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 .
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 2, 5, 12, and 16 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 the above claims, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of examination, the limitations following the phrase will not be considered part of the claimed invention.
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) 1-9, and 12-18 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Slemker et al. (U.S. Patent 6,358,453). Regarding Claim 1, Slemker et al., hereafter “Slemker,” show that it is known to carry out a method for producing an orthopedic device, characterized in that the orthopedic device is produced at least partially by means of an additive manufacturing process from at least one production material that is introduced into a support material in a flowable state and then hardens (Column 3, lines 15-18; Column 5, lines 8-31).
Regarding Claim 2, Slemker shows the method of claim 1 above, including one characterized in that the production material is supported during hardening by the support material and/or held in its position in a working space (Column 5, lines 32-57).
Regarding Claim 3, Slemker shows the method of claim 1 above, including one characterized in that the production material is composed of at least two components (Column 6, lines 29-35).
Regarding Claim 4, Slemker shows the method of claim 3 above, including one characterized in that the production material exhibits a Shore hardness after hardening whose value depends on the mixing ratio (shore hardness inherently is dependent upon the material, i.e. the material ratio with a particular mixing ratio).
Regarding Claim 5, Slemker shows the method of claim 1 above, including one characterized in that at least two different production materials are used (Column 6, lines 29-61).
Regarding Claim 6, Slemker shows the method of claim 1 above, including one characterized in that the at least one production material (12) is bonded with a separately produced component of the orthopedic device during the additive manufacturing process (Column 5, lines 32-57).
Regarding Claims 7-9, Slemker shows the method of claim 1 above, including one characterized in that, in the additive manufacturing process, the wall thickness of the orthopedic device is varied (Column 5, lines 41-45: dimensions (e.g. thickness, void/cavity) varied as directed).
Regarding Claims 12-13, Slemker shows the method of claim 1 above, characterized in that at least one pneumatic element is produced from the at least one production material by means of the additive manufacturing process (Column 4, lines 21-25, 42-52; Column 6, lines 45-61: pressure seal).
Regarding Claim 14, Slemker shows the method of claim 1 above, characterized in that measurement data is recorded from a patient and made available to an electrical and/or electronic control system, which is configured to control the additive manufacturing process at least on the basis of the measurement data (Column 4, lines 55-66).
Regarding Claim 15, Slemker shows the method of claim 1 above, characterized in that the orthopedic device is a prosthesis liner for use in a prosthesis socket, wherein the prosthesis socket comprises an accommodation space with a distal end and a proximal edge, the method comprising the following steps: a) determining a sealing lip course on an outer side of the prosthesis liner that corresponds to the course of a height contour of the prosthesis socket or on the basis of existing, known anatomical conditions of an amputation stump (Column 6, lines 45-61), and b) arranging a sealing lip on the outer side of the prosthesis liner along the determined sealing lip course by means of the at least one additive manufacturing process (Column 4, lines 38-41).
Regarding Claim 16, Slemker shows the method of claim 15 above, including one characterized in that the sealing lip is arranged on the prosthesis liner at an offset, preferably equidistant, in the distal direction to the proximal edge of the prosthesis socket (Column 4, lines 20-25, 38-41).
Regarding Claim 17, Slemker shows the method of claim 15 above, including one characterized in that the height contour of the prosthesis socket is captured optically, a digital 3D model is created, and the sealing lip course is determined depending on the recorded height contour (Column 4, lines 55-67).
Regarding Claim 18, Slemker shows an orthopedic device (Column 2, lines 43-45).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,144,749. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are merely broader versions of the patented claims, and therefore not patentably distinct therefrom, as they are effectively anticipated by the patented claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA HUSON whose telephone number is (571)272-1198. The examiner can normally be reached M-F 8a-4p.
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MONICA ANNE HUSON
Primary Examiner
Art Unit 1742
/MONICA A HUSON/Primary Examiner, Art Unit 1742
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