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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The subject matter of this application admits of illustration by a drawing to facilitate understanding of the invention. Applicant is required to furnish a drawing under 37 CFR 1.81(c). No new matter may be introduced in the required drawing. 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).
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: “at least one displacement device” in claim 15, “fastening device” in claim 19, “displacement device” in claim 21.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: fastening means in claim 19. It is noted that the claim does not state the fastening means function and does not state means for fastening what component to another. Examiner will interpret with art as best understood.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Objections
Claims 15-30 are objected to because of the following informalities:
The preamble of Claim 15 should recite “A fixation [[Fixation]] device” to stay consistent with US Practice. 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 15-30 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.
Claim 15 recites the limitation "a bone remote surfaced" in line 14-15. There is insufficient antecedent basis for this limitation in the claim. It is not clear if applicant is referring to the bone remote top surface recited in line 2 or a different bone remote surface. The examiner will treat with art as best understood.
Claim 20 line 1 recites “and/or” which renders the claim indefinite. It is not clear if applicant wants to use the term “and” or the term “or”. For examination purposes, the examiner will treat the claim with the term “or”.
Regarding claim 29, the phrase “preferably” (which is similar to the phrase "such as") renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
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 15-19, 21-25, 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Peng CN 205054388 (reference is made to the English Translation, attached herein) in view of Disegi US 2016/0038185.
Regarding Claim 15, Peng discloses a fixation device for transverse bone distraction (Fig 7), comprising
an elongated base (#1 and #12, see Fig below) having a bone-remote top surface (see Fig below), a bone-facing bottom surface (see Fig below), a central section (see Fig below, located between first and second ends), a first end and a second end (see Fig below),
a first outer fastener screw attached to the first end on the bottom surface of the base (see Fig below), and a second outer fastener screw attached to the second end on the bottom surface of the base (see Fig below),
at least one inner fastener screw attached to the central section on the bottom surface of the base (see Fig below), and
at least one displacement device (nut #3, see Fig below, see also Fig 2 to see the displacement device in isolation, see also Fig 3) configured to move the at least one inner fastener screw away from the bone relative to the outer fastener screws (Fig 2-3, bottom of page 3 to the first paragraph of page 4 where rotation of nut #3 displaces the screw #5 towards or away from bone),
the inner and outer fastener screws being configured to engage with the bone at their bone-facing ends (see Fig below, Fig 7), and
wherein, in a functional state of the fixation device, the at least one inner fastener screw, the outer fastener screws and the displacement device do not protrude beyond a bone-remote surface of the fixation device, such that the surface of the fixation device forms a substantially flat, projection-free surface (see 112 rejection above, where the outer surface of one of the bolts #12 can be considered “a bone-remote surface” and see Fig below, where nothing protrudes beyond the outer surface of either bolts #12 and provides a substantially flat projection free surface)
[(in an alternate interpretation, see bottom of page 3 into page 4 first paragraph, while shown as extending beyond the bone remote top surface, the first and second outer fasteners are secured to the fixation device via locking bolts #12, where the tops of the first and second outer fasteners are able to be secured to the fixation device such that the tops are flush or below the bone-remote top surface, likewise, nut #3 can be adjusted such that the top of screw #5 can be located flush to or below the remote top surface)(in other words the first and second outer fasteners and screw #5 are able to be placed such that they lie below or flush to the bone-remote top surface which would provide a substantially flat projection free surface)].
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Peng does not disclose the first and second outer fasteners and the inner fastener are Schanz screws.
Disegi discloses a fixation device (Fig 1) which uses fasteners (#26) in the form of Schanz screws (paragraph 22) to couple the fixation device to bone , where Schanz screws have sufficient length to extend out from the patients epidermis when anchored to bone (fig 1, paragraph 2, 22).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the first and second outer fasteners and inner fastener of Peng to be Schanz screws in view of Disegi above because these are known type of fasteners used in the art to secure a fixation device to bone and provide sufficient length to extend out from the patients epidermis when anchored to bone sufficient length to extend out from the patients epidermis when anchored to bone.
Regarding Claim 16, Peng as modified discloses the displacement device is actuated,
a) the at least one inner Schanz screw is fixed to the base, or
b) the at least one inner Schanz screw is movable relative to the base (as discussed in claim 15 above, bottom of page 3 to the first paragraph of page 4 in Peng).
Regarding Claim 17, Peng as modified discloses the displacement device comprises at least one component of the group consisting of a knurled or rotating head, a profiled screw head, a knurled nut (#3 in Peng, as seen in Fig 4, 7 and see bottom of page 3 to the first paragraph of page 4) , a knurled screw, a screw and a guide element.
Regarding Claim 18, Peng as modified discloses at least one fastening device (#9 and #5 in Peng, see Fig 4, 7, as well as bore #2 as seen in Fig 6 through which screw #5 extends through), each fastening device being configured to prevent or to enable a displacement of the inner Schanz screws or the outer Schanz screws, respectively (bottom of page 3 to the top of page 4 in Peng, where the fastening device secures the inner fastener/Schanz screw and enables displacement when the displacement device is actuated).
Regarding Claim 19, Peng as modified discloses the fastening device comprises a bore (#2, best seen in Fig 6 in Peng) on one side of the base and a fastening means (#5 in Peng, which fastens the inner fastener/Schanz screw to the displacement device) accommodated therein.
Regarding Claim 21, Peng as modified discloses the displacement device comprises an adjusting element (#3 in Peng, see Fig below) accommodated in a recess (see Figs of Peng below) in the base wherein a movement of the adjusting element causes a displacement of the at least one inner Schanz screw relative to the outer Schanz screws (bottom of page 3 to the top of page 4 in Peng).
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Regarding Claim 22, Peng as modified discloses the base comprises at least one recess on the side (see annotated Figs of Peng in Claim 21 above).
Regarding Claim 23, Peng as modified discloses the displacement device comprises an elongated inner body (#5 in Peng).
Regarding Claim 24, Peng as modified discloses the inner body being receivable in a receiving space on the bottom surface of the base (see Fig 7 in Peng and see Fig below).
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Regarding Claim 25, Peng as modified discloses the at least one inner Schanz screw is attached to the inner body (Schanz screw attached to inner body via a lower end #9 of the lower body, as seen in Fig 4, 7 in Peng).
Regarding Claim 27 Peng as modified discloses the base is at least partially configured as a tubular hollow body (as seen in Fig 3, 6 in Peng).
Regarding Claim 28 Peng as modified discloses at least the base is produced by means of 3D printing [examiner notes that this limitation is product by process and the device of Peng appears to be substantially identical to the device claimed, although produce by a different/undisclosed process, therefore the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983)].
Regarding Claim 28 Peng as modified discloses the displacement device is operable by means of an actuator (see Fig 7 in Peng, the displacement device includes a screw #5 with actuator #5 used to rotate the screw #5, see bottom of page 3 page 4 first paragraph in Peng), preferably electrically (see 112 rejection above).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Peng CN 205054388 and Disegi US 2016/0038185, as applied to claim 29 above and in further view of Biedermann US 2002/0143341.
Peng discloses the claimed invention as discussed above where the inner Schanz screw has a suitable thread for bone fixation at their lower end (#6 in Disegi in Fig 1) is coupled to the screw (#5 in Peng, see Fig 3) via a hole (#7, see Fig 3 in Peng), where the hole is made up of jaws that clamp onto the upper end inner fastener/Schanz screw (as seen in Fig 3 in Peng, page 3, paragraph starting on line 8 “As shown in picture 2, picture 1 ….) but does not disclose wherein the inner and/or outer Schanz screws comprise a metric thread at their upper end and a suitable thread for bone fixation at their lower end.
Biedermann discloses a screw having a smooth upper end (#14 as seen in Fig 1) or a metric thread at the upper end (#35 as seen in fig 9) coupled to a hole (inside #31, as seen in Fig 9) with jaws (#28) that clamp onto the other end to secure the threaded upper end to the hole (paragraph 29, 31).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Peng as modified to have the inner Schanz screw to include a metric thread on the upper end in view of Biedermann above because this provides a known alternate coupling to the hole of the screw (#5 of Peng). Examiner notes that with the modification, the metric threads allow additional securement to the screw (#5 of Peng).
Claim 30 are rejected under 35 U.S.C. 103 as being unpatentable over Peng CN 205054388 and Disegi US 2016/0038185, as applied to claim 29 above and in further view of Forsell US 2011/0196435.
Peng discloses the claimed invention as discussed above but does not disclose the actuator is an electric actuator.
Forsell discloses a displacement device (#938 and screw #937, Fig 35) the displacement device is operable by means of an electric actuator (#938, paragraph 422) to rotate the screw (paragraph 422, Fig 35), where the electric actuator includes an electric speed controller to control and set the speed of the actuator (paragraph 420).
It would have been obvious to one having ordinary skill in the at a time before the effective filing date of the claimed invention to modify the actuator of Peng as modified to be an electric actuator in view of Forsell above because this provides a known alternative actuator to rotate a screw, where the electric actuator includes an electric speed controller to control and set the speed of the actuator.
Claims 15, 23, 26 are rejected under 35 U.S.C. 103 as being unpatentable over Li CN 106108992(cited by applicant) (reference is made to the English Translation, attached herein) in view of Disegi US 2016/0038185.
Regarding Claim 15, Peng discloses a fixation device for transverse bone distraction (Fig 7), comprising
an elongated base (#1 and #6, see fig below) having a bone-remote top surface (see Fig below), a bone-facing bottom surface (see Fig below), a central section (see Fig below, located between first and second ends), a first end and a second end (see Fig below),
a first outer fastener screw attached to the first end on the bottom surface of the base (see Fig below), and a second outer fastener screw attached to the second end on the bottom surface of the base (see Fig below),
at least one inner fastener screw attached to the central section on the bottom surface of the base (see Fig below), and
at least one displacement device (Fig 2-3 below, where displacement device includes screw #9) configured to move the at least one inner fastener screw away from the bone relative to the outer fastener screws (page 6 last two paragraphs into page 7),
the inner and outer fastener screws being configured to engage with the bone at their bone-facing ends (see Fig below), and
wherein, in a functional state of the fixation device, the at least one inner fastener screw, the outer fastener screws and the displacement device do not protrude beyond a bone-remote surface of the fixation device, such that the surface of the fixation device forms a substantially flat, projection-free surface (see 112 rejection above, where the outer surface of one of the clamps #6 can be considered “a bone-remote surface” and see Fig below, where nothing protrudes beyond the outer surface of either clamp 6 and provides a substantially flat projection free surface)
[(in an alternate interpretation, see page 6, 6th paragraph and last two paragraphs into page 7, while shown as extending beyond the bone remote top surface, the first and second outer fasteners are secured to the fixation device via clamps #6, where the tops of the first and second outer fasteners are able to be secured to the fixation device such that the tops are flush or below the bone-remote top surface, likewise, nut #8 can be adjusted such that an end of the screw #9 can be located flush to or below the remote top surface)(in other words the first and second outer fasteners and screw #5 are able to be placed such below or flush to the bone-remote top surface which would provide a substantially flat projection free surface)].
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Peng does not disclose the first and second outer fasteners and the inner fastener are Schanz screws.
Disegi discloses a fixation device (Fig 1) which uses fasteners (#26) in the form of Schanz screws (paragraph 22) to couple the fixation device to bone , where Schanz screws have sufficient length to extend out from the patients epidermis when anchored to bone (fig 1, paragraph 2, 22).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the first and second outer fasteners and inner fastener of Peng to be Schanz screws in view of Disegi above because these are known type of fasteners used in the art to secure a fixation device to bone and provide sufficient length to extend out from the patients epidermis when anchored to bone sufficient length to extend out from the patients epidermis when anchored to bone.
Regarding Claim 23, Li as modified discloses the displacement device comprises an elongated inner body (#12, see fig 2-3 in Li, fig above in claim 15).
Regarding Claim 26, Li as modified discloses the displacement device comprises a threaded screw (#9 in Li , see Fig above in claim 15 )with a head (#10.1 as seen in Fig 3 in Li and see Fig above in claim 15), the threaded screw connecting the base to the inner body and being configured to move the inner body relative to the base towards or away from the bone by rotation (see Fig 2-3 in Li, rotation of nut #8 moves threaded screw #9, page 6 last two paragraphs into page 7 in Li).
Conclusion
See PTO-892 for art of cited interest, in particular other fixation devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773