DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
This action is Non-Final.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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: “biopsy element for” in claims 1, 4-8, 10, 17, 20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 12 is objected to because of the following informalities: abbreviations should be defined prior to usage for clarity: Claim 12 “LED” should be defined in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitation “wherein the distal section of the fluorescence endoscopy element in the biopsy element is axially positionable in a distal position and in a proximal position” renders the claim indefinite. The claim sets forth that the system is the two elements, but as set forth here it appears the two elements form a single element. This makes the metes and bounds of the claim unclear which renders the claim indefinite. Likely, the limitation should read “wherein the distal section of the fluorescence endoscopy element is positioned in the biopsy element and is axially positionable in a distal position and in a proximal position”.
Claim 4 recites the limitation "the pulling back" in line 4. There is insufficient antecedent basis for this limitation in the claim.
The dependent claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-14, 16, 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Der Zaag et al. (Van Der Zaag, US 2017/0319186).
Regarding claim 1 Van Der Zaag teaches a biopsy system comprising:
a biopsy element for taking a sample of tissue to be examined from an organic body (see at least Figures 6-7 collection of elements 10, 20, 30, 50); and
a fluorescence endoscopy element comprising a distal section with a decoupling of stimulation light and coupling of fluorescence light (see at least Figure 7 element 40, [0052]-[0054], [0068], [0076]),
wherein the distal section of the fluorescence endoscopy element in the biopsy element is axially positionable in a distal position and in a proximal position (see at least Figure 7),
wherein for receiving the sample of the tissue to be examined, the biopsy element comprises a receiving space which in the distal position of the distal section of the fluorescence endoscopy element is distally closed and in the proximal position of the distal section of the fluorescence endoscopy element is distally open (see at least Figure 7, interpreted as space inside element 20 which fits element 40, transition of 7B and 7C teaches this).
Regarding claim 2 Van Der Zaag teaches wherein in the distal position the distal section of the fluorescence endoscopy element completely fills the receiving space (see at least Figure 7B).
Regarding claim 3 Van Der Zaag teaches wherein the fluorescence endoscopy element is configured to optionally distally extract stimulation light and inject fluorescence light in the distal position of the distal section of the fluorescence endoscopy element, the proximal position of the distal section of the fluorescence endoscopy element and/or any intermediate position of the distal section of the fluorescence endoscopy element (optional limitations are not required, see also [0058]).
Regarding claim 5 Van Der Zaag teaches wherein a distal end of the distal section of the fluorescence endoscopy element in the distal position closes the receiving space in a flush manner with a distal tip of the biopsy element or distally projects from the distal tip of the biopsy element (see at least Figures 6-7).
Regarding claim 6 Van Der Zaag teaches wherein the distal section of the fluorescence endoscopy element is lockable in the distal position and/or the proximal position relative to the biopsy element (intended use reasonably taught by [0057] where element 40 is essentially fixed relative the element 20 between any actuation, which reasonably reads on lockable).
Regarding claim 7 Van Der Zaag teaches wherein a distal end of the distal section of the fluorescence endoscopy element is mounted rotationally fixed in a defined rotational position around a distal end longitudinal axis in the biopsy element, at least in a distal position (see at least [0057] Figures 6-7).
Regarding claim 8 Van Der Zaag teaches wherein a distal end of the distal section of the fluorescence endoscopy element and a distal tip of the biopsy element are bevelled at a same angle (see at least Figures 6-7).
Regarding claim 9 Van Der Zaag teaches wherein the angle is acute (see at least Figures 6-7, [0045]).
Regarding claim 10 Van Der Zaag teaches wherein a distal end of the distal section of the fluorescence endoscopy element and/or the biopsy element is/are configured as a disposable article for single use (intended use, the structures are capable of being used only once and disposed of).
Regarding claim 11 Van Der Zaag teaches wherein the fluorescence endoscopy element comprises a light guide with proximal coupling in of stimulation light and/or proximal decoupling of fluorescence light, wherein a distal end of the light guide distally extracts the stimulation light and/or distally couples in the fluorescence light (see at least [0053]-[0055], [0066]-[0068]).
Regarding claim 12 Van Der Zaag teaches wherein a distal end of the distal section of the fluorescence endoscopy element has an LED for decoupling stimulation light and/or an image sensor or a photodiode for coupling in fluorescence light (see at least [0076]).
Regarding claim 13 Van Der Zaag teaches wherein the fluorescence endoscopy element is configured to optionally proximally inject a first stimulation light and/or a second stimulation light, wherein the first stimulation light is on average shorter wave than the second stimulation light, and wherein the fluorescence endoscopy element is configured to optionally produce a first image or a first fluorescence signal of a first tissue area from the first fluorescence light stimulated with the first stimulation light and a second image or a second fluorescence signal from a second tissue area from the second fluorescence light stimulated with the second stimulation light (optional limitations are not required, see also Figure 9).
Regarding claim 14 Van Der Zaag teaches wherein proximally, the fluorescence endoscopy element comprises an optical component which is detachably coupleable or firmly coupled to the distal section of the fluorescence endoscopy element, wherein the optical component comprises a beam splitter with an image path side and an illumination path side, wherein to extract the fluorescence light an image sensor or a photodiode is detachably coupleable or firmly coupled to the image path side, and wherein to inject the stimulation light, a light source is detachably coupleable or firmly coupled to the illumination path side (see at least Figure 9, [0066], [0076]-[0077]).
Regarding claim 16 Van Der Zaag teaches wherein the fluorescence endoscopy element comprises an operating unit signal-connected or connectable with the image sensor or the photodiode and/or the light source, wherein the operating unit comprises an optical or acoustic display component, a control and supply component and an operating component (see at least Figure 9, [0066], [0074]-[0077]).
Regarding claim 18 Van Der Zaag teaches wherein the biopsy system is a system for fine-needle biopsy or fine-needle aspiration biopsy (intended use of the system does not limit any structures, see also Figures 6-7, 9, [0081]).
Claims 1, 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fritsch et al. (Fritsch, US 2008/0045859).
Regarding claims 1 and 4, Fritsch teaches a biopsy system comprising:
a biopsy element for taking a sample of tissue to be examined from an organic body (see at least Figure 4A-B element 5); and
a fluorescence endoscopy element comprising a distal section with a decoupling of stimulation light and coupling of fluorescence light (see at least Figures 4A-B element 66),
wherein the distal section of the fluorescence endoscopy element in the biopsy element is axially positionable in a distal position and in a proximal position (see at least Figures 4A-B),
wherein for receiving the sample of the tissue to be examined, the biopsy element comprises a receiving space which in the distal position of the distal section of the fluorescence endoscopy element is distally closed and in the proximal position of the distal section of the fluorescence endoscopy element is distally open (see at least Figures 4A-B, the intended use reasonably reads on the transitions from A-B where the space is interpreted as the space shown in 4B where element 60 is retracted such that chamber 40 and space of retraction further than chamber 40 is present);
wherein the distal section of the fluorescence endoscopy element is guided in a radially sealed manner in the biopsy element, so that in the receiving space, during the pulling back of the distal section of the fluorescence endoscopy element proximally in the biopsy element, a sucking-in effect is produced in the receiving space (see at least 4B, where the pulling back will naturally create a sucking in effect in chamber 40 and the space next to 66 further in than chamber 40 when retraction occurs and reasonably meets the requirements even though the desired function for sampling is through tube 22 some samples will remain in chamber 40 and on element 66 in use).
Claim Rejections - 35 USC § 103
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.
Claims 15, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Zaag et al. (Van Der Zaag, US 2017/0319186) as applied to claim 14 above, and further in view of Zeng et al. (Zeng, US 2014/0023993).
Regarding claim 15, the limitations are met by Van Der Zaag, except the limitations of wherein the optical component further comprises an optical longpass filter which transmits the fluorescence light more strongly to the image path side than the stimulation light, and/or comprises an optical shortpass filter which reflects the fluorescence light more strongly to the image path side than the stimulation light are not directly taught.
Zeng teaches a teaches a related system for imaging which can include endoscopic (see at least [0159]), and teaches optical element can include shortpass filter which reasonably teaches the limitations wherein the optical component further comprises an optical longpass filter which transmits the fluorescence light more strongly to the image path side than the stimulation light, and/or comprises an optical shortpass filter which reflects the fluorescence light more strongly to the image path side than the stimulation light (see at least [0086]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of filtering images of an endoscopy using known filtering techniques to improve images gathered.
Regarding claim 19, the limitations are met by Van Der Zaag in view of Zeng, where Van Der Zaag teaches wherein the fluorescence endoscopy element comprises an operating unit signal-connected or connectable with the image sensor or the photodiode and/or the light source, wherein the operating unit comprises an optical or acoustic display component, a control and supply component and an operating component (see at least Figure 9, [0066], [0074]-[0077]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Van Der Zaag et al. (Van Der Zaag, US 2017/0319186) in view of Zeng et al. (Zeng, US 2014/0023993) as applied to claim 15 above, and further in view of Boppart et al. (Boppart, US 2013/0345558).
Regarding claim 20, the limitations are met by Van Der Zaag in view of Zeng, where Zeng teaches optical components in a console can be included in a handheld device (see at least [0072]), where such components in a handheld would meet the intended multiple use as imaging and biopsy are performed by the handheld features in the proposed modification (see Figures 6-7 of Van Der Zaag), however, the limitations of wherein the optical component as set forth in claim 15 is arranged in a handpiece of the fluorescence endoscopy element to which the distal section of the fluorescence endoscopy element and the biopsy element is/are connected are not directly taught.
Boppart teaches a related system for imaging which can include endoscopic (see at least [0007]), and teaches that optical components can be included in a handheld probe, which reasonably teaches the limitations wherein the optical component is arranged in a handpiece of the fluorescence endoscopy element to which the distal section of the fluorescence endoscopy element and the biopsy element is/are connected (see at least Figure 1, [0038]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange components in a system from one known location to another as is known in the art for optical signal handling in console or handheld components. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Van Der Zaag et al. (Van Der Zaag, US 2017/0319186) as applied to claim 14 above, and further in view of Boppart et al. (Boppart, US 2013/0345558).
Regarding claim 17, the limitations are met by Van Der Zaag, except the limitations of wherein the optical component is arranged in a handpiece of the fluorescence endoscopy element to which the distal section of the fluorescence endoscopy element and the biopsy element is/are connected is not directly taught.
Boppart teaches a related system for imaging which can include endoscopic (see at least [0007]), and teaches that optical components can be included in a handheld probe, which reasonably teaches the limitations wherein the optical component is arranged in a handpiece of the fluorescence endoscopy element to which the distal section of the fluorescence endoscopy element and the biopsy element is/are connected (see at least Figure 1, [0038]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange components in a system from one known location to another as is known in the art for optical signal handling in console or handheld components. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791 ac