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 .
Election/Restrictions
Applicant's election with traverse of Invention I, the garment of claims 11-24, in the reply filed on 23 December 2025 is acknowledged. The traversal is on the ground(s) that examining the garment and method of making would not amount to an undue burden because the claims include overlapping subject matter. This is not found persuasive because the inventions are separately classified as set forth in the 10/28/2025 restriction requirement and would require unique classification searching and search strategy.
Applicant's election with traverse of Species G, shown in FIGS 8-9C and corresponding to claims 11-24 in the reply filed on 23 December 2025 is acknowledged. The traversal is on the ground(s) that Applicant disagrees the application contains claims directed to patentably different species. This is not found persuasive because only Species G has a gown body and so the claims containing a body portion (which is presumed to correspond to the disclosed “body”) are specific to Species G and no claims are generic.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
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 exterior layer and the interior layer (claims 11 and 22), the wicking layer extends past a distal end of the sleeve (claim 18; the FIGS do not show the distal end of the sleeve such that it can be determined the wicking layer extends past the distal end), foldable portion and seam portion (claim 20) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the exterior layer and the interior layer (claims 11 and 22), the wicking layer extends past a distal end of the sleeve (claim 18; paras. 0064 and 0065 support the wicking layer extending through part or all of the sleeve, but do not support the wicking layer extending past a distal end of the sleeve), foldable portion and seam portion (claim 20).
Claim Objections
Claim 19 is objected to because of the following informalities: “the” should not be capitalized. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 11-17 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 11 is indefinite because the relationship between the sleeve, wicking layer, and the wicking layer’s exterior and interior layers is not clear from the claims or the disclosure. The elected embodiment has a sleeve 501 and wicking layer 503 but there is no disclosure of the wicking layer 503 having an exterior and interior layer. Paras. 0036 and 0041 support the sleeve having a moisture wicking layer and an impervious layer, but not a wicking layer having a moisture wicking layer and an impervious layer, as required by claim 11. How many layers are being recited in claim 11:
A) three layers in total, where the three layers are (1) a sleeve, and a wicking layer which actually comprises two layers, the two layers being (2) an exterior and (3) an interior layer,
B) two layers in total, where the sleeve comprises (1) an exterior layer of impervious material and (2) an interior layer of wicking material, or
C) something else?
Examiner believes claim 11 is intended to recite the sleeve comprising an exterior layer formed of an impervious material and an interior layer formed of a moisture wicking material, as that would be consistent with the disclosure.
Claim 12 is rendered indefinite because it recites the sleeve comprises the impervious material. Is the sleeve the “exterior layer formed of an impervious material” of claim 11 or is the sleeve formed of the same impervious material as the exterior layer? Is the “sleeve” the “exterior layer” or are the “sleeve” and “exterior layer” two distinct elements?
Claim 22 is indefinite for the same reason as claim 11 above. There is no disclosure of the wicking layer having an exterior layer and an interior layer, only a disclosure of the sleeve having an exterior layer and an interior layer, rendering it unclear how many layers are being recited and their relationship to one another.
Claims that depend from a rejected claim are also rejected under 112.
The claims are examined as best understood.
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) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lopez (US 5444871 A).
As to claim 11, Lopez discloses a protective garment (“Medical gown with seamless sleeve protector,” title), comprising:
a body portion (20 in FIG 1);
a sleeve extending distally from the body portion (32 in FIG 1, or the combination of 32 and 34 in FIG 1).
Lopez does not expressly disclose a wicking layer contacting the sleeve at least a distal end of the sleeve, wherein the wicking layer comprises: an exterior layer formed of an impervious material; and an interior layer formed of a moisture wicking material configured to move moisture away from a wrist area of a wearer of the protective garment.
Lopez col 3 line 10-20 does disclose the sleeve comprises an interior layer 32 and an exterior layer 34 formed of an impervious material, but not that the interior layer 32 is a moisture wicking material. Lopez is silent as to the material of 32.
Lopez does disclose a conventional sleeve is a nonwoven layer and an impervious layer interior or exterior to the nonwoven layer (col 1 line 25-35), and the nonwoven layer is fabric that wicks (col 2 line 50- col 3 line 15).
Therefore, although Lopez is silent as to the material of the interior layer, a wicking sleeve layer is known to Lopez and would be within the scope of the reference.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide a wicking layer contacting the sleeve at least a distal end of the sleeve, wherein the wicking layer comprises: an exterior layer formed of an impervious material; and an interior layer formed of a moisture wicking material configured to move moisture away from a wrist area of a wearer of the protective garment, since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide a wicking layer contacting the sleeve at least a distal end of the sleeve, wherein the wicking layer comprises: an exterior layer formed of an impervious material; and an interior layer formed of a moisture wicking material configured to move moisture away from a wrist area of a wearer of the protective garment for the purpose of providing a comfortable layer for wearing adjacent the wearer’s body.
As to claim 12, Lopez discloses the protective garment of claim 11, wherein the sleeve comprises the impervious material and the exterior layer of the wicking layer is welded to an interior surface of the sleeve (col 3 line 30-35 discloses “thermal bonding”).
As to claim 13, Lopez discloses the protective garment of claim 12, wherein the impervious material comprises at least one of nonwoven materials, polypropylene, polyester, polyethylene (col 3 line 25-30 discloses “polyethylene”), or combinations thereof.
As to claim 14, Lopez discloses the protective garment of claim 11, further comprising a cuff member having a first end affixed to an exterior surface of the sleeve (38 in FIGS 5-6) and configured to be folded distally over the sleeve such that a distal portion of the sleeve is sandwiched between the cuff member and the wicking layer (capable of being folded and intended to be folded, as shown in FIG 5).
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lopez (US 5444871 A) as applied to claim 11 above, and further in view of Mellon et al. (US 5784720 A).
As to claim 15, Lopez does not disclose the protective garment of claim 11, wherein the wicking material comprises wool, bamboo, or a micromodal fabric, or a combination of two or more of wool, bamboo and micromodal fabric.
Mellon teaches a similar garment comprising a sleeve (G comprising 12), and further teaches wool (col 4 line 25-30).
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the wicking material comprises wool, bamboo, or a micromodal fabric, or a combination of two or more of wool, bamboo and micromodal fabric, since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the wicking material comprises wool, bamboo, or a micromodal fabric, or a combination of two or more of wool, bamboo and micromodal fabric, for the purpose of providing a material with properties of thermal regulation, odor resistance, comfort, and insulation.
As to claim 16, Lopez discloses the protective garment of claim 11, further comprising a hand portion extending distally from the distal end of the sleeve (38 in FIG 6), but does not disclose wherein the hand portion comprises a thumb loop configured to receive a thumb of the wearer.
Mellon teaches a similar hand portion extending distally from the distal end of the sleeve (10 extending from 12) including a thumb loop configured to receive a thumb of the wearer (30).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to provide the hand portion of Lopez with the thumb loop of Mellon, for the purpose of insulating the hand and fingers while maintaining finger and thumb dexterity and sense of touch (Mellon col 3 line 45-55) while also maintaining the sleeves in position on the arm by preventing them from riding up the arm.
As to claim 17, Lopez as modified discloses the protective garment of claim 16, wherein the hand portion further comprises a palm draping configured to cover at least a portion of a palm of the wearer (see annotated Lopez FIG 6 below, please note the term “palm draping” does not have any inherent structure and the claim does not lend any structure to the palm draping, so Lopez’ palm draping is the portion of the cuff 38 that will cover the palm when the cuff 38 is provided with a thumb loop as taught by Mellon and worn over a portion of the hand), but does not disclose wherein the hand portion further comprises the moisture wicking material that is configured to wick moisture away from a hand area of the wearer.
Although Lopez is silent as to the material of 38, Lopez as modified in claim 11 discloses a sleeve of wicking material and Mellon discloses wool, a material known to be wicking. Therefore, a wicking material for the hand portion is within the scope of the modified Lopez reference.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the hand portion further comprises the moisture wicking material that is configured to wick moisture away from a hand area of the wearer, since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the hand portion further comprises the moisture wicking material that is configured to wick moisture away from a hand area of the wearer for the purpose of providing a comfortable layer for wearing adjacent the wearer’s body.
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Claim(s) 18-19 and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lopez (US 5444871 A) in view of Mellon et al. (US 5784720 A).
As to claim 18, Lopez discloses a protective garment (“Medical gown with seamless sleeve protector,” title), comprising:
a body portion (20 in FIG 1);
a sleeve extending distally from the body portion (the combination of 32 and 34 in FIG 1).
a layer contacting the sleeve at least at a distal end of the sleeve (32, 38, or the combination of 32 and 38), wherein the layer extends past a distal end of the sleeve to form a hand portion (38 corresponds to the hand portion).
Lopez does not disclose the layer contacting the sleeve at least at a distal end of the sleeve is a wicking layer,
wherein the wicking layer comprises a moisture wicking material configured to move moisture away from a wrist area of a wearer of the protective garment,
the hand portion comprising a thumb loop configured to receive a thumb of the wearer, and wherein the hand portion further comprises the moisture wicking material and is configured to wick moisture away from a hand area of the wearer.
Regarding the hand portion comprising a thumb loop:
Mellon teaches a similar layer extending past a distal end of the sleeve to form a hand portion (10 extends past 12) the hand portion comprising a thumb loop configured to receive a thumb of the wearer (30).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to provide the hand portion of Lopez with the thumb loop of Mellon, for the purpose of insulating the hand and fingers while maintaining finger and thumb dexterity and sense of touch (Mellon col 3 line 45-55) while also maintaining the sleeves in position on the arm by preventing them from riding up the arm.
Regarding the wicking layer comprising a moisture wicking material, wherein the hand portion further comprises the moisture wicking material and is configured to wick moisture away from a hand area of the wearer:
Although Lopez is silent as to the material of 38, Lopez discloses conventional sleeves have a wicking layer (Lopez col 2 line 50- col 3 line 15). Therefore, a wicking material for the hand portion is within the scope of the modified Lopez reference.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide Lopez’ 32 and/ or 38 in a/ the moisture wicking material, wherein the hand portion further comprises the moisture wicking material and is configured to wick moisture away from a hand area of the wearer, since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide Lopez’ 32 and/ or 38 in a/ the moisture wicking material, wherein the hand portion further comprises the moisture wicking material and is configured to wick moisture away from a hand area of the wearer for the purpose of providing a comfortable layer for wearing adjacent the wearer’s body.
As to claim 19, Lopez as modified discloses the protective garment of claim 18, wherein: The hand portion further comprises a palm draping configured to cover at least a portion of a palm of the wearer (see annotated Lopez FIG 6 below, please note the term “palm draping” does not have any inherent structure and the claim does not lend any structure to the palm draping, so Lopez’ palm draping is the portion of the cuff 38 that will cover the palm when the cuff 38 is provided with a thumb loop as taught by Mellon and worn over a portion of the hand), and the thumb loop extends directly back in a proximal direction so as to leave a back of a hand of the wearer uncovered (at least to the degree shown in Applicant’s figures, which do not show how the garment leaves the back of a hand of the wearer uncovered, Lopez is capable of leaving at least a portion of the back of the hand uncovered, such as when the hand portion 38 is flipped up as shown in FIG 5).
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As to claim 22, Lopez discloses the protective garment of claim 18, wherein the wicking layer comprises: an exterior layer formed of an impervious material (34); and an interior layer formed of the moisture wicking material (this is the result of the modification presented in the rejection of claim 18 above, where 32/38 are obviously modifiable to be moisture wicking material).
As to claim 23, Lopez discloses the protective garment of claim 22, wherein the exterior layer of the wicking layer is welded to an interior surface of the sleeve by at least one of thermal seaming (Lopez col 3 line 30-35 discloses “thermal bonding”), chemical seaming, mechanical seaming, glue. and adhesive, or combinations of two or more thereof.
As to claim 24, Lopez does not disclose the protective garment of claim 18, wherein the wicking material comprises wool, bamboo, or a micromodal fabric, or a combination of two or more of wool, bamboo and micromodal fabric.
Mellon teaches a similar garment comprising a sleeve (G comprising 12), and further teaches wool (col 4 line 25-30).
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the wicking material comprises wool, bamboo, or a micromodal fabric, or a combination of two or more of wool, bamboo and micromodal fabric, since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the wicking material comprises wool, bamboo, or a micromodal fabric, or a combination of two or more of wool, bamboo and micromodal fabric, for the purpose of providing a material with properties of thermal regulation, odor resistance, comfort, and insulation.
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lopez (US 5444871 A) in view of Mellon et al. (US 5784720 A) as applied to claim 18 above, and further in view of Komorowski (US 7647648 B2).
As to claim 20, Lopez does not disclose the protective garment of claim 18, further comprising a cuff member attached to the exterior surface of the sleeve, the cuff member comprising a flap having a foldable portion and a seam portion, wherein: the seam portion is attached to the exterior surface of the sleeve by a seaming weld, the foldable portion is configured to be placed in a folded position in which it covers the seam portion and an unfolded position in which it extends proximally outwardly from the seam portion and does not cover the seam portion, the seam portion is configured to receive thereon a first O-ring of a first protective glove worn by a user of the fluid management system, wherein the seam portion prevents distal sliding of the first O-ring, and in the folded position, the foldable portion is configured to cover the first O-ring of the first protective glove and prevent distal sliding of the first O-ring sandwiched between the seam portion and foldable portion.
Komorowski teaches a similar protective garment (“Advanced isolation gown,” title) including a cuff member attached to the exterior surface of the sleeve (50/55 attached to unlabeled sleeve in FIG 7), the cuff member comprising a flap having a foldable portion and a seam portion (at least to the degree shown in Applicant’s figures, which do not show a foldable or seam portion, see annotated FIG 7 below which shows the foldable and seam portions, and the flap is the combination of the foldable and seam portions), wherein: the seam portion is attached to the exterior surface of the sleeve by a seaming weld (see annotated FIG 7 below; Examiner notes that the verb term "weld" is broad and merely means "to bring into close association or union". (Defn. No. 2 of "American Heritage® Dictionary of the English Language, Fifth Edition" entry via TheFreeDictionary.com)), the foldable portion is configured to be placed in a folded position in which it covers the seam portion and an unfolded position in which it extends proximally outwardly from the seam portion and does not cover the seam portion (capable of being placed in a folded position and an unfolded position, due to the flexibility of the material), the seam portion is configured to receive thereon a first O-ring of a first protective glove worn by a user of the fluid management system, wherein the seam portion prevents distal sliding of the first O-ring, and in the folded position (capable of receiving and preventing distal sliding, such as by wearing a glove having an O-ring in combination with the cuff), the foldable portion is configured to cover the first O-ring of the first protective glove and prevent distal sliding of the first O-ring sandwiched between the seam portion and foldable portion (capable of covering and capable of preventing distal sliding, such as by folding the cuff over the glove).
Komorowski has the same structure of Lopez as modified by Mellon, except Komorowski has the additional cuff. See Komorowski FIG 7, annotated below to show Komorowski has a sleeve and hand covering similar to the one that results from Lopez’ hand covering being modified to have Mellon’s thumb loop.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to provide a sleeve with both a hand covering as taught by Mellon and a cuff as taught by Komorowski, for the purpose of protection from contamination and to provide an extra layer of isolation (Komorowski col 5 line 1-5).
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As to claim 21, Lopez as modified discloses the protective garment of claim 20, wherein in the folded position, the foldable portion is further configured to prevent distal sliding of a second O-ring of a second protective glove when the second protective glove is worn over the first protective glove and over the foldable portion in the folded state (capable of preventing distal sliding).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SALLY HADEN whose telephone number is (571)272-6731. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Ostrup can be reached at 571-272-5559. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SALLY HADEN
Primary Examiner
Art Unit 3732
/SALLY HADEN/Primary Examiner, Art Unit 3732