Prosecution Insights
Last updated: October 02, 2026
Application No. 18/408,750

ACTIVE SUBSTANCE APPLICATOR FOR A JOINT IMPLANT, AND JOINT IMPLANT HAVING AN ACTIVE SUBSTANCE APPLICATOR

Non-Final OA §102§103§112
Filed
Jan 10, 2024
Priority
Mar 26, 2018 — EU 18163947.7 +2 more
Examiner
HOBAN, MELISSA A
Art Unit
Tech Center
Assignee
Waldemar Link GmbH & Co. Kg
OA Round
1 (Non-Final)
63%
Grant Probability
Moderate
1-2
OA Rounds
1y 1m
Est. Remaining
76%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allowance Rate
393 granted / 626 resolved
+2.8% vs TC avg
Moderate +14% lift
Without
With
+13.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
28 currently pending
Career history
674
Total Applications
across all art units

Statute-Specific Performance

§101
1.3%
-38.7% vs TC avg
§103
45.1%
+5.1% vs TC avg
§102
23.5%
-16.5% vs TC avg
§112
24.4%
-15.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 626 resolved cases

Office Action

§102 §103 §112
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 . Claim Objections Claims 3 and 5 are objected to because of the following informalities: Claim 3 recites “formed by at least one section of an outer side of the peripheral outer wall forms a friction surface”, which is awkwardly worded. The examiner suggests amending the claim to replace the word “forms” with the word – being – or – forming –, or re-wording the limitation to read – formed by a friction surface defined by at least one section of an outer side of the peripheral outer wall –. Claim 5 recites “the active substance chamber wall” in line 5, which appears to be referring to – the peripheral active substance chamber wall –. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1-19 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. Regarding claim 1, the phrase “can be” in line 6, renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05(d). claims 2-19 depend from claim 1 and are rendered indefinite for the same reason. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “at least 4, 6, 8, or 10 and a maximum of 30 application openings”, and the claim also recites “which are preferably distributed evenly over the application side” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation of a minimum size of 1 mm, and the claim also recites a minimum size of 0.5 mm which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation of a maximum size of 4 mm, and the claim also recites a maximum size of 3 mm or 2 mm which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. 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 use the word “means,” and are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a 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: a securing means in claim 1 and a tool-engaging means in claim 6. 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. The corresponding structures are: Securing means – snap-fit Tool-engaging means – a recess 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 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claim(s) 1-8, 10, and 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 8,475,505 B2 to Nebosky et al. (Nebosky) in view of US Patent No. 5,360,448 A to Thramann (Thramann), and further in view of US Patent Application Publication No. 2011/0130840 A1 to Oskouei (Oskouei). Regarding claim 1 Nebosky teaches an orthopedic screw having a plurality of regions, at least one of which may be porous (abstract). [AltContent: textbox (Annular recess)][AltContent: arrow][AltContent: connector][AltContent: textbox (Application side)][AltContent: textbox (Rear wall)][AltContent: arrow][AltContent: textbox (Rear face)][AltContent: arrow][AltContent: textbox (Front face)] PNG media_image1.png 318 232 media_image1.png Greyscale PNG media_image2.png 324 216 media_image2.png Greyscale Nebosky meets the limitations of an active substance application insert for an implant (orthopedic/pedicle screw; 10 is an active substance applicant insert that is fully capable of being for an implant as disclosed in col. 1, lines 56-62), comprising: a main body (body of screw; 10 as shown in fig. 3), an active substance chamber (reservoir; 18) formed in the main body, an application side (bottom portion of screw body as shown annotated fig. 3 above), which forms a front face (see annotated fig. 3 above) of the active substance chamber, wherein the application side has a plurality of application openings (channels/holes; 20), and a securing means with which the main body can be detachably secured in the implant (the upper portion of the screw is construed to be a securing means that is fully capable of being detachably secured in the implant), wherein in a state in which the main body is inserted into the implant, the application side faces outwards relative to the implant (the application side is construed to be fully capable of facing outwards relative to the implant when the main body is in an inserted state), such that the application openings connect the active substance chamber to an environment outside of the implant when the implant is in an implanted configuration (when implanted, the application openings of Nebosky connect the reservoir/active substance chamber to an environment outside of the implant), wherein on a side opposite the application side a rear wall is formed, which forms a rear face of the active substance chamber (annotated fig. 3 above shows a rear side/upper portion that is opposite the application side and forms a rear/top face) and which faces the implant in an inserted state (the rear face of the bone screw of Nebosky is fully capable of facing an implant in an inserted state), wherein the rear face comprises an annular recess wherein at least one section of the rear wall on the rear face of the active substance chamber is formed by a reclosable cover, wherein the reclosable cover is configured to fit in the annular recess. Nebosky also teaches that the screws can be used for attaching various soft tissues to bone and/or for attaching bone to bone, and/or for delivering therapeutic agents to soft tissue and/or bone in a variety of potential uses that involve implants (col. 1, lines 51-62). However, Nebosky does not explicitly teach an implant to which the screw is detachably secured such that in a state in which the main body is inserted into the implant, the application side faces outwards relative to the implant and the application openings connect the active substance chamber to an environment outside of the implant when the implant is in an implanted configuration or that a rear face of the active substance chamber faces the implant in an inserted state. Thramann discloses bone screws, similar to that of Nebosky, used in the fixation of artificial prosthesis or for a bone-tendon autograft in an ACL repair procedure (col. 1, lines 14-22). Thramann clearly shows that the main body of the screw can be detachably secured in the implant with the securing means (col. 8, lines 14-25 discloses that the screws engage countersink or seats 20 of prosthetic member 13, for example), wherein in a state in which the main body is inserted into the implant, the application side faces outwards relative to the implant (fig. 5 of Thramann below shows that the application side/bottom portion of the screw faces outward relative to the implant when the body is in an inserted state). [AltContent: rect] PNG media_image3.png 632 322 media_image3.png Greyscale It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the screw of Nebosky, which is used for delivering therapeutic agents to soft tissue and/or bone, is detachably secured in a prosthetic member, such as the acetabular implant of Thramann, with a securing means, in a way that the application side faces outward relative to the implant and the rear face faces the implant in an inserted state, as claimed by applicant, in order to provide fixation of the acetabular implant, as taught by Thramann, while also delivering therapeutic agents to the bone, as taught by Nebosky, thereby accomplishing long-term fixation as intended by both Thramann and Nebosky. It is also clear that the placement of the application side of the screw as taught by Thramann would result in the application openings connecting the active substance chamber to an environment outside of the implant when the implant is in an implanted configuration, as claimed. However, Nebosky in view of Thramann does not teach that the securing means is a snap fit. Oskouei teaches an attachment device that secures soft tissue to an orthopedic prosthetic implant or bone with fasteners (abstract) that are provided by screws (24) that are received through holes (28) (paragraph 0033). Oskouei also teaches that the fasteners may be provided by snap-fit pegs for fastening two parts together (paragraph 0033). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the countersink engagement securing means of Nebosky in view of Thramann, which connects bone to a prosthetic implant, with a snap fit securing means, as taught by Oskouei, since the substitution of one known connection configuration for another known connection configuration would yield predictable results to one of ordinary skill in the art in this case, particularly since there is no evidence of record that establishes that changing the type of securing means would result in a difference in function of the device of Nebosky in view of Thramann. Regarding claim 2 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 1. Nebosky also teaches wherein the main body has a peripheral outer wall between the front face and the rear face, which is formed cylindrically, in particular with a circular cross section, and which surrounds the active substance chamber (the head portion of the screw defines a peripheral outer wall as claimed; fig. 3). Regarding claim 3 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 2. Nebosky also teaches that the securing means formed by at least one section of an outer side of the peripheral outer wall forms a friction surface (fig. 3; the peripheral outer wall of the head of the screw is fully capable of being engaged with countersink or seats of the implant, as disclosed in col. 8, lines 14-25 of Thramann, which would result in at least some degree of friction as a result of the engagement between the two components and therefore the peripheral outer wall is construed to form a friction surface as claimed). Regarding claim 4 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 2. Nebosky also teaches wherein the peripheral outer wall forms at least one section of a peripheral active substance chamber wall between the application side and the rear face of the active substance chamber (annotated fig. 3 below shows that the peripheral outer wall forms an annular wall around at least one section of a peripheral active substance chamber wall between the application side and the rear face of the active substance chamber/reservoir; 18). [AltContent: textbox (Peripheral active substance chamber wall)][AltContent: arrow] PNG media_image1.png 318 232 media_image1.png Greyscale Regarding claim 5 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according claim 2, wherein at least one section of a peripheral active substance chamber wall between the application side and the rear face of the active substance chamber is formed separately from and inside the peripheral outer wall of the main body, such that a gap is formed along this section between the peripheral outer wall of the main body and the active substance chamber wall (annotated fig. 3 below shows a gap formed along a section between the peripheral outer wall and the active substance chamber wall). [AltContent: textbox (gap)][AltContent: arrow][AltContent: ] PNG media_image1.png 318 232 media_image1.png Greyscale Regarding claim 6 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 1. Nebosky also teaches wherein the application side is provided with a tool-engaging means for inserting and/or removing the active substance application insert (col. 5, lines 24-35 discloses a pin; 36 that is a radiopaque marker/tool for indicating position and orientation of the implant and would be beneficial for insertion and/or removal of the active substance insert; it can be seen from fig. 7A that an upper portion of the reservoir/recess accepts the pin and is therefore construed to be a tool-engaging means as claimed). Regarding claim 7 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 6. Nebosky also teaches wherein the tool-engaging means is formed as a recess (the upper portion of the reservoir is a recess that accepts the pin and is therefore construed to be a tool-engaging means as claimed). However, Nebosky does not teach that the recess has an internal thread. There is no evidence of record that establishes that adding an internal thread to the upper portion of the chamber/recess would result in a difference in function of the Nebosky device. Further, a person having ordinary skill in the art, being faced with modifying the upper portion of the chamber/recess to include an internal thread, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed internal thread. Lastly, applicant has not disclosed that the claimed internal thread solves any stated problem, indicating that the recess “preferably” has an internal thread, and contemplates a design that does not have an internal thread (specification at para. [0036]) and therefore it appears that the internal thread as claimed does not produce an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the recess/tool-engaging means of Nebosky to have an internal thread as an obvious matter of design choice within the skill of the art. Regarding claim 8 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 1. Nebosky also teaches wherein the application side has at least 4, 6, 8 or 10 and a maximum of 30 application openings, which are distributed over the application side (fig. 3 shows 7 application openings which is at least 4 or 6 and less than 30, and therefore meets the claim). Regarding claim 10 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 1. Nebosky also teaches wherein the application openings are circular, oval, rectangular and/or slit-shaped (the application openings; 20 are slit-shaped as shown in fig. 3). Regarding claim 14 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 1. Nebosky also teaches wherein the rear face is arranged perpendicularly to a longitudinal axis of the active substance application insert (annotated fig. 3 above shows that the rear face is perpendicularly arranged relative to the longitudinal axis of the screw). Regarding claim 15 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 1. Nebosky teaches wherein the application side is arranged at an angle to a longitudinal axis of the active substance application insert (fig. 3 shows that the screw has a tapered pointed end; therefore it is construed that the application side is arranged at an angle to a longitudinal axis of the screw/insert, at least at the tapered portion). Regarding claim 16 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 1. Nebosky teaches wherein the rear face is arranged perpendicularly to a longitudinal axis of the active substance application insert (annotated fig. 3 above shows that the rear face is perpendicularly arranged relative to the longitudinal axis of the screw), and wherein the application side is arranged at an angle to the longitudinal axis of the active substance application insert (fig. 3 shows that the screw has a tapered pointed end; therefore it is construed that the application side is arranged at an angle to a longitudinal axis of the screw/insert, at least at the tapered portion). Regarding claim 17 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 6. Nebosky also teaches wherein the tool-engaging means is a through-hole or a blind hole (upper portion of reservoir is shown to be a through-hole or a blind hole; fig. 7A). Nebosky also teaches that the screw may include one or more reservoirs (18), for the purpose of allowing for the long term delivery of the therapeutic agents (col. 4, lines 43-55). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include an additional reservoir such that no connection is made to the original reservoir/active substance chamber, in order to allow for the long term delivery of the therapeutic agents, as taught by Nebosky. Regarding claim 18 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 1. Nebosky also teaches wherein the active substance chamber further comprises a central column (fig. 3 shows that the reservoir; 18 is centrally located and resembles the structure of a column because it has a similar vertical form). Regarding claim 19 Nebosky in view of Thramann and Oskouei teaches an active substance application insert according to claim 1 (see rejection of claim 1 above). As explained above, Thramann also teaches an implant (the acetabular prosthesis device; 13), having at least one recess (the countersink or seats; 20) designed for receiving an active substance application insert (screw; 1) according to claim 1 (fig. 5). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the insert/screw of Nebosky, which is used for delivering therapeutic agents to soft tissue and/or bone, is detachably secured in an implant via a securing means, such as the acetabular implant of Thramann, in order to provide fixation of the acetabular implant, as taught by Thramann, while also delivering therapeutic agents to the bone, as taught by Nebosky, thereby accomplishing long-term fixation as intended by both Thramann and Nebosky. Further, as explained above, Oskouei teaches an attachment device that secures soft tissue to an orthopedic prosthetic implant or bone with fasteners (abstract) that are provided by screws, similar to that of Nebosky and Thramann, or by snap-fit pegs for fastening two parts together (paragraph 0033). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the screw-countersink engagement securing means of Nebosky in view of Thramann, which connects bone to a prosthetic implant, with a snap fit securing means, as taught by Oskouei, since the substitution of one known connection configuration for another known connection configuration would yield predictable results to one of ordinary skill in the art in this case, particularly since there is no evidence of record that establishes that changing the type of securing means would result in a difference in function of the device of Nebosky in view of Thramann. Claim(s) 9, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nebosky in view of Thramann and Oskouei, as applied to claim 1 above, and further in view of US Patent Application Publication No. 2006/0263401 A1 to Rubsamen (Rubsamen). Regarding claim 9 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 1. Nebosky also teaches the application openings (fig. 3). However, Nebosky does not explicitly teach the size of the application openings. Rubsamen teaches a formulation of controlled release particles which may be dispersed in a gel or included in an aqueous solution and administered to provide antimicrobial to the surrounding area and methods of preventing infection (abstract). Rubsamen further teaches a surgical screw (60) that includes circular holes (70) formed within the screw that are generally of a size in a range of about 1 micron to about 50 microns and may all be substantially the same size or vary in size to match groups of particles (active substance; paragraph 0170). Further still, Rubsamen teaches that the diameter of the holes could be varied greatly to obtain larger or smaller amounts of the drug as needed (paragraph 0178). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify a varied size of the application openings of Nebosky, which are intended to deliver the therapeutic agent, in order to properly obtain and allow delivery of the desired active substance, as taught by Rebsamen. However, Nebosky in view of Rubsamen does not expressly teach a minimum size of 0.5 mm or 1 mm or a maximum size of 2 mm, 3 mm or 4 mm as required by the claim. Rubsamen discloses that the diameter of the holes could be varied greatly to obtain larger or smaller amounts of the drug as needed (paragraph 0178). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the application openings of Rubsamen to have a size within the claimed range, as it involves only varying the dimension of a component disclosed to require variation. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the application openings of Rebsamen by making the application openings be a minimum size of 0.5 mm or 1 mm or a maximum size of 2 mm, 3 mm or 4 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Regarding claim 11 Nebosky in view of Thramann and Oskouei teaches the active substance application insert according to claim 1. Nebosky also teaches having at least one active substance (col. 3, lines 58-67 discloses therapeutic agents such as drugs or biologics) which fills the active substance chamber at least in part (col. 4, lines 43-49 discloses the therapeutic agents contained in the reservoir(s)/active substance chamber; 18). However, Nebosky does not explicitly teach that the therapeutic agent is in the form of a solid, beads, a granulate and/or a gel. Rubsamen teaches a formulation of controlled release particles which may be dispersed in a gel or included in an aqueous solution and administered to provide antimicrobial to the surrounding area and methods of preventing infection (abstract). Rebsamen also teaches that the particles may be dispersed in a gel, for the purpose of obtaining a desired drug release profile (paragraph 0010). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the active substance/therapeutic agent of Nebosky is in the form of a solid, beads, a granulate and/or a gel, in order to obtain a desired drug release profile, as taught by Rebsamen. Regarding claim 12 Nebosky in view of Thramann, Oskouei, and Rubsamen teaches the active substance application insert according to claim 11. Rubsamen also teaches wherein the at least one active substance comprises an antibiotic, for the purpose of preventing infection (abstract). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the at least one active substance of Nebosky comprises an antibiotic, in order to prevent infection, as taught by Rebsamen. Allowable Subject Matter Claim 13 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. The following is a statement of reasons for the indication of allowable subject matter: the prior art does not teach or fairly suggest the combination of elements claimed, particularly an active substance application insert that includes a peripheral outer wall that contacts a periphery of a cavity of the implant and a front face that is coplanar with a surface of the implant when in an insertion configuration. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /M.A.H/Examiner, Art Unit 3774 /SARAH W ALEMAN/Primary Examiner, Art Unit 3774
Read full office action

Prosecution Timeline

Jan 10, 2024
Application Filed
Sep 03, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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GRAFT SUSPENSION DEVICE
5y 3m to grant Granted Jun 02, 2026
Patent 12594165
EXPANDABLE MEDICAL IMPLANT FOR ADOLESCENT CRANIUM DEFECTS
4y 10m to grant Granted Apr 07, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
63%
Grant Probability
76%
With Interview (+13.7%)
3y 10m (~1y 1m remaining)
Median Time to Grant
Low
PTA Risk
Based on 626 resolved cases by this examiner. Grant probability derived from career allowance rate.

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