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 .
Status of Claims
Claims 1-20 are pending in this application. Claims 19-20 are newly added and Claims 1-20 have been examined on the merits.
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 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shah (US20210015427A1) in view of Hill (“A tool for functional brain imaging with lifespan compliance”, 2019, Nature Communications, 4785).
Regarding Claim 1,
Shah teaches a helmet system, comprising:
a helmet shell configured to fit the head of a human subject and comprised of a rigid material (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”).
and wherein the at least one sensor housing unit can be rotated after being fit within the at least two individual openings of the plurality of openings (corresponding disclosure in at least [0017], where there is rotation, or head movement of the subject, causing rotation of the helmet with the subject moving, ultimately rotating the sensor housing unit in the direction of the head movement “Head movements translate from the inner shell to the outer shell and by extension to all sensors in unison. The mating features can be used to achieve rigidity between inner and outer shells”).
Shah does not specify the helmet shell weighing approximately 450 grams or less.
Hill, 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 [pg. 7, Discussion], where the weight of a helmet system including the cables would be as low as 500 g, thus when subtracting the weight of the cables for the 81 sensors (each cable being 4g), the helmet itself would weight approximately 180 g “Each OPM weighs 20 g and so an 81-channel system, including the helmet, would weigh ~1800 g. Further, the cables to each OPM currently weigh 33g/m, and cables hanging from the head cause torque, which could become uncomfortable for long experimental durations, particularly for younger participants. However, these problems are solved by the availability of a new generation of commercial OPMs2, which are smaller (1.24 × 1.66 × 2.44 cm3), lighter (4 g) and use lighter cabling (3.3 g/m). This means that the weight of an 81-channel system could be as low as 500g, with cable weight being negligible”).
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 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.
Regarding Claim 2, Shah and Hill 2019 teach the limitations of Claim 1, and Hill 2019 further teaches the helmet shell weighs approximately 100 grams to approximately 350 grams (corresponding disclosure in at least [pg. 7, Discussion], where the weight of a helmet system including the cables would be as low as 500 g, thus when subtracting the weight of the cables for the 81 sensors (each cable being 4g), the helmet itself would weight approximately 180 g “Each OPM weighs 20 g and so an 81-channel system, including the helmet, would weigh ~1800 g. Further, the cables to each OPM currently weigh 33g/m, and cables hanging from the head cause torque, which could become uncomfortable for long experimental durations, particularly for younger participants. However, these problems are solved by the availability of a new generation of commercial OPMs2, which are smaller (1.24 × 1.66 × 2.44 cm3), lighter (4 g) and use lighter cabling (3.3 g/m). This means that the weight of an 81-channel system could be as low as 500g, with cable weight being negligible”).
Regarding Claim 5, Shah and Hill 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 Hill 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 Hill teach the limitations of Claim 1, and Hill 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 [pg. 2, Introduction], where the helmet is customized to fit any patient head “This means that an OPM-MEG system can be adapted to any head shape/size. Furthermore, if background magnetic fields are appropriately nulled19, OPMs can be mounted on the head and participants can move during scanning”).
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 Hill 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 Hill 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 Hill 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 Hill teach the limitations of Claim 12, and Hill 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 Hill 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 Hill 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 Hill 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.
Regarding Claim 19, Shah and Hill teach the limitations of Claim 1, and Hill further teaches wherein the helmet system weighs approximately 100 grams to approximately 450 grams (corresponding disclosure in at least [pg. 7, Discussion], where the weight of a helmet system including the cables would be as low as 500 g, thus when subtracting the weight of the cables for the 81 sensors (each cable being 4g), the helmet itself would weight approximately 180 g “Each OPM weighs 20 g and so an 81-channel system, including the helmet, would weigh ~1800 g. Further, the cables to each OPM currently weigh 33g/m, and cables hanging from the head cause torque, which could become uncomfortable for long experimental durations, particularly for younger participants. However, these problems are solved by the availability of a new generation of commercial OPMs2, which are smaller (1.24 × 1.66 × 2.44 cm3), lighter (4 g) and use lighter cabling (3.3 g/m). This means that the weight of an 81-channel system could be as low as 500g, with cable weight being negligible”).
Regarding Claim 20, Shah and Hill teach the limitations of Claim 1, and Hill further teaches wherein the helmet system weighs approximately 100 grams to approximately 350 grams (corresponding disclosure in at least [pg. 7, Discussion], where the weight of a helmet system including the cables would be as low as 500 g, thus when subtracting the weight of the cables for the 81 sensors (each cable being 4g), the helmet itself would weight approximately 180 g “Each OPM weighs 20 g and so an 81-channel system, including the helmet, would weigh ~1800 g. Further, the cables to each OPM currently weigh 33g/m, and cables hanging from the head cause torque, which could become uncomfortable for long experimental durations, particularly for younger participants. However, these problems are solved by the availability of a new generation of commercial OPMs2, which are smaller (1.24 × 1.66 × 2.44 cm3), lighter (4 g) and use lighter cabling (3.3 g/m). This means that the weight of an 81-channel system could be as low as 500g, with cable weight being negligible”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Shah (US20210015427A1) and Hill (“A tool for functional brain imaging with lifespan compliance”, 2019, Nature Communications, 4785) as applied in Claim 1 and in further view of Ono (US20160015552A1)
Regarding Claim 3, Shah and Hill teach the limitations of Claim 1, but do not teach wherein the helmet shell has a thickness of approximately 1 mm to approximately 6 mm.
Ono, in a similar field of endeavor (helmets to be worn on human subject) of 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.”)
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 a helmet shell with a thickness of approximately 1mm to 6 mm. One of the ordinary skill in the art would have been motivated to incorporate this because having a smaller thickness of a helmet shell makes the overall weight of the helmet lighter.
Claims 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Shah (US20210015427A1) and Hill (“A tool for functional brain imaging with lifespan compliance”, 2019, Nature Communications, 4785) 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 Hill 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 Hill 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 Hill (“A tool for functional brain imaging with lifespan compliance”, 2019, Nature Communications, 4785) as applied in Claim 1 and in further view of Morris (US20090048683A1).
Regarding Claim 14, Shah and Hill 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)“).).
Response to Arguments
Applicant's arguments filed 07/02/2026 regarding the Drawing Objections have been fully considered and the objection is withdrawn in light of the amendments.
Applicant's arguments filed 07/02/2026 regarding the Claim Objections have been fully considered and the objection is withdrawn in light of the amendments.
Applicant's arguments filed 07/02/2026 regarding the 35 U.S.C. 112b rejections have been fully considered but they are not persuasive. Applicant argues that a person of ordinary skill in the art of pediatric anatomy would understand the metes and bounds for a helmet shell “configured to fit the head of a human subject of approximately 2 months to approximately 24 months old”. However, the Specifications do not provide a measure of degree with numerical measurements of what a human subject approximately 2 months to approximately 24 months old head size would be. The claim is not indefinite if the specification provides examples or teachings that can be used to measure a degree even without a precise numerical measurement (See MPEP 2173.05(b)). Examiner notes that although there are various charts regarding a head circumference of human subjects between 2 months to 24 months old, these measurements widely vary depending on the development, sex, and growth of the subject. Thus, the limitation recited in Claim 5 is unclear.
Applicant further argues that a person of ordinary skill in the art of pediatric anatomy would understand the metes and bounds for a helmet shell “configured to fit a head shape characterized by normocephaly, brachycephaly, plagiocephaly, scaphocephaly, trigonocephaly, asymmetrical ears, or any combination thereof”. Although it is understood that the listed characterizations, such as brachycephaly, refer to a pediatric skull deformity, similar to the rejection of Claim 5, there is not a measure of degree with numerical measurements. The claim is not indefinite if the specification provides examples or teachings that can be used to measure a degree even without a precise numerical measurement (See MPEP 2173.05(b)).
Applicant's arguments filed 07/02/2026 regarding the 35 U.S.C. 103 rejections have been fully considered but they are not persuasive. Applicant argues that the two-shell design in the primary reference Shah is not taught in the instant application’s Claim 1. However, there is nothing that precludes the helmet shell system from being two elements that make up a helmet shell (see rejection above). Further, the reference Hill, which was added in light of the newly added amendments regarding the helmet shell rigidity and weight, teaches a modified bicycle helmet for the purposes of MEG. Thus, even in the case of a limitation being added into the instant application claim 1 to dissuade the use of a two part helmet shell, Hill would still meet the limitations of the design of the helmet shell.
Applicant’s further arguments with respect to claims 1 and 2 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
All remaining claims remain rejected due to their dependency to the rejected independent claim.
Conclusion
THIS ACTION IS MADE FINAL. 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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/K.E.K./Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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