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 .
Election/Restrictions
Claims 2-5, 8-12, 15-17, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 8 December 2025.
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 1, 7, 13-14 and 21-28 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.
Claims 1 and 13 are rejected on the basis that each contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 1 and 18 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: at a minimum, pulse oximeters are entirely differently classified from the various absorbent and medical components recited in the rest of the Markush grouping and have a different function of measuring rather than absorbing or medicating. See MPEP 2117.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claim(s) 1, 7 and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2009/0187098 to Makower et al. (Makower hereinafter).
Regarding claim 1, Makower teaches a tampon (570, 572) comprising absorbent material operatively associated (by inclusion) with an absorbent gelling material (e.g. hydrogel, see paragraph 228) for absorbing and retaining bodily fluids from a patient. The examiner notes that the claim requires only “at least one functional additive being selected from one or more of a first group… and a second group…”. As such, the disclosure of hydrogel, an absorbent gelling material, is sufficient to meet the functional additive limitation.
Regarding claim 7, Makower teaches that the absorbent material (hydrogel) is compressible and non-inflatable.
Regarding claim 13, Makower teaches a non-inflatable chassis (570, 572) including absorbent material (hydrogel, see paragraph 228) for absorbing and retaining bodily fluids and containing therein a functional additive (hydrogel).
Regarding claim 14, Makower teaches the use of cotton (which contains cellulose) in the chassis as a homogenous material (paragraph 228).
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.
Claim(s) 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Makower as applied to claims 1 and 13 above, and further in view of US Pre-Grant Publication 2022/0135750 to Robinson et al. (Robinson).
Regarding claim 21, Makower teaches the limitations of claim 1 as discussed above, but does not teach a biohydrogel nasal dressing. Robinson teaches a dissolvable biohydrogel including chitosan succinimide (paragraph 189) which promotes effective wound healing (paragraphs 7-8). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to include a dissolvable biohydrogel as taught by Robinson in order to promote effective wound healing by the tampon of Makower.
Regarding claim 22, Robinson teaches a dissolvable biohydrogel (chitosan succinimide) suitable for a nasal dressing.
Regarding claims 23-24, Robinson teaches that chitosan succinimide and dextran aldehyde (paragraph 19) with a glycerol humectant (paragraph 20) to be mixed at a point of use.
Claim(s) 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Makower in view of WO 2018/167882 to Fukuda et al. (Fukuda, copy and machine translation attached).
Regarding claim 25, Makower teaches the limitations of claim 1 as discussed above, but does not teach differing zones of density. Fukuda teaches that an absorbent article may include zones of differing density (page 8 of translation, second paragraph, “Since the hydrophilic fibers 14 of the first layer 11 are present relatively densely, the hydrophilicity is high”) in order to absorb fluid away from a contact surface (10a). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide zones of differing density as taught by Fukuda in the tampon of Makower in order to absorb fluid away from the external surface.
Regarding claim 26, Makower teaches the limitations of claim 1 as discussed above, but does not teach differing zones of density. Fukuda teaches that an absorbent article may include zones of differing density and hydrophilicity (which vary proportionally, page 8 of translation, second paragraph, “Since the hydrophilic fibers 14 of the first layer 11 are present relatively densely, the hydrophilicity is high”) in order to absorb fluid away from a contact surface (10a). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide zones of differing density and therefore hydrophilicity as taught by Fukuda in the tampon of Makower in order to absorb fluid away from the external surface.
Regarding claim 27, Makower teaches provision of an impermeable barrier (572) defining a surface which would have the effect of retaining fluids in the tampon to at least some effect.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 25 March 2026