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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 5, 2026 has been entered.
Response to Arguments
Applicant's arguments filed January 5, 2025 have been fully considered but they are not persuasive in view of the rejections set forth below addressing the amendments to the claims.
In response to applicant’s argument that Hibner does not disclose the one or more contact area reducing features configured to provide low friction guidance of the needle to facilitate accurate needle placement at designed needle speed, it is noted that this limitation is a functional limitation. The examiner maintains that the needle is not positively recited in the claim. Therefore, an arbitrary 14, 16, or 18 gauge needle of a needle gun can be inserted into the one or more modified guide holes, wherein the retaining ring can provide low friction guidance of the needle to facilitate accurate needle placement at a designed needle speed. As stated in the previous Office Action, the examiner maintains that although Hibner discloses friction between the contact area reducing feature (340) providing resistance to axial movement, the limitation ‘low friction guidance’ is sufficiently broad the encompass the contact area reducing feature of Hibner allowing low friction for resistance but not high enough to prevent the needle from axial movement relative to the guide hole. Furthermore, the arbitrary 14, 16, or 18 gauge needle can be sized or have a coefficient of friction such that the retaining ring provides only low friction guidance and resistance to facilitate accurate needle placement. Thus, applicant’s arguments are remain unpersuasive. For similar reasons, Rebellino also meets all of the claim limitations.
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 11-13, 15-18, 20 are 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 11 recites the limitation “where guide hole structure is positioned between the needle gun and the biological tissue” in the last two lines of the claim. This limitation positively recites the biological tissue which is directed to and encompasses a human organism.
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 8 and 18 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. Claim 8 recites the limitation “a spherical embossing on the inner surface of the one or more guide holes extending along an entirety of an axial length of the inner surface” in the amended claims. Claim 18 recites the limitation “a spherical embossing on the inner surface of the guide hole extending along an entire axial length of the inner surface of the guide hole” in the last lines of the claim. The limitation “along an entirety of an axial length” and “along an entire axial length” is not found in the specification. Although figure 4B shows spherical embossing, there are gaps between the spheres and thus the drawings do not show them extending ‘along an entirety of an axial length’ as claimed. Therefore, the limitation adds new matter into the claims since there is not sufficient support for “an entirety” in the originally filed disclosure.
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 1-3, 5, 6, 8-10, 21-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 8 recites the limitation "the one or more contact area reducing features" in the claims. There is insufficient antecedent basis for this limitation in the claim.
Claims 5 and 6 recites the limitation “the structure of claim 4” in line 1 of the claim, which renders the claim indefinite since claim 4 has been cancelled.
Claim 21 recites the limitation “wherein the plurality of circumferentially spaced apart ribs reduce a contact area of the needle with the inner surface of the guide structure by 50%”, which renders the claim indefinite because the needle is only functionally recited in claim 1 and this limitation positively requires the needle. The examiner interprets the limitation to be “wherein the plurality of circumferentially spaced apart ribs are configured to reduce a contact area of the needle with the inner surface of the guide structure by 50%” for examination purposes.
Claim 22 recites the limitation “wherein the plurality of circumferentially spaced apart ribs increase a needle velocity through the guide hole structure to 7 m/s or more”, which renders the claim indefinite because the needle is only functionally recited in claim 1 and this limitation positively requires the needle. The examiner interprets the limitation to be “wherein the plurality of circumferentially spaced apart ribs are configured to increase a needle velocity through the guide hole structure to 7 m/s or more.” for examination purposes.
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.
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 1, 2, 5, 6, 9, 10, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Hibner et al (US 20110092848) in view of Rebellino et al (US 20190083071).
Regarding claim 1, Hibner et al (hereafter Hibner) discloses a guide hole structure (304), comprising: a body defining one or more guide holes (336, 338) through the body between a first surface and a second surface; and a plurality of contact area reducing structures (340) forming and/or extending from an inner surface of the body to form the one or more guide holes, wherein the one or more contact area reducing features includes a plurality of circumferentially spaced apart ribs (each hole can have more than one associated retaining ring, paragraph 0110) disposed along an inner circumference of the inner surface and extending radially inward from the inner surface (figure 18A, paragraph 0108, each ring is spaced apart from one another), and configured to reduce a contact area of a shaft of a needle of a needle gun inserted into and/or through the one or more guide holes, wherein the needle is of a 14 gauge, 16 gauge, or 18 gauge size (paragraph 0041, 0104, biopsy device 14, any arbitrary needle of a needle gun of a 14, 16, or 18 gauge can be inserted into guide holes 336, 338, since the needle and needle gun are not positively recited), wherein the one or more contact area reducing features (340) is configured to provide low friction guidance (paragraph 0103, 0108; friction and resistance that still allows axial movement can be considered ‘low friction’, whereas preventing axial movement would be high friction) of the needle to facilitate accurate needle placement at a designed needle speed. Additionally, since Hibner teaches the guide cubes can be used with instruments of various diameters, such as sized biopsy devices, various sized portions of biopsy devices, such as needles, cannulas, obturators, or combinations of these and other components (paragraph 0104), it would have been obvious to one with ordinary skill in the art at the time of the invention to modify the device of Hibner to specifically have dimensions to meet the claimed limitations, since such a modification would have involved a mere change in the size of a component. 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).
Additionally, Rebellino teaches a similar device comprising: a guide hole structure (1300), comprising: a body (1310) defining one or more guide holes (1330) through the body between a first surface and a second surface (1312, 1314); and one or more contact area reducing features (1340) forming and/or extending from an inner surface of the body to form the one or more guide holes and configured to reduce a contact area of a shaft of a needle of a needle gun inserted into and/or through the one or more guide holes (paragraph 0078), wherein the one or more contact area reducing features (1340) is configured to provide low friction guidance (paragraph 0084, device is slid axially along length of cannula; there will inherently be friction between the material of the contact area reducing features 1340 that still allows axial movement, such that the friction can be considered ‘low friction’) of the needle to facilitate accurate needle placement at a designed needle speed, wherein the one or more contact area reducing features includes longitudinal ribs (1340, figure 16) circumferentially spaced apart extending along an axial direction and extending radially inwardly from the inner surface of the guide hole (paragraph 0078). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to substitute the ribs of Hibner with the ribs of Rebellino, since they were art recognized equivalents for providing low friction guidance at the time of the invention and it has been held that mere substitution of art recognized equivalents involves routine skill in the art.
Regarding claim 2, Hibner in view of Rebellino teaches all of the limitations set forth in claim 1, wherein the body defines a biopsy template, wherein the one or more guide holes include a plurality of guide holes disposed in a pattern (figure 18A, paragraph 0108).
Regarding claim 5, Hibner in view of Rebellino teaches all of the limitations set forth in claim 4, wherein the one or more contact area reducing structures provide a plurality of contact points, lines, and/or surfaces for the shaft to contact (two more retaining rings axially staggered would provide a plurality of contact points, paragraph 0110; retaining ring can also include several protrusions, paragraph 0108; Rebeillino also shows multiple contact area reducing structures, figure 16).
Regarding claim 6, Hibner in view of Rebellino teaches all of the limitations set forth in claim 1, wherein Rebellino teaches the one or more contact area reducing features structures includes longitudinal ribs extending along an axial direction and extending radially inwardly from the inner surface of the one or more guide holes (figure 16).
Regarding claim 9, Hibner in view of Rebellino teaches all of the limitations set forth in claim 1, wherein the structure is made of metal or hard plastic (paragraph 0076).
Regarding claim 10, Hibner in view of Rebellino teaches all of the limitations set forth in claim 1, wherein the structure is made of a non-ferromagnetic material for use within an MRI (hard plastics, paragraph 0076; MRI use paragraph 0062).
Regarding claims 21 and 22, Hibner in view of Rebellino teaches all of the limitations set forth in claim 1, wherein the plurality of circumferentially spaced apart ribs are configured to reduce a contact area of the needle with the inner surface of the guide structure by 50% and increase a needle velocity through the guide hole structure to 7 m/s or more (an arbitrary needle can be formed and configured to be inserted to meet these limitations, and the needle is not positively recited)
Claim 11, 12, 15, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hibner et al (US 20110092848) in view of Allaway (US 20150282880).
Regarding claim 11, Hibner et al (hereafter Hibner) discloses a guide hole structure (304), comprising: a body defining one or more guide holes (336, 338) through the body between a first surface and a second surface; and a plurality of contact area reducing structures (340) forming and/or extending from an inner surface of the body to form the one or more guide holes, wherein the one or more contact area reducing features includes a plurality of circumferentially spaced apart ribs (each hole can have more than one associated retaining ring, paragraph 0110) disposed along an inner circumference of the inner surface and extending radially inward from the inner surface (figure 18A, paragraph 0108, each ring is spaced apart from one another), and configured to reduce a contact area of a shaft of a needle of a needle gun inserted into and/or through the one or more guide holes (paragraph 0041, 0104, biopsy device 14), wherein the one or more contact area reducing features (340) is configured to provide low friction guidance (paragraph 0103, 0108; friction and resistance that still allows axial movement can be considered ‘low friction’, whereas preventing axial movement would be high friction) of the needle to facilitate accurate needle placement at a designed needle speed. Additionally, since Hibner teaches the guide cubes can be used with instruments of various diameters, such as sized biopsy devices, various sized portions of biopsy devices, such as needles, cannulas, obturators, or combinations of these and other components (paragraph 0104). Hibner does not specifically disclose the biopsy needle being a 14, 16, or 18 gauge needle. However, Allaway teaches it was known in the art at the time of the invention for a biopsy template system to include a biopsy needle gun (paragraph 0064) with a 18 gauge needle (paragraph 0111) in order to insert and extract any substance through the needle (paragraph 0062). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the biopsy needle of the system disclosed in Hibner to comprise a biopsy needle gun having a needle of a 18 gauge size, as taught as a known art-recognized equivalent firing biopsy needle at the time of the invention by Allaway, in order to insert and extract any substance through the needle, wherein the needle would further be configured to engage the guide hole structure and penetrate a biological tissue.
Regarding claim 12, Hibner in view of Allaway teaches all of the limitations set forth in claim 11, wherein the body defines a biopsy template, wherein the one or more guide holes include a plurality of guide holes disposed in a pattern (figure 18A, paragraph 0108).
Regarding claim 15, Hibner in view of Allaway teaches all of the limitations set forth in claim 11, wherein the one or more contact area reducing structures provide a plurality of contact points, lines, and/or surfaces for the shaft to contact (two more retaining rings axially staggered would provide a plurality of contact points, paragraph 0110; retaining ring can also include several protrusions, paragraph 0108).
Regarding claim 17, Hibner in view of Allaway teaches all of the limitations set forth in claim 11, wherein the one or more contact area reducing structures includes a plurality of circumferentially spaced apart ribs disposed along an inner circumference of the inner surface and extending radially inward from the inner surface (figure 18A, paragraph 0108).
Claim 11, 16, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Rebellino et al (US 20190083071) in view of Allaway (US 20150282880).
Regarding claim 11, Rebellino teaches a biopsy template system, comprising: a guide hole structure (1300), comprising: a body (1310) defining one or more guide holes (1330) through the body between a first surface and a second surface (1312, 1314); and a plurality of contact area reducing structures (1340) forming and/or extending from an inner surface of the body to form the one or more guide holes and configured to reduce a contact area of a shaft of a needle of a needle gun inserted into and/or through the one or more guide holes (paragraph 0078), wherein the one or more contact area reducing features (1340) is configured to provide low friction guidance (paragraph 0084, device is slid axially along length of cannula; there will inherently be friction between the material of the contact area reducing features 1340 that still allows axial movement, such that the friction can be considered 'low friction') of the needle to facilitate accurate needle placement at a designed needle speed. Rebellino further teaches using the system with a firing biopsy needle (paragraph 0003-0004), but does not specifically teach the firing biopsy needle is of a 14, 16, or 18 gauge, and that the guide cube is sized to receive a biopsy cannula (paragraph 0077). However, Allaway teaches it was known in the art at the time of the invention for a biopsy template system to include a biopsy needle gun (paragraph 0064) with a 18 gauge needle (paragraph 0111). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the firing biopsy needle of Rebellino comprise a biopsy needle gun having a needle of a 18 gauge size, as taught as a known art-recognized equivalent firing biopsy needle at the time of the invention by Allaway, in order to insert and extract any substance through the needle, wherein the needle would further be configured to engage the guide hole structure and penetrate a biological tissue.
Regarding claim 16, Rebellino in view of Allaway teaches all of the limitations set forth in claim 11, wherein the one or more contact area reducing features includes longitudinal ribs (1340, figure 16) extending along an axial direction and extending radially inwardly from the inner surface of the guide hole (paragraph 0078).
Regarding claim 17, Rebellino in view of Allaway teaches all of the limitations set forth in claim 14, wherein the one or more contact area reducing structures includes a plurality of circumferentially spaced apart ribs disposed along an inner circumference of the inner surface and extending radially inward from the inner surface (figure 16, 1340, paragraph 0078).
Claims 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hibner et al (US 20110092848) in view of Rebellino et al (US 20190083071), as applied to claims 2 above, and further in view of Whitmore, III et al (US 6036632).
Regarding claims 3, Hibner in view of Rebellino teaches all of the limitations set forth in claim 2, wherein Hibner further teaches the guide holes increased number of insertion points, but does not specifically disclose each guide hole is spaced about 5mm apart. However, Whitmore, III et al (hereafter Whitmore) teaches it was known in the art at the time of the invention for template grid systems to guide the placement of needles comprise a plurality of guide holes spaced at 5mm intervals (C:1, L:42-61). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make guide holes for a needle guide hole structure spaced about 5mm apart, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hibner et al (US 20110092848) in view of Reed et al (US 6679824).
Regarding claim 8, Hibner discloses a guide hole structure (304), comprising: a body defining one or more guide holes (336, 338) through the body between a first surface and a second surface; and a plurality of contact area reducing structures (340) forming and/or extending from an inner surface of the body to form the one or more guide holes and configured to reduce a contact area of a shaft of a needle of a needle gun inserted into and/or through the one or more guide holes (paragraph 0041, 0104, biopsy device 14), wherein Hibner further teaches the one or more contact area reducing features can include a plurality of protrusions and can include other shapes (paragraph 0108-0109) on the inner surface of the guide hole, but does not specifically disclose these protrusions include a spherical embossing. Reed et al (hereafter Reed) teaches it was known in the art at the time of the invention for spheres to be art-recognized equivalent surface features for contact area reducing features between needle contact surfaces (C:5, L:38-60). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the one or more contact area reducing features include spherical embossing protrusions as an art recognized equivalent to ridges and other protrusions for reducing surface contact at the time of the invention, wherein it would have also been obvious to make the one or more contact area reducing features along an entirety of an axial length of the inner surface, such that it provides low friction guidance of the needle to facilitate accurate needle placement at a designed needle speed, since it appears that the device would perform equally well with either designs and it has been held that a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results.
Claim 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hibner et al (US 20110092848) in view of Allaway (US 20150282880), as applied to claim 12 above, and further in view of Whitmore, III et al (US 6036632).
Regarding claim 13, Hibner in view of Allaway teaches all of the limitations set forth in claim 12, wherein Hibner further teaches the guide holes increased number of insertion points, but does not specifically disclose each guide hole is spaced about 5mm apart. However, Whitmore, III et al (hereafter Whitmore) teaches it was known in the art at the time of the invention for template grid systems to guide the placement of needles comprise a plurality of guide holes spaced at 5mm intervals (C:1, L:42-61). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make guide holes for a needle guide hole structure spaced about 5mm apart, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hibner et al (US 20110092848) in view of Allaway (US 20150282880), as applied to claim 11 above, and further in view of Reed et al (US 6679824).
Regarding claim 18, Hibner in view of Allaway teaches all of the limitations set forth in claim 11, wherein Hibner further teaches the one or more contact area reducing features can include protrusions and can include other shapes (paragraph 0108-0109) on the inner surface of the guide hole, but does not specifically disclose these protrusions include a spherical embossing. Reed et al (hereafter Reed) teaches it was known in the art at the time of the invention for spheres to be art-recognized equivalent surface features for contact area reducing features between needle contact surfaces (C:5, L:38-60). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the one or more contact area reducing features include spherical embossing protrusions along an entire axial length of the inner surface of the guide hole, as an art recognized equivalent to ridges and other protrusions for reducing surface contact at the time of the invention, since it appears that the device would perform equally well with either designs and it has been held that a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/ Primary Examiner, Art Unit 3771