DETAILED ACTION
The following Office Action is in response to the Preliminary Amendment filed on February 17, 2024. Claims 1-3, 6-7, 9, 11, 13, 16-22, 24, and 28-31 are currently pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claims 1, 3, 6, 9, 11, 17-22, 24, 28, and 30-31 are objected to because of the following informalities:
Concerning claims 1, 6, and 19-21, lines 13, 16, and 21 of claim 1, lines 3 and 5 of claim 6, lines 1 and 3 of claim 19, line 1 of claim 20, and line 2 of claim 21 recite the term “are portion”, which appears to be a misspelling of the term “arc portion”.
Concerning claim 3, line 2 of the claim recites the phrase “at bottom surface”, wherein the phrase is missing an article preceding “bottom surface”; line 4 recites the phrase “the ring portion remain immobile”, wherein the word “remain” appears to be mistakenly used in place of “remains”.
Concerning claim 6, line 1 of the claim recites “claim , 1”, which appears to be a typographical error of “claim 1,”; lines 1-2 recites “wherein the ring portion further comprising”, wherein the word “comprising” appears to be mistakenly used in place of “comprises”; line 3 of the claim recites the word “(102b)relative”, wherein they should be separate words “(102b) relative”.
Concerning claim 9, line 1 of the claim recites “wherein the base portion comprising”, wherein the word “comprising” appears to be mistakenly used in place of “comprises”; line 3 recites “102f”, but is missing parentheses.
Concerning claim 11, line 1 of the claim recites “claim , 1”, which appears to be a typographical error of “claim 1,”.
Concerning claim 17, line 1 of the claim recites “claim ,3”, which appears to be a typographical error of “claim 3,”.
Concerning claim 18, line 2 of the claim recites “configured at bottom of the ring portion”, wherein the word “bottom” should be preceded by an article.
Concerning claim 19, line 1 of the claim recites the phrase “wherein the are portion comprising”, wherein the word “comprising” appears to be mistakenly used in place of “comprises”.
Concerning claim 20, line 3 of the claim recites “102b”, but is missing parentheses; line 3 of the claim recites the phrase “for receiving screws that engages”, wherein the word “engages” appears to be mistakenly used in place of the word “engage”.
Concerning claim 24, lines 1-2 of the claim recites the phrase “wherein the plurality of stereotactic parameters further comprising”, wherein the word “comprising” appears to be mistakenly used in place of “comprises”; line 2 of the claim recites “type of the ring portion”, but it is not preceded by an article.
Concerning claim 28, line 3 of the claim recites “102e, 140a, 140b”, but is missing parentheses.
Concerning claim 30, lines 2-3 of the claim recites the phrase “located within respective a fiducial well”, wherein the word “respective” appears to be mistakenly added.
Concerning claim 31, line 4 of the claim recites the limitation of “CT/MRI scan”, but it is not preceded by an article.
Appropriate correction is required.
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 9, 17-18, 20-22, and 28-29 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.
Concerning claim 9, line 2 of the claim recites the limitation of “its surrounding wall”. There is a lack of antecedent basis for this limitation in the claim.
Concerning claim 17, lines 2-3 of the claim recite the limitations “wherein the angularly separated serrations and the angularly separated serrations connects the ring portion”. Although each limitation of “the angularly separated serrations” references a reference number in the drawings, these reference numbers are not to be given weight in the claims, thus creating an issue of indefiniteness as to which “angularly separated serrations” each instance is referencing to. For the purposes of compact prosecution, the first instance of “angularly separated serrations” will be interpreted as “the one or more sets of spaced apart angularly separated serrations of the ring portion” and the second instance of “angularly separated serrations” will be interpreted as “the one or more sets of spaced apart angularly separated serrations of the base portion”.
Concerning claim 18, line 1 of the claim recites the limitation of “the angularly separated serrations”. However, there are multiple sets of angularly separated serrations claimed, making it indefinite as to which set these angularly separated serrations are referring to. For the purposes of compact prosecution, the limitation will be interpreted as “the one or more sets of spaced apart angularly separated serrations of the ring portion”.
Concerning claim 20, line 1 of the claim recites the limitation of “the two opposing ends”. There is a lack of antecedent basis for this limitation in the claim.
Concerning claim 21, lines 1-2 of the claim recites the limitation of “the pair of angularly separated serrations”. However, claim 19 recites either “a pair of angularly separated serrations or angularly separated serrations”, therein making it indefinite as to whether the scope of the claim must include a pair of angularly separated serrations.
Concerning claim 22, the claim recites a list of coordinates received by the software program, but the last item of the list is not proceeded by “and”, “or”, or “and/or”, therein making the scope of the claim indefinite as to whether the scope must include all of said coordinates or just a single one of said coordinates. For the purposes of compact prosecution, the list will be interpreted as being “and/or”.
Concerning claim 28, the end of the claim recites “[sliding serration by desired angular resolution]]”. It is indefinite as to whether this bracketed limitation is intended to be included within the claim given the brackets and given its placement after the claim. For the purposes of compact prosecution, the limitation will be ignored; line 3 of the claim recites the limitation of “their serrations”. There is a lack of antecedent basis for this limitation in the claim.
Claim 29 is further rejected for being dependent on an indefinite claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 is dependent on a cancelled claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. For the purposes of compact prosecution, claim 13 will be interpreted as being dependent on claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 9, 16, 22, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sahni (US 2010/0082040).
Concerning claim 1, the Sahni prior art reference teaches an imaging guided whole body stereotactic device (Figures 1-9) adaptable to align and guide a medical device towards a target location in a human body during an intended medical procedure, the stereotactic device comprising: a base portion (Figure 1; 1) including a first set of reference markings (Figure 1; 10) representing base angles ranging from 0-360 degrees ([¶ 0022]), and one or more orifices located on an inner circumference for affixation of the base portion on the human body (Figure 2; 9); a ring portion removably affixable and rotationally positionable over the base portion (Figure 4; 16), an arc portion (Figure 1; 2) including a second set of reference markings representing arc angles ranging from one specific angular value to another angular value (Figure 4; 18); an instrument guide assembly having an instrument guide (Figure 1; 3), and an instrument guide cover removably or fixedly attached to the instrument guide (Figure 1; 4), the instrument guide is configured to engage or disengage to or from the arc portion ([¶ 0022]), wherein the instrument guide assembly comprises a conduit configured to guide the medical instrument towards a target location in the human body (Figure 1; 6); wherein, the base portion, the ring portion, the arc portion, and the instrument guide assembly are configured to be at least conveniently disengaged, and nearly instantaneously disengaged during the intended procedure (each portion may be seated on each other and be nearly instantly disengaged from each other by unseating each portion from another portion); and wherein, the device is manipulatable by varying a plurality of stereotactic parameters including the base angles, the arc angles, and a depth of insertion of the instrument or instrument length, wherein said parameters are capable of being derived from a software program product in order to hit the desired location using the device.
Concerning claim 2, the Sahni reference teaches the stereotactic device of claim 1, wherein the ring portion further comprises a plurality of inwardly curved engaging members (Figure 4; 16) that help in engagement of the ring portion to an elevated rail provided on the base portion (Figure 2; 7).
Concerning claim 9, the Sahni reference teaches the stereotactic device of claim 1, wherein the base portion comprises one or more slots located at a surrounding wall (Figure 2; 8), wherein said slots are capable of being used for facilitating one or more thumb screws to pass therethrough to engage the ring portion to the base portion.
Concerning claim 16, the Sahni reference teaches the stereotactic device of claim 1, wherein the base portion comprises a rail (Figure 2; 7), and the ring portion comprises a saddle that engages the rail (Figure 4; 17).
Concerning claims 22, the Sahni reference teaches the stereotactic device of claim 1, wherein given the software program product is not positively recited, it may be capable of receiving any number of coordinates.
Concerning claim 24, the Sahni reference teaches the stereotactic device of claim 1, wherein the plurality of stereotactic parameters is capable of comprising the type of ring portion and instrument guide to be used for a desired angular resolution, given said limitation is an intended use limitation and the device is capable of being manipulated by varying any number of parameters the user sees fit.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 3, 17-19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sahni (US 2010/0082040) in view of Piferi et al. (US 2017/0202631, hereinafter Piferi).
Concerning claims 3, 17-19, and 21, the Sahni reference teaches the stereotactic device of claim 1, wherein the reference teaches that the base portion may include a roughened lateral surface for securely fixing the ring portion to the base portion (Figure 2; 12 | [¶ 0022] | Claim 2), but it does not specifically teach one or more sets of spaced apart angularly separated serrations at a bottom surface of the ring portion for connecting the ring portion to one or more sets of angularly separated serrations provided on the base portion.
However, the Piferi reference teaches a stereotactic device, therein being in the same field of endeavor as the Sahni reference, wherein the stereotactic device includes a connector that connects to the base of the device via a set of spaced apart angularly separated serrations on a top surface of the connector (Figure 2B; serrations 305s are spaced along the perimeter of the coupling, therein defining at least two serrations that may define a set that are spaced apart and angularly separated) and a set of spaced apart angularly separated serrations on a bottom surface of the base (Figure 2C; serrations 307s are spaced along the perimeter of the coupling, therein defining at least two serrations that may define a set that are spaced apart and angularly separated), wherein said serrations are continuously formed.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the roughened lateral surface of the base portion of the Sahni reference with a set of spaced apart angularly separated serrations at a top surface of the base portion for connecting the base portion to a set of angularly separated serrations provided on the bottom surface of the ring portion as in the Piferi reference as an alternative structure of coupling and securing one portion of a stereotactic device to the base of the stereotactic device (Piferi; [¶ 0092]), wherein said sets of angularly separated serrations of the ring portion and base portion would constrain angular/rotational motion of the ring portion about a master center of the device.
Furthermore, the Sahni reference also teaches the arc portion having a roughened lateral surface for the purposes of securely fixing the instrument guide to the arc portion ([¶ 0027]), but does not specifically teach angularly separated serrations configured at the vertical/side face to help the arc portion in engagement with the instrument guide assembly.
However, it would further be obvious to replace the roughened lateral surface of the arc portion of the Sahni reference with at least a pair of angularly separated serrations at a vertical/side face of the arc portion for engaging the arc portion to at least a pair of angularly separated serrations on the instrument guide to help the arc portion in engagement with the instrument guide assembly as in the Piferi reference as an alternative structure of coupling and securing one portion of a stereotactic device to the another portion of the stereotactic device (Piferi; [¶ 0092]).
Claim(s) 6 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sahni (US 2010/0082040) in view of Sahni (US 2011/0190787, hereinafter Sahni ‘787).
Concerning claims 6 and 20, the Sahni reference teaches the stereotactic device of claim 1, but does not specifically teach the ring portion further comprising one or more provisions extending upward from the body of the ring to fixedly or removably mount the arc portion relative to the ring portion or opposing ends of the arc portion comprising a pair of provisions for receiving screws that engage the arc portion with the arc portion.
However, the Sahni ‘787 reference teaches a stereotactic device similar to that of the Sahni reference, wherein the ring portion comprises one or more provisions for removably mounting the arc portion relative to the ring portion (Figure 5; 17) and wherein the two opposing ends of the arc portion comprises a pair of provisions for receiving screws that engage the arc portion with the ring portion (Figure 6; 24).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the ring portion and the arc portion have one or more provisions for receiving screws for engaging the arc portion with the ring portion as in the Sahni ‘787 reference to allow the arc to be adjusted relative to the ring portion prior to securing the arc portion and ring portion relative to each other (Sahni ‘787; [¶ 0037]).
Although the Sahni ‘787 reference does not teach the provisions of the ring portion extending upward from the body of the ring portion, a person having ordinary skill in the art would recognize that the arc portion of the Sahni reference is coupled to the top portion of the ring portion, thus making it obvious to have the provisions on the ring portion positioned on the top portion of the ring extending vertically or upward to properly connect to the arc portion.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sahni (US 2010/0082040) in view of Cinquin et al. (US 2011/0126844, hereinafter Cinquin).
Concerning claim 7, the Sahni reference teaches the stereotactic device of claim 1, wherein the Sahni reference teaches a plurality of taps for screws formed on the ring portion for attachment of the ring portion to the base portion ([¶ 0026]), but does not specifically teach a plurality of clips.
However, the Cinquin reference teaches a stereotactic device similar to that of the Sahni reference, wherein the Cinquin reference teaches that the device may be assembled by means of screws to secure different parts of the device, wherein the reference also states that clip-fastening means may be used as an obvious alternative to screws ([¶ 0036]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the taps and screws of the Sahni reference with integrally formed or removably engaged clips as in the Cinquin reference given clips have been identified as an alternative securement means to screws (Cinquin; [¶ 0036]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sahni (US 2010/0082040) in view of Brabrand et al. (US 2012/0022368, hereinafter Brabrand).
Concerning claim 11, the Sahni reference teaches the stereotactic device of claim 1, but does not specifically teach one or more living hinges that helps in mounting or dismounting of the instrument guide to and from the arc portion.
However, the Brabrand reference teaches a stereotactic device similar to that of the Sahni reference, wherein the Brabrand reference further teaches one or more living hinges that helps in the mounting or dismounting of the instrument guide to and from the arc portion ([¶ 0052]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the instrument guide assembly of the Sahni reference include one or more living hinges as in the Brabrand reference to provide a releasable and secure connection from the guide arrangement to the arc portion (Brabrand; [¶ 0014]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sahni (US 2010/0082040) in view of Henze (US 2010/0211081).
Concerning claim 13, the Sahni reference teaches the stereotactic device of claim 1, wherein the instrument cover engages to and from the instrument via use of a locking pin ([¶ 0029-0031]), but does not specifically teach one or more pairs of clips.
However, the Henze reference teaches an instrument guide device, therein being in the same field of endeavor as the Sahni reference, wherein the Henze reference teaches that clips may be an obvious alternative to a pin as a fastening technique of various parts ([¶ 0054]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the locking pin of the Sahni reference with one or more pairs of clips given the Henze reference teaches that clips may be an obvious alternative to a locking pin (Henze; [¶ 0054]).
Claim(s) 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sahni (US 2010/0082040) in view of Fitzpatrick et al. (US 5,551,429, hereinafter Fitzpatrick).
Concerning claims 30-31, the Sahni reference teaches the stereotactic device of claim 1, further comprising one or more fiducial assemblies including a fiducial marker configured at the base portion (Figure 3; 14) comprising a suitable state of matter so as to be visible distinctly from other parts of the device upon imaging with a CT/MRI scan ([¶ 0022]), but does not specifically teach the fiducial marker being located within a fiducial well and enclosed with a fiducial cap.
However, the Fitzpatrick reference teaches a device including a fiducial marker, wherein the fiducial marker is formed by filling a well with a non-solid fiducial marker and sealing it with a cap (Column 3, Line 58 – Column 4, Line 6).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the fiducial marker of the Sahni reference be formed with a non-solid fiducial marker located within a fiducial well and enclosed using a bottom or top fiducial cap as in the Fitzpatrick reference given the Fitzpatrick reference teaches that a fiducial marker may be formed via said method (Fitzpatrick; Column 3, Line 58 – Column 4, Line 6).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Kato et al. reference (US 2018/0228568) teaches a stereotactic device with a base portion, a ring portion, an arc portion, and an instrument guide assembly, wherein the base portion, ring portion, and instrument guide assembly are disengageable; the Solar et al. (US 2017/0007349) teaches a stereotactic device including a base portion, a ring portion, and an arc portion, wherein the base and arc portion include reference markings; and the Daniels et al. reference (US 2020/0038110) teaches a stereotactic device including a base portion and a rotatable ring portion disengagable to an arc portion which includes an instrument guide assembly.
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/MARTIN T TON/Examiner, Art Unit 3771 12/5/2025