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 .
Election/Restrictions
Applicant's election with traverse of Group I (surgical instrument claims 1-9, 13, and 16-20) in the reply filed on September 12, 2025 is acknowledged. The traversal is on the ground(s) that the restriction is improper because the claims have unity via 37 CFR 1.475 (b). This is not found persuasive because under 37 CFR 1.475 (a) the groups lack unity of invention as pointed out in the restriction requirement. Part (a) is not reliant on or superseded by part (b).
The requirement is still deemed proper and is therefore made FINAL.
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 1-9, 13, and 16-20 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 1, line 2, “for example” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 9 has the limitation, “guide means for guiding the cutting of the bone”, which is being interpreted as a slot or hole for a drill bit, since the specification points to reference character 7 and this is shown as being a hole or slot in Figs. 6 and 12).
Claim 13 requires limitations “receiving means” and “interlocking means” these two phrases are being interpreted as holes (Fig. 2; 11) and side surfaces (Fig. 1; 111a and 111b) as mentioned in the specification and drawings.
Claim 16 requires the limitation “guide means for guiding” which is being interpreted as a through hole (Fig. 1; holes that 42 goes through).
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) 1-6, 9, 13, and 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ammann et al. (US 2013/0190885; “Ammann”).
Claim 1, Ammann discloses a surgical instrument (Fig. 16), suitable for protecting tissue during bone surgery (Fig. 16; paragraph [0110]), for example when cutting and/or drilling a bone (Fig. 16; paragraph [0110]), which surgical instrument comprises: a protective portion (portion placed up against the bone) intended to be positioned in a protective subcutaneous position between the tissues to be protected and a bone (Fig. 16; paragraph [0110]), which protective portion includes a front face (surface facing the bone) intended to bear on said bone (fig. 16), a gripping portion (160 or 155, any portion that can be gripped), suitable for gripping said surgical instrument (Fig. 16), a temporary stabilization portion (portions with the holes, such as where 145 and 150 point towards) which is designed to temporarily secure said surgical instrument to said bone (Fig. 16; paragraph [0103]), in said protective position (fig. 16), which temporary stabilization portion includes at least one through orifice (holes that 145 and 150 go through) which is intended to receive a temporarily implantable organ in said bone (Fig. 16).
Claim 2, Ammann discloses the surgical instrument according to claim 1, wherein said at least one through orifice is formed within the protective portion, on the side of the gripping portion (Fig. 16; the holes that 145 and 150 go through each meet this limitation).
Claim 3, Ammann discloses the surgical instrument according to claim 2, wherein the protective portion has a longitudinal axis (Fig. 16; axis running through 135), and wherein the temporary stabilization portion includes at least one through orifice which is implanted on one side of said longitudinal axis (Fig. 16; note how the holes do not lie directly on the axis, so they are beside the axis).
Claim 4, Ammann discloses the surgical instrument according to claim 3, wherein the temporary stabilization portion includes at least one pair of through orifices (Fig. 16, there are 5 holes on the device), implanted on either side of said longitudinal axis (Fig. 16).
Claim 5, Ammann discloses the surgical instrument according to claim 4, wherein the temporary stabilization portion includes at least two pairs of through orifices (Fig. 16; there are 5 holes), implanted on either side of said longitudinal axis and distributed over the length of said longitudinal axis (Fig. 16).
Claim 6, Ammann discloses the surgical instrument according to claim 2, wherein the temporary stabilization portion includes at least two non-parallel through orifices (Fig. 16; at least holes that 145 and 150 go through), each suitable for receiving a pin (Fig. 16; 145 and 150).
Claim 9, Ammann discloses the surgical instrument according to claim 1, wherein said surgical instrument includes guide means (Fig. 6; any of the holes) for guiding the cutting of the bone.
Claim 13, Ammann discloses the surgical instrument according to claim 1, wherein said surgical instrument includes receiving means (any of the holes in the device), suitable for receiving at least one accessory (Fig. 16), formed between the protective portion and the gripping portion (Fig. 16), which receiving means comprise interlocking means (side surfaces) suitable for receiving a complementary base of said accessory (Fig. 16).
Claim 16, Ammann discloses the surgical instrument according to claim 1, wherein said surgical instrument includes guide means (Fig. 16; any of the holes) for guiding the implantation of at least one pin (Fig. 16).
Claim 17, Ammann discloses the surgical instrument according to claim 16, wherein the means for guiding the implantation comprise a proximal orifice (top of the hole) defining a proximal axis (axis running across the diameter along the tool) extending parallel to a longitudinal axis of the protective portion (Fig. 16), directly underlying a cut line intended to be made in said bone, to position a pin involved in guiding the cut line (Fig. 16; a user can cut however they want and this device allows for this to occur).
Claim 18, Ammann discloses the surgical instrument according to claim 16, wherein the means for guiding the implantation comprise a distal orifice (bone facing side of the hole) which defines a distal axis (axis running through the hole) intersecting a cut line intended to be made in said bone, to position at least one pin selected from a cutting stop pin and a pin for guiding a second cut line (Fig. 16; a user can cut however they want and this device allows for this to occur).
Claim 19, Ammann discloses the surgical instrument according to claim 17, wherein the means for guiding the implantation comprise a distal orifice (bone facing side of the hole) which defines a distal axis (axis running through the hole) intersecting a cut line intended to be made in said bone, to position at least one pin selected from a cutting stop pin and a pin for guiding a second cut line (Fig. 16; a user can cut however they want and this device allows for this to occur).
Claim 20, Ammann discloses the surgical instrument according to claim 19, wherein the distal orifice is carried by assembly means (Fig. 16; 155)) enabling a mobility over a circular arc travel (note that the device can pivot or rotate about the axis created by 300 and 155), relative to the longitudinal axis of the protective portion and whose center coincides with a desired hinge point (Fig. 16).
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) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ammann et al. (US 2013/0190885; “Ammann”).
Claim 7, Ammann discloses the surgical instrument of claim 1.
However, Ammann does not disclose what the instrument (100) is made of.
Ammann teaches other parts of their device being made of radiotranslucent and/or radiopaque material (paragraph [0093]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make any part of the instrument out of radiotranslucent or radiopaque material, in order to make the device visible or not under fluoroscopy (paragraph [0093]).
Claim 8, Ammann discloses the surgical instrument according to claim 1, wherein the protective portion includes a groove (paragraph [0094]), opening on the side of said front face and defining a longitudinal axis of said protective portion (paragraph [0094]).
However, Ammann does not disclose what the instrument (100) is made of.
Ammann teaches other parts of their device being made of radiotranslucent and/or radiopaque material, such as stainless steel (paragraph [0093]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make any part of the instrument out of radiotranslucent or radiopaque material, in order to make the device visible or not under fluoroscopy (paragraph [0093]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Zade Coley/Primary Examiner, Art Unit 3775