DETAILED ACTIONNotice 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 1-20 are pending in the present application.
Claims 1, 7-11, 13, and 14 having been amended.
Claims 18-20 having been added hereby.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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.
Applicant's arguments filed 5/13/2026 have been fully considered but they are not persuasive.
Regarding the argument submitted for claims 9-11, 15, the applicant defines affinity. However one of ordinary skill in the art would recognize that any two materials would have slightly different affinities for different materials.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 3, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (EP 1938951 A2) in view of Oreglia (US 5470624 A).
Regarding Claim 1, Edwards teaches a packaging enclosure for an ostomy appliance (figure 3), the enclosure comprising:
a body having a base and an upstanding sidewall integral and contiguous with the base (32) and having a peripheral edge opposite the base (figure 3), the base and sidewall defining a storage region (paragraph 25), the base and sidewall formed from a first material (paragraph 26); and
a cover element (34), the cover element formed from a second material (paragraph 26, plastic).
Edwards fails to explicitly teach wherein the base and the cover element are configured to contact the ostomy appliance when the ostomy appliance is disposed in the storage region and the second material has a higher affinity for the ostomy appliance than an affinity of the first material affinity for the ostomy appliance. Oreglia teaches an ostomy bag wherein the base and the cover element are configured to contact the ostomy appliance when the ostomy appliance is disposed in the storage region (column 1, lines 9-20) and the second material has a higher affinity for the ostomy appliance than an affinity of the first material affinity for the ostomy appliance (column 2, lines 52-62). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the package of Edwards so second material has a higher affinity for the ostomy appliance than an affinity of the first material affinity for the ostomy appliance, similar to Oreglia, so that the ostomy device sticks to the packaging.
Regarding Claim 3, Edwards in view of Oreglia teaches a packaging enclosure of claim 1. Edwards further teaches wherein the cover element is sealed to the sidewall peripheral edge (paragraph 26)(figure 4).
Regarding Claim 5, Edwards in view of Oreglia teaches a packaging enclosure of claim 1. Edwards further teaches wherein the cover element includes a grasping region extending from an edge thereof (figure 3: rim).
Regarding Claim 19, Edwards in view of Oreglia teaches a packaging enclosure of claim 1. Edwards further teaches wherein the cover element is configured to remain affixed to the ostomy appliance when the cover element is released and removed from the body and thereby facilitate removal of the ostomy appliance from the storage region (figure 5f) .
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (EP 1938951 A2) in view of Russell (US 20160193003 A1).
Regarding Claim 2, Edwards in view of Oreglia teaches a packaging enclosure of claim 1. Edwards fails to include a pedestal formed in the body extending upwardly from the base. Russell teaches a packaging for an ostomy appliance including a pedestal (56) formed in the body extending upwardly from the base [0028] (figure 3 and 4). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the packaging of Edwards to include a pedestal formed in the body extending upwardly from the base, similar to Russell, in order to support the Ostomy Ring (as motivated by Russell, [0033]).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards (EP 1938951 A2) in view of Holden(US 20210369491 A1).
Regarding Claim 4, Edwards in view of Oreglia teaches a packaging enclosure of claim 1. Edwards fails to teach wherein the sidewall is circular in cross- section. In the same field of endeavor, Holden teaches an ostomy pouch wherein the sidewall is circular in cross- section (figure 1a). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the packing enclosure of Edwards, wherein the sidewall is circular in cross- section similar Holden in order to be compatible with an ostomy appliance.
Claim(s) 9-11, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Russell (US 20160193003 A1) in view of Rea (US 20210290426 A1).
Regarding Claim 9, Russell teaches an ostomy appliance and packaging enclosure, comprising:
an ostomy appliance, the ostomy appliance having first and second surfaces, the ostomy appliance formed from an adhesive material (figure 1, paragraph [15]);
a packaging enclosure comprising:
a body having a base and an upstanding sidewall integral and contiguous with the base and having a peripheral edge opposite the base, the base and sidewall defining a storage region, the base and sidewall formed from a first material (paragraph [20, 21 ]); and
a cover element (paragraph [17]), the cover element formed from a second material, wherein the ostomy appliance is positioned in the storage region with the first surface positioned on the base, wherein the cover element is positioned on the upstanding sidewall and in contact with the ostomy appliance second surface (figure 6)
Russell fails to teach wherein the second material has a higher affinity for the ostomy appliance than the first material affinity for the ostomy appliance. Rea teaches an ostomy appliance and packaging the second material (wafer) has a higher affinity for the ostomy appliance than the first material (pouch) affinity for the ostomy appliance (paragraph [0059: wafer adhesive removes ostomy appliance from pouch]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the packaging of Russel to include wherein the second material has a higher affinity for the ostomy appliance than the first material affinity for the ostomy appliance, similar to Rea, in order to remove the ostomy appliance in a sterile way.
Regarding Claim 10, Russell in view of Rea teaches an ostomy appliance and packaging enclosure of claim 9. Russell fails to teach wherein the ostomy appliance remains affixed to the cover element when the cover element is removed from the packaging enclosure. Rea teaches wherein the ostomy appliance remains affixed to the cover when the cover is removed from the packaging enclosure (paragraph [0059: wafer adhesive removes ostomy appliance from pouch]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the packaging of Russel to include wherein the ostomy appliance remains affixed to the cover when the cover is removed from the packaging enclosure, similar to Rea, in order to remove the ostomy appliance in a sterile way.
Regarding Claim 11, Russell in view of Rea teaches an ostomy appliance and packaging enclosure of claim 9. Russell further teaches wherein the cover element is sealed to the upstanding side wall (paragraph [0016-0017]).
Regarding Claim 15, Russell teaches an ostomy appliance and packaging enclosure of claim 9. Russell further teaches wherein the ostomy appliance is a barrier ring (64) (paragraph [0033](fig. 4)
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (EP 1938951 A2) in view of Seres (US 20200188161 A1).
Regarding Claim 6, Edwards in view of Oreglia teaches a packaging enclosure of claim 1. Edwards fails to explicitly teach wherein the body is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof. Seres teaches an Ostomy bag wherein the body is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof (paragraph [0267]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the packaging of Edwards, wherein the body is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof, similar to Seres so the container is flexible and sterile (Seres, paragraph [0267]).
Regarding Claim 7, Edwards in view of Oreglia teaches a packaging enclosure of claim 1. Edwards fails to explicitly teach wherein the cover element is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof. Seres teaches an Ostomy bag wherein the body is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof (paragraph [0267]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the packaging of Edwards, wherein the cover is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof, similar to Seres so the container is flexible and sterile (Seres, paragraph [0267]).
Regarding Claim 8, Edwards teaches a packaging enclosure of claim 6. Edwards fails to explicitly teach wherein the cover element is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof. Seres teaches an Ostomy bag wherein the body is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof (paragraph [0267]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the packaging of Edwards, wherein the cover is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof, similar to Seres so the container is flexible and sterile (Seres, paragraph [0267]).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Russell (US 20160193003 A1) in view of Rea (US 20210290426 A1) in view of Seres (US 20200188161 A1).
Regarding Claim 12, Russell in view of Rea teaches an ostomy appliance and packaging enclosure of claim 9. The combination fails to explicitly teach wherein the body is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof. Seres teaches an Ostomy bag wherein the body is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof (paragraph [0267]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the packaging of Russell, wherein the body is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof, similar to Seres so the container is flexible and sterile (Seres, paragraph [0267]).
Regarding Claim 13, Russell in view of Rea teaches an ostomy appliance and packaging enclosure of claim 9. The combination fails to explicitly teach wherein the cover element is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof. Seres teaches an Ostomy bag wherein the bag is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof (paragraph [0267]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the packaging of Russell, wherein the cover is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof, similar to Seres so the container is flexible and sterile (Seres, paragraph [0267]).
Regarding Claim 14, Russell in view of Rea and Seres teaches an ostomy appliance and packaging enclosure of claim 12. The combination fails to explicitly teach wherein the cover element is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof. Seres teaches an Ostomy bag wherein the bag is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof (paragraph [0267]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the packaging of Russell, wherein the cover is formed of polyethylene (PE), polyethylene terephthalate (PET), polypropylene, polyester, polyimide, polyoxymethylene, organosiloxane, or cellulosic or paper-based materials or combinations thereof, similar to Seres so the container is flexible and sterile (Seres, paragraph [0267]).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Russell (US 20160193003 A1) in view of Rea (US 20210290426 A1) in view of Austin (US 20220096262 A1).
Regarding Claim 16, Russell in view of Rea and Austin teaches an ostomy appliance and packaging enclosure of claim 15. Russell fails to teach wherein the barrier ring is formed from a hydrocolloid material. In the same field of endeavor, ostomy appliances, Austin teaches wherein the barrier ring is formed from a hydrocolloid material (paragraph [0033]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Russel teaches wherein the barrier ring is formed from a hydrocolloid material, similar to Austin, in order to last longer inside the cooler temperature of a well-ventilated pouch.
Regarding Claim 17, Russell in view of Rea and Austin teaches an ostomy appliance and packaging enclosure of claim 16. Russell fails to teach wherein the barrier ring material further includes ceramide. In the same field of endeavor, ostomy appliances, Austin teaches wherein the barrier ring material further includes ceramide (paragraph [0033]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Russel teaches wherein the barrier ring material further includes ceramide, similar to Austin, in order to last longer inside the cooler temperature of a well-ventilated pouch.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Russell (US 20160193003 A1) in view of Rea (US 20210290426 A1) in view of Allen (US 20240108492 A1)..
Regarding Claim 18, Russell in view of Rea teaches an ostomy appliance and packaging enclosure of claim 9. The combination fails to explicitly teach, wherein the cover element is formed from a flexible and pliable material. Allen teaches an Ostomy collection device wherein the cover element is formed from a flexible and pliable material [0042]. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the combination so wherein the cover element is formed from a flexible and pliable material similar to Allen so that the device fits in the cavity easily.
Claim(s) 20 are rejected under 35 U.S.C. 103 as being unpatentable over Russell (US 20160193003 A1) in view of Oreglia (US 5470624 A) in view of Allen (US 20240108492 A1).
Regarding Claim 20, Edwards in view of Oreglia teaches a packaging enclosure of claim 1. Edwards fails to explicitly teach wherein the cover element is formed from a flexible and pliable material. Allen teaches an Ostomy collection device wherein the cover element is formed from a flexible and pliable material [0042]. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the combination so wherein the cover element is formed from a flexible and pliable material similar to Allen so that the device fits in the cavity easily.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 11202719 B2, US 6071268 A, and US 4710182 A.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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.
/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
