DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The Amendment filed 8/11/2025 has been entered. The previous objection to the claims is withdrawn in light of applicant’s amendments. The previous rejection under 35 USC 112 is withdrawn in light of applicant’s amendments. Claims 1-24 remain pending in this application.
It is noted that the previous office action had mistakenly included the incorrect statutory basis (103) for the prior art rejection but the rejection of the claims by Bagby remains the same and has been properly indicated with the correct statutory basis (102) below.
Response to Arguments
Applicant's arguments filed 8/11/2025 have been fully considered but they are not persuasive.
With regard to applicant’s argument that Bagby fails to teach or suggest penetrating the leading end into the bone layer to a depth, the examiner disagrees. Bagby teaches that the diameter of the hole (29), which is formed in the bone layer between two adjacent vertebrae (26), is selected to be slightly smaller than the diameter of the basket (implantable device; 10) (col. 4, lines 11-15) and that an installing tool (16), such as a hammer, mallet, or any equivalent device, must be used to impact the basket (implantable device; 10) in the hole (29) between adjacent bones. This impaction into a slightly smaller hole requires penetration of the implantable device into the bone layer to a depth, as shown in fig. 8. Further, Bagby teaches that the basket (implantable device; 10) includes a rigid perforated cylindrical wall (11) that has a greater compressive strength than the bone structure into which it is implanted (col. 3, lines 27-32 and fig. 8). Further still, the bone layer between vertebrae is construed to remain despite the removal of bone, particularly since the term “bone layer” does not require the presence of intact natural bone, rather has been interpreted as a layer in which bone is normally present within a healthy joint. Therefore, the examiner maintains that the leading end of the implantable device of Bagby penetrates into the bone layer of the adjacent vertebrae to a depth, regardless of the presence of the hole (29).
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With regard to applicant’s argument that Bagby fails to disclose positioning the second section in the bone layer, the examiner disagrees. Fig. 8 of Bagby clearly shows the second section (12) of the implantable device (10) being positioned in the bone layer between adjacent vertebrae, as claimed, regardless of the presence of the hole (29), as explained above.
With regard to applicant’s argument that Bagby fails to teach or suggest positioning the joint-ward end in a position to facilitate transmission through the first fenestrations into a cartilage zone by positioning the joint-ward end at a transition area substantially between a cartilage layer in the cartilage zone or otherwise not extending entirely through the cartilage zone, the examiner disagrees. The cartilage layer in the cartilage zone between vertebrae is construed to remain despite the removal of cartilage, particularly since the terms “zone” and “layer” do not require the presence of intact natural cartilage. Therefore, the term “cartilage layer in the cartilage zone” has been interpreted as a location, i.e. layer or zone, in which cartilage can be and/or is normally present within a healthy joint. The examiner maintains that annotated fig. 8 of the previous office action shows that, at least a portion of the joint-ward end is positioned at a transition area, between the adjacent vertebrae and thereby between a cartilage layer in a cartilage zone, and that, at least a portion of the joint-ward end is beneath the cartilage zone. The alternative recitation “or otherwise not extending entirely through the cartilage zone” is moot because Bagby meets the limitation “such that the joint-ward end is beneath the cartilage zone”.
Terminal Disclaimer
The terminal disclaimer filed on 8/11/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent Nos. 10,610,364 and 11,298,235 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 3-11, 19, 20, 23, and 24 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by US Patent 4,501,269 to Bagby (Bagby).
Regarding at least claim 1
Bagby teaches a process for immediate stabilization and subsequent promotion of bone-to-bone fusion in a joint where separation of the bones is restricted by surrounding ligaments or other soft tissue (abstract).
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Bagby meets the limitations of a method of promoting healing in or adjacent to a portion of a bone layer at a treatment site within a body joint, the method comprising: providing an implantable device (10) having a body formed of material (col. 3, lines 27-29 discloses that the basket/device might be made of stainless steel or other material suitable for implantation purposes), the implantable device comprising: an axis defining an axial direction of the device (see annotated fig. 1 above); a first section comprising: a joint-ward end (14 in the first section; see annotated fig. 1 above) having an inner surface and an outer surface spaced apart from one another along the axial direction of the device (col. 2, lines 48-52 discloses that the basket/device is hollow and therefore has an inner surface and an outer surface separated from one another as shown in fig. 9), the joint-ward end further having first fenestrations (apertures; 15 and perforations; 23) extending fully through the joint-ward end in a manner that includes extending between and through the inner surface of the joint-ward end and the outer surface of the joint-ward end (col. 3, lines 38-41 discloses that the apertures are formed through the end 14 and col. 3, lines 44-46 discloses that the perforations extend through the wall 11 at the joint-ward end); and a second section (see annotated fig. 1 above) arranged along the axial direction from the first section and comprising: an opposing leading end (12); and a lateral wall (11) extending between the joint-ward end and the leading end (fig. 1), wherein the lateral wall is configured to engage the bone layer (26) at the treatment site (fig. 8); penetrating the leading end into the bone layer to a depth (fig. 9 shows that the leading end is penetrated into the bone layer to a depth): positioning the second section in the bone layer (fig. 9 shows that the second section is positioned in the bone layer); and positioning the joint-ward end in a position to facilitate transmission through the first fenestrations into a cartilage zone (the joint-ward end is shown roughly in annotated fig. 8 below as being positioned to facilitate transmission of the prongs of a tool through the first fenestrations as disclosed in col. 3, lines 52-56) by positioning the joint-ward end (14) at a transition area substantially between a cartilage layer in the cartilage zone and the bone layer (26) at the treatment site such that the joint-ward end is beneath the cartilage zone or otherwise not extending entirely through the cartilage zone (fig. 9 shows that at least portions of the joint-ward end 14 is positioned at a transition area between a cartilage layer and a bone layer such that it is beneath the cartilage zone).
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Regarding at least claim 3
Bagby teaches the method of claim 1, wherein the lateral wall (11) further comprises second fenestrations configured to promote osseointegration of the second section at the treatment site (diametrically opposed enlarged openings permit an enlarged bone ingrowth structure in alignment with the joint as disclosed in col. 3, lines 46-51; fig. 9).
Regarding at least claim 4
Bagby teaches the method of claim 1, wherein the first fenestrations promote intracellular nutrient transmission; or wherein the joint-ward end is substantially positioned such that the joint-ward end is arranged to permit cartilage growth through, around, and over the first fenestrations in the joint-ward end (the joint-ward end 14 is substantially positioned within a joint and is thereby arranged to permit cartilage to grow through, around, and over the first fenestrations as claimed, if/when cartilage is present).
Regarding at least claim 5
Bagby teaches the method of claim 1, wherein the cartilage layer is articular cartilage; or wherein the bone layer is a cortical bone base plate (articular cartilage is found at the spinal joint or ankle joint taught by Bagby) .
Regarding at least claim 6
Bagby teaches the method of claim 1, wherein healing includes mitigating bone hypertrophy when the joint-ward end is positioned at the transition area so as to protect against forces applied to the body joint (col. 2, lines 38-43 discloses bone growth through and around the basket/device and col. 4, line 68 through col. 5, lines 1-6 discloses a balance in forces when the joint-ward end is positioned at the transition area, which would both contribute to mitigation of bone hypertrophy as claimed).
Regarding at least claim 7
Bagby teaches the method of claim 6, wherein mitigating bone hypertrophy includes preventing trabecular thickening of cancellous bone (the balanced forces and allowance of bone growth through and around the basket is construed to mitigate bone hypertrophy would prevent trabecular thickening of cancellous bone as claimed).
Regarding at least claim 8
Bagby teaches the method of claim 1, wherein the transition area is located substantially in a cortical bone base plate; or wherein the transition area is located substantially between cancellous bone and the cartilage zone (the transition area is shown to be located substantially between cancellous bone and the cartilage zone as shown in fig. 9).
Regarding at least claim 9
Bagby teaches the method of claim 1, wherein the device inhibits bone growth into the cartilage zone when the joint-ward end is positioned at the transition area; or wherein the device prevents bone fracture when the joint-ward end is positioned at the transition area thus protecting against forces applied to the body joint (the basket/device of Bagby is used for stabilization in a joint and is construed to therefore prevent bone fracture when the joint-ward end is positioned at the transition area as claimed).
Regarding at least claim 10
Bagby teaches the method of claim 1, wherein at least one of: the body joint is a knee, shoulder, elbow, wrist, hip, spine, ankle, or finger; or the treatment site includes a subchondral lesion (Bagby teaches that the joint can be an ankle joint; col. 2, lines 30-32).
Regarding at least claim 11
Bagby teaches the method of claim 1, wherein the joint is selected from the group consisting of an acetabulofemoral joint, an acromioclavicular joint, a femoropatellar joint, a femorotibial joint, a glenohumeral joint, a humeroradial joint, a humeroulnar joint, an interphalangeal joint, a metacarpal joint, a radioulnar joint and a talocrural joint (Bagby teaches that the joint can be an ankle joint; col. 2, lines 30-32).
Regarding at least claim 19
Bagby teaches the method of claim 1, wherein the first section and the second section are reversibly attached (col. 3, lines 33-38 discloses a threaded cap at the end of the second section such that the first section is reversibly attached, via threaded rotation, to the second section).
Regarding at least claim 20
Bagby teaches the method of claim 1, wherein the first section and the second section are fused together (col. 5, lines 18-22 discloses that the first and second sections are fused together with the bone).
Regarding at least claim 23
Bagby teaches the method of claim 1, wherein the joint-ward end is positioned at a boundary of the transition area, said boundary being located substantially between a cancellous bone and the cartilage zone (fig. 9 shows that the joint-ward end 14 is positioned at a boundary of the transition area located substantially between a cancellous bone 26 and the cartilage zone).
Regarding at least claim 24
Bagby teaches the method of claim 1, wherein the joint-ward end forms a shape that substantially recreates the shape of a normal articulation surface on the bone after implantation when the joint-ward end is positioned at the treatment site (fig. 9 shows that the joint-ward end forms a shape that substantially recreates the shape of a normal articulation surface on the bone after implantation, particularly since the term substantially is broad).
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bagby in view of US Patent No. 5,026,373 to Ray et al. (Ray).
Bagby teaches the method of claim 1, including a lateral wall configured to engage the bone layer at the treatment site. However, Bagby does not teach wherein the lateral wall comprises threads configured to engage the bone layer at the treatment site.
Ray teaches a fusion cage having an external thread (12) for insertion into a threaded bore extending laterally between adjacent bony structures such as two vertebrae with the thread penetrating into cancellous bone of each of the vertebrae (abstract).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include threads on the lateral wall, in order to penetrate into the cancellous bone of each of the vertebrae, as taught by Ray.
Claim 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bagby in view of US Patent Application Publication No. 2004/0225360 A1 to Malone (Malone).
Bagby teaches the method of claim 1. However, Bagby does not explicitly teach cartilage regrowth at the treatment site.
Malone teaches bone implantable devices, such as interbody spinal fusion cages, that may be used to deliver substances to enhance the growth of cartilage in addition to bone, and would therefore result in regrowth of cartilage to a thickness that is substantially uniform after healing or a thickness that is substantially the same as a thickness of healthy native cartilage adjacent the treatment site after healing.
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 a thickness of cartilage regrowth at the treatment site is substantially uniform after healing or a thickness of cartilage regrowth at the treatment site is substantially the same as a thickness of healthy native cartilage adjacent the treatment site after healing, by delivering substances via the device to enhance the growth of cartilage, as taught by Malone, in order to enhance the healing of the surrounding tissues of Bagby.
Claims 13-17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bagby.
Regarding at least claim 13
Bagby teaches the method of claim 1, wherein the device is made at least in part from stainless steel or other material suitable for implantation purposes (col. 3, lines 27-30). However, Bagby does not teach that the material is titanium or alloys thereof.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Bagby to be made at least in part from titanium or alloys thereof, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claim 14
Bagby teaches the method of claim 1, wherein the device is made at least in part from stainless steel or other material suitable for implantation purposes (col. 3, lines 27-30). However, Bagby does not teach wherein the device is made at least in part from non-resorbable material.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Bagby to be made at least in part from non-resorbable material, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claim 15
Bagby teaches the method of claim 1, wherein the device is made at least in part from stainless steel or other material suitable for implantation purposes (col. 3, lines 27-30). However, Bagby does not teach wherein the device is made at least in part from polyether-ether-ketone (PEEK).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Bagby to be made at least in part from polyether-ether-ketone (PEEK), since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claim 16
Bagby teaches the method of claim 1, wherein the device is made at least in part from stainless steel or other material suitable for implantation purposes (col. 3, lines 27-30). However, Bagby does not teach wherein the device is made at least in part from a partially absorbable material or a fully absorbable material.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Bagby to be made at least in part from a partially absorbable material or a fully absorbable material, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claim 17
Bagby teaches the method of claim 1, wherein the device is made at least in part from stainless steel or other material suitable for implantation purposes (col. 3, lines 27-30). However, Bagby does not teach wherein the device is made at least in part from and/or includes at least one of: biocompatible plastic; a biocomposite polymer; a metal; a metal alloy; carbon fiber; cobalt chrome; nitinol; polycaprolactone (PCL); polyether-ether-ketone (PEEK); tantalum; titanium; foam metals; ceramics; ceramic composites; elastomer composites; elastomer-carbon fiber composites; chambered or fluid-filled materials; metal matrices; injectable gels; injectable composites with fluid and solid matrices; bone or bone-composite or allografts; crystal or hydroxyapatite materials; bioabsorbable composites; TCP; PLLA; silicone, biomaterial; biocompatible material; a biocomposite material; a biomimetic material; a bioactive material; a nanomaterial; a partially absorbable material; a fully absorbable material; a tissue forming material; a biphasic material; or a replaceable material.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Bagby to be made at least in part from and/or includes at least one of: biocompatible plastic; a biocomposite polymer; a metal; a metal alloy; carbon fiber; cobalt chrome; nitinol; polycaprolactone (PCL); polyether-ether-ketone (PEEK); tantalum; titanium foam metals; ceramics; ceramic composites; elastomer composites; elastomer-carbon fiber composites; chambered or fluid-filled materials; metal matrices; injectable gels; injectable composites with fluid and solid matrices; bone or bone-composite or allografts; crystal or hydroxyapatite materials; bioabsorbable composites; TCP; PLLA; silicone . biomaterial; biocompatible material; a biocomposite material; a biomimetic material; a bioactive material; a nanomaterial; a partially absorbable material; a fully absorbable material; a tissue forming material; a biphasic material; or a replaceable material, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Claim 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bagby in view of US Patent Application Publication No. 2011/0009964 to Schwartz et al. (Schwartz).
Bagby teaches the method of claim 1, including that the device is intended for osseointegration. However, Bagby does not teach wherein at least the outer surface of the joint-ward end is coated with hydroxyapatite.
Schwartz teaches a bone/cartilage implant having a coating, such as HA (hydroxyapatite) or titanium plasma spray for the purpose of assisting with bone integration (paragraph 0064).
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 device of Bagby to include that at least the outer surface of the joint-ward end is coated with hydroxyapatite, in order to assist with bone integration, as taught by Schwartz, particularly since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Claim 21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bagby in view of US Patent No. 4,839,215 to Starling et al. (Starling).
Bagby teaches the method of claim 1, wherein the lateral wall further comprises second fenestrations on the second section (diametrically opposed enlarged openings in the second section are construed to be second fenestrations as disclosed in col. 3, lines 46-51; fig. 9). However, Bagby does not teach wherein the second fenestrations are between 300 microns and 1200 microns in size.
Starling teaches implants to medical or tissue growth use (col. 4, lines 18-24). According to Starling, a number of medical workers have conducted research into the optimal pore size for bone implant material and have found that a pore size of at least 40 to 100 microns is needed to obtain osteoid growth and apertures with a diameter preferably greater than 200 microns are best for applications in which mineralized bone ingrowth is desired (col. 7, lines 4-21).
It would have been obvious to one having ordinary skill in the art at the time of the invention to specify a size of greater than 200 microns for the fenestrations on the second section, in order to obtain mineralized bone ingrowth. However, Bagby in view of Starling does not explicitly teach a range between 300 microns and 1200 microns.
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 fenestration size of Bagby in view of Starling from greater than 200 microns to between 300 microns and 1200 microns as applicant appears to have placed no criticality on the claimed range (see pp. [0076] indicating the size is between “about” 300 microns and 1200 microns) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bagby in view of US Patent No. 5,306,311 to Stone et al. (Stone).
Bagby teaches the method of claim 1, including first fenestrations on the joint-ward end of the first section. However, Bagby does not teach that the first fenestrations on the joint-ward end of the first section are between 100 microns to 800 microns in size to promote cartilage regrowth.
Stone further teaches that the prosthetic articular cartilage (10) is a matrix having a pore size in the approximate range of about 100 microns to about 400 microns, for the purpose of establishing a bioresorbable scaffold adapted for the ingrowth of articular chondrocytes and supporting natural articulating joint load forces (col. 3, lines 11-21).
It would have been obvious to one having ordinary skill in the art at the time of the invention to specify a size of about 100 microns to about 400 microns, in order to allow ingrowth of articular chondrocytes and support natural articulating joint load forces, as taught by Stone. However, Bagby in view of Stone does not explicitly teach a range between 100 microns to 800 microns.
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 fenestration size of Bagby in view of Stone from about 100 microns to about 400 microns to between 100 microns and 800 microns as applicant appears to have placed no criticality on the claimed range (see pp. [0076] indicating the size is between “about” 100 microns and 800 microns) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/M.A.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774