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 .
This Office action is responsive to an amendment filed June 30, 2025. Claims 11-17 & 28 are pending. Claims 1-10 & 18-27 have been canceled. New claim 28 has been added.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 12 & 15-16 & 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pasternak et al. (US 2014/0377148) (“Pasternak” hereinafter) in view of Jorulf (WO 93/20753), Jarial (US 2012/0022397) further in view of McGhie (US 2013/0102925).
In regards to claim 28, Pasternak discloses a core biopsy tissue sample processing system comprising:
a core biopsy needle 10 that has a distal portion with a cradle 18 comprising an axially extending floor, wherein said cradle 18 is configured to hold a tissue sample that has an exposed axially extending side of the entire length of the tissue sample facing up; and
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an insert (i.e., cassette 140, 260, 360, 400) comprising a strip platform (shown at
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least at figs. 5, 11A, 14A, 15A), a strip (146, 300, 412) of a material thereon configured to dislodge a tissue sample radially outward from said cradle 18 by lightly touching the exposed axially extending side of the tissue sample in a touch-and-go freehand motion in a direction approximately normal to the cradle floor and without a need for an adhesive or a special liquid attracting the sample to the strip (i.e., the Office notes that the biopsy needle and insert of Pasternak is fully capable of being used as claimed since the claimed touch-and-go action is a mere intended use limitation rather than a structural limitation of the claimed system) (see at least par 0024-0025, 0106-0108, 0152-0155, 0160-0162 & 0167-0172).
Pasternak discloses a core biopsy tissue sample processing system, that fails to explicitly teach a system comprising a core biopsy needle that has a central axis and a distal portion that has a cradle with an axially extending floor that is below the central axis and a row of teeth extending up from each lateral side of the cradle floor to a level approximating that of the central axis, without overhanging the floor and with the teeth of each row spaced axially from each other by inter- tooth axial spaces, wherein said cradle is configured to hold a tissue sample between the rows of teeth with an exposed top of the tissue sample extending up above the central axis; wherein the teeth are configured to protect the tissue sample below a top of the teeth from direct compression damage.
However, Jorulf teaches that it is known to provide a system comprising a core
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biopsy needle 10 that has a central axis and a distal portion that has a cradle 16 with an axially extending floor that is below the central axis (see at least abstract, figs. 1-4, pg. 9, lines 4-9 and pg. 10, lines 3-12).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Pasternak comprising a core biopsy needle that has a central axis and a distal portion that has a cradle with an axially extending floor that is below the central axis as taught by Jorulf since such a modification would amount to applying a known technique (i.e., the depth of the cradle as taught by Jorulf) to a known device (i.e., as taught by Pasternak) ready for improvement to achieve a predictable result of receiving a tissue sample therein using such well-known and understood notches in the art of biopsy needles (see at least pg. 10, lines 3-12 of Jorulf)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Pasternak as modified by Jorulf discloses a core biopsy tissue sample processing system, that fails to explicitly teach a system comprising a core biopsy needle that has a row of teeth extending up from each lateral side of the cradle floor to a level approximating that of the central axis, without overhanging the floor, wherein said cradle is configured to hold a tissue sample between the rows of teeth with an exposed top of the tissue sample extending up above the central axis; wherein the teeth are configured to protect the tissue sample below a top of the teeth from direct compression damage.
However, Jarial teaches that it is known to provide a system comprising a core biopsy needle that has a row of teeth 47 extending up from each lateral side of the cradle floor (26, 28) to a level approximating that of the central axis, without overhanging the floor, wherein said cradle (26, 28) is configured to hold a tissue sample between the rows of teeth 47 with an exposed top of the tissue sample extending up above the central axis; wherein the teeth 47 are configured to protect the tissue sample below a top of the teeth 47 from direct compression damage (see at least fig. 11 and par 0033-0034).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Pasternak as modified by Jorulf comprising a core biopsy needle that has a row of teeth extending up from each lateral side of the cradle floor to a level approximating that of the central axis, without overhanging the floor, wherein said cradle is configured to hold a tissue sample between the rows of teeth with an exposed top of the tissue sample extending up above the central axis; wherein the teeth are configured to protect the tissue sample below a top of the teeth from direct compression damage as taught by Jarial since such a modification would amount to applying a known technique (i.e., the plurality of teeth along the sides of the stylet notch as taught by Jarial) to a known device (i.e., the biopsy needle as taught by Pasternak) ready for improvement to achieve a predictable result such as improving cutting performance and preventing severed tissue cores from being compacted when the cannula is retracted so the clinician can visibly observe the true length and physical quality of the cores upon retrieval (see at least par 0033 of Jarial)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Pasternak as modified by Jorulf and Jarial discloses a core biopsy tissue sample processing system, that fails to explicitly teach a system comprising a core biopsy needle with the teeth of each row spaced axially from each other by inter- tooth axial spaces.
However, McGhie teaches that it is known to provide a system comprising a core biopsy needle with the teeth 504a of each row spaced axially from each other by inter- tooth axial spaces (see at least fig. 5 and par 0039-0042).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Pasternak as modified by Jorulf and Jarial with the teeth of each row spaced axially from each other by inter- tooth axial spaces as taught by McGhie since such a modification would amount to applying a known technique (i.e., the inter-tooth axial spaces between the plurality of teeth as taught by McGhie) to a known device (i.e., the biopsy needle as taught by Pasternak) ready for improvement to achieve a predictable result of gripping tissue as the outer cannula is thrown over the stylet (see at least part 0040 of McGhie) even with spaces between the plurality of projections/ridges (see at least par 0040 of McGhie)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 12, Pasternak discloses the core biopsy tissue sample processing system of claim 28, in which said strip (146, 300, 412) comprises fibrous cellulose paper (i.e., such as a mesh film of cellulose esters such as Immobilon-NC Transfer Membrane by Millipore) that is configured to dislodge said tissue sample without adhesives in said freehand, touch-and-go motion (see at least par 0107).
In regards to claim 15, Pasternak discloses the core biopsy tissue sample processing system of claim 28, in which said insert (i.e., cassette 140) includes channels (i.e., spaces between cassette base 142 and cassette cover 144 as shown in fig. 6C) at sides of said strip platform that are open to each other and into which sides of said strip slide (see at least figs. 5 & 6B-C).
In regards to claim 16, Pasternak discloses the core biopsy tissue sample processing system of claim 28, in which said insert (i.e., cassette 140, 260, 360, 400) includes surface features (150, 152, 310, 312) configured to retain said strip (146, 300, 412) in place over said platform (shown at least at figs. 5, 11A, 14A & 15A) (see at least par 0102, 0148 & 0151).
Claim(s) 11 & 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pasternak (‘148) in view of Jorulf (‘753), Jarial (‘397), McGhie (‘925) further in view of Morton et al. (US 2002/0183719) (“Morton” hereinafter).
In regards to claim 11, Pasternak as modified by Jorulf, Jarial and McGhie discloses the core biopsy tissue sample processing system of claim 28, that fails to explicitly teach a system in which said strip comprises Nylon 66 that is electrostatically positively charged sufficiently to dislodge said tissue sample without adhesives in said freehand, touch-and-go motion. However, Morton teaches that it is known to provide a system in which said strip comprises Nylon 66 that is electrostatically positively charged sufficiently to dislodge said tissue sample without adhesives (see at least fig. 4 and par 0061 & 0066-0070). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Pasternak as modified by Jorulf, Jarial and McGhie in which said strip comprises Nylon 66 that is electrostatically positively charged sufficiently to dislodge said tissue sample without adhesives, as taught by Morton, in said freehand, touch-and-go motion as taught by Pasternak since such a modification would amount to a simple substitution of one known element (i.e., as taught by Morton) for another (i.e., as taught by Pasternak) to obtain predictable results such as providing porous or absorptive materials, which may be modified for chemical binding or adsorption properties to facilitate collecting cellular and cellular component samples for cytological exam (see at least par 0061 & 0066 of Morton)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 14, Pasternak as modified by Jorulf, Jarial and McGhie discloses the core biopsy tissue sample processing system of claim 11, that fails to explicitly teach a system in which said strip comprises a polyamide that is electrostatically positively charged sufficiently to dislodge said tissue sample from said cradle 18 by said freehand, touch-and-go motion. However, Morton teaches that it is known to provide a system in which said strip comprises a polyamide (i.e., nylon 66) that is electrostatically positively charged sufficiently to dislodge said tissue sample (see at least fig. 4 and par 0061 & 0066-0070). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Pasternak as modified by Smith in which said strip comprises a polyamide that is electrostatically positively charged sufficiently to dislodge said tissue sample, as taught by Morton, from said cradle by said freehand, touch-and-go motion as taught by Pasternak since such a modification would amount to a simple substitution of one known element (i.e., as taught by Morton) for another (i.e., as taught by Pasternak) to obtain predictable results such as providing porous or absorptive materials, which may be modified for chemical binding or adsorption properties to facilitate collecting cellular and cellular component samples for cytological exam (see at least par 0061 & 0066 of Morton)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pasternak (‘148) in view of Jorulf (‘753), Jarial (‘397), McGhie (‘925) further in view of Sikes et al. (US 2019/0113512) (“Sikes” hereinafter).
Pasternak as modified by Jorulf, Jarial and McGhie discloses the core biopsy tissue sample processing system of claim 28, that fails to explicitly teach a system in which said strip comprises Cellulose Chromatography Paper that is configured to dislodge said tissue sample without adhesives in said freehand, touch-and-go motion.
However, Sikes teaches that it is known to provide a system in which said strip comprises Cellulose Chromatography Paper that is configured to dislodge said tissue sample without adhesives (see at least par 0016, 0026, 0036, 0041, 0043 & 0167).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Pasternak as modified by Jorulf, Jarial and McGhie in which said strip comprises Cellulose Chromatography Paper that is configured to dislodge said tissue sample without adhesives, as taught by Sikes, in said freehand, touch-and-go motion as taught by Pasternak since such a modification would amount to a simple substitution of one known element (i.e., as taught by Pasternak) for another (i.e., as taught by Sikes) to obtain predictable results such as providing a substrate-anchoring domain in a paper-based assay format permits the rapid and oriented adsorption of the antigen-binding protein (see at least par 0167 of Sikes)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pasternak (‘148) in view of Jorulf (‘753), Jarial (‘397), McGhie (‘925) further in view of Snoke et al. (US 2023/0134295) (“Snoke” hereinafter).
Pasternak as modified by Jorulf, Jarial and McGhie discloses the core biopsy tissue processing system of claim 28, that fails to explicitly teach a system in which said insert is configured to fit in an industry-standard biopsy sample cassette that has an interior opening with sides 30-35 mm by 25-30 mm and 4-6 mm depth.
However, Snoke teaches that it is known to provide a system in which said insert 800 is configured to fit in an industry-standard biopsy sample cassette 900 (see at least figs. 8-12B and par 0040-0042).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Pasternak as modified by Jorulf, Jarial and McGhie in which said insert is configured to fit in an industry-standard biopsy sample cassette as taught by Snoke since such a modification would amount to applying a known technique (i.e., as taught by Snoke) to a known device (i.e., as taught by Pasternak) ready for improvement to achieve a predictable result such as facilitating, storage and shipment of the insert to a pathology lab (see at least par 0042 of Snoke)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Pasternak as modified by Jorulf, Jarial, McGhie and Snoke discloses the core biopsy tissue processing system of claim 28, that fails to explicitly teach a system in which the industry-standard biopsy sample cassette has an interior opening with sides 30-35 mm by 25-30 mm and 4-6 mm depth.
However, since Snoke teaches accommodating the insert in an industry-standard biopsy sample cassette (i.e., available from Leica Biosystems Inc. of Buffalo Grove, Ill.) (see at least par 0040), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Pasternak as modified by Jorulf, Jarial, McGhie and Snoke in which the industry-standard biopsy sample cassette has an interior opening with sides 30-35 mm by 25-30 mm and 4-6 mm depth as claimed in order to accommodate the insert therein.
Claim(s) 17 & 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snoke et al. (US 2023/0134295) (“Snoke” hereinafter) in view of Jorulf (WO 93/20753), Jarial (US 2012/0022397) further in view of McGhie (US 2013/0102925).
In regards to claim 28, Snoke discloses a core biopsy tissue sample processing system comprising:
a core biopsy needle A2 that has a distal portion with a cradle A4 comprising an
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axially extending floor, wherein said cradle A4 is configured to hold a tissue sample that has an exposed side (see at least fig. 12A and par 0002); and
an insert 800 comprising a strip platform 808, a strip 840 of a material thereon that is configured to dislodge a tissue sample from said cradle A4 by lightly touching the exposed side of the tissue sample in a touch-and-go freehand motion of the cradle A4 relative to the strip 840, without a need for an adhesive (see at least figs. 8-12B and par 0006-0007, 0038 & 0040-0042).
Snoke discloses a core biopsy tissue sample processing system, that fails to explicitly teach a system comprising a core biopsy needle that has a central axis and a distal portion that has a cradle with an axially extending floor that is below the central axis and a row of teeth extending up from each lateral side of the cradle floor to a level approximating that of the central axis, without overhanging the floor and with the teeth of each row spaced axially from each other by inter- tooth axial spaces, wherein said cradle is configured to hold a tissue sample between the rows of teeth with an exposed top of the tissue sample extending up above the central axis; wherein the teeth are configured to protect the tissue sample below a top of the teeth from direct compression damage.
However, Jorulf teaches that it is known to provide a system comprising a core
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biopsy needle 10 that has a central axis and a distal portion that has a cradle 16 with an axially extending floor that is below the central axis (see at least abstract, figs. 1-4, pg. 9, lines 4-9 and pg. 10, lines 3-12).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Snoke comprising a core biopsy needle that has a central axis and a distal portion that has a cradle with an axially extending floor that is below the central axis as taught by Jorulf since such a modification would amount to applying a known technique (i.e., the depth of the cradle as taught by Jorulf) to a known device (i.e., as taught by Pasternak) ready for improvement to achieve a predictable result of receiving a tissue sample therein using such well-known and understood notches in the art of biopsy needles (see at least pg. 10, lines 3-12 of Jorulf)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Snoke as modified by Jorulf discloses a core biopsy tissue sample processing system, that fails to explicitly teach a system comprising a core biopsy needle that has a row of teeth extending up from each lateral side of the cradle floor to a level approximating that of the central axis, without overhanging the floor, wherein said cradle is configured to hold a tissue sample between the rows of teeth with an exposed top of the tissue sample extending up above the central axis; wherein the teeth are configured to protect the tissue sample below a top of the teeth from direct compression damage.
However, Jarial teaches that it is known to provide a system comprising a core biopsy needle that has a row of teeth 47 extending up from each lateral side of the cradle floor (26, 28) to a level approximating that of the central axis, without overhanging the floor, wherein said cradle (26, 28) is configured to hold a tissue sample between the rows of teeth 47 with an exposed top of the tissue sample extending up above the central axis; wherein the teeth 47 are configured to protect the tissue sample below a top of the teeth 47 from direct compression damage (see at least fig. 11 and par 0033-0034).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Snoke as modified by Jorulf comprising a core biopsy needle that has a row of teeth extending up from each lateral side of the cradle floor to a level approximating that of the central axis, without overhanging the floor, wherein said cradle is configured to hold a tissue sample between the rows of teeth with an exposed top of the tissue sample extending up above the central axis; wherein the teeth are configured to protect the tissue sample below a top of the teeth from direct compression damage as taught by Jarial since such a modification would amount to applying a known technique (i.e., the plurality of teeth along the sides of the stylet notch as taught by Jarial) to a known device (i.e., the biopsy needle as taught by Pasternak) ready for improvement to achieve a predictable result such as improving cutting performance and preventing severed tissue cores from being compacted when the cannula is retracted so the clinician can visibly observe the true length and physical quality of the cores upon retrieval (see at least par 0033 of Jarial)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Snoke as modified by Jorulf and Jarial discloses a core biopsy tissue sample processing system, that fails to explicitly teach a system comprising a core biopsy needle with the teeth of each row spaced axially from each other by inter- tooth axial spaces.
However, McGhie teaches that it is known to provide a system comprising a core biopsy needle with the teeth 504a of each row spaced axially from each other by inter- tooth axial spaces (see at least fig. 5 and par 0039-0042).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Snoke as modified by Jorulf and Jarial with the teeth of each row spaced axially from each other by inter- tooth axial spaces as taught by McGhie since such a modification would amount to applying a known technique (i.e., the inter-tooth axial spaces between the plurality of teeth as taught by McGhie) to a known device (i.e., the biopsy needle as taught by Snoke) ready for improvement to achieve a predictable result of gripping tissue as the outer cannula is thrown over the stylet (see at least part 0040 of McGhie) even with spaces between the plurality of projections/ridges (see at least par 0040 of McGhie)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 17, although Snoke teaches that it is known to provide a system in which said insert 800 is configured to fit in an industry-standard biopsy sample cassette 900 (see at least figs. 8-12B and par 0040-0042), Snoke as modified by Jorulf, Jarial and McGhie discloses the core biopsy tissue processing system of claim 28, that fails to explicitly teach a system in which the industry-standard biopsy sample cassette has an interior opening with sides 30-35 mm by 25-30 mm and 4-6 mm depth.
However, since Snoke teaches accommodating the insert in an industry-standard biopsy sample cassette (i.e., available from Leica Biosystems Inc. of Buffalo Grove, Ill.) (see at least par 0040), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Snoke as modified by Jorulf, Jarial and McGhie in which the industry-standard biopsy sample cassette has an interior opening with sides 30-35 mm by 25-30 mm and 4-6 mm depth as claimed in order to accommodate the insert therein.
Response to Arguments
Applicant’s arguments with respect to claim(s) 11-17 & 28 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/RENE T TOWA/Primary Examiner, Art Unit 3791