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 of claims 14-18 in the reply filed on 11/24/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/15/2023 has been considered by the examiner.
Drawings
The drawings are not of sufficient quality to permit examination. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
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 14-18 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Regarding claim 14, as claimed:
In limitation “A method for preparation of dental or orthopedic implant or screw (implantable medical device),” it is not clear if the screw is referred as implantable medical device or both the implant and screw are referring to implantable medical device. The Examiner suggests using language such as implantable medical implant in the preamble of the claim.
In limitation “a) preliminary preparation of a dental or orthopedic implant or screw (endo-osseous implantology) or selection of an available implant or screw,” it is not clear how or if the endo-osseous implantology and implantable medical device are different or same. Further it is not clear if “a dental or orthopedic implant or screw” is the same as what is being claimed or is different from what is claimed in the preamble. Furthermore, it is not clear what is meant by “an available implant or screw.” Is it known product or applicant’s invented implant.
In limitation “b) analysis of the intended location of the product, for example, morphological analysis by imaging tests such as computed tomography of the indicated location,” it is not clear what intended location is or what “the product” is being refereed to. No antecedent basis found for these terms. The terms “fox example” “such as” creates ambiguity about what is actually required by the claim. It renders claim unclear as to the metes and bounds of the invention.
Regarding limitation “c) obtaining patient data to verify integration needs,” it is not clear what data are being obtained and what is being meant by “verify integration needs.” What is being integrated?
Regarding limitation “d) analysis of implant loading or screw in order to determine an optimized implant topology wherein the textured surface is limited to the trabecular region and is determined geometrically by the shape of the implant/screw,” the whole limitation is vague and indefinite. It is not clear what is meant by implant loading. What are the input parameters for analysis to determine topology. It is not clear what the term “optimized” encompasses. “The textured surface” lacks antecedent basis in the claim.
Regarding limitation “e) computer model of a texture comprising porous surface design comprising pore size, wall thickness and other characteristics of the implant or screw surface wherein the thread pitch of said model is constant for any given data,” it is noted that no computing device is being claimed or associated with the claimed method. It is not clear what “computer model” encompasses. It is not clear what “other characteristics of the implant” encompasses. The “said model” and “the thread pitch” lacks antecedent basis in the claim.
Regarding limitation “f) reproduction of the texture in the implant in a controlled manner using the additive manufacturing technique,” it is not clear what is meant by reproduction of the texture in the implant. Is the texture reproduced? Is the “texture” referring to “the textured surface” as claimed in step c? How the texture in the implant produced using additive manufacturing technique. No functioning hardware is being claimed for the additive manufacturing to take place.
Regarding limitation “wherein said process comprises at least one of the following additional steps,” The term “said process” lacks antecedent basis in the claim.
Regarding limitations “g) heat treatment when applicable, for metallic and bioceramics only;
h) sintering when applicable, for bioceramics only;
i) machining when applicable, for metal only;
j) cleaning;
k) anodizing when applicable, for metallic ones only;
l) laser marking when applicable, according to the total dimension of the component;
m) quality control;
n) final cleaning;
o) packaging;
p) labeling; and
q) sterilization,”
it not clear how or when each or any of the above steps takes place or what it encompasses. It is not clear under what conditions any of the steps h, I, k, l become applicable. What do “quality control,” final cleaning,” “packaging,” “labeling” encompasses. The language “the total dimension of the component” lacks antecedent basis in the claim .
Regarding claim 15, it is not clear what is meant by “by means of...method.” What do the encompasses.
Regarding claim 16 “the pore diameter” lacks antecedent basis in the clam.
Regarding 17, Regarding “such as” language. See the rejection above. Further, retarding “metals” “polymers” “ceramics” “titanium and its alloys” “metal alloys” “biocermics,” it is not clear if the implant requires more than one type of materials. According to the specification, no specific materials are being disclosed or how multiple materials are being used to form the implant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Patel Yogesh whose telephone number is (571) 270-3646. The examiner can normally be reached between 9 AM – 5:30 PM on Monday, Thursday and Friday.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Bosques Edelmira, at (571) 270-5614.
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/YOGESH P PATEL/Primary Examiner, Art Unit 3772