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 .
Response to Arguments
Applicant's arguments filed 12/8/2025 have been fully considered but they are moot in view of the new grounds of rejection necessitated by the amendments.
Claim Objections
Claim 12 is objected to because of the following informalities:
In claim 12, line 1, “claims 1” should recite –claim 1--.
Appropriate correction is required.
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.
Claims 9 and 13 are 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. Claim 9 states “the third boundary line is parallel to the first boundary line” and claim 13 states “the fourth boundary line is parallel to the second boundary line”. The specification does not use the term “parallel” and none of the figures show these features, therefore claims 9 and 13 are directed to new matter.
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 1-14 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.
Regarding claim 1, lines 14-15 recite “with respect to the coating film”. It is unclear what this means or what structure is “with respect to the coating film”. Lines 13-14 recite “the plurality of boundary lines defined by a presence or absence of the coating film comprise a second boundary line…” so this limitation already seems to reference the second boundary line with respect to the coating film. Please clarify what “with respect to the coating film” means and applies to.
Similarly, claim 1, lines 17-18 recite “with respect to the layer member”. It is unclear what this means or what structure is “with respect to the layer member”. Lines 16-17 recite “one or more boundary lines on the base defined by a presence or absence of the layer member comprise a fourth boundary line…” so this limitation already seems to reference the fourth boundary line with respect to the layer member. Please clarify what “with respect to the layer member” means and applies to.
Claim 1 is further unclear because line 17 states that the fourth boundary line is “located on an upper side of the base” but lines 19-20 recite “the fourth boundary line is located farther on a lower side of the base than the second boundary line”. Both the second and fourth boundary lines are defined as being located on an upper side of the base, therefore it is unclear in line 19 when the claim states the fourth boundary line is located farther on a lower side of the base”. For examination, this limitation is interpreted to mean that the fourth boundary line is located lower on the base than the second boundary line.
Claim 8 is unclear because lines 1-3 recite “further comprising one or more boundary lines defined by a presence or absence of the layer member” but “one or more boundary lines defined by a presence or absence of the layer member” are already defined in claim 1, lines 16-17. “further comprising” makes it sound like this is an additional one or more boundary lines but it seems these are the same one or more boundary lines defined by a presence or absence of the layer member as recited in claim 1. Applicant may consider referring back to the one or more boundary lines defined by a presence or absence of the layer member instead of reciting “further comprising”.
Claim 8 is further unclear because line 6 states “the third boundary line is located further on an upper side of the base” but doesn’t say farther in which direction (on an upper side does not imply further up or down). As best understood this limitation is believed to mean that the third boundary line is located farther upward on an upper side of the base than the first boundary line. The examiner notes that claim 1 already recites that the first boundary line is located at a lower side of the base.
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.
Claims 1, 4-7, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Danoff et al. US 2006/0190080 (hereafter referred to as Danoff) in view of Anderson US 2005/0221259 (hereafter referred to as Anderson) and further in view of Tamabuchi et al. JP H1147173 A (hereafter referred to as Tamabuchi).
Regarding claim 1, Danoff discloses an artificial joint stem (fig.3) comprising a base elongated in an upper-and-lower direction where an upper side is defined as a proximal side when inside a human body, a coating film 36 on a part of the base (fig.3), containing a calcium phosphate-based material (pars.29 and 32; par.29 discloses hydroxyapatite as a bone growth stimulant and hydroxyapatite is a calcium phosphate-based material; par.32 discloses coating 36 is a bone growth stimulant), a plurality of boundary lines (considered the top line and bottom line of the coating 36) defined by a presence or absence of the coating film 36 (fig.3), and comprising a first boundary line (bottom line of coating 36) that is located at a lower side of the base, and that intersects the upper-and-lower direction, wherein a component of the first boundary line along the upper-and-lower direction is smaller than a component of the base along a width direction (fig.3 shows the first boundary line has a height component of zero therefore the height component of the first boundary line is smaller than the width of the base), the plurality of boundary lines defined by a presence or absence of the coating film comprise a second boundary line located on an upper side of the base (top line of coating 36 as shown in fig.3). Danoff discloses the invention substantially as claimed, but does not disclose the coating comprises an antimicrobial material.
Anderson teaches an artificial joint stem, in the same field of endeavor, wherein a calcium phosphate-based coating comprises an antimicrobial material for the purpose of reducing the need for antibiotics after implantation of the implant (par.17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add an antimicrobial agent as taught by Anderson to the calcium-phosphate coating material of Danoff in order to prevent infection and reduce the need for antibiotics after implantation of the implant. Danoff in view of Anderson discloses the invention substantially as claimed, but Danoff does not disclose a layer member located on a surface of the base, a surface of the layer member is a rough surface, or one or more boundary lines on the base defined by a presence or absence of the layer member comprise a fourth boundary line located on an upper side of the base and the fourth boundary line is located lower on the base than the second boundary line.
Tamabuchi teaches an artificial joint stem, in the same field of endeavor, wherein a layer member 6 (layer member 6 is a titanium coating as discussed in the translation on the last paragraph of pg.3 to the first paragraph of pg.4 and also in the translated abstract) is located on a surface of a base 4, a surface of the layer member is a rough surface (fig.3), and the rough layer 6 is further coated with a calcium phosphate-based material 7 (fig.3; abstract and last paragraph of pg.3 to the first paragraph of pg.4 of the translation). Tamabuchi teaches the rough layer member 6 is formed on the intertrochanteric portion of the stem for the purpose of improving safety and proper fit (abstract). Tamabuchi further teaches the calcium phosphate coating film covers both the rough layer 6 as well as the surface of the base 4 where the rough skin surface is not formed (see the last paragraph of pg.3 to the first paragraph of pg.4 in the translation). This means that a lower boundary line of the rough layer member 6 is located between an upper and lower boundary line of the calcium phosphate coating 7.
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 artificial joint stem of Danoff to include a titanium layer member forming a rough surface, under the calcium phosphate coating, on the intertrochanteric region of the artificial joint stem as taught by Tamabuchi in order to improve fit and safety of the artificial joint stem. Danoff in view of Anderson as modified to include the rough titanium layer member on the intertrochanteric portion of the stem as taught by Tamabuchi yields one or more boundary lines on the base defined by a presence or absence of the layer member comprise a fourth boundary line (considered the lower boundary of the rough layer member which is at the bottom of the intertrochanteric portion of the stem) located on an upper side of the base and the fourth boundary line is located lower on the base than the second boundary line (which is the top line of the coating layer of Danoff).
Regarding claims 4 and 5, see fig.3 of Danoff for the first/lower and second/upper boundary lines being straight.
Regarding claims 6 and 7, see fig.3 of Danoff for an upper portion, considered “a shrink portion” since it tapers inwardly in a downward direction and a lower portion having a constant width. The first/lower boundary line is located at the constant width portion and the upper boundary line is located at the shrink portion.
Regarding claim 14, see Danoff fig.3 for the length of the coating on the medial side (side where the neck portion protrudes) being less than the length of the coating on the lateral side.
Claims 1-6 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Adrey et al. US 5,139,522 (hereafter referred to as Adrey) in view of Anderson and further in view of Tamabuchi.
Regarding claim 1, Adrey discloses an artificial joint stem 1 comprising a base 2 elongated in an upper-and-lower direction where an upper side is defined as a proximal side when inside a human body, a coating film 10 on a part of the base, containing a calcium phosphate-based material (fig. 8; col.3, lines 55-64 discloses the coating is hydroxyapatite), and a plurality of boundary lines (upper line and lower line of the coating 10) defined by a presence or absence of the coating film, and comprising a first boundary line (lower line of coating 10) that is located at a lower side of the base, and that intersects the upper-and-lower direction, wherein a component of the first boundary line along the upper-and-lower direction is smaller than a component of the base along a width direction (fig.8 shows the first boundary line has a vertical component that is smaller than the width of the base), the plurality of boundary lines defined by a presence or absence of the coating film comprise a second boundary line (top line of coating 10 as shown in fig.8) located on an upper side of the base. Adrey discloses the invention substantially as claimed, but does not disclose the coating comprises an antimicrobial material.
Anderson teaches an artificial joint stem, in the same field of endeavor, wherein a calcium phosphate-based coating comprises an antimicrobial material for the purpose of reducing the need for antibiotics after implantation of the implant (par.17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add an antimicrobial agent as taught by Anderson to the calcium-phosphate coating material of Adrey in order to prevent infection and reduce the need for antibiotics after implantation of the implant. Adrey in view of Anderson discloses the invention substantially as claimed. Adrey further discloses a roughened portion (portion comprising cavities 9) on a surface of the base, wherein one or more boundary lines on the base defined by the presence or absence of the roughened portion comprise a fourth/upper boundary line located on an upper surface of the base, the fourth boundary line is located lower on the base than the second boundary line (in other words, the calcium phosphate-based coating extends above and below the roughened portion as shown in fig.8). However, Adrey discloses the roughened portion is formed by cavities in the surface of the stem, therefore Adrey in view of Anderson does not disclose that the roughened portion is a layer member located on a surface of the base, wherein the surface of the layer member is a rough surface.
Tamabuchi teaches an artificial joint stem, in the same field of endeavor, wherein a layer member 6 (layer member 6 is a titanium coating as discussed in the translation on the last paragraph of pg.3 to the first paragraph of pg.4 and also in the translated abstract) is located on a surface of a base 4, a surface of the layer member is a rough surface (fig.3), and the rough layer 6 is further coated with a calcium phosphate-based material 7 (fig.3; abstract and last paragraph of pg.3 to the first paragraph of pg.4 of the translation). Tamabuchi teaches the rough layer member 6 is formed on the intertrochanteric portion of the stem for the purpose of improving safety and proper fit (abstract). Tamabuchi further teaches the calcium phosphate coating film covers both the rough layer 6 as well as the surface of the base 4 where the rough skin surface is not formed (see the last paragraph of pg.3 to the first paragraph of pg.4 in the translation).
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 artificial joint stem of Adrey in view of Anderson by substituting a titanium layer member forming a rough surface as taught by Tamabuchi for the cavities of Adrey in order to provide optimal fit and safety of the artificial joint stem. Since both Adrey and Tamabuchi teach roughened intertrochanteric portions of an artificial joint stem for firm anchoring in bone tissue, it would have been further obvious to substitute the rough titanium layer taught by Tamabuchi for the cavities of Adrey as this is simple substitution of one known element for another to obtain predictable results (see MPEP 2143B).
Regarding claims 2 and 3, see fig.8 of Adrey which shows the top/second boundary line of coating 10 having a vertical component that is smaller than a width component.
Regarding claims 4 and 5, see fig.8 of Adrey for the first/lower and second/upper boundary lines of the coating film being straight.
Regarding claim 6, see fig.8 of Adrey for an upper portion, considered “a shrink portion” since it tapers inwardly in a downward direction. The upper boundary line is located at the shrink portion.
Regarding claim 8, see fig.8 of Adrey which shows the boundary lines of the rough surface. The third/lower boundary line of the rough surface is higher than the first boundary line and the fourth/upper boundary line of the rough surface is lower than the second boundary line. In other words, the coating 10 extends above and below the rough surface. As such, it would follow that Adrey as modified by Tamabuchi to have a layer member instead of cavities would likewise have the same third and fourth boundary lines formed by lower and upper boundaries of the rough layer member.
Regarding claims 9, 10, and 13, while Adrey in view of Anderson and Tamabuchi does not specifically show the third boundary line is parallel to the first boundary line, the third boundary line has a shape different from the first boundary line, or the fourth boundary line is parallel to the second boundary line, such shapes would have been an obvious matter of design choice since it has been held that changes in shape are a matter of design choice, which a person of ordinary skill in the art would have found obvious as they were not disclosed as being critical to the practice of the invention (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) MPEP 2144.04 IV B).
Regarding claim 11, see annotated fig.8 of Adrey below which shows the medial boundary line can be considered a third boundary line and this boundary line has a greater vertical component than a component of the base along the width direction.
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Regarding claim 12, see the annotated fig.8 of Adrey below for an apex and second boundary line as claimed.
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Regarding claim 14, see fig.8 of Adrey which shows the vertical height of the coating 10 on the medial side, where the neck portion 4 protrudes, is less than the vertical height of the coating on the lateral side, opposite to the side where the neck portion protrudes.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774