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 35-51 are pending, of which Claims 35, 36, 42 & 48 are independent. All claims are examined on the merits.
Claim Interpretation
Examiner notes that independent Claims 35 & 48 recites that the plunger insertion end is “deformed from a generally cylindrical shape to a polygon shape.” This limitation is interpreted to mean that in an earlier configuration, e.g., during an earlier stage in the manufacturing process, the plunger insertion end is cylindrical (with a circular cross-section), and a later configuration of the plunger insertion end is polygonal (with a polygonal cross-section). Examiner further notes that such an interpretation means that the limitation is a product-by-process limitation (see MPEP 2113). In other words, the limitation is simply reciting that the plunger insertion end has a polygonal shape. The method step to arrive at the polygonal shape is “the insertion end is deformed from a generally cylindrical shape” (emphasis added), which does not give patentability to the insertion end having a polygonal cross-section.
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 polygon shape.” Examiner notes that “cylindrical” is an adjective while “polygon” is a noun and recommends either changing both to adjectives or both to nouns. Additionally, cylinder is a three-dimensional object while polygon is a two-dimensional shape. Examiner thinks that the comparison should be between a circular cross-section and a polygonal cross-section for the plunger.
Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 39-41 & 45-47 are 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.
Re Claims 39 & 45, it is recited “wherein the fiber has undergone a cross-lapping to form at least two layers and has been needlepunched …” This limitation seems to suggest that the fiber (i.e., an individual strand, not a web) forms at least two layers and the fiber is also needlepunched. Examiner thinks that Applicant intends to recite that each of the at least two pads is formed of a cross-lapped web (also known as cross-laid), wherein the cross-lapped web has at least two layers. Additionally, Examiner thinks that Applicant intends to recite that the at least two layers of the cross-lapped web have been needlepunched (which would cause mechanical entanglement of fibers in the at least two layers, thus forming an integral web).
Claims 40-41 & 46-47 are rejected for being dependent from Claim 39 or 45.
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 36-47 are rejected under 35 U.S.C. 103 as being unpatentable over Edgett et al. (US 2008/0287902) in view of Graham (US 2019/0314213) and as evidenced by Code of Federal Regulations Title Chapter I Subchapter H Part 801 Subpart H (“21 CFR § 801.430 – User labeling for menstrual tampons”).
Re Claim 36, 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 attached 21 CFR § 801.430), 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 145 gsm. Graham discloses a tampon pledget of regular absorbency being formed from a material having a basis weight of 144 gsm ([0033]). 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 regular absorbency tampons.
Re Claim 37, Edgett and Graham 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 Graham 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 39, Edgett and Graham 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 does 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 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 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 Claim 42, Edgett discloses a super pledget having an absorbency of between about 9 g and about 12 g (e.g., [0047] or the attached 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 190 gsm. Graham discloses a tampon pledget of regular absorbency being formed from a material having a basis weight of 191 gsm ([0034]). 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 43-47, the limitations are taught by Edgett and Graham as explained for Claims 37-41 supra.
Allowable Subject Matter
Claims 35 & 48-51 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Re Claims 35 & 48, no prior art is found to disclose a plunger for a tampon applicator that comprises, inter alia, an insertion end having a polygonal cross-section as well as a body portion that is cylindrical. In other words, the claimed invention(s) involve a plunger that transitions from a circular cross-section in a mid-portion of the plunger to a polygonal cross-section at an insertion end of the plunger.
Relevant reference Avery, Jr. et al. (US 2005/0038373) discloses a plunger (30, Fig. 2) that has an insertion end (26) that is slitted (34) and deformed/compressed to have a larger diameter (D2, see Fig. 2 & [0024]). No detailed drawing is shown in Avery regarding the shape of the deformed insertion end, but it can be reasoned that said deformed insertion end may represent a flower with radiating petals, where each petal is separate from an adjacent petal by the slit, and such a flower shape would not be reasonably interpreted as a polygon by one skilled in the art.
Another relevant reference, Porat (US 6,248,089) discloses a tampon applicator plunger that can have a cross-section of different shapes, see Figs. 11-14 but does not disclose that a middle portion of the plunger has a circular cross-section while an insertion end of the plunger has a polygonal cross-section.
Claims 49-51 are allowed for being dependent from Claim 48.
Conclusion
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/SUSAN S SU/Primary Examiner, Art Unit 3781 25 April 2026
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