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 .
Claim Objections
Claims 12-14 and 24 are objected to because of the following informalities: Each of claims 12-14 and 24 recite “trail” throughout, which appears to be a misspelling of the word – trial –. Claim 12 also recites “a patient having surgery”, which appears to be referring to – the patient –, as previously recited in the preamble of the claim. Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “axis of revolution of the metaglene and the axis of revolution of the glenosphere intersect with each other”, as recited in claim 16, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
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: an assembling device to assemble the metaglene and the glenosphere 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: assembly means known to those skilled in the art such as clips or a screw/nut combination, etc. (see paragraph 00050 of applicant’s specification).
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
Claims 12-23 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 term “right” in claim 12 is a relative term which renders the claim indefinite. The term “right” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The location at which the center of rotation is positioned is rendered indefinite by the use of the term “right”.
Claim Rejections - 35 USC § 102
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.
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) 12-15, 17, and 21-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2016/0287401 A1 to Muir et al. (Muir).
Regarding claim 12
Muir teaches a glenoid trial and implant assembly for use in a reverse total shoulder arthroplasty and a method for using the same (abstract).
PNG
media_image1.png
648
402
media_image1.png
Greyscale
Muir meets the limitations of a method for attaching a reverse total shoulder prosthesis in a patient (abstract), comprising the steps of: a) attaching a glenoid trail implant in a patient's glenoid fossa (paragraph 0047 discloses installing the trial assembly on the glenoid; 24), wherein the glenoid trail implant comprises: a metaglene (adapter assembly; 28) having an axis of revolution and adapted to be temporarily assembled inside a glenoid fossa of a patient having surgery (paragraph 0058 discloses that the adapter assembly; 28 may not be used in the installed configuration and is therefore adapted to be temporarily assembled as claimed), and a glenosphere (glenoid trial; 30) having an axis of revolution and being integrally assembled to the metaglene (paragraph 0061 discloses integral assembly of the glenosphere/glenoid trial to the metaglene/adapter assembly), and intended to be received inside a cupula of a humeral trial implant (paragraph 0048 discloses that the concave surface of the humeral cup receives the glenoid trial) (b) attaching a humeral trial implant (humeral cup; 34) in the patient's humerus (22) (paragraph 0048 discloses attaching humeral trial implant/humeral cup to the humerus), c) checking that the glenoid and humeral trial implants are compatible in order to position the center of rotation of the shoulder joint at the right location according to the patient's morphological characteristics (paragraphs 0004 and 0070 disclose that, since anatomy varies among patients, the surgeon trials the surgically created shoulder joint by moving the humerus through a range of motion to evaluate the fit and function of the glenoid trial and determine whether the trialing is satisfactory – therefore, the trial implants are checked for compatibility in order to position the center of rotation of the shoulder joint at the right location according to the patient’s morphological characteristics as claimed).
Regarding claim 13
Muir teaches the method for attaching a reverse total shoulder prosthesis in a patient, according to claim 12, wherein if the glenoid and humeral trail implants are found to be incompatible, at least one of steps a), b) or c) is repeated, with at least one of a glenoid trial implant and a humeral trial implant of different dimensions (paragraph 0004 and 0070 discloses repeating the process of trialing with another glenoid trial that has a different size and/or shape if the trialing is unsatisfactory).
Regarding claim 14
Muir teaches the method for attaching a reverse total shoulder prosthesis in a patient, according to claim 12, wherein if the glenoid and humeral trail implants are found to be compatible, they are removed and replaced by final glenoid and humeral implants of identical dimensions to the glenoid trail implant and humeral trail implant, respectively (paragraphs 0005, 0047, and 0071 disclose that once a satisfactory trial is found, the surgeon selects a final implant that matches the size and shape of the trial and swaps out the trial for the final implant).
Regarding claim 15
Muir teaches the method for attaching a reverse total shoulder prosthesis in a patient, according to claim 12, wherein the axis of revolution of the metaglene and the glenosphere coincide (paragraph 0057 discloses that the adapter plate; 80 of the metaglene/adapter assembly; 28 can be designated at one of three positions with respect to the glenoid trial/glenosphere, as shown in fig. 5 –the axis of revolution of the metaglene and the glenosphere coincide in at least one of the designated positions and meets this limitation as claimed).
Regarding claim 17
Muir teaches the method for attaching a reverse total shoulder prosthesis in a patient, according to claim 12, wherein the axis of revolution of the metaglene and the glenosphere are parallel (paragraph 0057 discloses that the adapter plate; 80 of the metaglene/adapter assembly; 28 can be designated at one of three positions with respect to the glenoid trial/glenosphere, as shown in fig. 5 –the axis of revolution of the metaglene and the glenosphere are parallel in at least one of the designated positions and meets this limitation as claimed).
Regarding claim 21
Muir teaches the method for attaching a reverse total shoulder prosthesis in a patient, according to claim 12, wherein the glenoid trial implant comprises an assembling device to assemble the metaglene and the glenosphere (paragraph 0061 discloses assembling the metaglene/adapter assembly and the glenosphere via a cavity having a geometry that is non-circular and a shape of the adapter plate received therein – see claim interpretation above).
Regarding claim 22
Muir teaches the method for attaching a reverse total shoulder prosthesis in a patient, according to claim 12, wherein the metaglene and/or the glenosphere are made from plastic polymer, stainless steel, titanium, or an alloy of these materials (paragraph 0067 discloses medical grade titanium, etc.).
Regarding claim 23
Muir teaches the method for attaching a reverse total shoulder prosthesis in a patient, according to claim 12, wherein a set comprising several glenoid trial implants with different dimensions (paragraph 0047 discloses a plurality of trials of varying shapes and sizes).
Regarding claim 24
Muir teaches the method for attaching a reverse total shoulder prosthesis in a patient, according to claim 13, wherein if the glenoid and humeral trail implants are found to be compatible, they are removed and replaced by final glenoid and humeral implants of identical dimensions to the glenoid trail implant and humeral trail implant, respectively (paragraphs 0005, 0047, and 0071 disclose that once a satisfactory trial is found, the surgeon selects a final implant that matches the size and shape of the trial and swaps out the trial for the final implant).
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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muir, as applied to claim 12, in view of US Patent No. 6,749,637 B1 to Bahler (Bahler).
Muir teaches the method for attaching a reverse total shoulder prosthesis in a patient, according to claim 12, wherein the axes of revolution (A, B) of the metaglene and of the glenosphere can be parallel or coincidental. However, Muir does not teach that the axis of revolution of the metaglene and the axis of revolution of the glenosphere intersect with each other.
Bahler teaches an endoprosthesis for a shoulder joint that includes a rotating piece (33) rotatable about a first axis (27) and an axial directional piece (41), on which the spherical cap (head; 65) is disposed, rotatable around a second axis (37) such that the axes are transverse to one another (col. 15, lines 1-19), for the purpose of allowing necessary parameters to be adjusted so that the spherical cap can be placed at the optimal point corresponding to the original location of the cap (col. 14, lines 36-50).
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the invention of Muir to include a directional piece, such as that taught by Bahler, making it possible for the axes of revolution of the metaglene and of the glenosphere to intersect with each other, in order to allow necessary parameters to be adjusted so that the spherical cap can be placed at the optimal point corresponding to the original location of the cap, as taught by Bahler, and particularly in view of applicant’s specification which merely mentions intersection as an optional characteristic (paragraphs 00018-000020).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muir, as applied to claim 17, in view of US Patent Application Publication No. 2018/0280152 A1 to Mutchler et al. (Mutchler).
Muir teaches the method for attaching a reverse total shoulder prosthesis in a patient, according to claim 17, wherein the axis of revolution of the metaglene and the glenosphere are separated from each other by a distance (when the adapter plate is in an offset position as shown in fig. 1). However, Muir does not specify that the distance is between 0.5 and 5 mm.
Mutchler teaches a reverse shoulder implant to be disposed in a centered or eccentric position relative to a bone anchor, for the purpose of allowing a surgeon to treat a wider variety of patient anatomy with a kit that has fewer components (paragraph 0045). Mutchler also teaches that the offset between 0 mm and 4 mm (paragraph 0057).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the offset distance of Muir to be between 0 mm and 4 mm, in order to allow a surgeon to treat wider variety of patient anatomy, as taught by Mutchler. Further, it would have been obvious to modify the offset distance of Muir in view of Mutchler from between 0 mm and 4 mm to between 0.5 and 5 mm, preferably between 1 and 3 mm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muir.
Regarding claim 19
Muir teaches the method for attaching a reverse total shoulder prosthesis in a patient, according to claim 12, wherein the metaglene comprises a stop (baseplate component; 44) designed to act as a spacer between the glenosphere and the glenoid fossa when the trial implant is assembled inside the glenoid fossa (fig. 1 shows that the stop/baseplate component is placed between the glenoid trial/glenosphere and the glenoid bone and is therefore construed to act as a spacer), the stop having a thickness (fig. 21 shows a thickness of the baseplate/stop). However, Muir does not specify that the thickness is of less than or equal to 10 mm.
There is no evidence of record that establishes that changing the thickness of the stop would result in a difference in function of the Muir device. Further, a person having ordinary skill in the art, being faced with modifying the thickness of Muir, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thickness. Lastly, applicant has not disclosed that the claimed thickness solves any stated problem, indicating that the thickness “may” be within the claimed range, and offering other acceptable ranges (e.g., less than or equal to 6 mm, specification at para. [00023]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the stop of Muir to have an thickness of less than or equal to 10 mm as an obvious matter of design choice within the skill of the art.
Regarding claim 20
Muir teaches the method for attaching a reverse total shoulder prosthesis in a patient, according to claim 12, wherein the metaglene and the glenosphere are integrally formed and do not separate when the implant is attached to the glenoid bone (paragraph 0061). Further, at least in the instance when the adapter assembly/metaglene is not used in both the trialing configuration and the installed configuration, the adapter assembly/metaglene would not need to be removed from the glenoid trial when the surgeon swaps the trial for a final implant (paragraph 0058). However, Muir does not teach that the metaglene and the glenosphere are made in one piece, forming a monoblock implant.
There is no evidence of record that establishes that changing the formation of the implant would result in a difference in function of the Muir device. Further, a person having ordinary skill in the art, being faced with modifying the formation such that the metaglene and the glenosphere are made in one piece, forming a monoblock implant , would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed formation. Lastly, applicant has not disclosed that the claimed formation solves any stated problem, indicating that the implant “can” be monoblock, and offering other acceptable ranges (e.g., assembly means used to integrally attach the metaglene and the glenosphere so that they do not separate when the implant is attached inside the glenoid fossa or when the surgeon performs tests during the operation. Such assembly means are known to those skilled in the art. As non-limiting examples, clips or a screw/nut combination, etc. can be used., specification at para. [00050]) and therefore there appears to be no criticality placed on the formation as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the formation of the implant of Muir such that the metaglene and the glenosphere are made in one piece, forming a monoblock implant, as an obvious matter of design choice within the skill of the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.A.H/Examiner, Art Unit 3774
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
