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.
No claim elements are interpreted under 112(f).
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 26-27 and 34-38 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.
In regard to Claim 26, the first window is claimed as proximal to a second distal window as set forth in claim 21, the first window having a first maximum height greater than a second maximum height of the second window. The first window appears to refers to window 149C in Figure 9B. The claim recites that the first and second gap of claim 25 makes up a part of the first window. However, the gaps as recited appear to refer to that of window 149A-B such that the windows include a portion of the gaps. Window 149C does not appear to have any gaps that form part of the window as shown in Figure 9B. Since as best understood the first window is 149C, Claim 26 does not appear supported by the disclosure. However, if support exists, applicant is requested to show where said limitation is disclosed to clarify
In regard to Claim 27, the first window is claimed as proximal to a second distal window as set forth in claim 21, the first window having a first maximum height greater than a second maximum height of the second window. The first window appears to refers to window 149C in Figure 9B. However, Claim 27 recites that the first window is parallelogram shaped, which is disclosed as referring to windows 149A-B (0055 published spec). Since as best understood the first window is 149C, Claim 27 does not appear supported by the disclosure. However, if support exists, applicant is requested to show where said limitation is disclosed to clarify.
In regard to Claim 34, the recitation of “a maximum height of the second window is greater than a maximum height of the of the first window” does not appear supported by the disclosure. For example, Figure 9B appears to show the second window, which is defined by 149B per the claim, having a maximum height that is less than the maximum height of the first window, which is defined by 149C per the claim. Therefore, the claim does not appear supported by the disclosure. However, if support exists, applicant is requested to show where said limitation is disclosed to clarify.
In regard to Claim 37, the recitation that the first window (defined as 149C per the claim) is a parallelogram shaped does not appear supported by the disclosure. Paragraph 0055 of the filed specification states that “Each window 149A, 149B may be substantially parallelogram shaped.” Figure 9B of the disclosure echoes said disclosure with window 149A, 149B depicted as parallelogram shaped but window 149C as not. However, if support exists, applicant is requested to show where said limitation is disclosed to clarify.
Claims 35-36 and 38 are rejected by virtue of dependence on Claim 34.
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.
Claim(s) 21, 24, 25, 29, 30, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adkisson et al (US Pub No. 20170071585 – cited by applicant).
In regard to Claim 21, Adkisson et al disclose a biopsy forceps device, comprising:
an end effector 10, wherein the end effector includes a first jaw 14 and a second jaw 16 (0030),
wherein the first jaw opposes the second jaw, wherein the first jaw and the second jaw are coupled together and configured to move from an open configuration – Figure 7 – to a closed configuration, best seen in Figure 8,
wherein the first jaw includes a first edge and the second jaw includes a second edge, best seen in Figure 8, and
wherein at least a portion of the first edge contacts at least a portion of the second edge in the closed configuration of the end effector, best seen in Figure 8,
wherein the first jaw includes a first plurality of teeth 36 each having a base and a peak, best seen in Figure 5 and 7-8 (0030), wherein and the second jaw includes a second plurality of teeth each having a base and a peak, best seen in Figure 5 and 7-8 (0030), and
wherein, in the closed configuration of the end effector:
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a first window A is defined between the first edge of the first jaw and the second edge of the second jaw, see Figure 8 as annotated above,
wherein the first window has a first maximum height (height of window A goes from the top and along the entire right-side straight edge of the proximalmost tooth), best seen in Figure 8 as annotated above, and
a second window C is defined between the first edge of the first jaw and the second edge of the second jaw, wherein the second window is distal to the first window, best seen in Figure 8 as annotated above,
wherein the second window has a second maximum height (height of window C does from the top to the left-side straight edge of the top jaw), best seen in Figure 8 as annotated above,
wherein the first maximum height is greater than the second maximum height due to the height of the left-side straight edge of the top jaw ending higher up (thus defining the bottom of window C) than the bottom point of the proximalmost tooth (thus defining the bottom of window A), best seen in Figure 8 as annotated above.
24. The biopsy forceps device of claim 21, wherein the first window A is proximal to a proximalmost tooth of the first plurality of teeth and the proximalmost tooth of the second plurality of teeth, best seen in Figure 8 as annotated above.
25. The biopsy forceps device of claim 21, wherein a first gap is formed between a portion of the first edge that extends between the base of a proximalmost tooth of the first plurality of teeth (corresponding to window C) and the base of a second-most proximal tooth of the first plurality of teeth (corresponding to window B), and wherein a second gap is formed between a portion of the second edge that extends along the peak of a proximalmost tooth of the second plurality of teeth (forming the boundary of window B), best seen in Figure 8 as annotated above.
29. The biopsy forceps device of claim 21, wherein the first plurality of teeth 36 (not counting tooth 38a) are arranged on the first jaw to be symmetric about a longitudinal axis of the end effector, best seen in Figure 5 (0030), and the second plurality of teeth are arranged on the second jaw to be symmetric about the longitudinal axis, best seen in Figure 6.
30. The biopsy forceps device of claim 21, wherein at least one of the first jaw 14 and the second jaw 16 includes an aperture that extends between a substantially curved interior surface and a convex outer surface of each respective jaw, best seen in Figure 5.
33. The biopsy forceps device of claim 21, wherein a width of the first window A is greater than a width of the second window C – the left to right dimension of Window A is longest given the shape, best seen in Figure 8 as annotated above.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Adkisson et al as applied to Claim 21 above, further in view of Michelini et al (US Pat No. 11337715).
In regard to Claim 22, Adkisson et al disclose a third window B defined between the first edge of the first jaw and the second edge of the second jaw in the closed configuration, best seen in Figure 8 as annotated above. Window B is shown distal to window A.
However, Adkisson et al do not expressly disclose the third window is distal to the first window and the second window, wherein the third window has a third maximum height, and wherein the third maximum height is greater than the second maximum height.
Michelini teach that it is well-known in the art to provide an analogous biopsy forceps device comprising an end effector with a first jaw 20 and second jaw 22, each jaw having a plurality of teeth, each having a base and a peak, wherein, in the closed configuration of the biopsy forceps, a window is defined between a first edge of the first jaw and a second edge of the second jaw, in the same manner as Adkisson et al, best seen in Figure 5-6.
Michelini teach third window 100 being distal to second window 102 and first window 104, 106, best seen in Figure 6, and the third window has a third maximum height, and wherein the third maximum height is greater than the second maximum height – “large tear-drop shaped area 100 near the distal tip 74, two smaller, intermediate positioned and similar shaped areas 102, 104, and a circular shaped area 106 at the rear of the teeth… gap 100 may define an object capture area for the grasping device” (Col.7: 25-39), best seen in Figure 6.
Thus, Michelini et al teach the third distal window as defined having the third maximum height is greater than the second maximum height as an effective configuration for the end effector to provide an effective object capture area for the biopsy forceps device, since the third window is the most distal and would be where most of the tissue is grasped during use. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention of filing to modify Adkisson et al such that the third window is distal to the first window and the second window, wherein the third window has a third maximum height, and wherein the third maximum height is greater than the second maximum height as taught by Michelini et al to effectively provide an effective object capture area for the biopsy forceps device, since the third window is the most distal and would be where most of the tissue is grasped during use.
23. Adkisson et al teach a width of the second window B is equal to a width of the third window A, best seen in Figure 8 as annotated above.
Claim 27 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Adkisson et al in view of Bales (US Pub No. 20060184198 – cited by applicant).
In regard to Claim 27, Adkisson et al disclose the end effector is in the closed configuration above but do not expressly disclose the first window is parallelogram shaped.
Bales et al teach that it is well-known in the art to provide an analogous biopsy forceps device comprising an end effector with a first jaw and second jaw, each jaw having a plurality of teeth, each having a base and a peak, wherein, in the closed configuration of the biopsy forceps, a window is defined between a first edge of the first jaw and a second edge of the second jaw, in the same manner as Adkisson et al, wherein the window is parallelogram shaped due to the slanted sides of the teeth, best seen in Figure 59 as replicated below. The arrow in the annotated drawing points to the parallelogram shaped window.
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The window is formed by gaps in teeth 3292, best seen in Figure 55, with “such a configuration allows the captured tissue in the mouth portion 321 to flow or bulge out of the resulting spaces and, therefore, makes room for more tissue to be captured as the biopsy sample. Gaps at these junctions also provides the second benefit of minimizing edges that can scrape or otherwise damage the working channel of an endoscope as the end effector passes therethrough.”
Thus, Bales et al teach that the parallelogram shaped window effectively provides more room for the biopsy sample as well as minimizing edges on the end effector as it passes through the endoscope. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Adkisson et al such that the first window is parallelogram shaped as taught by Bales as an equally as effective configuration for the window that effectively provides more room for the biopsy sample as well as minimizing edges on the end effector as it passes through the endoscope.
32. Adkisson et al disclose a proximalmost tooth of the first plurality of teeth 36 (on top jaw 14) has a first height relative to the portion of the first edge that extends between the base of the proximalmost tooth and the base of a second-most proximal tooth of the first plurality of teeth, best seen in Figure 8, wherein the second-most proximal tooth has a second height relative to the portion of the first edge that extends between the base of the proximalmost tooth and the base of the second-most proximal tooth, best seen in Figure 8.
However, Adkisson et al do not expressly disclose the first height is less than the second height, in other words, that the second-most proximal tooth is longer than the proximalmost tooth.
Bales et al teach the distal-most teeth are larger, i.e. longer or with a greater height, than proximal teeth to effectively enable grabbing and cutting of the tissue (0175). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Adkisson et al such that the first height is less than the second height or, in other words, that the second-most proximal tooth is longer than the proximalmost tooth of the first plurality of teeth as suggested by Bales et al as an obvious change in the size of the tooth to enable more grabbing and cutting of the tissue of the second-most proximal tooth relative to the proximalmost tooth, wherein a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Adkisson et al as applied to Claim 21 above, further in view of Kaneko et al (US Pub No. 20150148803 – cited by applicant).
Adkisson et al disclose at least one tooth 36 of the first plurality of teeth has a triangular shape, best seen in Figure 5, wherein at least one tooth of the second plurality of teeth has a triangular shape, best seen in Figure 6-8.
However, Adkisson et al do not expressly disclose at least one tooth of the first plurality of teeth and at least one tooth of the second plurality of teeth has a trapezoidal shape.
Kaneko et al teach that it is well-known in the art to provide an analogous biopsy forceps device comprising at least a first tooth 35 from a plurality of teeth on both a first and second jaw that is generally trapezoidal shape such that it is better able to grasp the tissue between the surface of said trapezoidal teeth on the first and second jaw, best seen in Figure 1, 3-6 – “in a state where the teeth 35 of the first region 33A with the top surfaces 35a formed to be unsharp are in contact with the subject tissue reliably held between a pair of forceps pieces 30” (0028, 0031, 0039).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Adkisson et al such that at least one tooth from the plurality of teeth on both the first and second jaw has a trapezoidal shape as taught by Kaneko et al, to effectively provide a shape for the teeth to better grasp the tissue during use.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Adkisson et al in view of Haack et al (US Pub No. 20160256140 – cited by applicant).
Adkisson et al disclose the second plurality of teeth 36 are arranged on the second jaw as shown in Figure 8 but do not expressly disclose that a plane extending along an edge of a peak of (1) one or more teeth of the second plurality of teeth positioned at a distal end of the second jaw and (2) one or more second teeth positioned at a proximal end of the second jaw is inclined with respect to a horizontal plane by an angle of 1-5 degrees.
It is noted that applicant does not appear to disclose any criticality toward said specific angle as solving a particular problem, conferring a specific advantage, or providing a desired result other than being a possible configuration for said feature given the sizes of the teeth at the distal end vs the proximal end of the jaws.
Haack et al teach that it is well-known in the art to provide an analogous biopsy forceps device comprising an end effector with a first jaw and second jaw 300, each jaw having a plurality of teeth, wherein the plurality of teeth 302, 304, 306, 308, 310, 312, 314, 316 are arranged in said second jaw such that a plane extending along an edge of a peak of (1) one or more teeth of the second plurality of teeth positioned at a distal end of the second jaw and (2) one or more second teeth positioned at a proximal end of the second jaw is inclined with respect to a horizontal plane, best seen in Figure 11a, to effectively provide progressively longer teeth distally in the second jaw as an effective configuration for the teeth (0046). Figure 11a does not provide a value for the incline, but it does provide values for the increase in each tooth height from the proximal to distal position in the second jaw.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Adkisson et al such that a plane extending along an edge of a peak of (1) one or more teeth of the second plurality of teeth positioned at a distal end of the second jaw and (2) one or more second teeth positioned at a proximal end of the second jaw is inclined with respect to a horizontal plane as taught by Haack et al to effectively provide larger teeth distally in the jaw as an effective configuration for said teeth during use, wherein it would have been obvious to a skilled artisan to have the incline be an angle of 1-5 degrees as an obvious relative size of the distal teeth at the front end of the jaw relative to the proximal teeth at the rear end of the second jaw, respectively, wherein a skilled artisan would be motivated through routine experimentation to come up with those sizes for the desired effect.
Claims 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Adkisson et al (US Pub No. 20170071585 – cited by applicant) in view of Bales (US Pub No. 20060184198 – cited by applicant).
In regard to Claim 39, Adkisson et al disclose a biopsy forceps device, comprising:
an end effector 10, wherein the end effector includes a first jaw 14 and a second jaw 16 (0030),
wherein the first jaw opposes the second jaw, wherein the first jaw and the second jaw are coupled together and configured to move from an open configuration – Figure 7 – to a closed configuration, best seen in Figure 8,
wherein the first jaw includes a first edge, wherein the second jaw includes a second edge, best seen in Figure 8, and
wherein at least a portion of the first edge contacts at least a portion of the second edge in the closed configuration of the end effector, best seen in Figure 8,
wherein the first jaw includes a first plurality of teeth 36 each having a base and a peak, best seen in Figure 5 and 7-8 (0030), wherein and the second jaw includes a second plurality of teeth each having a base and a peak, best seen in Figure 5 and 7-8 (0030),
wherein, in the closed configuration of the end effector:
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a first window A (see annotated Figure 8 above) is defined between the first edge of the first jaw and the second edge of the second jaw, best seen in Figure 8 as annotated above,
wherein the first window has a first maximum width (left to right dimension of window A), and
a second window B is defined between the first edge of the first jaw and the second edge of the second jaw, best seen in Figure 8 as annotated above,
wherein the second window is distal to the first window, wherein the second window has a second maximum width (left to right dimension of window B), best seen in Figure 8 as annotated above; and
a third window C is defined between the first edge of the first jaw and the second edge of the second jaw, best seen in Figure 8 as annotated above,
wherein the third window is distal to the first window and the second window, wherein the third window has a third maximum width (left to right dimension of window C), best seen in Figure 8 as annotated above, and
wherein the first maximum width is greater than each of the second maximum width and the third maximum width (the left to right dimension of Window A is longest given the shape), best seen in Figure 8 as annotated above.
However, Adkisson et al do not expressly disclose the first window is parallelogram shaped.
Bales et al teach that it is well-known in the art to provide an analogous biopsy forceps device comprising an end effector with a first jaw and second jaw, each jaw having a plurality of teeth, each having a base and a peak, wherein, in the closed configuration of the biopsy forceps, a window is defined between a first edge of the first jaw and a second edge of the second jaw, in the same manner as Adkisson et al, wherein the window is parallelogram shaped due to the slanted sides of the teeth, best seen in Figure 59 as replicated below. The arrow in the annotated drawing points to the parallelogram shaped window.
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The window is formed by gaps in teeth 3292, best seen in Figure 55, with “such a configuration allows the captured tissue in the mouth portion 321 to flow or bulge out of the resulting spaces and, therefore, makes room for more tissue to be captured as the biopsy sample. Gaps at these junctions also provides the second benefit of minimizing edges that can scrape or otherwise damage the working channel of an endoscope as the end effector passes therethrough.”
Thus, Bales et al teach that the parallelogram shaped window effectively provides more room for the biopsy sample as well as minimizing edges on the end effector as it passes through the endoscope. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Adkisson et al such that the first window is parallelogram shaped as taught by Bales as an equally as effective configuration for the window that effectively provides more room for the biopsy sample as well as minimizing edges on the end effector as it passes through the endoscope.
40. Adkisson et al as modified disclose a proximalmost tooth of the first plurality of teeth 36 (on top jaw 14) has a first height relative to the portion of the first edge that extends between the base of the proximalmost tooth and the base of a second-most proximal tooth of the first plurality of teeth, best seen in Figure 8, wherein the second-most proximal tooth has a second height relative to the portion of the first edge that extends between the base of the proximalmost tooth and the base of the second-most proximal tooth, best seen in Figure 8.
However, Adkisson et al do not expressly disclose the first height is less than the second height, in other words, that the second-most proximal tooth is longer than the proximalmost tooth.
Bales et al teach the distal-most teeth are larger, i.e. longer or with a greater height, than proximal teeth to effectively enable grabbing and cutting of the tissue (0175). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Adkisson et al as modified by Bales et al such that the first height is less than the second height or, in other words, that the second-most proximal tooth is longer than the proximalmost tooth of the first plurality of teeth as suggested by Bales et al as an obvious change in the size of the tooth to enable more grabbing and cutting of the tissue of the second-most proximal tooth relative to the proximalmost tooth, wherein a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong Q NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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