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 .
Response to Amendment
This office action is responsive to the amendment filed on 09/16/2025. As directed by the amendment: claims 1, 2, 8, 9, and 13 have been amended, claims 4, 5, 7, 10, 12, and 15-20 have been cancelled and claims 21-31 have been added. Thus, claims 1-3, 6, 8, 9, 11, 13, 14, and 21-31 are presently pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 6, 8, 9, 11, 13, and 14 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 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 13 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baschnagel (US 20110160635 A1).
Regarding claim 13, Baschnagel discloses (fig. 1-3) a hygiene device for use with a body orifice of a living being (see abstract), the hygiene device comprising:
a) a head 130 adapted for use in the body orifice (see fig. 3 and [0042]), said head 130 being formed of one or more absorbent materials (cotton) that are adapted to collect substances from the body orifice (see note below);
b) a handle 106 connected to said head 130 (see [0038] and fig. 3) to enable said head to be inserted into the body orifice to collect substances and to be subsequently removed from the body orifice to remove the collected substances (see note below);
c) a dispensing system disposed in said handle for dispensing a desired solution to said head (see [0042]), said dispensing system including a tab 136 for releasing said desired solution to said head 130 (see [0042]).
The language “absorbent materials that are adapted to collect substances from the body orifice… to enable said head to be inserted into the body orifice to collect substances and to be subsequently removed from the body orifice to remove the collected substances” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Baschnagel meets the structural limitations of the claim, and is capable of enable said head to be inserted into the body orifice to collect substances and to be subsequently removed from the body orifice to remove the collected substances. The head is made of cotton and connected to the handle, therefore it is capable of being inserted into the body orifice to collect substances and subsequently removed from the body orifice to remove the collected substances.
Regarding claim 14, Baschnagel further discloses (fig. 1-3) said dispensing system includes a reservoir 128 adapted for containing said solution (see [0042]) and one or more channels 142 for transferring said solution from said reservoir 128 to said head 130 (see fiug. 3 and [0042]).
Claims 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heneghan (US 5,855,214).
Regarding claim 29 Heneghan discloses (fig. 7-11) a hygiene device for use with a body orifice of a living being (see abstract), the hygiene device comprising:
a) a head 18+12 (see fig. 9 and 11) adapted for use in the body orifice, said head 18+12 being formed from multiple layers of material that are adapted to collect substances from the body orifice (see note below) wherein said multiple layers of material include an inner layer 18 of material and an outer layer of material 12 (see fig. 9), said inner layer 18 of material having different properties than said outer layer 12 of material (see col. 2 ln. 57-66); and
b) a handle 14 connected to said head 18+12 (see col. 2 ln. 32-41) to enable said head to be inserted into the body orifice to collect substances and to be subsequently removed from the body orifice to remove the collected substances (see note below).
The language “that are adapted to collect substances from the body orifice… to enable said head to be inserted into the body orifice to collect substances and to be subsequently removed from the body orifice to remove the collected substances” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Heneghan meets the structural limitations of the claim, and is capable of enable said head to be inserted into the body orifice to collect substances and to be subsequently removed from the body orifice to remove the collected substances. The head is made of foam and connected to the handle, therefore it is capable of being inserted into the body orifice to collect substances and subsequently removed from the body orifice to remove the collected substances.
Regarding claim 30 Heneghan further discloses (fig. 7-11) said inner layer of material has a different rate of absorbency than said outer layer of material (see col. 2 ln. 57-66).
Regarding claim 31 Heneghan further discloses (fig. 7-11) said outer layer of material is softer than said inner layer of material (see col. 2 ln. 57-66).
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.
Claims 1-3, 6, 8, 9, 11, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20180333163 A1) in view of Monthony et al. (US 5,091,316).
Regarding claims 1 and 2 Anderson discloses (fig. 1-4) a hygiene device for use with a body orifice of a living being (see abstract), the hygiene device comprising:
a) a head 70 adapted for use in the body orifice (see fig. 2 and [0022]), said head 70 being formed from an absorbent sponge material adapted to collect substances from the body orifice (see [0028]); and
b) a handle 90 connected to said head 70 (see [0023] and fig. 3) to enable said head 70 to be inserted into the body orifice to collect substances and to be subsequently removed from the body orifice to remove the collected substances (see fig. 4 and [0030]).
Anderson is silent regarding said head being formed from an open cell polyurethane foam material having between 50 to 500 pores per inch; said head has between 80 to 120 pores per inch.
However Monthony, in the same filed of endeavor, teaches (fig. 1-2) a head 11 formed from an open cell polyurethane foam material (see col. 4 ln. 38-57) having between 50 to 500 pores per inch; said head has between 80 to 120 pores per inch (see col. 4 ln. 58-66).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective e filing date of the claimed invention, to modify Anderson to have said head being formed from an open cell polyurethane foam material having between 50 to 500 pores per inch; said head has between 80 to 120 pores per inch as taught by Monthony, for the purpose of uniquely being able to maintain viable microorganisms in the foam for a greater period of time (see Monthony col. 5 ln. 15-23).
Regarding claim 3, Anderson as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Anderson further discloses (fig. 1-4) a flange 82 that is adapted to limit the extent to which said head 70 may be inserted into the body orifice (see [0030]).
Regarding claim 6, Anderson as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Anderson further discloses (fig. 1-4) said head 70 is releasably attached to said handle 90 (see fig. 1 and [0028]).
Regarding claim 8, Anderson as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Anderson further discloses (fig. 1-4) said head 70 has a volumetric shape (see fig. 3) and said orifice has a volumetric shape (see fig. 4), and wherein the volumetric shape of said head generally corresponds to the volumetric shape of said orifice (see [0002]-[0004]).
Regarding claim 9, Anderson as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Anderson further discloses (fig. 1-4) said head 70 has a volume and said orifice has a volume, and wherein the volume of said head that is adapted to fill at least 25% of the volume of said orifice (see fig. 4).
Regarding claim 11, Anderson as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Anderson further discloses (fig. 1-4) said orifice comprises the anterior nares (see fig. 4).
Claims 1 and 23-25 are rejected under a variant interpretation of Anderson in view of Monthony
Regarding claims 1 Anderson discloses (fig. 1-4) a hygiene device for use with a body orifice of a living being (see abstract), the hygiene device comprising:
a) a head 20 adapted for use in the body orifice (see fig. 2 and [0022]), said head (70 of 20; see [0022]) being formed from an absorbent sponge material adapted to collect substances from the body orifice (see [0028]); and
b) a handle 90 connected to said head 20 (see [0023] and fig. 3) to enable said head 20 to be inserted into the body orifice to collect substances and to be subsequently removed from the body orifice to remove the collected substances (see fig. 4 and [0030]).
Anderson is silent regarding said head being formed from an open cell polyurethane foam material having between 50 to 500 pores per inch.
However Monthony, in the same filed of endeavor, teaches (fig. 1-2) a head 11 formed from an open cell polyurethane foam material (see col. 4 ln. 38-57) having between 50 to 500 pores per inch (see col. 4 ln. 58-66).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Anderson to have said sponge portion of said head being formed from an open cell polyurethane foam material having between 50 to 500 pores per inch as taught by Monthony, for the purpose of uniquely being able to maintain viable microorganisms in the foam for a greater period of time (see Monthony col. 5 ln. 15-23).
Regarding claim 23, Anderson as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Anderson further discloses (fig. 1-4) said head 20 is formed from multiple layers of material (70 and element defined as 26-28, see fig. 1 and [0022]-[0023]) wherein one of said multiple layers of material 70 is said open cell polyurethane foam material (70 is modified above in claim 1 to be said open cell polyurethane foam).
Regarding claim 24, Anderson as modified discloses the claimed invention substantially as claimed, as set forth above for claim 23. Anderson further discloses (fig. 1-4) said multiple layers of material include an inner layer of material (element defined as 26-28, see fig. 1 and [0023]) and an outer layer of material 70, wherein said inner layer of material has a different rate of absorbency than said outer layer of material (element defined as 26-28 is not a sponge material, thus has a different rate of absorbency).
Regarding claim 25, Anderson as modified discloses the claimed invention substantially as claimed, as set forth above for claim 23. Anderson further discloses (fig. 1-4) said multiple layers of material include an inner layer of material (element defined as 26-28, see fig. 1 and [0023]) and an outer layer of material 70, wherein said outer layer of material is softer than said inner layer of material (element defined as 26-28 is not a sponge material, is harder than 70).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson in view of Monthony as applied to claim 1 above, and further in view of George (US 4,935,001).
Regarding claim 26, Anderson as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Anderson as modified is silent regarding said open cell polyurethane foam material of said head is molded to define an outer surface with textured elements.
However George, in the same filed of endeavor, teaches (fig. 1) wherein an absorbent material of a head 12 (see col. 1 ln. 60 – col. 2 ln. 2) defines an outer surface with textured elements 16 (see fig. 1 and col. 2 ln. 7-13).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Anderson as modified to have said open cell polyurethane foam material of said head define an outer surface with textured elements as taught by George, for the purpose of improving the removal/application of substances by having elements that those substances can collect (see George col. 2 ln. 20-32).
Anderson as modified is silent regarding the textured surface is molded in the foam material.
The claimed phrase “said open cell polyurethane foam material of said head is molded to define an outer surface with textured elements” is being treated as a product by process limitation; that is, that the textured surface is molded in the foam material. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Anderson as modified is silent as to the process used to form the texture elements, it appears that the product in Anderson as modified would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of textured polyurethane foam.
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson in view of Monthony as applied to claim 1 above, and further in view of Baschnagel.
Regarding claim 27-28, Anderson as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Anderson as modified is silent regarding said handle is hollow and adapted to contain a desired solution for dispensing through said head; a tab for releasing said desired solution from said handle to said head.
However Baschnagel, in the same filed of endeavor, teaches (fig. 1-3) a handle 106 that is hollow and adapted to contain a desired solution for dispensing through a head 130 (see [0024]); a tab 136 for releasing said desired solution from said handle 106 to said head 130 (see [0042]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Anderson as modified to have said handle is hollow and adapted to contain a desired solution for dispensing through said head; a tab for releasing said desired solution from said handle to said head as taught by Baschnagel, for the purpose of being able to apply a medical treatment as needed (see Baschnagel [0044]).
Claims 1, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Heneghan in view of Monthony.
Regarding claim 1 Heneghan discloses (fig. 1-3) a hygiene device for use with a body orifice of a living being (see abstract), the hygiene device comprising:
a) a head 12 (see fig. 9 and 11) adapted for use in the body orifice, said head 12 being formed from an absorbent material adapted to collect substances from the body orifice (see note below); and
b) a handle 14 connected to said head 12 (see col. 2 ln. 32-41) to enable said head to be inserted into the body orifice to collect substances and to be subsequently removed from the body orifice to remove the collected substances (see note below).
The language “adapted to collect substances from the body orifice … to enable said head to be inserted into the body orifice to collect substances and to be subsequently removed from the body orifice to remove the collected substances” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Heneghan meets the structural limitations of the claim, and is capable of enable said head to be inserted into the body orifice to collect substances and to be subsequently removed from the body orifice to remove the collected substances. The head is made of foam and connected to the handle, therefore it is capable of being inserted into the body orifice to collect substances and subsequently removed from the body orifice to remove the collected substances.
Heneghan is silent regarding said head being formed from an open cell polyurethane foam material having between 50 to 500 pores per inch.
However Monthony, in the same filed of endeavor, teaches (fig. 1-2) a head 11 formed from an open cell polyurethane foam material (see col. 4 ln. 38-57) having between 50 to 500 pores per inch (see col. 4 ln. 58-66).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Heneghan to have said absorbent portion of said head being formed from an open cell polyurethane foam material having between 50 to 500 pores per inch as taught by Monthony, for the purpose of uniquely being able to maintain viable microorganisms in the foam for a greater period of time (see Monthony col. 5 ln. 15-23).
Regarding claim 21, Heneghan as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Heneghan further discloses (fig. 1-3) said handle has a post (straight portion of 16) and a collar (screw of 16; see fig. 2-3) that are adapted to receive and support said head 12 (see fig. 2-3 and col. 2 ln. 49-56)
Regarding claim 22, Heneghan as modified discloses the claimed invention substantially as claimed, as set forth above for claim 21. Heneghan as modified is silent regarding said head is molded onto said post over said collar.
The claimed phrase “said head is molded onto said post over said collar” is being treated as a product by process limitation; that is, that the said head is molded onto said post over said collar. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Heneghan as modified is silent as to the process used to form the texture elements, it appears that the product in Heneghan as modified would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of foam.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771