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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 3/3/2026 is acknowledged. Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/3/2026. The requirement is deemed proper and is therefore made FINAL.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 16 and its dependent claims are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 16 recites a first implant segment for attaching to the first pubic bone and a second implant segment for attaching to the second pubic bone, which positively recites parts of the human anatomy. Appropriate correction is required. It is recommended that the Applicant use functional language such as “configured to” or “configured for” to overcome the present rejection.
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, 6, 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. Regarding claims 3, 6, and 11, the term "preferably" renders the claim indefinite because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP § 2173.05(d). 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) 1-6, 8-10, 12-13, 16, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RU 14498 U1 (hereinafter “the ‘498 reference”).
The ‘498 reference discloses the following regarding claim 1: a medical implant for osteosynthesis of symphysis ruptures on the human pelvis, comprising a cranial plate (1) 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 (Figs. 1-2; pgs. 1-2 of the provided translation), a posterior plate (3) 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 (Figs. 1-2; pgs. 1-2), wherein the cranial plate and the posterior plate are connected to each other by means of at least one first connecting arm (right side element 2) (Fig. 2).
The ‘498 reference discloses the following regarding claim 2: the medical implant according to claim 1, wherein the first connecting arm is an eccentric connecting arm relative to the posterior plate and the cranial plate (Figs. 1-2, element 2 is interpreted as eccentric since it projects outwardly from the perimeter paths of the posterior and the cranial plates).
The ‘498 reference discloses the following regarding claim 3: the medical implant according to claim 1, further comprising a second connecting arm (left side element 2) (Fig. 2), wherein the second connecting arm is preferably an eccentric connecting arm relative to the posterior plate and the cranial plate (Figs. 1-2, element 2 is interpreted as eccentric since it projects outwardly from the perimeter paths of the posterior and the cranial plates).
The ‘498 reference discloses the following regarding claim 4: the medical implant according to claim 1, further comprising a positioning protrusion (screws) (pgs. 2-3) for at least partially engaging in the symphysis of the pelvis of the patient to be treated (pgs. 1-2).
The ‘498 reference 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. 2, when the screws are positioned within hole elements 4 and extend outwardly into the plane of space located between the arms).
The ‘498 reference discloses the following regarding claim 6: the medical implant according to claim 4, wherein the positioning protrusion is disposed centered on the implant (when screws are placed within the central holes of the implant), preferably in a plane of symmetry of the implant (Figs. 1-2).
The ‘498 reference discloses the following regarding claim 8: the medical implant according to claim 4, wherein the positioning protrusion is an elongated ridge (elongated body of a screw) transverse to a protrusion height (Fig. 1) of the positioning protrusion (when placed in the holes located on element 3).
The ‘498 reference discloses the following regarding claim 9: the medical implant according to claim 4, wherein the positioning protrusion extends substantially perpendicular from a contact surface on the cranial plate and/or the posterior plate of the medical implant (Figs. 1-2).
The ‘498 reference discloses the following regarding claim 10: the medical implant according to claim 4, wherein the positioning protrusion is provided on the posterior plate (Figs. 1-2; pgs. 2-3).
The ‘498 reference discloses the following regarding claim 12: the medical implant according to claim 1, wherein the posterior plate comprises first attaching holes (elements 4 located on element 3) provided for receiving first connecting means (screws) (pgs. 2-3), wherein the cranial plate comprises second attaching holes (elements 4 located on element 1) provided for receiving second connecting means (screws) (pgs. 2-3), and wherein the first attaching holes or the second attaching holes are implemented as oval holes (Figs. 1-2).
The ‘498 reference 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 (Figs. 1-2; pgs. 1-2).
The ‘498 reference discloses the following regarding claim 16: the medical implant according to claim 1, wherein a first implant segment (left side of element 1) for attaching to the first pubic bone and a second implant segment (right side of element 1) for attaching to the second pubic bone are implemented substantially mirror-symmetrical to each other (Fig. 2; pgs. 1-2).
The ‘498 reference 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 (Figs. 1-2).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over the ‘498 reference in view of Schulze (CN 101152103 A).
Regarding claim 7, the ‘498 reference discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the positioning protrusion comprising a blunt end face. Schulze teaches that it is well known in the art that a pubic bone fixation implant comprises positioning protrusions that have blunt end faces (326, 326’, 363E) (Figs. 22, 28-29, 31, 33; pgs. 11-14 of the provided translation), for the purpose of preserving additional bone while securing the device at its implanted location. It would have been obvious to one having ordinary skill in the art to modify the positioning protrusion of ‘the 498 reference to comprise a blunt end face, as taught by Schulze, in order to preserve additional bone while securing the device at its implanted location. Such a modification would be made with a reasonable expectation of success.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over the ‘498 reference.
The ‘498 reference discloses the limitations of the claimed invention, as described above. It further recites the positioning protrusion comprising a protrusion height (pgs. 2-3). 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 the ‘498 reference. 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 the ‘498 reference in view of Huang et al. (CN 2850538 Y; hereinafter “Huang”).
Regarding claim 14, the ‘498 reference 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 ‘the 498 reference 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, the ‘498 reference 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 ‘the 498 reference 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.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over the ‘498 reference in view of Kay et al. (Pub. No.: US 2006/0173459 A1; hereinafter “Kay”).
The ‘498 reference discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite a length of the posterior plate and a length of the cranial plate being substantially identical. Kay teaches that it is well known in the art that bone fixation implants comprise a variety of lengths for the plate components, including the posterior plate and the cranial plate having substantially the same lengths (e.g., Figs. 1, 9-10; paras. 0046-0049), for the purpose of providing the implant with the appropriate length needed to fit the implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the lengths of the plates of ‘the 498 reference to be substantially identical, as taught by Kay, in order to provide the implant with the appropriate length needed to fit the implantation site. Such a modification would be made with a reasonable expectation of success.
Conclusion
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANN HU/Primary Examiner, Art Unit 3774