Status under America Invents Act
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 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.
Rejections based on Prior Art
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.
Claims 1-3, 5-10, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Moisiadis (DE 4041378 A1)(as interpreted with attached EPO machine translation) in view of Hildmann et al (US 2014/0087331).
Moisiadis discloses a method of implanting a dental implant 10 in a patient’s jawbone wherein the jawbone is prepared with an osteotomy (translation paragraph [0009]), a dental implant 10 is provided having an external self-tapping thread 16 at a screw region (identified in the annotated drawing below – the annotated screw region is similar to that LS defined in applicant’s Figure 2) and a thread free proximal shaft region 12, and wherein the dental implant 10 is screwed into cancellous bone such that screw region 14 is engaged with cancellous bone 22 (translation paragraph [0010]; “the thread is only provided in the cancellous bone”).
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In regard to the limitation that “the screw region has a length of at most 4 mm,” Moisiadis discloses that the implant 10 may be provided in a preferred length of 8 mm and that “the threaded extension 14 and the implant shaft 12 each extend over half the total length” (translation paragraph [0030]). The examiner understands this language to mean that the members 12 and 14 together make up over half the length of the entire implant 10 that includes replacement tooth 38, secondary part 24, implant shaft 12 and threaded region 14 (Moisiadis refers to each of these elements as being part of the implant 10). From the Moisiadis Figure it is clear that the threaded region 14 is less than half the total length of the implant, which for the disclosed 8 mm implant would provide a threaded region length of less than 4mm as required by the claim. To the limited extent that the screw region 14 of Moisiadis isn’t explicitly disclosed as having a length of 4 mm or less, then one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to have constructed the Moisiadis dental implant with a screw region length of 4 mm or less based on the Moisiadis disclosure that the implant 10 total length may be preferably made 8 mm in length, the Illustration that clearly shows the threaded portion 14 as comprising a small part of the length and the disclosure that the threaded portion is only provided in the cancellous bone (translation, paragraph [0100]).
In regard to the newly amended limitation requiring the implant have an outer surface with a “roughness value Ra of at least 1.4µm and less than 3.5µm,” Hildmann et al teach that it is desirable to provide dental implants with a surface roughness of 0.5 to 5.0 Ra and “especially preferably 1.6 to 3.2 Ra has been found to particularly preferred” in order to provide optimal osseointegration of the implant (see paragraph [0036]). To have provided the Moisiadis dental implant with a surface roughness Ra of between 1.6 µm and 3.2 µm in order to provide for optimal osseointegration of the implant as taught by Hildmann et al would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. It is noted that Hildmann et al do not provide the micron measurement unit (µm) in the paragraph [0036] description, however, one of ordinary skill in the art would have readily understood that metric units were being referred to in the German origin reference.
In regard to claim 3, note translation paragraph [0009].
In regard to claim 6, Hildmann et al further teach that it is desirable to coat the dental implant with growth factors or other agents for improving the fusion of bone to the surface of the implant (paragraph [0036]). To have coated the Moisiadis implant with growth factors or other agents in order to promote osseointegration of the implant as taught by Hildmann et al would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Moisiadis (DE 4041378 A1) and Hildmann et al as applied above and in further view of Neumeyer (DE 10 2009 005 573 A1).
Neumeyer teaches that it is desirable to provide a dental implant having an oval cross-section and a tapering shape (note paragraph [0009] in the translation provided by applicant 9/26/2021). Neumeyer teaches that “due to the shape of its root [(the dental implant)] or shaft, ensures improved anchoring in the one tissue, with simplified placement of the root part with reliable preliminary fixation of the root part in the bone tissue after placement and up to final healing” (paragraph [0002] – translation). To have provided the Moisiadis implant with an oval and a tapered shape in order to improve the anchoring of the implant as taught by Neumeyer would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Applicant’s Response
Applicant’s amendment requiring that the implant have an outer surface with a “roughness value Ra of at least 1.4µm and less than 3.5µm” and remarks made with respect to Day (US 6,102,703) are found persuasive, however, as set forth in the new grounds of rejection above, other prior art dental implant references teach the common roughening feature.
Additionally, in response to the rejection based on Moisiadis, applicant argues that the Moisiadis “thread free proximal shaft is not tapered, it is irrefutably cylindrical” and “only the root 14, which is the screw region, and is distinct from the shaft 12, is tapered.” The examiner is not persuaded. Applicant’s arguments are not consistent with the language used in applicant’s own specification. Applicant’s Figure 2 embodiment is very similar to the implant of Moisiadis. Applicant explicitly states on page 14 of the written description that “the screw region 4 is limited to a length LS” which is illustrated in Figure 2. Claim 1 requires “a proximal shaft region adjoins the screw region” which the examiner understands with respect to applicant’s Figure 2 to include all of the length above LS including the illustrated tapered portion immediately above the identified LS screw region. And like applicant, Moisiadis also includes a tapered portion immediately above a screw region which the examiner has annotated in the Figure above in a manner consistent with how applicant has defined the screw region LS in their own Figure 2.
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Action Made Final
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 Ralph Lewis whose telephone number is (571)272-4712. The examiner can normally be reached Monday-Friday from 9AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eric Rosen, at (571) 272-4964. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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.
/RALPH A LEWIS/Primary Examiner, Art Unit 3772
(571) 272-4712