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 .
Election/Restrictions
The applicant states they have amended to overcome the lack of unity.
The applicant’s election in the response filed on 6/18/2026 of Group I (product claims 193-204), species B directed towards no polymeric inner layer or barrier layer (claims 193-202, 204) and species 4 directed towards a femoral condyle with transverse is acknowledged. The applicant’s arguments are directed towards newly added claim limitations and states the prior art does not contain a support part and therefore the special technical feature now overcomes the prior art.
The applicant states that claim 203 has unity with claim 193 because of the newly added support feature but no further arguments have been presented. A new unity of invention of restriction is noted below and the restriction requirement is therefore maintained.
The applicant states that the restriction requirement among the 15 prosthesis types is no longer necessary because the support feature is the same across all implant types. The implants themselves have different structures and accordingly this species restriction is maintained.
Accordingly claims 203 and 205-207 is/are withdrawn from examination. Upon allowance any withdrawn claims can be rejoined if they are updated to include any allowable subject matter.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 193-204, drawn to an implant.
Group II, claim(s) 205-207, drawn to an assembly method.
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Type of Implant:
Femoral stem (claim 204)
Acetabular cup (claim 204)
Fusion cage (claim 204)
Femoral condyle (claim 204)
Tibial tray (claim 204)
Spinal implant (claim 204)
Ankle joint (claim 204)
Shoulder joint (claim 204)
Elbow joint (claim 204)
Finger joint (claim 204)
Toe joint (claim 204)
Facet joint (claim 204)
Tempormandibular joint (claim 204)
Wrist joint (claim 204)
Dental implant (claim 204)
Implant features:
Use of a polymeric inner layer and barrier layer (claim 203)
No polymeric inner layer or barrier layer (claims 193-202, 204 do not recite a polymeric inner or barrier layer)
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: No claims are generic to all groups. Claim(s) 193 is/are generic to all species.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of an implant body, first porous structure with a holding space comprising channels or openings, and a composite, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Uzuyem (2017/0156869A1) in view of Koch (5139528A) and in view of Joshi (2009/0304775A1).
Uzuyem teaches a prosthetic implant characterized in that it comprises:
an implant body, as the substrate 20;
a first porous structure 22 or a composite containing such a first porous structure, connected with the substrate 20 (see fig 20).
However, Uzuyem does not teach said implant is provided with at least one holding space.
Uzuyem teaches a prosthetic implant characterized in that it comprises:
an implant body 20, as the substrate;
a first porous structure 22
or a composite containing such a first porous structure, connected with the substrate; wherein, the said composite comprises a first porous structure and an intermediate pre-connected or integrally formed with the first porous structure (the composite was not required due to the or statement and therefore this claim limitation is also not required);
and the solid volume fractions of the said substrate (implant 20) and intermediate (the intermediate is not positively recited due to the or statement above, the intermediate is part of the composite which is recited as an alternative) are both higher than that of the first porous structure 22. As shown in figures 1 and 13-14, the porous structure 22 is more porous than the implant 20 and therefore will have a higher solid volume fraction than porous structure 22.
However, Uzyem does not teach the intermediate includes a plurality of support parts or that the implant has at least one holding space.
Kock teaches the intermediate includes a plurality of support parts 4;
at least a part of each support part 4 is located within the first porous structure (fig 2; section with porous structure 2 contains support part 4);
a first end of the support part 4 is close to a first side of the first porous structure (fig 2);
a second end of the support part 4 is close to a second side of the first porous structure (extends through and therefore close to both ends abutting 6 and 1);
wherein, the first side is away from the substrate (implant, 1), and the second side is close to the substrate (implant, 1). (see 4 which extends through one layer and into a second layer; fig 2 and where one end is near to 1 and one end is opposite from 1)
It would have been obvious to one of ordinary skill in the art of bonding and welding materials at the time the invention was filed to use the support parts of Koch between the layers of Uzyem because this allows the layers to be connected by spot welding and ensures the electrodes have an adequate metal bridge (Col 2, lines 1-10).
Joshi teaches the said implant is provided with at least one holding space 110 for placement of a contained substance, which includes a sensor and/or drug (see title; 300);
the said holding space 110 is provided with channels or openings (pores 202; see varying porosity within 600, 602, 604 in fig 6) connecting the holding space 110 to an external space 100 (see fig 6).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the holding space and drug reservoir of Joshi in the implant of Uzyem because the agents are able to enhance the healing process and avoid infection without constant administration [0007-0008].
(The composite and its associated limitations is not required as the composite element is listed as an alternative above as a first porous structure OR a composite).
The applicant already previously elected and the unity of invention restriction was simply updated for the updated claim limitations. The restriction requirement is maintained.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
The applicant is strongly advised to proofread the claims with the restriction election response to facilitate compact prosecution.
Claim Objections
Claim(s) 193-197, 199, 200-201, 204 is/are objected to because of the following informalities:
In regard to claim 193, “intermediate” should be “intermediate structure”. Intermediate is a direction not an element by itself.
In regard to claim 194, “intermediate body” should be “an intermediate body” for proper grammar. “Coupling part” should be “a coupling part” for proper grammar.
In regard to claim 195, “wherein said component, comprising:” should be “wherein said component comprises”.
In regard to claim 196, “a holding space” in lines 3-4 should be “the holding space” for consistent antecedent basis throughout the claims.
In regard to claim 197, “channels” and “openings” should be “the channels” and “the openings” since these were previously recited in claim 193 from which claim 197 depends for clarity and consistent antecedent basis through the claims.
In regard to claim 199, “it” in line 3 of the claim should be “the first porous structure” for clarity.
In regard to claim 200, “sensors” should be “the sensors” for consistent antecedent basis throughout. In line 5 of the claim “processor” should be “a processor”. “Electromagnetic signal-triggered switch” should be “electromagnetic signal-triggered switch”. “Thereof;” should be followed by a colon instead of a semi-colon.
In regard to claim 201, “thereof;” should be followed by a colon instead of a semi-colon.
In regard to claim 204, “it” in line 2 of the claim should be “the implant” for consistent antecedent basis and clarity. “Followings” in line 2 of the claim should be “following”.
Appropriate correction is required. Due to the large number of errors, it is recommended to proofread the claims in their entirety.
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(s) 193, 195-198, 200-201, 204 is/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.
In regard to claim 193, the term “close” is a relative term which renders the claim indefinite. The term “close” 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. The instant disclosure does not provide any further clarification to the scope of the term close.
In regard to claim 193, “the solid volume fractions” in line 11 of the claim lacks proper antecedent basis.
In regard to claim 195, the claim is written as an improper Markush group. The claim should be written as “to achieve at least one of the following: A; B; or C” or as “to achieve at least one of the following from the group consisting of A; B; and C”. There is no transitional word such as and, or between the alternatives currently.
“The solid object” in line 19 of the claim lacks proper antecedent basis.
The limitation “which may connect a portion of struts at the first porous structure, adjacent to the holding space” renders the scope of the claim unclear since it is not clear if the struts are being positively claimed.
This claim is generally unclear, due partially to lacking transitional phrases of groups such as or. It is not clear which parts of the claim are being positively recited or are listing alternatives. The entirety of the claim should be proofread and alternative groups should be clearly listed with appropriate and/or statements.
In regard to claim 196, the statement of “alternatively” makes it unclear if the statement following is intended to be positively recited. As best understood by the examiner, this statement is interpreted the same manner as “or”. The instant disclosure does not provide further clarification.
In regard to claim 197, the claim is written as an improper Markush group. The claim should be written as “any of the following materials A; B; or C” or as “made of any of the following from the group consisting of A; B; and C”. There is no transitional word such as and, or between the alternatives currently.
Further, the terms “similar” and “slow” are relative terms which renders the claim indefinite. The terms “similar” and “slow” is/are 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. The instant disclosure does not provide any further clarification to the scope of the terms similar or slow.
In regard to claim 198, “either alone or in conjunction” is unclear. In conjunction with what? It appears a word is missing. The instant disclosure does not provide further clarification. It appears that “corresponding components” should be “the components” or “the other components” since claim 198 depends from claim 195. The various components should be clearly labeled.
In regard to claim 200, the claim is an improper Markush group. The claim should be written as “said device comprises any of the following following: A; B; or C” or as “the device is one or more from the group consisting of A; B; and C”. There is no transitional word such as and, or between the alternatives currently. Further “the transmission of information” lacks proper antecedent basis.
In regard to claim 201, the claim is an improper Markush group. The claim should be written as “the device comprises any of: A; B; or C” or as “the device is one or more from the group consisting of A; B; and C”. There is no transitional word such as and, or between the alternatives currently
In regard to claim 204, the claim is written as an improper Markush group. The claim should be written as “the implant is one of the following: A; B; or C” or as “the implant is one from the group consisting of A; B; and C”. There is no transitional word such as and, or between the alternatives currently.
Since all claims depend from claims 193 and 205, all claims are rejected under 112b. Due to the large number of issues, all claims should be proofread for clarity.
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.
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) 193-199, 204 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uzuyem (2017/0156869A1) in view of Koch (5139528A) and in view of Joshi (2009/0304775A1).
In regard to claim 193, Uzuyem teaches a prosthetic implant characterized in that it comprises:
an implant body 20, as the substrate;
a first porous structure 22
or a composite containing such a first porous structure, connected with the substrate; wherein, the said composite comprises a first porous structure and an intermediate pre-connected or integrally formed with the first porous structure (the composite was not required due to the or statement and therefore this claim limitation is also not required);
and the solid volume fractions of the said substrate (implant 20) and intermediate (the intermediate is not positively recited due to the or statement above, the intermediate is part of the composite which is recited as an alternative) are both higher than that of the first porous structure 22. As shown in figures 1 and 13-14, the porous structure 22 is more porous than the implant 20 and therefore will have a higher solid volume fraction than porous structure 22.
However, Uzyem does not teach the intermediate includes a plurality of support parts or that the implant has at least one holding space.
Kock teaches an intermediate which includes a plurality of support parts 4;
at least a part of each support part 4 is located within the first porous structure (fig 2; section with porous structure 2 contains support part 4);
a first end of the support part 4 is close to a first side of the first porous structure (fig 2);
a second end of the support part 4 is close to a second side of the first porous structure (extends through and therefore close to both ends abutting 6 and 1);
wherein, the first side is away from the substrate (implant, 1), and the second side is close to the substrate (implant, 1). (see 4 which extends through one layer and into a second layer; fig 2 and where one end is near to 1 and one end is opposite from 1)
It would have been obvious to one of ordinary skill in the art of bonding and welding materials at the time the invention was filed to use the support parts/intermediate of Koch between the layers of Uzyem because this allows the layers to be connected by spot welding and ensures the electrodes have an adequate metal bridge (Col 2, lines 1-10).
Joshi teaches the said implant is provided with at least one holding space 110 for placement of a contained substance, which includes a sensor and/or drug (see title; 300);
the said holding space 110 is provided with channels or openings (pores 202; see varying porosity within 600, 602, 604 in fig 6) connecting the holding space 110 to an external space 100 (see fig 6).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the holding space and drug reservoir of Joshi in the implant of Uzyem because the agents are able to enhance the healing process and avoid infection without constant administration [0007-0008].
In regard to claim 194, Uzyem meets the claim limitations as discussed in the rejection of claim 193, but does not teach the support part as claimed.
Koch further teaches the first end of the support part 4 exceeds or does not exceed the surface of the first side of the first porous structure (structure with 2; fig 2) (exceeds or does not exceed is all possible options); (see fig 2, exceeds the porous structure)
and the said intermediate further includes at least one of the following: intermediate body (4 is an intermediate body), covering at least a part of the surface of the second side of the first porous structure (extends outside of and therefore covers at least part of a surface due to the bulbous shape of the head in figure 2);
a plurality (defined as two or more) of the raised structures, distributed on the surface of the second side of either the first porous structure or the intermediate body; the raised structures face the substrate 1 (see fig 2; Col 2, lines 44-45: protuberances is plural, therefore a plurality);
a plurality of anchor points (interpreted as bulbous head of 4), with the body of which distributed on the second side of the first porous structure (see fig 2);
coupling part, connected between at least one pair of support parts or anchor point bodies.
In regard to claim 195, Uzyem meets the claim limitations as discussed in the rejection of claim 194, but does not teach said component as claimed.
Joshi further teaches
at least one component 200 of the implant 100,
maintaining the form of said component at the time of fabrication or processing thereon, or maintaining the form of the component at the time of connecting the first porous structure or composite to the substrate or processing thereon (these are product by process limitations, patentable only based on the resulting end structure; from is maintained in the final form as shown in figure 6), for use alone or in conjunction with other components to achieve at least one of the following:
forming at least part of the holding space;
forming at least part of the edge interface of the holding space (forms the outer edge of the holding space of 110 in figure 6);
forming a channel or opening of a holding space [0054: porosity of 602];
forming a channel or opening connecting with a holding space [0054: porosity of 602];
forming channels or openings to connect with channels or openings provided by other components;
forming an exposed surface of the implant, said exposed surface being exposed to an external open space (see 604 in figure 6);
forming channels or openings that connect to external open spaces (604 in figure 6);
forming a closure body for closing up the channels or openings of the holding space (604 forms a closure body for 110 as shown in figure 6);
securing the solid object (secures 110 as shown in figure 6); wherein said solid object comprises a solid contained substance, a capsule covering the contained substance, or an edge interface of the holding space [0061: 300 is encapsulated in a microsphere];
wherein, said channel or opening of said holding space is directly connected to other holding spaces, or external open spaces, or exposed surfaces of the prosthesis; or, alternatively, is connected to other holding spaces, or external open spaces (pores of 200 are connected to open spaces as shown in figure 6), or exposed surfaces of the prosthesis, by connecting to the channel or opening (pores 202) provided by one or more components 200;
said external open space containing the corresponding body part into which the prosthesis is implanted (the open space also contains 100 as shown in figure 6);
wherein said component 200, comprising:
a first porous structure 604, an intermediate 602, a substrate [0011: encapsulated with a polymer such as PLGA], a member 600 additionally provided to the prosthesis;
said member 600 additionally provided to the prosthesis, comprising a forming component and/or a filling body (600 meets the definition of a forming component or a filling body since this does not actually impart any structure);
said forming component, connected to at least one other component of the prosthesis; (this component is interpreted as not being chosen due to the or statement)
said filling body 600, comprising a filling surface (inner surface of 600) formed by solidification of a molten substance at a designated part of the prosthesis, (this is a product by process limitation, patentable only based on the end structure of a solidified component; see fig 6) which may connect a portion of struts at the first porous structure, adjacent to the holding space; (this statement is interpreted as not being positively recited)
said filling surface (inner surface of 600) is provided at the first porous structure 604 (see fig 6; at is interpreted as “in, on or near”) alone or in connection with other components;
the substance is a polymeric material or a material with the same or similar properties as the first porous structure or intermediate or substrate; similar properties include similar electrical conductivity, or similar solid volume fractions. [0039; 200 may be constructed of a polymer; 0044]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the at least one component and holding space/reservoir of Joshi in the implant of Uzyem because the agents are able to enhance the healing process and avoid infection without constant administration [0007-0008] and because the regulator element may regulate the delivery of the agent (abstract).
In regard to claim 196, Uzyen meets the claim limitations as discussed in the rejection of claim 195, but does not teach at least one said component as claimed.
Joshi further teaches at least one said component 200, when a part of it is removed, is used to form a holding space 110 (see figure 6), or to form a part of the space in the holding space, or to form a channel or opening in the holding space, or to connect the part in which it is located to the holding space or to an external open space;
the removed part (200), when reset to its original position, serves as a closure body to close up the channel or opening of the holding space 110 (see fig 6)
alternatively, at least one of said components 200, in a predetermined position at the implant, is adjacent to the holding space 110 and is connected to or used as a channel or opening in the holding space (fig 6);
closure of the channel or opening is achieved by said part adjacent to the holding space after said part is installed in place in the predetermined position. (see fig 6)
In regard to claim 197, Uzyem meets the claim limitations as discussed in the rejection of claim 194, but does not teach the channels and openings as claimed and therefore also does not teach closure bodies for closing the channels or openings.
Joshi further teaches 604 closure bodies for closing channels or openings (see pores within 600; 0059), are made of any of the following materials:
materials that can trigger themselves to open when the state of the environment they are in changes; [0061: encapsulated in a microsphere that breaks down when exposed to water; 0011];
materials that can react with a set substance to trigger opening; [0061: encapsulated in a microsphere that breaks down when exposed to water; 0011];
materials that can degrade within a set time frame; [0038: dissolve; a set time frame is any amount of time under the broadest reasonable interpretation]
materials that allow the channel of drugs; [0012; 0031]
materials that allow for slow release of drugs; [0012: desired rate; 0031; 0038: gradually release]
dissolvable materials [0061: encapsulated in a microsphere that breaks down when exposed to water; 0011];
polymeric materials; [0011: PLGA]
the same material as the first porous structure or intermediate or substrate;
the materials with similar properties to the first porous structure or intermediate or substrate.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the closure body of Joshi with the channels and openings of Joshi in the implant of Uzyem because this allows a particular flow rate to be achieved for the agent [0054-0055].
In regard to claim 198, Uzyen meets the claim limitations as discussed in the rejection of claim 195, characterized in that,
contained substances (300; fig 6; [0043: beneficial agents]), which are solids [0043: can be combined with polymers] that can be secured by corresponding components of the implant, either alone or in conjunction, or that are encapsulated in a solid capsule and placed in holding space [0044: encapsulated by a polymer] or secured by corresponding components of the implant (secured by 604, 602, 600), or that are placed in an holding space (within 110) with a solid edge interface on at least one side (100 forms a solid edge interface on at least one side; fig 6);
wherein the capsule [0044] that encapsulates the contained substances (300) is made of any of the following materials;
materials that can trigger themselves to open when the state of the environment they are in changes;
materials that can react with a set substance to trigger opening;
materials that can degrade within a set time frame;
materials that allow the channel of drugs to pass through;
materials that allow for slow release of drugs [0043:decompose when exposed to water]. (the solid capsule is recited in the alternative and therefore the limitations describing the solid capsule are not necessarily required by the claim)
In regard to claim 199, Uzyem meets the claim limitations as discussed in the rejection of claim 193, and further teaches the first porous structure 22 but does not teach the holding space as claimed.
Joshi further teaches the first porous structure or the composite in which it is located is provided with a holding space (it’s not clear if this is the same holding space as claim 193), or the substrate is provided with a holding space, or the substrate is provided with a holding space in conjunction with the first porous structure or the composite in which it is located; (the first holding space 110 when applied to the implant of Uzyem will be located between the first porous structure and the implant/composite)
the contained substance 300 may enter the holding space 110 or exit from it through a channel or opening (see pores 202 in figure 6 within 604, 602, 600) provided in the holding space 110; or the holding space 110 for holding the contained substance 300, through said channel or opening 202, for the transmission of electrical energy, or information, or set substances (intended use, must only be capable of; the pores are capable of transmitting electrical energy, information or the substance 300);
the channel or opening is open, or is opened from a closed state, before the object is placed in the holding space (this is a product by process limitation, patentable only based on the resulting structure; pores 202 are open at least at some point since the substance 300 is delivered therethrough; abstract)
after the object (interpreted as best understood to refer to substance 300) is placed in the holding space 110, the channel or opening 202 is at least partially open, or is closed (open or closed is all possible options) and awaiting subsequent opening, or is closed and no longer open; (these are product by process limitations, patentable only based on the resulting structure; the pores are open at some point to deliver substance 300; abstract)
said sensor detects at least one state around the environment in which it is located, inside or outside the implant, or detects a set substance; (the sensor was recited in the alternative in claim 193 and accordingly, is not actually required how the claim is currently written) the probe or detection surface for detection of the sensor is located on the exposed surface of the implant, or against a channel or opening that can be directly or indirectly connected to the exposed surface of the implant, or protrudes from a channel or opening in the holding space, or is located in the holding space; (the limitations regarding the sensor are read to not be positively recited based on claim 193; if the applicant desires to positively recite the sensor, please amend the claim language to make this clear)
said drug [0042: anti-bacterial drugs], delivered to the holding space 110 before, or during, or after the implantation procedure (this is product by process, patentable only based on the resulting end structure; see figure 6; before, during or after the procedure is all possible options);
said set substance [0042: 300 may include one or more medications including growth factors, anti-inflammatory drugs, anti-bacterial drugs], arriving earlier or later than, or at the same time as, the drug [0042 antibacterial drugs], in the holding space 110 for the drug and/or in the holding space for the sensor; (this is a product by process limitation, patentable only based on the resulting structure of a substance and a drug)
said set substance 300 [0042] being artificially input, or is self-generated in the environment in which the implant is placed, or is applied by means of a trigger device; (artificially input or self generated are product by process limitations, patentable only based on the resulting end structure)
said set substance 300 is delivered from the external open space, the exposed surface of the implant, other holding spaces, directly or through the channels or openings provided by the corresponding components, to the holding space for the drug and/or to the holding space for the sensor. (300 is delivered through the pores 202 as shown in figure 6 to the external open space; abstract)
It is recommended to proofread and correct this claim for clarity. It is also recommended to positively claim the sensor limitations.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the holding space, beneficial agents (drugs and substance) and openings or channels of Joshi in the implant of Uzyem because the agents are able to enhance the healing process and avoid infection without constant administration [0007-0008] and because the regulator including the channels and openings controls the flow of the beneficial agents [0041].
In regard to claim 204, Uzyen meets the claim limitations as discussed in the rejection of claim 193, and further teaches it (interpreted as the implant) is one of any of the followings:
femoral stem (see fig 1), acetabular cup, fusion cage, femoral condyle, tibial tray, spinal implant, ankle joint, shoulder joint, elbow joint, finger joint, toe joint, facet joint, temporomanibular joint, wrist joint, dental implant.
Claim(s) 200-202 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uzuyem (2017/0156869A1) in view of Koch (5139528A) and in view of Joshi (2009/0304775A1) and further in view of Boyden (2015/0238691A1).
In regard to claim 200, Uzyem meets the claim limitations as discussed in the rejection of claim 199, but does not teach the use of sensors.
Boyden teaches devices set up for implants, including sensors 145 [0057] (this limitation is interpreted to now positively be reciting the sensors);
said device further comprises any of the following or any combination thereof;
processor for analyzing the detection data from the sensor; [0090: microprocessor; see fig 6]
electromagnetic signal-triggered switch for receiving a magnetically induced signal corresponding to an external command and converting it into an electrical signal to control a sensor or other controlled device;
a counter or a timer for controlling the drug release timing or sensor measurement timing through counting or timing;
a trigger device for opening a channel or opening in the holding space, or for changing the state of the environment in which it is located, or for transforming the form of the drug, or for applying a set substance, or for removing the capsule for encapsulating the contained substance;
the trigger device is driven into action by receiving instructions from a sensor, or a processor, or an electromagnetic signal triggering switch, or an external device, or a counter, or a timer;
said trigger device is single-use, or re-usable;
wherein said device, may be integrated with other devices, or provided in the same holding space or a different holding space as the drug or other device (provided in its own holding space, see fig 4), or provided at a substrate or first porous structure or composite outside the holding space, or a separate implantable device outside the implant, or provided outside the body into which the implant is implanted;
the transmission of information between the devices is performed by wired or wireless means. (see figs 5-6; wireless transmission; wired or wireless is all possible options)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the sensor system and processor and medication unit of Boyden in the implant of Uzyem because this allows medication release controlled by a sensor unit (abstract) which allows release of medication to reduce inflammation incase of large loads [0026].
In regard to claim 201, Uzyem meets the claim limitations as discussed in the rejection of claim 200, but does not teach the device includes any electronics.
Boyden further teaches said device further comprises any of the following or any combination thereof;
the wireless charging module obtains electrical energy wirelessly from devices external to the implant or external to the human body, and supplies power to other devices that use electricity or electrical energy storage elements, either by wired or wireless means;
an electrical energy storage element that obtains electrical energy for storage from a device or wireless charging module external to the implant or external to the body, by wired or wireless means, and supplies power to other devices that use electricity with the stored electrical energy by wired or wireless means;
antennas or coils for transmitting electrical energy and/or information between devices inside the implant, or between devices inside and outside the implant, or between devices near the implant and outside the body, in wireless mode; [0035: antenna; figs 5-6]
in the wired mode, the cable for transmitting electrical energy and/or information is arranged in the channel of the holding space, and/or in the channel provided by the corresponding component and connected to the channel or opening of the holding space; said cable is connected between the devices inside the implant, or between the devices inside and outside the implant, or is connected at one end to the devices located inside the implant and at the other end to the interface located on the body surface.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the antenna and sensor/medication system of Boyden in the device of Uzyem because this allows sensor information to be transmitted to a remote device to be monitored [0060].
In regard to claim 202, Uzyem meets the claim limitations as discussed in the rejection of claim 201, but does not teach a channel as claimed.
Joshi further teaches
a channel (pores 202) for arranging cables, or for delivering drugs or set substances 300 (see fig 6; abstract), containing at least one of the following:
when the intermediate of the composite contains a raised structure, the spaces between adjacent raised structures are used as channels; (the composite has not necessarily been positively recited yet)
when a substrate is provided with a raised structure on the surface of the substrate on the side facing the first porous structure or composite, the spaces between adjacent substrate raised structures are used as channels;
a channel provided at the intermediate body when the intermediate of the composite contains the intermediate body, comprising a duct formed inside the intermediate body, or a first groove formed on the surface of the intermediate body near the base side, at least a portion of the first groove being open in the direction in which the base is located;
a channel (pores 202) provided at the substrate, comprising a duct formed inside the substrate (1200; [0062: may used channels instead of pores]),
or, alternatively, a second groove formed on the surface of the substrate near the side of the first porous structure or composite thereof, at least a portion of the second groove being open in the direction in which the first porous structure or composite thereof is located;
wherein, the first and second grooves are not provided at the same time; or, when provided at the same time, they are staggered from each other or they are interlocked to form a channel.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the duct system of Joshi applied to the device of Uzyem because it allows medication delivery to be released at a desired rate [0062].
Conclusion
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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