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 . Claims 1-13 are pending and examined below.
Specification
The disclosure is objected to because of the following informalities:
Paragraphs [0001] and [0002] are missing a period at the end of the sentence.
Appropriate correction is required.
Claim Objections
Applicant is advised that should claim 2 be found allowable, claim 3 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1-13 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 claims 1 & 13, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
All dependent claims are likewise rejected.
Claims 2-10 & 12 recites the limitation “barrier element”. It is unclear if this is “barrier element” is the same or different from “barrier-forming element” from claim 1, of which they depend from. For the purpose of examination, they are being considered the same.
Claim 4 gives multiple range parameters for Young's modulus. It is unclear which range is the claimed range.
Claim 5 gives multiple range parameters for flexural strength. It is unclear which range is the claimed range.
Claim 6 gives multiple range parameters for tensile strength. It is unclear which range is the claimed range.
Claim 10 recites that “the barrier element is resorbing” however, claim 10 depends from claim 1, which claim 1 says the barrier-forming element is a non-resorbing material. It appears the limitations of claim 10 and claim 1, from which claim 10 depends, cannot be met at the same time. Accordingly, the examiner cannot examine claim 10 with prior art until clarification is made.
Claim 11 depends from claim 10. Claim 11 cannot be examined until claim 10 is clarified.
Claim 12 recites “at least one runner (2) in the shape of a slit, specifically two runners in the shape of slits, preferably four runners in the shape of lateral slits”. It is unclear which amount of runners is/are claimed. It is also unclear if the runner is just a slit or a lateral slit.
Claim 13 recites the limitation "a barrier" in line 26 and “a surface of a bone”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this “barrier” and “a surface of a bone” is the same or different from claim 1.
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.
Claim 7 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. Claim 7 characterised in that the material of the barrier element is non-resorbing, which is claimed in Claim 1. 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.
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” and are 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 the "means" placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and "means" is not preceded by a structural modifier. Such claim limitation(s) is/are: means for attaching the barrier-forming element in claim 1.
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 § 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.
Claim(s) 1-3, 7, & 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bartee (US 20210085471 A1) in view of Freeman et al. (US 3925824 A), hereinafter, Freeman.
Regarding claim 1, Bartee teaches
a device (116 or 300, Figs. 1 & 4, Bartee) for bone regeneration intended to form a barrier for protecting a space (110 or 404, Figs. 1 & 4, ¶0026, Bartee) above a surface of a bone (B) (108 or 402, Figs. 1 & 4, Bartee), for example a tooth, to allow, after insertion of a biomaterial (408, Fig. 4, Bartee), which, while mineralising, will form new bone above existing bone (bone and tissue regeneration, ¶0026, Bartee), comprising
a self-supporting barrier-forming element in the shape of a dome (1) or a shell (Figs. 1 & 4, Bartee) and
means for attaching the barrier-forming element above the bone surface in order thus to form a volume where the biomaterial can be arranged to mineralise and form new bone grafting itself onto the previously present bone (fastened in place at the location of the discontinuity defect 110 by screws, tacks, pins, and/or other fasteners, ¶0025-0025, Figs. 1 & 4, Bartee),
characterised in that the barrier-forming element in the shape of a dome (1) or shell is made of a material, specifically a non-resorbing material (device may be removed after healing therefore it is non-resorbing, ¶0045, Bartee).
Bartee does not teach the barrier-forming element is radiotransparent. However, Freeman teaches material of bone joint devices (col. 1 lines 4-5, Freeman)
such that the barrier-forming element is radiotransparent (plastics material of the cap member is radiotransparent and allows x-ray examination of the bone, col. 4 lines 17-19), i.e. specifically allows through X-rays with a transmission coefficient of at least 60%, preferably at least 70 %, preferably 80%, even more preferably 90%, specifically substantially 100% (in this case, the Freeman device functions to be radiotransparent and is therefore capable of X-rays with a transmission coefficient of at least 60%, preferably at least 70 %, preferably 80%, even more preferably 90%, specifically substantially 100%).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bartee by incorporating radiotransparent as taught by Freeman in order to monitor the bone condition (col. 4 line 19, Freeman).
Regarding claim 2, Bartee teaches
characterised in that the barrier element (1) is self-supporting but can be deformed elastically, specifically by compression and/or flexion (Fig. 1, ¶0030, Bartee).
Regarding claim 3, Bartee teaches
characterised in that the barrier element (1) is self-supporting but can be deformed elastically by compression and/or flexion (Fig. 1, ¶0030, Bartee).
Regarding claim 7, Bartee teaches
characterised in that the material of the barrier element is non-resorbing (device can be removed, ¶0029, Bartee).
Regarding claim 12, Bartee teaches
characterised in that the barrier element (1) comprises at least one runner (2) in the shape of a slit, specifically two runners in the shape of slits, preferably four runners in the shape of lateral slits which extend in the direction perpendicular to the opening opposite the top of the barrier in the shape of a dome or shell and one or some corresponding respective osteosynthesis screw(s) (3), arranged in a respective slit runner allowing the barrier-forming element to be attached around the surface of bone to be regenerated, the movement of the screws in the runners allowing the volume protected by the barrier-forming element to be controlled, due to the possible deformation of the barrier-forming element (pilot holes, ¶0027, Bartee).
Regarding claim 13, Bartee teaches
characterised in that the device for bone regeneration forms a barrier for protecting, hermetically, the space above a surface of a bone, for example jaws (fig. 4, ¶0026, Bartee).
Claim(s) 4, 6, 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bartee in view of Freeman and further in view of Bagga et al. (US 20210260242 A1) hereinafter, Bagga.
Regarding claim 4, Bartee does not teach the Young’s modulus. However, Bagga teaches composite bioactive polymeric biomaterials for forming implantable medical devices (abstract)
characterised in that the material from which the barrier element is made has a Young's modulus of between 2 and 20 GPa, specifically between 2 and 15 GPa, more particularly between 2 and 5 GPa, specifically between 3 and 4 GPa (3.6 GPa, ¶0005, Bagga).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bartee and Freeman by incorporating the teachings by Bagga as these ranges are inherent in the material.
Regarding claim 6, Bartee does not teach the Young’s modulus. However, Bagga teaches
characterised in that the material of the barrier element has a tensile strength of between 50 and 120 MPa, specifically between 80 and 100 MPa (100 MPa, ¶0005, Bagga).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bartee and Freeman by incorporating the teachings by Bagga as these ranges are inherent in the material.
Regarding claim 8, Bartee does not teach the non-resorbing material is a polyaryletherketone (PAEK). However, Bagga teaches
characterised in that the non-resorbing material is a polyaryletherketone (PAEK) (main body and a bioactive component that includes a polyarylretherketone (PAEK), ¶0026, Bagga).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bartee and Freeman by incorporating the teachings by Bagga in order to provide mechanical support, but with the benefit of bioactivity, to initiate cellular activity and promote successful bone regeneration (¶0017, Bagga).
Regarding claim 9, Bartee does not teach PAEK in the form of a polyetheretherketone (PEEK) or a polyetherketoneketone (PEKK). However, Bagga teaches
characterised in that the barrier element is a PAEK in the form of a polyetheretherketone (PEEK) or a polyetherketoneketone (PEKK) (¶0021, Bagga).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bartee and Freeman by incorporating the teachings by Bagga in order to possess desirable load-bearing properties such as excellent mechanical properties, not bioactive, osteoproductive, or osteoconductive and resistant to thermal degradation, thus making it a desirable material for implantable medical devices. (¶0005, Bagga).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bartee in view of Freeman and further in view of Briscoe (US 20150289981 A1).
Regarding claim 5, Bartee does not teach the flexural strength. However, Briscoe teaches a prosthetic joint which is preferably polyetheretherketone (abstract)
characterised in that the material of the barrier element has a flexural strength of between 100 and 200 MPa, specifically between 150 and 190 MPa, specifically substantially equal to 180 MPa (145-164 MPa, ¶0028, Briscoe).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bartee and Freeman by incorporating the teachings by Briscoe as these ranges are inherent in the material.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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, Jerrah Edwards can be reached at (408) 918-7557. 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.
/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774