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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. DE10/2022/203561.5, filed on 04/08/2022.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains legal phraseology, (i.e., "by means of at least one biodegradable connection means"); it is formed of more than one paragraph; and it contains more than 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
In paragraph 17, line 2, “1000µm, 1250µm, 1500µm, 1750µm, and 1200µm” should read “1000µm, 1200µm,1250µm, 1500µm and 1750µm”
In paragraph 21, line 2, “4:1, 6:1, and 6:1” should read “4:1 and 6:1”.
Appropriate correction is required.
Claim Objections
Claim 13 objected to because of the following informalities:
In claim 13, line 1, .
Appropriate correction is required.
Claim Interpretation
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.
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.
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.
Claims 1, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Pointillart et al. (US 7208015), hereinafter referred to as Pointillart, in view of Aeschlimann et al. (US 2004/0030341), hereinafter referred to as Aeschlimann, and Huang (DE102313104801), hereinafter referred to as Huang.
Regarding claim 1, Pointillart discloses an implant system (see Fig. 1) for treating bone defects or discontinuities, comprising: a first implant element (see Fig. 1, element 1) configured for insertion into a bone defect or a discontinuity of a human bone, a second implant element (see Fig. 1, element 3) configured to be fixed to the human bone, wherein the first implant element is attachable to the second implant element by means of at least one connection means (see Fig 1, screw 5; this element is interpreted under 112(f) as pins or screws, see page 12 in the instant specification, and equivalents thereof) in order to fix the first implant element relative to the human bone (see Fig. 1), and wherein the first implant element (1) comprises a shell section (mesh tube; see Figs. 1-2) and an inner section (element 2) at least partially enclosed by the shell section (see Figs. 1-2), wherein the shell section (mesh tube) has a first pore-and-strut structure, PSS (the struts are the woven materials of the mesh and the pores being the mesh openings).
Pointillart fails to disclose the connection means is biodegradable.
Aeschlimann also discloses an implant system for treating bone defects or discontinuities comprising an implant element (stabilization plate 21) and at least one connection means (screws 7; see Fig. 2). Aeschlimann teaches that the connection means are biodegradable (see paragraphs [0002], [0057], [0060]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Pointillart’s at least one connection means to be biodegradable as taught by Aeschlimann in order to prevent the need for further operation for removal thereof (see paragraph [0002]).
Pointillart in view of Aeschlimann fails to disclose that the inner section (2) has a second pore-and-strut structure, PSS, differing from the first pore-and-strut structure.
Huang also discloses an implant for treating bone defects or discontinuities (see Fig. 8) comprising an implant element having a shell section (see Fig. 8, element 11) having a first pore-and-strut structure (element 11, three-dimensional hollow units are the pores where the cavities in the three-dimensional hollow units and the woven mesh body that make up the three-dimensional hollow units are the struts, see translation of paragraphs [0014] and [0053] on page 5) and an inner section (see Fig. 8, element 11’, different sized three-dimensional hollow units, see translation of paragraph [0053] on page 5) at least partially enclosed by the shell section. Huang teaches that the inner section has a second pore-and-strut structure, PSS, (Fig. 8, element 11’, different sized three-dimensional hollow units, see translation of paragraph [0053] on page 5) differing from the first pore-and-strut structure (Fig. 8, element 11, three-dimensional hollow units, see translation of paragraph [0053] on page 5). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner section of Pointillart in view of Aeschlimann to comprise a second pore-and-strut structure, PSS, differing from the first pore-and-strut structure as taught by Huang in order to provide an implant element that has better mechanical properties and encourage bone ingrowth (see translation paragraph [0053]).
Regarding claim 6, the combination of Pointillart, Aeschlimann, and Huang teaches the implant system as claimed in claim 1 but fails to teach wherein the second implant element is nonbiodegradable.
However, Aeschlimann further teaches the implant element (stabilization plate 21) is nonbiodegradable (see paragraph [0060], metallic material, which is nonbiodegradable). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the second implant of Pointillart in view of Aeschlimann and Huang to be nonbiodegradable as further taught by Aeschlimann in order to provide the second implant with sufficient strength to provide proper fixation and stability (see paragraph [0003], lines 2-4).
Regarding claim 7, the combination of Pointillart, Aeschlimann, and Huang teaches the implant system as recited in claim 1 and Pointillart further discloses wherein the second implant element (3) is in the form of a narrow reconstruction plate (see Fig. 1 and col. 2, lines 31-37 the plate is applied along the length of tube 1).
Claims 2, 8, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Pointillart, Aeschlimann, and Huang as applied to claim 1 above, and further in view of Johnson et al. (US 6527810), hereinafter referred to as Johnson.
Regarding claim 2, the combination of Pointillart, Aeschlimann, and Huang teaches the implant system as claimed in claim 1 but fails to teach wherein one of the first and second pore-and-strut structures has pore structures of greater than or equal to 200-700 micrometers in diameter.
However, Johnson also discloses a bone implant comprising pore-and-strut structures (see col. 3, lines 2-7, the article that comprises a continuous strong supportive framework having struts that define a plurality of interconnected interstices (pores)) and teaches pore structures of greater than or equal to 200-700 micrometers in diameter (see col. 4, line 65 through col. 5, line 1, implant pore sizes ranges from about 50µm to about 1000µm and preferably from about 200µm to about 600µm, which falls within the claimed range).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant system of Pointillart in view of Aeschlimann and Huang with the teachings of Johnson to create an implant element wherein one of the first and second pore-and-strut structures has pore structures of greater than or equal to 200-700 micrometers in diameter in order for the implant to sufficiently support bone ingrowth (see col. 7, lines 25-28).
Regarding claim 8, the combination of Pointillart, Aeschlimann, and Huang teaches the implant system as claimed in claim 1 but fails to teach wherein the shell section includes at least one polymer material.
However, Johnson discloses a bone substitute material that can be used to make implants and teaches the implant includes at least one polymer (see col 3, lines 36-39, implant material could be made from a combination of collagen, poly-lactic acid, poly-glycolic acid, chitin, gelatin, or any other resorbable polymer).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first implant of Pointillart in view of Aeschlimann and Huang with the teachings of Johnson to create an implant element wherein the shell section includes at least one polymer material such that the implant can assist in the induction of bone growth and provide structural stability as bone grows to replace the polymeric material (see col 3, lines 41-43).
Regarding claims 9 and 12, the combination of Pointillart, Aeschlimann, and Huang teaches the implant system as claimed in claim 1 but fails to teach wherein the inner section and shell section includes at least one ceramic material.
However, Johnson discloses a bone substitute material that can be used to make implants and teaches the implant includes at least one ceramic material (see col. 3, lines 21-24, ceramic material can be used to form a structural framework that defines interconnecting interstices in a bone implant).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant system of Pointillart in view of Aeschlimann and Huang with the teachings of Johnson to create an implant element wherein the inner section and shell section includes at least one ceramic material in order to create a strong supportive framework to provide structural stability and load bearing capability to the implant element (see col. 6, lines 39-41).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Pointillart, Aeschlimann, and Huang as applied to claim 1 above, and further in view of Nukavarapu et. al. (US 10307514), hereinafter referred to as Nukavarapu.
Regarding claim 3, the combination of Pointillart, Aeschlimann, and Huang teaches the implant system as claimed in claim 1 but fails to teach wherein one or both of the first and the second pore-and-strut structure has a gradient in the diameter of the pore structures.
However, Nukavarapu discloses a bone tissue scaffold material (see col. 5, lines 27-30, porous scaffolds comprising of biodegradable microspheres that are joined to form a scaffold) and teaches the scaffold has a gradient in the diameter of the pore structures (see col. 1, lines 27-32).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of Pointillart in view of Aeschlimann and Huang with the teachings Nukavarapu to create an implant element that contains a gradient in the diameters of the pore structures in order to better mimic the surrounding bone tissue (see col. 5, lines 53-55).
Claim 4, 5, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Pointillart, Aeschlimann, and Huang as applied to claim 1 above, and further in view of Rose et al. (US 8546456), hereinafter referred to as Rose.
Regarding claims 4 and 13, the combination of Pointillart, Aeschlimann, and Huang teaches the implant system as claimed in claim 1 but fails to teach wherein the first implant element inner section includes at least one biocomposite material.
However, Rose discloses a bone substitute scaffold material and teaches the scaffold includes at least one biocomposite material (see col. 12, lines 26-33, describes a bone substitute material that is made from polyurethane, a polymer material, and hydroxyapatite, a calcium phosphate material well known in the art).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant system of Pointillart in view of Aeschlimann and Huang with the teachings of Rose to create the inner section of the first implant element having at least one biocomposite material such that the implant helps to provide porosity and enhance permeability to help with bone ingrowth (see col. 2, lines 47-52).
Regarding claim 5, the combination of Pointillart, Aeschlimann, and Huang as modified by Rose, teaches all the limitations of claim 4 but fails to teach wherein one or both of the first and second pore-and-strut structure has a gradient in a distribution of at least one biocomposite material.
However, Rose further teaches the bone substitute scaffold material has a gradient in a distribution of at least one biocomposite material (see col. 3, lines 1-9, teaches that additional biocomposite materials can be added to manipulate the porosity and compressive properties of the section of the implant).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant system of Pointillart in view of Aeschlimann and Huang with the teachings of Rose to create one or both of the first and second pore-and-strut structure with a gradient in distribution of at least one biocomposite material in order to provide better structural and load bearing support in the area of the bone defect or discontinuity (see col. 3, lines 16-22).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Pointillart, Aeschlimann, and Huang as applied to claim 1 above, and further in view of Piecuch (US 2018/0228616), hereinafter referred to as Piecuch.
Regarding claim 10, the combination of Pointillart, Aeschlimann, and Huang teaches the implant system as claimed in claim 1 but fails to teach a method for producing an implant system according to claim 1, comprising additive manufacturing of at least a portion of the first implant element.
However, Piecuch discloses a method for producing an implant system and teaches additive manufacturing of at least a portion of the first implant element (see paragraph [0034], lines 11-14, teaches that a femoral component that has a porous core that is formed by additive manufacturing in which the additive manufactured porous section is configured to replace the porous structure of natural bone).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first implant of Pointillart in view of Aeschlimann and Huang with the teachings of Piecuch to produce the implant system of claim 1 from additive manufacturing to better mimic the structure of natural bone (see paragraph [0034], lines 11-14).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Pointillart, Aeschlimann, Huang, and Johnson as applied to claim 2 above, and further in view of Nukavarapu.
Regarding claim 11, the combination of Pointillart, Aeschlimann, Huang, and Johnson teaches the implant system as claimed in claim 2 but fails to teach wherein the other of the first and second pore-and-strut structures has pore structures of less than or equal to 150 micrometers in diameter.
However, Nukavarapu further discloses a bone scaffold material comprising pore structures (see col. 5, lines 27-30, porous scaffolds comprising of biodegradable microspheres that are joined to form a scaffold) and teaches pore structures of less than or equal to 150 micrometers in diameter (see col. 6, line 35, describes bone tissue scaffolds that have pore diameters of 100µm which is less than 150µm).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant system of Pointillart in view of Aeschlimann, Huang, and Johnson with the teachings of Nukavarapu to create an implant wherein the other of the first and second pore-and-strut structures has pore structures of less or equal to 150µm in order to better mimic the structure of the surrounding bone tissue (see col. 5, lines 53-55).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN ZHI-DE YAO whose telephone number is (571)272-5449. The examiner can normally be reached Monday - Friday 8:00 am to 5:00 pm.
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/J.Z.Y./ Patent Examiner, Art Unit 3774
/MELANIE R TYSON/ Supervisory Patent Examiner, Art Unit 3774