DETAILED ACTION
In Applicant’s Response filed 12/5/25, Applicant has amended claims 1, 8-9, 13, 16 and 20; and amended the abstract. Currently, claims 1-20 are pending.
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 Objections
Claims 1 and 16 are objected to because of the following informalities which require appropriate correction:
In claim 1 line 4: “dimensioned sufficiently large that” should be amended to recite “dimensioned to be sufficiently large so that”.
In claim 1 line 5: “and the umbilicus” should be amended to recite “and is configured such that the umbilicus”.
In claim 1 line 9: “required” should be “requires”.
In claim 16 lines 4-5: “dimensioned sufficiently large that” should be amended to recite “dimensioned to be sufficiently large so that”.
In claim 16 line 6: “and the umbilicus” should be amended to recite “and is configured such that the umbilicus”.
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(s) 1-20 are 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).
Specifically, Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claims 1, 9 and 16 each positively recites part of the human body in combination with the device. In each of these claims, the limitation reciting that “…the device…approximates rectus abdominus muscles…” of the claim encompasses a human being. It has been held that a claim directed to or including within its scope, a human being will not be considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the constitution. Accordingly, proper procedure where a claim is directed to an apparatus “attached to” the human body or any part thereof is to reject such claim under 35 U.S.C 101 with an explanation that, because the claim positively recites a part of the human body, it is directed to nonstatutory subject matter. See Animals – Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987). Therefore, for at least this reason, claims 1, 9 and 16 have been rejected under 35 USC 101. It is suggested that each of these claims be amended to recite that “the device…is configured to approximate rectus abdominus muscles…” in order to overcome this rejection.
Additionally, claim(s) 7 and 20 include the following structural limitations that are defined by areas of the human body: each of these claims recite: “a portion of the first section… which is in contact with skin”. Thus, claims 7 and 20 also define an invention that includes non-statutory subject matter. It is suggested that these claims be amended to recite: “a portion of the first section… which is configured to be in contact with skin…” in order to overcome this rejection.
Claims 2-6 and 8-19 each depend directly or indirectly from a rejected claim and, therefore, contain the same deficiencies as the claims from which they depend.
Allowable Subject Matter
Claims 1-20 are free of art but are still subject to the objections and rejections provided above. Additionally, any changes or amendments to the claims may result in new rejections under 35 USC 102 and/or 35 USC 103 being made in future Actions.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of independent claims 1, 9 and 16 could either not be found or was not suggested in the prior art of record.
With respect to claim 1, the subject matter not found was a device for treatment of an umbilical hernia of an infant or toddler comprising a first section that includes an opening therein and a plurality of extending sections wherein the first section requires greater force to stretch than each of the plurality of extending sections and wherein the device is configured to approximate rectus abdominus muscles of the infant or toddler when positioned around the umbilical hernia to promote closure of the umbilical hernia, in combination with the other elements in the claims.
With respect to claim 9, the subject matter not found was a method of treating an umbilical hernia of an infant or a toddler comprising applying a preassembled device that comprises a first section that includes an opening therein and a plurality of extending sections wherein the first section requires greater force to stretch than each of the plurality of extending sections such that the device is configured to approximate rectus abdominus muscles of the infant or toddler when positioned around the umbilical hernia to promote closure of the umbilical hernia, in combination with the other elements in the claims.
With respect to claim 16, the subject matter not found was a kit comprising a plurality of devices for treatment of an umbilical hernia in an infant or toddler, each of the devices comprising a first section that includes an opening therein that is positionable on the abdomen around the umbilical hernia and a plurality of extending sections wherein the first section requires greater force to stretch than each of the plurality of extending sections and the device thereby is configured to approximate rectus abdominus muscles of the infant or toddler when positioned on the abdomen to promote closure of the umbilical hernia, in combination with the other elements in the claims.
In Applicant’s Remarks (see Response filed 12/5/25) Applicant argued that “…tension provided by the stretched fingers of Arbesman relieves tension on the fascia underlying those fingers and does not directly affect the fascia underlying the central anchoring section of Arbesman…” (Remarks page 13). Applicant further argued that providing an opening in the central anchoring portion of Arbesman would be expected to reduce the amount of force required to stretch that section as compared to a section that does not include an opening (Remarks page 13). Additionally, Applicant argued that the disclosed lack of stretching/tension in the central anchoring portion of Arbesman relates only to application of the device because there is no stretching of the anchoring portion during application and that the elasticity and/or degree of stretching of the fingers indicates nothing about the relative force required to stretch the central anchoring portion of Arbesman (Remarks pages 13-14). The Office is persuaded by these arguments and, therefore, agrees that the prior art of record fails to disclose or suggest the subject matter of claims 1, 9 and 16 as outlined above. Claims 2-8 depend from claim 1 and, therefore, contain the same allowable limitations as claim 1. Claims 10-15 depend from claim 9 and, therefore, contain the same allowable limitations as claim 9. Claims 17-20 depend from claim 16 and, therefore, contain the same allowable limitations as claim 16.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 12/5/25 have been fully considered as follows:
Regarding the objections to the abstract, Applicant’s amendments have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the objections to the claims, Applicant’s amendments to claim 13 have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn. New objections have been given, however, as necessitated by Applicant’s amendments to the claims.
Regarding the claim rejections under 35 USC 103, Applicant’s amendments and arguments have been fully considered and are sufficient to overcome the rejections of record which, accordingly, have been withdrawn. The claims are free of art but are subject to new objections and rejections which were necessitated by Applicant’s amendments to the claims.
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 CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786