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 .
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, 8, 11, 12, 14-16, 18, 19, 21, 22, 24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4467476 (Herbert) in view of US 2404225 (Green).
Regarding claim 1, ‘476 discloses: A garment for protection of a wearer from radiation [fig.6 garment does provide at least some measure of protection from radiation including sunlight; further, “for protection of a wearer from radiation” is a statement of intended use in the preamble of the claim that has no patentable weight], comprising: an upper body section comprising a back portion, a first front portion, a second front portion and a neck opening [42, fig. 5], wherein the upper body section is configured to shield a region of a torso of the wearer from radiation [42 does provide some shielding of radiation of a torso]; a collar section being secured to the upper body section and upstanding from the neck opening, wherein the collar section is configured to shield a region of a thyroid of the wearer [52 does provide some shielding of radiation of a neck/thyroid]; and a front flap section comprising a first front flap portion extending downwardly from the front first portion [see annotated figs. 5 and 6] and a second front flap portion extending downwardly from the second front portion [see annotated figs. 5 and 6], wherein the front flap section is configured to shield a region of a gonad of the wearer [flaps annotated in figs. 5 and 6 below do provide some measure of shielding to the gonad region of a wearer]; wherein the final garment is integrated into one piece [see annotated figs.5 and 6 below; garment is coupled into a unitary garment in fig. 5 also see par. 18 which describes the ‘coupling between upper section 42 and lower section 44 can be disconnected’; when 42 and 44 are coupled they form a ‘unitary’ structure/garment].
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To further address the claimed limitation “the garment is in one piece”; if anticipation of the limitation is not conceded.
The MPEP 2144.04 is explicit:
B.Making Integral
In reLarson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”).
Instantly no unexpected results are stated in the instant specification regarding use of integral construction rather than piecemeal construction. Use of integral construction is wholly expected by one of ordinary skill in garment construction to inherently reduce the number of parts and therefore inherently reduce any ‘loss or mis-match’ of the garment components as there would no longer be any separate components.
Additionally, ‘225 shows in figures 1 and 2 a radiation protective garment that is produced in “one piece” construction. The “one piece” construction shown inherently reduces any loss/mismatch of components as there is only one garment component.
Therefore it would have been obvious to one of ordinary skill in the art prior to filing the invention to use a ‘one piece’/integral garment construction rather than a piecemeal garment construction as a matter of obvious engineering design choice and as taught by ‘225 which does use one piece garment construction inherently reducing the number of garment components from multiple components to a single component.
Regarding the remaining newly added limitation: ‘wherein the front flap section is longer than the back portion’; ‘225 is noted as it teaches explicitly, “The apron illustrated shields the person wearing it from the neckline across the entire front of the body and downwardly to any desired extent, such as to a level below the knees. It consists, therefore, of an upper body portion, marked generally 10, and a lower skirt portion 11, the latter of generally rectangular form, low enough to extend below the knees and wide enough so that its vertical side edges 12 are at or a little behind the outside trouser seams [par. 9].”.
The MPEP 2144.04 is explicit to changes in dimension/shape that do not provide any unexpected result:
A.Changes in Size/Proportion
In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package “of appreciable size and weight requiring handling by a lift truck” were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (“mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled.” 531 F.2d at 1053, 189 USPQ at 148.).
In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
B.Changes in Shape
In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Instantly, the claimed change in dimensions/shape are not shown to provide any different performance or unexpected result over the prior art that provides a user with desired coverage/protection from radiation which is the same performance/result as the claimed radiation garment dimensions.
Further, ‘225 figs. 1 and 2 show a front section longer than the back portion.
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Therefore it would have been obvious to one of ordinary skill in the art prior to filing the invention to modify the front section of ‘476 to extend over the front of the user to any desired extent such as a level below the knees and shorter than the back section as taught by ‘225 to provide a radiation protective garment with the desired amount of coverage on the front of the body during use of the garment.
Regarding claim 8, ‘476 discloses: wherein the collar section comprises a first distal end and a second distal end [seen clearly in fig. 5]; wherein the collar section comprises at least one second fastening means comprising a pair of complimentary assemblies [54; hook and loop fasteners on the collar], wherein the pair of complimentary assemblies comprise a first assembly integrally coupled to the first distal end of the collar section and a second assembly integrally coupled to the second distal end of the collar section; or any combination thereof [54; hook and loop fasteners on the collar inherently have integrally coupled complementary sections on each distal end of the collar].
Regarding claims 11 and 12, ‘476 discloses: wherein the front flap section comprises at least one third fastening means for releasably fastening a first vertical side edge of the first front flap portion and a second vertical side edge of the second front flap portion in a closed position [58, 60 and 62 are complementary fastening means shown in figs. 5 and 6 that do releasably fasten/open/close the flaps and vertical edges].
Regarding claim 14, ‘476 discloses: wherein the first front portion of the upper body section and the first front flap portion of the front flap section form one continuous first panel [upper garment section 42 when coupled by fasteners does ‘form a continuous first panel’ in that they are in immediate connection or spatial relationship with each other], and the second front portion of the upper body section and the second front flap portion of the front flap section form one continuous second panel [lower garment section 44 when coupled by fasteners does ‘form a continuous second panel’ in that they are in immediate connection or spatial relationship with each other].
Regarding claims 15 and 16, ‘476 discloses: wherein the first panel comprises at least one fastening means/complementary pair for releasably fastening a first vertical side edge of the first panel and a second vertical side edge of the second panel in a closed position and wherein the at least one fastening means comprises a pair of complimentary assemblies comprising a first assembly integrally coupled to the first vertical side edge of the first panel and a second assembly integrally coupled to the second vertical side edge of the second panel [58, 60, 62 are hook and loop/complementary pairs of fasteners that are integrally coupled to the vertical side edges of both the upper garment section 42 and the lower garment section 44; and do provide releasable fastening of both vertical side edges of both upper and lower garment sections].
Regarding claim 18, ‘476 discloses: the upper body section is in a vest shape [figs. 5 and 6; show a ‘vest shape’].
Regarding claim 19, ‘476 discloses: the garment is a garment for medical applications [nothing precludes the garment from being used ‘for medical applications’, prior art need only be capable of providing claimed functional limitations to disclose any claimed functional capabilities].
Regarding claim 21, ‘476 discloses: the garment comprises a uni-layer or a multi- layer [garment shown in figs. 5 and 6 is “uni-layer or multilayer”; it is noted this claim is disclosed by any garment, as all garments are encompassed by the requirement of being either a single layer or multilayered as claimed].
Regarding claim 22, ‘476 discloses: the multi-layer comprises at least one layer comprising a radiation protective material [the full disclosure of ‘476 includes under/inner X-ray attenuating apron; further the outer para-aramid layer of garment shown in figs 5 and 6 do provide some radiation protection capability].
Regarding claim 24, ‘476 discloses: the garment comprises a radiation protective material, wherein the radiation protective material is operable for at least one of dissipating, absorbing, neutralizing, and deflecting radiation [the coverage alone provided by the outer para-aramid layer of the garment shown in figs. 5 and 6 does provide at least some ‘deflection’ of radiation including sunlight/UV radiation].
Regarding claim 26, ‘476 discloses: wherein the collar section comprises at least one radiation protective material configured to protect a wearer's thyroid ; wherein the upper body section comprises at least one radiation protective material configured to protect a wearer's chest; wherein the front flap section comprises at least one radiation protective material of the front flap section configured to protect a wearer's reproductive organs [the coverage alone provided by the outer layer of the garment shown in figs. 5 and 6 does provide at least some ‘deflection’ of radiation including sunlight/UV radiation of collar/neck/thyroid/chest/reproductive organs; further, para-aramid is known to provide at least some levels of radiation shielding].
Claim(s) 2, 6, 29, 32, 38 and 39, is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4467476 (Herbert) in view of US 2404225 (Green) as above; and further in view of US 10790068 (Milstein et al.).
Regarding claim 2, ‘476 does disclose: wherein the upper body section comprises a first arm hole and a second arm hole [upper body section ‘holing elements’ include/comprise two arm holes]; wherein the upper body section comprises at least one first fastening means for releasably fastening a first vertical side edge of the first front portion and a second vertical side edge of the second front portion in a closed position; or any combination thereof [58, 60, 62; are hook and loop type fasteners which are inherently releasable fasteners and do provide opening/closing of the both vertical side edges].
‘476 does not disclose explicitly, “the upper body section comprises at least one holing element/front pocket”.
However, certainly all parties would likely concede that adding a pocket to a garment’s upper section would be wholly known and expected by a person of ordinary skill in the art of garment production as a widely used, common, and conventional modification to any garment to provide that garment with the ability to hold/carry items as desired by a user.
Further, ‘068 par. 64 explicitly teaches, “Each of the inner garment layer 12a, middle garment layer 12b, and outer garment layer 12c includes a plurality of shield elements 14 that are incorporated into a flexible substrate 16. For example, shield elements 14 may be embedded in flexible substrate 16, as shown in FIG. 2. Alternatively or in addition, shield elements 14 may be attached to a surface (e.g., an outer surface) of flexible substrate 16, inserted in a pocket or sleeve of flexible substrate 16, or otherwise attached to flexible substrate 16.”.
Therefore it would have been obvious to one of ordinary skill in the art of garment production and design prior to filing the invention to modify the garment of ‘476 to include outer pockets so that additional items can be held/carried by the garment as desired by the user.
Regarding claim 6, ‘476 fully discloses: wherein the at least one first fastening means comprises a pair of complimentary assemblies comprising a first assembly integrally coupled to the first vertical side edge of the first front portion and a second assembly integrally coupled to the second vertical side edge of the second front portion [58, 60, 62; are hook and loop type fasteners which are inherently, pairs of complementary releasable fasteners and do provide opening/closing of the both vertical side edges].
Regarding claims 29 and 32, ‘476 fully discloses radiation protection material as above but does not teach the recited radiation protective materials in claims 29 and 32.
However, ‘068 does teach in pars.65-66 and 74-75: “Shield elements 14 may be configured to attenuate one or more types of radiation. For example, in order to attenuate ionizing radiation in the form of energetic particles (e.g., solar wind particles, galactic cosmic ray particles, or other ions, neutrons, or other particles), shield elements may include materials that are composed of light nuclei (e.g., hydrogen, carbon, oxygen, or other light nuclei). For example, shield elements 14 may include polyethylene, polypropylene, or another hydrocarbon, water, or another material composed primarily of elements having a low atomic mass. In order to attenuate ionizing radiation in the form of energetic photons (e.g., x-rays or gamma rays, e.g., resulting from interaction of energetic charged particles with matter), shield elements 14 may include a material with a high atomic number. For example, shield elements 14 may include a metal (e.g., lead, gold, silver, tungsten, or another metal) or a metallic alloy in the form of a powder, pellets, coating, lining, layer, or another form. For example, a powder or pellet may have a particle diameter or other characteristic dimension in the range from less than a micrometer to about a millimeter.
In some cases, shield elements 14 may have a composition that is similar to that of flexible substrate 16. However, the density of the material of shield elements 14 may be denser than that of flexible substrate 16. For example, shield elements 14 may include high density polyethylene, while flexible substrate 16 includes low density polyethylene (e.g., polyethylene foam or fabric)…
For example, embedded shield elements 22 may include high-density polyethylene. Flexible substrate 16 may include polyethylene foam. Alternatively or in addition, flexible substrate 16 may include another type of material that is sufficiently thick so as to incorporate embedded shield elements 22 but sufficiently flexible or elastic so as enable bending of radiation protection garment 20.
Alternatively or in addition, embedded shield elements 22 or flexible substrate 16 may include a polymeric mixture that includes one or more of polyurethane, polyamide, polyvinyl chloride, polyvinyl alcohol, natural latex, polypropylene, ethylene vinyl acetate, polyester, or another polymer. One or more components may include an additive to improve the flexibility, strength, durability, or another property of the polymeric mixture or to ensure that the polymeric mixture has an appropriate uniformity and consistency. For example, an additive may include a plasticizer (e.g., epoxy soybean oil, ethylene glycol, propylene glycol, or another plasticizer), an emulsifier, a surfactant, a suspension agent, a leveling agent, a drying promoter, a flow enhancer, or other additive. A radiation attenuating material included in embedded shield elements 22 may include one or more of carbon nano-materials with absorbed hydrogen, metal hydrides such as LiH, MgH.sub.2, LiBH.sub.4, NaBH.sub.4, BeH.sub.2, TiH.sub.2 or ZrH.sub.2, palladium (and alloys) with absorbed hydrogen, hydrocarbons (polyethylene or (CH2).sub.n) with boron, quasi-crystals (e.g., TiZrNi), condensed hydrogen (solid and liquid), water (H.sub.2O), drinking water, cooling liquid, and other hydrogen rich materials or mixtures such as urine.”.
The teachings above do recite a radiation protective material comprising composite fabric/fiber/filament that includes polyvinyl among other known materials used to provide radiation protective material with radiation protection function and desired flexibility, strength, and/or durability.
Therefore it would have been obvious to one of ordinary skill in the art prior to filing the invention to modify a known radiation protective garment to use any number of known composite polymer/fabric/fiber/filaments including polyvinyl to provide a garment with desired radiation protection capability, flexibility, strength and durability.
Regarding claim 38, ‘476 does teach para-aramid that is known intrinsically to provide some level of radiopacity (see attached NPL document to current PTO-892 on para-aramid properties). ‘476 does not teach the claimed radiopaque substances in claim 38.
However, ‘068 does teach radiation protective garment that includes, “Shield elements 14 may be configured to attenuate one or more types of radiation. For example, in order to attenuate ionizing radiation in the form of energetic particles (e.g., solar wind particles, galactic cosmic ray particles, or other ions, neutrons, or other particles), shield elements may include materials that are composed of light nuclei (e.g., hydrogen, carbon, oxygen, or other light nuclei). For example, shield elements 14 may include polyethylene, polypropylene, or another hydrocarbon, water, or another material composed primarily of elements having a low atomic mass. In order to attenuate ionizing radiation in the form of energetic photons (e.g., x-rays or gamma rays, e.g., resulting from interaction of energetic charged particles with matter), shield elements 14 may include a material with a high atomic number. For example, shield elements 14 may include a metal (e.g., lead, gold, silver, tungsten, or another metal) or a metallic alloy in the form of a powder, pellets, coating, lining, layer, or another form. For example, a powder or pellet may have a particle diameter or other characteristic dimension in the range from less than a micrometer to about a millimeter [par. 65].”.
This recitation explicitly teaches gold as a known material for use in radiation shield elements.
Therefore it would have been obvious to one of ordinary skill in the art prior to filing the invention to modify a known radiation protective garment to use any number of known metallic materials including gold which is known to be inherently radiopaque to provide desired radiation protective capabilities to a garment.
Regarding claim 39, the combined teachings above do teach the use of gold intrinsically radiopaque as material for providing radiation protection. The combined teachings also teach the use of fabric/fiber/filaments in flexible radiation shield/substrates of a radiation protection garment.
The combined teachings do not teach an explicit composition by weight of the radiopaque material in the filaments of the fabric.
However, ‘068 does fully recognize the optimizable nature of the level of radiation protection of the radiation protective materials.
‘068 explicitly states, “Radiation protection device 10 is configurable to provide varying degrees of radiation protection (e.g., as quantifiable by radiation attenuation) or types of radiation protection (e.g., quantifiable by a ratio of attenuation of one type or energy of radiation to attenuation of another type or energy of radiation) to different parts of user 11. For example, one or more of a thickness of radiation protection device 10, a distribution of shield elements, a density, size, shape, or composition of shield elements, a number of layers, or another characteristic of radiation protection device 10 may vary from section to section of radiation protection device 10 [par. 52].
For example, a lower-protection section 10a of radiation protection device 10 may be thinner or otherwise provide lower attenuation than a higher-protection section 10b of radiation protection device 10. Characteristics of the radiation protection that is provided by radiation protection device 10 to each interior region of user 11 may be selected in accordance with a sensitivity of each interior region of user 11 to one or more types of radiation. For example, a more sensitive interior region of user 11 may have a relatively high concentration of stem cells, or may be otherwise more susceptible to mutagenesis, than another less sensitive interior region of user 11. Radiation protection device 10 may be configured such that, when worn by user 11, a higher-protection section 10b covers the more sensitive interior region and a lower-protection section 10a covers the less sensitive interior region…
Furthermore, limiting the protection to those interior regions of the user 11 that are most sensitive to the effects of radiation may enable effective protection without excessively increasing the mass or thickness of radiation protection device 10 [pars. 54 and 55].”.
The teachings above show ’68 explicitly recognizes the composition of the radiation shield as a known optimizable results oriented variable, in that it is wholly expected that increased radiopaque material would provide increased radiation protection and that modifying radiation protective material composition is known and predictably successful when varied to provide the appropriate levels of radiation protection to each user and in each specific radiation protection type of scenario.
Therefore it would have been obvious to one of ordinary skill in the art prior to filing the invention to modify the composition of radiopaque material in a radiation protection device to provide the optimum desired levels of radiation protection to each user’s radiation sensitivity and to each specific radiation needs of the specific use scenario.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the same reference(s) applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Affidavit dated 12/2/2025 has been considered. There is no clear nexus shown between the claimed limitations in the instant application and noted sales/revenue cited in the affidavit. The term “seamless” is not in the claims or in the specification; ‘one piece’ garment construction could include stitching or various other “seams” forming permanent attachment of components into a “one piece”. The noted sales/revenue show no explicit nexus between the claimed structure of the garment; further sales/revenue are not shown to be an improvement over sales of prior art radiation garments as a result of the claimed limitations of the instant application.
Anecdotal statements presented are not persuasive evidence of the required clear nexus between claimed limitations and the noted sales/revenue data.
Garments in all technological fields of endeavor since the inception of garments have inherently addressed the problem of ‘fit’ and ‘potential mis-match/loss’ of components. Desired garment fit/coverage and any potential mis-match/loss of garment components are not only specific to “X-ray/radiation protection” garments as these issues have existed for garments since their inception as articles to provide desired coverage of the multiple body parts of a user.
No other arguments are presented, it appears all other rejections are conceded.
As these are the arguments provided and new rejection parameters are added to address newly added claim limitations the rejection is considered to be proper.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H MUROMOTO JR whose telephone number is (571)272-4991. The examiner can normally be reached M-Th 730-1730.
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/ROBERT H MUROMOTO JR/Primary Examiner, Art Unit 3732