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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/12/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Species I (claims 1-10) in the reply filed on 5/29/26 is acknowledged.
Claims 11-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/29/26.
Drawings
The drawings are objected to because Figures 5A-16 have not been made by a process which will give them satisfactory reproduction characteristics on a printed patent. Drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. See 37 CFR 1.84. Appropriate correction is required.
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 § 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.
Claims 1, 9, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by De Palo (US 2,471,864).
Regarding claim 1, De Palo discloses (Figures 1-12) a device for performing a male circumcision, the device comprising: a ring component comprising: a first ring portion (42); and a shaft (30) defining a longitudinal axis and extending proximally from the ring portion (Figure 5), wherein the shaft comprises a longitudinal groove (50; Figures 5 and 7); and a foreskin holder coupled to the ring component and configured to move axially along the shaft, the foreskin holder comprising: a lateral tab (52), extending radially inward (Figure 6), that engages with the longitudinal groove (50) to inhibit lateral movement of the foreskin holder with respect to the ring component (Column 2, lines 30-49); and a second ring portion (20), wherein distal movement of the second ring portion clamps a foreskin (60) between the first ring portion (42) and the second ring portion (20; Figures 10 and 11).
Regarding claim 9, De Palo discloses (Figures 5-7) that the longitudinal groove (50) has a uniform radial depth along a longitudinal length of the groove with respect to an outer surface of the shaft (30).
Regarding claim 10, De Palo discloses (Figure 6) that the lateral tab (52) is disposed on a longitudinal bottom of a concave portion of an arm (10) of the foreskin holder.
Claims 1-4, 6, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kostrzewski (US 2012/0078265 A1).
Regarding claim 1, Kostrzewski discloses (Figures 1-19) a device for performing a male circumcision, the device comprising: a ring component comprising: a first ring portion (ring portion formed at bottom of anvil 60, formed by first section 65 and second section 66 in Figure 2); and a shaft defining a longitudinal axis and extending proximally from the ring portion (remainder of anvil 60 extending upwards from the ring portion), wherein the shaft comprises a longitudinal groove (between guiding protrusions 69, Figure 3); and a foreskin holder (20, 40, 43) coupled to the ring component and configured to move axially along the shaft (Figures 13 and 14), the foreskin holder comprising: a lateral tab (formed between external guide grooves 33, Figure 3), extending radially inward, that engages with the longitudinal groove to inhibit lateral movement of the foreskin holder with respect to the ring component (paragraphs 0047, 0063); and a second ring portion (26), wherein distal movement of the second ring portion clamps a foreskin between the first ring portion and the second ring portion (Figures 13-15; paragraphs 0066-0067).
Regarding claim 2, Kostrzewski discloses that the foreskin holder includes two axially-aligned lateral tabs, both configured to engage with the longitudinal groove (plurality of tabs between 33; Figure 3; paragraph 0063).
Regarding claim 3, Kostrzewski discloses (Figure 3) that the shaft comprises two longitudinal grooves (plurality of longitudinal grooves between guiding protrusions 69) and the foreskin holder includes two lateral tabs (plurality of tabs between 33), each of which engages with a respective one of the two longitudinal grooves (paragraph 0063).
Regarding claim 4, Kostrzewski discloses (Figure 3) that the foreskin holder comprises four lateral tabs comprising two pairs of axially-aligned lateral tabs, each pair of axially-aligned lateral tabs engaging with a respective one of the two longitudinal grooves (see at least two pairs of tabs between 33 and plurality of mating grooves between 69, Figure 3, paragraph 0063).
Regarding claim 6, Kostrzewski discloses (Figure 3) the two longitudinal grooves are radially opposed from each other (the plurality of grooves extend around the circumference of the anvil, between guiding protrusions 69).
Regarding claim 7, Kostrzewski discloses (Figures 1-3 and 9-14) that the shaft comprises a bulbous portion (the shaft bulges outward from the ring component), wherein the longitudinal groove extends into the bulbous portion (grooves between guiding protrusions extend into this portion).
Allowable Subject Matter
Claims 5 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 5 recites that the foreskin holder comprises two arms, each comprising a concave portion, wherein each pair of tabs is associated with a respective one of the arms, with a first one of the tabs in the pair disposed on a longitudinal top of the concave portion and a second one of the tabs in the pair disposed on a longitudinal bottom of the concave portion. These limitations, in combination with the limitations in claim 1 and intervening claims 3 and 4, are not disclosed or suggested by the prior art of record. Both the De Palo reference and the Kostrzewski reference fail to disclose the combination of features required by claim 5.
Tomlinson (US 2008/0004654 A1) discloses a foreskin holder (14; Figures 2-3C) comprising two arms (38), each comprising a concave portion (54), as claimed. However, there is no disclosure or suggestion to modify the arms to each comprise a pair of tabs, with a first one of the tabs in the pair disposed on a longitudinal top of the concave portion and a second one of the tabs in the pair disposed on a longitudinal bottom of the concave portion, as required by claim 5.
Claim 8 recites that the foreskin holder comprises an arm disposed proximally of the second ring portion, the arm comprising a concave portion that interacts with the bulbous portion of the shaft, the lateral tab defined on the arm. These limitations, in combination with the limitations of claim 1 and intervening claim 7, are not disclosed or suggested in the prior art of record. Both the De Palo reference and the Kostrzewski reference fail to disclose the combination of features required by claim 8.
Tomlinson also discloses (Figures 1A, 1B, 4A-9C) a shaft (18) that comprises a bulbous portion (34) and the foreskin holder comprises an arm (38) disposed proximally of the second ring portion, the arm comprising a concave portion (54) that interacts with the bulbous portion of the shaft (paragraph 0028). However, there is no disclosure or suggestion to modify the shaft to comprise a longitudinal groove extending into the bulbous portion and the lateral tab to be defined on the arm, as required by claims 7 and 8.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Santora (US 2,238,660; Figures 1-4), Blais et al. (US 2,296,594; Figures 1-7), and Livoti (US 2,688,969) also disclose devices for performing male circumcision with tab-groove mechanisms to prevent rotation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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/C.D.K/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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