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
In view of the amendments filed on 6/3/2026, the 35 U.S.C. 101 rejection, cited in the office action of 3/26/2026, is moot.
In view of the amendments filed on 6/3/2026, the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections, cited in the office action of 3/26/2026, are moot.
Applicant’s arguments with respect to claim(s) 1-3, 5-7, and 9-18 have been considered, but are moot in view of the new grounds of rejection.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “by means of” in claim 1.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 9-11 and their dependent claims 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. Amended claim 1 states that the positioning protrusion is extending over an entire width of the posterior plate. Claim 9 states that the positioning protrusion extends substantially perpendicular from a contact surface on the cranial plate and/or the posterior plate of the medical implant. Claim 10 states that the positioning protrusion is provided on the posterior plate. It is unclear from the claim language if the positioning protrusion is on the cranial plate or the posterior plate and/or if there is more than one positioning protrusion. Appropriate correction is required.
Claim 11 recites a protrusion height. It is unclear if this is intended to be the same element as the protrusion height recited in claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-7, 9-10, 12-13, and 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soffiatti et al. (WO 2014/111907 A1; hereinafter “Soffiatti”).
Soffiatti discloses the following regarding claim 1: a medical implant for osteosynthesis of symphysis ruptures on the human pelvis, comprising a cranial plate (202) implemented for being attached from a cranial side to a first pubic bone and a second pubic bone of a patient to be treated in order to connect the pubic bones (Fig. 11, where the dimensions allow the implant to be fully capable of being applied to public bones), a posterior plate (203) implemented for being attached from a posterior side to the first pubic bone and the second pubic bone of the patient in order to connect the pubic bones (Fig. 11), wherein the cranial plate and the posterior plate are connected to each other by means of at least one first connecting arm (209, 211, 211’) (Fig. 11), wherein the medical implant further comprises a positioning protrusion (208) for at least partially engaging in the symphysis of the pelvis of a patient to be treated (Fig. 11), wherein the positioning protrusion is an elongated ridge transverse to a protrusion height of the positioning protrusion and extending over an entire width of the posterior plate (Fig. 11).
Soffiatti discloses the following regarding claim 2: the medical implant according to claim 1, wherein the first connecting arm (at upper portions of elements 211, 211’) is an eccentric connecting arm relative to the posterior plate and the cranial plate (Fig. 11).
Soffiatti discloses the following regarding claim 3: the medical implant according to claim 1, further comprising a second connecting arm (209).
Soffiatti discloses the following regarding claim 5: the medical implant according to claim 3, wherein the positioning protrusion is disposed between the first connecting arm and the second connecting arm (Fig. 11).
Soffiatti discloses the following regarding claim 6: the medical implant according to claim 1, wherein the positioning protrusion is disposed centered on the implant (Fig. 11).
Soffiatti discloses the following regarding claim 7: the medical implant according to claim 1, wherein the positioning protrusion comprises a blunt end face (Fig. 11).
Soffiatti discloses the following regarding claim 9: the medical implant according to claim 1, wherein the positioning protrusion extends substantially perpendicular from a contact surface (upper surface) on the cranial plate and/or the posterior plate of the medical implant (Fig. 11).
Soffiatti discloses the following regarding claim 10: the medical implant according to claim 1, wherein the positioning protrusion is provided on the posterior plate (Fig. 11).
Soffiatti discloses the following regarding claim 12: the medical implant according to claim 1, wherein the posterior plate comprises first attaching holes (226, opening holding element 206) provided for receiving first connecting means (Fig. 11), wherein the cranial plate comprises second attaching holes (226, opening for element 205) provided for receiving second connecting means (Fig. 11), and wherein the first attaching holes or the second attaching holes are implemented as oval holes (Figs. 11-12).
Soffiatti discloses the following regarding claim 13: the medical implant according to claim 12, wherein a longitudinal axis of the oval holes is substantially oriented along a pelvic ring direction (Fig. 11).
Soffiatti discloses the following regarding claim 16: the medical implant according to claim 1, wherein a first implant segment (perimeter surfaces of element 202) configured for attaching to the first pubic bone and a second implant segment (perimeter surfaces of element 203) for attaching to the second pubic bone are implemented substantially mirror-symmetrical to each other (Fig. 11).
Soffiatti discloses the following regarding claim 17: the medical implant according to claim 1, wherein a length of the posterior plate and a length of the cranial plate are substantially identical (Fig. 11).
Soffiatti discloses the following regarding claim 18: the medical implant according to claim 1, wherein the at least one connecting arm is disposed spaced apart in a pelvic ring direction from ends of the posterior plate and/or ends of the cranial plate (Fig. 11).
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soffiatti.
Soffiatti discloses the limitations of the claimed invention, as described above. It further recites the positioning protrusion comprising a protrusion height (Fig. 11). However, it does not explicitly describe the value of the height of the protrusion. The optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal protrusion height needed to achieve the desired results and to fit the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the protrusion height, would have been obvious at the time of applicant's invention in view of the teachings of Soffiatti. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. Such a modification would be made with a reasonable expectation of success.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soffiatti in view of Huang et al. (CN 2850538 Y; hereinafter “Huang”).
Regarding claim 14, Soffiatti discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the connecting arm comprising a lower rigidity than the posterior plate and the cranial plate, so that an alignment of the posterior plate can be adjusted relative to the cranial plate by plastically deforming the connecting arm. Huang teaches that it is well known in the art that a pubic bone fixation implant comprises connection portions having a lower rigidity, so that an alignment of the posterior plate can be adjusted by plastically deforming the connecting arm (pgs. 1-2 of the provided translation), for the purpose of ensuring that the implant will properly fit and conform to the surrounding bone. It would have been obvious to one having ordinary skill in the art to modify the connecting arm of Soffiatti to comprise a lower rigidity, as taught by Huang, in order to ensure that the implant will properly fit and conform to the surrounding bone. Such a modification would be made with a reasonable expectation of success.
Regarding claim 15, Soffiatti discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the cranial plate or the posterior plate being convex in a transversal plane. Huang teaches that it is well known in the art that a pubic bone fixation implant comprises an upper, cranial plate and a lower, posterior plate having convex shapes in a transversal plane (Figs. 1, 4), for the purpose of providing the implant with the desired shape and dimensions needed to properly fit the bone. It would have been obvious to one having ordinary skill in the art to modify the plates of Soffiatti to comprise a convex shape, as taught by Huang, in order to provide the implant with the desired shape and dimensions needed to properly fit the bone. Such a modification would be made with a reasonable expectation of success.
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 Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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