measuring the biochemical markers in the tumor..and correlating this with microcirculation values…”; see claim 8, “the device also allows to detection of changes in the cervical microcirculation…”; ). As set forth in paragraphs [0046], the portion can comprise of biopsy needles, forceps, snares, etc. and further a biopsy tool can be used to collect tissue samples, wherein the ultrasound image can guide the biopsy tool (see paragraph [0053]). Further, Yu discloses that the device can be used to see both surface and inside tissue of organs, can be used to generate three-dimensional images of various organs and body parts, such as ovaries, fallopian tubes, uterus, prostate and various tumors and/or polyps, the device can be used to treat any tissue of the body and any organ and vessel of the body, including the uterus, which includes the cervix, and further the device can be combined with known methods of urological, or gynecological diagnosis, surgery and surgery of other tissues and organs (paragraphs [0054]-[0057]). Yu et al. further disclose that the portion for sampling or intervention can include injection needles (paragraph [0046]). As such, the device of Yu is capable of being used and/or allow the specific functions as set forth in claims 3-16 (i.e. the device can acquire images and/or biopsy samples which can be used to for the timely decision of per case based best therapy, allow measuring the biochemical markers, monitor changes of cervical microcirculation, detect changes, etc.; further, with regards to claim 6, as set forth in paragraph [0046], the portion for sampling or intervention can include injection needles which are capable of being used to deliver any fluid, including anti-tumor or anti-prematurity treatment) and therefore meets the above limitations.
With regards to claim 17, Yu discloses that in addition to the diagnostic use of the device related to the study of the microcirculation, the device can be assembled as a band around the Uterine Cervix in early pregnancy and transmit data predicting PTB and of complications such as Pre-Eclampsia along the way (paragraph [0047], [0051], referring to the cannula having flexible cables that provide for steering or bending of the cannula (740) in multiple directions, and therefore the flexibility of the cannula/probe portion of the device allows the device to be assembled a band around anatomy, such as the uterine cervix; paragraph [0049], referring to the handle portion may comprise components configured to process image data or establish communication with other external devices, wherein the communication may be wireless or wired communication and thus the device can transmit data; Figure 7). With regards to the device being assembled as a band specifically “around the Uterine Cervix in early pregnancy” and that the data transmitted is specifically “data predicting PTB and of complications such as Pre-Eclampsia along the way”, the limitations are directed to an intended use and/or manner of operating the claimed device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114, Section II. Since the device of Yu is capable of being used in the uterus/cervix (paragraph [0055]) and is capable of transmitting any type of data, including data predicting PTB and of complications such as Pre-Eclampsia along the way, Yu meets the limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Landesman et al. (US Pub No. 2021/0007596) discloses a system for imaging and examination of a cervix, comprising an endo-cervical endoscope and including a control module (Abstract; paragraph [0195]; Figure 22A,B).
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798