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 Amendment
The amendments made to claims 1, 2, 6, 7, 13, and 16-18 in the response filed 8/31/25 are acknowledged.
Claims 1-3, 6, 7, 9, 13, and 16-18 are now pending in the application and are examined below.
Response to Arguments
Applicant's arguments filed 8/31/25 have been fully considered but they are not persuasive.
Applicant’s argument (p. 7): “Watson discloses a mesh fabric comprising a plurality of layers of polymer plastic sheets that are sealed together, the sealing process creates the open channels within which microbeads are placed. The hexagonal aperture would be cut through the layers of the material after the Sealing process has been carried out. (column no. 8 line 1 to 9). Applicant submits that Watson orthopedic cast of mesh fabric cannot contain or hold liquid composition resin. However, Watson's orthopedic cast of mesh fabric comprising polymer plastic materials the web material created is pliable and formable around the limb of the patient, evacuation of the channels with an appropriate vacuum pump creates a rigid skeleton structure. As long as a negative pressure differential is maintained, rigidity of the Structure is maintained (column no. 8 line 10 to 21). Applicant submits that Watson fails to suggest or teaches a top layer [110] and a bottom layer [120], together forming a hollow tube [10], wherein the top layer [110] comprises ribs [110'] that interconnect with ribs [120'] of the bottom layer [120]”
Examiner’s response: Watson discloses an orthopaedic immobilizer 60 (figs. 5 and 6 and col. 1, lines 15-16) characterized by a top layer 69a and a bottom layer 69b, together forming a polygon hollow tube 64 (fig. 6 and col. 7, lines 45-52, sheets 69a/b are sealed to form interior channels 64, and the base of the bottom layer 69b is interpreted to be the bottom horizontal base of each hexagonal cross section), the top layer 69a includes ribs connecting with ribs of the bottom layer 69b (please see annotated fig. A, which shows the ribs of the top and bottom layers being the sloping sidewalls of the channels 64, in the same manner as Applicant’s ribs). The sealing of the sheets and the use of vacuum to create rigidity indicate that the top and bottom layers must be fully sealed together, which would be capable of holding a liquid resin.
Applicant’s argument (p. 7): “Lomakin's teachings of a separable, customizable kit actually teach away from the present invention, which eliminates user preparation by providing a fully integrated, pre-filled device. A person of ordinary skill in the art seeking the benefits of Lomakin would not be motivated to restructure it into a prefilled tube.”
Examiner’s response: Lomakin does not criticize or discredit the use of a pre-filled device, and actually states in [0004] that the composite of the invention may reduce time to achieve curing to mere minutes, making the device more adaptable to real life applications. Clearly, Lomakin encourages convenience and speed.
Applicant’s argument (p. 7): “Watson in view of Lomakin, and any other secondary references, fail to suggest a hollow tube (10) which is pre-filled with a liquid resin composition, wherein the tube is constructed from polysiloxane, and liquid resin composition starts curing after removing the wrapper that triggers a curing reaction in an orthopaedic immobilizer. Whereas, the present invention is a hollow tube (10) pre-filled with a liquid resin composition, wherein the tube is constructed from polysiloxane, and allows for curing of pre-filled liquid resin composition within the structure, which is not possible in Watson's and Lomakin's mesh fabric polymer plastic materials orthopedic cast design due to the thermal and mechanical limitations of its materials. Importantly, the use of polysiloxane enables pre-filling of the tube with resin.”
Examiner’s response: In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). See the rejection below for claim 1, which outlines how Watson, Lomakin, and Combs teaches the claimed limitations in combination.
Applicant’s argument (p. 8): “The applicant respectfully submits that the person of ordinary skill in the art would not have reasonably expected the observed advantages to result merely from substituting a conventional polymeric material with polysiloxane, particularly in applications involving a honeycomb or skeletal structural configuration. The Watson in view of Lomakin does not teach or suggest that such a substitution would inherently provide enhanced liquid resin retention within mesh fabric layers of a polymeric plastic sheet. The applicant respectfully submits that the mesh fabric of polymer sheets as disclosed in Watson lack the structural characteristics necessary to be formed into a hollow tubular configuration. Thus the polymer sheets typically do not possess elastic properties to conform effectively to anatomical contours, thereby limiting their applicability in body-conforming implementations.”
Examiner’s response: The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Further, Watson explicitly states in col. 8, lines 27-36 that the hardenable material can be a variety of compositions, and that the inventive aspect of the disclosure is the cellular geometry of the open mesh fabric and the larger apertures; therefore, one of ordinary skill in the art would have considered exploring other hardenable materials to replace to the beads.
Applicant’s argument (p. 8-9): “Applicant submits that there is no suggestion, teaching, or motivation in Watson in view of lomakin to utilize a removable layer to initiate a transformation of the immobilizer's properties (e.g., from flexible to rigid). Applicant submits that the methodology of web material created which is pliable and formable around the limb of the patient and evacuation of the channels with an appropriate vacuum pump as described in Watson does not teaches or discloses polysiloxane tube prefilled with liquid resin in the hollow tubes and liquid resin composition starts curing after removing the wrapper that triggers a curing reaction in an orthopaedic immobilizer.”
Examiner’s response: In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). However, Lomakin further teaches the curing process is initiated by a visible light source applied externally after removal of a protective layer ([0078], the photocurable composite (which includes its outer surface) may be packed in aluminum foil or otherwise light opaque bag to prevent ambient light from hardening the composition pre-use; thus, when the foil or opaque bag is removed, the resin would be cured by the ambient/visible light). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the immobilizer such that the curing process is initiated by a visible light source applied externally after removal of a protective layer, as taught by Lomakin, because substituting the beads with a resin that is hardenable by exposure to visible light would obviate the need for a vacuum pump to evacuate air from the device to harden the immobilizer; removing the immobilizer from an opaque bag to instantly cure the hardenable resin would be much easier to use, particularly in emergency settings.
Applicant’s argument (p. 10): “There is no teaching, suggestion, or motivation to modify Watson to incorporate a hollow tube (10) pre-filled with a liquid resin composition, wherein the tube is made of polysiloxane and permits curing of the pre-filled liquid resin composition within the structure. There is no reasoned explanation supported by evidence (as required by Arendi) that would lead a person of ordinary skill in the art (POSITA) to combine Watson and Lomakin in the manner required to arrive at the claimed invention. The claimed feature a curing process triggered a top and bottom layers forming a hollow tube pre-filled with a liquid resin composition, wherein the tube is made of polysiloxane a hollow tube (10) pre-filled with a liquid resin composition goes to the heart of the invention and represents precisely the type of missing limitation that requires evidentiary support, rather than mere conjecture or reliance on common sense.
Examiner’s response: It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Watson to incorporate a hollow tube (10) pre-filled with a liquid resin composition, wherein the tube is made of polysiloxane and permits curing of the pre-filled liquid resin composition within the structure, because silicone is a hypoallergenic material well-known for use in medical devices that are used on the body, and because substituting the beads with a resin that is hardenable by exposure to visible light would obviate the need for a vacuum pump to evacuate air from the device to harden the immobilizer; removing the immobilizer from an opaque bag to instantly cure the hardenable resin would be much easier to use, particularly in emergency settings; lastly, please note that Watson explicitly states in col. 8, lines 27-36 that the hardenable material can be a variety of compositions, and that the inventive aspect of the disclosure is the cellular geometry of the open mesh fabric and the larger apertures; therefore, one of ordinary skill in the art would have considered exploring other hardenable materials to replace to the beads.
Applicant’s argument (p. 10): “Applicant submits that the Watson in view of Lomakin discloses a product of hindsight reconstruction, wherein elements are selectively combined with knowledge of the Applicant's invention.”
Examiner’s response: In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant’s argument (p. 11): “Upon a thorough and careful review of Watson, it is evident that Watson does not disclose, teach, or suggest a hollow tube being prefilled. Nowhere in Watson is there any disclosure or implication that a structural hollow tube is prefilled with any material, nor does Watson provide any teaching or motivation that would lead a person of ordinary skill in the art (POSITA) to prefill a mesh fabric or polymer plastic sheet forming a polygonal structure prior to sealing or assembly.”
Examiner’s response: Watson states in col. 8, lines 1-5 that the beads are placed between the layers and then heat sealed, indicating that the device is pre-filled with the beads in the channels.
Applicant’s argument (p. 11-13): Applicant points out various differences between the present invention and Watson, such as the polysiloxane material with a top and bottom layer forming a tube, the tube being pre-filled with a composition of resin, a method for forming the hollow tube, polysiloxane material capable of forming to and fitting the body that is different from Watson’s material.
Examiner’s response: For the sake of avoiding redundancy, please refer to the body of the rejection below, which outlines how Watson in view of Lomakin and Combs teaches in combination the polysiloxane material with a top and bottom layer forming a tube, the tube being pre-filled with a composition of resin. Regarding the method, please note that the instant claims are drawn to a device, not a method. Regarding the polysiloxane, please note that Lomakin teaches a polysiloxanes orthopaedic immobilizer 100 ([0004], orthopedic casts and splints; fig. 1 shows sheath 150 over light-curable material 110; [0083], the sheath can be made of silicone, which is a polysiloxane).
Applicant’s argument (p. 14): Applicant states again how Watson fails to disclose the polysiloxane immobilizer as claimed with top and bottom layers and ribs forming a hollow tube, and pre-filled with the curable liquid resin.
Examiner’s response: For the sake of avoiding redundancy, please refer to the body of the rejection below, which outlines how Watson in view of Lomakin and Combs teaches in combination the polysiloxane material with a top and bottom layer and ribs forming a tube, the tube being pre-filled with a composition of resin.
Applicant’s argument (p. 15): Claims 2 and 3 are not disclosed by Watson, Lomakin, and Combs, because one of ordinary skill in the art would not have been motivated to combine them in a manner that yields the claimed sequence of claim 2, and because the prior art does not disclose any thermal protection.
Examiner’s response: It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the top layer of Watson to be a polysiloxane material such that the orthopaedic immobilizer is a polysiloxanes orthopaedic immobilizer, and to have modified the hardenable composition of Watson to be a composition of resin; b. the composition of resin is configured to be cured in a curing process with exposure of visible light having wavelength of 400-470nm after peeling off a protective layer; c. the protective layer is wrapped around the top layer to prevent the composition from curing, as taught by Lomakin, because silicone is a hypoallergenic material well-known for use in medical devices that are used on the body, and because substituting the beads with a resin that is hardenable by exposure to visible light would obviate the need for a vacuum pump to evacuate air from the device to harden the immobilizer; removing the immobilizer from an opaque bag to instantly cure the hardenable resin would be much easier to use, particularly in emergency settings; lastly, please note that Watson explicitly states in col. 8, lines 27-36 that the hardenable material can be a variety of compositions, and that the inventive aspect of the disclosure is the cellular geometry of the open mesh fabric and the larger apertures; therefore, one of ordinary skill in the art would have considered exploring other hardenable materials to replace to the beads. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the contact layer of Watson in view of Lomakin to be a foam layer to protect the skin against heat generation during the curing process, as taught by Combs, to provide a padded effect and increase comfort. Please note the foam of Combs would be capable of providing protection against heat by forming a barrier.
Applicant’s argument (p. 15): “Watson in view of Lomakin, does not teach or suggest a pre-filled cavity containing a curable resin, particularly not a matrix. Watson relies entirely on temporary mechanical stabilization via vacuum pressure, with no chemical curing or permanent transformation involved. Watson specifically discloses that rigidity is lost upon the loss of vacuum pressure (see col. 8, lines 1-20), which underscores the temporary and reversible nature of the structural rigidity. The present invention achieves permanent rigidity through curing of pre-filled liquid resin composition in polysiloxane tube, resulting in a solidified internal structure via irreversible chemical transformation. Watson in view of Lomakin rely on physical deformation or air evacuation to maintain shape, which is inherently reversible. Thus, the fundamental mechanisms by which rigidity is achieved differ significantly. This difference in function (chemical vs. mechanical) and result (permanent vs. temporary rigidity) leads to a patentably distinct structure.”
Examiner’s response: Watson in view of Lomakin teach in combination the polygon hollow tube 64 consisting of a cavity (fig. 6 of Watson, inner cavity of hexagonal tube 64) wherein the composition of resin is pre-filled before being configured to be applied to a fractured limb (Watson further discloses in col. 8, lines 1-20 that the tube 64 is pre-filled with beads; as previously modified by Lomakin, the beads are replaced by a resin composition), because substituting the beads with a resin that is hardenable by exposure to visible light would obviate the need for a vacuum pump to evacuate air from the device to harden the immobilizer. The physical combination of Watson and Lomakin thus results in the claimed invention and function. As stated above, please note Watson contemplates the beads being a different form of hardenable composition, which has been subsequently taught by Lomakin.
Applicant’s argument (p. 16): “Watson discloses a device made from polymer sheeting (plastic) materials (e.g., polymer sheeting 69a and 69b), which are sealed to create internal channels for microbeads. But the Watson does not discloses a top layer [110] and a bottom layer [120], together forming a hollow tube [10], wherein the top layer [110] comprises ribs [110'] that interconnect with ribs [120'] of the bottom layer [120]. The construction allow containment of beads, the material used (plastic) inherently lacks the elasticity, stretchability, and temperature resistance disclosed in the present invention. Notably: Applicant submits that the plastics used in Watson are non-elastic and become brittle under mechanical deformation. They are unable to conform to varying anatomical shapes in a reusable or stretchable manner. Furthermore, such plastics tend to degrade or fail under repeated heating or curing cycles, rendering them unsuitable for applications requiring thermoforming and flexibility. The applicants respectfully submits that the , Watson's reliance on plastic materials would teach away from using flexible, stretchable elastomers. Attempting to stretch or form-fit Watson's plastic components would result in material failure. Applicant submit that one of ordinary skill would not be motivated to substitute plastic with highly elastic materials without hindsight.”
Examiner’s response: In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Lomakin has been provided to teach modification of the hardenable composition (beads to cured resin) and outer material (polysiloxanes). Further, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, since Watson already contemplates a different hardenable composition, one of ordinary skill in the art would understand that variation in outer shell material may be necessary. Watson explicitly states in col. 8, lines 27-36 that the hardenable material can be a variety of compositions, and thus the inventive aspect of the disclosure is the cellular geometry of the open mesh fabric and the larger apertures; therefore, one of ordinary skill in the art would have considered exploring other hardenable materials and accommodating outer materials.
Applicant’s argument (p. 17): “In response of the claim 16, the present invention discloses the immobilizer further comprises an apparatus comprising a locking mechanism that is integrally or detachably connected to the top layer (110) and bottom layer (120), said apparatus being configured to fasten the immobilizer (100) when wrapping around body parts, but Lomakin does not disclose or suggest any mechanism being connected directly to both the top and bottom layers of the immobilizer as claimed.”
Examiner’s response: Lomakin teaches an apparatus comprising a locking mechanism which fastens said apparatus when wrapping around body parts ([0074], the composite can be used with buckles or Velcro, which can both be considered locking mechanisms to fit the device around the patient). The claim requires the fastening mechanism to be operatively coupled to the immobilizer, not specifically directly connected to both the top and bottom layers of the immobilizer.
Applicant’s argument (p. 17): “In response of claim 17, the present invention discloses an immobilizer (100) that is both pre-fabricated and stretchable due to its elasticity, allowing it to conform to varying sizes and contours of a body part. This stretchable nature enables enhanced fit, comfort, and functionality during immobilization of a limb or other body part. The stretchability and elasticity are critical to the invention's performance and are central to the novelty of the claimed subject matter. Applicants submit that, even if one were to combine the teachings of Watson with those of other references, the essential characteristics of elasticity, stretchability, and adaptive fitting disclosed in the present application would neither be suggested nor rendered obvious to a person of ordinary skill in the art. The prior art provides no motivation to replace Watson's rigid plastic sheets with an elastic, stretchable material, nor does it teach or suggest that such a modification would result in the functional advantages claimed.”
Examiner’s response: While Watson in view of Lomakin further in view of Combs is silent on the immobilizer being stretchable due to elasticity, and because of the elasticity the immobilizer can fit on to variable sizes and contours of a body part, Rind teaches an analogous immobilizer 10 (fig. 1 and col. 1, lines 7-9) being stretchable due to elasticity, and because of the elasticity the immobilizer 10 can fit on to variable sizes and contours of a body part (col. 4, lines 20-30, the network-like device before hardening can be stretched in either the horizontal or vertical direction to conform to a body part). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the immobilizer of Watson in view of Lomakin further in view of Combs to be stretchable due to elasticity, and because of the elasticity the immobilizer can fit on to variable sizes and contours of a body part, as taught by Rind, so that the immobilizer can be used on a variety of body parts where necessary.
Claim Objections
Claims 1, 2, 6, 9, and 16 are objected to because of the following informalities:
“by;” in claim 1, line 4 should be amended to recite –by:--
“prevents” in claim 1, line 13 should be amended to recite –prevent—
“v. the top layer [110] comprises ribs [110’] connecting with ribs [120’] of the bottom layer [120]” in claim 1, lines 14-15 should be deleted from the claim
“reduce” in claim 1, line 20 should be amended to recite –to reduce—
“to the skin against heat” in claim 1, line 20 should be amended to recite –to the skin from heat—
“provides” in claim 1, line 22 should be amended to recite –provide—
“is initiated” in claim 2, line 1 should be amended to recite –is configured to be initiated—
“a protective” in claim 2, line 3 should be amended to recite –the protective—
“the uniform dispersion” in claim 6, line 3 should be amended to recite –uniform dispersion—
“to inhabits is configured to prevents” in claim 6, line 5 should be amended to recite –to prevent—
“cushioning it from the skin against a hard shell” in claim 9, lines 4-5 should be amended to recite –cushioning the skin against a hard shell—
“fasteing” in claim 16, line 2 should be amended to recite –fastening—
Appropriate correction is required.
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 6 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.
Regarding claim 6, the claim recites the limitation “the cavities” in line 4. There is insufficient antecedent basis for this limitation in the claim.
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) 1-3, 6, 7, 9, 13, 16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson US 6,673,029 B1 in view of Lomakin et al. US 2018/0126029 A1 further in view of Combs US 2017/0209293 A1.
Regarding claim 1, Watson discloses an orthopaedic immobilizer 60 (figs. 5 and 6 and col. 1, lines 15-16) comprising
a top layer 69a and a bottom layer 69b, together forming a hollow tube 64 (fig. 6 and col. 7, lines 45-52, sheets 69a/b are sealed to form interior channels 64, and the base of the bottom layer 69b is interpreted to be the bottom horizontal base of each hexagonal cross section), characterized by:
the top layer 69a includes ribs connecting with ribs of the bottom layer 69b (please see annotated fig. A below, which shows the ribs of the top and bottom layers being the sloping sidewalls of the channels 64, in the same manner as Applicant’s ribs);
the hollow tube 64 pre-filled with a hardenable composition 68 (fig. 6 and col. 8, lines 1-20);
the top layer 69a comprises ribs connecting with ribs of the bottom layer 69b;
the ribs of the bottom layer 69b connect with the ribs of the top layer 69a (please see annotated fig. A below, which shows the ribs of the top and bottom layers being the sloping sidewalls of the channels 64, in the same manner as Applicant’s ribs);
a contact layer 72 is attached to the bottom layer 69b (fig. 6 and col. 8, lines 20-25);
wherein, the hollow tube 64 is configured to provide a point of contact between the skin and the immobilizer (annotated fig. A, where the downwardly protruding nature of the hollow tube 64 provides a point of contact between the skin and the contact layer 72 of the immobilizer 60).
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Watson is silent on the orthopaedic immobilizer being a polysiloxanes orthopaedic immobilizer; wherein the hardenable composition is a composition of resin; iii. the composition of resin is configured to be cured in a curing process with exposure of visible light having wavelength of 400-470nm after peeling off a protective layer; iv. the protective layer is wrapped around the top layer to prevent the composition from curing.
However, Lomakin teaches a polysiloxanes orthopaedic immobilizer 100 ([0004], orthopedic casts and splints; fig. 1 shows sheath 150 over light-curable material 110; [0083], the sheath can be made of silicone, which is a polysiloxane); wherein the hardenable composition is a composition of resin 110 (fig. 1 and [0092], light-curable resin 110 goes from a first conformable state to a cured or hardened state); iii. the composition of resin 110 is configured to be cured in a curing process with exposure of visible light having wavelength of 400-470nm ([0068], the light-curable resin may polymerize upon exposure to light with a wavelength from 280 to 700 nm) after peeling off a protective layer; iv. the protective layer is wrapped around the top layer 150 to prevent the composition of resin from curing ([0078], the photocurable composite, which is provided with top layer/sheath 150 as shown in fig. 1, may be packed in aluminum foil or otherwise light opaque bag to prevent ambient light from hardening the composition pre-use; thus, when the foil or opaque bag is removed, the resin would be cured by the ambient/visible light).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the top layer of Watson to be a polysiloxane material such that the orthopaedic immobilizer is a polysiloxanes orthopaedic immobilizer, and to have modified the hardenable composition of Watson to be a composition of resin; iii. the composition of resin is configured to be cured in a curing process with exposure of visible light having wavelength of 400-470nm after peeling off a protective layer; iv. the protective layer is wrapped around the top layer to prevent the composition from curing, as taught by Lomakin, because silicone is a hypoallergenic material well-known for use in medical devices that are used on the body, and because substituting the beads with a resin that is hardenable by exposure to visible light would obviate the need for a vacuum pump to evacuate air from the device to harden the immobilizer; removing the immobilizer from an opaque bag to instantly cure the hardenable resin would be much easier to use, particularly in emergency settings; lastly, please note that Watson explicitly states in col. 8, lines 27-36 that the hardenable material can be a variety of compositions, and that the inventive aspect of the disclosure is the cellular geometry of the open mesh fabric and the larger apertures; therefore, one of ordinary skill in the art would have considered exploring other hardenable materials to replace to the beads.
Watson in view of Lomakin is silent on the contact layer being a foam layer configured to reduce heat transfer to the skin against heat generating during the curing process.
However, Combs teaches an analogous contact layer 12 for a splint 10 (fig. 6 and [0032], sleeve 12 of splint 10) being a foam layer configured to reduce heat transfer to the skin against heat generating during the curing process ([0032], the sleeve 12 can be foam; therefore, since the contact layer of Watson in view of Lomakin lines the immobilizer having a curable resin, when the contact layer is modified to be foam, as taught by Combs, it would be capable of reducing heat transfer by forming a barrier).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the contact layer of Watson in view of Lomakin to be a foam layer configured to reduce heat transfer to the skin against heat generating during the curing process, as taught by Combs, to provide a padded effect and increase comfort.
Regarding claim 2, Watson in view of Lomakin further in view of Combs discloses the claimed invention as discussed above.
Watson is silent on the curing process being initiated by a visible light source applied externally after removal of a protective layer.
However, Lomakin further teaches the curing process being initiated by a visible light source applied externally after removal of a protective layer ([0078], the photocurable composite (which includes its outer surface) may be packed in aluminum foil or otherwise light opaque bag to prevent ambient light from hardening the composition pre-use; thus, when the foil or opaque bag is removed, the resin would be cured by the ambient/visible light).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the immobilizer of Watson in view of Lomakin further in view of Combs such that the curing process being initiated by a visible light source applied externally after removal of a protective layer, as taught by Lomakin, because substituting the beads with a resin that is hardenable by exposure to visible light would obviate the need for a vacuum pump to evacuate air from the device to harden the immobilizer; removing the immobilizer from an opaque bag to instantly cure the hardenable resin would be much easier to use, particularly in emergency settings.
Regarding claim 3, Watson in view of Lomakin further in view of Combs discloses the claimed invention as discussed above.
Watson in view of Lomakin further in view of Combs teaches in combination the foam layer being configured to protect the skin against heat generation during polymerization of the composition of resin (Watson discloses the contact layer, Lomakin has been provided to teach the curable resin composition, and Combs has been provided to modify the contact layer to be foam; therefore, in combination, these references teach the foam contact layer forming a protective barrier between the skin and any heat generation), in order to protect the skin of the patient.
Regarding claim 6, Watson in view of Lomakin further in view of Combs discloses the claimed invention as discussed above.
Watson further discloses the hollow tube 64 being further configured to optimize the uniform dispersion of both visible light distribution, and viscous fluid distribution within the cavities during the curing process (fig. 6, the sloping sidewalls formed by the hexagonal tubes 64 allows more light and fluid (as shown by the “AIR FLOW” arrow) to transmit through the intervening apertures 70 and would thus be capable of optimizing uniform dispersion of light) and structurally arranged to prevent direct contact of the skin and the immobilizer 60 (fig. 6, due to the downwardly protruding nature of hexagonal tubes 64 and the intervening apertures 70, there is no direct contact of the skin and the immobilizer where the tubes 64 slope away from the skin; please see annotated fig. A).
Regarding claim 7, Watson in view of Lomakin further in view of Combs discloses the claimed invention as discussed above.
Watson in view of Lomakin teach in combination the hollow tube 64 consisting of a cavity (fig. 6 of Watson, inner cavity of hexagonal tube 64) wherein the composition of resin is pre-filled before being configured to be applied to a fractured limb (Watson further discloses in col. 8, lines 1-20 that the tube 64 is pre-filled with beads; as previously modified by Lomakin, the beads are replaced by a resin composition), because substituting the beads with a resin that is hardenable by exposure to visible light would obviate the need for a vacuum pump to evacuate air from the device to harden the immobilizer.
Regarding claim 9, Watson in view of Lomakin further in view of Combs discloses the claimed invention as discussed above.
Watson in view of Lomakin further in view of Combs further teaches in combination the foam layer being a padding layer 12 made up of closed cell synthetic elastomer ([0032] of Combs, sleeve 12 can be made of closed-cell foam such as neoprene or polyurethane and may include an elastomer) which gives insulation from exothermic heat produced during the curing process and further adapted to protect the skin by being configured to cushion it from the skin against a hard shell formed by the resin after curing (since the contact layer of Watson in view of Lomakin lines the immobilizer having a curable resin, when the contact layer is modified to be closed cell synthetic elastomer foam, as taught by Combs, it would be capable of protecting the skin against any exothermic heat and would cushion the skin), to provide a padded effect and increase comfort.
Regarding claim 13, Watson in view of Lomakin further in view of Combs discloses the claimed invention as discussed above.
Watson further discloses the immobilizer structure 60 being structurally arranged in a matrix form (figs. 5 and 6, hexagonal apertures 70 and hexagonal tubes 64 form a matrix of polygons).
Regarding claim 16, Watson in view of Lomakin further in view of Combs discloses the claimed invention as discussed above.
Watson is silent on an apparatus comprising a locking mechanism and fastening mechanism operatively coupled to the orthopedic immobilizer which fastens said apparatus when wrapping around body parts.
However, Lomakin further teaches an apparatus comprising a locking mechanism and fastening mechanism operatively coupled to the orthopedic immobilizer which fastens said apparatus when wrapping around body parts ([0074], the composite can be used with buckles; as known in the art, a buckle requires two components to be secured together, and one can be considered the locking mechanism while the other can be considered the fastening mechanism, to fit the device around the patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the immobilizer of Watson in view of Lomakin further in view of Combs with an apparatus comprising a locking mechanism and fastening mechanism operatively coupled to the orthopedic immobilizer which fastens said apparatus when wrapping around body parts, as taught by Lomakin, “to aid in device conformability to the injury or patient and/or better fit” ([0074]).
Regarding claim 18, Watson in view of Lomakin further in view of Combs discloses the claimed invention as discussed above.
Watson further discloses the immobilizer comprising a matrix structure configured to admit air to the skin and allow sweat to evaporate (fig. 6 shows air flow through the hexagonal/polygonal aperture 70, which is located within the overall matrix/scaffolding of the honeycomb-channeled device, which would admit air to the skin and allow sweat to evaporate).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson US 6,673,029 B1 in view of Lomakin et al. US 2018/0126029 A1 further in view of Combs US 2017/0209293 A1 and Rind US 4,483,332.
Regarding claim 17, Watson in view of Lomakin further in view of Combs discloses the claimed invention as discussed above.
Watson further discloses the immobilizer 60 being prefabricated (col. 8, lines 1-20, the channels 62 are prefilled with beads).
Watson in view of Lomakin further in view of Combs is silent on the immobilizer being stretchable due to elasticity, and because of the elasticity the immobilizer can fit on to variable sizes and contours of a body part.
However, Rind teaches an analogous immobilizer 10 (fig. 1 and col. 1, lines 7-9) being stretchable due to elasticity, and because of the elasticity the immobilizer 10 can fit on to variable sizes and contours of a body part (col. 4, lines 20-30, the network-like device before hardening can be stretched in either the horizontal or vertical direction to conform to a body part).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the immobilizer of Watson in view of Lomakin further in view of Combs to be stretchable due to elasticity, and because of the elasticity the immobilizer can fit on to variable sizes and contours of a body part, as taught by Rind, so that the immobilizer can be used on a variety of body parts where necessary.
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.
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/MICHELLE J LEE/Primary Examiner, Art Unit 3786
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