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 .
Clams 1 and 6-12 have been presented for examination.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “image data acquisition unit” and “image data creation unit” in claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 12 is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Claim limitations “image data acquisition unit” and “image data creation unit” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is devoid of adequate structure to perform the claimed function. There is no disclosure of any particular structure, either explicitly or inherently, to perform the acquisition of image data or create image data. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
It should be noted that the examiner recognizes that the specification also discloses an “image data acquisition device” and a “design image data creation device” which do have structure (0046 and 0048 respectively). But these “devices” are not tied to the claimed “units” and appear to be separate from one another as seen between Figures 3 and 4.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. As described above, the disclosure does not provide adequate structure to perform the claimed function of acquiring the image data and creating image data. The specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6-8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Specifically, claim 1 recites the rod-shaped member for use in a dental shaped object for a mandibular. Claim 6, changes the dental shaped object and the rod-shaped member to instead be used for a maxilla. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1 and 6-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hasan1.
Referring to claim 1, Hasan teaches the method substantially comprising:
acquiring image data of a dental shaped object having a side-wall portion forming a horseshoe-shaped concave portion [0066].
having a reinforcing member that reinforces the side-wall portion in CAD wherein the reinforcing member has rod shaped members connecting front surfaces of left and right portions of an inner side-wall portion in a dental shaped object for a mandibular, wherein the rod-shaped member is linear and the rod-shaped member connects back side end portions of the left and right portions of the inner side-wall portion in an oral cavity [300 Figs. 3E, 0006, 0024, 0066]
image data of the dental shaped object is connected to image data of a reinforcing member [0066].
In summary, Hasan teaches acquiring a 3D model of a dental shaped object (i.e. denture base) which includes a reinforcing support structure [abstract]. Hasan receives the model so that the dental shaped object can be 3D printed. Since the support structure is part of the 3D model, it necessarily was generated via CAD which is used to create 3D models. While Hasan teaches acquiring such a model, the acquisition is not explicitly directed to the creation of the model but rather reception of the completed 3D model. That said, the received 3D model inherently must have been generated at some point prior to Hasan receiving it. Because the dental shaped object is “custom” and “patient specific” [0007] the actual shape of dental shaped object would need to be established before any reinforcing support structure(s) could be introduced. Specifically, if the patient had a smaller sized mouth, the support structure would be shorter as opposed to a patient with a larger mouth. In other words, the support structure could not be a “one size fits all” proposition since a support structure too small would not properly span the sides of the dental object while a support structure too large would encroach upon the void which contacts the patient’s jaw. In addition, some variants include multiple attachment points which would require knowledge of the size and shape of the dental object in order to determine the proper connection points. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to create and connect the support structures after receiving the specific 3D digital model of the patient specific denture base because then it would be possible to know the appropriate size and position of where to place the support structure(s) on the dental shaped object for 3D printing.
Lastly, even if it is possible to create and position/connect the support structure before receiving the 3D model of the dental shaped object or during generation of the dental shaped object, it would have been at least obvious to try connecting the support after acquiring the dental shaped object model because there are only a limited number of known possibilities with how the 3D model of the dental object and support structure could be connected and a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.
While Hasan teaches the invention substantially as claimed above, it is not explicitly taught 1) the reinforcing member has only one rod-shaped member; and 2) the rod-shaped member connects the lower ends of the left and right portions of the inner side-wall portion. In other words, Hasan teaches using two reinforcement members [300 and 310 Fig. 3E] instead of a single reinforcement member and also does not explicitly teach where the reinforcement members connect to the side-wall portion with respect to the vertical direction.
With respect to point 1), the examiner is taking official notice that it is well known in the art that a design and complexity of a reinforcement member and the number of reinforcement members dictate the rigidity of the object being supported2. It would have been obvious by design choice to one of ordinary skill in the art before the effective filing date to modify Hasan to only use reinforcement member (300) in Fig. 3E because doing so would simplify the structure used to reinforce the denture arch at the cost of less rigidity3.
With respect to point 2) we see that Hasan connects the inner side-wall portion of the dental shaped object with rod-shaped member (300) but does not explicitly teach where the rod-shaped member connects to the side-walls with respect to the vertical direction. In other words, it is unclear if the rod-shaped member connects the side-walls at the upper ends (closer to the tooth sockets), the lower ends (furthest from the tooth sockets), or somewhere between the upper and lower ends. It would have been obvious to one of ordinary skill in the art to try connecting the rod-shaped member (300) to the lower ends of the left and right portions of the inner side-wall portion because there is only a limited amount of known possible mounting points as indicated above and there is a reasonable expectation of success that connecting the rod-shaped member at the lower ends would provide reinforcement to the dental shaped object to keep it stable as intended by Hasan [0050].
Referring to claims 6-7, Hasan further teaches support structures for a dental shaped object for a maxilla [Figs. 4A-F, 0025, 0050]. While the support structures are explicitly shown to bridge the left and right portions of the inner side-walls this appears to be because the palate portion of the denture obstructs the direct path between the outer buccal side-walls. The examiner is taking official notice that there are palate-less/roofless and even partial dentures that would not include the palate portion and in such a situation, it would have been obvious to one of ordinary skill in the art before the effective filing date to try bracing the dental shaped object between the outer side-walls (left and right portions of the outer side-walls) because a person has good reason to pursue the known options within his or her technical grasp especially when there is a reasonable expectation of success. Since the support structure adds rigidity to the denture by providing cross bracing to the inner side-walls, attaching cross bracing to the outer side-walls would provide substantially the same rigidity thus expectation of success would be plausible.
Referring to claim 8, Hasan teaches including multiple support structures which can be connected to various points of the dentures. In fact, Hasan implies that the structural support design is a matter of design choice due to the different variations presented in Fig. 3A-H. In addition, Hasan teaches that the variations presented in Figs. 3A-H can also be applied to maxillary denture bases as well as mandibular. Fig. 3E in Hasan shows that support structures can exist at both the front and back of the denture wherein the front support is connected to the inner side-walls. It would have been obvious to one of ordinary skill in the art before the effective filing date to include a second support structure like that of 310 Fig. 3E to the modified palate-less denture because it would provide further rigidity to the dental shaped object when curing.
Referring to claim 9, Hasan teaches the dental shaped object being a denture base which is custom and patient-specific to ensure a proper fit [0006-0007]. We can see in the cross section of the denture base [Fig. 5] that the fit of the denture base would include proper fit to the alveolar ridge. Specifically, we see the example in Fig. 5B where it is clear that the alveolar ridge has regressed compared to that in Fig. 5A.
Referring to claim 10, this is rejected on the same basis as set forth hereinabove. Inherently the 3D model taught in Hasan would have had to be generated. In addition, Hasan teaches the 3D model is provided for a 3D printer to manufacture the dental shaped object [0066].
Referring to claim 11, Hasan teaches the support structures are removable. The examiner is taking official notice that when removing support structures in 3D printed objects, a mark is left behind where the support attached to the 3D printed object4. Therefore, it is obvious if not inherent that the dental shaped object that is 3D printed in Hasan would have connection marks once the support structure is removed.
Referring to claim 12, this is rejected on the same basis as set forth hereinabove. Hasan teaches the method and therefore teaches the apparatus for performing the method.
Response to Arguments
Applicant's arguments filed 1/29/26 have been fully considered but they are not persuasive.
In the REMARKS, applicants argue in substance that Hasan 1) uses more than a single linear rod-shaped member; and 2) Hasan does not depict its bracing body connecting the lower ends in the vertical direction, of the front surfaces of the inner side-wall portions.
Referring to applicants first argument, while applicant is correct that Hasan includes two rod-shaped members in Fig. 3E, it is believed that using a single rod-shaped member would have been an obvious variant. Specifically, it is known that the more an object is structurally supported, the more rigid it becomes. The tradeoff becomes how much rigidity is desired which then dictates how robust of a support structure becomes needed. In Hasan, it is pretty clear that support for both the crown and the base are desired. Therefore, we see the support structure(s) reinforcing both the crown and base of the dental device. The amount of rigidity becomes a matter of design choice that is weighed against how much deformation is tolerable. Hasan has a higher tolerance with respect to the amount of allowable deformation which is why we see bracing near both the crown and base in Fig. 3E. But simply removing the rod supporting the crown in Hasan does not break Hasan, nor does Hasan teach away from a single support brace. It may not be explicitly taught, but one of ordinary skill understands the tradeoffs and can make decisions accordingly and can rely on different variations of the support structure based on their needs.
One of ordinary skill would understand that either support in Hasan could be eliminated and the only downside would be that either the crown or base would have less support. It should be noted that there does not appear to be anything special in the rod design in the instant application that allows for a single rod-shaped member to provide the same support as each of the configurations in Hasan. As far as the examiner can tell, the rod-shaped member is just a rod, same as in Hasan and does not provide complete arch support using a single rod.
It should be noted that devices which operate “on basically the same principle and in the same manner” wherein the differences, in addition to being well known, “solves no stated problem and would be an obvious matter of design choice within the skill of the art” are obvious variations of one another and thus not patentably distinct. See In re Kuhle, 188 USPQ 7 (CCPA 1975).
Referring to applicants second argument, the examiner acknowledges that Hasan does not explicitly teach connecting the rod-shaped member to the lower ends of the left and right portions of the inner side-wall. As stated above with respect to claim 1, it is recognized that there are a few limited points with which to connect the rod-shaped member. Therefore, the rod-shaped member for bracing the dental shaped object must be connected either to the higher ends, lower ends or somewhere in between (i.e., the middle). Due to the finite number of identified, predictable connection points, it would have been obvious to one or ordinary skill in the art before the effective filing date to try any of the potential points as there is a reasonable expectation of success that any of the connection points will provide support to brace the dental shaped object, this includes the lower ends of the left and right portions of the inner side-wall portion.
The examiner would like to point out that the position of the rod-shaped member is ultimately a matter of design choice. This appears to be acknowledged by applicant since applicant shows the rod-shaped member being located at the back side end portions [Fig. 9A-C], the front side [Figs. 9D-E] and in between [Fig. 9F]. Furthermore, applicant also shows that the rod-shaped member being connected at the lower ends [Figs. 9C and E-F] and the higher ends [Figs. 9A-B and D]. The examiner has not found any mention that, the rod-shaped member being connected at the back side end portions at the lower ends of the inner side wall provides an unexpected result. This reinforces the assertion that the location of the rod-shaped member is an obvious design choice and thus, applicants claim to connect the rod-shaped member to the lower end is an obvious variation and thus not patentably distinct, similar to that above with respect to the response to argument 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK A CONNOLLY whose telephone number is (571)272-3666. The examiner can normally be reached Monday-Friday 9am-5pm.
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, Kamini Shah can be reached at 571-272-2279. 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.
/MARK A CONNOLLY/Primary Examiner, Art Unit 2115 2/13/26
1 Cited in the previous office action
2 As an example, one could refer to a roof structure found in a residential home and compare collar ties with trusses. Both provide structural support, but a truss is more complex compared to a simple collar tie and provides significantly more support and stiffness.
3 Further rationale can be found below in the Response to Arguments section.
4 This is consistent with applicants’ own disclosure which indicates that “connection marks 19 of the reinforcing member 18 are formed… after the reinforcing member 18 is removed.” [0063]. Also [0093] in corresponding PGPUB 2023/0301759