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 .
Status of Claims
Claims 35-52 are pending, of which Claims 35-36, 39, 42, 45, & 48 are amended and Claim 52 is new. No new matter is found.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 35 & 48 are objected to because of the following informalities:
Re Claims 35 & 48, each claim recites that the plunger insertion end is “deformed from a generally cylindrical shape to a polygonal shape.” It is noted that cylindrical is describing a three-dimensional structure while polygonal is describing a two-dimensional element and thus it is not reasonable that the plunger insertion end changes, along an axial length of the plunger, from a three-dimensional shape to a two-dimensional shape. The deformation should be from a circular cross-section to a polygonal cross-section (such an interpretation is based on the Specification).
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 36-38, 42-44 & 52 are rejected under 35 U.S.C. 103 as being unpatentable over Edgett et al. (US 2008/0287902) in view of Schmidt-Forst et al. (US 2013/0018342) and as evidenced by Code of Federal Regulations Title Chapter I Subchapter H Part 801 Subpart H (attached in Non-Final Rejection mailed on 4/30/2026).
Re Claims 36 & 52, Edgett discloses a regular pledget having an absorbency of between about 6 g and about 9 g ("regular" absorbency is well defined in the tampon industry to be 6-9 grams, see 21 CFR § 801.430 attached in Non-Final Rejection mailed on 4/30/2026), wherein the gram-per gram absorbency is between about 5 g/g and about 6 g/g ([0040] discloses that the regular pledget weight is 1.52 g, given an absorbency of 6-9 g, that yields a gram per gram absorbency of to 3.95 to 5.92 g). Edgett does not expressly disclose wherein the pledget has a basis weight of between about 120 gsm and about 140 gsm, or that the basis weight is between 120 gsm and 130 gsm.
Schmidt-Forst discloses a tampon pledget of regular absorbency being formed from a material having a basis weight of 120-150 gsm ([0026]). It would have been obvious to one skilled in the art at the time of filing to modify Edgett with Schmidt-Forst’s absorbent material basis weight because it is a known suitable range for creating regular absorbency tampons.
Re Claim 37, Edgett and Schmidt-Forst combine to disclose claim 36, Edgett further discloses wherein the pledget comprises fiber, wherein the fiber is cotton or rayon or combinations thereof (see [0033]).
Re Claim 38, Edgett and Schmidt-Forst combine to disclose claim 37, but neither explicitly discloses wherein the pledget comprises 100% cotton fiber. However, since Edgett discloses that the list of possible absorbent materials as alternatives of each other ([0033]), suggesting that one skilled in the art would contemplate using only one material out of said list of material to form the absorbent pledget.
Re Claim 42, Edgett discloses a super pledget having an absorbency of between about 9 g and about 12 g (e.g., [0047] or the 21 CFR § 801.430), wherein the gram-per-gram absorbency is between about 5 g/g and about 6 g/g (Table 6a). Edgett does not expressly disclose wherein the pledget has a basis weight of between about 160 gsm and about 175 gsm.
Schmidt-Forst discloses a tampon pledget of super absorbency being formed from a material having a basis weight of 170-180 gsm ([0026]). It would have been obvious to one skilled in the art at the time of filing to modify Edgett with Graham's absorbent material basis weight because it is a known suitable range for creating super absorbency tampons.
Re Claims 43-44, the limitations are taught by Edgett and Schmidt-Forst as explained for Claims 37-38 supra.
Claims 39-41 & 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over Edgett and Schmidt-Forst as applied to claim 37 or 43 above, and further in view of Graham (US 2019/0314213).
Re Claim 39, Edgett and Schmidt-Forst combine to disclose claim 37, and Edgett further discloses wherein the pledget has a cross-pad configuration having at least two pads (see Fig. 1), wherein the at least two pads each comprise the fiber. Edgett and Schmidt-Forst do not disclose wherein each of the at least two pads is formed of a cross-lapped web, wherein the cross-lapped web comprises at least two layers and has been needlepunched with about 40 punches per square centimeter to about 80 punches per square centimeter.
Graham discloses using a cross-lapped multi-layer web ([0026]) that is needlepunched at a density of 60 punches/cm² ([0033]) as the absorbent material for a tampon pledget. It would have been obvious to one skilled in the art at the time of filing to modify further with Graham since it is a known material suitable for use as tampon absorbent material.
Re Claim 40, Edgett, Schmidt-Forst and Graham combine to disclose claim 39, Edgett further discloses wherein the at least two pads have a length between about 7.6 cm and about 12.7 cm, and width of between about 2.54 cm and about 7.6 cm (see e.g., [0026]-[0029] disclosing top pad may be 3.5" long by 1.5" wide and the bottom pad may also be 3.5" long by 1.5" wide).
Re Claim 41, Edgett, Schmidt-Forst and Graham combine to disclose claim 40, but neither explicitly discloses wherein each of the at least two pads comprises 100% cotton. However, since Edgett discloses that the list of possible absorbent materials as alternatives of each other ([0033]), suggesting that one skilled in the art would contemplate using only one material out of said list of material to form the absorbent pledget.
Re Claims 45-47, the limitations are taught by Edgett and Graham as explained for Claims 39-41 supra.
Allowable Subject Matter
Claims 35 & 48-51 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The reasons were indicated in the Non-Final Rejection mailed on 4/30/2026.
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.
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/SUSAN S SU/Primary Examiner, Art Unit 3781 9 July 2026
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