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 .
Drawings
The drawings are objected to because Fig. 1 depicts 80a on both ends of the blade 80. The specification defines 80a as the first end and 80b as the opposite leading end of the blade 80. The side opposite the blade holder 82 should be designated “80b” to indicate that it is the opposite leading end rather than the first end. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: [0044] on Page 14 of the specification recites “the front slot 96”. The front slot is designated by the reference number 90, while reference number 96 is used to designate the tissue cavity. Therefore, the specification should be amended to recite “the front slot 90” in [0044].
Appropriate correction is required.
Claim Objections
Claim 12 is objected to because of the following informality: “has and end width” should read “has an end width” (line 2). Appropriate correction is required.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-18 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites “A cutting device for precisely cutting a tissue sample” (line 1), which encompasses a portion of the human body. In order to overcome the rejection, the claim may be amended to recite “A cutting device configured for precisely cutting a tissue sample”. Claims 2-18 are rejected based on their dependence on claim 1.
Claim 2 recites “a force applicator for moving the top plate toward the base plate to apply downward force on the base plate and against a tissue sample” in line 2, which encompasses a portion of the human body. In order to overcome the rejection, the claim may be amended to recite “a force applicator configured for moving the top plate toward the base plate to apply downward force on the base plate and against a tissue sample”.
Claim 5 recited “for reducing or minimizing lateral movement or shifting of a tissue sample” in line 3. which encompasses a portion of the human body. In order to overcome the rejection, the claim may be amended to recite “for reducing or minimizing lateral movement or shifting of a tissue sample”.
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 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “a tissue sample” in line 1, line 15, line 21, and line 35. It is unclear if these recitations of “a tissue sample” are all meant to refer to the same sample, or if these are different samples. Additionally, if these are meant to be different samples, is unclear is “the tissue sample” as recited in line 15 and line 16 are meant to refer to the tissue sample in line 1 or line 15. Further clarification is required. Claims 2-18 are rejected based on their dependence on claim 1.
Claim 2 recites the limitation “a tissue sample” in line 2. It is unclear if this recitation of “a tissue sample” is meant to be the same as the tissue samples in claim 1, or if these are different samples. Additionally, if these are meant to be different samples, is unclear is “the tissue sample” as recited in line 3 is meant to refer to the tissue samples in claim 1 or the tissue sample in claim 2, line 2. Further clarification is required.
Claim 2 recites “applies substantially uniform downward force” in lines 21-22. The term “substantially” in claim 2 is a relative term which renders the claim indefinite. The term “substantially” 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. What degree if uniform downward force is considered “substantial”? Further clarification is required.
Claim 4 recites “the bottom surface” in line 4. It is unclear if this meant to refer to the bottom surface of the top plate, or the bottom surface of the raised layer. Further clarification is required.
Claim 4 recites “a tissue sample” in line 4. It is unclear if this recitation of “a tissue sample” is meant to be the same as the tissue samples in claim 1, or if these are different samples. Further clarification is required.
Claim 5 recites “the raised layer” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites “a tissue sample” in line 3. It is unclear if this recitation of “a tissue sample” is meant to be the same as the tissue samples in claim 1, or if these are different samples. Further clarification is required.
Claim 8 recites “a cavity depth” in line 8. It is unclear if this is meant to refer to the same “cavity depth” recited in claim 1, line 19, or if these are meant to be different cavity depths. Further clarification is required.
Claim 8 recites “a tissue sample” in line 2. It is unclear if this recitation of “a tissue sample” is meant to be the same as the tissue samples in claim 1, or if these are different samples. Further clarification is required.
Claim 12 recites “a tissue” in line 6. It is unclear if this recitation of “a tissue” is meant to be the same as the tissue samples in claim 1, or if these are different samples. Further clarification is required.
Claim 13 recites the limitation "the uniform width" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites “a tissue sample” in line 5. It is unclear if this recitation of “a tissue” is meant to be the same as the tissue samples in claim 1, “the tissue sample” in claim 14 line 2, or if these are different samples. Further clarification is required.
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.
Claims 1, 3-5, 7-9, 11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190178757 A1 (Umihira et al.) Second Example [0060-0067] in view of Umihira’s First Example [0045-0059].
Regarding claim 1, Umihira’s Second Example teaches a cutting device for precisely cutting a tissue sample with increased control and precision to produce a tissue form having desired size and shape ([0006] “a tissue dividing jig for dividing a needle biopsy tissue in a longitudinal direction”), the device comprising:
a body ([0060] “a tissue dividing jig 200”; Figs. 6-7) which comprises:
a base plate extending between a first end and an opposite second end of the body ([0060] “tissue dividing base 201”), and having:
a top surface (Fig. 6 depicts the top side of tissue dividing base 201 facing upward),
a recess having a recess bottom and an open cross-section and which extends, into the base plate, a recess depth which is measured from the top surface of the base plate to the recess bottom ([0060] “sheet-like member 209”; Figs. 6-7 depicts member 209 being recessed into the base 201a),
a front wall and an opposite back wall which form opposite sides of the open cross-section of the recess, each of the front and back walls extending between the first end and the second end of the body and from the top surface of the base plate to the recess bottom, wherein the base plate has a width defined by a distance between outer edges of the front and back walls ([0064] “a perspective view of a tissue dividing base 201A according to a modified example of the tissue dividing jig of this example. In this modified example, a biopsy needle guide 220A provided in the tissue dividing base 201A is longer than the biopsy needle guide 220. By using the biopsy needle guide 220A, fixation of the biopsy needle 120 in the lengthwise direction can be achieved reliably. As a result, it is possible to suppress unintentional movement of the biopsy needle 120 and thus to place a needle biopsy tissue S at a predetermined position on the tissue placement portion 202 more reliably”),
a tissue cavity sized and shaped for receiving a tissue sample therein and which restricts and minimizes movement of the tissue sample thereby facilitating cutting the tissue sample in a controlled, precise and consistent manner, the tissue cavity being positioned within the recess and extending further into the base plate and having a cavity bottom and a cavity depth which is measured from the recess bottom to the cavity bottom ([0060] “The tissue dividing base 201 has a tissue placement portion 202 on which the needle biopsy tissue S is to be placed.”; Figs. 6-7), and
a cutting guide for receiving and guiding a blade while cutting a tissue sample disposed in the tissue cavity, the cutting guide comprising a front slot through the front wall of the base plate, and a corresponding back slot through the back wall of the base plate, the front and back slots having equal lengths, being mirror images of one another, and being oriented in alignment with one another and with the recess bottom in the base plate, ([0060] “The cutting blade set 203 is provided with a cutting blade member 205 and guide portions 20”; [0066]; Fig. 6 depicts an opening in the center of pressing member 215 that is configured to fit blade 206, with biopsy needle guide 221 on the front and back sides that have equal lengths through the depth of the pressing member 215.), and
a top plate which is sized and shaped to cover the top surface and the entire recess of the base plate by extending beyond the open cross-section of the recess ([0060] “a cutting blade member 205 and guide portions 207”); and
an elongate blade having a first end, an opposite leading end, a linear cutting edge extending from the first end to the leading end, and an exposed length of the blade comprising at least a portion of the cutting edge, along the lengths of the aligned front and back slots, from aligned beginning end portions to aligned terminal ends of the aligned front and back slots, which enables precise cutting, along a single plane, of a tissue sample disposed in the tissue cavity ([0062] “The cutting blade member 205 is provided with a cutting blade 206 that extends in the longitudinal direction of the tissue placement portion 202. The cutting blade 206 is disposed at a position where the cutting blade 206 divides the needle biopsy tissue S placed on the tissue placement portion 202 into two fragments in the longitudinal direction”; Fig. 6).
Umihira’s Second Example does not explicitly teach wherein the exposed length extends farther than the width of the base plate for extending through both the front slot and the back slot, and wherein the elongate length of the blade has a width sized to facilitate lateral movement of the blade.
However,
Umihira’s First Example does not explicitly teach wherein the exposed length extends farther than the width of the base plate for extending through both the front slot and the back slot, and wherein the elongate length of the blade has a width sized to facilitate lateral movement of the blade (Fig. 4C depicts blade 106 being elongated from the guide hole; [0053] “moving the cutting blade member 105 along the guide hole 108 of the positioned guide portion 107, the cutting blade 106 is lowered to reach the needle biopsy tissue S (see FIG. 3) and divides the needle biopsy tissue S. At this time, by disposing the cutting blade 106 to be placed at the center of the valley-like recess of the tissue placement portion 102”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught in the Second Example to include an elongated blade to fit along the slots. One would have been motivated to make this modification because this allows the tissue to be divided into two fragments and the blade member to be in a fixed position, as suggested by Umihira [0046, 0053].
Regarding claim 3, Umihira teaches the cutting device of Claim 1, wherein the recess depth is uniform across the recess ([0060] “sheet-like member 209”; Figs. 6-7 depicts member 209 being recessed into the base 201a at a uniform depth).
Regarding claim 4, Umihira teaches the cutting device of Claim 1, wherein the top plate includes a raised layer protruding from a bottom surface of the top plate, the raised layer having a bottom surface with a cross sectional size and shape for being securely and slidably received in the recess of the base plate and for enabling the bottom surface to contact and apply pressure to a tissue sample disposed in the tissue cavity ([0062] “The cutting blade member 205 is provided with a cutting blade 206 that extends in the longitudinal direction of the tissue placement portion 202. The cutting blade 206 is disposed at a position where the cutting blade 206 divides the needle biopsy tissue S placed on the tissue placement portion 202 into two fragments in the longitudinal direction … the cutting blade set 203 is moved toward the tissue dividing base 201.”).
Regarding claim 5, Umihira teaches the cutting device of Claim 1, wherein the bottom surface of the raised layer of the top plate includes a tissue contact feature selected from a rough texture, a plurality of projections, or a combination thereof, for reducing or minimizing lateral movement or shifting of a tissue sample disposed in the cavity during cutting ([0066] “By using the pressing member 215, the sheet-like member 209 is held during the transfer and the cutting of the needle biopsy tissue S to prevent lifting and slippage of the sheet-like member 209, whereby the transfer and the cutting of the needle biopsy tissue S can be performed more smoothly.”).
Regarding claim 7, Kucklick teaches the cutting device of Claim 1, wherein the tissue cavity is sized and shaped to receive and retain a particular type of tissue sample, based on the dimensions of the particular type of tissue sample ([0004] “To avoid such drawbacks, it is conceivable to divide the biopsy tissue after being collected from the needle and before being processed. However, such division after collecting the biopsy tissue requires fairly expert skill and equipment that is not generally available in clinics where biopsies are performed. Furthermore, even if extreme care is taken to divide the biopsy tissue evenly, it is difficult to perform consistent division over the entire length of the core”; [0007] “the cutting blade is disposed at a position where the cutting blade divides the needle biopsy tissue placed on the tissue placement portion into two fragments in the longitudinal direction.”).
Regarding claim 8, Umihira teaches the cutting device of Claim 1, wherein the tissue cavity has a cavity depth selected based on an expected thickness of a tissue sample to be reshaped ([0004]; [0006]; “the tissue dividing base and the cutting blade set have a positioning mechanism that fixes their positions mutually”; [0051] “maintain the three-dimensional structure of the needle biopsy tissue S”; The device is configured to prevent deformation/compression by fixing the position of the components and maintaining the 3D depth of the sample).
Regarding claim 9, Umihira the cutting device of Claim 1, wherein the cavity depth is uniform across the tissue cavity ([0060] “The tissue dividing base 201 has a tissue placement portion 202 on which the needle biopsy tissue S is to be placed.”; Figs. 6-7 depict tissue placement portion 202 being uniform depth).
Regarding claim 11, Umihira teaches the cutting device of Claim 1, wherein each of the front and back slots is horizontally oriented on the front and back walls, respectively, of the base plate ([0063] “the tissue dividing jig 200 is provided with a biopsy needle guide 220.”; [0066] “the biopsy needle guide 221 also can function as a biopsy needle stopper portion.” – Figs. 6-8 depict the slots being horizontally oriented. The claim language does not specify what the horizontal orientation is in reference to, so any direction may be considered horizontal under broadest reasonable interpretation.).
Regarding claim 14, Umihira teaches the cutting device of Claim 1, further comprising one or more spacers for adjusting the cavity depth and thereby allowing controlled cutting of the tissue sample to produce a cut tissue having a desired tissue thickness, each of the one or more spacers having a spacer thickness and being sized and shaped to fit into the tissue cavity, lying flat on the cavity bottom and underneath a tissue sample when the tissue sample is disposed in the tissue cavity ([0054] “As the sheet-like member 109, a filter paper, a pressure-sensitive adhesive sheet, a pressure-sensitive adhesive film, a nonwoven fabric sheet, or the like can be used suitably.”; [0055] “a breathable material such as filter paper may be used.”).
Regarding claim 15, Umihira teaches the cutting device of Claim 1, further comprising an assembly guide for facilitating assembly of the body with the top plate aligned over the base plate in a position in which the top plate entirely covers the recess (Fig. 6; [0060] “he cutting blade set 203 is provided with a cutting blade member 205 and guide portions 207. In this example, the guide portions 207 are formed integrally with the cutting blade member 205”), the assembly guide comprising:
two or more elongate stud guides, each of which is affixed by a first end thereof to the base plate and extends upward, from the top surface of the base plate to an opposite free second end thereof, wherein at least a first one of the two or more elongate stud guides is proximate to the first end of the body and at least a second one of the one or more elongate stud guides is proximate to the second end of the body ([0061] “The positioning mechanism in this example is composed of positioning pins 210 formed on the tissue dividing base 201 and the guide portions 207 formed on the cutting blade member 205. That is, the guide portions 207 function as positioning holes, and positioning of the tissue dividing base 201 and the cutting blade set 203 is achieved by inserting the positioning pins 210 into the guide portions 207 to combine them.”; Fig. 6), and
two or more assembly bores, each of which extends though the top plate and is sized and shaped for receiving therethrough the second end of a respective one of the two or more elongate stud guides, wherein each of the two or more assembly bores is positioned on the top plate in alignment with a corresponding one of the two or more elongate stud guides ([0062] “where the positions of the guide portions 207 coincide with the positions of the positioning pins 210, the positioning pins 210 are inserted into the guide portions 207”; Fig. 6).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 20190178757 A1 (Umihira et al.) Second Example in view of Umihira’s First Example, further in view of US 20160192910 A1 (Kucklick, Theodore R.).
Regarding claim 6, Umihira teaches the cutting device of Claim 5.
Umihira does not explicitly teach wherein the tissue cavity is sized and shaped to receive and retain a meniscus cartilage sample.
However,
Kucklick teaches wherein the tissue cavity is sized and shaped to receive and retain a meniscus cartilage sample ([0006] “a device, system, and method for collecting previously discarded blood, cartilage, synovium, bone, meniscus and other tissue samples”; [0016]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Umihira to include receiving a meniscus cartilage sample. One would have been motivated to make this modification because the meniscus tissue can be harvest from arthroscopic procedures and can be tested for pathogens and other biologic information [Abstract, 0019].
Claims 10 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190178757 A1 (Umihira et al.) Second Example in view of Umihira’s First Example, further in view of US 9533427 B1 (Heintzelman et al.).
Regarding claim 10, Umihira teaches the cutting device of Claim 1.
Umihira does not explicitly teach wherein the blade further includes a blade holder affixed to the first end of the blade and covering a portion of the cutting edge to provide a safe place of the blade for a user to safely hold and move the blade.
However,
Heintzelman teaches wherein the blade further includes a blade holder affixed to the first end of the blade and covering a portion of the cutting edge to provide a safe place of the blade for a user to safely hold and move the blade (Col. 3, line 20 “a first blade block cover 214”; Col. 13, lines 45-59).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Umihira to include a blade holder. One would have been motivated to make this modification because the blade block cover is used to retain the blade and allow for changing of blades for sample collection, as suggested by Heintzelman (Col. 4, lines 45-53, Fig. 6).
Regarding claim 16, Umihira teaches the cutting device of Claim 1.
Umihira does not explicitly teach further comprising a handle which is securely affixed to one of the first end or the second end of the body and provides a safe and ergonomic place for a user to grip and hold the body steady during handling and use of the cutting device.
However,
Heintzelman teaches further comprising a handle which is securely affixed to one of the first end or the second end of the body and provides a safe and ergonomic place for a user to grip and hold the body steady during handling and use of the cutting device (Col. 6, lines 23-28 “Handle 230 may include a mechanism that enables a user of sample cutter 200 to move cutting assembly 208 along the length of slide rail 206. In some implementations, the user may grab handle 230 with a hand and may move cutting assembly 208 along the length of slide rail 206 in order to cut a sample.”, Fig. 4).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Umihira to include a handle. One would have been motivated to make this modification because the handle allows the device to be grabbed with ahand in order to cut a sample, as suggested by Heintzelman (Col. 6, lines 23-28).
Regarding claim 17, Umihira teaches the cutting device of Claim 1.
Umihira does not explicitly teach further comprising three or more stabilizing feet, each of which is affixed at a first end thereof to and extends from a bottom of the base plate.
However,
Heintzelman teaches further comprising three or more stabilizing feet, each of which is affixed at a first end thereof to and extends from a bottom of the base plate (Col. 3, line 26 “a rubber foot 248”; Col. 7, lines 54-57 “Rubber foot 248 may include a mechanism that supports base plate 202 and prevents base plate 202 from sliding on a surface on which sample cutter 200 is placed. In some implementations, rubber foot 248”; Fig. 2).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Umihira to include stabilizing feet. One would have been motivated to make this modification because the rubber feet support the base plate and prevent the base plate from sliding on the surface upon which the sample cutter is placed, as suggested by Heintzelman (Col. 7, lines 54-57).
Regarding claim 18, Umihira teaches the cutting device of Claim 1.
Umihira does not explicitly teach further comprising four stabilizing feet, each of which is affixed at a first end thereof to and extends from a bottom of the base plate, wherein the base plate has a rectilinear shape and each of the four stabilizing feet is affixed proximate a respective comer of the base plate and has a rubber bumper on an end thereof which is opposite the first end for providing a slip resistant contact points with a supporting surface.
However,
Heintzelman teaches further comprising four stabilizing feet, each of which is affixed at a first end thereof to and extends from a bottom of the base plate, wherein the base plate has a rectilinear shape and each of the four stabilizing feet is affixed proximate a respective comer of the base plate and has a rubber bumper on an end thereof which is opposite the first end for providing a slip resistant contact points with a supporting surface (Col. 3, lines 26-27 “a rubber foot 248, a bumper 250”; Col. 7, lines 54-57 “Rubber foot 248 may include a mechanism that supports base plate 202 and prevents base plate 202 from sliding on a surface on which sample cutter 200 is placed. In some implementations, rubber foot 248”; Col. 7, lines 63-67 “Bumper 250 may include a mechanism that prevents carriage 204 (e.g., and cutting assembly 208) from moving past another end of slide rail 206 (e.g., the end of slide rail 206 that is opposite to the end adjacent to grab catch block 236).”; Fig. 2).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Umihira to include stabilizing feet and a bumber. One would have been motivated to make this modification because the rubber feet and bumper support the base plate and prevent the base plate from sliding on the surface upon which the sample cutter is placed and prevent the assembly from moving, as suggested by Heintzelman (Col. 7, lines 54-57, 63-67).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EVELYN GRACE PARK whose telephone number is (571)272-0651. The examiner can normally be reached Monday - Friday, 9AM - 5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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