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 Objections
Claim 1 is objected to because of the following informalities:
“the attachment features of the adapter” should recite “[[the]] attachment features of the adapter” as there is no antecedent basis.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Attachment features in claim 1 are being interpreted as any mechanism for wrapping the harness around the thigh of a patient (para. [00024])
Securing features in claim 1 will be interpreted as any mechanism for securing the adapter (para. [00064]).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Drawings
The drawings are objected to because at least Figs. 2F, 3A-3B, 5a-5f, 6B, 7a-8b, 14, 15, 16 contain improper shading. 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.
Election/Restrictions
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 22, 2026.
Applicant’s election without traverse of Group 1: Claims 1-11 in the reply filed on June 22, 2026 is acknowledged.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3, 5-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cathey (US 2012/0323082 A1).
Regarding claim 1, Cathey discloses a device for reducing injury to a patient during a labor and delivery procedure (paras. [0011]-[0020]), comprising: an adapter 10 shaped to engage with a proximal end of a vaginal canal dilation device 20 and to allow the distal end of the dilation device to extend distally from the adapter (paras. [0014]-[0017] Fig. 3) and having mounts (i.e., as shown in Fig. 3 such that 12 is attached to 10 via 16) for receiving a retention harness 12, and a retention harness made of flexible material (para. [0015]) and having a length sufficient to wrap around a thigh 32 of the patient and having a section that traverses the thigh of the patient at a location superior the pubic arch of the patient and having securing features that are shaped to engage with the attachment features of the adapter (Fig. 3para. [0016]), whereby the retention harness restricts the adapter from moving proximally away from the birth canal of the patient (para. [0017]).
Regarding claim 2, Cathey discloses the device of claim 1. Cathey also discloses wherein the retention harness comprises one or more straps of elastic material (para. [0016]).
Regarding claim 3, Cathey discloses the device of claim 2. Cathey also discloses wherein the one or more straps of elastic material include a fastener (i.e., buckle 14) to allowing the one or more straps to form a closed loop around the body of a patient (para. [0015]; Figs. 1-3).
Regarding claim 5, Cathey discloses the device of claim 2. Cathey also discloses wherein the retention harness comprises one strap of flexible material sized to wrap around the waist and around the thighs of the patient to form a harness having two sections of strap positioned between the thighs of the patient and superior to the pubic arch of the patient (Figs. 1-3).
Regarding claim 6, Cathey discloses the device of claim 1. Cathey also discloses wherein the retention harness has a release that disconnects the harness from the patient (i.e., at 14) or the adapter (i.e., at 18).
Cathey is fully capable of having the release disconnect upon application of a proximally directed force that exceeds an expected force of a baby traveling proximally through the birth canal during delivery (i.e., at least 18), if one desired to do so - note that the limitations of claim 6 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Regarding claim 7, Cathey discloses the device of claim 6. Cathey also discloses wherein the release comprises hook and loop fastener arranged on the strap to provide a frangible release for disconnecting the harness from the patient or the adapter (i.e., 18 which is disclosed to be a fastener).
Regarding claim 8, Cathey discloses the device of claim 1. Cathey also discloses wherein the mounts comprise arms extending radially and proximally from the adapter to form a bend that is sized to engage with the retention harness (i.e., Fig. 2 shows 16 which has cutouts to accommodate 12 such that each of the corners form arms around the slot and a bend that engages the harness).
Regarding claim 9, Cathey discloses the device of claim 6. Cathey also discloses wherein the arms are formed as rails that attach to the sides of the adapter and provide an interior slot for receiving the retention harness (i.e., attach via 16 and provide a slot that receives the harness).
Regarding claim 10, Cathey discloses the device of claim 1. Cathey also discloses wherein the adapter comprises a plastic body shaped to fit about a portion of the dilation device (para. [0015]; Fig. 1).
Regarding claim 11, Cathey discloses the device of claim 1. Cathey also discloses wherein the adapter is an integral part of the vaginal canal dilation device (para. [0014]-[0020]).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Cathey in view of Haller et al. (US 2007/0142702 A1).
Regarding claim 4, Cathey discloses the device of claim 2. Cathey doesn’t directly disclose wherein the one or more straps include a hook and loop fastener for allowing the one or more straps to form a closed loop around one or more thighs of the patient.
Cathey does disclose a buckle 14 for allowing the one or more straps to firm a closed loop around one or more thighs of the patient.
Haller teaches the known interchangeability of a hook and loop fastener and a buckle, wherein either a hook and loop fastener or buckle (para. [0035]) can be used with predictable results to one of ordinary skill.
Therefore, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of using a hook and loop fastener in Cathey, since Haller teaches that hook and loop fasteners and buckles are known interchangeable equivalents and therefore the simple substitution of a hook and loop fastener for a buckle would be predictable to a person of ordinary skill in the art without any unexpected results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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