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 .
Drawings
The drawings are objected to because of the following reasons:
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the inflatable air bladder must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings (in particular, Figures 1, 2A-B, 3A, 3C, 3B, 4A-D, 9A-C) use shading, which has not aided in understanding the invention and hinders the quality of the drawings (see 1.84(m) in the MPEP).
Further, the drawings use writing to describe the elements in each Figure. The writing should be replaced with reference characters for legibility purposes (see 1.84(I) in MPEP). Further, reference characters are not included in the Figures to notate specific elements that are pertinent to the Claims (see 1.84(p) in MPEP).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Applicant is advised that should claim 6 be found allowable, claim 7 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 5 and 8 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 5 recites the limitation “helmet shell is configured to fit the head of a human subject of approximately 2 months to approximately 24 months old”. It is unclear what the metes and bounds are of the shell is configured to fit a specific age range as the size of a human head varies even within an age range. For purposes of examination, the limitation will be construed as the helmet fitting a size of approximately 35 cm to 55 cm. However, further clarification is required.
Claim 8 recites the limitation “the helmet shell is configured to fit a head shape characterized by normocephaly, brachycephaly, plagiocephaly, scaphocephaly,trigonocephaly, asymmetrical ears, or any combination thereof. It is unclear what the metes and bounds are of the shape configured to fit a specific characterization of a head shape and how this is determined. For purposes of examination, the limitation will be construed as a helmet shell that is fitted to a head prior, which would fit any head shape. However, further clarification is required.
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.
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 1, 3, 5-13 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Shah (US20210015427A1) in view of Ono (US20160015552A1).
Regarding Claim 1,
Shah teaches a helmet system, comprising:
a helmet shell configured to fit the head of a human subject (corresponding disclosure in at least [0014], where the helmet is customized to fit any patient head “The interior surface of the inner shell is customized to fit the precise shape and form of each patient's head and may be a rigid or semi-rigid in form, while the outer shell may be flexible, semi-rigid or rigid, fitting over the inner shell and used for a patient with any head size or shape”, the inner and outer shell being construed to being the “helmet shell” as the two in combination make up the helmet shell [0014] “With this two-shell design, helmet preparation time is greatly minimized by allowing the inner shell to be easily replaced and mated to the outer shell” );
at least one sensor housing unit, configured to hold a magnetoencephalography field sensor (corresponding disclosure in at least [0036], where there are openings to receive the sensor “ the inner shell 201 may be fabricated with one or more openings 204A to receive sensors 203, and/or reduce weight or create ventilation for the head of the patient” and further in [0018], where the housing holds the magnetoencephalography field sensor (OPM) “The number of the sensors can vary as well. In addition to OPM sensors, the helmet may also accommodate other sensors, such as electroencephalogram (EEG) electrodes, functional near infrared spectroscopy (fNIRS) sensors, accelerometers or gyroscopes for example”);
and a plurality of openings disposed in the helmet shell, wherein at least two individual openings of the plurality of openings are configured to receive and securely fit the sensor housing unit (corresponding disclosure in at least [0047] and Figure 8, where there are a plurality of openings, where the opening receives a sensor “The outer shell maintains the position of the sensors, allowing them to slide and lock onto the inner shell through the outer shell openings 204B into the inner shell openings 204A”).
Shah does not specify the helmet shell weighing approximately 450 grams or less.
Ono, in a similar field of endeavor, teaches a similar concept (helmets, wearable device) of a helmet shell weighing approximately 450 grams or less (corresponding disclosure in at least [0031], where the weight of the helmet is 63 g “The average diameter of the opening in the upper surface of the shell was about 90 mm, and 82 of the through-holes with a diameter of 11.0 mm were formed in the shell. The Shore D hardness of the shell was 77, the relative density of the shell was 95%, and the total weight of the shell was 63.0 g”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a helmet shell weighting 450 g or less as taught by Ono. One of the ordinary skill in the art would have been motivated to incorporate this because a lightweight helmet ensures comfortability for the user when it’s worn during procedures.
Regarding Claim 3, Shah and Ono teach the limitations of Claim 1, and Ono further teaches wherein the helmet shell has a thickness of approximately 1 mm to approximately 6 mm (corresponding disclosure in at least [0027], where the helmet portion has a thickness between 1-6 mm “The thickness of the shell 4, except the thick-walled reinforcing portion 18, may be of the order of 2 to 4 mm.”)
Regarding Claim 5, Shah and Ono teach the limitations of Claim 1, and Shah further teaches wherein the helmet shell is configured to fit the head of a human subject of approximately 2 months to approximately 24 months old (corresponding disclosure in at least [0014], where the helmet fits the subject’s head “The interior surface of the inner shell is customized to fit the precise shape and form of each patient's head and may be a rigid or semi-rigid in form, while the outer shell may be flexible, semi-rigid or rigid, fitting over the inner shell and used for a patient with any head size or shape”).
Applicant is respectfully reminded that 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 the instant case, the helmet of the combined references has met the structural limitations of the claim, and would therefore be expected to be capable of performing the intended use claimed, e.g. being capable of fitting the head of a human subject, depending on the subject and way in which the helmet is worn.
Regarding Claim 6, Shah and Ono teach the limitations of Claim 1, and Shah further teaches the helmet system of claim 1, wherein the helmet shell is configured to fit the head of a human subject with an occipital frontal circumference of approximately 35 cm to approximately 55 cm (corresponding disclosure in at least [0043]-[0044], where the helmet size is determined by the mold of the patient head, and thus is able to be configured to fit the head of a human subject head with an occipital front circumference of approximately 35-55 cm “The rigid inner shell 201 was modeled after a patient's head shape, obtained using 3D scanning technology, and designed using computer aided design (CAD), and then finally 3D printed… Alternately, a mold of the patient's head may be made”, and further in [0014], where the helmet fits the subject’s head “The interior surface of the inner shell is customized to fit the precise shape and form of each patient's head and may be a rigid or semi-rigid in form, while the outer shell may be flexible, semi-rigid or rigid, fitting over the inner shell and used for a patient with any head size or shape”).
Applicant is respectfully reminded that 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 the instant case, the helmet of the combined references has met the structural limitations of the claim, and would therefore be expected to be capable of performing the intended use claimed, e.g. being capable of fitting the head of a human subject as claimed, depending on the subject and way in which the helmet is worn.
Regarding Claim 7, Shah and Ono teach the limitations of Claim 1, and Shah further teaches the helmet system of claim 1, wherein the helmet shell is configured to fit the head of a human subject with an occipital frontal circumference of approximately 35 cm to 55 cm (corresponding disclosure in at least [0043]-[0044], where the helmet size is determined by the mold of the patient head, and thus is able to be configured to fit the head of a human subject head with an occipital front circumference of approximately 35-55 cm “The rigid inner shell 201 was modeled after a patient's head shape, obtained using 3D scanning technology, and designed using computer aided design (CAD), and then finally 3D printed… Alternately, a mold of the patient's head may be made”, and further in [0014], where the helmet fits the subject’s head “The interior surface of the inner shell is customized to fit the precise shape and form of each patient's head and may be a rigid or semi-rigid in form, while the outer shell may be flexible, semi-rigid or rigid, fitting over the inner shell and used for a patient with any head size or shape”).
Shah discloses the claimed invention except for the helmet shell fitting the head of a human subject with an occipital frontal circumference of approximately 35 cm to 55 cm. It would have been an obvious matter of design choice to customize the shell to fit the precise shape and form of each patient’s head since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding Claim 8, Shah and Ono teach the limitations of Claim 1, and Ono further teaches wherein the helmet shell is configured to fit a head shape characterized by normocephaly, brachycephaly, plagiocephaly, scaphocephaly,trigonocephaly, asymmetrical ears, or any combination thereof (corresponding disclosure in at least [0024], where the helmet is used for various cranial deformations “The cranial deformation correction helmet configured in accordance with the present invention will be described in further detail by reference to the accompanying drawings showing its preferred embodiment” and further in [0014], where the helmet is customized to fit any patient head “The interior surface of the inner shell is customized to fit the precise shape and form of each patient's head and may be a rigid or semi-rigid in form, while the outer shell may be flexible, semi-rigid or rigid, fitting over the inner shell and used for a patient with any head size or shape”).
Applicant is respectfully reminded that 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 the instant case, the helmet of the combined references has met the structural limitations of the claim, and would therefore be expected to be capable of performing the intended use claimed, e.g. being capable of fitting the head of a human subject characterized as claimed, depending on the subject and way in which the helmet is worn.
Regarding Claim 10, Shah and Ono teach the limitations of Claim 1, and Shah further teaches wherein the magnetoencephalography field sensor is an optically pumped magnetometer (corresponding disclosure in at least [0006], where the sensors used are optically pumped magnetometers (OPMs) “The present invention is an easily customizable multi-shell MEG helmet that utilizes noncryogenic optically pumped magnetometers (OPMs)”).
Regarding Claim 11, Shah and Ono teach the limitations of Claim 1, and Shah further teaches wherein the plurality of openings comprises between 2 to approximately 50 openings in the helmet shell (corresponding disclosure in at least [0036] and Figure 3, where there is more than one opening “ the inner shell 201 may be fabricated with one or more openings 204A to receive sensors 203, and/or reduce weight or create ventilation for the head of the patient”).
Shah discloses the claimed invention including one or more openings, but is not specific about the particular range of between 2 to approximately 50 openings. It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to make the number of openings in a range between 2 to approximately 50 openings because doing so would allow for a tailored number of attachment points and adjustments according to a particular user’s head shape and comfort needs while still providing structural integrity for the helmet, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 (ii)(A). It is also noted that Applicant has not provided criticality for the particular range claimed.
Regarding Claim 12, Shah and Ono teach the limitations of Claim 1, and Shah further teaches the plurality of openings each individually have a shape characterized as circular, oval, or polygonal (corresponding disclosure in at least [0047] and Figure 3, where there are a plurality of openings, which have a polygonal shape “The outer shell maintains the position of the sensors, allowing them to slide and lock onto the inner shell through the outer shell openings 204B into the inner shell openings 204A”)
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Figure 3 of Shah
Regarding Claim 13, Shah and Ono teach the limitations of Claim 12, and Ono further teaches wherein each shape individually has a longest diameter ranging from approximately 5 mm to approximately 25 mm (corresponding disclosure in at least [0026], where the openings are 5-15 mm in diameter “ Each of the through-holes 16 is preferably a circular hole having a diameter of 5 to 15 mm”).
Regarding Claim 16, The combined references of Shah and Ono teach a kit,
comprising the helmet system of Claim 1 (i.e., a helmet shell configured to fit the head of a human subject (corresponding disclosure in at least [0014] of Shah, where the helmet is customized to fit any patient head “The interior surface of the inner shell is customized to fit the precise shape and form of each patient's head and may be a rigid or semi-rigid in form, while the outer shell may be flexible, semi-rigid or rigid, fitting over the inner shell and used for a patient with any head size or shape”, the inner and outer shell being construed to being the “helmet shell” as the two in combination make up the helmet shell [0014] “With this two-shell design, helmet preparation time is greatly minimized by allowing the inner shell to be easily replaced and mated to the outer shell” ),
the helmet shell weighing approximately 450 grams or less (corresponding disclosure in at least [0031], where the weight of the helmet is 63 g “The average diameter of the opening in the upper surface of the shell was about 90 mm, and 82 of the through-holes with a diameter of 11.0 mm were formed in the shell. The Shore D hardness of the shell was 77, the relative density of the shell was 95%, and the total weight of the shell was 63.0 g”);
at least one sensor housing unit, configured to hold a magnetoencephalography field sensor (corresponding disclosure in at least [0036] of Shah, where there are openings to receive the sensor “ the inner shell 201 may be fabricated with one or more openings 204A to receive sensors 203, and/or reduce weight or create ventilation for the head of the patient” and further in [0018] of Shah, where the housing holds the magnetoencephalography field sensor (OPM) “The number of the sensors can vary as well. In addition to OPM sensors, the helmet may also accommodate other sensors, such as electroencephalogram (EEG) electrodes, functional near infrared spectroscopy (fNIRS) sensors, accelerometers or gyroscopes for example”);
and a plurality of openings disposed in the helmet shell, wherein at least two individual openings of the plurality of openings are configured to receive and securely fit the sensor housing unit (corresponding disclosure in at least [0047] and Figure 8, where there are a plurality of openings, where the opening receives a sensor “The outer shell maintains the position of the sensors, allowing them to slide and lock onto the inner shell through the outer shell openings 204B into the inner shell openings 204A”) (),
and further comprising at least one magnetoencephalography field sensor (corresponding disclosure in at least [0006] of Shah, where the sensors used are optically pumped magnetometers (OPMs) “The present invention is an easily customizable multi-shell MEG helmet that utilizes noncryogenic optically pumped magnetometers (OPMs)”).
Regarding claim 17, Shah and Ono teach the limitations of Claim 16, and Shah further teaches wherein the magnetoencephalography field sensor is an optically pumped magnetometer (corresponding disclosure in at least [0006], where the sensors used are optically pumped magnetometers (OPMs) “The present invention is an easily customizable multi-shell MEG helmet that utilizes noncryogenic optically pumped magnetometers (OPMs)”).
Regarding claim 18, Shah and Ono teach the limitations of Claim 16, and Shah further teaches a cap configured to fit the head of the human subject (corresponding disclosure in at least [0047], where there’s a cap which fits the human head “To complete the two-shell MEG helmet, an outer shell 202 was made of a flexible cap of fabric fitted with ABS plastic sensor holders”).
Applicant is respectfully reminded that 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 the instant case, the helmet of the combined references has met the structural limitations of the claim, and would therefore be expected to be capable of performing the intended use claimed, e.g. being capable of fitting the head of a human subject as claimed, depending on the subject and way in which the helmet is worn.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Shah (US20210015427A1) and Ono (US20160015552A1) as applied in Claim 1 and in further view of Hill (“Multi-channel whole-head OPM-MEG: Helmet design and a comparison with a conventional system”, 2020, Neuroimage, Vol 219, as disclosed in Applicant IDS).
Regarding Claim 2, Shah and Ono teach the limitations of Claim 1, but does not teach wherein the helmet shell weighs approximately 100 grams to approximately 350 grams.
Hill, in a similar field of endeavor, teaches a similar concept (wearable MEG) of the helmet shell weighs approximately 100 grams to approximately 350 grams (corresponding disclosure in at least [pg. 3, 2.2 “Helmet Design”], where there is a lightweight helmet (the cap, which is described to be a flexible helmet in [pg. 5, 2.4 “Experimental method”] “6 times using OPM-MEG with the flexible helmet”) of 309 g with sensors “The cap is also light-weight and comfortable to wear for the participant, with a total weight of 309 g (when containing 49 sensors)”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a helmet shell weighting approximately 100 grams to approximately 350 grams as taught by Hill. One of the ordinary skill in the art would have been motivated to incorporate this because a lightweight helmet ensures comfortability for the user when it’s worn during procedures.
Claims 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Shah (US20210015427A1) and Ono (US20160015552A1) as applied in Claim 1 and in further view of BCN3D (“The most popular 3D printing materials in FDM and their properties”, 2022, BCN3D).
Regarding Claim 4, Shah and Ono teach the limitations of Claim 1, and Shah further teaches wherein the helmet shell (corresponding disclosure in at least [0046], where the helmet shell is made of a thermoplastic “In FDM and/or FFF printing, a continuous filament of a thermoplastic material is heated to a temperature of about 205° C. so that it can be extruded as a hair-thin filament and fused into the shape of the printed object. In our case, we used ABS plastic filament of 1.75 mm diameter to print the inner shell”).
“BCN3D”, in a similar field of endeavor, teaches a similar concept (3D printing material) of polylactic acid, polyethylene terephthalate glycol, or a combination thereof (corresponding disclosure in at least [pg. 2-3, “PLA], where PLA as a material is described as a commonly used PLA in thermoplastics “Polylactic acid, more commonly known as PLA, is the most widely used 3D filament because it is so easy to print”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of PLA as taught by “BCN3D”. One of the ordinary skill in the art would have been motivated to incorporate this because PLA is a commonly used filament for 3D printing with thermoplastics, particularly in prototyping. Regarding Claim 9, Shah and Ono teach the limitations of Claim 1, and Shah further teaches wherein the sensor housing unit is comprised of a thermoplastic (corresponding disclosure in at least [0049], where the sensor housing unit (sensor holder) is made via 3D printing “Other features including the mating features with the outer shell, bracket and sensor holder and vent holes were added to the inner shell using the Fusion 360 software. Once the inner shell model was complete it was sent to the Raise3D N2 Plus 3D printer as an .stl file for fabrication” and further in [0047], where the sensors are printed using ABS (a commonly used strong and flexible material “To complete the two-shell MEG helmet, an outer shell 202 was made of a flexible cap of fabric fitted with ABS plastic sensor holders”).
Shah does not teach the thermoplastic copolyester, thermoplastic polyurethane, or a combination thereof.
“BCN3D”, in a similar field of endeavor, teaches a similar concept (3D printing material) of thermoplastic copolyester, thermoplastic polyurethane, or a combination thereof (corresponding disclosure in at least [pg.3, “PET-G”], where the use of thermoplastic copolyester is discussed “PET-G (glycolized polyethylene terephthalate) is another material widely used in the 3D printing world and could be said to be an intermediate between PLA and ABS”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of PETG as taught by “BCN3D”. One of the ordinary skill in the art would have been motivated to incorporate this because PETG is a widely used material in 3D printing and is extremely versatile for printing.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Shah (US20210015427A1) and Ono (US20160015552A1) as applied in Claim 1 and in further view of Morris (US20090048683A1).
Regarding Claim 14, Shah and Ono teach the limitations of Claim 1, but does not teach at least one inflatable air bladder attached to an inner surface of the helmet shell.
Petre, in a similar field of endeavor, teaches a similar concept (padding) of at least one inflatable air bladder attached to an inner surface of the helmet shell (corresponding disclosure in at least [0038], where there is an inflatable air bladder(“Bladder 32 is expanded by way of a filler material … Examples of suitable filler materials include air”). ).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated an inflatable air bladder attached to an inner surface of the helmet shell as taught by Morris. One of the ordinary skill in the art would have been motivated to incorporate this because the inflatable bladder serves as padding for the user to avoid discomfort while wearing the helmet.
Regarding Claim 15, the combined references noted above teach the limitations of Claim 14, and Morris further teaches wherein the inflatable air bladder, padding, or both is comprised of a high molecular weight polyethylene or a derivative thereof (corresponding disclosure in at least [0046], where the material of the bladder is described (polyethylene) “The material for the bladder can be flexible… Other possible bladder materials include, but are not limited to, polyester (PET), metal, woven Kevlar, ultra high molecular weight polyethylene (UHMWPE)“).).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Johnson (US11684304B2) teaches a helmet using magnetometers to detect magnetic fields, Shapiro (US11801003B2) teaches a wearable OPM, and Osaka (US20220304605A1) teaches a wearable measurement device with sensor holders for magnetic sensors i.e. OPM.
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/K.E.K./Examiner, Art Unit 3797
/ANNE M KOZAK/Supervisory Patent Examiner, Art Unit 3797