DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 3/5/26 have been fully considered but they are not persuasive. Applicant argues the prior art does not teach the use of tessellation of polyhedral for producing branch vessel architecture. However, again as mentioned previously the examiner was conveying that using 3D printing techniques such as a tessellation of polyhedral was known and Billiet was just an example. The rejection was a combination and Miller taught the intended product of a first vessel architecture and a second vessel architecture that are each tubular and branching; wherein the first and second vessel architectures are fluidically independent from each other in a hydrogel as this was not disputed. So a prima facie case of obviousness was established as one can use intuitive understanding as both Miller and Billiet are high level teachings such that one can form the resulting structure as a possible result. Thus, the applicant provided no evidence the final product was not different but only that the process of manufacture, since a product by process recitation was being used. The burden is on the applicant to show some distinctness of the resulting product of which no evidence has been presented. However, more importantly to the amendment, the deletion of the “product-by-process” limitation to make the claim now require the tessellation of polyhedral is ambiguous because it appears this “device” is an intermediate state because according to the specification the faces and vertices of the tessellation of polyhedral are removed to then result in the final product of the hydrogel with the first and second architectures with branched tubular structures therein. Therefore, the claim is indefinite as to what is the device an intermediate developing structure? Or the final apparatus, which would not have the tessellation of polyhedral, correct? There appears to be contradictions of scope between a final product produced by a potential process and an intended device or formation structure. One cannot claim both. Further, Applicant is advised to make clear the intent because a generic or nondescriptive preamble is unclear. Thus, Applicant is warned that if now switching to an intermediate product, the claims will be withdrawn by original presentation for changing the claimed invention during prosecution. SEE MPEP 821.03 and also 806.05.
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 1-27, 84-90 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-27, 84-90 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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. Evidence that claims 1 fail(s) to correspond in scope with that which the inventor or a joint inventor, or for pre-AIA applications the applicant regards as the invention can be found in the replies filed 8/13/25 and 3/5/26. In that paper, the inventor or a joint inventor, or for pre-AIA applications the applicant has stated “branch vessel architecture within a hydrogel” are formed from a tessellation of polyhedra, and this statement indicates that the invention is different from what is defined in the claim(s) because the claim(s) 1 now require the product or device to include a “tessellation of polyhedral” whereas it was argued to be used with production. Thus, before the claim did not necessarily require the tessellation of polyhedral to be present but used to produce which than can change in the manufacture completion of the final product. Applicant’s own specification states in numerous paragraphs (8, 59, 86, 111, 120, 146) the first vascular component of the model can comprises removing the faces and/or the vertices of the polyhedra, and using the remaining topology as a vascular skeleton. Thus, what is the “DEVICE” of the preamble of the claims a final product or now an intermediate state?
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,2,4-12,15-27,88-90 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (2018/0002658) in view of Billiet et al. (2011/0200478) as evidenced by Borenstein et al. (2002/0182241). Miller et al. disclose a device comprising a hydrogel matrix including a photoabsorber, paragraphs 8-12. Fig. 5shows a void architecture in the matrix having a first vessel architecture and a second vessel architecture that are each tubular and branching with the first and second vessel architectures are fluidically independent from each other. It is noted that Miller et al. disclose (paragraph 96) that space filling model is used within the hydrogel matrix with two fluid channels separate formed. It is also noted that there can be structures formed that are fractal space filling structures that fill a plane without leaving gaps. Since Miller et al. disclose the same product of a hydrogel with the photoabsorber and voids, it is fully capable of being formed from other 3D printing processes. It is noted, Miller was silent as to a device with a tessellation of polyhedral that could produce the branched vessel architecture. Billiet et al. teach (abstract) that implants can be formed of foamed products. Billiet et al. further teach (paragraph 72) that the space filling foam product can be a tessellation of polyhedra. It would have been obvious to one of ordinary skill in the art to use a device that has a tessellation of polyhedra as taught by Billiet et al. to produce within a hydrogel matrix of Miller et al. a branched structure resulting with a stable, uniform, foam model defining the branching vessel architectures, see Billiet. It is noted that Billiet teaches (paragraphs 30,34,95) end desired configuration can be constructed by removal of material of the tessellation of polyhedra. Borenstein et al. additionally state (paragraphs 84,85) it is known that sacrificial casting or removal of material results in structures within a scaffold, to create vascular structure or branched architecture. Therefore per the modification of 3D printing disclosed by Miller and using tessellations of polyhedral taught by Billiet, one can produce the claimed first vessel architecture and a second vessel architecture that are each tubular and branching with the first and second vessel architectures are fluidically independent from each other as intended to be the final product of Miller and Borenstein further provide evidence that removal of material suggested by Billiet is not an unpredictable structure that couldn’t be produced. With respect to claim 2, Miller et al. did not detail the specificity of visible light allowed to pass on the device when imaging, but did state devices can be imaged to view functionality of the device, paragraphs 115,116. It would have been obvious to one of ordinary skill in the art to allow 90% of visible light incident on the device to pass through and allow imaging of the device disclosed by Miller et al. because any implanted structure in a patient must sufficiently function/replace the natural lumen anatomy and flow capabilities, thus it is an obvious expedient to assure the device is fully imageable. With respect to claims 4-6, Miller et al. discloses (See paragraphs 62,71) a photoabsorber and since the light- absorbing additives are considered indistinguishable from the recited photoabsorber, the photoabsorber can reasonably be considered degradable independent of any degradation of the remaining hydrogel matrix. In addition, it can reasonably be construed that as a result of how the combined additives work with the photoabsorber, the photoabsorber is capable of being degradable by chemical or physical processes, see again paragraphs 62,71. Further itis also reasonable to consider the photoabsorber as photobleachable, or removable by boiling as the light absorbing additives disclosed by Miller are considered indistinguishable from the photoabsorber. Plus since the claimed photoabsorber is disclosed and at the same level of scope as claimed, a composition and its properties are inseparable, thus the photoabsorber possesses the same properties as claimed. Regarding claim 7, Miller et al. disclose (paragraphs 77,95) the void architecture is multi-vascular and comprise a torus entangled with a torus knot, Fig. 5. Regarding claim 8, Billiet teaches (paragraph 72) the tessellation of polyhedra is a Weaire-Phelan space filling foam model of two dodecahedron and six tetrakaidecahedron cells. With respect to claim 9, Miller discloses (paragraph 5) blood vessels can be designed using the modeling. Regarding claim 10, Miller discloses (paragraph 89) the architecture is a tessellation model of an airway, Fig. 5. With respect to claims 11,12,15 Miller further disclose a multivascular and functional valve and capable of being positioned at any position in the void structure, paragraph 78. Regarding claim 16, it can be construed the matrix is monolithic structure as it is one unit, Fig. 5. Regarding claim 17, Miller discloses (paragraphs 8,60,61) the hydrogel matrix is photopolymerizable. With respect to claim 18, Miller discloses (paragraphs 8,11,80) various technology use to provide an additive manufacturing process to produce the device. Regarding claim 19, it can be construed the first and second vessel architectures are entangled, see Figs. 5,10. With respect to claim 21, Miller discloses (paragraphs 51,53,73) the device can be porous. Regarding claim 22, Miller discloses the device can be implantable, paragraph 67. With respect to claim 20, as best understood, Miller discloses (paragraph 79) there can be multiple or additional vessel architectures and are coupled, thus they can be construed to be ensheathed or considered as multiple joined subunits. Regarding claims 23,24 Miller discloses (paragraphs 60,71) a photoabsorber such as tartrazine, yellow food coloring, riboflavin, phenol red, can be selected as an additive. Further since the additives are the same as claimed the photoabsorber is hydrophilic. With respect to claims 25, 26 Miller discloses (paragraphs 62,71) a photoabsorber such as Curcumin, turmeric, alpha carotene, beta carotene, saffron can be selected as an additive. Further since the additives are the same as claimed the photoabsorber is hydrophobic. With respect to claim 27, Miller et al. did not detail the device being constructed with three or more architectures fluidically independent from each other and from the first and second vessel architectures. It is noted that Miller does disclose the device can be constructed with three or more architectures, paragraph 79 and that variations can be made. In addition Miller et al. disclose a manufacturing process indistinguishable from the manufacture of the claimed device and thus the manufacture of the device of Miller is capable of producing three or more vessel architectures fluidically independent from each other and from the first and second vessel architectures. It would have been obvious to one of ordinary skill in the art using desired specifications for the patient per analytic modeling one is capable of discovering the optimal design such that one can select three or more vessel architectures fluidically independent from each other and from the first and second vessel architectures involving only routine skill in the art. With respect to claim 88, Miller discloses (abstract) the device is used for tissue replacement. It would have been obvious to one of ordinary skill in the art to provide the tissue repair device matrix with tubular architectures of Miller as modified with Billiet and implant in the tissue site needing repair such as lungs, see Miller paragraph 64. Regarding claim 89, Miller discloses (paragraph 64) multiple networks are used or what can be construed as subunits. Regarding claim 90, Miller did disclose the use of a thickener, paragraph 68. In addition Miller discloses (paragraph 68) xanthan gum can be used in the hydrogel matrix, but did not disclose the concentration. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the composition of Miller including the xanthan gum to include a concentration of 0.02 wt% to 2 wt% because where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable composition comprising a thickener to prevent settling, such that the xanthan gum used in the Miller hydrogel matrix is obvious to modify its concentration as it only involves routine skill in the art to thereby produce a suitable scaffold matrix for cell regenerative reconstruction.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (2018/0002658) in view of Billiet et al. (20110200478) as evidenced by Borenstein as applied to claim 1 above, and further in view of Garcia et al. (Smart-pH-responsive antimicrobial hydrogel scaffolds..). Miller et al. in view of Billiet et al. is explained supra. However, Miller as modified by Billiet did not explicitly disclose the photoabsorber has been at least partially washed out of the device. Garcia teaches (page 3) the photoabsorber has been at least partially washed out of the device. It would have been obvious to one of ordinary skill in the art to have the photoabsorber washed out of the device as taught by Garcia with the device of Miller as modified by Billiet such that the material is removed after it served its purpose in formation of the device.
Claim(s) 13,84,85,87 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (2018/0002658) in view of Billiet et al. (20110200478) as evidenced by Borenstein as applied to claim 1 above, and further in view of Houston et al. (EP 1314406). Miller et al. in view of Billiet et al. is explained supra. However, Miller as modified by Billiet did not explicitly disclose including a fluidic static mixer. Houston et al. teach (paragraph 5) vessel architectures that are tubular (Fig. 1) can include a fluidic static mixer 2 to effect flow therein. It would have been obvious to one of ordinary skill in the art to utilize a fluidic static mixer as taught by Houston et al. with the vessel architecture of Miller et al. as modified by Billiet et al. such that it improves flow therethrough, paragraph 30 of Houston. Regarding claim 84, it would have been an obvious expedient to use the photoabsorber with the fluid static mixer incorporated in the tubular vessel architectures of Miller as the fluid passes therethrough when perfusing, see Miller paragraph 12 to assure when formed it allows the lumens to fully formed. Regarding claim 85, Miller discloses (paragraph 60) the use of tartrazine is selected for components due to its advantage of controlling extent of gelation of prepolymerization mixture by impacting the gelation kinetics and final gel rheological properties. With respect to claim 87, Miller discloses components are made by additive manufacturing, paragraph 8.
Allowable Subject Matter
Claims 14, 86 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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 BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4756. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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