DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The Amendment filed 2/10/2026 has been entered. Claims 15-19, 22, 24-25, 27-29, 31-32, and 34-36 remain pending in this application.
Response to Arguments
Applicant's arguments filed 2/10/2026 have been fully considered but they are not persuasive.
With regard to applicant’s argument on pages 9-11 that the claimed angles are being measured in the same way as Pearl, the examiner disagrees. Applicant’s “inclination angle” appears to be measuring a vertex angle of the triangle formed by the longitudinal axis and the resection plane. The examiner maintains that Pearl shows a similar vertex angle, which is interpreted to be the same as the inclination angle claimed by applicant. The medial offset of Pearl, as shown in annotated figs. 2A-C, is also clearly shown to be a function of the vertex angle (interpreted to be the inclination angle as claimed) such that a smaller vertex angle (interpreted to be the inclination angle as claimed) corresponds to a smaller medial offset, as shown in annotated figs. 2A-C below (figs. 2A-C of Pearl clearly show that the proximal body straightens/shifts toward the left, in the same way as applicant’s resulting in the same corresponding angle/medial offset - see applicant’s fig. 11A which shows more of a curvature of the proximal body compared to fig. 11C which shows less of a curvature of the proximal body). In further similarity, applicant’s figs. 11A-C have also been annotated below to show an angle which is measured between a side of the triangle and a horizontal reference line/longitudinal axis defined by the distal body portion, similar to the inclination angle explicitly disclosed by Pearl (it can be seen from applicant’s figs. 11A-C and also figs. 2A-C of Pearl that the resection plane tilts upward as the curvature of the proximal body straightens/shifts toward the left, resulting in the same relationship between the angles and medial offset of the stem components). If further clarification is needed, the examiner invites applicant to schedule a telephone interview to discuss this interpretation.
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The examiner acknowledges that the previous rejection inadvertently listed fig. 2A of Pearl on page 6 as an example of a smaller inclination angle corresponding to a smaller medial offset, which should have been fig. 2C, and fig. 2C of Pearl on page 8 as an example of a larger inclination angle corresponding to a larger medial offset, which should have been fig. 2A. It is apparent from applicant’s response on pages 9 and 11 that applicant understood that this was a typographical error. The examiner’s position remains unchanged and the rejection has been amended to correctly identify the corresponding figures.
With regard to applicant’s argument on page 11 that Pearl does not teach the newly amended limitations of claims 19 and 29, the examiner disagrees. See rejection below for further explanation.
With regard to applicant’s argument on pages 11-12 that it would not have been to modify the offset of Pearl, the examiner disagrees. The examiner maintains that the amount of offset is disclosed by Pearl to be a result effective variable in that changing the offset changes positioning of the head with respect to the humeral canal which affects the avoidance of impingement and the accommodation of anatomical requirements of the individual patient (paragraph 0029). Further, the examiner maintains that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Pearl device to have an offset within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Pearl, which discloses at least one embodiment having an offset of 4 mm, by making the medial offset between 4 mm and 15 mm as a matter of routine optimization.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 15, 16, 18, 19, 24, 25, 28, 29, 31, and 34 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by US Patent Application Publication No. 2001/0041940 A1 to Pearl (Pearl).
Regarding at least claim 15
Pearl teaches a humeral prosthetic device having a body, a stem for anchoring the device in a humeral canal of a humerus, and a head for replacing a natural humeral head of the humerus (abstract).
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Pearl meets the limitations of a system of orthopedic devices for joint reconstruction surgery, the system comprising: an articular component (head; 13); a plurality of stem components (figs. 2A-2D) configured to couple with the articular component, each stem component comprising: a distal body portion (11a-11d) configured to be inserted into a central cavity region created in a bone of the joint (the stem is for anchoring the device in a humeral canal of a humerus; abstract), the distal body portion defining a longitudinal axis (SCL), a proximal body portion (body; 12) defining a resection plane configured to be disposed in-plane with a resection surface of the bone when applied to a patient (the body of Pearl includes a planar surface that is fully capable of being disposed in-plane with a resection surface of a bone when implanted), the longitudinal axis extending through the resection plane (figs. 2A-2D), the resection plane defining a proximal-most limit of the proximal body (the resection plane defined by the planar surface of the body 12 defines a proximal-most limit of the body), the proximal-most limit disposed in-plane with the resection surface of the bone (the proximal-most limit is fully capable of being disposed in-plane with the resection surface of the bone in the same way as applicant’s), the resection surface having a center (the center of the resection plane is shown in annotated figs. 2A-2C above), the resection plane oriented at an inclination angle with respect to the longitudinal axis (annotated figs. 2A-2C show an inclination angle of the resection plane oriented with respect to the longitudinal axis); and a tapered coupling extending from the resection plane defined by the proximal body and the articular component (paragraph 0036 discloses tapered press-fits may be used to retain the insert in the recess 19 of the head 13); wherein at least two of the plurality of stem components include different inclination angles (the stem components shown in each of figs. 2A-2D include different inclination angles), and wherein a medial offset between the longitudinal axis defined by the distal body portion and the center of the resection surface of each stem component of the plurality of stem components is a function of the inclination angle such that a smaller inclination angle corresponds to a smaller medial offset (see annotated figs. 2A-2C above, which show that the medial offset is a function of the inclination angle such that a smaller inclination angle, as shown in fig. 2C, corresponds to a smaller medial offset).
Regarding at least claim 16
Pearl teaches the system of Claim 15 wherein the tapered coupling of each stem component of the plurality of stem components is configured to couple each stem component to the articular component (fig. 1B shows that the opening/aperture is configured to receive the insert portion of the head; paragraph 0036).
Regarding at least claim 18
Pearl teaches the system of Claim 15, wherein each of the plurality of stem components includes a medial side and a lateral side, the medial side and the lateral side extending from the resection plane of the proximal body portion to a base of the distal body portion (figs. 2A-2D show that each stem component includes a medial side and a lateral side, each extending from the resection plane to a base of the distal body portion as claimed).
Regarding at least claim 19
Pearl teaches the system of Claim 18, wherein each of the medial side and the lateral side comprise a continuous curvature (the term “curvature” is defined as the degree to which something is curved; therefore the medial and lateral sides of the stem shown in fig. 2A, for example, can be construed to each comprise the curvature at the distal end where they meet – it can be seen from fig. 2A, for example, that the curvature is continuous since there is no interruption in the curve forming the distal end where the medial and lateral sides of the stem meet).
Regarding at least claim 24
Pearl teaches the system of Claim 15, wherein each of the plurality of stem components is configured to be inserted into a central cavity region of a humerus (the stem components are for anchoring in a humeral canal; abstract).
Regarding at least claim 25
Similar to the explanation above, Pearl meets the limitations of a system of orthopedic devices for joint reconstruction surgery (abstract), the system comprising: an articular component (13); a plurality of stem components (figs. 2A-2D) configured to couple with the articular component, each stem component comprising: a distal body portion (11a-11d) configured to be inserted into a central cavity region created in a bone of the joint, the distal body portion defining a longitudinal axis (SCL), a proximal body portion (12) defining a resection plane configured to be disposed in-plane with a resection surface of the bone when applied to a patient, the longitudinal axis extending through the resection plane, the resection plane defining a proximal-most limit of the proximal body (figs. 2A-2D show that the resection plane of the body 12 defines a proximal-most limit of the body), the proximal-most limit disposed in-plane with the resection surface of the bone, the resection surface having a center (the center of the resection surface is shown in annotated figs. 2A-2C above), the resection plane oriented at an inclination angle with respect to the longitudinal axis defined by the distal body portion (annotated figs. 2A-2C show an inclination angle of the resection plane oriented with respect to the longitudinal axis), and a tapered coupled located adjacent to the resection plane of the proximal body (paragraph 0036 discloses a tapered coupling as claimed); wherein at least two of the plurality of stem components include different inclination angles (figs. 2A-2D show different inclination angles), and wherein a medial offset between the longitudinal axis defined by the distal body portion and the center of the resection surface of each stem component of the plurality of stem components is a function of the inclination angle such that a larger inclination angle corresponds to a larger medial offset (see annotated figs. 2A-2C above, which show that the medial offset is a function of the inclination angle such that a larger inclination angle, as shown in fig. 2A, corresponds to a larger medial offset).
Regarding at least claim 28
Pearl teaches the system of Claim 25, wherein each of the plurality of stem components includes a medial side and a lateral side, the medial side and the lateral side extending from the resection plane of the proximal body portion to a base of the distal body portion (figs. 2A-2D show that each stem component includes a medial side and a lateral side, each extending from the resection plane to a base of the distal body portion as claimed).
Regarding at least claim 29
Pearl teaches the system of Claim 28, wherein each of the medial side and the lateral side comprise a continuous curvature (the term “curvature” is defined as the degree to which something is curved – therefore, this limitation appears to be merely requiring that the medial and lateral sides can be curved to any degree, which could include no curve at all and is met by the straight sides of Pearl; in another interpretation, the medial and lateral sides of the stem shown in fig. 2A, for example, can be construed to each comprise the curvature at the distal end where they meet – it can be seen from fig. 2A, for example, that the curvature is continuous since there is no interruption in the curve forming the distal end where the medial and lateral sides of the stem meet).
Regarding at least claim 31
Pearl teaches the system of Claim 25, wherein the articular component is coupled to a stem component of the plurality of stem components, a center of the articular component is spaced from the longitudinal axis defined by the distal body portion of the stem component at a medial offset distance based on a contour of the proximal body portion (figs. 2A-2D show that a center is spaced from the longitudinal axis/SCL at a medial offset distance depending on the shape/contour of the proximal body 12; shown roughly below in annotated figs. 2A and 2D above).
Regarding at least claim 34
Pearl teaches the system of Claim 25, wherein each of the plurality of stem components is configured to be inserted into a central cavity region of a humerus (the stem components are for anchoring in a humeral canal; abstract).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 17, 22, 27, 32, 35, and 36 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pearl.
Regarding at least claims 17 and 27
Pearl teaches the system of Claims 15 and 25. Pearl also teaches that the stem may be secured to the body using any conventional fixation system (paragraph 0029). However, Pearl does not teach wherein each of the plurality of stem components is monolithic.
There is no evidence of record that establishes that changing the formation of the stem would result in a difference in function of the Pearl device. Further, a person having ordinary skill in the art, being faced with modifying stem of Pearl 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 monolithic formation. Lastly, applicant has not disclosed that the claimed monolithic formation solves any stated problem, and though the figures appear to support that the stem components are monolithic, the specification does not mention this feature and therefore there appears to be no criticality placed on the monolithic formation of the stem components 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 set screw and screw aperture arrangement of the stem components of Pearl to be monolithic in formation as an obvious matter of design choice within the skill of the art. It has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding at least claims 22 and 32
Pearl teaches the system of Claims 15 and 31. Pearl also teaches embodiments in which the offset varies between 0 mm and 4 mm (paragraph 0050). However, Pearl does not explicitly teach wherein each of the plurality of stem components of the system has a medial offset of between 4 mm and 15 mm.
As disclosed by Pearl, the amount of offset is disclosed to be a result effective variable in that changing the offset changes positioning of the head with respect to the humeral canal which affects the avoidance of impingement and the accommodation of anatomical requirements of the individual patient (paragraph 0029). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Pearl device to have an offset within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Pearl by making the medial offset between 4 mm and 15 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding at least claims 35 and 36
Pearl teaches the system of claims 17 and 27. Pearl also teaches embodiments in which the offset varies between 0 mm and 4 mm (paragraph 0050). Further, Pearl teaches an inclination angle of each stem component of the plurality of stem components that appear to be between 0 degrees and 90 degrees (annotated figs. 2A-2C above show inclination angles). However, Pearl does not explicitly teach wherein: the medial offset between the longitudinal axis defined by the distal body portion and the center of the resection surface of each stem component of the plurality of stem components is between 4 mm to 15 mm, and the inclination angle of each stem component of the plurality of stem components is between 30 degrees to 55 degrees.
As disclosed by Pearl, the amount of offset is disclosed to be a result effective variable in that changing the offset changes positioning of the head with respect to the humeral canal which affects the avoidance of impingement and the accommodation of anatomical requirements of the individual patient (paragraph 0029). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Pearl device to have an offset within the claimed range and an inclination angle within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Pearl by making the medial offset between 4 mm and 15 mm and the inclination angle between 30 degrees and 55 degrees as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 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.
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/M.A.H/
Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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