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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 2 objected to because of the following informalities: “proximal part” refers to the elbow joint (as defined in line 2 of claim 2). In line 10 of claim 2 the reference to “proximal part” is inconsistent, as the limitation is referencing the angulation joint, not the elbow joint. Instead, it should read “proximal angulation coupling.” Appropriate correction is required.
Claim 4 objected to because of the following informalities: “a combined locking and fixing element” in line 7 of claim 4 should read “the combined locking and fixing element,” as these elements were already defined in the claim. Appropriate correction is required.
Claim 5 objected to because of the following informalities: “form the angulation joint have one degree of rotational freedom” should read “form the angulating joint having one degree of rotational freedom”. Appropriate correction is required.
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: “a locking element configured for locking a direction and/or axial rotational angle of the ulnar stem portion” and “a fixing element configured for fixing the linking body to the remainder of the ulnar stem portion” in claim 4.
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 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 3 and 10 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.
The terms “preferably” and “more preferably” in Claims 3 and 10 renders the claims indefinite, since it is unclear as to whether the limitations that follow the term “preferably” is required.
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.
Claim(s) 1-2, 5, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Palmer (USPAP 20140135937) in view of Berelsman (USPAP 20100179661).
Regarding claim 1, Palmer discloses an elbow joint prosthetic implant (10) comprising: a humeral component (200) comprising a humeral stem portion (203) configured for placement within the humeral intramedullary canal of a subject ([0059]), an ulnar component (100) comprising an ulnar stem portion (106) configured for placement within the ulnar intramedullary canal of the subject ([0090]), the humeral component (200) and ulnar component (100) are connected by an implant elbow joint (where 305 is the proximal elbow joint and 218 is the distal elbow joint), the ulnar component further comprises an angulation joint (where 102 is the proximal angulation coupling and 304 is the distal angulation coupling) that is separate from the implant elbow joint (305/218), the angulation joint has at least one degree of freedom of rotational movement ([0046]). Palmer fails to disclose that is the angulation joint is configured to adjust and fix a varus-valgus direction of the ulnar stem portion.
Berelsman also discloses an elbow joint prosthetic implant ([0003]) comprising an angulation joint (FIG 18, #400). Berelsman teaches the angulation joint (400) is configured to adjust and fix a varus-valgus direction of the ulnar stem portion ([122], FIG 19B, #400b).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Palmer so that the angulation joint is configured to adjust and fix a varus-valgus direction of the ulnar stem portion, as taught by Berelsman, as this permits a surgeon to tailor the degree of varus/valgus constraint in a desired manner ([14]).
Regarding claim 2, Palmer as modified by Berelsman discloses the invention of claim 1, wherein the implant elbow joint (305/218) comprises a proximal part (218) configured to couple to a distal part (305) thereby forming the implant elbow joint; the angulation joint (102/304) comprises a proximal angulation coupling (102) configured to couple to a distal angulation coupling (304), thereby forming the angulation joint, the ulnar component (100) comprises a linking body (112) having a proximal end (bottom end in FIG 1) and a distal end (top end in FIG 1), the proximal end of the linking body is disposed with, or connected to, the distal part (305) of the elbow joint (FIG 1), the distal end of the linking body is disposed with, or connected to, the proximal angulation coupling (102) of the angulation joint (FIG 1), a position and/or orientation of the distal elbow coupling and the proximal angulation coupling is fixed ([55], FIG 6B), and the linking body (112) is dismountable from the ulnar component ([49]).
Regarding claim 5, Palmer as modified by Berelsman discloses the proximal angulation coupling (102) and distal angulation coupling (304) form the angulation joint having one degree of rotational freedom ([64], FIG 2), one of the proximal angulation coupling or distal angulation coupling comprises a tapered member ([46], 105), the other of the proximal angulation coupling or distal angulation coupling comprises a reciprocating tapered hole ([46], “the surface of side walls 105 is configured to mate and articulate with bearing member 300.” If side walls 105 are tapered, then the opening 304 must be correspondingly tapered to mate and articulate) configured to engage the tapered member thereby forming the one degree of rotational freedom angulation joint ([64], FIG 2, Line 5-5 shows the degree of rotational freedom).
Regarding claim 7, Palmer as modified by Berelsman discloses the elbow joint prosthetic implant according to claim 1, wherein the ulnar stem portion (106) is a rigid monoblock ([49], “stem being integrally fixed to stem connector member”).
Regarding claim 8, Palmer as modified by Berelsman discloses the ulnar stem portion (106) is least partially articulated, allowing the ulnar stem portion (106) to conform to the shape of the ulnar intramedullary canal ([50]; Stem 106 may be configured to be match anatomically with the intramedullary canal, which is equivalent to being at least partially articulated)). Additionally or alternatively, the ulnar portion (106) is capable of being articulated relative to the humeral component (abstract, [0005]).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Palmer (20140135937) in view of Berelsman (20100179661) as applied to claim 2 above, and further in view of Deransart (11364127).
Palmer in view of Berelsman discloses the invention of claim 2, but fails to disclose a plurality of linking bodies, at least two all having a different fixed position and/or different fixed orientation relation between the elbow joint distal part and the proximal angulation coupling, at least two preferably all of plurality of linking bodies has a different fixed distance (h) between the elbow joint distal part and the proximal angulation coupling.
Deransart also discloses a prosthetic implant (Col 2, Line 11). Deransart teaches the implant comprises a plurality of linking bodies (FIG 7F, #168), at least two all having a different fixed position and/or different fixed orientation relation between the joint distal part (FIG 7F, #163B) and the proximal angulation coupling (FIG 7F, #164), at least two preferably all of plurality of linking bodies has a different fixed distance (h) between the elbow joint distal part and the proximal angulation coupling (Col. 10, Line 44, where having or eliminating the middle portion of the coupler is the same as the coupler having at least two different fixed distances).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Palmer in view of Berelsman to include a plurality of linking bodies, at least two all having a different fixed position and/or different fixed orientation relation between the elbow joint distal part and the proximal angulation coupling, at least two preferably all of plurality of linking bodies has a different fixed distance (h) between the elbow joint distal part and the proximal angulation coupling, as taught by Deransart, in order to allow for a clinician to make or change reconstruction decisions during surgery (Col. 10, line 30).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Palmer (20140135937) in view of Berelsman (20100179661) as applied to claim 2 above, and further in view of Orbay (20200397591).
Regarding claim 4, Palmer as modified by Berelsman discloses the invention of claim 1 and the presence of a connecting mechanism (112), but does not disclose a locking element configured for locking a direction and/or axial rotational angle of the ulnar stem portion, a fixing element configured for fixing the linking body to the remainder of the ulnar stem portion, a combined locking and fixing element configured for both locking a direction and/or axial rotational angle of the ulnar stem portion and fixing the linking body to the remainder of the ulnar stem portion.
Berelsman further teaches a locking element (FIG 20B, #800, 806; this element is interpreted under 112(f) as a fixation screw, see page 16, line 16 of the instant application, and equivalents thereof) configured for locking a direction and/or axial rotational angle of the ulnar stem portion (FIG 20B, #14p’. Paragraph 127: “prevent bearing insert from rotating relative to integrally attached cage portion”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Palmer in view of Berelsman to include a locking element configured for locking a direction and/or axial rotational angle of the ulnar stem portion as taught by Berelsman in order to minimize stress in the bearing components and more accurately mimic normal joint motion ([10]).
Orbay teaches a fixing element (208; this element is interpreted under 112(f) as a threaded member, see page 20, line 13 of the instant application, and equivalents thereof) configured for fixing the linking body to the remainder of the ulnar stem portion (Paragraph 44: “ Thread 303 is adapted to engage the thread 208 on the inner surface of the entrance 207 of the ulnar head component 200.” Ulnar head component 200 is part of ulnar medullary stem 104).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Palmer in view of Berelsman with Orbay to include a fixing element configured for fixing the linking body to the remainder of the ulnar stem portion as taught by Orbay to provide joint stability ([0008]).
It would also be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the locking and fixing element configured for both locking a direction and/or axial rotational angle of the ulnar stem portion and fixing the linking body to the remainder of the ulnar stem portion, as taught by both Berelsman and Orbay, to increase the accuracy and stability of the joint (Berelsman [10]; Orbay [0008]).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Palmer (20140135937) in view of Berelsman (20100179661) as applied to claim 5 above, and further in view of Stockmans (20220160514).
Palmer in view of Berelsman discloses the invention of claim 5 but does not disclose the proximal angulation coupling and distal angulation coupling form the angulation joint having two or three degrees of rotational freedom, one of the proximal angulation coupling or distal angulation coupling comprises a spherical member, the other of proximal angulation coupling or distal angulation coupling comprises a reciprocating socket configured to engage the spherical member, thereby forming the two or three degrees of rotational freedom angulation joint.
Stockmans also discloses a prosthetic implant (100) comprising proximal (FIG 5, #120) and distal angulation couplings (FIG 5, #110) for joints, such as an elbow [0002]. One of the proximal angulation coupling (FIG 5, #120) or distal angulation coupling (FIG 5, #100) comprises a spherical member (FIG 5, #121), the other of proximal angulation coupling (FIG 5, #120) or distal angulation coupling (FIG 5, #100) comprises a reciprocating socket configured to engage the spherical member (FIG 4, #103), thereby forming the two or three degrees of rotational freedom angulation joint, as it is understood in the art that ball and socket joints form two or three degrees of rotational freedom.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Palmer in view of Berelsman to include the proximal angulation coupling and distal angulation coupling form the angulation joint having two or three degrees of rotational freedom, one of the proximal angulation coupling or distal angulation coupling comprises a spherical member, the other of proximal angulation coupling or distal angulation coupling comprises a reciprocating socket configured to engage the spherical member, thereby forming the two or three degrees of rotational freedom angulation joint as taught by Stockman in order to provide an improved implant with controlled impingement and reduced wear [0006; 0008].
Claim(s) 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Palmer (20140135937) in view of Stossel (EP 0575107A1).
Regarding claim 9, Palmer discloses a kit ([95]) comprising a humeral component (200) comprising a humeral stem portion (203) configured for placement within the humeral intramedullary canal of a subject ([59], FIG 4), at least two ulnar components (100, [96], “a plurality of ulnar components”) each being a monoblock ([49] , “stem being integrally fixed to stem connector member”), wherein each ulnar component (100) comprises: an ulnar stem portion (106) configured for placement within the ulnar intramedullary canal of the subject ([96], “configured to… gain immediate fixation within the intramedullary canal of the ulna”); a distal part (305) of an implant elbow joint (218/305) configured to engage with a corresponding proximal part (218) of the implant elbow joint (218/305) of the humeral component (200, [97], “may also include various sized transverse fixation devices”), thereby forming the implant elbow joint (FIG 2). Palmer fails to disclose that the at least two of the ulnar components mutually differ in a valgus-varus direction of the ulnar stem portion, at least one of the ulnar components has a valgus angle of between -1° and 4 or between 9 and 29.
Stossel also discloses a humeral component (Figs. 1-2) and teaches that the at least two of the ulnar components (2) mutually differ in a valgus-varus direction (alpha) of the ulnar stem portion, at least one of the ulnar components (2) has a valgus angle of between -1° and 4 or between 9 and 29 (Page 2, Line 12; Stossel teaches that the invention can be offset by up to 10 degrees in a valgus direction). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Palmer to include that the at least two of the ulnar components mutually differ in a valgus-varus direction of the ulnar stem portion, at least one of the ulnar components has a valgus angle of between -1° and 4 or between 9 and 29, as taught by Stossel, in order to replace [an] injured articulation (Page 1, Line 18), and provide a physiologically accurate angle.
Regarding claim 10, Palmer in view of Stossel discloses the invention of claim 9 but does not disclose that the at least one ulnar component has a valgus angle between 9 and 29, preferably between 10 and 20, more preferably between 12 and 18. Stossel further teaches that the invention can be offset by up to 10 degrees in a valgus direction (Page 2, Line 12). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Palmer in view of Stossel to include that the at least two of the ulnar components mutually differ in a valgus-varus direction of the ulnar stem portion, at least one of the ulnar components has a valgus angle of between -1° and 4 or between 9 and 29, as further taught by Stossel, in order to be used to replace [an] injured articulation (Page 1, Line 18), and provide a physiologically accurate angle.
Regarding claim 11, Palmer discloses a humeral component (200) comprising a humeral stem portion (203) configured for placement within the humeral intramedullary canal of a subject ([59], FIG 4), an ulnar component (100) that is a monoblock ([49] , “stem being integrally fixed to stem connector member”), comprising: an ulnar stem portion (106) configured for placement within the ulnar intramedullary canal of the subject ([96], “configured to… gain immediate fixation within the intramedullary canal of the ulna”); a distal part (305) of an implant elbow joint (218/305) configured to engage with a corresponding proximal part (218) of the implant elbow joint (218/305) of the humeral component, thereby forming the implant elbow joint (see Fig. 2). Palmer fails to disclose that the at least one ulnar component has a valgus angle between 9 and 29, preferably between 10 and 20, more preferably between 12 and 18.
Stossel also discloses a humeral component (Figs. 1-2) and teaches that the at least two of the ulnar components (2) mutually differ in a valgus-varus direction (alpha) of the ulnar stem portion, at least one of the ulnar components (2) has a valgus angle of between -1° and 4 or between 9 and 29 (Page 2, Line 12; Stossel teaches that the invention can be offset by up to 10 degrees in a valgus direction). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Palmer to include that the at least two of the ulnar components mutually differ in a valgus-varus direction of the ulnar stem portion, at least one of the ulnar components has a valgus angle of between -1° and 4 or between 9 and 29, as taught by Stossel, in order to be used to replace [an] injured articulation (Page 1, Line 18), and provide a physiologically accurate angle.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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/R.F.N./Patent Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774