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
Applicant’s election of Group III, claims 11-17, in the reply filed on 08/07/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-10 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/07/2026.
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 11-17 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.
Claim 11 recites the limitation "the substrate" in 9. There is insufficient antecedent basis for this limitation in the claim. The prior lines of the claim do not recite a substrate.
Claim 11 recites the limitation “a cleansing matrix associated with the substrate and covering cleaning port or recess” and this limitation renders the claim unclear because it is unclear whether the cleaning port or recess is a positively recited structural element of the article, and it is unclear if the substrate comprises the cleaning port or recess.
In view of the forgoing, for the purpose of examination on the merits, the claim has been interpreted as covering a patentable single-use sanitizing article configured to sanitize a luer access device, optionally a needleless medical valve, or portion thereof, the article comprising: a. a container formed to provide a sealed internal cavity, wherein the container comprises an access port sealingly covered by a cover removably adhered or attached to an exterior portion of the container surrounding the access port that, when removed, allows access to the internal cavity of the container; and b. disposed in the internal cavity of the container, a sanitizing component comprising: (i) a cleansing matrix; (ii) a sanitizing reagent dispersed in the matrix; and, optionally (iii) a substrate associated with the cleansing matrix wherein the substrate comprises a cleaning port or recess which is covered by the cleansing matrix, wherein the article optionally is sterile.
Regarding claim 12, the limitation “wherein when the substrate is a naturally occurring material, the naturally occurring material is optionally a natural sponge, and wherein when the substrate is a synthetic material, the synthetic material is optionally selected from the group consisting of a fibrous composition, a foam, and a gel” renders the claim indefinite because the prior lines of the claim refer to a material of the cleansing matrix rather than the substrate. For the purpose of examination on the merits, the claim has been interpreted as covering “wherein when the cleansing matrix comprises a naturally occurring material, the naturally occurring material is optionally a natural sponge, and wherein when the cleansing matrix comprises a synthetic material, the synthetic material is optionally selected from the group consisting of a fibrous composition, a foam, and a gel.”
Dependent claims are rejected for the same reason(s) as the base claim(s) upon which they depend.
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 11-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ferlic (US Patent Application Publication 2017/0157386).
Regarding claim 11, Ferlic discloses a single use sanitizing article configured to sanitize a luer access device (Abstract, para. 17), the article comprising:
a container (1002) formed to provide a sealed inner cavity (para. 121-122), wherein the container comprises an access port sealingly covered by a cover (1006) removably attached to an exterior portion of the container surrounding the access port that, when removed, allows access to the internal cavity of the container (para. 121-122, 132-134) (Figs. 25-30, sheets 23-26 of 32); and
disposed in the internal cavity of the container, a sanitizing component (para. 121) comprising:
a cleansing matrix (para. 124-125); and
a sanitizing reagent dispersed in the matrix (para. 124-125).
As to the limitation of wherein the article is configured to sanitize optionally a needleless medical valve, or portion thereof, this limitation is optional and therefore does not introduce a patentable distinction over the prior art. Nonetheless, Ferlic discloses wherein the article is configured to sanitize a needleless medical valve (para. 127).
As to the limitation of wherein the sanitizing component comprises optionally a substrate associated with the cleansing matrix wherein the substrate comprises a cleaning port or recess which is covered by the cleansing matrix, this limitation is optional and therefore does not introduce a patentable distinction over the prior art.
As to the limitation of wherein the article is optionally sterile, this limitation is optional and therefore does not introduce a patentable distinction over the prior art. Nonetheless, Ferlic discloses wherein the article is sterile (para. 144).
Regarding claim 12, Ferlic discloses wherein the cleansing matrix comprises an absorbent material (para. 124), wherein the absorbent material is a natural sponge (para. 124).
Regarding claim 13, Ferlic discloses wherein the sanitizing reagent is a liquid formulation (para. 124). As to the limitation of optionally an aqueous solution, optionally a solution comprising an alcohol and water, optionally isopropyl alcohol and water, optionally 70% isopropyl alcohol and water, this limitation is optional and therefore does not introduce a patentable distinction over the prior art. Nonetheless, Ferlic discloses wherein the sanitizing reagent comprises isopropyl alcohol (para. 66) (understood to refer to a solution comprising isopropyl alcohol and water is notoriously well understood in the art).
Regarding claim 14, Ferlic discloses wherein the sanitizing reagent comprises at least one of alcohol, chlorhexidine, iodine, or silver (para. 66).
Regarding claim 15, Ferlic discloses wherein the container comprises a laminated foil (para. 135).
Regarding claim 16, the claim is directed to an outer surface of the container being labeled. Issues related to printed matter analysis can be found in MPEP 2111-2112. The Examiner asserts that the claim limitation of the outer surface of the container being labeled is not directed toward printed matter because the claimed labeling does not include the content of information. However, even if it should be found that the claim limitation is directed toward printed matter, the claim limitation is nonfunctional, as there is no functional relationship between the outer surface and the labeling. It has been held that nonfunctional printed matter does not distinguish a claimed product from an otherwise identical prior art product (MPEP 2112.01); therefore, introducing the feature of labeling would not introduce a patentable distinction over the prior art. Ferlic discloses the article according to claim 11, and the container has an outer surface (Fig. 25, sheet 23 of 32). Therefore, Ferlic fully meets claim 16.
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 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ferlic (US Patent Application Publication 2017/0157386) in view of Fangrow (US Patent Application Publication 2019/0282795).
Regarding claim 17, Ferlic discloses a single use sanitizing article configured to sanitize a luer access device (Abstract, para. 17), the article comprising:
a container (1002) formed to provide a sealed inner cavity (para. 121-122), wherein the container comprises an access port sealingly covered by a cover (1006) removably attached to an exterior portion of the container surrounding the access port that, when removed, allows access to the internal cavity of the container (para. 121-122, 132-134) (Figs. 25-30, sheets 23-26 of 32); and
disposed in the internal cavity of the container, a sanitizing component (para. 121) comprising:
a cleansing matrix (para. 124-125); and
a sanitizing reagent dispersed in the matrix (para. 124-125).
As to the limitation of wherein the article is configured to sanitize optionally a needleless medical valve, or portion thereof, this limitation is optional and therefore does not introduce a patentable distinction over the prior art. Nonetheless, Ferlic discloses wherein the article is configured to sanitize a needleless medical valve (para. 127).
As to the limitation of wherein the sanitizing component comprises optionally a substrate associated with the cleansing matrix wherein the substrate comprises a cleaning port or recess which is covered by the cleansing matrix, this limitation is optional and therefore does not introduce a patentable distinction over the prior art.
As to the limitation of wherein the article is optionally sterile, this limitation is optional and therefore does not introduce a patentable distinction over the prior art. Nonetheless, Ferlic discloses wherein the article is sterile (para. 144).
Therefore, Ferlic discloses the article according to claim 11.
Ferlic discloses, in an adjacent embodiment, a package comprising a sanitizing article configured to sanitize a luer access device (Abstract, para. 112-116) (Fig. 24, sheet 22 of 32), wherein the package is configured to maintain the article in a sterile environment until it is needed by a user (para. 116).
Ferlic is silent as to a package comprising a plurality of the articles according to claim 11.
Fangrow discloses a package comprising a plurality of articles (para. 154), each of the articles comprising an article for sanitizing a luer access device (para. 9). Fangrow discloses that the package is configured to protect the articles from contamination (para. 177) and is further configured to dispense one article at a time to a user (para. 157).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the invention disclosed by Ferlic to comprise a package comprising a plurality of the articles, as Fangrow discloses that it was known in the art to provide a package containing a plurality of luer-sanitizing articles wherein the package protects the articles from contamination and dispenses one article at a time, and the skilled artisan would have been motivated to allow for the dispensing of one or more articles as needed by a user.
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 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-13, 15, and 17 of U.S. Patent No. 11,369,783. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 11, claim 10 of the reference patent recites:
“A patentable single-use sanitizing article configured to sanitize a luer access device, optionally a needleless medical valve, or portion thereof, the article comprising:
a. a laminated foil container formed to provide a sealed internal cavity, wherein the laminated foil container comprises an access port sealingly covered by a cover removably adhered or attached to an exterior portion of the laminated foil container surrounding the access port such that when the cover is removed the access port allows access to the internal cavity of the laminated foil container; and
b. disposed in the internal cavity and accessible via the access port, a sanitizing component comprising:
(i) a cleansing matrix;
(ii) a sanitizing reagent dispersed in the cleansing matrix; and
(iii) a substrate associated with the cleansing matrix, wherein the substrate comprises a cleaning port or recess that is alignable with the access port of the laminated foil container and wherein at least a portion of the cleansing matrix is disposed between the container's access port and the substrate's cleaning port or recess, wherein the substrate's cleaning port or recess is sized to accommodate a portion of the cleansing matrix and a valve portion of a needleless medical valve when the valve portion of the needleless medical valve is in sanitizing association with the cleansing matrix during a sanitizing operation.”
Regarding claim 12, claim 11 of the reference patent recites “wherein the cleansing matrix comprises an absorbent material selected from the group consisting of a naturally occurring material and a synthetic material, wherein when the cleansing matrix is a naturally occurring material, the naturally occurring material is optionally a natural sponge, and wherein when the cleansing matrix is a synthetic material, the synthetic material is optionally selected from the group consisting of a fibrous composition, a foam, and a gel.”
Regarding claim 13, claim 12 of the reference patent recites “wherein the sanitizing reagent is a liquid formulation, optionally an aqueous solution, optionally a solution comprising an alcohol and water, optionally isopropyl alcohol and water, optionally 70% isopropyl alcohol and water”.
Regarding claim 14, claim 13 of the reference patent recites: “wherein the sanitizing reagent comprises one or more sanitizing compounds selected from the group consisting of an alcohol, chlorhexidine, hydrogen peroxide, iodine, silver ions, and a combination of any two or more of the foregoing”.
Regarding claim 15, claim 10 of the reference patent recites “a laminated foil container”.
Regarding claim 16, claim 15 of the reference patent recites “wherein an outer surface of the laminated foil container is labeled”.
Regarding claim 17, claim 17 of the reference patent recites “A package comprising a plurality of articles” of claim 10, wherein the article according to claim 10 reads on the article of claim 11 of the instant application as set forth above.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lynn (US Patent Application Publication 2008/0038167) is directed to a luer sanitizing device in the form of a pouch.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY KIPOUROS whose telephone number is (571)272-0658. The examiner can normally be reached M-F 8.30-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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