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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/25/2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to the 35 U.S.C. § 102 and 103 rejections of claim(s) 1-20 have been considered but are moot in view of the new grounds for rejection.
Applicant has amended claim to recite that the package is arranged “such that the non-HCT/P bone growth factor is retained in the graft window during transportation of the body of the implant in the package.” In response to Applicant’s amendment Examiner has added reference Donner 2016 (US Pub No.: 2016/0278818).
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 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) 1-5, 7, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donner (US Pub No.: 2019/0083271) in view of Erbe (US Pub No.: 2018/0085491), Walsh (US Pub No.: 2013/0006368), Zamora (US Pub No.: 2008/0063622) and Donner 2016 (US Pub No.: 2016/0278818).
Regarding claim 1, Donner (US Pub No.: 2019/0083271) discloses an implant for fusing a sacroiliac joint (fusion of a sacroiliac joint with a system/device in the abstract), comprising: a body (the implant assembly, being part 14 as per [0203]) having a first face and a second face (shown in figures 2A-2B and 3. Said body is taken to be equivalent to the structure shown in figure 12B with a top part 228 and bottom part 228 in [0234]) disposed in an opposing relationship to one another (shown in figure 12B and 2A), the first face configured for abutting contact with a sacrum and the second face configured for abutting contact with an ilium when the body of the implant is inserted into the sacroiliac joint (as the device is a sacroiliac joint in the abstract, and said joint is between the sacrum and ilium in [0003], abutment with the sacrum and ilium is present with the device. Also disclosed in [0203]), a graft window disposed within the body of the implant and opening to the first and the second faces (being part 234 defined in [0235]. Graft window also disclosed in [0259] and [0264]), whereby the graft window provides a passage between the first and the second faces through the body of the implant (shown with part 234 in figure 12B).
However, Donner does not teach that the implant is prepackaged, the body composed of human cells, tissues, or cellular or tissue-based products (HCT/Ps), or a non-HCT/P bone growth factor prepacked within the graft window; wherein the non-HCT/P bone growth factor is at least partially synthetic and is prepacked into the graft window prior to being packaged offsite from a surgery room; and a package hermetically sealing the body of the implant and the non-HCT/P bone growth factor prepacked into the graft window thereof, wherein the non- HCT/P bone growth factor is prepacked into the graft window prior to sealing the implant within the package.
Instead, Erbe (US Pub No.: 2018/0085491) teaches an instance wherein the body of the implant is composed of human cells, tissues, or cellular or tissue-based products(HCT/Ps) (HTC/P materials used for clinical use in [0011] and [0152] with the table presented with [0152], with use in an implant disclosed in [0153], wherein a sacroiliac joint is taken to be used to compensate for a lack of bone or bone quality), with a non-HCT/P bone growth factor prepacked within the graft window (Erbe teaches demineralized Bone in [0009] that would have growth factors in [0010] This material can be incorporated into the graft window of Donner in place of the biocompatible material that is between the proximal and distal members of Donner in [0058] and [0234], wherein the space between said members of Donner would comprise a graft window, as per the placement of said material in [0234] and figure 12B), wherein the non-HCT/P bone growth factor is prepacked into the graft window prior to being packaged offsite from a surgery room (packaging of bone graft compositions in a kit is disclosed in [0226], where a packaging in a kit implies an offsite packaging as said packaging would not be required if the composition was to be used immediately after preparation of the composition).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the HTC/P material and the demineralized bone matrix present in Erbe to comprise the main body of Donner for the purpose of providing material details not present in Donner, while utilizing a material that is disclosed to induce osteogenesis with a means of production that would be highly reproducible and provide great consistency and reliability (in paragraph [0152] and the subsequent table between paragraphs [0152] and [0153]).
From here, Donner in view of Erbe does not teach wherein the non-HCT/P bone growth factor is at least partially synthetic and is prepacked into the graft window prior to being packaged offsite from a surgery room.
Instead, Zamora (US Pub No.: 2008/0063622) teaches wherein the non-HCT/P bone growth factor is at least partially synthetic (synthetic growth factor is disclosed in [0014]-[0015] with a treatment and repair of bone also disclosed, where the growth factor (B2A2-K-NS in [0014]) is not human cell, tissue, or cellular and tissue based).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a synthetic growth factor found in Zamora into the combination involving Donner for the purpose of incorporating a growth factor that may be specifically tailored depending on an intended use for the growth factor, as per [0019].
Donner in view of Erbe and Walsh also does not teach a package hermetically sealing the body of the implant and the non-HCT/P bone growth factor prepacked into the graft window thereof, wherein the non-HCT/P bone growth factor is prepacked into the graft window prior to sealing the implant within the package such that the non-HCT/P bone growth factor is retained in the graft window during transportation of the body of the implant in the package.
Instead, Donner 2016 (US Pub No.: 2016/0278818) does teach a package hermetically sealing the body of the implant and the non-HCT/P bone growth factor prepacked into the graft window thereof (figure 113 as per [0335]-[0338] is a packaging that holds an implant. Graft window implied in figure 113 where part 5000 is the main package while implants 25 and anchors 30 are visible in sterile individual packages 5002 and 5004), wherein the non-HCT/P bone growth factor is prepacked into the graft window prior to sealing the implant within the package such that the non-HCT/P bone growth factor is retained in the graft window during transportation of the body of the implant in the package (as a kit is present with a sterile packaging disclosed in [0336], a packaging of a growth factor and implant in a growth window is present. As a kit is present in [0336], it stands to reason that the kit with the packaging is transportable before an implantation procedure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the packaging/kit of Donner 2016 into the combination of Donner, Erbe, and Zamora for the purpose of providing a sterile package for the devie of Donner where multiple implants and anchor members are provided in the package in [0336] to allow for a surgeon to determine an appropriate implant size based on the procedure.
Examiner notes that Donner 2016 does not explicitly teach a hermetically sealing. Instead, Walsh (US Pub No.: 2013/0006368) teaches a package hermetically sealing the body of the implant and the non-HCT/P bone growth factor prepacked into the graft window thereof (hermetically sealed plastic trays containing completed implants disclosed in [0099], wherein the implants are disclosed as being joint implants).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the hermetically sealed packaging of Walsh into Donner and Erbe for the purpose of providing a packaging that would allow for the implant device to be stored before use, wherein the hermetically sealed packaging is beneficial in that it would allow for a storage of the device that will protect said device from any contamination. Additionally, the containers are disclosed as being sterilizable with an e-beam as per [0099], providing additional benefit to the containers of Walsh.
Regarding claim 2, Donner in view of Erbe, Zamora, Donner 2016 and Walsh teach the prepackaged implant of claim 1, However, Donner does not teach an instance wherein the non-HCT/P bone growth factor comprises demineralized bone matrix (DBM) fibers and a carrier.
Instead, Erbe does teach an instance wherein the non-HCT/P bone growth factor comprises demineralized bone matrix (DBM) fibers (demineralized bone matrices in [0009], later disclosed for use in a bone graft in [0149]. Fibers are implied to be present as per the structure of a demineralized bone matrix) and a carrier (as the matrix has inorganic materials removed leaving behind a collagen matrix in [0009], a collagen is taken as being the carrier).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the HTC/P material and the demineralized bone matrix present in Erbe to comprise the main body of Donner for the purpose of providing material details not present in Donner, while utilizing a material that is disclosed to induce osteogenesis with a means of production that would be highly reproducible and provide great consistency and reliability (in paragraph [0152] and the subsequent table between paragraphs [0152] and [0153]).
Regarding claim 3, Donner in view of Erbe, Zamora, Donner 2016 and Walsh teach the prepackaged implant of claim 2. However, Donner does not teach an instance wherein the carrier is collagen.
Instead, Erbe does teach an instance wherein the carrier is collagen (in [0009]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the HTC/P material and the demineralized bone matrix present in Erbe to comprise the main body of Donner for the purpose of providing material details not present in Donner, while utilizing a material that is disclosed to induce osteogenesis with a means of production that would be highly reproducible and provide great consistency and reliability (in paragraph [0152] and the subsequent table between paragraphs [0152] and [0153]).
Regarding claim 4, Donner in view of Erbe, Zamora, Donner 2016 and Walsh teach the prepackaged implant of claim 2. However, Donner alone does not teach an instance wherein at least some of the DBM fibers traverse the graft window and are configured to connect the sacrum and the ilium when the implant is positioned within the sacroiliac joint.
Instead, Erbe would teach an instance wherein at least some of the DBM fibers traverse the graft window (the DBM Fibers of Erbe can be incorporated into the graft window of Donner such that they span across said graft window. The graft window of Donner is part 234 defined in [0235]. Graft window also disclosed in [0259] and [0264]) and are configured to connect the sacrum and the ilium when the implant is positioned within the sacroiliac joint (as the graft window of the sacroiliac joint of Donner would be placed between the sacrum and ilium, and as the DBM of Erbe is applied to bone and bone related tissue as per [0003] of Erbe, a connection of the sacrum and ilium will occur if the DBM of Erbe is placed within the graft window of Donner).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the HTC/P material and the demineralized bone matrix present in Erbe to comprise the main body of Donner for the purpose of providing material details not present in Donner, while utilizing a material that is disclosed to induce osteogenesis with a means of production that would be highly reproducible and provide great consistency and reliability (in paragraph [0152] and the subsequent table between paragraphs [0152] and [0153]).
Regarding claim 5, Donner in view of Erbe, Zamora, Donner 2016 and Walsh teaches the prepackaged implant of claim 1. However, Donner does not teach an instance wherein the non-HCT/P bone growth factor is freeze-dried.
Instead, Erbe does teach an instance wherein the non-HCT/P bone growth factor is freeze-dried (in [0021], lyophilizing and drying of a bone is disclosed, wherein lyophilizing and drying is equivalent to freeze drying).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the HTC/P material and the demineralized bone matrix present in Erbe to comprise the main body of Donner for the purpose of providing material details not present in Donner, while utilizing a material that is disclosed to induce osteogenesis with a means of production that would be highly reproducible and provide great consistency and reliability (in paragraph [0152] and the subsequent table between paragraphs [0152] and [0153]).
Regarding claim 7, Donner in view of Erbe, Zamora, Donner 2016 and Walsh teach the prepackaged implant of claim 1, wherein the body of the implant and the prepacked non-HCT/P bone growth factor collectively constitute a medical device (a device is disclosed in figure 2 of Donner, with figures like figure 12B showing a construct that can be classified as a device)
Regarding claim 11, Donner in view of Erbe, Walsh and Zamora teaches the prepackaged implant of claim 1, with Donner further comprising a retaining structure (part 18, shown in figure 2B and disclosed as an anchor element in [0203]) disposed within the graft window (part 18 would extend through the graft window in figure 2B).
It is noted that Donner by itself does not teach an instance wherein the retaining structure is configured to retain the non-HCT/P bone growth factor within the graft window.
However, it is argued that Donner in view of Erbe would teach an instance wherein the retaining structure (being part 18) is configured to retain the non-HCT/P bone growth factor within the graft window (being the demineralized bone in [0009] of Erbe that would have growth factors in [0010]). Here, it is argued that the retaining structure of Erbe would be able to retain the non-HCT/P bone growth factor of Erbe when placed within the window of Donner as the location of the bone growth factor of Erbe and the retaining structure of Donner would overlap, thereby meaning that the retaining structure would also retain the material of Erbe with the device of Donner.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the retaining structure of Donner hold a bone growth factor of Erbe as the retaining structure of Donner would hold the device in place as well as the non-HCT/P growth factor of Erbe as the retaining structure of Donner is disclosed as being a bone screw in [0203]. It is noted that, as Donner does teach that the transverse passageway between the distal and proximal members may receive “an anchor or biocompatible material,” Donner does not teach both at the same time. However, as anchor would secure the device within the body (as it is disclosed as a bone screw in [0203]) and the biocompatible material of Erbe and Donner would promote a bone growth (in paragraph [0152] of Erbe and in [0254] of Donner, where said biological material is taken to be equivalent to the biocompatible material of [0058]), it is argued that including both a retaining anchor and a biocompatible material would provide benefits for the device of Donner in view of Erbe as having both elements would hold the device in the body while promoting a bone growth.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donner (US Pub No.: 2019/0083271) in view of Erbe (US Pub No.: 2018/0085491), Walsh (US Pub No.: 2013/0006368) and Zamora (US Pub No.: 2008/0063622) and Donner 2016 (US Pub No.: 2016/0278818) in further view of Miller (US Pub No.: 2008/0091270).
Regarding claim 6, Donner in view of Erbe, Zamora, Donner 2016 and Walsh teaches the prepackaged implant of claim 5. However, Donner does not teach an instance wherein the DBM fibers are configured to expand when the body of the implant is placed into the sacroiliac joint.
Instead, Erbe does teach an instance wherein the DBM fibers are configured to expand (expansion of DBM fibers in [0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the HTC/P material and the demineralized bone matrix present in Erbe to comprise the main body of Donner for the purpose of providing material details not present in Donner, while utilizing a material that is disclosed to induce osteogenesis with a means of production that would be highly reproducible and provide great consistency and reliability (in paragraph [0152] and the subsequent table between paragraphs [0152] and [0153]).
However, Erbe does not teach an instance wherein the DBM fibers are configured to expand when the body of the implant is placed into the sacroiliac joint.
Instead, Miller (US Pub No.: 2008/0091270) teaches an instance wherein DBM fibers (disclosed in the abstract, as well as [0043]) are configured to expand when the body of the implant is placed into the sacroiliac joint (expansion of the demineralized bone matrix and fibers when placed in the body present in [0043]-[0046] and [0052]. It is noted that a sacroiliac joint is not specifically disclosed. However, the device is in the same field of endeavor as an osteoimplant like an intervertebral body fusion device is present in the abstract, where a sacroiliac joint is a type of intervertebral body fusion device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the material properties of the DBM fibers of Miller into the combination involving Donner for the purpose of imparting a material property onto the DBM of Erbe that will promote a bone healing as per [0041], that is beneficial toward the functions of the device of Donner and the material of Erbe.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donner (US Pub No.: 2019/0083271) in view of Erbe (US Pub No.: 2018/0085491), Walsh (US Pub No.: 2013/0006368) and Zamora (US Pub No.: 2008/0063622) and Donner 2016 (US Pub No.: 2016/0278818) in further view of Golgolewski (US Patent No.: 5,676,699).
Regarding claim 9, Donner in view of Erbe, Zamora, Donner 2016 and Walsh teach the prepackaged implant of claim 1. However, said prior art does not teach an instance further comprising a membrane affixed to the first or the second face of the body of the implant and configured to retain the non- HCT/P bone growth factor within the graft window.
Instead, Golgolewski (US Patent No.: 5,676,699) teaches an instance further comprising a membrane (in the abstract) affixed to the first or the second face of the body of the implant (it is argued that said membrane can be affixed to one of the faces of the implant of Donner) and configured to retain the non- HCT/P bone growth factor within the graft window (in column 3 lines 21-43, a space between two membranes that may contain a demineralized bone powder is present. Here, it is argued that the demineralized bone matrix of Erbe can be implemented in place of the demineralized bone powder of Golgolewski, wherein the membranes would be implemented on the first and/or second face of the body of the implant of Donner).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the membrane of Gogolewski into the combination involving Donner for the purpose of providing an additional means that would promote a bone growth (in column 1 lines 58-65). It also stands to reason that the membrane would be able to hold the demineralized bone matrix of Erbe within the device of Donner as the matrix is holding a demineralized bone in column 3 lines 21-43.
Regarding claim 10, Donner in view of Erbe, Zamora, Donner 2016, Walsh, and Gogolewski teaches the prepackaged implant of claim 9. However, Donner does not teach an instance wherein the membrane is configured to be dissolved or bioabsorbed when the implant is placed into the sacroiliac joint.
Instead, Gogolewski teaches an instance wherein the membrane is configured to be dissolved or bioabsorbed when the implant is placed into the sacroiliac joint (in column 1 lines 29-32 and column 1 lines 43-46, a membrane that is absorbed by bone or is biodegradable is present. Additionally, a degradation of the membrane at a body temperature is in claim 1 of Gogolewski.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the membrane of Gogolewski into the combination involving Donner for the purpose of providing an additional means that would promote a bone growth (in column 1 lines 58-65). It also stands to reason that the membrane would be able to hold the demineralized bone matrix of Erbe within the device of Donner as the matrix is holding a demineralized bone in column 3 lines 21-43.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hunt (US Pub No.: 2021/0228360) teaches a sacroiliac joint in the abstract with a growth factor packed into a central region of an implant in [0055]. Compton (US Patent No.: 10/219,841) teaches a sacroiliac joint connector (claim 1 lines 11-16) with a pathway for bone growth through a graft in column 8 lines 40-49.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AREN PATEL whose telephone number is (571)272-0144. The examiner can normally be reached 7:00 - 4:30 M-Th.
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, Jerrah C. Edwards can be reached on (408) 918-7557. 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.
/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774