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. NL2029879, filed on 11/23/2021.
Claim Objections
Claim 9 objected to because of the following informalities: “wherein said article is sized and dimensioned to generically at least partly cover multiple shape variants within a class of prostheses or implants.”. Examiner recommends correcting to “at least partially and generically”. Appropriate correction is required.
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 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: “means for monitoring a temperature change in said article “ 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 § 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 8-10, 13-18, and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nelissen et al. WO 2020067898 A2, herein referred to as Neilssen.
Regarding claim 1, Neilssen discloses a shaped article sized (Fig 1, apparatus 18/10; pg 16 lines 31- pg 17 lines 14) and dimensioned to at least partly and removably cover a prosthetic or implant (pg 16 lines 31- pg 17 lines 14; fully capable of being removed), wherein said shaped article comprises means for monitoring a temperature change in said article (this element is interpreted under 112(f) as a “a visual indication of whether a predetermined temperature or temperature change” see [0042] of the instant application, and equivalents thereof; Pg 24 lines 15-25 “The method comprises real time visualization and/or measurement, such as provided by a display connected to or associated with an infra-red thermal camera.”; The visual indication is a display connected to the measuring apparatus or an associated infra-red thermal camera; Additionally, Fig 12 show a read visual indication of temperature using aforementioned infra-red camera.).
Regarding claim 2, Neilssen discloses wherein said means for monitoring a temperature change in said article comprises one or more temperature sensors (pg 24 lines 20-25, “In at least some examples, the method comprises automatically adapting the heating with an integral thermal sensor and a (micro-)controller 25 comprised in the heating apparatus 10, 110.”) attached to or embedded in said shaped article.
Regarding claim 8, further comprising one or more coils at least partly embedded in said shaped article, wherein said one or more coils (Fig 1, 12) are configured to inductively heat at least a portion of the prosthetic or implant (pg 25 lines 4-6).
Regarding claim 9, wherein said article is sized and dimensioned to generically at least partly cover multiple shape variants within a class of prostheses or implants (pg 16 lines 31- pg 17 lines 14).
Regarding claim 10, Neilssen discloses wherein said article is sized and dimensioned to generically at least partly cover an implant or prosthetic selected from the group consisting of: a tibial component for knee replacement surgery, a femoral component for replacement surgery, a tibial component for ankle replacement surgery, a talar component for ankle replacement surgery, a glenoid component for shoulder replacement surgery (pg 1 lines 19-23), a humeral (stem) component for shoulder replacement surgery, an acetabular component for hip replacement surgery, a femoral stem implant component for hip replacement surgery (pg 1 lines 19-23).
Regarding claim 13, Neilssen discloses wherein said shaped article comprises one or more induction coils configured for inductively heating at least a portion of said shaped article (pg 25 lines 4-6; pg 18 lines 4-6).
Regarding claim 14, Neilssen discloses wherein said shaped article comprises one or more temperature sensors attached to or embedded in said shaped article (pg 24 lines 20-25, “In at least some examples, the method comprises automatically adapting the heating with an integral thermal sensor and a (micro-)controller 25 comprised in the heating apparatus 10, 110.”).
Regarding claim 15, Neilssen discloses a method of inductively heating at least a portion of a prosthetic or implant (pg 19 lines 1-7), the method comprising a) covering at least portion a prosthetic or implant with the shaped article according to claim 1 (pg 19 lines 1-7); and) inductively heating said at least a portion of the prosthetic or implant using one or more induction coils (pg 19 lines 1-7).
Regarding claim 16, Neilssen discloses wherein the inductively heating of at least a portion of the prosthetic or implant using one or more induction coils occurs via one or more induction coils embedded in the shaped article (pg 19 lines 1-7).
Regarding claim 17, Neilssen discloses wherein the method comprises inductively heating the portion of the prosthetic or implant until a predetermined visual indication representing a predetermined temperature or temperature change has been reached in at least a portion of said article (Pg 24 lines 15-25 “The method comprises real time visualization and/or measurement, such as provided by a display connected to or associated with an infra-red thermal camera.”; The visual indication is a display connected to the measuring apparatus or an associated infra-red thermal camera; Additionally, Fig 12 show a read visual indication of temperature using aforementioned infra-red camera.).
Regarding claim 18, Neilssen discloses wherein the method further comprises administering a biocidal, preferably antimicrobial, a composition effective in reducing the count of harmful microorganisms at a concentration at the location of the prosthetic or implant suitable to achieve a reduction of the count of microorganisms (pg 21 lines 23-25).
Regarding claim 20, Neilssen discloses wherein the biocidal composition is an antimicrobial composition (pg 21 lines 23-25).
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.
Claim(s) 3-5, 7, 11-12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neilssen in view of Chandler et al. EP 2130520 A1, herein referred to as Chandler.
Regarding claim 3, Nielssen discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose wherein said means for monitoring a temperature change in said article comprises a material that is capable of providing a visual indication of whether a predetermined temperature or temperature change has been reached in at least a portion of said article.
But Chandler teaches wherein said means for monitoring a temperature change in said article comprises a material that is capable of providing a visual indication of whether a predetermined temperature or temperature change has been reached in at least a portion of said article ([0019-0020]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify the Neilssen to incorporate wherein said means for monitoring a temperature change in said article comprises a material that is capable of providing a visual indication of whether a predetermined temperature or temperature change has been reached in at least a portion of said article, as taught and suggested by Chandler in order allow biocompatible film formation over an implant (Chandler [0009])
Regarding claim 4, Niellssen/Chandler discloses the invention substantially as claimed and as discussed above with respect to claim 3, and additionally teaches wherein said material that is capable of providing said visual indication comprises a material that exhibits a change in optical transmittance, a change in optical reflectance, a change in luminescence, or a combination thereof in response to a temperature change (Chandler [0019-0020])
Regarding claim 5, Niellssen/Chandler discloses the invention substantially as claimed and as discussed above with respect to claim 4, and additionally teaches wherein said material that displays a change in optical transmittance, a change in optical reflectance, a change in luminescence, or a combination thereof is a thermochromic pigment, thermochromic polymer, thermochromic ink, or thermochromic dye; and said material that displays a change in optical transmittance, a change in optical reflectance, a change in luminescence, or a combination thereof is embedded in, [[or]] provided as a coating on, or a combination thereof, said shaped article (Chandler [0019-0020]).
Regarding claim 7, Niellssen/Chandler discloses the invention substantially as claimed and as discussed above with respect to claim 3, and additionally teaches wherein the body of said shaped article is made of a biocompatible plastic or rubber ([Chandler [0020] describes biocompatible polymers).
Regarding claim 11, Niellssen/Chandler discloses the invention substantially as claimed and as discussed above with respect to claim 7, and additionally teaches Neilssen discloses wherein said shaped article is in the form of a flexible sheet (Chandler [0014]).
Regarding claim 12, Niellssen/Chandler discloses the invention substantially as claimed and as discussed above with respect to claim 7, and additionally teaches wherein said shaped article is dimensioned to substantially follow the contours of an external surface of the prosthetic or implant (Chandler [0006], Chandler teaches conforming media to contour to desired shape of an implanted prosthesis).
Regarding claim 19, Niellssen/Chandler discloses the invention substantially as claimed and as discussed above with respect to claim 11 teaches wherein said flexible sheet can be further modelled and/or cut into a desired shape (Chandler [0014]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.F./ /THOMAS C BARRETT/Patent Examiner, Art Unit 3774 SPE, Art Unit 3799
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