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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Regarding claims 6, 12, 15, the phrase “packaging means” use the word means, wherein paragraph 48 of the disclosure states that the packaging means is made primarily of plastic and the packaging means can be designed as a blister.
Claim Rejections - 35 USC § 112(b)
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 4-6, 8, 10, 12, and 13 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.
Claim 4 recites the limitation "the outer surface" in ll. 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 5, 6, 12, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Regarding claim 8, ll. 3, the phrase “can be” is indefinite.
Regarding claim 10, ll. 3, the term “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Regarding claim 12, ll. 1, the phrase “can be” is indefinite.
Claim 12 recites the limitation "the packaging means" in ll. 3-4. There is insufficient antecedent basis for this limitation in the claim.
The term “smooth” in claim 12 is a relative term which renders the claim indefinite. The term “smooth” 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.
Regarding claim 13, ll. 3-4, the phrase “can be” is indefinite.
Examiner’s Note
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.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 8-11, 13, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vogt (US 2017/0095283).
Regarding claim 1, Vogt discloses a kit (figures 1-5) for producing and extruding bone cement (Abstract), comprising a first container (1) which contains a first component (3) (e.g. bone cement powder, ¶140) for producing bone cement (¶140), a second container (30) which contains a second component (e.g. monomer fluid, ¶148) for producing bone cement (¶148), a mixing apparatus (6+7) (¶141) for manually mixing the first component (3) and the second component (e.g. monomer fluid, ¶148) in the first container (1) for the purpose of producing bone cement (figures 1-5), an extruding apparatus (e.g. extrusion device, ¶157) for manually extruding the produced bone cement from the first container (1) (¶157).
Regarding claim 8, Vogt discloses wherein the second container (30) is arranged in an apparatus (figures 1-5) for storing and opening the second container (30), wherein the apparatus (figures 1-5) for storing and opening the second container (30) is or can be fluidically connected to the first container (1) in order to transfer the second component (e.g. monomer fluid, ¶148) into the first container (1).
Regarding claim 9, Vogt discloses wherein the first container (1) and/or the second container (30) is arranged separately from the extruding apparatus (e.g. extrusion device, ¶157) (figures 1-5).
Regarding claim 10, Vogt discloses wherein the mixing apparatus (6+7) is at least partially arranged in the first container (1) (figures 1-5), wherein the first container (1) with the mixing apparatus (6+7) and the extruding apparatus (e.g. extrusion device, ¶157) are arranged in parallel (figures 1-5), preferably one above the other.
Regarding claim 11, Vogt discloses wherein the first container (1), the second container (30), the mixing apparatus (6+7) and the extruding apparatus (e.g. extrusion device, ¶157) consist in total of a maximum of 20% metal (¶11).
Regarding claim 13, Vogt discloses wherein the apparatus for storing and opening the second container (30): comprises a buckling region (28) for buckling the apparatus such that the second container (30) can be opened by buckling (¶149), or comprises an outer shell, an inner shell, and a shearing element, wherein the outer shell and the inner shell are displaceable relative to each other, and the second container is moved by the relative displacement with respect to the shearing element in order to open the second container by shearing a part of the second container.
Regarding claim 14, Vogt discloses for pressing out an amount of between 50 g and 130 g of bone cement from the first container (1) (considered functional).
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) 2, 5, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vogt (US 2017/0095283).
Regarding claim 2, Vogt’s kit discloses all the features/elements as claimed including wherein the mixing apparatus (6+7) is at least partially arranged in the first container (1), wherein the extruding apparatus (e.g. extrusion device, ¶157) has an axial extension A (¶157), and the first container (1) with the mixing apparatus (6+7) has an axial extension B (figures 1-5). Yet, Vogt lacks a detailed description on wherein, for the ratio A/B, the following applies: A/B
≥
0.9 and/or A/B
≤
1.5.
However, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Vogt’s kit with wherein, for the ratio A/B, the following applies: A/B
≥
0.9 and/or A/B
≤
1.5, since the prior art discovering optimum or workable ranges involves routine experimentation in the art.
Regarding claim 5, Vogt’s kit discloses all the features/elements as claimed but lacks a detailed description on wherein the extruding apparatus is designed to extrude the bone cement from the first container with an extruding force of at least 0.7 kN, in particular at least 1.0kN.
However, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Vogt’s kit with wherein the extruding apparatus is designed to extrude the bone cement from the first container with an extruding force of at least 0.7 kN, in particular at least 1.0kN, since it is known that discovering an optimum value involves routine skill in the art.
Regarding claim 7, Vogt’s kit discloses all the features/elements as claimed including wherein the first container (1) contains a PMMA bone cement powder (¶140) and/or the second container (30) contains a monomer liquid (¶148). Yet, Vogt lacks a detailed description on wherein the first container contains as the first component an amount of at least 40 g of a PMMA bone cement powder, and/or in that the second container contains as the second component an amount of at least 18 ml of a monomer liquid.
However, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Vogt’s kit with wherein the first container contains as the first component an amount of at least 40 g of a PMMA bone cement powder, and/or in that the second container contains as the second component an amount of at least 18 ml of a monomer liquid, since it is known that discovering an optimum value involves routine skill in the art.
Claim(s) 6 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vogt (US 2017/0095283) in view of Gage (US 2014/0088712).
Regarding claim 6, Vogt’s kit discloses all the features/elements as claimed but lacks wherein the kit comprises a packaging means, and the components of the kit are enclosed in the packaging means, in particular so as to be airtight and/or sterile.
However, Gage teaches a packaging means (150) (¶36), and components of the kit (figure 8) are enclosed in the packaging means (¶36), in particular so as to be airtight and/or sterile (¶36).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Vogt’s kit with a packaging means, and the components of the kit are enclosed in the packaging means, in particular so as to be airtight and/or sterile as taught by Gage, since such a modification would provide a sterile barrier to outside contaminants and moisture prior to introduction of the package into a sterile surgical field (¶36).
Regarding claim 15, Vogt discloses a method for using a kit according to Claim 1 (see claim 1 above), comprising mixing the first component (3) (e.g. bone cement powder, ¶140) with the second component (e.g. monomer fluid, ¶148) in the first container (1) using the mixing apparatus (6+7) for the purpose of producing bone cement (figures 1-5), extruding (via extrusion device, ¶157) the produced bone cement from the first container (1) using the extruding apparatus (¶157).
Yet, Vogt lacks a packaging means of the kit.
However, Gage teaches a packaging means (150) (¶36), and components of the kit (figure 8) are enclosed in the packaging means (¶36).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Vogt’s method having a kit with packaging means of the kit as taught by Vogt, since such a modification would provide a sterile barrier to outside contaminants and moisture prior to introduction of the package into a sterile surgical field (¶36).
Thus, the modified Vogt’s method has removing the extruding apparatus (¶157 of Vogt) from a packaging means of the kit (¶36 of Gage).
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 4 and 12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775