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 .
Specification
The disclosure is objected to because of the following informalities: in paragraphs [0041] and [0044], reference number 03 has been used to indicate two different elements. In [0041], 03 is “an adjustment thread” and in [0044] 03 is “the regulating thread”.
Appropriate correction is required.
Claim Objections
Claims 1-5 are replete with claim objections including grammatical errors and missing words. The following list is exemplative, but not exhaustive, and the applicant is encouraged to review the claims for additional errors that may not have been cited. Appropriate correction is required.
Claims 1-6 are missing the article in the preamble before “Dental surgical guide fixation device” and “Fixation device” required to render the claims grammatically correct.
Claim 1 is objected to for the use of dashes in an inconsistent manner. Although technically not incorrect, the dashes in Claim 1 are inconsistent, as they are used to delineate separate elements, but are not always used when a new element is introduced. Additionally, the dashed claim section beginning with line 12 is confusing in punctuation and length, as well as in verb tense.
Claim 1 additionally is missing an article in line 10 before the word “regulating element.” The word “surgical” is missing before the word “guide” in lines 17 and 18, if indeed the guide referenced in these lines is the surgical guide of line 14.
Claim 4 is missing articles before the words “thread” and “chamfered thread” as well as a comma after “chambered thread” unless the limitation is meant to be inclusive of a “chamfered thread and a fitting by interference.”
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 recites sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation is: fixation means in claim 4.
Because this claim limitation is not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is 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 limitation 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 does not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-6 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 replete insufficient antecedent basis for limitations in the claims. The following listing is exemplative and not exhaustive, and the applicant is encouraged to review the claims for additional errors that may not have been cited.
Claim 1 recites the limitation "the apical region" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the body" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the regulating thread" in line 11. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if the “regulating thread” is meant to be the same element as the “adjustment thread” of the fixed pin or if it is a different element.
Claim 1 recites the limitation "the regulator" in 13. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this element is meant to be the same element as the “regulating element” or is a different element.
Claim 1 recites the limitation "the fixation thread" in line 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the surface of the patient’s mouth" in line 18. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the coronal region" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The term “substantially smaller diameter” in claim 1 is a relative term which renders the claim indefinite. The term “substantially smaller diameter” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, anything smaller will be considered “substantially smaller.”
In Claim 1, the term “an implant dental” in line 8 is confusing. The preamble of the claim cites use of the dental surgical guide fixation device in an implant; however the examiner is unfamiliar with the meaning of an “implant dental” and believes that the applicant intends to recite a “dental implant.” Appropriate correction is required.
In Claims 2-6, it is unclear if the “Fixation device according to claim 1” is intended to refer to the “Dental surgical guide fixation device” or if an additional fixation device is being recited. Consistent terminology within the claims is encouraged to lend clarity to the claims.
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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yi (WO 2010/036045 A2, as per Figures and English translation provided).
Regarding Claim 1, Yi discloses a dental surgical guide fixation device (Figure 3, 10), fixed in an internal region of at least one implant characterized by comprising a fixed pin (200), pin has a substantially smaller diameter than the rest of said fixed pin (as seen in Figure 5) in order to allow the apical region to be fixed to the internal region of an implant dental. Yi further discloses a regulating element (Figure 6, 300) comprising an internal thread (Figure 6, 304) configured so as to be threaded to the regulating thread (regulating thread will be interpreted to be the same as the adjustment thread 206) of the fixed pin, the regulating element further comprising a guide fixation region (apical portion of 300) the regulator (regulator will be interpreted to be the same as the regulating element) being configured so as to be threaded onto the fixed pin (as seen in Figure 2), the fixed pin being passed through a hole in a surgical guide and fixed to the internal thread of a dental implant through the fixation thread present in the apical region in order to create a support point (Figure 2), and the guide fixation region comes into contact with the guide and the regulating element is threaded on the fixed pin in order to compress the guide between the guide fixation region and the surface of the patient's mouth (device of Yi is capable of use in this manner).
Regarding Claim 2, Yi discloses the fixation device according to claim 1, and further discloses a grooved surface (see grooves at sides of 400) in the coronal region and/or a key connector (400).
Regarding Claim 3, Yi discloses the fixation device according to claim 1, and further discloses that the regulating element additionally comprises a handling region (top of element 300 as seen in Figure 3) provided with ridges (top of element 300 as seen in Figure 3 would be a handling region and contains multiple ridges as seen in Figures 2-3).
Regarding Claim 4, Yi discloses the fixation device according to claim 1, and further discloses that the guide fixation region is provided with fixation means to receive the surgical guide, said fixation means being one of a thread, chamfered thread and fitting by interference (as seen in Figure 4).
Regarding Claim 6, Yi discloses the fixation device according to claim 1, and further discloses that the fixed pin and the regulator can be fixed using a key or manually (Figure 3 where 300 has a hex key attachment receptacle, and the threaded portions can be fixed manually).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yi in view of BLAY et al. (US 2025/0090282 A1, hereinafter “Blay”.
Yi discloses the invention of Claim 1 substantially as described above, but does not specifically disclose that the fixation device is made of surgical stainless steel or titanium. In the same art of dental fixation devices, Blay teaches the use of titanium for the fixation components ([0050]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to construct the fixation device of Yi from titanium as is taught by Blay, as titanium is a well-known material for dental fixation devices known to be durable and lightweight.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE L NELSON whose telephone number is (571)270-5368. The examiner can normally be reached M - F 7:30-4:30 PT.
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, Eric Rosen can be reached at 571-270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINE L NELSON/Examiner, Art Unit 3772
/EDWARD MORAN/Primary Examiner, Art Unit 3772