DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-17 of U.S. Patent No. 10,507,333. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 10,507,333 discloses a species that anticipates the current genus claims.
The claims map as follows:
For present claims 21 and 22, claim 1 of US 10,507,333 discloses all elements (the runners, nodes, electromagnets with micro-coils, runners containing conductors/wires, and a controller). The patent further recites additional specifics about each component thus making the patent claims a species that anticipates the present genus claim.
For present claim 23, claim 3 of US 10,507,333 recites the same limitation.
For present claim 24, claim 4 of US 10,507,333 recites the same limitation.
For present claim 25, claim 5 of US 10,507,333 recites the same limitation.
For present claim 26, claim 6 of US 10,507,333 recites the same limitation.
For present claim 27, claim 7 of US 10,507,333 recites the same limitation.
For present claim 28, claim 8 of US 10,507,333 recites a species that contains the same limitations specified in the present claim.
For present claim 29, claim 9 of US 10,507,333 recites a species that contains the same limitations specified in the present claim.
For present claim 30, claim 10 of US 10,507,333 recites a species that contains the same limitations specified in the present claim. While claim 10 of the patent does not recite the limitations “where the duty cycle comprises…completely off”, this is merely the definition of duty cycle and its application to the coils, which naturally already be present in the patent.
For present claim 31, claim 11 of US 10,507,333 recites a species that contains the same limitations specified in the present claim.
For present claim 32, claim 12 of US 10,507,333 recites a species that contains the same limitations specified in the present claim.
For present claim 33, claim 13 of US 10,507,333 recites a species that contains the same limitations specified in the present claim.
For present claim 34, claim 14 of US 10,507,333 recites the same steps and limitations specified in the present claim (the providing, positioning, controlling, and directing steps). Claim 14 of the patent further recites additional specifics about each step thus making the patent claims a species that anticipates the present genus claim.
For present claim 35, claim 15 of US 10,507,333 recites the same limitations.
For present claim 36, claim 16 of US 10,507,333 recites the same limitations. Claim 16 of the patent further recites additional specifics about each step thus making the patent claims a species that anticipates the present genus claim.
For present claims 37, claim 17 of US 10,507,333 discloses the same steps and limitations specified in the present claim (the providing, interconnecting, selecting, and embedding steps). Claim 17 of the patent further recites additional specifics about each step thus making the patent claims a species that anticipates the present genus claim.
For present claim 38, claim 17 discloses the runners being used as sides and the electromagnets being used as vertices in the web, which would requires the arranging step, thus making the claim 17 anticipate the present genus claim.
For present claim 39, claim 19 of US 10,507,333 recites the same limitations, though worded in a more specific manner, thus making it a species that anticipates the present genus claim.
For present claim 40, claim 20 of US 10,507,333 recites the same limitations, though the present claim recites the term “pre-determined” in front of the pulsing regimen. However, without knowing specifics, any chosen pulsing regimen can be considered as pre-determined.
Claim 21-22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18 of U.S. Patent No. 9,498,639. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 9,498,639 discloses a species that anticipates the current genus claims.
For present claims 21 and 22, claim 18 of US 9,498,639 discloses all elements (the runners, nodes, electromagnets with micro-coils, runners containing conductors/wires, and a controller). The patent further recites additional specifics about each component thus making the patent claims a species that anticipates the present genus claim.
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,844,956. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 11,844,956 discloses a species that anticipates the current genus claims.
For present claim 21, claim 1 of US 11,844,956 discloses all elements (the runners, nodes, electromagnets with micro-coils, and runners containing conductors). The patent further recites additional specifics about each component thus making it a species that anticipates the present genus claim.
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11,213,692. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 11,213,692 discloses a species that anticipates the current genus claim.
For present claim 21, all elements (the runners, nodes, electromagnets with micro-coils, and runners containing conductors) are disclosed by claim 11 of US 11,213,692. The patent recites additional specifics that are not present in the present claim which makes it a species that anticipates the present genus claim.
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 24-33, 36, and 39 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.
Claim 24 recites the limitation "the placing" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 25-27 inherit the deficiencies of claim 24 and are likewise rejected.
Claim 28 recites the limitation "the plurality of micro-coils" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It also cannot be determined which micro-coils are being referred to.
Claim 30 recites the limitation "the percentage" in line 3 and “the total time” in line 4. There is insufficient antecedent basis for these limitations in the claim
Claim 33 recites the limitation “a subject” in line 2. It is not clear if this is a new instance or refers to the subject in line 3 of claim 32.
Claim 36 recites the limitation "the corresponding at least one flat surfaces" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 39 recites the limitation "a body to which applied" in line 3. This appears to be missing text which renders the meaning unclear.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21-22, 34, 35, and 37-38 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US 5,344,384 (Ostrow et al., hereinafter Ostrow).
In regards to claims 21-22, “web” is being defined as a complicated arrangement or pattern of things as defined by Merriam-Webster’s online dictionary. Ostrow discloses an arrangement with the following components in figures 1-6 and describes the components in column 3, line 29-column 6, line 8:
runners (element 30);
nodes interconnected by the runners (element 38);
electromagnets embedded in the nodes, each electromagnet comprising a coil (element 42 can be considered as a micro-coil) wrapped around a core (element 32); and
a controller (element 24 of figure 1).
As shown in figures 1 and 3, the runners are flexible to move in three dimensions to conform the web to an arbitrary shape conformal to a portion of the body. The cores in the electromagnets act as a flux guide due to their natural ability to focus magnetic flux and would define a central axis for each electromagnet. As shown in figures 4 and 6, wires are embedded within the runners to form interconnections between the nodes that can activate the electromagnets. In addition, another set of wires (element 38) is present and also connects the nodes. As shown in figure 1, the controller is connected to the nodes and is effective to dose an exposure of a portion of the body to a pulsed electromagnetic field, flux guided by the cores by activating the micro-coils (column 4, line 33 – column 5, line 19).
In regards to claims 34, 35, and 37-38, “web” is being defined as a complicated arrangement or pattern of things as defined by Merriam-Webster’s online dictionary. Ostrow discloses providing a system of electromagnets with the following components in figures 1-6 and describes the components in column 3, line 29-column 6, line 8:
runners (element 30);
nodes interconnected by the runners (element 38);
electromagnets embedded in the nodes, each electromagnet comprising a coil (element 42) wrapped around a core (element 32); and
a controller (element 24 of figure 1).
As shown in figures 1 and 3, the runners are flexible to move in three dimensions and are positioned in a web to an arbitrary shape conformal to a portion of the body. The positions shown on figure 1 would have required selecting a portion of a body, with the portion defining a treatment surface and positioning the nodes proximate the surface by forming the web in a n arbitrary shape conformal to the portion of the body. The cores in the electromagnets act as a flux guide due to their natural ability to focus magnetic flux and would a define a central axis for each electromagnet with the central axis of each coil being pointed directly at the at least one of a body and a member. As shown in figures 4 and 6, wires (which are conductors) are embedded within the runners to form interconnections between the nodes that can activate the electromagnets. In addition, another set of wires (element 38) is present and also connects the nodes. As shown in figure 1, the controller is connected to the nodes and would be positioned between a source of power and the power connection and controls the activation of the electromagnets to exposure of a portion of the body to a pulsed electromagnetic field, and directs a concentrated magnetic flux from each core by activating the micro-coils in a pre-determined pulsing regimen (column 4, line 33 – column 5, line 19). In addition, as noted in the figures of Ostrow, the nodes and runners form a plurality of polygons. As shown in figure 3 below, the polygon has legs formed by a preselected number of runners and vertices formed by the nodes corresponding to the polygon, and the runners corresponding to those nodes. This can also be considered as arranging the runners as sides and the electromagnets as nodes acting as vertices in the web.
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Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 23-31 and 36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 5,344,384 (Ostrow et al.) as applied to claims 1 and 15 above, and further in view of US 6,132,362 (Tepper et al., hereinafter Tepper).
In regards to claim 23, Ostrow and Tepper disclose the limitations of claim 22. In addition, as shown in the figures of Ostrow, the nodes comprise at least one substantially flat surface.
In regards to claim 24, Ostrow and Tepper disclose the limitations of claim 23. In addition, Ostrow mentions that the runners are bendable (column 3, lines 39-51) which would effect the placing of the nodes proximate a surface of the portion of the body.
In regards to claim 25, Ostrow and Tepper disclose the limitations of claim 24, but do not explicitly state that the nodes and runners are homogenously molded. However, unless a structural limitation is provided by the process limitation, patentability of product-by-process claims are based on the product itself (see MPEP 2113[R-1]). Therefore, since it appears that the process does not limit the claims in terms of structure, Ostrow discloses the nodes and runners (see claim 1 above), which meets the limitations recited in the instant claim.
In regards to claim 26 and 27, Ostrow and Tepper disclose the limitations of claim 25. In addition, as noted in the figures of Ostrow, the nodes and runners form a plurality of polygons. As shown in figure 3 below, the polygon has sides formed by a preselected number of runners and vertices formed by the nodes corresponding to the polygon, and the runners corresponding to those nodes.
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In regards to claims 28 and 29, Ostrow and Tepper disclose the limitations of claim 21. In addition. As shown by Ostrow in column 4, line 33- column 5, line 39, the controller delivers power to the coils and automatically controls and provides a dosing regimen with a pulse frequency preferably at 16 Hz. While Ostrow does not explicitly show an operator interface to control the dosing, the presence of a switch to turn the device on or off is usually present as noted by Tepper in figure 5B, which can be considered an operator interface to control the dosing. As such it would have been obvious to one of ordinary skill in the art to integrate a power switch into the device of Ostrow as taught by Tepper in order to turn the device on or off.
In regards to claim 30, Ostrow and Tepper disclose the limitations of claim 29. In addition, Ostrow shows that operation of a duty cycle (column 5, lines 28-36) that falls within the range specified in claim 30, thus meeting the limitations of the claim.
In regards to claim 31, Ostrow and Tepper disclose the limitations of claim 28. In addition, the limitation of claim 31 is directed to the intended use of the controller. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regards to claim 36, Ostrow discloses the limitations of claim 35. As noted in the rejection of claim 35 above, Ostrow also discloses the limitations specified in regards to the central axis and the controller. In the figures of Ostrow, the nodes and runners form a plurality of polygons with the nodes comprising at least one substantially flat surface. In addition, as shown in figure 3 below, the polygon has sides formed by a preselected number of runners and vertices formed by the nodes corresponding to the polygon, and the runners corresponding to those nodes.
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In addition, Ostrow mentions that the runners are bendable (column 3, lines 39-51) and shows them being bent on a human patient in figure 1, which would effect the placing of the nodes and their corresponding substantially flat surface that is proximate and effectively at least one of parallel and tangent to the surface of the portion of the body. Ostrow teaches the limitations of claim 15, but does not explicitly state that the web is formed of an elastomeric polymer. Tepper teaches a PEMF design that uses an elastomeric polymer, polyurethane in this case, and states that the elastomer allows for bendability while maintain a selected degree of rigidity (column 4, lines 56-column 6, line 24). In addition, polyurethane is a synthetic material. Thus, it would have been obvious to one of ordinary skill in the art at the time the invention was made to use a synthetic elastomeric polymer as taught by Tepper in the web in the method of Ostrow in order to allow for bendability while maintaining a degree of rigidity. Ostrow and Tepper do not explicitly state that the nodes and runners are homogenously molded. However, unless a structural limitation is provided by the process limitation, patentability of product-by-process claims are based on the product itself (see MPEP 2113[R-1]). Therefore, since it appears that the process does not limit the claims in terms of structure, Ostrow discloses the nodes and runners (see claim 1 above), which meets the limitations recited in the instant claim.
Claim 32 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 5,344,384 (Ostrow et al.) as applied to claim 31 above, and further in view of US 2005/0124846 (Pasula).
In regards to claim 32, Ostrow discloses the limitations of claim 31 but does not state that the apparatus comprises a bed positioned with the web. Pasula discloses an electromagnetic treatment system and discloses incorporating it into a bed (paragraph 28). Pasula shows in figure 1 and 2 a bed with the magnetic field generating element located below the supporting surface. Pasula further states advantages in paragraph 35 such as allowing for treatment while without suffering harmful effects and for treatment to occur while sleeping. Thus, it would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the device of Ostrow into a bed as taught by Pasula in order to allow for treatment while sleeping.
Claim 33 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 5,344,384 (Ostrow et al.) in view of US 2005/0124846 (Pasula) as applied to claim 32 above, and further in view of US 5,554,835 (Newham).
In regards to claim 33, Ostrow and Pasula disclose the limitations of claim 32. Pasula does disclose the presence of a switch to turn coils or off (paragraph 33). However, neither Ostrow nor Pasula not state the presence of a switch positioned proximate the web at a location effective to be responsive to a subject weighting the web. Newham teaches a pressure switch as a way to detect the presence of user on a bed by completing a circuit in the presence of extra weight (see figure 2; column 1, lines 6-12, column 4 lines 1-20). As such, it would be obvious for one of ordinary skill in the art at the time the invention was made to modify the circuit of Pasula that has a switch by using the sensor that detects breaks in the circuit with the pressure sensor taught by Newham as the on/off switch for the device in order to detect the presence of a user on a bed for electromagnetic therapy.
Claims 39-40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 5,344,384 (Ostrow et al.).
In regards to claim 39, Ostrow discloses arbitrarily shaping and positioning the nodes with the central axes embedded therein directed directly into at least one of a body and a member of a body to which a magnetic flux is applied.
In regards to claim 40, Ostrow discloses the limitations of claim 39. In addition, Ostrow discloses that the controller is connected to the nodes and would be positioned between a source of power and the power connection and controls the activation of the electromagnets to exposure of a portion of the body to a pulsed electromagnetic field, and directs a concentrated magnetic flux from each core by activating the micro-coils in a pre-determined pulsing regimen (column 4, line 33 – column 5, line 19).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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