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 .
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 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.
DETAILED ACTION
The present application, filed on May 18, 2026, in which claims 1, 5, 6, 9-11, 13, 18, 22-23, 26-27, 53, and 79-85 were presented for examination, of which claims 79-85 were withdrawn by the Examiner due to not being drawn to the elected embodiment, are being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species I (Fig. 1A-1F) in the reply filed on May 18, 2026 is acknowledged.
As MPEP 821 Treatment of Claims Held To Be Drawn to Nonelected Inventions states,
Claims found to be drawn to nonelected inventions, including claims drawn to nonelected species or inventions that may be eligible for rejoinder, are treated as indicated in MPEP § 821.01 through § 821.04.
All claims that the examiner finds are not directed to the elected invention are withdrawn from further consideration by the examiner in accordance with 37 CFR 1.142(b). See MPEP § 821.01 through § 821.04. The examiner should clearly set forth in the Office action the reasons why the claims withdrawn from consideration are not readable on the elected invention. Applicant may traverse the requirement pursuant to 37 CFR 1.143. If a final requirement for restriction is made by the examiner, applicant may file a petition under 37 CFR 1.144 for review of the restriction requirement if the applicant made a timely traversal. See In re Hengehold, 440 F.2d 1395, 169 USPQ 473 (CCPA 1971). When an election results in the withdrawal of claims such that the assigned examiner believes the C* classification picture is incorrect, the examiner should submit a C* classification challenge prior to an action on the merits of the elected claims to ensure the C* classification picture on the application appropriately reflects the elected invention.
The following claims are withdrawn from consideration as they are directed to a nonelected invention: Claims 79-85. See 37 CFR 1.142(b).
These claims are not drawn to the elected invention as required by the restriction, due to method claims and claims directed to a kit, which are not found within the apparatus elected in Species I.
Therefore, Examiner has withdrawn claims 79-85.
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 “medical device (claim 9)” 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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 26 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 26, the limitation “wherein the infant is a preterm infant” in lines: 1-2 is positively claiming the human organism of a preterm infant. Examiner suggests changing the limitation to include functional language, such as “configured to”, “intended for”, and the like.
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.
Claim 53 is 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.
Regarding claim 53, the limitation “wherein the first sleeve portion and the second sleeve portion comprise a reversible opening spanning a full-length of the first sleeve portion, the second sleeve portion, or a combination thereof,” lines: 10-12 is indefinite because it is at first written to where both sleeve portions have to have the reversible opening but then later explains it could be one or the other. Examiner assumes the limitation should be interpreted as “wherein the first sleeve portion and/or the second sleeve portion comprise a reversible opening spanning a full-length of the first sleeve portion, the second sleeve portion, or a combination thereof”.
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.
Claims 1, 5, 10, 11, 13, 23, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Blackburn et al. “Blackburn” (US PG Pub. 20190069609) in view of Rogers (US Patent 7,418,741).
Regarding claim 1, Blackburn discloses a pediatric garment (invention shown in Fig. 1-2), comprising:
a) a body portion (body of 30) comprising a front portion (see annotated Fig. 2 below) and a back portion (see annotated Fig. 2 below) connected to the front portion (as shown in annotated Fig. 1 below), and an upper left side of the front portion (see annotated Fig. 2 below);
b) a first sleeve portion (32) and a second sleeve portion (32), wherein the first sleeve portion is connected to an upper right side of the body portion (see annotated Fig. 2 below) and the second sleeve portion is connected to an upper left side of the body portion (see annotated Fig. 2 below); and
c) a first leg portion (34) and a second leg portion (34), wherein the first leg portion is connected to a lower right side of the body portion (see annotated Fig. 2 below) and the second leg portion is connected to a lower left side of the body portion (see annotated Fig. 2 below), wherein the first sleeve portion or the second sleeve portion comprises a reversible hand covering comprising a fold-over portion (see annotated Fig. 1 below).
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Fig. 1-Examiner Annotated
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Fig. 2-Examiner Annotated
Blackburn does not disclose wherein an upper left side of the front portion comprises a sensor access point comprising a reversible opening;
However, Rogers teaches yet another garment in the field of endeavor of being worn by a patient (Abstract), wherein Rogers teaches an upper left side of the front portion (region where element 16 is positioned in Fig. 1) comprises a sensor access point (16) comprising a reversible opening (Col. 2, lines: 11-15 and lines: 18-22, opening 24, which flap 16 covers).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the upper left side of the front portion as disclosed by Blackburn, by incorporating a sensor access point comprising a reversible opening as taught by Rogers, in order to allow access to the wearers body at the site at the opening for insertion of tubes (Col. 2, lines: 22-25).
Regarding claim 5, Blackburn in view of Rogers disclose wherein the front portion of the body portion (body of 30 of Blackburn) comprises one or more body access regions (region of element 38, in Fig. 1 and 2).
Regarding claim 10, Blackburn in view of Rogers disclose wherein the one or more body access regions (region of element 38, in Fig. 1 and 2 of Blackburn) comprises a reversible opening (opening formed from zipper, 38) comprising a fastener (38).
Regarding claim 11, Blackburn in view of Rogers disclose wherein the fastener comprises a zipper (Par. 0033, lines: 1-4 of Blackburn).
Regarding claim 13, Blackburn in view of Rogers disclose wherein the zipper (38 of Blackburn) extends to, or from, a safety cover (46, Fig. 1 and 2) configured to substantially prevent exposure of the zipper from inside the pediatric garment (“configured to…garment” is considered as a functional limitation, the device of the prior art discloses substantially all of the claimed structural elements and therefore it is fully capable to perform the claimed function).
Regarding claim 23, Blackburn in view of Rogers disclose wherein the pediatric garment (invention shown in Fig. 1-2 of Blackburn) is in a size suited for an infant, a toddler, a child (Abstract).
Regarding claim 26, Blackburn in view of Rogers disclose wherein the infant is a preterm infant (Par. 0030 of Blackburn, examiner notes one of ordinary skill in the art would recognize the garment shown in Fig. 1-2 is capable of being used on a preterm infant).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Blackburn in view of Rogers, further in view of Ochoa et al. “Ochoa” (US PG Pub. 2008/0000006), hereinafter Ochoa.
Regarding claim 6, Blackburn in view of Rogers disclose the invention substantially as claimed above.
They do not explicitly disclose wherein the first sleeve portion and/or the second sleeve portion comprises a reversible opening spanning a full-length of the first sleeve portion or the second sleeve portion.
However, Ochoa teaches yet another pediatric garment (Par. 0060), wherein Ochoa teaches the first sleeve portion comprises a reversible opening spanning a full-length of the first sleeve portion (Par. 0009, examiner notes as shown in Fig. 6A and 6C, where a first sleeve portion is shown with fasteners along a full length of the sleeve, in order to form the reversible opening).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first sleeve portion as disclosed by Blackburn in view of Rogers, by incorporating a reversible opening spanning a full-length of the first sleeve portion as taught by Ochoa, in order to enhance ease of putting on and taking off the garment.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Blackburn in view of Rogers, further in view of Thompson (US PG Pub. 2006/0247745), hereinafter Thompson.
Regarding claim 9, Blackburn in view of Rogers disclose wherein the one or more body access regions (region of element 38, in Fig. 1 and 2 of Blackburn) is configured to provide a medical device access to a body of an individual wearing the pediatric garment (“configured to…garment” is considered as a functional limitation, the device of the prior art discloses substantially all of the claimed structural elements and therefore it is fully capable to perform the claimed function).
They do not explicitly disclose the medical device comprises intravenous therapy lines, gastrostomy tubes, respirators, blood pressure monitor,endotracheal tube, cardiopulmonary monitor, electrocardiogram, phototherapy device,pulse oximeter, ventilator, nasal cannula, feeding tube, infant warming device,intravenous line, umbilical catheter, apnea monitor, central line, mechanical ventilator, nasogastric tube, orogastric tube, oxygen tube, arterial line, infusion and syringe pumps, bubble CPAP, incubator, or any combination thereof.
However, Thompson teaches yet another pediatric garment (Par. 0033), wherein Thompson teaches the garment (10, Fig. 1) includes one or more access apertures (22) to accept a medical device (Par. 0034, lines: 1-3), wherein the medical device comprises an electrocardiogram (Par. 0034, lines: 7-11).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the garment as disclosed by Blackburn in view of Rogers, by incorporating a medical device comprising an electrocardiogram as taught by Thompson, in order to check a patient’s health.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Blackburn in view of Rogers, further in view of Reyes et al. “Reyes” (US PG Pub. 2018/0092413), hereinafter Reyes.
Regarding claim 18, Blackburn in view of Rogers disclose the invention substantially as claimed above.
They do not explicitly disclose wherein the first leg portion,the second leg portion, or a combination thereof comprises ruching extending at a perpendicular angle from a midline of the leg portion.
However, Reyes teaches yet another pediatric garment (Par. 0040), wherein Reyes teaches the first leg portion (708, left leg, Fig. 7), the second leg portion (708, right leg), or a combination thereof comprises ruching (720, Par. 0050) extending at a perpendicular angle from a midline of the leg portion (examiner notes as shown in annotated Fig. 7 below, where element 720 is perpendicular with the annotated midline of the leg portion).
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Fig. 7-Examiner Annotated
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the leg portions as disclosed by Blackburn in view of Rogers, by incorporating a ruching extending at a perpendicular angle from a midline of the leg portion as taught by Reyes, in order to enhance the aesthetic appeal of the garment.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Blackburn in view of Rogers, further in view of Fay et al. “Fay” (US PG Pub. 2018/0049480), hereinafter Fay.
Regarding claim 22, Blackburn in view of Rogers disclose the invention substantially as claimed above.
They do not explicitly disclose the body portion, the first sleeve portion, the second sleeve portion, the first leg portion, the second leg portion, or a combination thereof comprises a fabric, and wherein the fabric comprises organic bamboo.
However, Fay teaches yet another pediatric garment, wherein Fay teaches the body portion, the first sleeve portion, the second sleeve portion, the first leg portion, the second leg portion, or a combination thereof comprises a fabric, and wherein the fabric comprises organic bamboo (Par. 0041, lines: 6-10 and Par. 0042, lines: 1-3, examiner notes the whole garment comprises organic bamboo).
It would have been obvious for a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to use organic bamboo as taught by Fay as the material for the garment of Blackburn in view of Rogers. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, because organic bamboo was a well-known material for pediatric garments as taught by Fay, in order to enhance user comfort.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Blackburn in view of Ochoa.
Regarding claim 53, Blackburn discloses a pediatric garment (invention shown in Fig. 1-2), comprising:
a) a body portion (body of 30) comprising a front portion (see annotated Fig. 2 above) and a back portion (see annotated Fig. 2 above) connected to the front portion (as shown in annotated Fig. 1 above);
b) a first sleeve portion (32) and a second sleeve portion (32), wherein the first sleeve portion is connected to an upper right side of the body portion (see annotated Fig. 2 above) and the second sleeve portion is connected to an upper left side of the body portion (see annotated Fig. 2 above); and
c) a first leg portion (34) and a second leg portion (34), wherein the first leg portion is connected to a lower right side of the body portion (see annotated Fig. 2 above) and the second leg portion is connected to a lower left side of the body portion (see annotated Fig. 2 above),
wherein the first sleeve portion or the second sleeve portion comprises a reversible hand covering comprising a fold-over portion (see annotated Fig. 1 above).
Blackburn does not explicitly disclose wherein the first sleeve portion and the second sleeve portion comprise a reversible opening spanning a full-length of the first sleeve portion, the second sleeve portion, or a combination thereof.
However, Ochoa teaches yet another pediatric garment (Par. 0060), wherein Ochoa teaches the first sleeve portion comprises a reversible opening spanning a full-length of the first sleeve portion (Par. 0009, examiner notes as shown in Fig. 6A and 6C, where a first sleeve portion is shown with fasteners along a full length of the sleeve, in order to form the reversible opening).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first sleeve portion as disclosed by Blackburn, by incorporating a reversible opening spanning a full-length of the first sleeve portion as taught by Ochoa, in order to enhance ease of putting on and taking off the garment.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 27 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Blackburn.
Regarding claim 27, Blackburn discloses a pediatric garment (invention shown in Fig. 1-2), comprising:
a) a body portion (body of 30) comprising a front portion (see annotated Fig. 2 above) and a back portion (see annotated Fig. 2 above) connected to the front portion (as shown in annotated Fig. 1 above);
b) a first sleeve portion (32) and a second sleeve portion (32), wherein the first sleeve portion is connected to an upper right side of the body portion (see annotated Fig. 2 above) and the second sleeve portion is connected to an upper left side of the body portion (see annotated Fig. 2 above); and
c) a first leg portion (34) and a second leg portion (34), wherein the first leg portion is connected to a lower right side of the body portion (see annotated Fig. 2 above) and the second leg portion is connected to a lower left side of the body portion (see annotated Fig. 2 above),
wherein the front portion of the body portion comprises at least two body access regions (Par. 0033, lines: 1-7, regions of elements 192 and 194 in Fig. 14, examiner notes in the embodiment presented in Fig. 1 and 2 it is noted there can be more than one zipper, 38, present, which forms the “body access regions”), and wherein the first sleeve portion or the second sleeve portion comprises a reversible hand covering comprising a fold-over portion (see annotated Fig. 1 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent (See PTO-892) to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAKOTA MARIN whose telephone number is (571)272-3529. The examiner can normally be reached Mon.-Fri., 9:00AM-6:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ALISSA TOMPKINS can be reached at (571) 272-3425. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAKOTA MARIN/Examiner, Art Unit 3732
/ALISSA J TOMPKINS/Supervisory Patent Examiner, Art Unit 3732
