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
Applicant’s election of Group I (Claims 1-3 and 8-15; drawn to a method of forming a prefabricated innervated pre-vascularized pre-laminated (PIPP) flap having a stoma or lumen) in the reply filed on November 25, 2024, is acknowledged.
Claims 16-19 and 21-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Groups II), there being no allowable generic or linking claim. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
DETAILED ACTION
The claims filed on February 2, 2026, have been acknowledged. Claims 4-7, 20, 25-30, and 41 were cancelled. Claims 1, 16, 32, and 39-30 were amended. Claim 42 is new. In light of the Applicant’s elected invention, claims 16-19 and 21-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-3, 8-15, 31-40, and 42 are pending and examined on the merits.
Rejections and/or objections not reiterated from the previous office action mailed October 1, 2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
The applicant claims domestic priority from U.S. provisional application No. 63/120,568, filed on December 2, 2020. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-3, 8-15, 31-40, and 42 receive domestic benefit from U.S. provisional application No. 63/120,568, filed on December 2, 2020.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 8-15, 31-35, 37-39, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Kuo et al. (J. C. Melville et al. (eds.), Regenerative Strategies for Maxillary and Mandibular Reconstruction: Chapter 6 Principles of Soft Tissue Engineering for Craniomaxillofacial Reconstruction. 53-70. 2019. Published March 2019), in view of United States Patent Application No. 20180116788 (Kozin). This is a new rejection that is substantially similar to a previous rejection of record made in response to Applicant’s amendments to the claims. Any aspect of Applicant’s traversal that is relevant to the new rejection of record is addressed below.
Regarding claims 1 and 31, Kuo teaches a method of functional reconstruction of lips wherein a prefabricated innervated prevascularized prelaminated (PIPP) designer microvascular free flap is constructed for the functional lip reconstruction
A functional lip will be reconstructed by the following steps:
Two 1.0 cm circular punch biopsies, the posterior auricular area for autogenous skin keratinocytes and the buccal (cheek) mucosa for autogenous oral keratinocytes, will be taken.
A mucocutaneous (M/C) construct will be manufactured in vitro in a cGMP facility with the autogenous skin and oral keratinocytes using an appropriate template for M/C fabrication that would address the size and geometry of the defect to be reconstructed
An ex vivo fabricated M/C construct will be grafted onto the latissimus dorsi muscle (LDM) to create a prefabricated innervated prevascularized prelaminated (PIPP) flap. The implantation of the M/C construct will be placed parallel to the muscle fibers of the LDM as well as parallel to the motor nerve and blood supply based on the thoracodorsal vessels. The parallel position of the neurovascular bundle and M/C construct will facilitate the surgical inset of the flap and the functional dilation and contraction of the muscle fibers. The location of the M/C construct will be just below the angle of the scapula in order to allow for an appropriate length of the neurovascular pedicle.
A stoma within the M/C construct will be created at the time of grafting onto the LDM such that the long axis of the opening is parallel to the muscle fibers to simulate the orbicularis oris muscle. The stoma or opening will be maintained with an inert obturator fabricated from a 3D printer.
The designer prelaminated flap at 2–3 weeks postimplantation will be harvested.
A microvascular free transfer to the recipient site containing the thoracodorsal artery, vein, and motor nerve to the external carotid or facial artery, external jugular or facial vein, and a branch of the facial nerve will be performed, respectively (page 57, column 1, paragraph 3-page 58, paragraph 5).
Kuo teaches that in a defined period of time, the M/C constructs mature, integrate, and develop a microcapillary system (i.e. microvasculature) with the underlying muscle flap (page 56, column 2, paragraph 1).
Kuo is silent as to the design of the obturator component.
However, Kozin teaches a 3D printed prosthetic device for occluding a superior semicircular canal dehiscence to correspond to the size and shape of a patient’s semicircular canal defect. The prosthesis is placed within the lumen of the semicircular canal to plug the opening (paragraphs 0019, 0055-0058, and 0104). Figure 11 depicts an obturator component, as shown in the annotation of Figure 11 and additional top-down and side views. The device has three portions (defined as a base, obturator, and anchor portion). The base defines a central longitudinal axis, the obturator and anchor portions define a first and second axis that are perpendicular to the central longitudinal axis while also being perpendicular to each other (i.e. non-parallel) as shown in the top-down and side views of prosthetic device of Kozin. The obturator portion is between the base and the anchor and the anchor extends beyond the obturator portion along the second axis.
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Annotation of Figure 11 and Top-down and Side View
Kozin does not teach a planar surface perpendicular to the central longitudinal axis as the base portion of their device has a curved surface that would be perpendicular rather than a planar surface. However, it would have been obvious to one of ordinary skill in the art that the shape of the base portion could be modified to use a planar surface, as was done with the anchor portion, instead of a curved surface as this change would represent a well understood design choice. Kozin does teach that the shape of their prosthetic devices can be formed in other shapes, such as a square, that would have planar surfaces (paragraph 0058). Furthermore, MPEP2144.04(IV)B states that in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the obturator of Kuo with design of Kozin because they are used for related purposes. Kuo uses their 3D printed obturator to hold open a lumen during composite formation at the donor site. The 3D printed device of Kozin is used to occlude a hole (or lumen) in the ear canal. The device of Kozin would also have the same result of preventing cell growth in the occluded hole based on its design. Furthermore, Kozin teaches that Figure 11 comprises handles intended to aid in the placement of the prosthesis. As the device of Kozin could also perform the stated function of the obturator component of Kuo and includes handles to aid in placement of the device, it would have been obvious that the device of Figure 11 could be used as an obturator component in the method and would read on the obturator component as recited in instant claim 1, as shown above. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Regarding the stabilizing by disposing the obturator portion in an opening of the composite, Kozin already teaches that their prosthetic device can be handled and manipulated by the placement handle 1102 until the occluding prosthesis 1100 is placed in a dehiscence. Once placed, a user can remove the placement handle 1102. Therefore, the handle portion can optionally be removed after placement. As such, the handle would not be used to close the lumen and allow growth of the composite around the obturator. That only leaves two options, the obturator portion and the base portion for closing the lumen. It would be well understood that the obturator portion of the device of Kozin can be used to hold open the lumen as this would ensure that the obturator stays in the lumen throughout the development period for the composite as the base and anchor portion would prevent it from becoming dislodged or falling out during this period. Furthermore, Kozin already identifies that the placement handle can be removed within the dehiscence after placement. Therefore, it would be well understood that the handle could, instead, be removed at the end of the development period to allow for easy removable of the prosthetic device once the construct is fully formed and ready for transplantation and limiting the damage to the PIPP flap during removal.
Regarding claim 2, Kuo, as stated supra, teaches that a stoma within the M/C construct will be created at the time of grafting onto the LDM such that the long axis of the opening is parallel to the muscle fibers to simulate the orbicularis oris muscle. The stoma or opening will be maintained with an inert obturator fabricated from a 3D printer (page 58, column 1, paragraph 2).
Although Kuo is silent as to when the obturator component is removed, it would be well understood that it would need to be maintained throughout the 2-3 week development period otherwise the stroma or lumen could close (page 58, column 1, paragraphs 2-3).
Figure 6.2 of Kuo teaches that they use surgical harvesting of the PIPP flap as a free flap (page 57, column 1, paragraph 3).
Regarding claim 3, Kuo, as stated supra, teaches that a stoma within the M/C construct will be created at the time of grafting onto the LDM such that the long axis of the opening is parallel to the muscle fibers to simulate the orbicularis oris muscle. The stoma or opening will be maintained with an inert obturator fabricated from a 3D printer (page 58, column 1, paragraph 2).
Regarding claim 8, Kuo, as stated supra, teaches that the functional lip reconstruction involves two 1.0 cm circular punch biopsies, the posterior auricular area for autogenous skin keratinocytes and the buccal (cheek) mucosa for autogenous oral keratinocytes being taken.
A mucocutaneous (M/C; or MCC) construct will be manufactured in vitro in a cGMP facility with the autogenous skin and oral keratinocytes using an appropriate template for M/C fabrication that would address the size and geometry of the defect to be reconstructed (page 57, column 2, paragraph 2-page 58, paragraph 1)
Kuo teaches that the mucocutaneous junction, an area where mucosa and skin tissue meet, is a complex structure. The restoration of such structure by a tissue-engineered device requires a co-culture of oral and skin keratinocytes separated by cell-free zone that allows both types of cells to gradually merge and migrate toward one another to create the mucocutaneous junction (i.e. two regions). In the case of lip restoration, the tissue-engineered mucocutaneous junction construct will be implanted into the latissimus dorsi muscle, with the stoma or opening in the device paralleling the muscle fibers (page 63, column 2, paragraph 13-page 65, column 1, paragraph 1 and Figure 6.11).
Regarding claim 9, Kuo, as stated supra, teaches a mucocutaneous (M/C) construct will be manufactured in vitro in a cGMP facility with the autogenous skin and oral keratinocytes using an appropriate template for M/C fabrication that would address the size and geometry of the defect to be reconstructed (page 57, column 2, paragraph 2).
Regarding claim 10, Kuo teaches that the tissue-engineered human mucosa and skin keratinocytes on the same piece of dermal matrix (M/C constructs) are cultured in vitro (page 56, column 2, paragraph 1). Kuo teaches a method of co-culturing skin keratinocytes and mucosa keratinocytes wherein the skin and mucosa are separated by a barrier on a non-immunogenic acellular dermal matrix (AlloDerm; El-Hadidy evidences that AlloDerm is an acellular non-immunogenic dermal matrix (page 70, column 1, paragraph 1 and column 2, paragraph 3). The cells were cultured in medium (a first liquid phase) with 0.06 mM Ca+2 and the barrier for 1 day, at liquid phase in medium with 1.2 mM Ca+2 for 4 days (second liquid phase), and at air-liquid phase in medium with 1.2 mM Ca+2 for 10 days (page 62, column 2, paragraph 2 and page 66, column 1, paragraph 5-page 67, column 2, paragraph 67 and Figures 6.8-6.11).
Regarding claims 11-12, Kuo, as stated supra, teaches two 1.0 cm circular punch biopsies, the posterior auricular area for autogenous skin keratinocytes and the buccal (cheek) mucosa for autogenous oral keratinocytes, will be taken (page 57, column 2, paragraph 2). Kuo teaches methods of extracting the oral and skin keratinocytes and amplifying the population by culturing the isolated cells further (page 61, column 1, paragraph 2-page 62, column 1, paragraph 14).
Regarding claim 13, Kuo, as stated supra, teaches two 1.0 cm circular punch biopsies, the posterior auricular area for autogenous skin keratinocytes and the buccal (cheek) mucosa for autogenous oral keratinocytes, will be taken (page 57, column 2, paragraph 2).
Regarding claim 14, Kuo, as stated supra, teaches the construct is grafted onto the LDM (page 58, column 1, paragraph 2).
Regarding claim 15, Kuo, as stated supra, teaches that the flap is harvested 2-3 weeks after implantation (page 58, column 1, paragraph 3). As Kuo teaches the harvesting can occur at 2 weeks post-implantation, this is within the range of claim 15.
Regarding claim 32, although Kozin shows that their base portion is rectangular in Figure 11, Kozin teaches that other shapes can be used such as a tubular shape (i.e. cylindrical). The particular size and shape of the device can be altered to control the size and shape of the occluding prosthesis. For example, the size and shape can be based on a measurement of a particular dehiscence of an individual patient (paragraphs 0058 and 0104). Furthermore, MPEP2144.04(IV)B states that in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Regarding claim 33, as can be seen in Figure 11, the base comprises a constant thickness that would also occur if the base was modified to be a square shape.
Regarding claim 34, Kozin teaches that although Figure 11 shows that their obturator portion is rectangular, other shapes can be used such as a tubular shape (i.e. cylindrical). The particular size and shape of the device can be altered to control the size and shape of the occluding prosthesis. For example, the size and shape can be based on a measurement of a particular dehiscence of an individual patient (paragraphs 0058 and 0104). As the shape is dependent on the shape of the patient’s defect, the obturator portion could be elliptical cylindrical and would have a first axis that is a major axis of the ellipse that would be perpendicular to the longitudinal axis and maintain a non-parallel relationship to the second axis.
Regarding claim 35, as can be seen in Figure 11, the anchor is a rectangular prism.
Regarding claims 37-38, as can be seen in Figure 11, the device has a single-piece unitary structure and a solid construction following 3D printing.
Regarding claim 39, Kuo, as stated supra, teaches that a stoma within the M/C construct will be created at the time of grafting onto the LDM such that the long axis of the opening is parallel to the muscle fibers to simulate the orbicularis oris muscle. Furthermore, as the obturator portion of the device of Kozin can be used to hold open the lumen, the cell construct would necessarily be along the central longitudinal axis of the obturator component and the device can be oriented to place the muscle between the base portion and the cell construct during implantation. As the muscle fibers are parallel to the opening and the base portion extends from the obturator portion, it would have been obvious that the base portion could extend past the muscle fibers after implantation.
Regarding claim 42, the main difference between claim 1 and claim 42 is that the base portion is cylindrical and has a constant thickness and the obturator component is elliptical cylindrical with the first axis being a major axis of the ellipse. These additional claim limitations have been addressed above separately. As these are the only changes, the whole rejection for claim 1 is not repeated here. Instead, only the additional limitations are addressed here. As stated supra, although Kozin shows that their base portion and obturator are rectangular in Figure 11, Kozin teaches that other shapes can be used such as a tubular shape (i.e. cylindrical). The particular size and shape of the device can be altered to control the size and shape of the occluding prosthesis. For example, the size and shape can be based on a measurement of a particular dehiscence of an individual patient (paragraphs 0058 and 0104). As the shape is dependent on the shape of the patient’s defect, the obturator portion could be elliptical cylindrical and would have a first axis that is a major axis of the ellipse that would be perpendicular to the longitudinal axis and maintain a non-parallel relationship to the second axis. As can be seen in Figure 11, the base comprises a constant thickness that would also occur if the base was modified to be a cylindrical shape.
Furthermore, MPEP2144.04(IV)B states that in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Response to Arguments
Applicant's arguments filed February 2, 2026, are acknowledged.
Applicant argues that it would not have been obvious that the prosthetic would not be used such that Kuo's composite is between a planar surface of Kozin's semi-circular portion (interpreted by the Office as a base portion) and Kozin's handle 1102 (interpreted by the Office as an anchor portion). First, the only planar surfaces of Kozin's semi- circular portion are on its sides, which are neither perpendicular to a central longitudinal axis nor capable of cooperating with the handle 1102 such that a composite could be disposed therebetween. Second, Kozin discloses removal of its handle after placement and not continued use of the handle to participate in stabilization of a composite (page 15, paragraph 1).
Applicant's arguments have been fully considered but they are not persuasive.
As stated in the rejection above, Kozin does not teach a planar surface perpendicular to the central longitudinal axis as the base portion of their device has a curved surface that would be perpendicular rather than a planar surface. However, it would have been obvious to one of ordinary skill in the art that the shape of the base portion could be modified to use a planar surface, as was done with the anchor portion, instead of a curved surface as this change would represent a well understood design choice. Kozin does teach that the shape of their prosthetic devices can be formed in other shapes, such as a square, that would have planar surfaces (paragraph 0058). Furthermore, MPEP2144.04(IV)B states that in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Regarding removal of the handle, Kozin already teaches that their prosthetic device can be handled and manipulated by the placement handle 1102 until the occluding prosthesis 1100 is placed in a dehiscence. Once placed, a user can remove the placement handle 1102. Therefore, the handle portion can optionally be removed after placement. Furthermore, as Kozin already identifies that the placement handle can be removed within the dehiscence after placement, it would be well understood that the handle could, instead, be removed at the end of the development period to allow for easy removable of the prosthetic device once the construct is fully formed and ready for transplantation and limiting the damage to the PIPP flap during removal.
Claims 1 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Kuo et al. (J. C. Melville et al. (eds.), Regenerative Strategies for Maxillary and Mandibular Reconstruction: Chapter 6 Principles of Soft Tissue Engineering for Craniomaxillofacial Reconstruction. 53-70. 2019. Published March 2019), in view of United States Patent Application No. 20180116788 (Kozin) as applied to claim 1 above, and further in view of United States Patent Application No. 20200188090 (Zopf). This rejection is repeated in regards to the rejection in the Non-final Office action mailed on October 1, 2026. Applicant’s traversal has been addressed above.
The teachings of Kuo and Kozin are as discussed above.
The combined teachings of Kuo and Kozin do not teach wherein the obturator component comprises biocompatible silicone.
However, Zopf teaches implants for tissue reconstruction and that biocompatible silicone can be used during a multistage implantation process for a removable guard that serves as a placeholder for a first stage tissue scaffold to provide a precise shape upon removal and facilitates the precise fit of a second stage scaffold module (abstract and paragraph 0064).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used biocompatible silicone for constructing the obturator component to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to use biocompatible silicone with a reasonable expectation of success because Kuo and Kopf are using temporary implantation devices (obturator and removable guard, respectively) to maintain a specific shape in their tissue reconstruction composite. As Kopf teaches that their device is constructed of biocompatible silicone, it would be well understood that the obturator component of Kuo and Kozin could also be constructed of biocompatible silicone as they both perform similar functions and are removed as part of the tissue reconstruction methods. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Claims 1, 3, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Kuo et al. (J. C. Melville et al. (eds.), Regenerative Strategies for Maxillary and Mandibular Reconstruction: Chapter 6 Principles of Soft Tissue Engineering for Craniomaxillofacial Reconstruction. 53-70. 2019. Published March 2019), in view of United States Patent Application No. 20180116788 (Kozin) as applied to claims 1, 3, and 39 above, and further in view of United States Patent No. 9226736 (Obermiller). This rejection is repeated in regards to the rejection in the Non-final Office action mailed on October 1, 2026. Applicant’s traversal has been addressed above.
The teachings of Kuo and Kozin are as discussed above. Kozin teaches that once the occluding prosthesis is positioned, any commonly used tissue or bone adhesive or securing agent can be added to hold the prosthesis in place, such as synthetic collagen (paragraph 0093).
The combined teachings of Kuo and Kozin do not teach wherein a biocompatible sheet is disposed between the muscle and base portion nor between the cell construct and anchor portion.
However, Obermiller teaches treating a fistula opening by filling the opening with a layered volumetric construct. This construct can additionally include rolled remodelable material (i.e. a sheet) such as an collagenous extracellular matrix material to enhance the deployment and securement of the fistula plug within the hole.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of performing a PIPP flap of the combined teachings of Kuo and Kozin by coating the obturator component in a sheet of biocompatible collagenous extracellular matrix, as identified by Obermiller, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to combine with a reasonable expectation of success because the obturator component of Kuo and the volumetric construct of Obermiller are both inserted into holes (or lumen) and Obermiller teaches that the rolled remodelable material (i.e. a sheet) can be made of collagenous extracellular matrix material to enhance the deployment and securement of the fistula plug within the hole and Kozin teaches that their once positioned, their occluding device can include additional agents to secure it in place, which is the stated function of the rolled remodelable material of Obermiller. Therefore, it would have been obvious to modify the obturator component to include a coating of a rolled remodelable collagenous extracellular matrix material (a first biocompatible sheet) that can be performed before placing the obturator in the lumen to help secure the obturator in place during the development of the microvascular system at the donor site as the lumen would close if the obturator becomes dislodged. Furthermore, Kozin teaches that additional tissue or bone adhesive or securing agents can be added to hold the prosthesis in place once the occluding prosthesis is positioned. Therefore, a second biocompatible sheet could be used between the cell construct and the anchor portion after placing the obturator within the lumen to further secure it in place. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
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 KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
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/KEENAN A BATES/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
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