DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Election/Restriction
Applicant’s election without traverse of Group II, claims 47-55, type I collagen, and gelatin in the reply filed on 27 March 2026, is acknowledged.
Status of Claims
Claims 1-3, 5, 9, 12-16, 21, and 47-55 are pending in the instant Office Action.
Claims 1-3, 5, 9, 12-16, and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 March 2026.
Claims 47-55 are under consideration in the instant Office Action, to the extent of the following elected species:
the specific one or more polymerizable monomers are type I collagen and
the specific sacrificial polymerizable scaffold is gelatin.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 28 December 2023, and 17 July 2025, were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim 50 is 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 50 recites the apparatus of claim 47, “further comprising a motor configured to rotate the inner cylinder”. However, claim 47 already recites the inner cylinder as being “configured to be rotated by a motor” in line 2. It is unclear in what respect the motor of claim 50 differs from, or adds to, the motor already required by claim 47. It is not clear whether claim 50 is attempting to require the explicit inclusion of the motor as a structural element of the claimed apparatus (when claim 47 only requires the inner cylinder to be configured for rotation by a motor) or merely recites the same motor already required by claim 47. As a result, the metes and bounds of claim 50 cannot be determined with reasonable certainty and the claim is indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 50 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 50 recites the apparatus of claim 47, “further comprising a motor configured to rotate the inner cylinder”. However, claim 47 already recites the inner cylinder as being “configured to be rotated by a motor” in line 2. Because the motor is already required by claim 47, claim 50 does not introduce any additional structural or functional limitation and merely restates, in slightly different words, a feature already present in claim 47. A dependent claim must specify a further limitation of the subject matter claimed; merely repeating an element or limitation already recited in the parent base claim does not further limit the base claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 47-54 are rejected under 35 U.S.C. 103 as being unpatentable over Paukshto et al. (WIPO International Patent Publication No. WO 2010/019625 A2, published on 18 February 2010, provided by Applicant in the IDS filed on 28 December 2023, hereafter referred to as Paukshto) in view of Deer et al. (U.S. Patent No. 4,878,379 A, published on 7 November 1989, hereafter referred to as Hart).
Paukshto teaches structures comprising biopolymer and biocomposite materials and methods of their production (Abstract). In some embodiments, the structures are collagen-based (para. [0017]), including the specific species collagen I (para. [0085]). In some embodiments, Paukshto teaches the use of shearing force, created by a flow through a narrow gap, on a collagen solution to produce a collagen biomaterial layer (para. [0025], [0086], and [0088]). The narrow gap may be created by an apparatus containing two parallel plates (para. [0025]) or concentric cylinders (para. [0088]). In the embodiment that the apparatus uses cylinders, Paukshto teaches that a hollow cylinder may have positioned within a solid cylindrical mandrel, forming a “shearing gap” which can create the biopolymeric material when under the force of high pressure and is considered to make the apparatus “configured to apply shear flow to a liquid” as recited in instant claim 48 (para. [0088]).
The shearing gap is taught to be capable of fine adjustment, with the sides being parallel (para. [0025]) or slightly tapered (para. [0088]). The description of the apparatus containing parallel, concentric cylinders is considered equivalent to the uniformity recited in instant claim 49. Paukshto further teaches that the mandrel may be axially displaced with respect to the hollow cylinder and may have a different rotational velocity, which is interpreted as equivalent to being capable of independently rotating as recited in instant claim 47, “perpendicularly movable” as recited in instant claim 51, and capable of removal as recited in instant claim 53 (para. [0088]). Finally, Paukshto teaches that materials suitable for use in their method include glass and stainless steel (para. [0086]).
Paukshto does not teach their production apparatus to comprise a motor to rotate the inner cylindrical mandrel nor a base attached to the outer cylinder. These deficiencies are offset by the teachings of Deer.
Deer teaches a rheometer comprising movable shearing elements (Abstract). Their invention is focused upon devices with “relatively displaceable elements…for subjecting an intervening sample of material to shear forces, and more particularly to so-called rotation rheometers in which the relative displacement of the elements is rotational” (col. 1, lines 18-23). Figure 1 depicts one embodiment of the rheometer, which utilizes a base to provide stability and is connected to the lower shearing element (col. 6, lines 6-22). Figure 1 further depicts an electric motor which can be used to control the torque applied to a spindle, which subsequently spins (col. 6, lines 23-36). Finally, Deer teaches that other forms of shearing elements can be used in the device, including concentric cylinders as depicted in Figure 5 (col. 6, lines 48-50).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Deer with the invention of Paukshto because the use of a known technique to improve a similar device in the same way yields predictable results. Paukshto teaches a device for producing structures from biomaterials which comprises concentric cylinders, with one taught to be a mandrel, that are independently rotatable, may move with respect to each other, apply shear force to flowing liquid, and may be made from stainless steel. Paukshto is silent with respect to the method in which the cylinders are rotated and the device outside of the two cylinders. In view of the teachings of Deer, one of ordinary skill would be motivated to use a motor to rotate the inner mandrel because Deer teaches the use of a motor to be suitable when rotating concentric cylinders to generate a shear force. In addition, the ordinary artisan would be motivated to connect the lower cylinder to a base for support because Paukshto is silent regarding stability of the device and Deer teaches the use of a base to connect the individual parts of the device and provide stability, which an ordinary artisan would recognize as useful. As a result, there is a reasonable expectation of success in arriving at the invention of claims 47-54 in view of the teachings of Paukshto and Deer.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Paukshto (WIPO International Patent Publication No. WO 2010/019625 A2, published on 18 February 2010, provided by Applicant in the IDS filed on 28 December 2023) in view of Deer (U.S. Patent No. 4,878,379 A, published on 7 November 1989) as applied to claims 47-54 above, and further in view of Mónico et al. (J. Fluid Mech. 2014, 747, 1., hereafter referred to as Mónico).
Paukshto and Deer are described above, and particularly relevant to claim 55, Paukshto teaches that the flow conditions in their invention may be Couette, Taylor-Couette, and/or plane or axisymmetric Poiseuille flow (para. [0047] and [0088]).
Paukshto and Deer do not teach the ratio of the diameters of the concentric cylinders. This deficiency is offset by the teachings of Mónico.
Mónico teaches an analysis of optimal Taylor-Couette (TC) flow as a function of radius ratios (Abstract). TC flow is defined as the flow between two coaxial cylinders which are independently rotating, as depicted in Figure 1 (pg. 1-2, Introduction, para. 1). The radius ratio, represented by h in the teachings of Mónico, is defined as the radius of the inner cylinder (ri ) divided by the ratio of the outer cylinder (ro) (i.e., ri / ro) (pg. 2, Introduction, para. 3). Mónico teaches that optimal transport in TC flow is dependent on the radius ratio h, with previous studies reporting that optimal transport occurs in the range of h=0.5-0.714, but little data was available outside of that range (pg. 3, para. 3 - pg. 4, para. 1). The range of h=0.5-0.714 corresponds to a ratio of the outer cylinder to the inner cylinder of 2:1 to 1.4:1 for both the radius and diameter, given that the diameter is equal to twice the value of the radius, which falls within the range recited in instant claim 55.
Through experiments and direct numerical simulations, Mónico concluded that optimal transport occurs at “smaller gaps, i.e., for larger h” and that at the largest gap tested (h=0.5) transitions in flow topology meant suboptimal flow (pg. 25, Summary and conclusions). With the caveat that further research is needed for h<0.5 and that a balance between Coriolis forces and inertia terms must be made, Mónico concluded that their findings were consistent with previous research that optimal transport occurs in the range of h=0.5-0.714.
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). These guidelines apply to the range of ratios between cylinder diameters, as the range taught by Mónico falls within the range recited in instant claim 55.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Mónico with the invention rendered obvious by the teachings of Paukshto and Deer because the combination of a prior art elements from similar devices according to known methods yields predictable results. Paukshto and Deer rendered obvious a device for producing structures from biomaterials which comprises concentric cylinders, with one taught to be a mandrel that may be driven by a motor, that are independently rotatable, may move with respect to each other, apply shear force to flowing liquid, may be made from stainless steel, and with a lower cylinder that is connected to a base for support. Paukshto and Deer are silent on the ratio of diameters of spinning concentric cylinders. In view of the teachings of Mónico, one of ordinary skill would be motivated to use a ratio of ri / ro (h) of 0.5-0.714, which is equivalent to 2:1 to 1.4:1, because it provides missing information that the ordinary artisan would need to complete the invention of Paukshto and Deer. In addition, Mónico teaches this ratio of radii to provide optimal flow of fluids through the concentric cylinders, which a person of ordinary skill would recognize as desirable. As a result, there is a reasonable expectation of success in arriving at the invention of instant claim 55 in view of the teachings of Paukshto and Deer and further in view of the teachings of Mónico.
Conclusion
No claims are allowed.
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/S.J.S./
Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
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