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: lines, numbers and letters are not uniformly thick and well defined; and numbers and reference characters are not plain and legible for all figures. This applies to shading. Solid black shading areas are not permitted, expect when used to represent bar graphs or color. See for example, Figures 12-13. 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.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 recites “a lock state” in line 2 which should recite “a locked state”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: Claim 7 recites “lock member” in line 5 which should recite “lock members”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: Claim 6 recites “respective recess” in line 2 which should recite “respective concave recess”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: alignment members in claim 5.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 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 8-9 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 8-9 recite the limitation "each lock member" in line 1, respectively. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cavanaugh (US 2021/0016104 A1).
Regarding claim 1, Cavanaugh discloses a needle lock device (Figs. 10A-15 or Figs. 3 and 9, wherein the template 902 shown in Fig. 9 may be used in conjunction with the template holder 300 of Fig. 3; [0060]) comprising: an outer frame (outer frame of multilayered template 1000; Fig. 15; or template compartment 320; Fig. 3); a plurality of support members (first layers 1002A and 1002B; Fig. 10A or sockets 1002; Fig. 8) mounted to the outer frame (Fig. 15 or Fig. 8); a plurality of needle holders (needle guides 1006, 1006A-C; Fig. 10A; or balls 1014), wherein at least one needle holder (1006 or 1014) is disposed on each of the support members (Fig. 10A or Figs. 8-9), each needle holder (1006 or 1014) defining a passage (passage through needle insertion cylinder 1008 or opening 1006) configured to receive a needle (needle insertion cylinder 1008 may be sized to receive a 15 or 18 gauge needle; [0062]; or opening 1006 is dimensioned to receive a catheter; therefore, a needle; [0059]); and a lock mechanism (including at least second layer 1004; Figs. 10A, 12C, 14; or locking knobs 330A and 330B) configured to operate each needle holder (1006 or 1014) between a free state (when the actuator 1404 is depressed and apertures 1008A and 1008B are in coaxial alignment with the second layer 1004; [0067]; or when locking knobs 330A and 330B are unlocked; [0060]) and a locked state (when the actuator 1404 is released and apertures 1008A and 1008B are in misalignment with the second layer 1004; Fig. 14; [0067]; or when locking knobs 330A and 330B are locked to lock horizontal and/or vertical rows to the openings 106; [0060]), wherein, in the free state, the needle holder (1006) is movable relative to the outer frame and allows translation of the needle through the passage, and wherein, in the locked state, the needle holder is fixed relative to the outer frame and prevents translation of the needle through the passage ([0067] or [0060]).
Regarding claim 2, Cavanaugh discloses wherein each needle holder (1006) is compressible (formed of a deformable material; [0066]) for varying a size of the passage between the free state and the lock state (Figs. 13A-13B; [0066]).
Regarding claim 3, Cavanaugh discloses wherein each needle holder (1006) comprises at least one slot (slot through which cylinder 1008 is inserted) configured to reduce a force for compressing the needle holder (Figs. 13A-13B).
Regarding claim 4, Cavanaugh discloses wherein each support member (1002A, 1002B or 1002) comprises at least one concave recess (partially spherical portion; Figs. 11A-11B; or circular portion; Fig. 8), and wherein each of the at least one needle holder (1006 or 1014) is disposed in a respective concave recess (Fig. 10A or Figs. 8-9).
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.
Claim(s) 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cavanaugh (US 2021/0016104 A1) in view of Hogendijk et al. (US 2003/0139642 A1).
Regarding claim 5, Cavanaugh fails to disclose a plurality of alignment members (interpreted under 112(f) as protrusions or pins 602; Fig. 6D and equivalents thereof) each configured to align a longitudinal axis of the passage of a respective needle holder along a direction substantially perpendicular to a plane formed by the outer frame.
However, Hogendijk teaches a needle guide apparats (100; Figs. 3A-3B) comprising a support member (support 130, socket 120; Figs. 3A-4B) and a needle holder (guide body 110) and further comprising an alignment member (protruding retaining knob 170) that fits within a slot (175) of the needle holder (110) and is configured to align a longitudinal axis of the passage of a needle holder (110) along a direction substantially perpendicular to a plane formed by the outer frame (Figs. 4A-4D; [0050]) for the purpose of allowing the needle holder to slide along a meridian without impeding rotation ([0050]-[0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least some of the plurality of support members of Cavanaugh to include protrusions i.e., alignment members, and the needle holders of Cavanaugh to include slots to accommodate the protrusions as taught by Hogendijk in order to allow the needle holders to slide smoothly and easily along a meridian without impeding rotation thereof.
Regarding claim 6, Cavanaugh fails to disclose a protrusion configured to retain each needle holder in the respective recess.
However, Hogendijk teaches a needle guide apparats (100; Figs. 3A-3B) comprising a support member (support 130, socket 120; Figs. 3A-4B) and a needle holder (guide body 110) and further comprising a protrusion (protruding retaining knob 170) that fits within a slot (175) of the needle holder (110) and is configured to retain each needle holder in a concave recess of the support member (Figs. 4A-4D; [0050]) for the purpose of allowing the needle holder to slide along a meridian without impeding rotation ([0050]-[0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least some of the plurality of support members of Cavanaugh to include protrusions and the needle holders of Cavanaugh to include slots to accommodate the protrusions as taught by Hogendijk in order to allow the needle holders to slide smoothly and easily along a meridian without impeding rotation thereof.
Regarding claim 7, modified Cavanaugh discloses the invention as claimed above, and Cavanaugh further discloses wherein the plurality of support members (1002A, 1002B) are parallel to each other (Fig. 10A), and wherein the lock mechanism (1004) comprises a plurality of parallel lock members (as each row in the template 1000 of Fig. 15 includes a second layer 1004) mounted to the outer frame such that the support members are substantially perpendicular to the lock members (Fig. 14), the support members and lock member defining a grid for containing the needle holders (see template 1000 of Fig. 15).
Regarding claim 8, modified Cavanaugh discloses the invention as claimed above, and Cavanaugh further discloses wherein each lock member (330A, 330B) comprises a cam profile (as the locking knobs 330A, 330B may be connected to a cam system; [0039]) and is rotatable between a first position and a second position for operating an adjacent needle holder between the free state and the locked state ([0039]; [0066]).
Regarding claim 9, modified Cavanaugh fails to explicitly disclose wherein each lock member is configured to rotate at an opposite direction from an adjacent lock member.
However, Cavanaugh teaches that each lock member (330A, 330B) rotates to move the needle holders between the free state and the locked state ([0039]; [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lock members of modified Cavanaugh to rotate at an opposite direction from an adjacent lock member as an obvious matter of design choice, since applicant has not disclosed that the direction of rotation solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with regardless if the knob(s) were turned in a clockwise or a counterclockwise direction to achieve the locked state.
3. Claim(s) 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cavanaugh (US 2021/0016104 A1) in view of Glossop (US 2019/0231471 A1).
Regarding claims 14-17, Cavanaugh discloses the needle lock device according to claim 1 (see claim 1 above) but fails to disclose a user interface device; and a processor; wherein the user interface device is configured to provide a plurality of entry points corresponding to the passages of the plurality of needle holders; and wherein, based on a selected target point, the processor is configured to determine an entry point satisfying one or more parameters, wherein the one or more parameters comprise a shortest distance between the entry point and the target point, wherein the one or more parameters comprise an absence of a critical structure between the entry point and the target point, wherein the one or more parameters comprise a preset angle between the entry point and the target point.
However, Cavanaugh teaches computers may be used to calculate the treatment plan based, in part, on the additional degrees of freedom, such that the positioning the needles (catheters 112/needles) could be done either by a computer or a person; [0036]; [0059]).
Glossop teaches a needle guide system (Fig. 3) comprising a user interface device (computer device 301); and a processor (processor 305); wherein the user interface device is configured to provide a plurality of entry points corresponding to the passages of the plurality of needle holders (as control application 307 may generate and display the position of a targeting template relative to a location in a target lesion; [0124]); and wherein, based on a selected target point, the processor is configured to determine an entry point satisfying one or more parameters (as a projected path of the target paths of the targeting template is displayed; [0124]), wherein the one or more parameters comprise a shortest distance between the entry point and the target point (as 307 generates the closest approach from a needle or other instrument passing through a hole in the template to the target lesion; [0124]), wherein the one or more parameters comprise an absence of a critical structure between the entry point and the target point (as the projected path does not intersect tissue; [0124]), wherein the one or more parameters comprise a preset angle between the entry point and the target point (as the projected path is inherently at an angle with respect to the template through which the needle or other instrument is passed; [0124]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle lock device of Cavanaugh to be part of a needle guide system including a user interface device and processer as claimed in light of the teachings of Cavanaugh and Glossop in order to select a proper path for a needle to a target site robotically, improving the precision of the needle path and deployment to the target site.
Allowable Subject Matter
Claims 10-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Cavanaugh (US 2021/0016104 A1) or Hogendijk et al. (US 2003/0139642 A1), does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, the claimed invention of dependent claim 10, which recites, inter alia “wherein each of the support members comprises an elongated rod having ends supported by the outer frame, the elongated rod being rotatable about its longitudinal axis.”
The support members of Cavanaugh (first layers 1002A and 1002B; Fig. 10A or sockets 1002; Fig. 8) are not elongated rods and are instead concave semi-spherical recesses. Even if second layer 1004 was interpreted as a support member, it would not be rotatable about its longitudinal axis. Instead, second layer 1004 is translatable about its longitudinal axis. Modifying 1004 to be rotatable could interfere with its intended locking purpose. Hogendijk discloses a support member comprising an elongated rod (230; Fig. 7) having an end supported by an outer frame (80), the elongated rod being rotatable about its longitudinal axis ([0055]). However, Hogendijk fails to disclose a lock mechanism and modifying the needle holders of Cavanaugh to be on an elongated rod as taught by Hogendijk would prevent the locking mechanism (1004) of Cavanaugh from being able to pinch/lock the needle holders (1006), as the locking mechanism (1004) is displaced along the longitudinal axis (Figs. 13A, 13B). Thus, modifying Cavanaugh to include the elongated rod of Hogendijk would render the locking mechanism of Cavanaugh inoperable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Noras (US 2020/0000443 A1) is noted for teaching a needle guide that uses rails i.e., an elongated rod.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771