Prosecution Insights
Last updated: August 07, 2026
Application No. 18/980,438

SANITARY BAG FOR MEDICAL USE

Non-Final OA §102§103§DP
Filed
Dec 13, 2024
Priority
Dec 15, 2023 — FR 2314270 +1 more
Examiner
WRUBLESKI, MATTHEW JAMES
Art Unit
Tech Center
Assignee
Cleanis
OA Round
1 (Non-Final)
60%
Grant Probability
Moderate
1-2
OA Rounds
1y 4m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allowance Rate
67 granted / 112 resolved
At TC average
Strong +59% interview lift
Without
With
+59.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
41 currently pending
Career history
153
Total Applications
across all art units

Statute-Specific Performance

§101
1.3%
-38.7% vs TC avg
§103
56.9%
+16.9% vs TC avg
§102
20.0%
-20.0% vs TC avg
§112
16.6%
-23.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 112 resolved cases

Office Action

§102 §103 §DP
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 . Claim Objections Claim 2-8 objected to because of the following informalities: The claims use the term “being” causing a grammatical issue. Claim 2 reads “the plastic film as claim in claim 1, being translucent” but should read “the plastic film of claim 1, where the film is translucent.” Claim 3 reads “the plastic film as claim in claim 1, being white in color…”. The claim should read “the plastic film of claim 1, where the film is white…”. Claim 4 reads “the plastic film as claim in claim 1, being transparent”. The claim should read “the plastic film of claim 1, where the film is transparent”. Claim 5 reads “the plastic film as claim in claim 1, said recycled plastic being manufactured from a recycled plastic resin of sufficiently high grade that the melt flow…”. The claim should read “the plastic film of claim 1, where said recycled plastic is manufactured from a recycled plastic resin of sufficiently high grade such that the melt flow…”. Claim 6 reads “the plastic film as claim in claim 1, said recycled plastic being manufactured from a recycled plastic resin of sufficiently high grade that the resin density…”. The claim should read “the plastic film of claim 1, where said recycled plastic is manufactured from a recycled plastic resin of sufficiently high grade such that the resin density……” Claim 7 reads “the envelope being formed”. The claim should read “where the envelope is formed”. Claim 7 also reads “notably slidably mounted” and should read “said aperture slidably mounted” Claim 8 reads “the bag being a sanitary bag, in particular for medical use”. The claim should read “where the bag is a sanitary bag, configured for medical use”. Appropriate correction is required. Claim Rejections - 35 USC § 102 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 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Bayne US 2023/0363595, hereafter Bayne. Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bayne US 2023/0363595, hereafter Bayne, provided in the IDS filed 06/20/2025. Regarding Claim 1, Bayne discloses a plastic film (bag 21) comprising more than 30% recycled plastic (para. 0039). The examiner notes that as the bag is made from recycled plastic, it is interpreted that it comprises 100% recycled plastic. 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. The examiner notes that as seen above, Bayne can be used to reject claim 1 under 35 U.S.C 102(a)(1) and (a)(2). However, as a means to achieve compact prosecution in view of the dependent claims, the examiner provides a second rejection of Bayne under 35 U.S.C 103. Claim(s) 1,5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bayne in view of Olson et al. US 2017/0175066, hereafter Olson, and as evidenced by Leahy, M. (2019, March 25). Understanding plastic recycling codes: Your guide to the RIC. Understanding Plastic Recycling Codes: Your Guide to the RIC. https://sustainablebrands.com/read/understanding-plastic-recycling-codes-your-guide-to-the-ric, hereafter Leahy. . Regarding Claim 1, Bayne discloses a plastic film (bag 21) comprising more than 30% recycled plastic (para. 0039). The examiner notes that as the bag is made from recycled plastic, it is interpreted that it comprises 100% recycled plastic. However, should applicant argue that the bag is not a film, in an effort to achieve compact prosecution the examiner brings in prior art reference Olsen to teach that a biological material bag (thus Olson is considered analogous to the claimed invention) may suitably be made from a low-density polyethylene (LDPE) film (para. 0016). Per the same citation, said LDPE has a melt index of 0.8 to 2.5 g/10 min. Per paragraph 0072, the film comprises LDPE, where the second film layer may use the same LDPE (para. 0077). As further detailed under para. 0072 the bag is stated to be able to be made from various polymers or a combination, therefore it is interpreted that the bag be made from only one type of polymer and thus would be made from 100% of said polymer. Per para. 0116¸ LDPE used has a density of 0.88-0.925 g/cm3 . Therefore, as Olson teaches that biological material storage bags may be suitably made from a LDPE film, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use LDPE as the recycled material as taught by Bayne. The examiner notes that should applicant argue that LDPE is not recycled, the examiner points to the evidentiary reference Leahy, according to the Resin Identification Code (RIC), type 4 correlates to LDPE which although not accepted by most curbside programs, is accepted for in-store drop off recycling, thus evidencing that LDPE is recyclable. Regarding Claim 5, Bayne and Olson teach the plastic film as claimed in claim 1, said recycled plastic being manufactured from a recycled plastic of sufficiently high grade that the melt flow index of the resin is greater than or equal to 1.40 g/10 min. As detailed under the 103 rejection of Claim 1, Olson teaches that LDPE used for films for said bags has a melt flow index of 0.8 to 2.5 g/10 min. As the prior art range overlaps with the claimed range, and there is a lack of criticality in the claimed range found in applicant’s specification, the range of Olson anticipates the claimed range and thus reads to the claimed limitation. Regarding Claim 6, Bayne and Olson teach the plastic film as claimed in claim 1, said recycled plastic being manufactured from a recycled plastic resin of sufficiently high grade that the resin density is greater than 0.9 g/cm3. As detailed under the 103 rejection of Claim 1, Olson teaches that LDPE used for films for said bags has a density of 0.88-0.925 g/cm3. As the prior art range overlaps with the claimed range, and there is a lack of criticality in the claimed range found in applicant’s specification, the range of Olson anticipates the claimed range and thus reads to the claimed limitation. Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bayne in view of Olson and Leahy as evidenced by ULINE 9x12'' Mil Colored Poly Bags- White 9 x 12" 2 Mil Colored Poly Bags - White https://www.uline.com/Product/Detail/S-15159W/Flat-Poly-Bags/9-x-12-2-Mil-Colored-Poly-Bags-White , hereafter ULINE. Regarding Claim 2, Bayne and Olson teach the plastic film as claimed in claim 1. While Bayne is disclosed to be made from a plastic, it is not specifically stated that the film is translucent. The evidentiary ULINE reference depicts a bag, made from RIC #4 (evidenced by Leahy to be LDPE), that is white. As seen in the image provided, the bag allows light through allowing the objects to be seen on this inside (in this case a paintbrush). Therefore, as ULINE evidences that LDPE bags are able to let light through to see objects within, it is interpreted that the bag of Bayne and Olson is translucent. Regarding Claim 3, Bayne and Olson teach the plastic film as claimed in claim 1, but fail to teach the bag being white in color when viewed under white light. The evidentiary ULINE reference depicts a bag, made from RIC #4 (evidenced by Leahy to be LDPE), that is white. Therefore, as ULINE evidences LDPE bags may be white, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to manufacture the LDPE bag of the prior art to be white, as said color of bag is known in the art. Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bayne in view of Olson and Leahy as evidenced by ULINE 6x16'' .65 Mil Newspaper Bags https://www.uline.com/Product/Detail/S-12341/Flat-Poly-Bags/6-x-16-65-Mil-Newspaper-Bags , hereafter ULINE2. Regarding Claim 4, Bayne and Olson teach the plastic film as claimed in Claim 1, but fail to specifically teach the bag being transparent. The evidentiary ULINE2 reference depicts a bag, made from RIC #4 (evidenced by Leahy to be LDPE), that is transparent. Therefore, as ULINE2 evidences that LDPE bags are transparent, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to manufacture the LDPE bag of the prior art to be transparent, as said property of bags is known in the art. Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bayne in view of Olson and further in view of Huguenin FR 3081103, hereafter Huguenin. The examiner notes that Huguenin was provided in the parent application. However, the examiner attaches a copy as well as a translation in this application. Regarding Claim 7, Bayne and Olson teach a bag comprising. However, as seen in figure 6 of Bayne, the bag is open and thus does not read to the limitation of a leak tight envelope provided with an aperture, the envelope being formed from a plastic film as claimed in claim 1, optionally, at least one tie for closing said aperture, notably slidably mounted in a hem of the envelope so that extraction of said closing tie from said hem reduces said aperture. Huguenin teaches a sanitary bag (10) comprising an envelope (12), first and second closure ties (141 and 142) extending in hems (241 and 242) and an opening (20), interpreted as an aperture (see page 1, first paragraph). The examiner further notes that the closure links are mounted in the hems such that extraction constricts the opening (see page 1, third paragraph). Further, per page 2 third and fourth paragraph, the closure ties tighten the bag and then are tightened again to seal the bag and isolate its contents from the outside. Per page 4, first paragraph, the bag of Huguenin is made from polyethylene. Therefore, as a means to seal waste contents disposed in the polyethylene bag of Bayne and Olson, it would have been obvious to one having ordinary skill in the art to form the bag in the envelope configuration with closure links as taught by Huguenin. Doing so would merely require the simple substitution of one known (open plastic bag) element for another plastic (bag with closure links) to obtain predictable results, that being the sealing and isolating or waste within the bag, and thus a prima facie case of obviousness exists. Regarding Claim 8, Bayne, Olson, and Huguenin teach the bag as claimed in claim 7, the bag being a sanitary bag, in particular for medical use. Per the abstract of Bayne, the bag is used for human waste collection and disposal and is thus interpreted to be a sanitary bag for medical use. Regarding Claim 9, Bayne, Olson, and Huguenin teach the bag as claimed in Claim 7, but fails to specially teach that the bag is configured for the safe storage and/or transportation of food products. However, the examiner notes that per MPEP Section 2114 "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, as Bayne and Olson teach a plastic film bag with an aperture made of the film of claim 1, and use for storage/transportation of food is functional language that would reasonably be able to be performed by said bag, Bayne and Olson read to the claimed limitation. Regarding Claim 10, Bayne, Olson, and Huguenin teach the bag as claimed in Claim 7, but fail to specifically teach that the bag is configured for industrial use. However, the examiner notes that per MPEP Section 2114 "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, as Bayne and Olson teach a plastic film bag with an aperture made of the film of claim 1, and industrial use is functional language that would reasonably be able to be performed by said bag, Bayne and Olson read to the claimed limitation. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1-18 of U.S. Patent No. US 12594207, hereafter 207. Although the claims at issue are not identical, they are not patentably distinct from each other because: Instant Application Claim Corresponding Claim of US 12594207 1 1 2 See obviousness type double patenting below 3 3 4 See obviousness type double patenting below 5 2 6 3 7 1 8 1 9 1 10 1 Regarding claims 8-10, the instant claims recite an intended use of the device. Per MPEP Section 2114 "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, as the structure required by the claims is subject to a double patenting rejection (instant claims 1 and 7 and read to by claim 1 of 207) the intended use of the device would also be read to be claim 1 of 207. Claims 2 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12594207 in view of ULINE and ULINE2 as provided under the 103 rejections. Regarding Claim 2, while 207 is made from a plastic (per claim 1 of 207), it is not specifically stated that the film is translucent. The evidentiary ULINE reference depicts a bag, made from RIC #4 (evidenced by Leahy to be LDPE), that allows light through allowing the objects to be seen on this inside (in this case a paintbrush). Therefore, as ULINE evidences that LDPE bags are able to let light through to see objects within, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to make the bag of 207 translucent. Regarding Claim 4, while 207 is made from a plastic (per claim 1 of 207), it is not specifically stated that the film is transparent. The evidentiary ULINE2 reference depicts a bag, made from RIC #4 (evidenced by Leahy to be LDPE), is see-through, or transparent. Therefore, as ULINE2 evidences that LDPE bags are transparent, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to manufacture the LDPE bag of 207 to be transparent, as said property of bags is known in the art. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST. 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 at 571-270-5879. 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. /MATTHEW WRUBLESKI/Examiner, Art Unit 3781 /ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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Prosecution Timeline

Dec 13, 2024
Application Filed
Jul 30, 2026
Non-Final Rejection mailed — §102, §103, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
60%
Grant Probability
99%
With Interview (+59.4%)
3y 0m (~1y 4m remaining)
Median Time to Grant
Low
PTA Risk
Based on 112 resolved cases by this examiner. Grant probability derived from career allowance rate.

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