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 September 1, 2026 is acknowledged.
Claims 30-31 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected medical product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 1, 2026.
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 15-29 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.
Claim 15 recites, “the steps of: a) manufacturing, or forming by additive construction, at least one functional element on a surface of a base body; and b) connecting the at least one functional element to the base body after step a).” The verb “connecting” indicates that this connecting occurs after the formation of the at least one functional element on a surface of a base body. It is unclear how such a limitation could be met, as once the at least one functional element is formed on the surface of the base body, it would already be connected.
Reference is made to page 3 of Applicant’s disclosure, mimicking the claim language, followed by the sentence, “Preferably, the at least one functional element is connected, in particular indirectly or directly, to the base body by substance or material bonding after step a) is carried out.” This sentence suggests that the intended meaning is for the at least one functional element to still be connected to the base body after the formation step of step a. For the purpose of examination, claim 15 is interpreted on this basis.
Given the application’s origination in German, it is believed that this confusion occurred in translation. Applicant is encouraged to certify a new translation of this section, and amend the specification and claim accordingly.
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) 15-20 and 25-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tempco (US 2019/0039286).
Regarding claim 15, Tempco discloses a method for producing a medical product ([0004-05]), the method comprising the steps of: a) manufacturing, or forming by additive construction, at least one functional element (distal portion of a screw, [0005]) on a surface of a base body (proximal portion of a screw, [0005]); and b) connecting the at least one functional element to the base body after step a) (screw is formed together, [0005], Fig. 15), wherein the base body is produced by a non-additive manufacturing method (proximal portion produced by a traditional method, such as subtractive manufacturing, [0029]).
Regarding claim 16, Tempco discloses wherein step a) is carried out by deposit welding (direct metal laser sintering, [0027]).
Regarding claim 17, Tempco discloses wherein step a) is carried out by a beam sintering method or a beam melting method (selective laser sintering/melting, electron beam melting, [0027]).
Regarding claim 18, Tempco discloses wherein the at least one functional element is configured differently than the base body when carrying out step a) (thread shows differences in shape, proximal portion has screw head, Fig. 15; interpretation is in view of [0042] of Applicant’s disclosure).
Regarding claim 19, Tempco discloses wherein a component, a component section or a group of components of an implant is used as the base body (proximal component of bone fastener, [0005]), and when carrying out step a) the component, the component section or the group of components of the implant is additively constructed or manufactured on the surface of the base body as the at least one functional element (distal component of bone fastener, [0005]).
Regarding claim 20, Tempco discloses wherein the implant is an endoprosthesis (spinal implants [0004]).
Regarding claim 25, Tempco discloses wherein a component, a component section or a group of components of a medical instrument is used as the base body (proximal component of bone fastener, [0005]), and when carrying out step a) the component, the component section or the group of components of the medical instrument is additively constructed or manufactured as the at least one functional element on the surface of the base body (distal component of bone fastener on surface of proximal component, [0005])).
Regarding claim 26, Tempco discloses wherein the medical instrument a retention and/or clamp instrument (bone fastener, [0005]).
Regarding claim 27, Tempco discloses wherein the component, the component section or the group of components is a link or link section (bone fastener, [0005]).
Claim(s) 15-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun (KR 20160078583).
Regarding claim 15, Sun discloses a method for producing a medical product (patient-customized tibia coupling member, abstract), the method comprising the steps of: a) manufacturing, or forming by additive construction, at least one functional element (stem 20, p. 6, Fig. 5) on a surface of a base body (plate 10, p. 6, Fig. 5); and b) connecting the at least one functional element to the base body after step a) (stem 20 formed on plate 10, p. 6, Fig. 5), wherein the base body is produced by a non-additive manufacturing method (plate 10 formed through a casting or forging process, p. 6).
Regarding claim 16, Sun discloses wherein step a) is carried out by deposit welding (direct energy deposition, p. 4-5).
Regarding claim 17, Sun discloses wherein step a) is carried out by a beam sintering method or a beam melting method (selective laser sintering, p. 4).
Regarding claim 18, Sun discloses wherein the at least one functional element is configured differently than the base body when carrying out step a) (differences between plate 10 and stem 20, Fig. 5).
Regarding claim 19, Sun discloses wherein a component, a component section or a group of components of an implant is used as the base body (plate 10, p. 6, Fig. 5), and when carrying out step a) the component, the component section or the group of components of the implant is additively constructed or manufactured on the surface of the base body as the at least one functional element (stem 20, p. 6, Fig. 5).
Regarding claim 20, Sun discloses wherein the implant is an endoprosthesis (tibia joint member, p. 6, Fig. 5).
Regarding claim 21, Sun discloses wherein the endoprosthesis is selected from the group consisting of a knee joint endoprosthesis, and an ankle joint endoprosthesis (tibia joint member, p. 6, Fig. 5.
Regarding claim 22, Sun discloses wherein the component or the group of components is a shaft for a lower leg prosthesis (stem 20 for tibia joint member, p. 6, Fig. 5).
Regarding claim 23, Sun discloses wherein a component that is cylindrical or conical at least in sections is used as the base body (plate 10 is at least cylindrical in sections, Fig. 5b), and when carrying out step a) a joint shaft is additively constructed or manufactured as the at least one functional element on a surface of the component (stem 20 additively manufactured on plate 10, p. 6, Fig. 5b).
Regarding claim 24, Sun discloses wherein a lower leg prosthesis is used as the base body (plate 10 as a lower leg prosthesis for tibia, abstract, p. 6, Fig. 5b), and when carrying out step a) a shaft is additively constructed or manufactured as the at least one functional element on a surface of the lower leg prosthesis (stem 20 additively manufactured on plate 10 for tibia prosthesis, p. 6, Fig. 5b).
Claim(s) 15, 18, and 25-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salguero (US 2021/0196367).
Regarding claim 15, Salguero discloses a method for producing a medical product ([0244]), the method comprising the steps of: a) manufacturing, or forming by additive construction, at least one functional element (printed fill material 2782, [0303], Fig. 75) on a surface of a base body (clamp jaw 2786, [0303], Fig. 75); and b) connecting the at least one functional element to the base body after step a) (formed together, [0303], Fig. 75), wherein the base body is produced by a non-additive manufacturing method (molding, [0244]).
Regarding claim 18, Salguero discloses wherein the at least one functional element is configured differently than the base body when carrying out step a) (fill material 2782 different from clamp jaw 2786, [0303], Fig. 75).
Regarding claim 25, Salguero discloses wherein a component, a component section or a group of components of a medical instrument is used as the base body (clamp for clamp arm, [0303]), and when carrying out step a) the component, the component section or the group of components of the medical instrument is additively constructed or manufactured as the at least one functional element on the surface of the base body (printed fill material, [0303]).
Regarding claim 26, Salguero discloses wherein the medical instrument is a clamp instrument (abstract, [0303]).
Regarding claim 27, Salguero discloseswherein the component, the component section or the group of components is selected from the group consisting of branches or branch sections, grips or grip sections, a link or link section, mouth parts or mouth sections, gripping or retaining jaws or gripping or retaining jaw sections, holding and/or clamping jaws or holding and/or clamping jaw sections, cutting and/or separating jaws or cutting and/or separating jaw sections, and groups of components consisting of at least two of the aforementioned components (levers for clamp jaw, [0303]).
Regarding claim 28, Salguero discloses wherein: a group of components of a medical instrument is used as the base body (clamp jaw structure and levers, [0303], Fig. 75), the group of components comprising two branches or branch sections mounted movably in rotation or pivoting on one another by a link (levers pivoting, [0192]), each branch or each branch section comprising a grip or grip section at a proximal end (grip that is squeezed to move the levers, [0342], Fig. 86), and when carrying out step a) a functional section is additively constructed or manufactured as the at least one functional element on a distal end of the branch or of the branch section (printed fill material 2782 extends from levers, [0303], Fig. 75).
Regarding claim 29, Salguero discloses wherein: a group of components of a medical instrument is used as the base body, the group of components comprising two branches or branch sections mounted movably in rotation or pivoting on one another by a link (levers pivoting, [0192]), each branch or each branch section comprising a grip or grip section at a proximal end (grip that is squeezed to move the levers, [0342], Fig. 86) and a functional section at a distal end (clamp jaw 2786, [0303], Fig. 75), each functional section having a recess for receiving an insert (Fig. 75) and when carrying out step a) an insert complementary in shape to a shape of the recesses respectively is additively constructed or manufactured as the at least one functional element in the recesses (printed fill material, [0303], Fig. 75).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tempco (US 2019/0039286) as applied to claims 20 and 19, respectively, above, and further in view of Yao (US 2023/0225870).
Regarding claim 21, Tempco teaches a method substantially as claimed. Tempco does not disclose wherein the endoprosthesis is selected from the group consisting of a hip joint endoprosthesis, a knee joint endoprosthesis, a shoulder joint endoprosthesis, an elbow joint endoprosthesis, an ankle joint endoprosthesis and a finger joint endoprosthesis.
However, in the same field of endeavor of manufacturing prostheses, including additively ([0002-03]), Yao teaches wherein the component or the group of components is selected from the group consisting of an artificial acetabulum, an artificial acetabular insert, and groups of components consisting of at least two of the aforementioned components (acetabular cup, [0374]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Tempco to produce screws for an acetabular cup because [0374] of Yao teaches that an artificial acetabular cup has through-holes for fixation devices such as screws, and the bone fasteners of Tempco are such screws (see [0005] and Fig. 15).
Regarding claim 21, Tempco teaches a method substantially as claimed. Tempco does not disclose wherein the component or the group of components is selected from the group consisting of an artificial acetabulum, an artificial acetabular insert, an artificial femoral head insert, an artificial femoral head, a hip joint shaft, a cylinder or cone for a hip joint shaft, an upper leg prosthesis, a shaft for an upper leg prosthesis, a lower leg prosthesis, a shaft for a lower leg prosthesis, and groups of components consisting of at least two of the aforementioned components.
However, in the same field of endeavor of manufacturing prostheses, including additively ([0002-03]), Yao teaches wherein the component or the group of components is selected from the group consisting of an artificial acetabulum, an artificial acetabular insert, and groups of components consisting of at least two of the aforementioned components (acetabular cup, [0374]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Tempco to produce screws for an acetabular cup because [0374] of Yao teaches that an artificial acetabular cup has through-holes for fixation devices such as screws, and the bone fasteners of Tempco are such screws (see [0005] and Fig. 15).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tempco (US 11,229,465) teaches subject matter similar to Tempco (US 2019/0039286), cited above. Salguero (US 11,779,387) teaches subject matter similar to Salguero (US 2021/0196367), cited above. Yao (US 2025/0049574) teaches subject matter similar to Yao (US 2023/0225870), cited above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J CHIDIAC whose telephone number is (571)272-6131. The examiner can normally be reached 8:30 AM - 6:00 PM.
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, Sam Xiao Zhao can be reached at 571-270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS J CHIDIAC/ Examiner, Art Unit 1744
/John J. DeRusso/ Primary Examiner, Art Unit 1744
