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 . Claims 1-25 are pending and examined below.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the following:
-100, 101, & 103 in Fig. 1D
-106, 108, & 110 in Fig. 1E
-150, 152, 154, & 166 in Fig. 1F
-40, 42, & 44 in Figs. 4A-4C
-50, 52, 54, & 56 in Figs. 5A-5C
-60, 62, 64, 66, 68, 70, 72, 74, 80, & 82 in Figs. 7A-7D
-100 & 102 in Fig. 8A
as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because
-reference character “72” has been used to designate both handheld printer and catheter or syringe in Figs. 1H and 1I
- reference character “92” has been used to designate both hydrogels and solid structure in Figs. 2G and 2H.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
-40, 42, & 44 in Fig. 1D
-50, 52, & 54 in Fig. 1E
-60, 62, 64, & 66 in Fig. 1F
-88 in Fig. 3C.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-25 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.
Claim 1 recites the limitation “the microparticles ” in line 5. It is unclear if this is the same or different from “hydrogel microparticles” from line 3. For the purpose of examination, they are regarded as the same.
Claim 4 recites the limitation “the microparticles ” in line 2. It is unclear if this is the same or different from “a catheter, syringe” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 5 recites the limitation “the microparticles” in line 1. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 5 recites the limitation “a syringe or catheter” in lines 1- 2. It is unclear if this is the same or different from “a catheter, syringe” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 5 recites the limitation “a support or encapsulating structure” in lines 2-3. It is unclear if this is the same or different from “a support or encapsulating structure” from claim 4 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 5 recites the limitation “a support or encapsulating structure” in lines 1-2 and 3. It is unclear how the microparticles are extruded with “a support or encapsulating structure” through a syringe into another one of “a support or encapsulating structure”.
Claim 6 recites the limitation “microparticle” in line 1. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 6 recites the limitation “the defect” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation “the microparticles” in line 3. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 7 recites the limitation “the microparticles” in lines 1 & 3. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 8 recites the limitation “the microparticles” in line 1. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 8 recites the limitation “ a three-dimensional viscoelastic hydrogel microparticle matrix” in line 3. It is unclear if this is the same or different from “a viscoelastic hydrogel microparticle three-dimensional material” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 9 recites the limitation “the gel microparticles” in line 1. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 10 recites the limitation “the microparticles” in line 1. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 11 recites the limitation “the gel microparticles” in line 1. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 12 recites the limitation “the microparticles” in line 1. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 12 recites the limitation “the passage” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the vagina or rectum or urethra” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation “the microparticles” in line 1. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 15 recites the limitation “microparticles” in lines 1 & 2. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 18 recites the limitation “microparticles” in line 4. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 18 recites the limitation “ a catheter” in line 2. It is unclear if this is the same or different from “a catheter” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 19 recites the limitation “the microparticles” in line 1. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 20 recites the limitation “microparticles” in line 2. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 20 recites the limitation “syringe” in line 2. It is unclear if this is the same or different from “syringe” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 21 recites the limitation “a sterile syringe” in line 1. It is unclear if this is the same or different from “syringe” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 21 recites the limitation “a catheter” in lines 1-2. It is unclear if this is the same or different from “a catheter” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 22 recites the limitation “a catheter” in line 1. It is unclear if this is the same or different from “syringe” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 23 recites the limitation “microparticles” in line 1. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 24 recites the limitation “the tip” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation “a catheter” in line 2. It is unclear if this is the same or different from “a catheter” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 25 recites the limitation “a syringe” in line 3. It is unclear if this is the same or different from “syringe” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Claim 25 recites the limitation “the microparticles” in line 3 and “gel microparticles” in line 9. It is unclear if this is the same or different from “hydrogel microparticles” from claim 1 from which it depends. For the purpose of examination, they are regarded as the same.
Regarding claims 10, 13, 22 & 23, the phrase "such as" 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).
All dependent claims are likewise rejected as they depend from claim 1.
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-15, 18, & 20-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wallace et al. (US 6063061 A) hereinafter, Wallace.
Regarding claim 1, Wallace teaches
a minimally invasive method of creating a tissue filler, occluding agent, or tissue seal in a site in a patient in need thereof (Figs. 1-3B, filler for tissue voids, col. 2 line 9) comprising administering into the site (Figs. 1-3B) a suspension of biocompatible hydrogel microparticles between about ten and 1000 microns in diameter (0.01 mm-1.5 mm, col. 3 line 62) using a catheter, syringe, or ink printer type device (10, Fig. 1) to apply the microparticles to form a viscoelastic hydrogel microparticle three-dimensional material at the site (Figs. 1-3B, col. 7, lines 7-9).
Regarding claim 2, Wallace teaches
wherein the hydrogel microparticles have a diameter of between about 10 and 100 microns (0.01 mm-1.5 mm, col. 3 line 62).
Regarding claim 3, Wallace teaches
further comprising crosslinking or sealing with a tissue adhesive the three-dimensional material (col. 3 lines 27-29).
Regarding claim 4, Wallace teaches
further comprising providing a support (patch, Fig. 2B, col. 13 lines 18-29) or encapsulating structure, preferably a surgical mesh, fabric, membrane, synthetic or biological matrix, at the time of implantation, prior to, with, or after administration of the microparticles (patch, Fig. 2B, col. 13 lines 18-29).
Regarding claim 7, Wallace teaches
wherein the microparticles are injected with force applied by gravity or applied pressure, preferably between 0.2 and 5 PSI (since the syringe is manually pressed, it is inherent that the average hand could produce between 0.2 and 5 PSI, col. 7 lines 60-63), preferably wherein the microparticles suspension is in an unjammed state and subsequently stabilizes or self-assembles into a solid-like structure (col. 8 lines 5-9).
Regarding claim 8, Wallace teaches
comprising administering the microparticles into a tissue defect, tissue tear, tissue lumen, appendage/outpouching or diseased tissue to form a three-dimensional viscoelastic hydrogel microparticle matrix (Figs. 1-3B).
Regarding claim 9, Wallace teaches
comprising injecting the gel microparticles into cardiac anatomical features to form a three-dimensional structure occluding the left atrial appendage or repairing ventricular or atrial septal defect (heart, col. 13, lines 63-67).
Regarding claim 10, Wallace teaches
wherein the microparticles are administered to a vein or artery to fill or occlude a site to repair a vascular defect, such as a cerebral, aortic or peripheral aneurysm (blood vessels, vascular organs, and the like, col. 13, lines 63-67).
Regarding claim 11, Wallace teaches
comprising injecting the gel microparticles to repair a post surgical or obstetrical defect (Fig. 1, col. 13 lines 1-7).
Regarding claim 12, Wallace teaches
wherein the microparticles are administered to form blockages to the passage of urine and fecal matter between the vagina or rectum or urethra (Fig. 3, col. 1 lines 18-23 & col. 13 lines 1-7).
Regarding claim 13, Wallace teaches
wherein the microparticles are used to form a peri-device occlusion to prevent leakage post implantation of devices such as occluder devices, valves, stents, and flow diverters (Fig. 1, col. 1 lines 18-23 & col. 13 lines 1-7).
Regarding claim 14, Wallace teaches
wherein the leaks are associated with endovascular coils, endovascular plugs, or transcatheter aortic valve implantation (heart, col. 13, lines 63-67).
Regarding claim 15, Wallace teaches
wherein microparticles are administered to form a homogenous structure, or a heterogeneous structure wherein microparticles having different composition and/or size are interspersed and/or layered (col. 5 lines 1-11).
Regarding claim 18, Wallace teaches
comprising administering hydrogel microparticles using a catheter or cystoscope, optionally wherein the catheter is a multi-lumen catheter with multiple ports for attaching syringes (col. 17 lines 2-5) or vials of microparticles/bioagents/sealants, wherein the catheter includes optic fibers in the catheter for delivering light, catheters including balloons on an end of the catheter for stabilization, or catheters including a suction device at an end for ensuring stabilization on tissue.
Regarding claim 20, Wallace teaches
a kit for use in the method of claim 1 comprising a vial or syringe containing microparticles either in suspension or lyophilized for resuspension, typically with sterile water (Fig. 4, col. 13 lines 42-62).
Regarding claim 21, Wallace teaches
comprising a sterile syringe for attachment to a catheter (Fig. 4, col. 13 lines 42-62).
Regarding claim 22, Wallace teaches
further comprising a catheter/delivery tool, optionally comprising effector ends such as a nozzle, needle, mesh, or means for dispensing sealant (col. 17 lines 2-5).
Regarding claim 23, Wallace teaches
comprising microparticles with different attributes such as size, shape, and mechanics, depending on the target application (col. 5 lines 1-11).
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) 5 & 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace in view of Mundahl et al. (US 20210282882 A1) hereinafter, Mundahl.
Regarding claim 5, Wallace does not teach the microparticles are extruded with a support or encapsulating structure through a syringe or catheter.
However, Mundahl teaches hydrogel-securing structures that comprise anchoring element that is configured to anchor the structure to bodily tissue and a hydrogel-retaining element that is configured to retain a hydrogel mass (abstract, Mundahl)
wherein the microparticles are extruded with a support (110b, Fig. 11A, Mundahl) or encapsulating structure through a syringe or catheter (120, Fig. 11A, Mundahl) or into the site to be treated containing a support or encapsulating structure (¶0083, Mundahl).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wallace by incorporating the teaching above as taught by Mundahl in order to maintain the position of the hydrogel relative to the pancreas (or other anchoring tissue) (¶0083, Mundahl).
Regarding claim 24, Wallace does not teach a distensible boundary encapsulating structure. However, Mundahl teaches
comprising a distensible boundary encapsulating structure (110b, Fig. 11A, Mundahl), optionally pre-loaded in the tip of a catheter (120, Fig. 11B, Mundahl).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wallace by incorporating the teaching above as taught by Mundahl in order to maintain the position of the hydrogel relative to the pancreas (or other anchoring tissue) (¶0083, Mundahl).
Regarding claim 25, Wallace teaches
a method of administering the materials in the kits of claim 20 (Fig. 4, Wallace), comprising
providing a syringe (90, Fig. 4, Wallace) containing the microparticles in a suspension (col. 13 lines 42-48, Wallace),
attaching the syringe to a catheter (col. 17 lines 3-4, Wallace),
navigating the catheter tip to the target site (col. 16 lines 63-67 & col. 17 lines 1-8, Wallace),
extruding the required amount of material for occlusion (col. 13 lines 14-15, Wallace), and
withdrawing the catheter and execute a self-sealing mechanism to close the mesh and prevent gel microparticles escape (Fig. 2B, Wallace),
preferably wherein the self- sealing mechanism is a patch, a sealant, a photopolymerization step, or a drawstring (Fig. 2B, Wallace).
Wallace does not teach confirming with fluoroscopy. However, Mundahl teaches
preferably confirming with fluoroscopy (radiopaque properties, ¶0064, Mundahl).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wallace by incorporating the teaching above as taught by Mundahl in order to allow operators to adjust treatment plans to better locate the disease and better prevent adverse events (¶0064, Mundahl).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace in view of Mundahl and further in view of Griffin et al. (US 20160279283 A1) hereinafter, Griffin.
Regarding claim 6, Wallace teaches
wherein the mesh size prevents microparticle escape (patch in Fig. 2B, Wallace). Wallace does not teach tissue integration. However, Griffin teaches a microporous gel system to form a covalently-stabilized scaffold where cells are able to quickly infiltrate the interstitial spaces of the assembled scaffold (abstract, Griffin)
wherein the mesh (10, Fig. 11, Griffin) size may allow tissue integration (¶0169, Griffin), resulting in stabilization of the defect as cells infiltrate, using the microparticles and mesh as scaffold to form tissue to permanently repair the defect or occlude the structure (Fig. 11, ¶0169, Griffin).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wallace in view of Mundahl by incorporating the teaching above as taught by Griffin in order to grow, stimulate, and ultimately effectuate the healing process of the tissue (¶0169, Griffin).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace in view of Griffin.
Regarding claim 16, Wallace does not teach interstitial spacing. However, Griffin teaches
wherein the microparticle matrix has sufficient interstitial spacing to allow cells (106, Fig. 2C, Griffin) to migrate into the matrix to form tissue (¶0169, Griffin).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wallace by incorporating the teaching above as taught by Griffin in order to grow, stimulate, and ultimately effectuate the healing process of the tissue (¶0169, Griffin).
Regarding claim 17, Wallace does not teach dispersing light. However, Griffin teaches
comprising stabilizing the hydrogel microparticles by dispersing light through a light diffusing fiber tip to the top of the hydrogel microparticle structure to polymerize the gel (124, Fig. 11, ¶0169).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wallace by incorporating the teaching above as taught by Griffin in order to anneal the microgel (abstract, Griffin).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace in view of Farha et al. (US 20230355832 A1) hereinafter, Farha.
Regarding claim 19, Wallace does not teach an external magnetically driven catheter. However, Farha teaches embolization of a blood vessel in a body, wherein at least one gelling component is biocompatible, biodegradable, with radiopaque capability and in liquid form to be supplied to a blood vessel by means of a single or multi lumen microcatheter (abstract, Farha)
wherein the microparticles are administered using an external magnetically driven catheter (22, Fig. 4A-F, ¶0083 & 0088, Farha).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wallace by incorporating the teaching above as taught by Farha in order to improve control and reduces the risk of inadvertent injury to bystander structures (¶0082, Farha).
Conclusion
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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774