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 as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 132, 134, 136 (Figs. 13-14 and 16-18) and 234, 236 (Fig. 19), 522, 534, 536 (Fig. 32). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 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.
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: bridge member and locating member in Claim 12.
The disclosure cites that:
The bridge member may be dimensioned to interconnect the guide body and a locating member, may be integrally formed with the locating member or may be a separate component fixedly attached or otherwise secured to the locating member ([000101]), and may be dimensioned to span across and interconnect adjacent bones of a joint of the anatomy ([000102]); and
The locating member may include one or more patient-specific dimensions and/or patient-specific surfaces to establish a pre-selected position and orientation of the instrument guide relative to an anatomical surface of the anatomy, may be configurable to establish the position and orientation of the alignment guide relative to the anatomy based on one or more settings which may be specified in the surgical plane ([00094]), may be integrally formed with the bridge member or may be a separate component fixedly attached or otherwise secured to the bridge member ([000101]), and may establish one or more guide passages ([000103]).
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 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.
Claim 12 is 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.
The claim recites the limitations “bridge member” and “locating member” which are interpreted under 35 U.S.C. 112(f) according to analysis made of record. The “bridge member” and “locating member” are described exclusively in terms of the functions they perform, without naming a structure intended to be used, and therefore applicant has not demonstrated possession of that structure.
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.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitations “bridge member” and “locating member” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any specific, sufficient structure that performs the function of the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 1-10 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murasawa et al. (JP 2020156802) cited from the Espacenet translation.
Regarding Claim 1, Murasawa teaches an alignment guide, (Figs. 7a-7b “quality control phantom 107”), for surgical imaging, (Fig. 1 and [2-1. Configuration of Quality Control Phantom 107 According to Embodiment 2] “Like the quality control phantom 7 according to the embodiment, the quality control phantom 107 is installed on the bed portion 4 (see FIG. 1) of the radiotherapy system 1”), comprising:
a) a guide body, (Fig. 7a), including first and second sidewalls interconnecting proximal and distal portions to bound a cavity (see examiner-labeled Fig. 7a, reproduced below);
b) wherein the proximal portion includes a foreground sight, (see examiner-labeled Fig. 7a, reproduced below), the distal portion includes a background sight, (see examiner-labeled Fig. 7a, reproduced below), and the foreground sight is visually alignable with the background sight to indicate an orientation of the alignment guide relative to a field of view of an imaging device (Fig. 10 and [2-2. How to Use Quality Control Phantom 107 According to Embodiment 2] “in the method of adjusting the line laser sight using the quality control phantom 107, as shown in FIG. 10, the X-ray image 191R is used, and the near plate and the far side plate of the quality control phantom 107 are used. The position, orientation, and inclination of the phantom body 108 are adjusted so that the axis of the near side plate and the axis of the far side plate grasped from the reference index and the like are aligned.”); and
c) wherein a first alignment opening extends along a first reference plane between the first sidewall and the cavity, (see examiner-labeled Fig. 7a, reproduced below, and where the first reference plane is the Z-X plane according to the coordinate system in Fig. 7a), a second alignment opening extends along a second reference plane between the second sidewall and the cavity, (see examiner-labeled Fig. 7a, reproduced below, and where the second reference plane is the X-Y plane according to the coordinate system in Fig. 7a), and the first and second reference planes are transverse to each other and intersect along the background sight (Fig. 7a, where the planes intersect through the center of the cross on the left hidden side of the phantom 107).
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Fig. 7a of Murasawa
Regarding Claim 2, Murasawa teaches all limitations of Claim 1, as discussed above. Furthermore, Murasawa teaches wherein the guide body is securable to an instrument guide (Fig. 7b, [2-2. How to Use Quality Control Phantom 107 According to Embodiment 2] “The base 110 has a substantially rectangular base plate 111 and a level foot 112 attached to a corner of the base plate 111” and/or “mounting arm 220 for mounting the radiation imaging object”).
Regarding Claim 3, Murasawa teaches all limitations of Claim 1, as discussed above. Furthermore, Murasawa teaches wherein the first and second reference planes are substantially perpendicular to each other (as shown in Figs. 7a-7b).
Regarding Claim 4, Murasawa teaches all limitations of Claim 1, as discussed above. Furthermore, Murasawa teaches wherein:
a) the first and second alignment openings extend from a proximal face of the proximal portion (Fig. 7a); and
b) an arc shaped channel extends about a periphery of the foreground sight to interconnect the first and second alignment openings along the proximal face (Figs. 7a-7b and [2-1. Configuration of Quality Control Phantom 107 According to Embodiment 2] “The peephole 195 is a portion other than the through slit narrow portion 193 and the through slit wide portion 194, and is a hole that is largely hollowed out so that the back side can be easily viewed. The peephole 195 shown in FIG. 8 is a circular hole having a large opening in each region partitioned by the narrow portion 193 of the through slit.”).
Regarding Claim 5, Murasawa teaches all limitations of Claim 1, as discussed above. Furthermore, Murasawa teaches wherein the background sight includes first and second alignment members that intersect at a junction to establish a cross-shaped geometry (Fig. 7a, where the first and second alignment members of Murasawa intersect to establish a cross-shaped geometry, see examiner-labeled figure above.).
Regarding Claim 6, Murasawa teaches all limitations of Claim 5, as discussed above. Furthermore, Murasawa teaches wherein the first and second reference planes follow the respective first and second alignment members and intersect the junction (Fig. 7a).
Regarding Claim 7, Murasawa teaches all limitations of Claim 1, as discussed above. Furthermore, Murasawa teaches wherein:
a) the foreground sight includes an elliptical body situated in an elliptical opening along a proximal face of the proximal portion (Figs. 7a and 8, and [2-1. Configuration of Quality Control Phantom 107 According to Embodiment 2] “The peephole 195 shown in FIG. 8 is a circular hole having a large opening in each region”); and
b) the elliptical body includes a cross-shaped opening alignable with a central portion of the background sight ([2-2. How to Use Quality Control Phantom 107 According to Embodiment 2] “The position, orientation, and inclination of the phantom body 108 are adjusted so that the axis of the near side plate and the axis of the far side plate grasped from the reference index and the like are aligned.”).
Regarding Claim 8, Murasawa teaches all limitations of Claim 1, as discussed above. Furthermore, Murasawa teaches wherein the first and second reference planes intersect along the cross-shaped opening and the central portion (Fig. 7a, where the first and second alignment members of Murasawa intersect along the cross-shaped opening and the central portion, see examiner-labeled figure above.).
Regarding Claim 9, Murasawa teaches all limitations of Claim 1, as discussed above. Furthermore, Murasawa teaches one or more guide passages dimensioned to receive a respective guide element (Figs. 8, 11a, and 11b and [2-1. Configuration of Quality Control Phantom 107 According to Embodiment 2] “through slit narrow portion 193, a through slit wide portion 194 […] The through slit narrow portion 193 is a through groove formed with a width narrower than the width of the line laser projection line projected by the line laser sighting device 5. The through-slit wide portion 194 is a through-hole formed on the through-slit narrow portion 193 or on an extension line with a width wider than the width of the line laser projection line projected by the line laser sighting device 5.” Where the line the laser forms is interpreted as the respective guide element.).
Regarding Claim 10, Murasawa teaches all limitations of Claim 9, as discussed above. Furthermore, Murasawa teaches wherein the one or more guide passages include first and second guide passages that extend along respective passage axes, and the passage axes are substantially parallel to each other (Fig. 9).
Regarding Claim 14, Murasawa teaches all limitations of Claim 1, as discussed above. Furthermore, Murasawa teaches wherein the guide body comprises a metallic material ([2-3. Effect of Embodiment 2] “A metal plate material such as an aluminum plate material may be used as long as it corresponds to the energy level of the radiation used.”).
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Murasawa et al. (JP 2020156802), cited from the Espacenet translation, further in view of Barmes et al. (US 20210059769).
Regarding Claim 12, Murasawa teaches all limitations of Claim 9, as discussed above. However, Murasawa does not explicitly teach wherein the one or more guide passages include first and second guide passages, and further comprising: a bridge member interconnecting the guide body and a locating member, the bridge member dimensioned to span across a joint of an anatomy; wherein the first guide passage is established in the guide body, and the second guide passage is established in the locating member.
In an analogous laser-based implant alignment field of endeavor, Barmes teaches an alignment guide, (Fig. 34 and [0162] “system 410”), wherein the one or more guide passages include first, ([0163] “slot or aperture 431”), and second, ([0174] “The auxiliary alignment member 490 may be movably coupled to the wing member 480”), guide passages, and further comprising:
a) a bridge member interconnecting the guide body and a locating member, (Fig. 34, [0171] “the wing member 480 may be flat/planar wing and configured to extend from the guide block 430,” and [0174] “The auxiliary alignment member 490 may be movably coupled to the wing member 480”), the bridge member dimensioned to span across a joint of an anatomy (Fig. 34 and [0171] “the wing member 480 (itself or a flat surface thereof) may extend along a plane aligned with the joint line of the anatomical configuration/structures of the patient (e.g., an ankle joint) and/or of a particular implant replacing such configuration/structures (e.g., a total ankle replacement implant) implanted on/in a resected bone that is/are resected (at least partially) via the guide block 430 and/or another component or portion of the guide system 410.”);
b) wherein the first guide passage is established in the guide body, ([163] “slot or aperture 431 of a guide block 430”), and the second guide passage is established in the locating member ([0174] “The auxiliary alignment member 490 may be movably coupled to the wing member 480”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Murasawa with the bridge member of Barmes because the modification allows for prior or subsequent use to a laser device as another reference guide to align the guide and/or the system as a whole to the anatomical configuration/structures of the patient (e.g., to the alignment axis (e.g., an anatomical or mechanical axis) of anatomical structures of interest), as taught by Barmes in [0173]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
